Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1696589536854.pdf (United States)
247d), and the provision of such serv- ices as part of the public health and medical response to such an emergency, consistent with title XXVIII of such Act (42 U.S.C.

300hh et seq.

), including related to the capacity of the mental health and substance use disorder workforce and flexibilities provided to awardees of mental health and substance use disorder programs.
(e) GAO REPORT.—Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on programs and activities of the Substance Abuse and Mental Health Services Admin- istration to support the provision of mental health and substance use disorder services and related activities dur- ing the COVID–19 pandemic, including the provision of such services as part of the medical and public health re- sponse to such pandemic.
Such report shall— (1) examine the role played by the advisory councils described in section 502 of the Public Health Service Act (42 U.S.C.

290aa–1) and the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3239 National Mental Health and Substance Use Policy Laboratory established under section 501A of such Act (42 U.S.C.
290aa–0) in providing technical as- sistance and recommendations to the Substance Abuse and Mental Health Services Administration to support the response of such agency to the public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C.
247d) with re- spect to COVID–19; (2) describe the manner in which existing awardees of mental health and substance use dis- order programs provided and altered delivery of services during such public health emergency, includ- ing information on the populations served by such awardees and any barriers faced in delivering serv- ices; and (3) describe activities of the Substance Abuse and Mental Health Services Administration to sup- port the response to such public health emergency, including through technical assistance, provision of services, and any flexibilities provided to such exist- ing awardees, and any barriers faced in imple- menting such activities.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3240 SEC.

2113.

TRAUMA CARE REAUTHORIZATION.

(a) IN GENERAL.—Section 1201 of the Public Health Service Act (42 U.S.C.
300d) is amended— (1) in subsection (a)— (A) in paragraph (3)— (i) by inserting ‘‘analyze,’’ after ‘‘com- pile,’’; and (ii) by inserting ‘‘and medically under- served areas’’ before the semicolon; (B) in paragraph (4), by adding ‘‘and’’ after the semicolon; (C) by striking paragraph (5); and (D) by redesignating paragraph (6) as paragraph (5); (2) by redesignating subsection (b) as sub- section (c); and (3) by inserting after subsection (a) the fol- lowing: ‘‘(b) TRAUMA CARE READINESS AND COORDINA- TION.—The Secretary, acting through the Assistant Sec- retary for Preparedness and Response, shall support the efforts of States and consortia of States to coordinate and improve emergency medical services and trauma care dur- ing a public health emergency declared by the Secretary pursuant to section 319 or a major disaster or emergency declared by the President under section 401 or 501, re- 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3241 spectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act.
Such support may include— ‘‘(1) developing, issuing, and updating guid- ance, as appropriate, to support the coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care; ‘‘(2) disseminating, as appropriate, information on evidence-based or evidence-informed trauma care practices, taking into consideration emergency med- ical services and trauma care systems, including such practices identified through activities conducted under subsection (a) and which may include the identification and dissemination of performance metrics, as applicable and appropriate; and ‘‘(3) other activities, as appropriate, to optimize a coordinated and flexible approach to the emer- gency response and medical surge capacity of hos- pitals, other health care facilities, critical care, and emergency medical systems.’’.
(b) GRANTS TO IMPROVE TRAUMA CARE IN RURAL AREAS.—Section 1202 of the Public Health Service Act (42 U.S.C.

300d–3) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3242 (1) by amending the section heading to read as follows: ‘‘GRANTS TO IMPROVE TRAUMA CARE IN RURAL AREAS’’; (2) by amending subsections (a) and (b) to read as follows: ‘‘(a) IN GENERAL.—The Secretary shall award grants to eligible entities for the purpose of carrying out research and demonstration projects to support the im- provement of emergency medical services and trauma care in rural areas through the development of innovative uses of technology, training and education, transportation of seriously injured patients for the purposes of receiving such emergency medical services, access to prehospital care, evaluation of protocols for the purposes of improve- ment of outcomes and dissemination of any related best practices, activities to facilitate clinical research, as appli- cable and appropriate, and increasing communication and coordination with applicable State or Tribal trauma sys- tems.
‘‘(b) ELIGIBLE ENTITIES.— ‘‘(1) IN GENERAL.—To be eligible to receive a grant under this section, an entity shall be a public or private entity that provides trauma care in a rural area.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3243 ‘‘(2) PRIORITY.—In awarding grants under this section, the Secretary shall give priority to eligible entities that will provide services under the grant in any rural area identified by a State under section 1214(d)(1).’’; and (3) by adding at the end the following: ‘‘(d) REPORTS.—An entity that receives a grant under this section shall submit to the Secretary such re- ports as the Secretary may require to inform administra- tion of the program under this section.’’.
(c) COMPETITIVE GRANTS FOR TRAUMA CENTERS.— Section 1204 of the Public Health Service Act (42 U.S.C.
300d–6) is amended— (1) by amending the section heading to read as follows: ‘‘COMPETITIVE GRANTS FOR TRAUMA CENTERS’’; (2) in subsection (a)— (A) by striking ‘‘that design, implement, and evaluate’’ and inserting ‘‘to design, imple- ment, and evaluate new or existing’’; (B) by striking ‘‘emergency care’’ and in- serting ‘‘emergency medical’’; and (C) by inserting ‘‘, and improve access to trauma care within such systems’’ before the period; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3244 (3) in subsection (b)(1), by striking subpara- graphs (A) and (B) and inserting the following: ‘‘(A) a State or consortia of States; ‘‘(B) an Indian Tribe or Tribal organiza- tion (as defined in section 4 of the Indian Self- Determination and Education Assistance Act); ‘‘(C) a consortium of level I, II, or III trauma centers designated by applicable State or local agencies within an applicable State or region, and, as applicable, other emergency services providers; or ‘‘(D) a consortium or partnership of non- profit Indian Health Service, Indian Tribal, and urban Indian trauma centers.’’; (4) in subsection (c)— (A) in the matter preceding paragraph (1)— (i) by striking ‘‘that proposes a pilot project’’; (ii) by striking ‘‘an emergency medical and trauma system that—’’ and inserting ‘‘a new or existing emergency medical and trauma system.
Such eligible entity shall use amounts awarded under this sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3245 section to carry out 2 or more of the fol- lowing activities:’’; (B) in paragraph (1) — (i) by striking ‘‘coordinates’’ and in- serting ‘‘Strengthening coordination and communication’’; and (ii) by striking ‘‘an approach to emer- gency medical and trauma system access throughout the region, including 9–1–1 Public Safety Answering Points and emer- gency medical dispatch;’’ and inserting ‘‘approaches to improve situational aware- ness and emergency medical and trauma system access.’’; (C) in paragraph (2)— (i) by striking ‘‘includes’’ and insert- ing ‘‘Providing’’; (ii) by inserting ‘‘support patient movement to’’ after ‘‘region to’’; and (iii) by striking the semicolon and in- serting a period; (D) in paragraph (3)— (i) by striking ‘‘allows for’’ and insert- ing ‘‘Improving’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3246 (ii) by striking ‘‘; and’’ and inserting a period; (E) in paragraph (4), by striking ‘‘includes a consistent’’ and inserting ‘‘Supporting a con- sistent’’; and (F) by adding at the end the following: ‘‘(5) Establishing, implementing, and dissemi- nating, or utilizing existing, as applicable, evidence- based or evidence-informed practices across facilities within such emergency medical and trauma system to improve health outcomes, including such practices related to management of injuries, and the ability of such facilities to surge.
‘‘(6) Conducting activities to facilitate clinical research, as applicable and appropriate.’’; (5) in subsection (d)(2)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking ‘‘the proposed’’ and inserting ‘‘the applicable emergency medical and trauma system’’; (ii) in clause (i), by inserting ‘‘or Tribal entity’’ after ‘‘equivalent State of- fice’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3247 (iii) in clause (vi), by striking ‘‘; and’’ and inserting a semicolon; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: ‘‘(B) for eligible entities described in sub- paragraph (C) or (D) of subsection (b)(1), a de- scription of, and evidence of, coordination with the applicable State Office of Emergency Med- ical Services (or equivalent State Office) or ap- plicable such office for a Tribe or Tribal organi- zation; and’’; (6) in subsection (e), by adding at the end the following: ‘‘(3) EFFECTIVE DATE.—The matching require- ment described in paragraph (1) shall take effect on October 1, 2025.’’; (7) in subsection (f), by striking ‘‘population in a medically underserved area’’ and inserting ‘‘medi- cally underserved population’’; (8) in subsection (g)— (A) in the matter preceding paragraph (1), by striking ‘‘described in’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3248 (B) in paragraph (2), by striking ‘‘the sys- tem characteristics that contribute to’’ and in- serting ‘‘opportunities for improvement, includ- ing recommendations for how to improve’’; (C) by striking paragraph (4); (D) by redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively; (E) in paragraph (4), as so redesignated, by striking ‘‘; and’’ and inserting a semicolon; (F) in paragraph (5), as so redesignated, by striking the period and inserting ‘‘; and’’; and (G) by adding at the end the following: ‘‘(6) any evidence-based or evidence-informed strategies developed or utilized pursuant to sub- section (c)(5).’’; and (9) by amending subsection (h) to read as fol- lows: ‘‘(h) DISSEMINATION OF FINDINGS.—Not later than 1 year after the completion of the final project under sub- section (a), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the informa- tion contained in each report submitted pursuant to sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3249 section (g) and any additional actions planned by the Sec- retary related to regionalized emergency care and trauma systems.’’.

(d) PROGRAM FUNDING.—Section 1232(a) of the Public Health Service Act (42 U.S.C.

300d–32(a)) is amended by striking ‘‘2010 through 2014’’ and inserting ‘‘2023 through 2027’’.

SEC.

2114.

ASSESSMENT OF CONTAINMENT AND MITIGA- TION OF INFECTIOUS DISEASES.
(a) GAO STUDY.—The Comptroller General of the United States shall conduct a study that reviews a geo- graphically diverse sample of States and territories that, in response to the COVID–19 pandemic, implemented pre- paredness and response plans that included isolation and quarantine recommendations or requirements.
Such study shall include— (1) a review of such State and territorial pre- paredness and response plans in place during the COVID–19 pandemic, an assessment of the extent to which such plans facilitated or presented chal- lenges to State and territorial responses to such public health emergency, including response activi- ties relating to isolation and quarantine to prevent the spread of COVID–19; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3250 (2) a description of the technical assistance pro- vided by the Federal Government to help States and territories facilitate such response activities during responses to relevant public health emergencies de- clared by the Secretary of Health and Human Serv- ices pursuant to section 319 of the Public Health Service Act, including the public health emergency with respect to COVID–19, and a review of the de- gree to which such State and territorial plans were implemented and subsequently revised in response to the COVID–19 pandemic to address any challenges.
(b) REPORT.—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit a report on the study under subsection (a) to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Rep- resentatives.

19 SEC.

2115.

CONSIDERATION OF UNIQUE CHALLENGES IN NONCONTIGUOUS STATES AND TERRITORIES.
During any public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C.

247d), the Secretary of Health and Human Services shall conduct quarterly meetings or consultations, as applicable or appropriate, with noncontiguous States and territories December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3251 with regard to addressing unique public health challenges in such States and territories associated with such public health emergency.
Subtitle Public B—Improving Health Preparedness and Re- sponse Capacity CHAPTER 1—IMPROVING PUBLIC HEALTH EMERGENCY RESPONSES SEC.

2201.

ADDRESSING FACTORS RELATED TO IMPROVING HEALTH OUTCOMES.

(a) IN GENERAL.—Part B of title III of the Public Health Service Act (42 U.S.C.

243 et seq.)

is amended— (1) by inserting after section 317U the fol- lowing: ‘‘SEC.

317V.

ADDRESSING FACTORS RELATED TO IMPROV- ING HEALTH OUTCOMES.
‘‘(a) IN GENERAL.—The Secretary may, as appro- priate, award grants, contracts, or cooperative agreements to eligible entities for the conduct of evidence-based or evi- dence-informed projects, which may include the develop- ment of networks to improve health outcomes by improv- ing the capacity of such entities to address factors that contribute to negative health outcomes in communities.
‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive an award under this section, an entity shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3252 ‘‘(1)(A) be a State, local, or Tribal health de- partment, community-based organization, Indian Tribe or Tribal organization (as such terms are de- fined in section 4 of the Indian Self-Determination and Education Assistance Act), urban Indian orga- nization (as defined in section 4 of the Indian Health Care Improvement Act), or other public or private entity, as the Secretary determines appro- priate; or ‘‘(B) be a consortia of entities described in sub- paragraph (A) or a public-private partnership, in- cluding a community partnership; ‘‘(2) submit to the Secretary an application at such time, in such manner, and containing such in- formation as the Secretary shall require; ‘‘(3) in the case of an entity other than a com- munity-based organization, demonstrate a history of successfully working with an established community- based organization to address health outcomes; and ‘‘(4) submit a plan to conduct activities de- scribed in subsection (a) based on a community needs assessment that takes into account community input.
‘‘(c) USE OF FUNDS.—An entity described in sub- section (b) shall use funds received under subsection (a), December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3253 in consultation with State, local, and Tribal health depart- ments, community-based organizations, entities serving medically underserved communities, and other entities, as applicable, for one or more of the following purposes: ‘‘(1) Supporting the implementation, evaluation, and dissemination of strategies, through evidence-in- formed or evidence-based programs and through the support and use of public health and health care professionals to address factors related to health outcomes.
‘‘(2) Establishing, maintaining, or improving, in consultation with State, local, or Tribal health de- partments, technology platforms or networks to sup- port, in a manner that is consistent with applicable Federal and State privacy law— ‘‘(A) coordination among appropriate enti- ties, and, as applicable and appropriate, activi- ties to improve such coordination; ‘‘(B) information sharing on health and re- lated social services; and ‘‘(C) technical assistance and related sup- port for entities participating in the platforms or networks.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3254 ‘‘(3) Implementing best practices for improving health outcomes and reducing disease among under- served populations.

‘‘(4) Supporting consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, research, and other relevant activities.
‘‘(d) BEST PRACTICES AND TECHNICAL ASSIST- ANCE.—The Secretary, in consultation with the Director of the Office of Minority Health, the National Coordinator for Health Information Technology, and the Adminis- trator of the Administration for Community Living, may award grants, contracts, and cooperative agreements to public or nonprofit private entities, including minority serving institutions (defined, for purposes of this sub- section, as institutions and programs described in section 326(e)(1) of the Higher Education Act of 1965 and insti- tutions described in section 371(a) of such Act of 1965), to— ‘‘(1) identify or facilitate the development of best practices to support improved health outcomes for underserved populations; ‘‘(2) provide technical assistance, training, and evaluation assistance to award recipients under sub- section (a); December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3255 ‘‘(3) disseminate best practices, including to award recipients under subsection (a); and ‘‘(4) leverage, establish, or operate regional cen- ters to develop, evaluate, and disseminate effective strategies on factors related to health outcomes, in- cluding supporting research and training related to such strategies.
‘‘(e) AWARD PERIODS.—The Secretary shall issue awards under this section for periods of not more than 5 years and may issue extensions of such award periods for an additional period of up to 3 years.

‘‘(f) REPORT.—Not later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes information on ac- tivities funded under this section.
Such report shall in- clude a description of— ‘‘(1) changes in the capacity of public health entities to address factors related to health outcomes in communities, including any applicable platforms or networks developed or utilized to coordinate health and related social services and any changes in workforce capacity or capabilities; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3256 ‘‘(2) improvements in health outcomes and in reducing health disparities in medically underserved communities; ‘‘(3) activities conducted to support consider- ation of factors related to health outcomes in pre- paring for, and responding to, public health emer- gencies, through outreach, education, and other rel- evant activities; ‘‘(4) communities and populations served by re- cipients of awards under subsection (a); ‘‘(5) activities supported under subsection (e); and ‘‘(6) other relevant activities and outcomes, as determined by the Secretary.
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appro- priated $35,000,000 for each of fiscal years 2023 through 2027.
Of the amounts appropriated under this subsection for a fiscal year, 5 percent shall be reserved for awards under subsection (a) to Indian Tribes and Tribal organiza- tions (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), urban Indian organizations (as defined in section 4 of the Indian Health Care Improvement Act), and Tribal health depart- ments.’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3257 (2) by striking section 330D (42 U.S.C.

254c– 4).
(b) GAO STUDY AND REPORT.—Not later than 4 years after the date of enactment of this Act, the Comp- troller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Energy and Committee on Energy and Commerce of the House of Representatives a report on the program authorized under section 317V of the Public Health Service Act, as added by subsection (a), including a review of the outcomes and effectiveness of the program and coordination with other programs in the Department of Health and Human Services with similar goals to en- sure that there was no unnecessary duplication of efforts.
CHAPTER 2—IMPROVING STATE, LOCAL, AND TRIBAL PUBLIC HEALTH DATA SEC.

2211.

MODERNIZING STATE, LOCAL, AND TRIBAL BIO- SURVEILLANCE CAPABILITIES AND INFEC- TIOUS DISEASE DATA.

Section 319D of the Public Health Service Act (42 U.S.C.

247d–4) is amended— 22 23 24 (1) in subsection (a)(3)— (A) in the matter that precedes subpara- graph (A), by striking ‘‘.

Activities’’ and all December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3258 that follows through ‘‘include’’ and inserting ‘‘, by’’; and (B) in subparagraph (D), by inserting ‘‘, infectious disease outbreaks,’’ after ‘‘bioter- rorism’’; (2) in subsection (b)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking ‘‘, and local’’ and inserting ‘‘, local, and Tribal’’; and (II) by adding ‘‘and’’ after the semicolon; (ii) in subparagraph (B), by striking ‘‘; and’’ and inserting ‘‘;’’; and (iii) by striking subparagraph (C); and (B) in paragraph (2)— (i) by inserting ‘‘, deidentified’’ before ‘‘information’’; and (ii) by adding at the end the fol- lowing: ‘‘The Secretary shall ensure that the activities carried out pursuant to the previous sentence are conducted in a man- ner that protects personal privacy, to the extent required by applicable Federal and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3259 State information privacy or security law, at a minimum.’’; (3) in subsection (c)— (A) in paragraph (1)— (i) by inserting ‘‘modernize,’’ after ‘‘establish,’’; (ii) by inserting ‘‘that is deidentified, as applicable,’’ after ‘‘share data and infor- mation’’; (iii) by inserting ‘‘, to the extent prac- ticable’’ before the period of the second sentence; and (iv) by adding at the end the fol- lowing: ‘‘The Secretary shall ensure that the activities carried out pursuant to this paragraph are conducted in a manner that protects personal privacy, to the extent re- quired by applicable Federal and State in- formation privacy or security law, at a minimum.’’; (B) in paragraph (3)— (i) in subparagraph (A)— (I) in clause (iii), by adding ‘‘and’’ after the semicolon; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3260 (II) in clause (iv), by striking ‘‘; and’’ and inserting a period; and (III) by striking clause (v); and (ii) in subparagraph (B), by inserting ‘‘, and make recommendations to improve the quality of data collected pursuant to subparagraph (A) to ensure complete, ac- curate, and timely sharing of such data, as appropriate, across such elements as de- scribed in subparagraph (A)’’ after ‘‘under subparagraph (A)’’; (C) in paragraph (5)— (i) in subparagraph (A)— (I) in the matter preceding clause (i), by striking ‘‘and operating’’ and inserting ‘‘, operating, and updating, as appropriate,’’; (II) in clause (iii)— (aa) by inserting ‘‘that is deidentified, as applicable,’’ after ‘‘analyses’’; and (bb) by inserting ‘‘in accord- ance with applicable Federal and State privacy and security law’’ before the semicolon at the end; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3261 (III) in clause (iv), by striking ‘‘and’’ at the end; (IV) in clause (v), by striking the period and inserting ‘‘; and’’; and (V) by adding at the end the fol- lowing: ‘‘(vi) in collaboration with State, local, and Tribal public health officials, integrate and update applicable existing public health data systems and networks of the Department of Health and Human Serv- ices to reflect technological advancements, consistent with section 2823, as applica- ble.’’; and (ii) in subparagraph (B)— (I) in clause (i), by inserting ‘‘and 180 days after the date of enact- ment of the PREVENT Pandemics Act,’’ after ‘‘Innovation Act of 2019,’’; (II) in clause (ii), by striking ‘‘and other representatives as the Sec- retary determines appropriate’’ and inserting ‘‘experts in State-based pub- lic health data systems; experts in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3262 standards and implementation speci- fications, including transaction stand- ards; and experts in privacy and data security’’; and (III) in clause (iii)— (aa) in subclause (IV), by inserting ‘‘, including existing public health data systems’’ be- fore the semicolon; (bb) in subclause (V), by striking ‘‘and’’ at the end; (cc) in subclause (VI), by striking the period and inserting a semicolon; and (dd) by adding at the end the following: ‘‘(VII) strategies to integrate lab- oratory and public health data sys- tems and capabilities to support rapid and accurate reporting of laboratory test results and associated relevant data; ‘‘(VIII) strategies to improve the collection, reporting, and dissemina- tion of relevant, aggregated, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3263 deidentified demographic data to in- form responses to public health emer- gencies, including identification of at- risk populations and to address poten- tial health disparities; and ‘‘(IX) strategies to improve the electronic exchange of health informa- tion, as appropriate, between State and local health departments and health care providers and facilities to improve the detection of, and re- sponses to, potentially catastrophic in- fectious disease outbreaks.’’; (D) in paragraph (6)(A)— (i) in the matter preceding clause (i), by inserting ‘‘and every 5 years there- after,’’ after ‘‘Innovation Act of 2019,’’ (ii) in clause (iii)— (I) in subclause (III), by striking ‘‘and’’ at the end; and (II) by adding at the end the fol- lowing: ‘‘(V) improve coordination and collaboration, as appropriate, with other Federal departments to improve December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3264 the capabilities of the network and re- duce administrative burden on State, local, and Tribal entities; and ‘‘(VI) implement applicable les- sons learned from recent public health emergencies to address gaps in situa- tional awareness and biosurveillance capabilities;’’; (iii) in clause (iv), by striking ‘‘and’’ at the end; (iv) in clause (v), by striking the pe- riod and inserting ‘‘, including a descrip- tion of how such steps will further the goals of the network, consistent with para- graph (1); and’’; and (v) by adding at the end the following: ‘‘(vi) identifies and demonstrates measurable steps the Secretary will take to further develop and integrate infectious disease detection, support rapid, accurate, and secure sharing of laboratory test re- sults, deidentified as appropriate, during a public health emergency, and improve co- ordination and collaboration with State, local, and Tribal public health officials, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3265 clinical laboratories, and other entities with expertise in public health surveillance.’’; and (E) by adding at the end the following: ‘‘(9) RULES OF CONSTRUCTION.— ‘‘(A) Nothing in this subsection shall be construed to supplant, in whole or in part, State, local, or Tribal activities or responsibil- ities related to public health surveillance.
‘‘(B) Nothing in this subsection shall be construed to alter the authority of the Secretary with respect to the types of data the Secretary may receive through systems supported or es- tablished under this section.’’; (4) in subsection (d)— (A) in paragraph (2)— (i) in subparagraph (A)— (I) by inserting ‘‘deidentified’’ before ‘‘data, information’’; and (II) by inserting ‘‘, in consulta- tion with such State or consortium of States’’ before the semicolon; (ii) in subparagraph (C), by inserting ‘‘, including any public-private partner- ships or other partnerships entered into to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3266 improve such capacity’’ before the semi- colon; and (B) by adding at the end the following: ‘‘(6) NON-DUPLICATION OF EFFORT.—The Sec- retary shall ensure that activities carried out under an award under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the Department of Health and Human Services.’’; (5) by striking subsection (e); (6) by redesignating subsections (f), (g), (h), (i), and (j), as subsections (e), (f), (g), (h), and (i), respectively; (7) by striking subsection (h), as redesignated by paragraph (6), and inserting the following: ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated— ‘‘(1) to carry out subsection (a), $25,000,000 for each of fiscal years 2022 and 2023; and ‘‘(2) to carry out subsections (b), (c), and (d), $136,800,000 for each of fiscal years 2022 and 2023.’’; and (8) by striking ‘‘tribal’’ each place it appears and inserting ‘‘Tribal’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3267 SEC.

2212.

GENOMIC SEQUENCING, ANALYTICS, AND PUB- LIC HEALTH SURVEILLANCE OF PATHOGENS.
(a) GUIDANCE SUPPORTING GENOMIC SEQUENCING OF PATHOGENS COLLABORATION.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), in consultation with the heads of other Federal departments or agencies, as appropriate, shall issue guidance to support collaboration relating to genomic sequencing of pathogens, including the use of new and innovative approaches and technology for the detec- tion, characterization, and sequencing of pathogens, to im- prove public health surveillance and preparedness and re- sponse activities, consistent with section 2824 of the Pub- lic Health Service Act, as added by subsection (b).
Such guidance shall address the secure sharing, for public health surveillance purposes, of specimens of such patho- gens, between appropriate entities and public health au- thorities, consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C.
1320d–2 note), as applicable, and in a manner that protects personal pri- vacy to the extent required by applicable privacy law, at a minimum, and the appropriate use of sequence data de- 24 rived from such specimens.

25 26 (b) GENOMIC SEQUENCING PROGRAM.—Title XXVIII of the Public Health Service Act (42 U.S.C.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3268 300hh et seq.)

is amended by adding at the end the fol- lowing: ‘‘SEC.

2824.
2824.

GENOMIC SEQUENCING, ANALYTICS, AND PUB- LIC HEALTH SURVEILLANCE OF PATHOGENS PROGRAM.
‘‘(a) GENOMIC SEQUENCING, ANALYTICS, AND PUB- LIC HEALTH SURVEILLANCE OF PATHOGENS PRO- GRAM.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in con- sultation with the Director of the National Institutes of Health and heads of other departments and agencies, as appropriate, shall strengthen and expand activities related to genomic sequencing of pathogens, including through new and innovative approaches and technology for the de- tection, characterization, and sequencing of pathogens, analytics, and public health surveillance, including— ‘‘(1) continuing and expanding activities, which may include existing genomic sequencing activities related to advanced molecular detection, to— ‘‘(A) identify and respond to emerging in- fectious disease threats; and ‘‘(B) identify the potential use of genomic sequencing technologies, advanced computing, and other advanced technology to inform sur- veillance activities and incorporate the use of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3269 such technologies, as appropriate, into related activities; ‘‘(2) providing technical assistance and guid- ance to State, Tribal, local, and territorial public health departments to increase the capacity of such departments to perform genomic sequencing of pathogens, including recipients of funding under sec- tion 2821; ‘‘(3) carrying out activities to enhance the capa- bilities of the public health workforce with respect to pathogen genomics, epidemiology, and bioinformatics, including through training; and ‘‘(4) continuing and expanding activities, as ap- plicable, with public and private entities, including relevant departments and agencies, laboratories, aca- demic institutions, and industry.
‘‘(b) PARTNERSHIPS.—For the purposes of carrying out the activities described in subsection (a), the Sec- retary, acting through the Director of the Centers for Dis- ease Control and Prevention, may award grants, contracts, or cooperative agreements to entities, including academic and other laboratories, with expertise in genomic sequenc- ing for public health purposes, including new and innova- tive approaches to, and related technology for, the detec- tion, characterization, and sequencing of pathogens.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3270 ‘‘(c) CENTERS OF EXCELLENCE.— ‘‘(1) IN GENERAL.—The Secretary shall, as ap- propriate, award grants, contracts, or cooperative agreements to public health agencies for the estab- lishment or operation of centers of excellence to pro- mote innovation in pathogen genomics and molecular epidemiology to improve the control of and response to pathogens that may cause a public health emer- gency.
Such centers shall, as appropriate— ‘‘(A) identify and evaluate the use of genomics, or other related technologies that may advance public health preparedness and re- sponse; ‘‘(B) improve the identification, develop- ment, and use of tools for integrating and ana- lyzing genomic and epidemiologic data; ‘‘(C) assist with genomic surveillance of, and response to, infectious diseases, including analysis of pathogen genomic data; ‘‘(D) conduct applied research to improve public health surveillance of, and response to, infectious diseases through innovation in patho- gen genomics and molecular epidemiology; and ‘‘(E) develop and provide training mate- rials for experts in the fields of genomics, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3271 microbiology, bioinformatics, epidemiology, and other fields, as appropriate.
‘‘(2) REQUIREMENTS.—To be eligible for an award under paragraph (1), an entity shall submit to the Secretary an application containing such in- formation as the Secretary may require, including a description of how the entity will partner, as applica- ble, with academic institutions or a consortium of academic partners that have relevant expertise, such as microbial genomics, molecular epidemiology, or the application of bioinformatics or statistics.’’.
(c) REPORT TO CONGRESS.—Not later than 90 days after the date of enactment of the PREVENT Pandemics Act, and 90 days following expenditure of all funds under section 2402 of the American Rescue Plan Act of 2021 (Public Law 117–2), the Director of the Centers for Dis- ease Control and Prevention shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives outlining how funds awarded under such section 2402 were expended as of the date of such report.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3272 SEC.

2213.

SUPPORTING STATE, LOCAL, AND TRIBAL PUB- LIC HEALTH DATA.

(a) DESIGNATION OF PUBLIC HEALTH DATA STAND- ARDS.—Section 2823(a)(2) of the Public Health Service Act (42 U.S.C.
300hh–33(a)(2)) is amended— (1) by striking ‘‘In carrying out’’ and inserting the following: ‘‘(A) IN GENERAL.—In carrying out’’; and (2) by striking ‘‘shall, as appropriate and’’ and inserting ‘‘shall, not later than 2 years after the date of enactment of the PREVENT Pandemics Act,’’; and (3) by adding at the end the following: ‘‘(B) NO DUPLICATIVE EFFORTS.— ‘‘(i) IN GENERAL.—In carrying out the requirements of this paragraph, the Secretary, in consultation with the Office of the National Coordinator for Health In- formation Technology, may use input gath- ered (including input and recommendations gathered from the Health Information Technology Advisory Committee), and ma- terials developed, prior to the date of en- actment of the PREVENT Pandemics Act.
‘‘(ii) DESIGNATION OF STANDARDS.— Consistent with sections 13111 and 13112 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3273 of the HITECH Act, the data and tech- nology standards designated pursuant to this paragraph shall align with the stand- ards and implementation specifications previously adopted by the Secretary pursu- ant to section 3004, as applicable.
‘‘(C) PRIVACY AND SECURITY.—Nothing in this paragraph shall be construed as modifying applicable Federal or State information privacy or security law.’’.
(b) STUDY ON LABORATORY INFORMATION STAND- ARDS.— (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Office of the National Coordinator for Health Information Tech- nology shall conduct a study to review the use of standards for electronic ordering and reporting of laboratory test results.
(2) AREAS OF CONCENTRATION.—In conducting the study under paragraph (1), the Office of the Na- tional Coordinator for Health Information Tech- nology shall— (A) determine the extent to which clinical laboratories are using standards for electronic December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3274 ordering and reporting of laboratory test re- sults; (B) assess trends in laboratory compliance with standards for ordering and reporting lab- oratory test results and the effect of such trends on the interoperability of laboratory data with public health data systems; (C) identify challenges related to collection and reporting of demographic and other data elements with respect to laboratory test results; (D) identify any challenges associated with using or complying with standards and report- ing laboratory test results with data elements identified in standards for electronic ordering and reporting of such results; and (E) review other relevant areas determined appropriate by the Office of the National Coor- dinator for Health Information Technology.
(3) REPORT.—Not later than 2 years after the date of enactment of this Act, the Office of the Na- tional Coordinator for Health Information Tech- nology shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3275 findings of the study conducted under paragraph (1).
(c) DATA USE AGREEMENTS.— (1) INTERAGENCY DATA USE AGREEMENTS WITHIN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR PUBLIC HEALTH EMERGENCIES.— (A) IN GENERAL.—The Secretary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’) shall, as appro- priate, facilitate the development of, or updates to, memoranda of understanding, data use agreements, or other applicable interagency agreements regarding appropriate access, ex- change, and use of public health data between the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Pre- paredness and Response, other relevant agen- cies or offices within the Department of Health and Human Services, and other relevant Fed- eral agencies, in order to prepare for, identify, monitor, and respond to declared or potential public health emergencies.
(B) REQUIREMENTS.—In carrying out ac- tivities pursuant to subparagraph (A), the Sec- retary shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3276 (i) ensure that the agreements and memoranda of understanding described in such subparagraph— (I) address the methods of grant- ing access to data held by one agency or office with another to support the respective missions of such agencies or offices; (II) consider minimum necessary principles of data sharing for appro- priate use; (III) include appropriate privacy and cybersecurity protections; and (IV) are subject to regular up- dates, as appropriate; (ii) collaborate with the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Prepared- ness and Response, the Office of the Chief Information Officer, and, as appropriate, the Office of the National Coordinator for Health Information Technology, and other entities within the Department of Health and Human Services; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3277 (iii) consider the terms and conditions of any existing data use agreements with other public or private entities and any need for updates to such existing agree- ments, consistent with paragraph (2).
(2) DATA USE AGREEMENTS WITH EXTERNAL ENTITIES.—The Secretary, acting through the Di- rector of the Centers for Disease Control and Pre- vention and the Assistant Secretary for Prepared- ness and Response, may update memoranda of un- derstanding, data use agreements, or other applica- ble agreements and contracts to improve appropriate access, exchange, and use of public health data be- tween the Centers for Disease Control and Preven- tion and the Office of the Assistant Secretary for Preparedness and Response and external entities, in- cluding State, Tribal, and territorial health depart- ments, laboratories, hospitals and other health care providers, electronic health records vendors, and other entities, as applicable and appropriate, in order to prepare for, identify, monitor, and respond to declared or potential public health emergencies.
(3) REPORT.—Not later than 90 days after the date of enactment of this Act, the Secretary shall re- port to the Committee on Health, Education, Labor, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3278 and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representa- tives on the status of the agreements under this sub- section.
(d) IMPROVING INFORMATION SHARING AND AVAIL- ABILITY OF PUBLIC HEALTH DATA.—Part A of title III of the Public Health Service Act (42 U.S.C.

241 et seq.)

is amended by adding at the end the following: ‘‘SEC.

310B.

IMPROVING STATE, LOCAL, AND TRIBAL INFOR- MATION SHARING.
‘‘(a) IN GENERAL.—The Secretary may, in consulta- tion with State, local, and Tribal public health officials, carry out activities to improve the availability of appro- priate and applicable public health data related to commu- nicable diseases, and information sharing between, the Di- rector of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, and such State, local, and Tribal public health officials, which may include such data from— ‘‘(1) health care providers and facilities; ‘‘(2) public health and clinical laboratories; ‘‘(3) health information exchanges and health information networks; and ‘‘(4) State, local, and Tribal health depart- ments.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3279 ‘‘(b) CONTENT, FORM, AND MANNER.—The Sec- retary shall, consistent with the requirements of this sec- tion, work with such officials and relevant stakeholders to provide information on the content, form, and manner in which such data, deidentified as applicable, may most ef- fectively support the ability of State, local, and Tribal health departments to respond to such communicable dis- eases, including related to the collection and reporting of demographic and other relevant data elements.
Such form and manner requirements shall align with the standards and implementation specifications adopted by the Sec- retary under section 3004, as applicable.

‘‘(c) DECREASED BURDEN.—In facilitating the co- ordination of efforts under subsection (a), the Secretary shall make reasonable efforts to limit reported public health data to the minimum necessary information needed to accomplish the intended public health purpose.
‘‘(d) EXEMPTION OF CERTAIN PUBLIC HEALTH DATA FROM DISCLOSURE.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may exempt from disclosure under section 552(b)(3) of title 5, United States Code, public health data that are gathered under this section if— ‘‘(1) an individual is identified through such data; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3280 ‘‘(2) there is at least a very small risk, as deter- mined by current scientific practices or statistical methods, that some combination of the information, the request, and other available data sources or the application of technology could be used to deduce the identity of an individual.’’.
(e) IMPROVING STATE, LOCAL, AND TRIBAL PUBLIC HEALTH DATA.— (1) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall award grants, contracts, or coop- erative agreements to eligible entities for purposes of identifying, developing, or disseminating best prac- tices in electronic health information and the use of designated data standards and implementation speci- fications, including privacy standards, to improve the quality and completeness of data, including demo- graphic data used for public health purposes.
(2) ELIGIBLE ENTITIES.—To be eligible to re- ceive an award under this subsection an entity shall— (A) be a health care provider, academic medical center, community-based organization, State, local governmental entity, Indian Tribe or Tribal organization (as such terms are de- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3281 fined in section 4 of the Indian Self Determina- tion and Education Assistance Act (25 U.S.C.

5304)), urban Indian organization (as defined in section 4 of the Indian Health Care Improve- ment Act (25 U.S.C.

1603)), or other appro- priate public or private nonprofit entity, or a consortia of any such entities; and (B) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(3) ACTIVITIES.—Entities receiving awards under this subsection shall use such award to de- velop and test best practices for training health care providers to use standards and implementation spec- ifications that assist in the capture, access, ex- change, and use of electronic health information, deidentified as applicable, such as demographic in- formation, disability status, veteran status, and functional status.
Such activities shall include, at a minimum— (A) improving, understanding, and using data standards and implementation specifica- tions; (B) developing or identifying methods to improve communication with patients in a December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3282 culturally- and linguistically-appropriate man- ner, including to better capture information re- lated to demographics of such individuals; (C) developing methods for accurately cat- egorizing and recording patient responses using available data standards; (D) educating providers regarding the util- ity of such information for public health pur- poses and the importance of accurate collection and recording of such data; and (E) providing information regarding how data will be deidentified if used for such public health purposes, as applicable and appropriate.
(4) REPORTING.— (A) REPORTING BY AWARD RECIPIENTS.— Each recipient of an award under this sub- section shall submit to the Secretary a report on the results of best practices identified, devel- oped, or disseminated through such award.
(B) REPORT TO CONGRESS.—Not later than 1 year after the completion of the program under this subsection, the Secretary shall sub- mit a report to Congress on the success of best practices developed under such program, oppor- tunities for further dissemination of such best December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3283 practices, and recommendations for improving the capture, access, exchange, and use of infor- mation to improve public health and reduce health disparities.

(5) NON-DUPLICATION OF EFFORTS.—The Sec- retary shall ensure that the activities and programs carried out under this subsection are free of unnec- essary duplication of effort.
(f) RULES OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to— (1) supplant, in whole or in part, State, local, or Tribal activities or responsibilities related to pub- lic health surveillance, as applicable; (2) alter the authority of the Secretary with re- spect to the types of data the Secretary may receive through systems supported or established in this sec- tion or other laws; or (3) modify applicable Federal or State informa- tion privacy or security law.
SEC.

2214.

EPIDEMIC FORECASTING AND OUTBREAK ANA- LYTICS.

Title XXVIII of the Public Health Service Act (42 U.S.C.

300hh et seq.

), as amended by section 2212, is fur- ther amended by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3284 ‘‘SEC.

2825.

EPIDEMIC FORECASTING AND OUTBREAK ANA- LYTICS.


‘‘(a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Pre- vention, shall continue activities related to the develop- ment of infectious disease outbreak analysis capabilities to enhance the prediction, modeling, and forecasting of po- tential public health emergencies and other infectious dis- ease outbreaks, which may include activities to support preparedness for, and response to, such emergencies and outbreaks.
In carrying out this subsection, the Secretary shall identify strategies to include and leverage, as appro- priate, the capabilities to public and private entities, which may include conducting such activities through collabo- rative partnerships with public and private entities, includ- ing academic institutions, and other Federal agencies, con- sistent with section 319D, as applicable.
‘‘(b) CONSIDERATIONS.—In carrying out subsection (a), the Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention, may consider public health data and, as appropriate, other data sources related to preparedness for, or response to, public health emergencies and infectious disease outbreaks.
‘‘(c) ANNUAL REPORTS.—Not later than 1 year after the date of enactment of this section, and annually there- after for each of the subsequent 4 years, the Secretary 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3285 shall prepare and submit a report, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, regarding an update on progress on activities conducted under this section to develop infec- tious disease outbreak analysis capabilities and any addi- tional information relevant to such efforts.’’.

SEC.

2215.

PUBLIC HEALTH DATA TRANSPARENCY.


(a) REPORT.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report assessing practices, objectives, and associated progress and challenges in achieving such objectives, of the Centers of Disease Con- trol and Prevention with respect to the collection and dis- semination of public health data related to a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C.
247d) or a potential public 18 health emergency.

19 (b) PLAN.—Not later than 180 days following the issuance of the report pursuant to paragraph (1), the Di- rector of the Centers for Disease Control and Prevention shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives 25 a plan that shall include— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3286 (1) steps to improve the timely reporting and dissemination of deidentified public health data re- lated to a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C.
247d) or a potential public health emergency that is collected by the Centers for Disease Control and Prevention, including any associated barriers; (2) recommendations to Congress regarding gaps in such practices and objectives described in subsection (a); and (3) considerations regarding the requirements and limitations of data use agreements for such pur- poses, as applicable, and any efforts undertaken to address those requirements and limitations.

SEC.

2216.
SEC.

2216.

GAO REPORT ON PUBLIC HEALTH PREPARED- NESS, RESPONSE, AND RECOVERY DATA CA- PABILITIES.

(a) STUDY.—The Comptroller General of the United States (referred to in this section as the ‘‘Comptroller General’’) shall conduct a study on the efforts of the De- partment of Health and Human Services to ensure that public health preparedness, response, and recovery data capabilities related to pandemic and other biological threats are not unnecessarily duplicative, overlapping, or fragmented.
Such study shall include— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3287 (1) a comprehensive list of all public health pre- paredness, response, and recovery data collection, such as incidence and prevalence of disease tracking, hospitalizations, critical care capacity, and testing programs, at the Department of Health and Human Services, as identified by the department and its component agencies; (2) an analysis of any duplication, overlap, or fragmentation of the programs identified in para- graph (1); (3) identification of any efforts of the Depart- ment of Health and Human Services to reduce un- necessary duplication and improve coordination, effi- ciency, and effectiveness of such programs and any associated challenges; (4) any practices that threaten individual pri- vacy and recommendations to improve the protection of individual, identifiable data; and (5) a description of the funding and other re- sources dedicated to the operation of each such pro- gram identified in paragraph (1).
(b) REPORTING.— (1) IN GENERAL.—Based on the study con- ducted under subsection (a), the Comptroller Gen- eral shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3288 (A) not later than 6 months after the date of enactment of this Act, provide a briefing to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives; and (B) not later than 18 months after the date of enactment of this Act, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives a complete report on such study.
(2) RECOMMENDATIONS.—The report under paragraph (1)(B) shall include recommendations, as appropriate, with respect to public health prepared- ness, response, and recovery data programs at the Department of Health and Human Services, to— (A) streamline data collection and reduce fragmentation and address any associated chal- lenges; (B) reduce duplication in such programs; and (C) improve information-sharing across programs.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3289 CHAPTER 3—REVITALIZING THE PUBLIC HEALTH WORKFORCE SEC.

2221.

IMPROVING RECRUITMENT AND RETENTION OF THE FRONTLINE PUBLIC HEALTH WORK- FORCE.

(a) IN GENERAL.—Section 776 of the Public Health Service Act (42 U.S.C.
295f–1) is amended— (1) in subsection (a)— (A) by striking ‘‘supply of’’ and inserting ‘‘supply of, and encourage recruitment and re- tention of,’’; and (B) by striking ‘‘Federal,’’; (2) in subsection (b)— (A) by amending paragraph (1)(A) to read as follows: ‘‘(1)(A)(i) be accepted for enrollment, or be en- rolled, as a student in an accredited institution of higher education or school of public health in the final semester (or equivalent) of a program leading to a certificate or degree, including a master’s or doctoral degree, in public health, epidemiology, lab- oratory sciences, data systems, data science, data analytics, informatics, statistics, or another subject matter related to public health; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3290 ‘‘(ii) be employed by, or have accepted employ- ment with, a State, local, or Tribal public health agency, or a related training fellowship at such State, local, or Tribal public health agency, as recog- nized by the Secretary, to commence upon gradua- tion; or’’; and (B) in paragraph (1)(B)— (i) in clause (i)— (I) by striking ‘‘accredited edu- cational institution in a State or terri- tory’’ and inserting ‘‘accredited insti- tution of higher education or school of public health’’; and (II) by striking ‘‘a public health or health professions degree or certifi- cate’’ and inserting ‘‘a certificate or degree, including a master’s or doc- toral degree, in public health, epidemi- ology, laboratory sciences, data sys- tems, data science, data analytics, informatics, statistics, or another sub- ject matter related to public health’’; and (ii) in clause (ii)— (I) by striking ‘‘Federal,’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3291 (II) by striking ‘‘fellowship,’’ and inserting ‘‘fellowship at such State, local, or Tribal public health agency,’’; (3) in subsection (c)(2)— (A) by striking ‘‘Federal,’’; and (B) by striking ‘‘equal to the greater of— ’’ and all that follows through the end of sub- paragraph (B) and inserting ‘‘of at least 3 con- secutive years;’’; (4) in subsection (d)— (A) by amending paragraph (1) to read as follows: ‘‘(1) IN GENERAL.—A loan repayment provided for an individual under a written contract under the Program shall consist of payment, in accordance with paragraph (2), for the individual toward the outstanding principal and interest on education loans incurred by the individual in the pursuit of the relevant degree or certificate described in subsection (b)(1) in accordance with the terms of the con- tract.’’; and (B) in paragraph (2)— (i) by striking ‘‘For each year’’ and inserting the following: ‘‘(A) IN GENERAL.—For each year’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3292 (ii) by striking ‘‘$35,000’’ and insert- ing ‘‘$50,000’’; (iii) by striking ‘‘$105,000’’ and in- serting ‘‘$150,000’’; and (iv) by adding at the end the fol- lowing: ‘‘(B) CONSIDERATIONS.—The Secretary may take action in making awards under this section to ensure that— ‘‘(i) an appropriate proportion of con- tracts are awarded to individuals who are eligible to participate in the program pur- suant to subsection (b)(1)(A); and ‘‘(ii) contracts awarded under this section are equitably distributed among— ‘‘(I) the geographical regions of the United States; ‘‘(II) local, State, and Tribal public health departments; and ‘‘(III) such public health depart- ments under subclause (II) serving rural and urban areas.’’; (5) in subsection (e), by striking ‘‘receiving a degree or certificate from a health professions or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3293 other related school’’ and inserting ‘‘with a contract to serve under subsection (c)’’; (6) in subsection (f), by adding at the end the following: ‘‘In the event that a participant fails to ei- ther begin or complete the obligated service require- ment of the loan repayment contract under this sec- tion, the Secretary may waive or suspend either the unfulfilled service or the assessed damages as pro- vided for under section 338E(d), as appropriate.’’; (7) by redesignating subsection (g) as sub- section (i); (8) by inserting after subsection (f) the fol- lowing: ‘‘(g) ELIGIBLE LOANS.—The loans eligible for repay- ment under this section are each of the following: ‘‘(1) Any loan for education or training for em- ployment by a health department.
‘‘(2) Any loan under part E of title VIII (relat- ing to nursing student loans).

‘‘(3) Any Federal Direct Stafford Loan, Fed- eral Direct PLUS Loan, Federal Direct Unsub- sidized Stafford Loan, or Federal Direct Consolida- tion Loan (as such terms are used in section 455 of the Higher Education Act of 1965).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3294 ‘‘(4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.

‘‘(5) Any other Federal loan, as the Secretary determines appropriate.
‘‘(h) PILOT PROGRAM.— ‘‘(1) IN GENERAL.—The Secretary shall, as ap- propriate, establish a pilot program, to be known as the Bio-Preparedness Workforce Pilot Program, to provide for loan repayment for health professionals with expertise in infectious diseases and emergency preparedness and response activities to ensure an adequate supply of such professionals.
Such program shall be administered consistent with the require- ments of this section, except that, to be eligible to participate in the pilot program, an individual shall— ‘‘(A)(i) be accepted for enrollment, or be enrolled, as a student in an accredited institu- tion of higher education in the final semester (or equivalent) of a program leading to a health professions degree or certificate program rel- evant to such program; or ‘‘(ii) have graduated, during the preceding 10-year period, from an accredited institution of higher education with a health professions December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3295 degree or certificate program relevant to such program; and ‘‘(B) be employed by, or have accepted em- ployment with— ‘‘(i) a Federal health care facility; ‘‘(ii) a nonprofit health care facility that is located in a health professional shortage area (as defined in section 332), a frontier health professional shortage area (as defined in section 799B), or a medi- cally underserved community (as defined in section 799B); ‘‘(iii) an entity receiving assistance under title XXVI for the provision of clin- ical services; ‘‘(iv) a health program, or a facility, operated by an Indian Tribe or Tribal or- ganization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act) or by an urban Indian organization (as defined in section 4 of the Indian Health Care Im- provement Act); or ‘‘(v) another relevant entity deter- mined appropriate by the Secretary, as a December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3296 health professional with expertise in infec- tious diseases or emergency preparedness and response.

‘‘(2) NON-DUPLICATION OF EFFORT.—The Sec- retary shall ensure that the pilot program estab- lished under paragraph (1) does not unnecessarily duplicate the National Health Service Corps Loan Repayment Program, or any other loan repayment program operated by the Department of Health and Human Services.
‘‘(3) EVALUATION AND REPORT TO CON- GRESS.— ‘‘(A) IN GENERAL.—The Secretary shall evaluate the pilot program at the conclusion of the first cycle of recipients funded by the pilot program.

‘‘(B) REPORT.— ‘‘(i) IN GENERAL.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the evaluation under subpara- graph (A).
The report shall include, at a minimum, outcomes information from the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3297 pilot program, including any impact on re- cruitment and retention of health profes- sionals with expertise in infectious diseases and emergency preparedness and response activities.
‘‘(ii) RECOMMENDATION.—The report under this subparagraph shall include a recommendation by the Secretary as to whether the pilot program under this sub- section should be extended.’’; (9) in subsection (i), as so redesignated, by striking ‘‘$195,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011 through 2015’’ and inserting ‘‘$100,000,000 for each of fiscal years 2023 through 2025’’; and (10) by striking ‘‘tribal’’ each place such term appears and inserting ‘‘Tribal’’.
(b) GAO STUDY ON PUBLIC HEALTH WORK- FORCE.—Not later than 2 years after the date of enact- ment of this Act, the Comptroller General of the United States shall— 23 24 25 (1) conduct an evaluation of what is known about the public health workforce in the United States, which shall address— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3298 (A) existing gaps in the Federal, State, local, Tribal, and territorial public health work- force, including positions that may be required to prepare for, and respond to, a public health emergency such as COVID–19; (B) challenges associated with the hiring, recruitment, and retention of the Federal, State, local, Tribal, and territorial public health workforce; and (C) Federal efforts to improve hiring, re- cruitment, and retention of the public health workforce; and (2) submit to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review.
SEC.

2222.

AWARDS TO SUPPORT COMMUNITY HEALTH WORKERS AND COMMUNITY HEALTH.

(a) IN GENERAL.—Section 399V of the Public Health Service Act (42 U.S.C.

280g–11) is amended— (1) by amending the section heading to read as follows: ‘‘AWARDS TO SUPPORT COMMUNITY HEALTH WORKERS AND COMMUNITY HEALTH’’; (2) by amending subsection (a) to read as fol- lows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3299 ‘‘(a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to eligible en- tities to promote positive health behaviors and outcomes for populations in medically underserved communities by leveraging community health workers, including by ad- dressing ongoing and longer-term community health needs, and by building the capacity of the community health worker workforce.
Such grants, contracts, and co- operative agreements shall be awarded in alignment and coordination with existing funding arrangements sup- porting community health workers.’’; (3) in subsection (b)— (A) in the matter preceding paragraph (1)— (i) by striking ‘‘Grants awarded’’ and inserting ‘‘Subject to any requirements for the scope of licensure, registration, or cer- tification of a community health worker under applicable State law, grants, con- tracts, and cooperative agreements award- ed’’; and (ii) by striking ‘‘support community health workers’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3300 (B) by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), re- spectively; (C) by striking paragraphs (1) and (2) and inserting the following: ‘‘(1) recruit, hire, train, and retain community health workers that reflect the needs of the commu- nity; ‘‘(2) support community health workers in pro- viding education and outreach, in a community set- ting, regarding— ‘‘(A) health conditions prevalent in— ‘‘(i) medically underserved commu- nities (as defined in section 799B), par- ticularly racial and ethnic minority popu- lations; and ‘‘(ii) other such at-risk populations or geographic areas that may require addi- tional support during public health emer- gencies, which may include counties identi- fied by the Secretary using applicable measures developed by the Centers for Dis- ease Control and Prevention or other Fed- eral agencies; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3301 ‘‘(B) addressing health disparities, includ- ing by— ‘‘(i) promoting awareness of services and resources to increase access to health care, mental health and substance use dis- order services, child services, technology, housing services, educational services, nu- trition services, employment services, and other services; and ‘‘(ii) assisting in conducting individual and community needs assessments; ‘‘(3) educate community members, including re- garding effective strategies to promote healthy be- haviors;’’; (D) in paragraph (4), as so redesignated, by striking ‘‘to educate’’ and inserting ‘‘edu- cate’’; (E) in paragraph (5), as so redesignated— (i) by striking ‘‘to identify’’ and in- serting ‘‘identify’’; (ii) by striking ‘‘healthcare agencies’’ and inserting ‘‘health care agencies’’; and (iii) by striking ‘‘healthcare services and to eliminate duplicative care; or’’ and inserting ‘‘health care services and to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3302 streamline care, including serving as a liai- son between communities and health care agencies; and’’; and (F) in paragraph (6), as so redesignated— (i) by striking ‘‘to educate, guide, and provide’’ and inserting ‘‘support commu- nity health workers in educating, guiding, or providing’’; and (ii) by striking ‘‘maternal health and prenatal care’’ and inserting ‘‘chronic dis- eases, maternal health, prenatal, and postpartum care in order to improve ma- ternal and infant health outcomes’’; (4) in subsection (c), by striking ‘‘Each eligible entity’’ and all that follows through ‘‘accompanied by’’ and inserting ‘‘To be eligible to receive an award under subsection (a), an entity shall prepare and submit to the Secretary an application at such time, in such manner, and containing’’; (5) in subsection (d)— (A) in the matter preceding paragraph (1), by striking ‘‘awarding grants’’ and inserting ‘‘making awards’’; (B) by amending paragraph (1) to read as follows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3303 ‘‘(1) propose to serve— ‘‘(A) areas with populations that have a high rate of chronic disease, infant mortality, or maternal morbidity and mortality; ‘‘(B) low-income populations, including medically underserved populations (as defined in section 330(b)(3)); ‘‘(C) populations residing in health profes- sional shortage areas (as defined in section 332(a)); ‘‘(D) populations residing in maternity care health professional target areas identified under section 332(k); or ‘‘(E) rural or traditionally underserved populations, including racial and ethnic minor- ity populations or low-income populations;’’; (C) in paragraph (2), by striking ‘‘; and’’ and inserting ‘‘, including rural populations and racial and ethnic minority populations;’’; (D) in paragraph (3), by striking ‘‘with community health workers.’’ and inserting ‘‘and established relationships with community health workers in the communities expected to be served by the program;’’ and (E) by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3304 ‘‘(4) develop a plan for providing services to the extent practicable, in the language and cultural con- text most appropriate to individuals expected to be served by the program; and ‘‘(5) propose to use evidence-informed or evi- dence-based practices, as applicable and appro- priate.’’; (6) in subsection (e)— (A) by striking ‘‘community health worker programs’’ and inserting ‘‘eligible entities’’; and (B) by striking ‘‘and one-stop delivery sys- tems under section 121(e)’’ and inserting ‘‘, health professions schools, minority-serving in- stitutions (defined, for purposes of this sub- section, as institutions and programs described in section 326(e)(1) of the Higher Education Act of 1965 and institutions described in sec- tion 371(a) of such Act), area health education centers under section 751 of this Act, and one- stop delivery systems under section 121’’; (7) by striking subsections (f), (g), (h), (i), and (j) and inserting the following: ‘‘(f) TECHNICAL ASSISTANCE.—The Secretary may provide to eligible entities that receive awards under sub- section (a) technical assistance with respect to planning, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3305 development, and operation of community health worker programs authorized or supported under this section.
‘‘(g) DISSEMINATION OF BEST PRACTICES.—Not later than 4 years after the date of enactment of the PRE- VENT Pandemics Act, the Secretary shall, based on ac- tivities carried out under this section and in consultation with relevant stakeholders, identify and disseminate evi- dence-based or evidence-informed practices regarding re- cruitment and retention of community health workers and paraprofessionals to address ongoing public health and community health needs, and to prepare for, and respond to, future public health emergencies.
‘‘(h) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the PREVENT Pandemics Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Com- mittee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appro- priations of the House of Representatives a report con- cerning the effectiveness of the program under this section in addressing ongoing public health and community health needs.
Such report shall include recommendations regard- ing any improvements to such program, including rec- ommendations for how to improve recruitment, training, and retention of the community health workforce.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3306 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section, there are authorized to be appropriated $50,000,000 for each of fiscal years 2023 through 2027.’’; (8) by redesignating subsection (k) as sub- section (j); and (9) in subsection (j), as so redesignated— (A) by striking paragraphs (1), (2), and (4); (B) by redesignating paragraph (3) as paragraph (1); (C) in paragraph (1), as so redesignated— (i) by striking ‘‘entity (including a State or public subdivision of a State’’ and inserting ‘‘entity, including a State or po- litical subdivision of a State, an Indian Tribe or Tribal organization, an urban In- dian organization, a community-based or- ganization’’; and (ii) by striking ‘‘as defined in section 1861(aa) of the Social Security Act))’’ and inserting ‘‘(as defined in section 1861(aa)(4) of the Social Security Act)’’; and (D) by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3307 ‘‘(2) INDIAN TRIBE; TRIBAL ORGANIZATION.— The terms ‘Indian Tribe’ and ‘Tribal organization’ have the meanings given the terms ‘Indian tribe’ and ‘tribal organization’, respectively, in section 4 of the Indian Self-Determination and Education Assistance Act.

‘‘(3) URBAN INDIAN ORGANIZATION.—The term ‘urban Indian organization’ has the meaning given such term in section 4 of the Indian Health Care Improvement Act.’’.
(b) GAO STUDY AND REPORT.—Not later than 1 year after the date of submission of the report under sub- section (h) of section 399V of the Public Health Service Act (42 U.S.C.
280g–11), as amended by subsection (a), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the program authorized under such section 399V, includ- ing a review of the efforts of the Secretary of Health and Human Services to coordinate such program with applica- ble programs of the Health Resources and Services Ad- ministration to ensure there is no unnecessary duplication of efforts among such programs, and identification of any areas of duplication.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3308 SEC.

2223.

IMPROVING PUBLIC HEALTH EMERGENCY RE- SPONSE CAPACITY.

(a) CERTAIN APPOINTMENTS TO SUPPORT PUBLIC HEALTH EMERGENCY RESPONSES.—Section 319 of the Public Health Service Act (42 U.S.C.
247d) is amended by adding at the end the following: ‘‘(g) CERTAIN APPOINTMENTS TO SUPPORT PUBLIC HEALTH EMERGENCY RESPONSES.— ‘‘(1) IN GENERAL.—In order to support the ini- tial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, United States Code, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to— ‘‘(A) address a critical hiring need directly related to responding to a public health emer- gency declared by the Secretary under this sec- tion; or ‘‘(B) address a severe shortage of can- didates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emer- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3309 gency declared by the Secretary under this sec- tion.

‘‘(2) NUMBER OF APPOINTMENTS.—Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than— ‘‘(A) 400 individuals under paragraph (1)(A); and ‘‘(B) 100 individuals under paragraph (1)(B).
‘‘(3) COMPENSATION.—The annual rate of basic pay of an individual appointed under this sub- section shall be determined in accordance with chap- ter 51 and subchapter III of chapter 53 of title 5, United States Code.
‘‘(4) REPORTING.—The Secretary shall estab- lish and maintain records regarding the use of the authority under this subsection, including— ‘‘(A) the number of positions filled through such authority; ‘‘(B) the types of appointments of such po- sitions; ‘‘(C) the titles, occupational series, and grades of such positions; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3310 ‘‘(D) the number of positions publicly no- ticed to be filled under such authority; ‘‘(E) the number of qualified applicants who apply for such positions; ‘‘(F) the qualification criteria for such po- sitions; and ‘‘(G) the demographic information of indi- viduals appointed to such positions.
‘‘(5) NOTIFICATION TO CONGRESS.—In the event the Secretary, within a single fiscal year, di- rectly appoints more than 50 percent of the individ- uals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, in- clude— ‘‘(A) information on each such appoint- ment within such fiscal year; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3311 ‘‘(B) a description of how each such posi- tion relates to the requirements of subpara- graph (A) or (B) of paragraph (1); and ‘‘(C) the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year.
‘‘(6) REPORTS TO CONGRESS.—Not later than September 30, 2023, and annually thereafter for each fiscal year in which the authority under this subsection is used, the Secretary shall submit to the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Commerce of the House of Representatives a re- port describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the re- quirements of subparagraph (A) or (B) of paragraph (1).
‘‘(7) SUNSET.—The authority under this sub- section shall expire on September 30, 2028.’’.

(b) GAO REPORT.—Not later than 1 year after the issuance of the initial report under subsection (g)(6) of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3312 section 319 of the Public Health Service Act (42 U.S.C.
247d), as added by subsection (a), and again 180 days after the date on which the authority provided under sec- tion 319(g) of such Act expires pursuant to paragraph (7) of such section, the Comptroller General of the United States shall submit to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Rep- resentatives a report on the use of the authority provided under such section.
Such report shall, in a manner that protects personal privacy, at a minimum, include informa- 12 tion on— (1) the number of positions publicly noticed and filled under the authority of each of subparagraphs (A) and (B) of such section 319(g)(1); (2) the occupational series, grades, and types of appointments of such positions; (3) how such positions related to addressing a need or shortage described in subparagraph (A) or (B) of such section; (4) how the Secretary of Health and Human Services made appointment decisions under each of subparagraphs (A) and (B) of such section; (5) sources used to identify candidates for fill- ing such positions; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3313 (6) the number of individuals appointed under each such subparagraph; (7) aggregated demographic information related to individuals appointed under each such subpara- graph; and (8) any challenges, limitations, or gaps related to the use of the authority under each such subpara- graph and any related recommendations to address such challenges, limitations, or gaps.

SEC.

2224.

INCREASING EDUCATIONAL OPPORTUNITIES FOR ALLIED HEALTH PROFESSIONS.
Section 755(b) of the Public Health Service Act (42 U.S.C.
294e(b)) is amended by adding at the end the fol- lowing: ‘‘(4) Increasing educational opportunities in physical therapy, occupational therapy, respiratory therapy, audiology, and speech-language pathology professions, which may include offering scholarships or stipends and carrying out other activities to im- prove retention, for individuals from disadvantaged backgrounds or individuals who are underrep- resented in such professions.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3314 SEC.

2225.

PUBLIC HEALTH SERVICE CORPS ANNUAL AND SICK LEAVE.

(a) IN GENERAL.—Section 219 of the Public Health Service Act (42 U.S.C.
210–1) is amended— (1) in subsection (a)— (A) by striking ‘‘Reserve Corps’’ and in- serting ‘‘Ready Reserve Corps’’; and (B) by striking ‘‘: Provided, That such reg- ulations shall not authorize annual leave to be accumulated in excess of sixty days’’; (2) by inserting after subsection (a) the fol- lowing: ‘‘(b) The regulations described in subsection (a) may authorize accumulated annual leave of not more than 120 days for any commissioned officer of the Regular Corps or officer of the Ready Reserve Corps on active duty.’’; and (3) by redesignating subsection (d) as sub- section (c).
(b) APPLICATION.—The amendments made by sub- section (a) shall apply with respect to accumulated annual leave (as defined in section 219 of the Public Health Serv- ice Act (42 U.S.C.

210–1)) that a commissioned officer of the Regular Corps or officer of the Ready Reserve Corps on active duty would, but for the regulations de- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3315 scribed in such section, lose at the end of fiscal year 2022 or a subsequent fiscal year.

SEC.
SEC.

2226.

LEADERSHIP EXCHANGE PILOT FOR PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE POSITIONS AT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.

Title XXVIII of the Public Health Service Act (42 U.S.C.

300hh et seq.

), as amended by section 2214, is fur- ther amended by adding at the end the following: ‘‘SEC.

2826.

LEADERSHIP EXCHANGE PILOT FOR PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE POSITIONS AT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.
‘‘(a) IN GENERAL.—The Secretary may, not later than 1 year after the date of enactment of the PREVENT Pandemics Act, establish a voluntary program to provide additional training to individuals in eligible positions, as described in subsection (c), to support the continuous pro- fessional development of such individuals.
‘‘(b) CRITERIA.— ‘‘(1) DURATION.—The program under sub- section (a) shall provide for fellowships, details, or other relevant placements with Federal agencies or departments, or State or local health departments, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3316 pursuant to the guidance issued under paragraph (2), for a maximum period of 2 years.
‘‘(2) GUIDANCE.—The Secretary shall issue guidance establishing criteria for identifying place- ments that demonstrate ongoing sufficient mastery of knowledge, skills, and abilities to satisfy the field experience criteria under the program established under subsection (a), including assignments and ex- periences that develop public health and medical pre- paredness and response expertise.
‘‘(c) ELIGIBLE POSITION.—For purposes of sub- section (a), the term ‘eligible position’ means any position at the Department of Health and Human Services at or above grade GS–13 of the General Schedule, or the equiv- alent, for which not less than 50 percent of the time of such position is spent on activities related to public health preparedness or response.
‘‘(d) PILOT PERIOD AND FINAL REPORT.—The pilot program authorized under this section shall not exceed 5 years.

Not later than 90 days after the end of the pro- gram, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3317 ‘‘(1) the number of individuals who participated in such pilot, as applicable; ‘‘(2) a description of the professional growth ex- perience in which individuals participated; and ‘‘(3) an assessment of the outcomes of such program, including a recommendation on whether such program should be continued.’’.

SEC.

2227.

CONTINUING EDUCATIONAL SUPPORT FOR HEALTH PROFESSIONALS SERVING IN RURAL AND UNDERSERVED COMMUNITIES.

Section 752 of the Public Health Service Act (42 U.S.C.
294b) is amended— (1) in the section heading, by inserting ‘‘RURAL AND’’ after ‘‘SERVING IN’’; (2) in subsection (a)— (A) by striking ‘‘shall make grants to, and enter into contracts with, eligible entities’’ and inserting ‘‘, as appropriate, shall make grants to, and enter into contracts with, eligible enti- ties to support access to accredited continuing medical education for primary care physicians and health care providers at community health centers or rural health clinics to improve and increase access to care for patients in rural and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3318 medically underserved areas.
Such grants or contracts may be used’’; (B) by striking ‘‘faculty members’’ and in- serting ‘‘health care providers’’; and (C) by inserting ‘‘increase primary care physician and health care provider knowledge,’’ after ‘‘practice environment,’’; (3) in subsection (b), by inserting ‘‘, such as a community health center or rural health clinic’’ be- fore the period; (4) in subsection (c), by striking ‘‘by require.’’ and inserting the following: ‘‘may require, includ- ing— ‘‘(1) a description of how participation in activi- ties funded under this section will help improve ac- cess to, and quality of, health care services and training needs of primary care physicians and health care providers; and ‘‘(2) a plan for providing peer-to-peer training, as appropriate.’’; (5) by amending subsection (d) to read as fol- lows: ‘‘(d) USE OF FUNDS.— ‘‘(1) IN GENERAL.—An eligible entity shall use amounts awarded under a grant or contract under December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3319 this section to provide innovative supportive activi- ties to enhance education for primary care physi- cians and health care providers described in sub- section (a) through distance learning, continuing educational activities, collaborative conferences, and electronic and telelearning activities, with priority for primary care providers who are seeking addi- tional education in specialty fields such as infectious disease, endocrinology, pediatrics, mental health and substance use disorders, pain management, geri- atrics, and other areas, as appropriate, in order to— ‘‘(A) improve retention of primary care physicians and health care providers and in- crease access to specialty health care services for patients; and ‘‘(B) support access to the integration of specialty care through existing service delivery locations and care across settings.
‘‘(2) CLARIFICATION.—Entities may use amounts awarded under a grant or contract under this section for continuing educational activities that include a clinical training component, including in- person patient care, in the respective community health center or rural health clinic, with the primary care physician or health care provider at such site December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3320 and the clinical specialist from whom such additional training is being provided.’’; (6) by redesignating subsection (e) as sub- section (g); (7) by inserting after subsection (d) the fol- lowing: ‘‘(e) ADMINISTRATIVE EXPENSES.—An entity that revives a grant or contract under this section shall use not more than 5 percent of the amounts received under the grant or contract under this section for administrative 11 expenses.
‘‘(f) NON-DUPLICATION OF EFFORT.—The Secretary shall ensure that activities under this section do not un- necessarily duplicate efforts of other programs overseen by the Health Resources and Services Administration, in- cluding activities described in section 330N.’’; and (8) in subsection (g), as so redesignated, by striking ‘‘the fiscal years 2010 through 2014, and such sums as may be necessary for each subsequent fiscal year’’ and inserting ‘‘fiscal years 2023 through 2025’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3321 CHAPTER 4—ENHANCING PUBLIC HEALTH PREPAREDNESS AND RESPONSE SEC.

2231.

CENTERS FOR PUBLIC HEALTH PREPAREDNESS AND RESPONSE.

(a) IN GENERAL.—Section 319F of the Public Health Service Act (42 U.S.C.
247d–6) is amended— (1) by striking subsection (d) and inserting the following: ‘‘(d) CENTERS FOR PUBLIC HEALTH PREPAREDNESS 10 AND RESPONSE.— ‘‘(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants, con- tracts, or cooperative agreements to institutions of higher education, including accredited schools of public health, or other nonprofit private entities to establish or maintain a network of Centers for Pub- lic Health Preparedness and Response (referred to in this subsection as ‘Centers’).
‘‘(2) ELIGIBILITY.—To be eligible to receive an award under this subsection, an entity shall submit to the Secretary an application containing such in- formation as the Secretary may require, including a description of how the entity will— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3322 ‘‘(A) coordinate relevant activities with ap- plicable State, local, and Tribal health depart- ments and officials, health care facilities, and health care coalitions to improve public health preparedness and response, as informed by the public health preparedness and response needs of the community, or communities, involved; ‘‘(B) prioritize efforts to implement evi- dence-informed or evidence-based practices to improve public health preparedness and re- sponse, including by helping to reduce the transmission of emerging infectious diseases; and ‘‘(C) use funds awarded under this sub- section, including by carrying out any activities described in paragraph (3).
‘‘(3) USE OF FUNDS.—The Centers established or maintained under this subsection shall use funds awarded under this subsection to carry out activities to advance public health preparedness and response capabilities, which may include— ‘‘(A) identifying, translating, and dissemi- nating promising research findings or strategies into evidence-informed or evidence-based prac- tices to inform preparedness for, and responses December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3323 to, chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and other public health emergencies, which may include conducting research related to public health preparedness and response systems; ‘‘(B) improving awareness of such evi- dence-informed or evidence-based practices and other relevant scientific or public health infor- mation among health care professionals, public health professionals, other stakeholders, and the public, including through the development, eval- uation, and dissemination of trainings and training materials, consistent with section 2802(b)(2), as applicable and appropriate, and with consideration given to existing training materials, to support preparedness for, and re- sponses to, such threats; ‘‘(C) utilizing and expanding relevant tech- nological and analytical capabilities to inform public health and medical preparedness and re- sponse efforts; ‘‘(D) expanding activities, including through public-private partnerships, related to public health preparedness and response, in- cluding participation in drills and exercises and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3324 training public health experts, as appropriate; and ‘‘(E) providing technical assistance and ex- pertise that relies on evidence-based practices, as applicable, related to responses to public health emergencies, as appropriate, to State, local, and Tribal health departments and other entities pursuant to paragraph (2)(A).
‘‘(4) DISTRIBUTION OF AWARDS.—In awarding grants, contracts, or cooperative agreements under this subsection, the Secretary shall support not fewer than 10 Centers, subject to the availability of appropriations, and ensure that such awards are eq- uitably distributed among the geographical regions of the United States.’’; and (2) in subsection (f)(1)(C), by striking ‘‘, of which $5,000,000 shall be used to carry out para- graphs (3) through (5) of such subsection’’.
(b) REPEAL.—Section 319G of the Public Health Service Act (42 U.S.C.

247d–7) is repealed.

SEC.

2232.

VACCINE DISTRIBUTION PLANS.

Section 319A of the Public Health Service Act (42 U.S.C.

247d–1) is amended— 24 (1) in subsection (a)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3325 (A) by inserting ‘‘, or other federally pur- chased vaccine to address another pandemic’’ before the period at the end of the first sen- tence; and (B) by inserting ‘‘or other pandemic’’ be- fore the period at the end of the second sen- tence; and (2) in subsection (d), by inserting ‘‘or other pandemics’’ after ‘‘influenza pandemics’’.

SEC.

2233.

COORDINATION AND COLLABORATION REGARD- ING BLOOD SUPPLY.
The Secretary of Health and Human Services, or the Secretary’s designee, shall— (1) ensure coordination and collaboration be- tween relevant Federal departments and agencies re- lated to the safety and availability of the blood sup- ply, including— (A) the Department of Health and Human Services, including the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Office of the Assistant Sec- retary for Preparedness and Response, the Na- tional Institutes of Health, the Centers for December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3326 Medicare & Medicaid Services, and the Health Resources and Services Administration; (B) the Department of Defense; and (C) the Department of Veterans Affairs; and (2) consult and communicate with private stakeholders, including blood collection establish- ments, health care providers, accreditation organiza- tions, researchers, and patients, regarding issues re- lated to the safety and availability of the blood sup- ply.

SEC.

2234.
SEC.

2234.

SUPPORTING LABORATORY CAPACITY AND INTERNATIONAL COLLABORATION TO AD- DRESS ANTIMICROBIAL RESISTANCE.

Section 319E of the Public Health Service Act (42 U.S.C.
247d–5) is amended— (1) by redesignating subsections (k), (l), and (m) as subsections (m), (n), and (o), respectively; and (2) by inserting after subsection (j), the fol- lowing: ‘‘(k) NETWORK OF ANTIBIOTIC RESISTANCE RE- 23 GIONAL LABORATORIES.— 24 25 ‘‘(1) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3327 Control and Prevention, shall, as appropriate, main- tain a network of antibiotic resistance laboratory sites to ensure the maintenance of appropriate capa- bilities, within existing laboratory capacity main- tained or supported by the Centers for Disease Con- trol and Prevention, to— ‘‘(A) identify and monitor the emergence and changes in the patterns of antimicrobial-re- sistant pathogens; ‘‘(B) detect, identify, confirm, and isolate such resistant pathogens, including, as appro- priate, performing such activities upon the re- quest of another laboratory and providing re- lated technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of such resistant pathogens; and ‘‘(C) perform activities to support the diag- nosis of such resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable treatments.
‘‘(2) GEOGRAPHIC DISTRIBUTION.—The Sec- retary shall ensure that such capacity and capabili- ties are appropriately distributed among the geo- graphical regions of the United States.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3328 ‘‘(3) PARTNERSHIPS AND NONDUPLICATION OF CURRENT DOMESTIC CAPACITY.—Activities sup- ported under this subsection may be based in an academic center, a State health department, or other facility operated by a public or private entity that carries out relevant laboratory or public health sur- veillance activities.
‘‘(l) INTERNATIONAL COLLABORATION.— ‘‘(1) IN GENERAL.—The Secretary, in coordina- tion with heads of other relevant Federal depart- ments and agencies, shall support activities related to addressing antimicrobial resistance internation- ally, including by— ‘‘(A) supporting basic, translational, epide- miological, and clinical research related to anti- microbial-resistant pathogens, including such pathogens that have not yet been detected in the United States, and improving related public health surveillance systems, and laboratory and other response capacity; and ‘‘(B) providing technical assistance related to antimicrobial resistant infection and control activities.
‘‘(2) AWARDS.—In carrying out paragraph (1), the Secretary may award grants, contracts, or coop- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3329 erative agreements to public and private entities, in- cluding nongovernmental organizations, with appli- cable expertise, for purposes of supporting new and innovative approaches to the prevention, detection, and mitigation of antimicrobial-resistant patho- gens.’’.

SEC.

2235.

ONE HEALTH FRAMEWORK.


(a) ONE HEALTH FRAMEWORK.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Director of the Centers for Disease Control and Prevention, shall develop, or update as appropriate, in coordination with other Fed- eral departments and agencies, as appropriate, a One Health framework to address zoonotic diseases and ad- vance public health preparedness.
(b) ONE HEALTH COORDINATION.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall coordinate with the Sec- retary of Agriculture and the Secretary of the Interior to develop a One Health coordination mechanism at the Fed- eral level to strengthen One Health collaboration related to prevention, detection, control, and response for zoonotic diseases and related One Health work across the Federal Government.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3330 (c) REPORTING.—Not later than 1 year after the date of enactment of this Act, the Secretary shall submit to the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report pro- viding an update on the activities under subsections (a) and (b).

SEC.

2236.

SUPPORTING CHILDREN DURING PUBLIC HEALTH EMERGENCIES.
Section 2811A of the Public Health Service Act (42 U.S.C.
300hh–10b) is amended— (1) in subsection (b)— (A) in paragraph (2)— (i) by striking ‘‘and behavioral’’ and inserting ‘‘, behavioral, developmental’’; and (ii) by striking ‘‘; and’’ and inserting a semicolon; (B) in paragraph (3), by striking the pe- riod and inserting ‘‘; and’’; and (C) by adding at the end the following: ‘‘(4) provide advice and consultation with re- spect to continuity of care and education for all chil- dren and supporting parents and caregivers during all-hazards emergencies.’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3331 (2) in subsection (d)(2)— (A) in subparagraph (C), by striking ‘‘care; and’’ and inserting ‘‘care;’’; (B) by redesignating subparagraph (D) as subparagraph (E); (C) by inserting after subparagraph (C) the following: ‘‘(D) at least 4 non-Federal members rep- resenting child care settings, State or local edu- cational agencies, individuals with expertise in children with disabilities, and parents; and’’; and (D) in subparagraph (E), as so redesig- nated— (i) by striking clause (ii); and (ii) by redesignating clauses (iii) and (iv) as clauses (ii) and (iii), respectively.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3332 Subtitle C—Accelerating Research and Countermeasure Discovery CHAPTER 1—FOSTERING RESEARCH AND DEVELOPMENT AND IMPROVING CO- ORDINATION SEC.

2301.

RESEARCH CENTERS FOR PATHOGENS OF PAN- DEMIC CONCERN.

Subpart 6 of part C of title IV of the Public Health Service Act is amended by inserting after section 447C (42 U.S.C.

285f–4) the following: ‘‘SEC.

447D.


RESEARCH CENTERS FOR PATHOGENS OF PAN- DEMIC CONCERN.
‘‘(a) IN GENERAL.—The Director of the Institute, in collaboration, as appropriate, with the directors of applica- ble institutes, centers, and divisions of the National Insti- tutes of Health, the Assistant Secretary for Preparedness and Response, and the Director of the Biomedical Ad- vanced Research and Development Authority, shall estab- lish or continue a multidisciplinary research program to advance the discovery and preclinical development of med- ical products for priority virus families and other viral pathogens with a significant potential to cause a pan- demic, through support for research centers.
‘‘(b) USES OF FUNDS.—The Director of the Institute shall award funding through grants, contracts, or coopera- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3333 tive agreements to public or private entities to provide support for research centers described in subsection (a) for the purpose of— ‘‘(1) conducting basic research through pre- clinical development of new medical products or technologies, including platform technologies, to ad- dress pathogens of pandemic concern; ‘‘(2) identifying potential targets for thera- peutic candidates, including antivirals, to treat such pathogens; ‘‘(3) identifying existing medical products with the potential to address such pathogens, including candidates that could be used in outpatient settings; and ‘‘(4) carrying out or supporting other research related to medical products to address such patho- gens, as determined appropriate by the Director.
‘‘(c) COORDINATION.—The Director of the Institute shall, as appropriate, provide for the coordination of ac- tivities among the centers described in subsection (a), in- cluding through— 22 23 24 ‘‘(1) facilitating the exchange of information and regular communication among the centers, as appropriate; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3334 ‘‘(2) requiring the periodic preparation and sub- mission to the Director of reports on the activities of each center.

‘‘(d) PRIORITY.—In awarding funding through grants, contracts, or cooperative agreements under sub- section (a), the Director of the Institute shall, as appro- priate, give priority to applicants with existing frameworks and partnerships, as applicable, to support the advance- ment of such research.
10 ‘‘(e) COLLABORATION.—The Director of the Institute 11 shall— ‘‘(1) collaborate with the heads of other appro- priate Federal departments, agencies, and offices with respect to the identification of additional pri- ority virus families and other viral pathogens with a significant potential to cause a pandemic; and ‘‘(2) collaborate with the Director of the Bio- medical Advanced Research and Development Au- thority with respect to the research conducted by centers described in subsection (a), including, as ap- propriate, providing any updates on the research ad- vancements made by such centers, identifying any advanced research and development needs for such countermeasures, consistent with section 319L(a)(6), and taking into consideration existing December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3335 manufacturing capacity and future capacity needs for such medical products or technologies, including platform technologies, supported by the centers de- scribed in subsection (a).

‘‘(f) SUPPLEMENT, NOT SUPPLANT.—Any support received by a center described in subsection (a) under this section shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported.’’.

SEC.

2302.
SEC.

2302.

IMPROVING MEDICAL COUNTERMEASURE RE- SEARCH COORDINATION.

Section 402(b) in the Public Health Service Act (42 13 U.S.C.
282(b)) is amended— (1) in paragraph (24), by striking ‘‘and’’ at the end; (2) in paragraph (25), by striking the period and inserting a semicolon; and (3) by inserting after paragraph (25) the fol- lowing: ‘‘(26) shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Fed- eral agencies and offices, as appropriate, regarding December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3336 research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging in- fectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;’’.

SEC.

2303.

ACCESSING SPECIMEN SAMPLES AND DIAG- NOSTIC TESTS.
(a) IMPROVING RESEARCH AND DEVELOPMENT OF MEDICAL COUNTERMEASURES FOR NOVEL PATHO- GENS.— (1) SAMPLE ACCESS.—Not later than 1 year after the date of enactment of this Act, the Sec- retary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’) shall make pub- licly available policies and procedures related to pub- lic and private entities accessing specimens of, or specimens containing, pathogens or suitable surro- gates for, or alternatives to, such pathogens as the Secretary determines appropriate to support public health preparedness and response activities or bio- medical research for purposes of the development and validation, as applicable, of medical products to address emerging infectious diseases and for use to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3337 otherwise respond to emerging infectious diseases.

Such policies and procedures shall take into account, as appropriate, any applicable existing Federal re- sources.
(2) GUIDANCE.—The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including— (A) the method for requesting such sam- ples; (B) considerations for sample availability and use of suitable surrogates or alternatives to such pathogens, as appropriate, including appli- cable safeguard and security measures; and (C) information required to be provided in order to receive such samples or suitable surro- gates or alternatives.
(b) EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.—Title III of the Public Health Service Act is amended by inserting after section 319A (42 U.S.C.

1 247d–1) the following: ‘‘SEC.

319B.

EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.


‘‘The Secretary may contract with public and private entities, as appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3338 of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency.’’.

SEC.

2304.

NATIONAL ACADEMIES OF SCIENCES, ENGINEER- ING, AND MEDICINE STUDY ON NATURAL IM- MUNITY IN RELATION TO THE COVID–19 PAN- DEMIC.
(a) IN GENERAL.—Not later than 45 days after the date of enactment of this Act, the Secretary of Health and Human Services shall seek to enter into a contract with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the ‘‘National Academies’’) to conduct a study related to the current sci- entific evidence on the durability of immunity to COVID– 19.
(b) INCLUSIONS.—The study pursuant to the con- tract under subsection (a) shall include— (1) an assessment of scientific evidence related to the durability of immunity resulting from SARS– CoV–2 infection, COVID–19 vaccination, or both, including any differences between population groups; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3339 (2) an assessment of the extent to which the Federal Government makes publicly available the scientific evidence used by relevant Federal depart- ments and agencies to inform public health rec- ommendations related to immunity resulting from SARS–CoV–2 infection and COVID–19 vaccination; and (3) a summary of scientific studies and evidence related to SARS–CoV–2 infection-acquired immunity from a sample of other countries or multilateral or- ganizations.
(c) REPORT.—Not later than 18 months after the date of enactment of this Act, the National Academies shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the study pursuant to subsection (a).

CHAPTER 2—IMPROVING BIOSAFETY AND BIOSECURITY SEC.

2311.

IMPROVING CONTROL AND OVERSIGHT OF SE- LECT BIOLOGICAL AGENTS AND TOXINS.
Section 351A of the Public Health Service Act (42 U.S.C.

262a) is amended— 24 25 (1) in subsection (b)(1), by amending subpara- graph (A) to read as follows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3340 ‘‘(A) proper training, including with re- spect to notification requirements under this section, of— ‘‘(i) individuals who are involved in the handling and use of such agents and toxins, including appropriate skills to han- dle such agents and toxins; ‘‘(ii) individuals whose responsibilities routinely place them in close proximity to laboratory facilities in which such agents and toxins are being transferred, pos- sessed, or used; and ‘‘(iii) individuals who perform admin- istrative or oversight functions of the facil- ity related to the transfer, possession, or use of such agents and toxins on behalf of registered persons;’’; (2) in subsection (e)(1), by striking ‘‘(including the risk of use in domestic or international ter- rorism)’’ and inserting ‘‘(including risks posed by the release, theft, or loss of such agent or toxin, or use in domestic or international terrorism)’’; (3) in subsection (k)— (A) by redesignating paragraphs (1) and (2) as paragraphs (2) and (3), respectively; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3341 (B) by inserting before paragraph (2), as so redesignated, the following: ‘‘(1) NOTIFICATION WITH RESPECT TO FED- ERAL FACILITIES.—In the event of the release, loss, or theft of an agent or toxin listed by the Secretary pursuant to subsection (a)(1), or by the Secretary of Agriculture pursuant to section 212(a)(1) of the Ag- ricultural Bioterrorism Protection Act of 2002, from or within a laboratory facility owned or operated by the Department of Health and Human Services, or other Federal laboratory facility subject to the re- quirements of this section, the Secretary, in a man- ner that does not compromise national security, shall— ‘‘(A) not later than 72 hours after such event is reported to the Secretary, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives of such event, including— ‘‘(i) the Federal laboratory facility in which such release, loss, or theft occurred; and ‘‘(ii) the circumstances of such re- lease, loss, or theft; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3342 ‘‘(B) not later than 14 days after such no- tification, update such Committees on— ‘‘(i) any actions taken or planned by the Secretary to mitigate any potential threat such release, loss, or theft may pose to public health and safety; and ‘‘(ii) any actions taken or planned by the Secretary to review the circumstances of such release, loss, or theft, and prevent similar events.’’; and (C) by amending paragraph (2), as so re- designated, to read as follows: ‘‘(2) ANNUAL REPORT.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Representatives on an annual basis a report— ‘‘(A) summarizing the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (re- lating to releases), during the preceding fiscal year; ‘‘(B) describing actions taken by the Sec- retary to address such incidents, such as any corrective action plans required and steps taken December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3343 to promote adherence to, and compliance with, safety and security best practices, standards, and regulations; and ‘‘(C) describing any gaps, challenges, or limitations with respect to ensuring that such safety and security practices are consistently applied and adhered to, and actions taken to address such gaps, challenges, or limitations.’’; and (4) in subsection (m), by striking ‘‘fiscal years 2002 through 2007’’ and inserting ‘‘fiscal years 2023 through 2027’’.

SEC.

2312.
SEC.

2312.

STRATEGY FOR FEDERAL HIGH-CONTAINMENT LABORATORIES.
(a) STRATEGY FOR FEDERAL HIGH-CONTAINMENT LABORATORIES.—Not later than 1 year after the date of enactment of this Act, the Director of the Office of Science and Technology Policy, in consultation with relevant Fed- eral departments and agencies, shall establish a strategy for the management, maintenance, and oversight of feder- ally-owned laboratory facilities operating at Biosafety Level 3 or 4, including equivalent classification levels and facilities with Biosafety Level 4 capabilities.
Such strategy shall include— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3344 (1) a description of the roles and responsibil- ities of relevant Federal departments and agencies with respect to the management, maintenance, and oversight of Biosafety Level 3 or 4 laboratory facili- ties; (2) an assessment of the needs of the Federal Government with respect to Biosafety Level 3 or 4 laboratory facilities; (3) a summary of existing federally-owned Bio- safety Level 3 or 4 laboratory facility capacity; (4) a summary of other Biosafety Level 3 or 4 laboratory facility capacity established through Fed- eral funds; (5) a description of how the capacity described in paragraphs (3) and (4) addresses the needs of the Federal Government, including— (A) how relevant Federal departments and agencies coordinate to provide access to appro- priate laboratory facilities to reduce unneces- sary duplication; and (B) any gaps in such capacity related to such needs; (6) a summary of plans that are in place for the maintenance of such capacity within each rel- evant Federal department or agency, as applicable December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3345 and appropriate, including processes for determining whether to maintain or expand such capacity, and a description of how the Federal Government will ad- dress rapid changes in the need for such capacity within each relevant Federal department or agency during a public health emergency; and (7) a description of how the heads of relevant Federal departments and agencies will coordinate to ensure appropriate oversight of federally-owned lab- oratory facility capacity and leverage such capacity within each relevant Federal department, as appro- priate, to fulfill the needs of each Federal depart- ment and agency in order to reduce unnecessary du- plication and improve collaboration within the Fed- eral Government.
(b) CLARIFICATION.—The strategy under subsection (a) shall not be construed to supersede the authorities of each relevant Federal department or agency with respect to the management, maintenance, and oversight of the Federally-owned laboratory facilities operated by any such Federal department or agency.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3346 SEC.

2313.
3346 SEC.

2313.

NATIONAL SCIENCE ADVISORY BOARD FOR BIO- SECURITY.

(a) IN GENERAL.—Part A of title IV of the Public Health Service Act (42 U.S.C.

281 et seq.)

is amended by adding at the end the following: ‘‘SEC.

404O.

NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.


‘‘(a) ESTABLISHMENT.—The Secretary, acting through the Director of NIH, shall establish an advisory committee, to be known as the ‘National Science Advisory Board for Biosecurity’ (referred to in this section as the 12 ‘Board’).
26 ‘‘(b) DUTIES.— ‘‘(1) IN GENERAL.—The National Science Advi- sory Board for Biosecurity referred to in section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417) (referred to in this section as the ‘Board’) shall provide technical advice, guidance, or recommendations, to relevant Federal depart- ments and agencies related to biosafety and biosecu- rity oversight of biomedical research, including— ‘‘(A) oversight of federally-conducted or federally-supported dual use biomedical re- search, such as the review of policies or frame- works used to assess and appropriately manage safety and security risks associated with such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3347 research, taking into consideration national se- curity concerns, the potential benefits of such research, considerations related to the research community, transparency, and public avail- ability of information, and international re- search collaboration; and ‘‘(B) continuing to carry out the activities required under section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417).
‘‘(c) CONSIDERATIONS.—In carrying out the duties under subsection (b), the Board may consider strategies to improve the safety and security of biomedical research, including through— ‘‘(1) leveraging or using new technologies and scientific advancements to reduce safety and security risks associated with such research and improve con- tainment of pathogens; and ‘‘(2) outreach to, and education and training of, researchers, laboratory personnel, and other appro- priate individuals with respect to safety and security risks associated with such research and mitigation of such risks.
‘‘(d) MEMBERSHIP.—The Board shall be composed of 25 the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3348 ‘‘(1) Non-voting, ex officio members, including the following: ‘‘(A) At least one representative of each of the following: ‘‘(i) The Department of Health and Human Services.

‘‘(ii) The Department of Defense.

‘‘(iii) The Department of Agriculture.

‘‘(iv) The Department of Homeland Security.

‘‘(v) The Department of Energy.

‘‘(vi) The Department of State.


‘‘(vii) The Office of Science and Tech- nology Policy.

‘‘(viii) The Office of the Director of National Intelligence.

‘‘(B) Representatives of such other Federal departments or agencies as the Secretary deter- mines appropriate to carry out the requirements of this section.
‘‘(2) Individuals, appointed by the Secretary, with expertise in biology, infectious diseases, public health, ethics, national security, and other fields, as the Secretary determines appropriate, who shall serve as voting members.’’.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3349 (b) ORDERLY TRANSITION.—The Secretary of Health and Human Services shall take such steps as are necessary to provide for the orderly transition to the au- thority of the National Science Advisory Board for Bio- security established under section 404O of the Public Health Service Act, as added by subsection (a), from any authority of the Board described in section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417), as in effect on the day before the date of enact- 10 ment of this Act.
(c) APPLICATION.—The requirements under section 404O of the Public Health Service Act, as added by sub- section (a), related to the mission, activities, or functions of the National Science Advisory Board for Biosecurity shall not apply until the completion of any work under- taken by such Board before the date of enactment of this 17 Act.

18 SEC.

2314.

RESEARCH TO IMPROVE BIOSAFETY.


(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’) shall, as appropriate, conduct or support research to improve the safe conduct of biomedical research activi- ties involving pathogens of pandemic potential or biologi- cal agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C.

262a(a)(1)).
262a(a)(1)).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3350 (b) REPORT.—Not later than 5 years after the date of enactment of this Act, the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding an overview of any research conducted or sup- ported under this section, any relevant findings, and steps the Secretary is taking to disseminate any such findings to support the reduction of risks associated with bio- medical research involving pathogens of pandemic poten- tial or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C.
13 262a(a)(1)).

14 SEC.

2315.

FEDERALLY-FUNDED RESEARCH WITH EN- HANCED PATHOGENS OF PANDEMIC POTEN- TIAL.
(a) REVIEW AND OVERSIGHT OF ENHANCED PATHO- GENS OF PANDEMIC POTENTIAL.— (1) IN GENERAL.—The Director of the Office of Science and Technology Policy (referred to in this section as the ‘‘Director’’), in consultation with the heads of relevant Federal departments and agencies, shall— (A) not later than 1 year after the date of enactment of this Act— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3351 (i) continue or conduct a review of ex- isting Federal policies related to research proposed for Federal funding that may be reasonably anticipated to involve the cre- ation, transfer, or use of enhanced patho- gens of pandemic potential; and (ii) establish or update a Federal pol- icy for the consistent review and oversight of such proposed research that appro- priately considers the risks associated with, and potential benefits of, such research; and (B) not less than every 4 years thereafter, review and update such policy, as necessary and appropriate, to ensure that such policy fully ac- counts for relevant research that may be rea- sonably anticipated to involve the creation, transfer, or use of enhanced pathogens of pan- demic potential, takes into consideration the benefits of such research, and supports the mitigation of related risks.
(2) REQUIREMENTS.—The policy established pursuant to paragraph (1) shall include— (A) a clear scope to support the consistent identification of research proposals subject to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3352 such policy by relevant Federal departments and agencies; (B) a framework for such reviews that ac- counts for safety, security, and ethical consider- ations related to the creation, transfer, or use of enhanced pathogens of pandemic potential; (C) measures to enhance the transparency and public availability of information related to such research activities in a manner that does not compromise national security, the safety and security of such research activities, or any identifiable, sensitive information of relevant in- dividuals; and (D) consistent procedures across relevant Federal department and agencies to ensure that— (i) proposed research that has been determined to have scientific and technical merit and may be subject to such policy is identified and referred for review; (ii) subjected research activities con- ducted under an award, including activities undertaken by any subrecipients of such award, are monitored regularly throughout the project period to ensure compliance December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3353 with such policy and the terms and condi- tions of such award; and (iii) in the event that federally-funded research activities not subject to such pol- icy produce unanticipated results related to the creation, transfer, or use of enhanced pathogens of pandemic potential, such re- search activities are identified and appro- priately reviewed under such policy.
(3) CLARIFICATION.—Reviews required pursu- ant to this section shall be in addition to any appli- cable requirements for research project applications required under the Public Health Service Act, in- cluding reviews required under section 492 of such Act (42 U.S.C.

289a), as applicable, or other appli- cable laws.


(b) IMPLEMENTATION.— (1) IN GENERAL.—The Director shall direct all heads of relevant Federal departments and agencies to update, modernize, or promulgate applicable im- plementing guidance to implement the requirements of this section.
(2) UPDATES.—Consistent with the require- ments under subsection (a)(1)(B), the Director shall require all heads of relevant Federal departments December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3354 and agencies to update such policies consistent with any changes to the policy established pursuant to subsection (a)(1).
(c) LIMITATIONS ON COUNTRIES OF CONCERN CON- DUCTING CERTAIN RESEARCH.— (1) IN GENERAL.—Beginning not later than 60 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall not fund research conducted by a foreign entity at a fa- cility located in a country of concern, in the esti- mation of the Director of National Intelligence or the head of another relevant Federal department or agency, as appropriate, in consultation with the Sec- retary of Health and Human Services, involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C.
262a(a)(1)).

(2) CONDITIONS FOR LIFTING OR SUSPENDING PROHIBITION.—The Secretary of Health and Human Services may lift or suspend the prohibition of funding under paragraph (1)— (A) only after the review required under subsection (a)(1)(A)(i) is complete; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3355 (B) only if the Secretary notifies Congress not less than 15 days before such prohibition is lifted or suspended.

CHAPTER 3—PREVENTING UNDUE FOR- EIGN INFLUENCE IN BIOMEDICAL RE- SEARCH SEC.

2321.

FOREIGN TALENT RECRUITMENT PROGRAMS.


(a) INTRAMURAL RESEARCH.— (1) IN GENERAL.—Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this chapter as the ‘‘Secretary’’) shall prohibit personnel of the National Institutes of Health engaged in in- tramural research from participation in foreign tal- ent recruitment programs.
(2) EXEMPTION.—Paragraph (1) shall not apply to participation in international conferences or other international exchanges, partnerships, or pro- grams, for which such participation has been ap- proved by the National Institutes of Health.

In such circumstances, the National Institutes of Health shall ensure appropriate training is provided to the participant on how to respond to overtures from in- dividuals associated with foreign talent recruitment programs.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3356 (b) EXTRAMURAL RESEARCH.—The Secretary shall require disclosure of participation in foreign talent recruit- ment programs, including the provision of copies of all grants, contracts, or other agreements related to such pro- grams, and other supporting documentation related to such programs, as a condition of receipt of Federal extra- mural biomedical research funding awarded through the Department of Health and Human Services.
(c) CONSISTENCY.—The Secretary shall ensure that the policies developed, updated, or issued pursuant to sub- sections (a) and (b) are, to the greatest extent practicable, consistent with the requirements of subtitle D of title VI of division B of Public Law 117–167 (42 U.S.C.

19231 et seq.)

related to foreign talent recruitment programs.

SEC.

2322.

SECURING IDENTIFIABLE, SENSITIVE INFORMA- TION AND ADDRESSING OTHER NATIONAL SECURITY RISKS RELATED TO RESEARCH.
(a) IN GENERAL.—The Secretary of Health and Human Services, in consultation with the Director of Na- tional Intelligence, the Secretary of State, the Secretary of Defense, and other national security experts, as appro- priate, shall ensure that biomedical research conducted or supported by the National Institutes of Health and other relevant agencies and offices within the Department of Health and Human Services is conducted or supported in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3357 a manner that appropriately considers national security risks, including national security implications related to research involving the sequencing of human genomic infor- mation, and collection, analysis, or storage of identifiable, sensitive information, as defined in section 301(d)(4) of the Public Health Service Act (42 U.S.C.

241(d)(4)), and the potential misuse of such data.
Not later than 2 years after the date of enactment of this Act, the Secretary shall ensure that the National Institutes of Health and other relevant agencies and offices within the Department of Health and Human Services, in consultation with the heads of agencies and national security experts, including the Office of the National Security within the Department of Health and Human Services— (1) develop a comprehensive framework and policies for assessing and managing such national security risks that includes, or review and update, as appropriate, the current (as of the date of review) such framework and policies to include— (A) criteria for how and when to conduct risk assessments for projects that may have na- tional security implications; (B) security controls and training for re- searchers or entities, including peer reviewers, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3358 that manage or have access to such data that may present national security risks; and (C) methods to incorporate risk mitigation in the process for funding such projects that may have national security implications and monitor associated research activities following issuance of an award, including changes in the terms and conditions related to the use of such funds, as appropriate; (2) not later than 1 year after the framework and policies are developed or reviewed and updated, as applicable, under paragraph (1), develop and im- plement controls to ensure that— (A) researchers or entities involved in projects reviewed under the framework and rel- evant policies, including such projects that manage or have access to sensitive, identifiable information, have complied with the require- ments of paragraph (1) and ongoing require- ments with such paragraph; (B) consideration of funding for projects that may have national security implications takes into account the extent to which the coun- try in which the proposed research will be con- ducted or supported poses a risk to the integ- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3359 rity of the United States biomedical research enterprise; and (C) data access committees reviewing data access requests for projects that may have na- tional security risks, as appropriate, include members with expertise in current and emerg- ing national security threats, in order to make appropriate decisions, including related to ac- cess to such identifiable, sensitive information; and (3) not later than 2 years after the framework and relevant policies are developed or reviewed and updated, as applicable, under paragraph (1), update data access and sharing policies related to human genomic data, as applicable, based on current and emerging national security threats.
(b) CONGRESSIONAL BRIEFING.—Not later than 1 year after the date of enactment of this Act, the Secretary shall provide a briefing to the Committee on Health, Edu- cation, Labor, and Pensions and the Select Committee on Intelligence of the Senate and the Committee on Energy and Commerce and the Permanent Select Committee on Intelligence of the House of Representatives on the activi- ties required under subsection (a).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

SEC.

2323.

DUTIES OF THE DIRECTOR.

3360 Section 402(b) in the Public Health Service Act (42 U.S.C.
282(b)), as amended by section 2302, is further amended by inserting after paragraph (26) (as added by section 2302) the following: ‘‘(27) shall consult with the Director of the Of- fice of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of Na- tional Intelligence, the Director of the Federal Bu- reau of Investigation, and the heads of other appro- priate agencies on a regular basis, regarding bio- medical research conducted or supported by the Na- tional Institutes of Health that may affect or be af- fected by matters of national security; ‘‘(28) shall ensure that recipients of awards from the National Institutes of Health, and, as ap- propriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, includ- ing information collected, stored, managed, or ana- lyzed by domestic and non-domestic entities; and ‘‘(29) shall ensure that recipients of awards from the National Institutes of Health are in compli- ance with the terms and conditions of such award, 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3361 which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.’’.

SEC.

2324.

PROTECTING AMERICA’S BIOMEDICAL RE- SEARCH ENTERPRISE.
(a) IN GENERAL.—The Secretary, in consultation with the Assistant to the President for National Security Affairs, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other relevant departments and agencies, and in consulta- tion with research institutions and research advocacy or- ganizations or other relevant experts, as appropriate, 13 shall— (1) identify ways to improve the protection of intellectual property and other proprietary informa- tion, as well as identifiable, sensitive information of participants in biomedical research and development, from national security risks and other applicable threats, including the identification of gaps in poli- cies and procedures in such areas related to bio- medical research and development supported by the Department of Health and Human Services, and make recommendations to institutions of higher edu- cation or other entities that have traditionally re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3362 ceived Federal funding for biomedical research to protect such information; (2) identify or develop strategies to prevent, mitigate, and address national security risks and threats in biomedical research and development sup- ported by the Federal Government, including such threats associated with foreign talent programs, by countries seeking to exploit United States technology and other proprietary information as it relates to such biomedical research and development, and make recommendations for additional policies and procedures to protect such information; (3) identify national security risks and potential misuse of proprietary information, and identifiable, sensitive information of biomedical research partici- pants and other applicable risks, including with re- spect to peer review, and make recommendations for additional policies and procedures to protect such in- formation; (4) develop a framework to identify areas of biomedical research and development supported by the Federal Government that are emerging areas of interest for state actors and would compromise na- tional security if they were to be subjected to undue foreign influence; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3363 (5) regularly review recommendations or poli- cies developed under this section and make addi- tional recommendations or updates, as appropriate.
(b) REPORT TO PRESIDENT AND TO CONGRESS.— Not later than 1 year after the date of enactment of this Act, the Secretary shall prepare and submit, in a manner that does not compromise national security, to the Presi- dent and the Committee on Health, Education, Labor, and Pensions and the Select Committee on Intelligence of the Senate, the Committee on Energy and Commerce and the Permanent Select Committee on Intelligence of the House of Representatives, and other congressional committees as appropriate, a report on the findings and recommenda- tions pursuant to subsection (a).
SEC.

2325.

GAO STUDY.
(a) IN GENERAL.—The Comptroller General of the United States (referred to in this section as the ‘‘Comp- troller General’’) shall conduct a study to assess the extent to which the Department of Health and Human Services (referred to in this section as the ‘‘Department’’) utilizes or provides funding to entities that utilize such funds for human genomic sequencing services or genetic services (as such term is defined in section 201(6) of the Genetic In- formation Nondiscrimination Act of 2008 (42 U.S.C.
2000ff(6))) provided by entities, or subsidiaries of such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3364 entities, organized under the laws of a country or coun- tries of concern, in the estimation of the Director of Na- tional Intelligence or the head of another Federal depart- ment or agency, as appropriate.
(b) CONSIDERATIONS.—In carrying out the study under this section, the Comptroller General shall— (1) consider— (A) the extent to which the country or countries of concern could obtain human genomic information of citizens and residents of the United States from such entities that se- quence, analyze, collect, or store human genomic information and which the Director of National Intelligence or the head of another Federal department or agency reasonably an- ticipates may use such information in a manner inconsistent with the national security interests of the United States; (B) whether the Department or recipient of such funds from the Department sought to provide funding to, or to use, domestic entities with no such ties to the country or countries of concern for such purposes and any barriers to the use of domestic entities; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3365 (C) whether data use agreements, data se- curity measures, and other such measures taken by the Department or recipient of such funds from the Department are sufficient to protect the identifiable, sensitive information of the people of the United States and the national se- curity interests of the United States; and (2) make recommendations to address any vulnerabilities to the United States national security identified, as appropriate.
(c) ESTIMATION.—In conducting the study under this section, the Comptroller General may, as appropriate and necessary to complete such study, investigate specific in- stances of such utilization of genetic sequencing services or genetic services, as described in subsection (a), to produce estimates of the potential prevalence of such utili- zation among entities in receipt of Departmental funds.
(d) REPORT.—Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit a report on the study under this section, in a man- ner that does not compromise national security, to the Committee on Health, Education, Labor, and Pensions and the Select Committee on Intelligence of the Senate, and the Committee on Energy and Commerce and the Per- manent Select Committee on Intelligence of the House of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3366 Representatives.

The report shall be submitted in unclassi- fied form, to the extent practicable, but may include a classified annex.

SEC.

2326.

REPORT ON PROGRESS TO ADDRESS UNDUE FOREIGN INFLUENCE.
Not later than 1 year after the date of enactment of this Act and annually thereafter, the Secretary shall prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce in the House of Rep- resentatives, in a manner that does not compromise na- tional security, a report on actions taken by the Sec- 13 retary— (1) to address cases of noncompliance with dis- closure requirements or research misconduct related to foreign influence, including— (A) the number of potential noncompliance cases investigated by the National Institutes of Health or reported to the National Institutes of Health by a research institution, including re- lating to undisclosed research support, undis- closed conflicts of interest or other conflicts of commitment, and peer review violations; (B) the number of cases referred to the Office of Inspector General of the Department December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3367 of Health and Human Services, the Office of National Security of the Department of Health and Human Services, the Federal Bureau of In- vestigation, or other law enforcement agencies; (C) a description of enforcement actions taken for noncompliance related to undue for- eign influence; and (D) any other relevant information; and (2) to prevent, address, and mitigate instances of noncompliance with disclosure requirements or re- search misconduct related to foreign influence.
CHAPTER 4—ADVANCED RESEARCH PROJECTS AGENCY–HEALTH SEC.

2331.

ADVANCED RESEARCH PROJECTS AGENCY– HEALTH.

(a) IN GENERAL.—Title IV of the Public Health Service Act is amended by adding at the end the following: ‘‘PART J—ADVANCED RESEARCH PROJECTS AGENCY–HEALTH.

‘‘SEC.

499A.

ADVANCED RESEARCH PROJECTS AGENCY– HEALTH.


‘‘(a) ESTABLISHMENT.— ‘‘(1) IN GENERAL.—There is established within the National Institutes of Health the Advanced Re- search Projects Agency–Health (referred to in this December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3368 section as ‘ARPA–H’).


Not later than 180 days after the date of enactment of this section, the Sec- retary shall transfer all functions, personnel, mis- sions, activities, authorities, and funds of the Ad- vanced Research Projects Agency for Health as in existence on the date of enactment of this section, to ARPA–H established by the preceding sentence.
‘‘(2) ORGANIZATION.— ‘‘(A) IN GENERAL.—There shall be within ARPA–H— ‘‘(i) an Office of the Director; ‘‘(ii) not more than 8 program offices; and ‘‘(iii) such special project offices as the Director may establish.

‘‘(B) REQUIREMENT.—Not fewer than two-thirds of the program offices of ARPA–H shall be exclusively dedicated to supporting re- search and development activities, consistent with the goals and functions described in sub- section (b).
‘‘(C) NOTIFICATION.—The Director shall submit a notification to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3369 and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives if the Director deter- mines that additional program offices are re- quired to carry out this section.
‘‘(3) EXEMPTION FROM CERTAIN POLICIES OF NIH.— ‘‘(A) IN GENERAL.—Except as otherwise provided for in this section, and subject to sub- paragraph (B), in establishing ARPA–H pursu- ant to paragraph (1), the Secretary may exempt ARPA–H from policies and requirements of the National Institutes of Health that are in effect on the day before the date of enactment of this section as necessary and appropriate to ensure ARPA–H can most effectively achieve the goals described in subsection (b)(1).
‘‘(B) NOTICE.—Not later than 90 days after the date of enactment of this section, the Secretary shall publish a notice in the Federal Register describing the specific policies and re- quirements of the National Institutes of Health from which the Secretary intends to exempt ARPA–H, including a rationale for such exemp- tions.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3370 ‘‘(b) GOALS AND FUNCTIONS.— ‘‘(1) GOALS.—The goals of ARPA–H shall be to— ‘‘(A) foster the development of novel, breakthrough, and broadly applicable capabili- ties and technologies to accelerate trans- formative innovation in biomedical science and medicine in a manner that cannot be readily ac- complished through traditional Federal bio- medical research and development programs or commercial activity; ‘‘(B) revolutionize the detection, diagnosis, mitigation, prevention, treatment, and cure of diseases and health conditions by overcoming long-term and significant technological and sci- entific barriers to developing transformative health technologies; ‘‘(C) promote high-risk, high-reward inno- vation to enable the advancement of trans- formative health technologies; and ‘‘(D) contribute to ensuring the United States— ‘‘(i) pursues initiatives that aim to maintain global leadership in science and innovation; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3371 ‘‘(ii) improves the health and wellbeing of its citizens by supporting the advancement of biomedical science and in- novation.
‘‘(2) FUNCTIONS.—ARPA–H shall achieve the goals specified in paragraph (1) by addressing spe- cific scientific or technical questions by involving high-impact transformative, translational, applied, and advanced research in relevant areas of science, by supporting— ‘‘(A) discovery, identification, and pro- motion of revolutionary advancements in science; ‘‘(B) translation of scientific discoveries into transformative health technologies with po- tential application for biomedical science and medicine; ‘‘(C) creation of platform capabilities that draw on multiple disciplines; ‘‘(D) delivery of proofs of concept that demonstrate meaningful advances with potential clinical application; ‘‘(E) development of new capabilities and methods to identify potential targets and tech- nological strategies for early disease detection December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3372 and intervention, such as advanced computa- tional tools and predictive models; and ‘‘(F) acceleration of transformational health technological advances in areas with lim- ited technical certainty.

‘‘(c) DIRECTOR.— ‘‘(1) IN GENERAL.—The President shall ap- point a director of ARPA–H (in this section referred to as the ‘Director’).
‘‘(2) QUALIFICATIONS.—The Director shall be an individual who, by reason of professional back- ground and experience— ‘‘(A) is especially qualified to advise the Secretary on, and manage— ‘‘(i) research and development pro- grams; and ‘‘(ii) large-scale, high-risk initiatives with respect to health research and tech- nology development across multiple sectors, including identifying and supporting poten- tially transformative health technologies; and ‘‘(B) has a demonstrated ability to identify and develop partnerships to address strategic December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3373 needs in meeting the goals described in sub- section (b)(1).

‘‘(3) REPORTING.—The Director shall report to the Secretary of Health and Human Services.

‘‘(4) DUTIES.—The duties of the Director shall include the following: ‘‘(A) Establish strategic goals, objectives, and priorities for ARPA–H to advance the goals described in subsection (b)(1).

‘‘(B) Approve the projects and programs of ARPA–H and restructure, expand, or terminate any project or program within ARPA–H that is not achieving its goals.
‘‘(C) Develop funding criteria and assess the success of programs through the establish- ment of technical milestones.

‘‘(D) Request that applications for funding disclose current and previous research and de- velopment efforts related to such applications, as appropriate, and identify any challenges as- sociated with such efforts, including any sci- entific or technical barriers encountered in the course of such efforts or challenges in securing sources of funding, as applicable.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3374 ‘‘(E) Coordinate with the heads of relevant Federal departments and agencies to facilitate sharing of data and information, as applicable and appropriate, and ensure that research sup- ported by ARPA–H is informed by and supple- ments, not supplants, the activities of such de- partments and agencies and is free of unneces- sary duplication of effort.
‘‘(F) Ensure ARPA–H does not provide funding for a project unless the program man- ager determines that the project aligns with the goals described in subsection (b)(1).
‘‘(G) Prioritize investments based on con- siderations such as— ‘‘(i) scientific opportunity and poten- tial impact, especially in areas that fit within the strategies and operating prac- tices of ARPA–H and require public-pri- vate partnerships to effectively advance re- search and development activities; and ‘‘(ii) the potential applications that an innovation may have to address areas of currently unmet need in medicine and health, including health disparities and the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3375 potential to prevent progression to serious disease.
‘‘(H) Encourage strategic collaboration and partnerships with a broad range of entities, which may include institutions of higher edu- cation, minority-serving institutions (defined, for the purposes of this section, as institutions and programs described in section 326(e)(1) of the Higher Education Act of 1965 and institu- tions described in section 371(a) of such Act), industry, nonprofit organizations, Federally funded research and development centers, or consortia of such entities.
‘‘(5) TERM.—Notwithstanding section 405(a)(2), the Director— ‘‘(A) shall be appointed for a 4-year term; and ‘‘(B) may be reappointed for 1 consecutive 4-year term.
‘‘(6) AUTONOMY OF AGENCY REGARDING REC- OMMENDATIONS AND TESTIMONY.—No office or agency of the United States shall have authority to require the Director to submit legislative rec- ommendations, or testimony or comments on legisla- tion, to any officer or agency of the United States December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3376 for approval, comments, or review prior to the sub- mission of such recommendations, testimony or com- ments to Congress, if such recommendations, testi- mony, or comments to Congress include a statement indicating that the views expressed therein are those of the Director and do not necessarily reflect the views of the President or another Federal depart- ment, agency, or office.

‘‘(7) DEPUTY DIRECTOR.—The Director shall appoint a Deputy Director to serve as the principal assistant to the Director.
‘‘(8) NONAPPLICATION OF CERTAIN PROVI- SION.—The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Ap- propriations Act, 1993 (Public Law 102–394; 42 U.S.C.

238f note) related to consultants and indi- vidual scientists appointed for limited periods of time shall not apply to the Director appointed under this subsection.
‘‘(d) APPLICATION OF CERTAIN FLEXIBILITIES.— The flexibilities provided to the National Institutes of Health under section 301(g) shall apply to ARPA–H with respect to the functions described in subsection (b)(2).

‘‘(e) PROTECTION OF INFORMATION.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3377 ‘‘(1) NO AUTHORIZATION FOR DISCLOSURE.— Nothing in this section shall be construed as author- izing the Director to disclose any information that is a trade secret or other privileged or confidential in- formation subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
‘‘(2) REPORTING.—If there have been requests under section 522 of title 5, United States Code, or the Secretary has used such authority to withhold information within the preceding year, not later than 1 year after the date of enactment of this section, and annually thereafter, the Director shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on En- ergy and Commerce of the House of Representatives on— ‘‘(A) the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclo- sure; and ‘‘(B) the nature of any request under sec- tion 552 of title 5, United States Code, or sec- tion 1905 of title 18, United States Code, that was denied using such authority.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3378 ‘‘(3) CLARIFICATION.—The protections for trade secrets or other privileged or confidential in- formation described in paragraph (1) shall not be construed to limit the availability or disclosure of in- formation necessary to inform and facilitate the evaluation required under subsection (k)(2).
Any such information made available to members of the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the ‘National Academies’) for such evaluation shall be kept con- fidential by such members and shall not be used for any purposes other than informing and facilitating the evaluation required under subsection (k)(2).
‘‘(f) COOPERATION WITH THE FOOD AND DRUG AD- MINISTRATION.— ‘‘(1) IN GENERAL.—In order to facilitate the enhanced collaboration and communication with re- spect to the most current priorities of ARPA–H, the Food and Drug Administration may meet with ARPA–H and any other Federal partners at appro- priate intervals to discuss the development status, and actions that may be taken to facilitate the devel- opment, of medical products and projects that are the highest priorities to ARPA–H.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3379 ‘‘(2) REIMBURSEMENT.—Utilizing interagency agreements or other appropriate resource allocation mechanisms available, the Director shall reimburse, using funds made available to ARPA–H, the Food and Drug Administration, as appropriate, for activi- ties identified by the Commissioner of Food and Drugs and the Director as being conducted by the Food and Drug Administration under the authority of this subsection.
‘‘(g) AWARDS.— ‘‘(1) IN GENERAL.—In carrying out this sec- tion, the Director may— ‘‘(A) award grants and cooperative agree- ments, which shall include requirements to pub- licly report indirect facilities and administrative costs, broken out by fixed capital costs, admin- istrative overhead, and labor costs; ‘‘(B) award contracts, which may include multi-year contracts subject to section 3903 of title 41, United States Code; ‘‘(C) award cash prizes, utilizing the au- thorities and processes established under sec- tion 24 of the Stevenson-Wydler Technology In- novation Act of 1980; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3380 ‘‘(D) enter into other transactions, as de- fined by section 319L(a)(3), subject to para- graph (2).

‘‘(2) LIMITATIONS ON ENTERING INTO OTHER TRANSACTIONS.— ‘‘(A) USE OF COMPETITIVE PROCE- DURES.—To the maximum extent practicable, competitive procedures shall be used when en- tering into other transactions under this sec- tion.
‘‘(B) WRITTEN DETERMINATION RE- QUIRED.—The authority of paragraph (1)(D) may be exercised for a project if the program manager— ‘‘(i) submits a request to the Director for each individual use of such authority before conducting or supporting a pro- gram, including an explanation of why the use of such authority is essential to pro- moting the success of the project; ‘‘(ii) receives approval for the use of such authority from the Director; and ‘‘(iii) for each year in which the pro- gram manager has used such authority in accordance with this paragraph, submits a December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3381 report to the Director on the activities of the program related to such project.

‘‘(3) EXEMPTIONS FROM CERTAIN REQUIRE- MENTS.—Research funded by ARPA–H shall not be subject to the requirements of section 406(a)(3)(A)(ii) or section 492.
‘‘(h) FACILITIES AUTHORITY.— ‘‘(1) IN GENERAL.—The Director is authorized, for administrative purposes, to— ‘‘(A) acquire (by purchase, lease, con- demnation or otherwise), construct, improve, re- pair, operate, and maintain such real and per- sonal property as are necessary to carry out this section; and ‘‘(B) lease an interest in property for not more than 20 years, notwithstanding section 1341(a)(1) of title 31, United States Code.
‘‘(2) LOCATIONS.— ‘‘(A) IN GENERAL.—ARPA–H, including its headquarters, shall not be located on any part of the existing National Institutes of Health campuses.

‘‘(B) NUMBER OF LOCATIONS.—ARPA–H shall have offices or facilities in not less than 3 geographic areas.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3382 ‘‘(C) CONSIDERATIONS.—In determining the location of each office or facility, the Direc- tor shall make a fair and open consideration of— ‘‘(i) the characteristics of the intended location; and ‘‘(ii) the extent to which such location will facilitate advancement of the goals and functions specified in subsection (b).
‘‘(i) PERSONNEL.— ‘‘(1) IN GENERAL.—The Director may— ‘‘(A) appoint and remove scientific, engi- neering, medical, and professional personnel, which may include temporary or term-limited appointments as determined by the Director to fulfill the mission of ARPA–H, without regard to any provision in title 5, United States Code, governing appointments and removals under the civil service laws; ‘‘(B) notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, United States Code, fix the base pay compensation of such personnel at a rate to be determined by the Director, up December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3383 to the amount of annual compensation (exclud- ing expenses) specified in section 102 of title 3, United States Code; and ‘‘(C) contract with private recruiting firms for assistance in identifying highly qualified candidates for technical positions needed to carry out this section.
‘‘(2) SUPPORT STAFF.—The Director may use authorities in existence on the date of enactment of this section that are provided to the Secretary to hire administrative, financial, clerical, and other staff necessary to carry out functions that support the goals and functions described in subsection (b).

‘‘(3) NUMBER OF PERSONNEL.—The Director may appoint not more than 210 personnel under this section.
The Director shall submit a notification to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Com- merce and the Committee on Appropriations of the House of Representatives if the Director determines that additional personnel are required to carry out this section.
‘‘(4) CLARIFICATION ON PREVIOUS POSI- TIONS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3384 ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), the Director shall ensure that the personnel who are appointed to staff or support ARPA–H are individuals who, at the time of appointment and for 3 years prior to such appointment, were not employed by the National Institutes of Health.
The Director may grant an exemption only for individuals who are uniquely qualified, by way of profes- sional background and expertise, to advance the goals and functions specified in subsection (b).

‘‘(B) NONAPPLICATION OF PROVISION.— The restriction provided under subparagraph (A) shall not apply to any individuals who are employed by ARPA–H on the date of enact- ment of this section.
‘‘(5) ADDITIONAL CONSIDERATIONS.—In ap- pointing personnel under this subsection, the Direc- tor— ‘‘(A) may contract with private entities for the purposes of recruitment services; ‘‘(B) shall make efforts to recruit a diverse workforce, including individuals underrep- resented in science, engineering, and medicine, including racial and ethnic minorities, provided December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3385 such efforts do not conflict with applicable Fed- eral civil rights law, and individuals with a vari- ety of professional experiences or backgrounds; and ‘‘(C) shall recruit program managers with demonstrated expertise in a wide range of sci- entific disciplines and management skills.
‘‘(6) USE OF INTERGOVERNMENTAL PER- SONNEL ACT.—To the extent needed to carry out the authorities under paragraph (1) and the goals and functions specified in subsection (b), the Direc- tor may utilize hiring authorities under sections 3371 through 3376 of title 5, United States Code.
‘‘(7) AUTHORITY TO ACCEPT FEDERAL DETAILEES.—The Director may accept officers or employees of the United States or members of the uniformed service on a detail from an element of the Federal Government, on a reimbursable or a nonre- imbursable basis, as jointly agreed to by the heads of the receiving and detailing elements, for a period not to exceed 3 years.
‘‘(j) PROGRAM MANAGERS.— ‘‘(1) IN GENERAL.—The Director shall appoint program managers for 3-year terms (and may re- appoint such program managers for 1 additional December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3386 consecutive 3-year term) for the programs carried out by ARPA–H.
‘‘(2) DUTIES.—A program manager shall— ‘‘(A) establish, in consultation with the Di- rector, research and development goals for pro- grams, including timelines and milestones, and make such goals available to the public; ‘‘(B) manage applications and proposals, through the appropriate officials, for making awards as described in subsection (g) for activi- ties consistent with the goals and functions de- scribed in subsection (b); ‘‘(C) issue funding opportunity announce- ments, using uniform administrative processes, as appropriate; ‘‘(D) select, on the basis of merit, each of the projects to be supported under a program carried out by ARPA–H, and taking into con- sideration— ‘‘(i) the scientific, technical merit, and novelty of the proposed project; ‘‘(ii) the ability of the applicant to successfully carry out the proposed project; ‘‘(iii) the potential future commercial applications of the project proposed by the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3387 applicant, including whether such applica- tions may have the potential to address areas of currently unmet need within bio- medicine and improve health outcomes; ‘‘(iv) the degree to which the proposed project has the potential to transform bio- medicine and addresses a scientific or tech- nical question pursuant to subsection (b); ‘‘(v) the potential for the project to take an interdisciplinary approach; and ‘‘(vi) such other criteria as established by the Director; ‘‘(E) provide project oversight and man- agement of strategic initiatives to advance the program, including by conducting project re- views not later than 18 months after the date of funding awards to identify and monitor progress of milestones with respect to each project and prior to disbursement of additional funds; ‘‘(F) provide recommendations to the Di- rector with respect to advancing the goals and functions specified in subsection (b); ‘‘(G) encourage research collaborations and cultivate opportunities for the application or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3388 utilization of successful projects, including through identifying and supporting applicable public-private partnerships or partnerships be- tween or among award recipients; ‘‘(H) provide recommendations to the Di- rector to establish, expand, restructure, or ter- minate partnerships or projects; and ‘‘(I) communicate and collaborate with leaders and experts within the health care and biomedical research and development fields, in- cluding from both the public and private sectors and, as necessary, through the convening of workshops and meetings, to identify research and development gaps and opportunities and so- licit stakeholder input on programs and goals.
‘‘(k) REPORTS AND EVALUATION.— ‘‘(1) ANNUAL REPORT.— ‘‘(A) IN GENERAL.—Beginning not later than 1 year after the date of enactment of this section, as part of the annual budget request submitted for each fiscal year, the Director shall submit a report on the actions under- taken, and the results generated, by ARPA–H, including— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3389 ‘‘(i) a description of projects sup- ported by ARPA–H in the previous fiscal year and whether such projects are meet- ing the goals developed by the Director pursuant to subsection (c)(4)(A); ‘‘(ii) a description of projects termi- nated in the previous fiscal year, and the reason for such termination; ‘‘(iii) a description of planned pro- grams starting in the next fiscal year, pending the availability of funding; ‘‘(iv) activities conducted in coordina- tion with other Federal departments and agencies; ‘‘(v) a description of any successes with, or barriers to, coordinating with other Federal departments and agencies to achieve the goals and functions under sub- section (b); ‘‘(vi) aggregated demographic infor- mation, if available, of direct recipients and performers in funded projects and of the ARPA–H workforce (consistent with the reporting requirements under para- graph (3)); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3390 ‘‘(vii) a summary of award recipient compliance with section 2321 of the PRE- VENT Pandemics Act.

‘‘(B) SUBMISSION TO CONGRESS.—The re- port under subparagraph (A) shall be submitted to— ‘‘(i) the Committee on Energy and Commerce and the Committee on Appro- priations of the House of Representatives; and ‘‘(ii) the Committee on Health, Edu- cation, Labor, and Pensions and the Com- mittee on Appropriations of the Senate.
‘‘(2) EVALUATION.— ‘‘(A) IN GENERAL.—Not later than 5 years after the date of the enactment of this section, the Director shall seek to enter into an agree- ment with the National Academies under which the National Academies conducts an evaluation of whether ARPA–H is meeting the goals and functions specified in subsection (b).
‘‘(B) SUBMISSION OF RESULTS.—The agreement entered into under subparagraph (A) shall require the National Academies to submit the evaluation conducted under such agreement December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3391 to the Director, the Committee on Health, Edu- cation, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, and make the report publicly available.
‘‘(3) REPORTING RELATED TO ARPA–H PER- SONNEL.— ‘‘(A) IN GENERAL.—The Director shall es- tablish and maintain records regarding the use of the authority under subsection (i)(1)(A), in- cluding— ‘‘(i) the number of positions filled through such authority; ‘‘(ii) the types of appointments of such positions; ‘‘(iii) the titles, occupational series, and grades of such positions; ‘‘(iv) the number of positions publicly noticed to be filled under such authority; ‘‘(v) the number of qualified appli- cants who apply for such positions; ‘‘(vi) the qualification criteria for such positions; and ‘‘(vii) the demographic information of individuals appointed to such positions.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3392 ‘‘(B) REPORTS TO CONGRESS.—Not later than 2 years after the date of enactment of this section, and annually thereafter for each fiscal year in which such authority is used, the Direc- tor shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report de- scribing the total number of appointments filled under subsection (i) within the fiscal year and how the positions relate to the goals and func- tions of ARPA–H.
‘‘(C) GAO REPORT.—Not later than 2 years after the date of enactment of this sec- tion, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Com- merce of the House of Representatives a report on the use of the authority provided under sub- section (i)(1)(A).
Such report shall, in a man- ner that protects personal privacy, to the extent required by applicable Federal and State pri- vacy law, at a minimum, include information on— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3393 ‘‘(i) the number of positions publicly noticed and filled under the authority under subsection (i); ‘‘(ii) the occupational series, grades, and types of appointments of such posi- tions; ‘‘(iii) how such positions related to ad- vancing the goals and functions of ARPA– H; ‘‘(iv) how the Director made appoint- ment decisions under subsection (i); ‘‘(v) a summary of sources used to identify candidates for filling such posi- tions, as applicable; ‘‘(vi) the number of individuals ap- pointed; ‘‘(vii) aggregated demographic infor- mation related to individuals appointed; and ‘‘(viii) any challenges, limitations, or gaps related to the use of the authority under subsection (i) and any related rec- ommendations to address such challenges, limitations, or gaps.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3394 ‘‘(l) STRATEGIC PLAN.—Not later than 1 year after the date of the enactment of this section, and every 3 years thereafter, the Director shall provide to the Com- mittee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Com- mittee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a strategic plan describing how ARPA–H will carry out investments each fiscal year in the following 3-year period.
The re- quirements regarding individual institute and center stra- tegic plans under section 402(m), including paragraph (3) of such subsection, shall not apply to ARPA–H.
‘‘(m) INDEPENDENT REVIEW.—Not later than 1 year after the date of the enactment of this section, and every 4 years thereafter, the Comptroller General of the United States shall conduct, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an independent review of the bio- medical research and development portfolio of the Depart- ment of Health and Human Services, including ARPA– H, the National Institutes of Health, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3395 ‘‘(1) to assess the degree of any potential dupli- cation of existing Federal programs and projects; and ‘‘(2) to make any recommendations regarding any potential reorganization, consolidation, or termi- nation of such programs and projects.
‘‘(n) PRIORITIZATION.— ‘‘(1) IN GENERAL.—The Director shall— ‘‘(A) prioritize awarding grants, coopera- tive agreements, contracts, prizes, and other transaction awards to entities that will conduct funded work in the United States; ‘‘(B) as appropriate and practicable, en- courage nondomestic recipients of any grants, cooperative agreements, contracts, prizes, and other transactions under this section to collabo- rate with a domestic entity; ‘‘(C) not make awards under this section to nondomestic entities organized under the laws of a covered foreign country (as defined in section 119C of the National Security Act of 1947 (50 U.S.C.
3059)); and ‘‘(D) in accordance with the requirements of chapter 33 of title 41, United States Code, and the Federal Acquisition Regulation, not December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3396 make awards under this section to entities that have more than 3 ongoing concurrent awards under this section.
‘‘(2) CLARIFICATION.—In making an award under this section, the Director may waive the re- quirements of subparagraphs (A), (B), and (D) of paragraph (1) if such requirements cannot reason- ably be met, and the proposed project has the poten- tial to advance the goals described in subsection (b)(1).

The Director shall provide notice to Congress not later than 30 days after waiving such require- ments.
‘‘(o) ADDITIONAL CONSULTATION.—In carrying out this section, the Director may consult with— ‘‘(1) the President’s Council of Advisors on Science and Technology; ‘‘(2) representatives of professional or scientific organizations, including academia and industry, with expertise in specific technologies under consideration or development by ARPA–H; ‘‘(3) an existing advisory committee providing advice to the Secretary or the head of any operating or staff division of the Department; ‘‘(4) the advisory committee established under subsection (p); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3397 ‘‘(5) any other entity the Director may deem appropriate.

‘‘(p) ADVISORY COMMITTEE.— ‘‘(1) IN GENERAL.—There is established an ARPA–H Interagency Advisory Committee (referred to in this subsection as the ‘Advisory Committee’) to coordinate efforts and provide advice and assistance on specific program or project tasks and the overall direction of ARPA–H.
‘‘(2) MEMBERS.—The Advisory Committee es- tablished under paragraph (1) shall consist of the heads of the following agencies or their designees: ‘‘(A) The National Institutes of Health.

‘‘(B) The Centers for Disease Control and Prevention.

‘‘(C) The Food and Drug Administration.

‘‘(D) The Office of the Assistant Secretary for Preparedness and Response.

‘‘(E) The Office of the Assistant Secretary of Health.

‘‘(F) The Defense Advanced Research Projects Agency.
‘‘(G) The Office of Science of the Depart- ment of Energy.

‘‘(H) The National Science Foundation.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3398 ‘‘(I) Any other agency or office with sub- ject matter expertise that the Director of ARPA–H determines appropriate to advance programs or projects under this section.

‘‘(3) NONAPPLICABILITY OF FACA.—The Fed- eral Advisory Committee Act (5 U.S.C.

App.)
App.)

shall not apply to the Advisory Committee.

‘‘(4) ADVISORY NATURE.—The functions of the Advisory Committee shall be advisory in nature, and nothing in this subsection shall be construed as granting such Committee authority over the activi- ties authorized under this section.
‘‘(5) PERFORMANCE MEASURES FRAMEWORK.— ‘‘(A) IN GENERAL.—The Director, in con- sultation with the Advisory Committee, shall de- velop a performance measures framework for programs or projects supported by ARPA–H in order to inform and facilitate the evaluation re- quired under subsection (k)(2), including identi- fication of any data needed to perform such evaluation, ‘‘(B) AVAILABILITY OF PERFORMANCE MEASURES.—The Director shall provide to the National Academies such performance measures December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3399 and data necessary to perform the evaluation required under subsection (k)(2).

‘‘(q) RULE OF CONSTRUCTION.—The authorities under this section, with respect to the Director, are addi- tional authorities that do not supersede or modify any ex- isting authorities.
‘‘(r) TRANSFORMATIVE HEALTH TECHNOLOGY DE- FINED.—In this section, the term ‘transformative health technology’ means a novel, broadly applicable capability or 10 technology— ‘‘(1) that has potential to revolutionize the de- tection, diagnosis, mitigation, prevention, cure, or treatment of a disease or health condition that can cause severe health outcomes and which is an area of currently unmet need; and ‘‘(2) for which— ‘‘(A) significant scientific or technical chal- lenges exist; or ‘‘(B) incentives in the commercial market are unlikely to result in the adequate or timely development of such capability or technology.
‘‘(s) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there is authorized to be appro- priated $500,000,000 for each of the fiscal years 2024 through 2028, to remain available until expended.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3400 ‘‘(t) ADDITIONAL BUDGET CLARIFICATION.—Any budget request for ARPA–H shall propose a separate ap- propriation from the other accounts of the National Insti- tutes of Health.’’.
(b) GAO REPORT ON CERTAIN RESEARCH REQUIRE- MENTS.—The Comptroller General of the United States shall conduct a review to assess the extent to which rel- evant research conducted or supported by the National In- stitutes of Health meets Federal animal research require- ments pursuant of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
Such re- view shall also consider whether, for research conducted or supported by the National Institutes of Health that in- volves the use of animals, the processes of the National Institutes of Health for reviewing initial research pro- posals and monitoring funded research include a review of project protocols and methods to ensure that results generated by such project may be reasonably anticipated to be reproducible and replicable and achieve similar re- sults, as applicable, in clinical trials.
Not later than 2 years after the date of enactment of this Act, the Comp- troller General shall submit a report on the review re- quired under this subsection to the Committee on Health, Education, Labor, and Pensions of the Senate and the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3401 Committee on Energy and Commerce of the House of Representatives.

Subtitle and D—Modernizing Strengthening the Supply Chain for Vital Medical Products SEC.

2401.
2401.

WARM BASE MANUFACTURING CAPACITY FOR MEDICAL COUNTERMEASURES.

(a) IN GENERAL.—Section 319L of the Public Health Service Act (42 U.S.C.
247d–7e) is amended— (1) in subsection (a)(6)(B)— (A) by redesignating clauses (iv) and (v) as clauses (v) and (vi), respectively; (B) by inserting after clause (iii), the fol- lowing: ‘‘(iv) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of ad- vanced manufacturing and platform tech- nologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products;’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3402 (C) in clause (vi) (as so redesignated), by inserting ‘‘manufacturing,’’ after ‘‘improve- ment,’’; (2) in subsection (b)— (A) in the first sentence of paragraph (1), by inserting ‘‘support for domestic manufac- turing surge capacity and capabilities,’’ after ‘‘initiatives for innovation,’’; and (B) in paragraph (2)— (i) in subparagraph (B), by striking ‘‘and’’ at the end; (ii) by redesignating subparagraph (C) as subparagraph (D); and (iii) by inserting after subparagraph (B), the following: ‘‘(C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufac- turing and platform technologies, to increase the availability of products that are or may be- come qualified countermeasures or qualified pandemic or epidemic products; and’’; (3) in subsection (c)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3403 (A) in paragraph (2)(B), by inserting be- fore the semicolon ‘‘, including through the es- tablishment and maintenance of domestic man- ufacturing surge capacity and capabilities, con- sistent with subsection (a)(6)(B)(iv)’’; (B) in paragraph (4)— (i) in subparagraph (A)— (I) in clause (i)— (aa) in subclause (I), by striking ‘‘and’’ at the end; and (bb) by adding at the end the following: ‘‘(III) facilitating such commu- nication, as appropriate, regarding manufacturing surge capacity and ca- pabilities with respect to qualified countermeasures and qualified pan- demic or epidemic products to prepare for, or respond to, a public health emergency or potential public health emergency; and ‘‘(IV) facilitating such commu- nication, as appropriate and in a man- ner that does not compromise national security, with respect to potential eli- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3404 gibility for the material threat medical countermeasure priority review vouch- er program under section 565A of the Federal Food, Drug, and Cosmetic Act;’’; (II) in clause (ii)(III), by striking ‘‘and’’ at the end; (III) by redesignating clause (iii) as clause (iv); and (IV) by inserting after clause (ii), the following: ‘‘(iii) communicate regularly with enti- ties in receipt of an award pursuant to subparagraph (B)(v), and facilitate com- munication between such entities and other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning and response regard- ing the availability of countermeasures and the maintenance of domestic manufac- turing surge capacity and capabilities, in- cluding any planned uses of such capacity and capabilities in the near- and mid-term, and identification of any significant chal- lenges related to the long-term mainte- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3405 nance of such capacity and capabilities; and’’; (ii) in subparagraph (B)— (I) in clause (iii), by striking ‘‘and’’ at the end; (II) in clause (iv), by striking the period and inserting ‘‘; and’’; and (III) by adding at the end the following: ‘‘(v) award contracts, grants, and co- operative agreements and enter into other transactions to support, maintain, and im- prove domestic manufacturing surge capac- ity and capabilities, including through sup- porting flexible or advanced manufac- turing, to ensure that additional capacity is available to rapidly manufacture prod- ucts that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency.’’; (iii) in subparagraph (C)— (I) in clause (i), by striking ‘‘and’’ at the end; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3406 (II) in clause (ii), by striking the period at the end and inserting ‘‘; and’’; and (III) by adding at the end the following: ‘‘(iii) consult with the Commissioner of Food and Drugs, pursuant to section 565(b)(2) of the Federal Food, Drug, and Cosmetic Act, to ensure that facilities per- forming manufacturing, pursuant to an award under subparagraph (B)(v), are in compliance with applicable requirements under such Act and this Act, as appro- priate, including current good manufac- turing practice pursuant to section 501(a)(2)(B) of the Food, Drug, and Cos- metic Act; and’’; (iv) in subparagraph (D)(i), by insert- ing ‘‘, including to improve manufacturing capacities and capabilities for medical countermeasures’’ before the semicolon; (v) in subparagraph (E)(ix), by strik- ing ‘‘2023’’ and inserting ‘‘2028’’; and (vi) by adding at the end the fol- lowing: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3407 ‘‘(G) ANNUAL REPORTS BY AWARD RECIPI- ENTS.—As a condition of receiving an award under subparagraph (B)(v), a recipient shall de- velop and submit to the Secretary annual re- ports related to the maintenance of such capac- ity and capabilities, including ensuring that such capacity and capabilities are able to sup- port the rapid manufacture of countermeasures as required by the Secretary.’’; and (C) in paragraph (5), by adding at the end the following: ‘‘(H) SUPPORTING WARM-BASE AND SURGE CAPACITY AND CAPABILITIES.—Pursuant to an award under subparagraph (B)(v), the Sec- retary may make payments for activities nec- essary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manu- facture of countermeasures as required by the Secretary to prepare for, or respond to, an ex- isting or potential public health emergency or otherwise address threats that pose a signifi- cant level of risk to national security.
The Sec- retary may support the utilization of such ca- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3408 pacity and capabilities under awards for coun- termeasure and product advanced research and development, as appropriate, to provide for the maintenance of such capacity and capabilities.’’; and (4) in subsection (f)— (A) in paragraph (1), by striking ‘‘Not later than 180 days after the date of enactment of this subsection’’ and inserting ‘‘Not later than 180 days after the date of enactment of the PREVENT Pandemics Act’’; (B) in paragraph (2)— (i) in the matter preceding subpara- graph (A), by striking ‘‘this subsection’’ and inserting ‘‘the PREVENT Pandemics Act’’; (ii) in subparagraph (B), by striking ‘‘and’’ at the end; and (iii) in subparagraph (C), by striking the period and inserting ‘‘; and’’; and (C) by adding at the end the following: ‘‘(D) plans for the near-, mid-, and long- term sustainment of manufacturing activities carried out under this section, including such activities pursuant to subsection (c)(5)(H), spe- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3409 cific actions to regularly assess the ability of re- cipients of an award under subsection (c)(4)(B)(v) to rapidly manufacture counter- measures as required by the Secretary, and rec- ommendations to address challenges, if any, re- lated to such activities.’’.

SEC.

2402.

SUPPLY CHAIN CONSIDERATIONS FOR THE STRATEGIC NATIONAL STOCKPILE.

Subclause (II) of section 319F–2(a)(2)(B)(i) of the Public Health Service Act (42 U.S.C.
247d– 6b(a)(2)(B)(i)) is amended to read as follows: ‘‘(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (with- out disclosing proprietary informa- tion), including— ‘‘(aa) consideration of the effect such additions or modifica- tions may have on the availability of such products and ancillary medical supplies on the health care system; and ‘‘(bb) an assessment of the current supply chain for such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3410 products, including information on supply chain redundancies, any known domestic manufac- turing capacity for such prod- ucts, and any related vulnerabilities;’’.

SEC.

2403.

STRATEGIC NATIONAL STOCKPILE EQUIPMENT MAINTENANCE.

Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C.
247d–6b(a)(3)) is amended— (1) in subparagraph (B), by inserting ‘‘, regu- larly reviewed, and updated’’ after ‘‘followed’’; and (2) by amending subparagraph (D) to read as follows: ‘‘(D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that— ‘‘(i) emerging threats, advanced tech- nologies, and new countermeasures are adequately considered; ‘‘(ii) the potential depletion of coun- termeasures currently in the stockpile is identified and appropriately addressed, in- cluding through necessary replenishment; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3411 ‘‘(iii) such contents are in working condition or usable, as applicable, and are ready for deployment, which may include conducting maintenance services on such contents of the stockpile and disposing of such contents that are no longer in work- ing condition, or usable, as applicable;’’.

SEC.

2404.

IMPROVING TRANSPARENCY AND PREDICT- ABILITY OF PROCESSES OF THE STRATEGIC NATIONAL STOCKPILE.
(a) GUIDANCE.—Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’) shall issue guidance describing the processes by which the Secretary deploys the contents of the Strategic National Stockpile under section 319F–2(a) of the Public Health Service Act (42 U.S.C.
247d–6b(a)), or otherwise distributes medical countermeasures, as applicable, to States, territories, Indian Tribes and Tribal organizations (as such terms are defined under section 4 of the Indian Self-Determination and Education Assistance Act), and other applicable entities.
Such guidance shall include in- formation related to processes by which to request access to the contents of the Strategic National Stockpile, factors considered by the Secretary when making deployment or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3412 distribution decisions, and processes and points of contact through which entities may contact the Secretary to ad- dress any issues related to products requested or received by such entity from the stockpile, and on other relevant topics.

(b) ANNUAL MEETINGS.—Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C.
247d–6b(a)(3)) is amended— (1) in subparagraph (I), by striking ‘‘and’’ at the end; (2) in subparagraph (J), by striking the period at the end and inserting ‘‘; and’’; and (3) by adding at the end the following: ‘‘(K) convene meetings, not less than once per year, with representatives from State, local, and Tribal health departments or officials, rel- evant industries, other Federal agencies, and other appropriate stakeholders, in a manner that does not compromise national security, to coordinate and share information related to maintenance and use of the stockpile, including a description of future countermeasure needs and additions, modifications, and replenish- ments of the contents of the stockpile, and con- siderations related to the manufacturing and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3413 procurement of products consistent with the re- quirements of the with the requirements of chapter 83 of title 41, United States Code (commonly referred to as the ‘Buy American Act’), as appropriate.’’.

SEC.

2405.

IMPROVING SUPPLY CHAIN FLEXIBILITY FOR THE STRATEGIC NATIONAL STOCKPILE.

(a) IN GENERAL.—Section 319F–2 of the Public Health Service Act (42 U.S.C.
247d–6b) is amended— (1) in subsection (a)— (A) in paragraph (3)(F), by striking ‘‘as required by the Secretary of Homeland Secu- rity’’ and inserting ‘‘at the discretion of the Secretary, in consultation with, or at the re- quest of, the Secretary of Homeland Security,’’; (B) by redesignating paragraphs (5) and (6) as paragraphs (6) and (7), respectively; (C) by inserting after paragraph (4) the following: ‘‘(5) VENDOR-MANAGED INVENTORY AND WARM-BASE SURGE CAPACITY.— ‘‘(A) IN GENERAL.—For the purposes of maintaining the stockpile under paragraph (1) and carrying out procedures under paragraph (3), the Secretary may enter into contracts or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3414 cooperative agreements with vendors, which may include manufacturers or distributors of medical products, with respect to medical prod- ucts intended to be delivered to the ownership of the Federal Government.
Each such contract or cooperative agreement shall be subject to such terms and conditions as the Secretary may specify, including terms and conditions with re- spect to— ‘‘(i) procurement, maintenance, stor- age, and delivery of products, in alignment with inventory management and other ap- plicable best practices, under such contract or cooperative agreement, which may con- sider, as appropriate, costs of transporting and handling such products; or ‘‘(ii) maintenance of domestic manu- facturing capacity and capabilities of such products to ensure additional reserved pro- duction capacity and capabilities are avail- able, and that such capacity and capabili- ties are able to support the rapid manufac- ture, purchase, storage, and delivery of such products, as required by the Sec- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3415 retary to prepare for, or respond to, an ex- isting or potential public health emergency.
‘‘(B) REPORT.—Not later than 2 years after the date of enactment of the PREVENT Pandemics Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on any con- tracts or cooperative agreements entered into under subparagraph (A) for purposes of estab- lishing and maintaining vendor-managed inven- tory or reserve manufacturing capacity and ca- pabilities for products intended for the stock- pile, including a description of— ‘‘(i) the amount of each award; ‘‘(ii) the recipient of each award; ‘‘(iii) the product or products covered through each award; and ‘‘(iv) how the Secretary works with each recipient to ensure situational aware- ness related to the manufacturing capacity for, or inventory of, such products and co- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3416 ordinates the distribution and deployment of such products, as appropriate and appli- cable.’’; and (D) in subparagraph (A) of paragraph (6), as so redesignated— (i) in clause (viii), by striking ‘‘; and’’ and inserting a semicolon; (ii) in clause (ix), by striking the pe- riod and inserting ‘‘; and’’; and (iii) by adding at the end the fol- lowing: ‘‘(x) with respect to reports issued in 2027 or any subsequent year, an assess- ment of selected contracts or cooperative agreements entered into pursuant to para- graph (5).’’; and (2) in subsection (c)(2)(C), by striking ‘‘on an annual basis’’ and inserting ‘‘not later than March 15 of each year’’.
(b) AUTHORIZATION OF APPROPRIATIONS.—Section 319F–2(f)(1) of the Public Health Service Act (42 U.S.C.

247d–6b(f)(1)) is amended by striking ‘‘$610,000,000 for each of fiscal years 2019 through 2023’’ and inserting ‘‘$610,000,000 for each of fiscal years 2019 through December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3417 2021, and $750,000,000 for each of fiscal years 2022 and 2023’’.

SEC.

2406.
SEC.

2406.

REIMBURSEMENT FOR CERTAIN SUPPLIES.

Paragraph (7) of section 319F–2(a) of the Public Health Service Act (42 U.S.C.

247d–6b(a)), as so redesig- nated by section 405(a)(1)(B), is amended to read as fol- lows: ‘‘(7) REIMBURSEMENT FOR CERTAIN SUP- PLIES.— ‘‘(A) IN GENERAL.—The Secretary may, at appropriate intervals, make available for pur- chase excess contents procured for, and main- tained within, the stockpile under paragraph (1) to any Federal agency or State, local, or Tribal government.
The Secretary shall make such contents available for purchase only if— ‘‘(i) such contents are in excess of what is required for appropriate mainte- nance of such stockpile; ‘‘(ii) the Secretary determines that the costs for maintaining such excess con- tents are not appropriate to expend to meet the needs of the stockpile; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3418 ‘‘(iii) the Secretary determines that such action does not compromise national security and is in the national interest.
‘‘(B) REIMBURSEMENT AND COLLEC- TION.—The Secretary may require reimburse- ment for contents that are made available under subparagraph (A), in an amount that re- flects the cost of acquiring and maintaining such contents and the costs incurred to make available such contents in the time and manner specified by the Secretary.
Amounts collected under this subsection shall be credited to the appropriations account or fund that incurred the costs to procure such contents, and shall re- main available, without further appropriation, until expended, for the purposes of the appro- priation account or fund so credited.

‘‘(C) RULE OF CONSTRUCTION.—This paragraph shall not be construed to preclude transfers of contents in the stockpile under other authorities.
‘‘(D) REPORT.—Not later than 2 years after the date of enactment of the PREVENT Pandemics Act, and annually thereafter, the Secretary shall submit to the Committee on December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3419 Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on the use of the authority provided under this paragraph, in- cluding details of each action taken pursuant to this paragraph, the account or fund to which any collected amounts have been credited, and how the Secretary has used such amounts.
‘‘(E) SUNSET.—The authority under this paragraph shall terminate on September 30, 2028.’’.

SEC.

2407.

ACTION REPORTING ON STOCKPILE DEPLETION.

Section 319 of the Public Health Service Act (42 U.S.C.
247d), as amended by section 2223, is further amended by adding at the end the following: ‘‘(h) STOCKPILE DEPLETION REPORTING.—The Sec- retary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under sec- tion 319F–2(a) to respond to a public health emergency declared by the Secretary under this section or an emer- gency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency As- sistance Act, and every 30 days thereafter until the expira- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3420 tion or termination of such public health emergency, emer- gency, or major disaster, submit a report to the Com- mittee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Com- mittee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on— ‘‘(1) the deployment of the contents of the stockpile in response to State, local, and Tribal re- quests; ‘‘(2) the amount of such products that remain within the stockpile following such deployment; and ‘‘(3) plans to replenish such products, as appro- priate, including related timeframes and any barriers or limitations to replenishment.’’.
SEC.

2408.

PROVISION OF MEDICAL COUNTERMEASURES TO INDIAN PROGRAMS AND FACILITIES.

(a) CLARIFICATION.—Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C.

247d–6b(a)(3)) is amended— (1) in subparagraph (C), by striking ‘‘and local’’ and inserting ‘‘local, and Tribal’’; and (2) in subparagraph ( J), by striking ‘‘and local’’ and inserting ‘‘local, and Tribal’’.
(b) DISTRIBUTION OF MEDICAL COUNTERMEASURES TO INDIAN TRIBES.—Title III of the Public Health Serv- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3421 ice Act (42 U.S.C.

241 et seq.)

is amended by inserting after section 319F–4 the following: ‘‘SEC.

319F–5.

PROVISION OF MEDICAL COUNTERMEASURES TO INDIAN PROGRAMS AND FACILITIES.
‘‘In the event that the Secretary deploys the contents of the Strategic National Stockpile under section 319F– 2(a), or otherwise distributes medical countermeasures to States to respond to a public health emergency declared by the Secretary under section 319, the Secretary shall, in consultation with the applicable States, make such con- tents or countermeasures directly available to Indian Tribes and Tribal organizations (as such terms are de- fined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C.
5304), which may include through health programs or facilities operated by the Indian Health Service, that are affected by such public 17 health emergency.’’.

18 19 20 SEC.

2409.

GRANTS FOR STATE STRATEGIC STOCKPILES.

(a) Section 319F–2 of the Public Health Service Act (42 U.S.C.
247d–6b) is amended by adding at the end 21 the following: 22 ‘‘(i) PILOT PROGRAM TO SUPPORT STATE MEDICAL 23 STOCKPILES.— 24 25 ‘‘(1) IN GENERAL.—The Secretary, in consulta- tion with the Assistant Secretary for Preparedness December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3422 and Response and the Director of the Centers for Disease Control and Prevention, shall award grants or cooperative agreements to not fewer than 5 States, or consortia of States, with consideration given to distribution among the geographical regions of the United States, to establish, expand, or main- tain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies determined by the State to be nec- essary to respond to a public health emergency de- clared by the Governor of a State or by the Sec- retary under section 319, or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, in order to support the preparedness goals described in paragraphs (2) through (6) and (8) of section 2802(b).
A recipient of such an award may not use award funds to support the stockpiling of security countermeasures (as defined in subsection (c)(1), unless the eligible entity provides justification for maintaining such countermeasures and the Secretary determines such justification is appropriate and ap- plicable.

‘‘(2) REQUIREMENTS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3423 ‘‘(A) APPLICATION.—To be eligible to re- ceive an award under paragraph (1), an entity shall prepare, in consultation with appropriate health care entities and health officials within the jurisdiction of such State or States, and submit to the Secretary an application that con- tains such information as the Secretary may re- quire, including— ‘‘(i) a plan for such stockpile, con- sistent with paragraph (4), including— ‘‘(I) a description of the activities such entity will carry out under the agreement; ‘‘(II) an assurance that such en- tity will use funds under such award in alignment with the requirements of chapter 83 of title 41, United States Code (commonly referred to as the ‘Buy American Act’); and ‘‘(III) an outline of proposed ex- penses; and ‘‘(ii) a description of how such entity will coordinate with relevant entities in re- ceipt of an award under section 319C–1 or 319C–2 pursuant to paragraph (4), includ- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3424 ing through promoting alignment between the stockpile plan established pursuant to clause (i) and applicable plans that are es- tablished by such entity pursuant to sec- tion 319C–1 or 319C–2.
‘‘(B) MATCHING FUNDS.— ‘‘(i) Subject to clause (ii), the Sec- retary may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make avail- able non-Federal contributions toward such costs in an amount equal to— ‘‘(I) for each of fiscal years 2023 and 2024, not less than $1 for each $20 of Federal funds provided in the award; and ‘‘(II) for fiscal year 2025 and each fiscal year thereafter, not less than $1 for each $10 of Federal funds provided in the award.
‘‘(ii) WAIVER.—The Secretary may, upon the request of a State, waive the re- quirement under clause (i), in whole or in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3425 part, if the Secretary determines that ex- traordinary economic conditions in the State in the fiscal year involved or in the previous fiscal year justify the waiver.

A waiver provided by the Secretary under this subparagraph shall apply only to the fiscal year involved.
‘‘(C) ADMINISTRATIVE EXPENSES.—Not more than 10 percent of amounts received by an entity pursuant to an award under this sub- section may be used for administrative ex- penses.

‘‘(3) LEAD ENTITY.—An entity in receipt of an award under paragraph (1) may designate a lead en- tity, which may be a public or private entity, as ap- propriate, to manage the stockpile at the direction of the State or consortium of States.
‘‘(4) USE OF FUNDS.—An entity in receipt of an award under paragraph (1) shall use such funds to— ‘‘(A) purchase, store, and maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies to be used during a pub- lic health emergency, major disaster, or emer- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3426 gency described in paragraph (1), in such num- bers, types, and amounts as the entity deter- mines necessary, consistent with such entity’s stockpile plan established pursuant to para- graph (2)(A)(i); ‘‘(B) deploy the stockpile as required by the entity to respond to an actual or potential public health emergency, major disaster, or other emergency described in paragraph (1); ‘‘(C) replenish and make necessary addi- tions or modifications to the contents of such stockpile, including to address potential deple- tion; ‘‘(D) in consultation with Federal, State, and local officials, take into consideration the availability, deployment, dispensing, and admin- istration requirements of medical products with- in the stockpile; ‘‘(E) ensure that procedures are followed for inventory management and accounting, and for the physical security of the stockpile, as ap- propriate; ‘‘(F) review and revise, as appropriate, the contents of the stockpile on a regular basis to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3427 ensure that, to the extent practicable, new tech- nologies and medical products are considered; ‘‘(G) carry out exercises, drills, and other training for purposes of stockpile deployment, dispensing, and administration of medical prod- ucts, and for purposes of assessing the capa- bility of such stockpile to address the medical supply needs of public health emergencies, major disasters, or other emergencies described in paragraph (1) of varying types and scales, which may be conducted in accordance with re- quirements related to exercises, drills, and other training for recipients of awards under section 319C–1 or 319C–2, as applicable; and ‘‘(H) carry out other activities related to the State strategic stockpile as the entity deter- mines appropriate, to support State efforts to prepare for, and respond to, public health threats.
‘‘(5) SUPPLEMENT NOT SUPPLANT.—Awards under paragraph (1) shall supplement, not supplant, the maintenance and use of the Strategic National Stockpile by the Secretary under subsection (a).

‘‘(6) GUIDANCE FOR STATES.—Not later than 180 days after the date of enactment of this sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3428 section, the Secretary, in consultation with States, health officials, and other relevant stakeholders, as appropriate, shall issue guidance, and update such guidance as appropriate, for States related to main- taining and replenishing a stockpile of medical prod- ucts, which may include strategies and best practices related to— ‘‘(A) types of medical products and med- ical supplies that are critical to respond to pub- lic health emergencies, and may be appropriate for inclusion in a stockpile by States, with con- sideration of threats that require the large-scale and simultaneous deployment of stockpiles, in- cluding the stockpile maintained by the Sec- retary pursuant to subsection (a), and long- term public health and medical response needs; ‘‘(B) appropriate management of the con- tents of a stockpile, including management by vendors of reserve amounts of medical products and supplies intended to be delivered to the ownership of the State and appropriate disposi- tion of excess products, as applicable; and ‘‘(C) the procurement of medical products and medical supplies consistent with the re- quirements of chapter 83 of title 41, United December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3429 States Code (commonly referred to as the ‘Buy American Act’).

‘‘(7) TECHNICAL ASSISTANCE.—The Secretary shall provide assistance to States, including technical assistance, as appropriate, in establishing, maintain- ing, improving, and utilizing a medical stockpile, in- cluding appropriate inventory management and dis- position of products.
‘‘(8) REPORTING.— ‘‘(A) STATE REPORTS.—Each entity re- ceiving an award under paragraph (1) shall up- date, as appropriate, the plan established pur- suant to paragraph (2)(A)(i) and submit to the Secretary an annual report on implementation of such plan, including any changes to the con- tents of the stockpile supported under such award.
The Secretary shall use information ob- tained from such reports to inform the mainte- nance and management of the Strategic Na- tional Stockpile pursuant to subsection (a).
‘‘(B) REPORTS TO CONGRESS.—Not later than 1 year after the initial issuance of awards pursuant to paragraph (1), and annually there- after for the duration of the program estab- lished under this subsection, the Secretary shall December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3430 submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Ap- propriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representa- tives a report on such program, including— ‘‘(i) Federal and State expenditures to support stockpiles under such program; ‘‘(ii) activities conducted pursuant to paragraph (4); and ‘‘(iii) any additional information from the States that the Secretary determines relevant.
‘‘(9) AUTHORIZATION OF APPROPRIATIONS.— To carry out this subsection, there is authorized to be appropriated $3,500,000,000 for each of fiscal years 2023 and 2024, to remain available until ex- pended.’’.

(b) GAO REPORT.—Not later than 3 years after the date on which awards are first issued pursuant to sub- section (i)(1) of section 319F–2 of the Public Health Serv- ice Act (42 U.S.C.
247d–6b), as added by subsection (a), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3431 Commerce of the House of Representatives a report on the State stockpiles established or maintained pursuant to this section.
Such report shall include an assessment of— (1) coordination and communication between the Secretary of Health and Human Services and entities in receipt of an award under this section, or a lead entity designated by such entity; (2) technical assistance provided by the Sec- retary of Health and Human Services to such enti- ties; and (3) the impact of such stockpiles on the ability of the State to prepare for and respond to a public health emergency, major disaster, or other emer- gency described in subsection (i)(1) of section 319F– 2 of the Public Health Service Act (42 U.S.C.
247d– 6b), as added by subsection (a), including the avail- ability and distribution of items from such State stockpile to health care entities and other applicable entities.

SEC.

2410.

STUDY ON INCENTIVES FOR DOMESTIC PRODUC- TION OF GENERIC MEDICINES.
(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’), acting through the Assistant Secretary for Plan- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3432 ning and Evaluation of the Department of Health and Human Services shall— (1) conduct a study on the feasibility, including related to sustainment, and potential effectiveness, and utility of providing incentives for increased do- mestic production and capacity of specified generic medicines and their active pharmaceutical ingredi- ents, which may include through applicable nonprofit or for-profit private entities; and (2) not later than 1 year after the date of en- actment of this Act, submit a report on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on En- ergy and Commerce of the House of Representa- tives.
(b) SPECIFIED GENERIC MEDICINE.—In this section, the term ‘‘specified generic medicine’’ means a generic drug approved under section 505(j) of the Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) that is — (1) used to prevent, mitigate, or treat a serious or life-threatening disease or condition, or used in a common procedure that could be life-threatening without such medicine; (2) an antibiotic or antifungal used to treat a serious or life threatening infectious disease; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3433 (3) critical to the public health during a public health emergency; or (4) life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debili- tating disease or condition.

SEC.

2411.

INCREASED MANUFACTURING CAPACITY FOR CERTAIN CRITICAL ANTIBIOTIC DRUGS.
(a) PROGRAM.— (1) IN GENERAL.—The Secretary, in consulta- tion with the Assistant Secretary for Preparedness and Response and Commissioner of Food and Drugs, may award contracts to increase the domes- tic manufacturing capacity of certain antibiotic drugs with identified supply chain vulnerabilities, or the active pharmaceutical ingredient or key starting material of such antibiotic drugs.
(2) ELIGIBLE ENTITIES.—To be eligible to re- ceive an award under this subsection, an entity shall— (A) be a manufacturer that is in compli- ance with, or demonstrates capability to comply with, the relevant requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.

); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3434 (B) prepare and submit to the Secretary an application at such time, and in such man- ner, and containing such information as the Secretary may require, including— (i) a description of proposed activities to be supported by an award under this subsection to increase manufacturing ca- pacity for such antibiotic drug or drugs; (ii) the antibiotic drug or drugs, or re- lated active pharmaceutical ingredients or key starting materials for such drug or drugs, that such entity intends to manu- facture with any increased manufacturing capacity supported by an award under this subsection; (iii) any additional products such in- creased manufacturing capacity could be used to manufacture; (iv) a description of the current sup- ply chain for such antibiotic drugs, includ- ing any existing and applicable manufac- turing facilities, known vulnerabilities in the supply chain, known or potential sup- ply limitations, such as foreign export re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3435 strictions, or subsidies from foreign gov- ernments, as applicable; (v) a description of how such entity may use advanced or flexible manufac- turing in carrying out the terms of an award under this subsection; and (vi) a strategic plan regarding the maintenance, operation, and sustainment of such increased manufacturing capacity following the expiration of a contract under this subsection.
(3) USE OF FUNDS.—A recipient of an award under this subsection shall use such funds to build, expand, upgrade, modify, or recommission a facility located in the United States, which may include the purchase or upgrade of equipment, as applicable, to support increased manufacturing capacity of certain antibiotic drugs for which supply chain vulnerabilities exist, or the active pharmaceutical in- gredient or key starting material of such antibiotic drugs.
(4) REPORTS.—An entity in receipt of an award under this subsection shall submit to the Sec- retary such reports as the Secretary may require re- lated to increasing domestic manufacturing capacity December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3436 of antibiotic drugs pursuant to a contract under this subsection, including actions taken to implement the strategic plan required under paragraph (2)(B)(vi).
(5) CONTRACT TERMS.—The following shall apply to a contract to support increased domestic manufacturing capacity under this subsection: (A) MILESTONE-BASED PAYMENTS.—The Secretary may provide payment, including ad- vance payment or partial payment for signifi- cant milestones, if the Secretary makes a deter- mination that such payment is necessary and appropriate.
(B) REPAYMENT.—The contract shall pro- vide that such payment is required to be repaid if there is a failure to perform by the manufac- turer under the contract; if the specified mile- stones are reached, an advance or partial pay- ment shall not be required to be repaid.

(C) CONTRACT DURATION.— (i) IN GENERAL.—Each contract shall be for a period not to exceed 5 years.

(ii) NON-RENEWABILITY.—A contract shall not be renewable.
(iii) NOTIFICATIONS OF EXTENSIONS AND TERMINATIONS.—If the Secretary de- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3437 cides to terminate a contract prior to its expiration, the Secretary shall notify the manufacturer within 90 days of such de- termination.
(D) ADDITIONAL TERMS.—The Secretary, in any contract under this subsection— (i) may specify— (I) the amount of funding that will be dedicated by the Secretary for supporting increased manufacturing capacity under such contract; and (II) the amount of manufac- turing capacity that such eligible enti- ty must meet; and (ii) shall provide a clear statement of defined Federal Government purpose lim- ited to uses related to increasing domestic manufacturing capacity for antibiotic drugs to address identified supply chain vulnerabilities and challenges to estab- lishing and maintaining domestic manufac- turing capacity.
(E) SUSTAINMENT.—Each contract shall provide for the eligible entity to update the strategic plan required under paragraph December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3438 (2)(B)(vi) throughout the duration of such con- tract, as required by the Secretary.
(b) REPORT.—Not later than 2 years after the date of enactment of this Act and every year thereafter until the termination or expiration of all such contracts, the Secretary shall submit to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Rep- resentatives a report on any activities supported under subsection (a), including— (1) the antibiotic drugs for which the Secretary prioritized awards under subsection (a), including a description of how the Secretary consulted with stakeholders to inform such prioritization; (2) information regarding each contract award- ed pursuant to subsection (a), including— (A) the recipient of each such contract, in- cluding any recipients of a subaward; (B) the milestone and performance re- quirements pursuant to each such contract; (C) the duration of each such contract; (D) the amount of funding provided by the Secretary pursuant to each such contract, in- cluding any advanced or partial payments; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3439 (E) the antibiotic drugs supported through each such contract, including a description of the medical necessity of each such antibiotic drug and any supply chain vulnerabilities, limi- tations, and related characteristics identified pursuant to subsection (a)(2)(B)(iv) for each such antibiotic drug; and (F) the amount of increased manufac- turing capacity for such antibiotic drug that each such contract supports; and (3) a description of how such contracts address supply chain vulnerabilities, including increasing manufacturing capacity of antibiotic drugs in the United States; and (4) a description of the strategic plan submitted pursuant to subsection (a)(2)(B)(vi) by each recipi- ent of an award under subsection (a).
(c) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed— (1) to limit, directly or indirectly, or otherwise impact the private distribution, purchase, or sale of antibiotic drugs or active pharmaceutical ingredients or key starting materials; or (2) to authorize the Secretary to disclose any information that is a trade secret, or other privileged December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3440 or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

(d) DEFINITIONS.—For purposes of this section: (1) ACTIVE PHARMACEUTICAL INGREDIENT.— The term ‘‘active pharmaceutical ingredient’’ has the meaning given such term in section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

379j–41).
379j–41).

(2) ANTIBIOTIC DRUG.—The term ‘‘antibiotic drug’’ means an antibacterial or antifungal drug ap- proved by the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

355(j)) that is of significant priority to providing health care and is medically necessary to have available at all times in an amount adequate to serve patient needs.
(3) KEY STARTING MATERIAL.—The term ‘‘key starting material’’ means any component of a drug that the Secretary determines to be necessary to the safety and effectiveness of the drug.

(4) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Health and Human Services.
(e) SUNSET.—The authority to enter into new con- tracts under this section shall cease to be effective 3 years December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3441 after the date of enactment of this Act, and, beginning on the date that is 8 years after the date of enactment of this Act, this section shall have no force or effect.
Subtitle E—Enhancing Develop- ment and Combating Shortages of Medical Products CHAPTER 1—DEVELOPMENT AND REVIEW SEC.

2501.

ACCELERATING COUNTERMEASURE DEVELOP- MENT AND REVIEW.

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–4) is amended by adding at the 12 end the following: ‘‘(h) ACCELERATING COUNTERMEASURE DEVELOP- MENT AND REVIEW DURING AN EMERGENCY.— ‘‘(1) ACCELERATION OF COUNTERMEASURE DE- VELOPMENT AND REVIEW.—The Secretary may, at the request of the sponsor of a countermeasure, dur- ing a domestic, military, or public health emergency or material threat described in section 564A(a)(1)(C), expedite the development and review of countermeasures that are intended to address such domestic, military, or public health emergency or material threat for approval, licensure, clearance, or authorization under this title or section 351 of the Public Health Service Act.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3442 ‘‘(2) ACTIONS.—The actions to expedite the de- velopment and review of a countermeasure under paragraph (1) may include the following: ‘‘(A) Expedited review of submissions made by sponsors of countermeasures to the Food and Drug Administration, including roll- ing submissions of countermeasure applications and other submissions.
‘‘(B) Expedited and increased engagement with sponsors regarding countermeasure devel- opment and manufacturing, including— ‘‘(i) holding meetings with the sponsor and the review team and providing timely advice to, and interactive communication with, the sponsor regarding the develop- ment of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval, licensure, clearance, or author- ization is as efficient as practicable; ‘‘(ii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3443 ‘‘(iii) assigning a cross-disciplinary project lead for the review team to facili- tate; ‘‘(iv) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of pa- tients exposed to a potentially less effica- cious treatment; and ‘‘(v) streamlining the review of ap- proved, licensed, cleared, or authorized countermeasures to treat or prevent new or emerging threats, including the review of any changes to such countermeasures.
‘‘(C) Expedited issuance of guidance docu- ments and publication of other regulatory infor- mation regarding countermeasure development and manufacturing.

‘‘(D) Other steps to expedite the develop- ment and review of a countermeasure applica- tion submitted for approval, licensure, clear- ance, or authorization, as the Secretary deter- mines appropriate.
‘‘(3) LIMITATION OF EFFECT.—Nothing in this subsection shall be construed to require the Sec- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3444 retary to grant, or take any other action related to, a request of a sponsor to expedite the development and review of a countermeasure for approval, licen- sure, clearance, or authorization under paragraph (1).’’.

SEC.

2502.
SEC.

2502.

THIRD PARTY TEST EVALUATION DURING EMER- GENCIES.

(a) IN GENERAL.—Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–4), as amend- ed by section 2501, is further amended by adding at the 11 end the following: 12 ‘‘(i) THIRD PARTY EVALUATION OF TESTS USED 13 DURING AN EMERGENCY.— ‘‘(1) IN GENERAL.—For purposes of conducting evaluations regarding whether an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations (or any successor regula- tions)) for which a request for emergency use au- thorization is submitted under section 564 meets the criteria for issuance of such authorization, the Sec- retary may, as appropriate, consult with persons with appropriate expertise with respect to such eval- uations or enter into cooperative agreements or con- tracts with such persons under which such persons conduct such evaluations and make such rec- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3445 ommendations, including, as appropriate, evaluations and recommendations regarding the scope of author- ization and conditions of authorization.
‘‘(2) REQUIREMENTS REGARDING EVALUATIONS AND RECOMMENDATIONS.— ‘‘(A) IN GENERAL.—In evaluating and making recommendations to the Secretary re- garding the validity, accuracy, and reliability of in vitro diagnostic products, as described in paragraph (1), a person shall consider and doc- ument whether the relevant criteria under sub- section (c)(2) of section 564 for issuance of au- thorization under such section are met with re- spect to the in vitro diagnostic product.
‘‘(B) WRITTEN RECOMMENDATIONS.—Rec- ommendations made by a person under this subsection shall be submitted to the Secretary in writing, and shall include the reasons for such recommendation and other information that may be requested by the Secretary.
‘‘(3) RULE OF CONSTRUCTION.— Nothing in this subsection shall be construed to require the Sec- retary to consult with, or enter into cooperative agreements or contracts with, persons as described in paragraph (1) for purposes of authorizing an in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3446 vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section 564.’’.

(b) GUIDANCE.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’) shall issue draft guidance on consultations with persons under subsection (i) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–4), as added by subsection (a), including consider- ations concerning conflicts of interest, compensation ar- rangements, and information sharing.

Not later than 1 year after the public comment period on such draft guid- ance ends, the Secretary shall issue a revised draft guid- 15 ance or final guidance.

16 SEC.

2503.

PLATFORM TECHNOLOGIES.


(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after sec- tion 506J of such Act (21 U.S.C.

356j) the following: ‘‘SEC.

506K.

PLATFORM TECHNOLOGIES.

‘‘(a) IN GENERAL.—The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b).
‘‘(b) CRITERIA.—A platform technology incorporated within or utilized by a drug or biological product is eligible December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3447 for designation as a designated platform technology under this section if— ‘‘(1) the platform technology is incorporated in, or utilized by, a drug approved under section 505 of this Act or a biological product licensed under sec- tion 351 of the Public Health Service Act; ‘‘(2) preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph (1), or a sponsor that has been grant- ed a right of reference to data submitted in the ap- plication for such drug, demonstrates that the plat- form technology has the potential to be incorporated in, or utilized by, more than one drug without an ad- verse effect on quality, manufacturing, or safety; and ‘‘(3) data or information submitted by the ap- plicable person under paragraph (2) indicates that incorporation or utilization of the platform tech- nology has a reasonable likelihood to bring signifi- cant efficiencies to the drug development or manu- facturing process and to the review process.
‘‘(c) REQUEST FOR DESIGNATION.—A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 505(i) of this Act December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3448 or section 351(a)(3) of the Public Health Service Act for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request.

‘‘(d) DESIGNATION.— ‘‘(1) IN GENERAL.—Not later than 90 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the plat- form technology that is the subject of the request meets the criteria described in subsection (b).
‘‘(2) DESIGNATION.—If the Secretary deter- mines that the platform technology meets the cri- teria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the develop- ment and review of any subsequent application sub- mitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate.
‘‘(3) DETERMINATION NOT TO DESIGNATE.—If the Secretary determines that the platform tech- nology does not meet the criteria under subsection (b), the Secretary shall include with the determina- tion not to designate the technology a written de- scription of the rationale for such determination.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3449 ‘‘(4) REVOCATION OF DESIGNATION.—The Sec- retary may revoke a designation made under para- graph (2), if the Secretary determines that the des- ignated platform technology no longer meets the cri- teria described in subsection (b).

The Secretary shall communicate the determination to revoke a designa- tion to the requesting sponsor in writing, including a description of the rationale for such determination.
‘‘(5) APPLICABILITY.—Nothing in this section shall prevent a product that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eli- gible under this Act or the Public Health Service Act.
‘‘(e) ACTIONS.—The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a designated platform technology, including— ‘‘(1) engaging in early interactions with the sponsor to discuss the use of the designated plat- form technology and what is known about such tech- nology, including data previously submitted that is relevant to establishing, as applicable, safety or effi- cacy under section 505(b) of this Act or safety, pu- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3450 rity, or potency under section 351(a) of the Public Health Service Act; ‘‘(2) providing timely advice to, and interactive communication with, the sponsor regarding the de- velopment of the drug that proposes to use the des- ignated platform technology to ensure that the devel- opment program designed to gather data necessary for approval or licensure is as efficient as prac- ticable, which may include holding meetings with the sponsor and the review team throughout the develop- ment of the drug; and ‘‘(3) considering inspectional findings, including prior findings, related to the manufacture of a drug that incorporates or utilizes the designated platform technology.
‘‘(f) LEVERAGING DATA FROM DESIGNATED PLAT- FORM TECHNOLOGIES.—The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this Act and section 351(a) of the Public Health Service Act, allow the sponsor of an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 564, in order to support ap- proval, licensure, or authorization, to reference or rely upon data and information within an application or re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3451 quest for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that— ‘‘(1) such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection (d) was granted; or ‘‘(2) the sponsor relying on such data and in- formation received a right of reference to such data and information from the sponsor described in para- graph (1).
‘‘(g) CHANGES TO A DESIGNATED PLATFORM TECH- NOLOGY.—A sponsor of more than one application ap- proved under section 505(b) of this Act or section 351(a) of the Public Health Service Act for drugs that incor- porate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such drug that incor- porates or utilizes the same designated platform tech- nology.
Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols regarding December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3452 how such changes to the platform technology would be made for each applicable drug or biological product.
‘‘(h) DEFINITIONS.—For purposes of this section: ‘‘(1) The term ‘platform technology’ means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates— ‘‘(A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or bio- logical product; ‘‘(B) can be adapted for, incorporated into, or utilized by, more than one drug or biological product sharing common structural elements; and ‘‘(C) facilitates the manufacture or devel- opment of more than one drug or biological product through a standardized production or manufacturing process or processes.
‘‘(2) The term ‘designated platform technology’ means a platform technology that is designated as a platform technology under subsection (d).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3453 ‘‘(i) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to— ‘‘(1) alter the authority of the Secretary to ap- prove drugs pursuant to section 505 of this Act or license biological products pursuant to section 351 of the Public Health Service Act, including standards of evidence and applicable conditions for approval or licensure under the applicable Act; or ‘‘(2) confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product referencing infor- mation contained in another application submitted by the holder of an approved application under sec- tion 505(c) of this Act or of a license under section 351(a) of the Public Health Service Act.’’.
(b) GUIDANCE.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’) shall issue draft guidance on the implementation of this section.
Such guidance shall include examples of drugs that can be manufactured using platform tech- nologies, including drugs that contain or consist of vectors and nucleic acids, information about the Secretary’s re- view of platform technologies, information regarding sub- mitting for designation, considerations for persons submit- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3454 ting a request for designation who have been granted a right of reference, the implementation of the designated platform technology designation program, efficiencies that may be achieved in the development and review of prod- ucts that incorporate or utilize designated platform tech- nologies, and recommendations and requirements for mak- ing and reporting manufacturing changes to a designated platform technology in accordance with section 506K(g) of the Federal Food, Drug, and Cosmetic Act (as added 10 by subsection (a)) and section 506A of such Act (21 11 U.S.C.
356a), as applicable.
(c) REPORT.—Not later than September 30, 2026, and annually thereafter until September 30, 2029, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that shall include— (1) the number of requests for designation under the program under section 506K of the Fed- eral Food, Drug, and Cosmetic Act, as added by subsection (a); (2) the number of designations under such pro- gram issued, active, and revoked; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3455 (3) the resources required to carry out such program (including the review time used for full- time equivalent employees); (4) any efficiencies gained in the development, manufacturing, and review processes associated with such designations; and (5) recommendations, if any, to strengthen the program to better leverage platform technologies that can be used in more than one drug and meet patient needs in a manner as timely as possible, tak- ing into consideration the resources available to the Secretary of Health and Human Services for car- rying out such program.
SEC.

2504.

INCREASING EUA DECISION TRANSPARENCY.

Section 564(h) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
360bbb–3(h)) is amended— (1) in paragraph (1)— (A) by inserting ‘‘on the internet website of the Food and Drug Administration and’’ after ‘‘promptly publish’’; (B) by striking ‘‘application under section 505(i), 512(j), or 520(g), even if such summary may indirectly reveal the existence of such ap- plication’’ and inserting ‘‘application, request, or submission under this section or section December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3456 505(b), 505(i), 505(j), 512(b), 512(j), 512(n), 515, 510(k), 513(f)(2), 520(g), 520(m), 571, or 572 of this Act, or section 351(a) or 351(k) of the Public Health Service Act, even if such summary may reveal the existence of such an application, request, or submission, or data con- tained in such application, request, or submis- sion’’; and (C) by inserting before the period at the end of the second sentence the following: ‘‘, which may include a summary of the data and information supporting such revisions’’; and (2) in paragraph (2), by adding at the end the following: ‘‘Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for pur- poses of section 1905 of title 18, United States Code’’.
SEC.

2505.

IMPROVING FDA GUIDANCE AND COMMUNICA- TION.

(a) FDA REPORT AND IMPLEMENTATION OF GOOD GUIDANCE PRACTICES.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’) shall develop, and publish on the website of the Food and Drug Administration— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3457 (1) a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies; and (2) a plan for implementation of such best practices, including across other applicable agencies, which shall address— (A) streamlining development and review of guidance documents within centers and across the Food and Drug Administration; (B) streamlining processes for regulatory submissions to the Food and Drug Administra- tion, including through the revision or issuance of guidance documents; and (C) implementing innovative guidance de- velopment processes and practices and transitioning or updating guidance issued dur- ing the COVID–19 public health emergency, as appropriate.
(b) REPORT AND IMPLEMENTATION OF FDA BEST PRACTICES FOR COMMUNICATING WITH EXTERNAL STAKEHOLDERS.—The Secretary, acting through the Commissioner of Food and Drugs, shall develop and pub- lish on the website of the Food and Drug Administration December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3458 a report on the practices of the Food and Drug Adminis- tration to broadly communicate with external stake- holders, other than through guidance documents, which shall include— (1) a review of the types and methods of public communication that the Food and Drug Administra- tion uses to communicate and interact with medical product sponsors and other external stakeholders; (2) the identification of best practices for the efficient development, issuance, and use of such communications; and (3) a plan for implementation of best practices for communication with external stakeholders, which shall address— (A) advancing the use of innovative forms of communication, including novel document types and formats, to provide increased regu- latory clarity to product sponsors and other stakeholders, and advancing methods of com- municating and interacting with medical prod- uct sponsors and other external stakeholders, including the use of tools such as product sub- mission templates, webinars, and frequently asked questions communications; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3459 (B) streamlining processes for regulatory submissions; and (C) implementing innovative communica- tion development processes and transitioning or updating communication practices used during the COVID–19 public health emergency, as ap- propriate.
(c) CONSULTATION.—In developing and publishing the report and implementation plan under this section, the Secretary shall consult with stakeholders, including re- searchers, academic organizations, pharmaceutical, bio- technology, and medical device developers, clinical re- search organizations, clinical laboratories, health care pro- viders, patient groups, and other appropriate stakeholders.
(d) MANNER OF ISSUANCE.— For purposes of car- rying out this section, the Secretary may update an exist- ing report or plan, and may combine the reports and im- plementation plans described in subsections (a) and (b) into one or more documents.
(e) TIMING.—The Secretary shall— (1) not later than 1 year after the date of en- actment of this Act, publish a draft of the reports and plans required under this section; and (2) not later than 180 days after publication of the draft reports and plans under paragraph (1)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3460 (A) publish a final report and plan; and (B) begin implementation of the best prac- tices pursuant to such final plan.
CHAPTER 2—MITIGATING SHORTAGES SEC.

2511.

ENSURING REGISTRATION OF FOREIGN DRUG AND DEVICE MANUFACTURERS.

(a) REGISTRATION OF CERTAIN FOREIGN ESTAB- LISHMENTS.—Section 510(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(i)) is amended by add- ing at the end the following: ‘‘(5) The requirements of paragraphs (1) and (2) shall apply regardless of whether the drug or device under- goes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or of- fered for import into the United States.’’.
(b) UPDATING REGULATIONS.—Not later than 2 years after the date of enactment of this Act, the Sec- retary of Health and Human Services shall update regula- tions, as appropriate, to implement the amendment made 21 by subsection (a).

22 23 24 25 SEC.

2512.

EXTENDING EXPIRATION DATES FOR CERTAIN DRUGS.

(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3461 Human Services (referred to in this section as the ‘‘Sec- retary’’) shall issue draft guidance, or revise existing guid- ance, to address recommendations for sponsors of applica- tions submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355) or section 351 of the Public Health Service Act (42 U.S.C.
262) regard- ing— (1) the submission of stability testing data in such applications, including considerations for data requirements that could be streamlined or reduced to facilitate faster review of longer proposed expira- tion dates; (2) establishing in the labeling of drugs the longest feasible expiration date scientifically sup- ported by such data, taking into consideration how extended expiration dates may— (A) help prevent or mitigate drug short- ages; and (B) affect product quality; and (3) the use of innovative approaches for drug and combination product stability modeling to sup- port initial product expiration dates and expiration date extensions.
(b) REPORT.—Not later than 2 years after the date of enactment of this Act, and again 2 years thereafter, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3462 the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— (1) the number of drugs for which the Sec- retary has requested the manufacturer make a label- ing change regarding the expiration date; and (2) for each drug for which the Secretary has requested a labeling change with respect to the expi- ration date, information regarding the circumstances of such request, including— (A) the name and dose of such drug; (B) the rationale for the request; (C) whether the drug, at the time of the request, was listed on the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356e), or was at risk of shortage; (D) whether the request was made in con- nection with a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C.

247d); and (E) whether the manufacturer made the requested change by the requested date, and for instances where the manufacturer does not December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3463 make the requested change, the manufacturer’s justification for not making the change, if the manufacturer agrees to provide such justifica- tion for inclusion in the report.

SEC.

2513.

COMBATING COUNTERFEIT DEVICES.

(a) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331) is amend- ed by adding at the end the following: ‘‘(fff)(1) Forging, counterfeiting, simulating, or false- ly representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.
‘‘(2) Making, selling, disposing of, or keeping in pos- session, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container, packaging, or la- beling thereof so as to render such device a counterfeit device.
22 23 24 ‘‘(3) The doing of any act which causes a device to be a counterfeit device, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit device.’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3464 (b) PENALTIES.—Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333) is amended— (1) in subsection (b)(8), by inserting ‘‘, or who violates section 301(fff)(3) by knowingly making, selling or dispensing, or holding for sale or dis- pensing, a counterfeit device,’’ after ‘‘a counterfeit drug’’; and (2) in subsection (c), by inserting ‘‘; or (6) for having violated section 301(fff)(2) if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing in- volved would result in a device being a counterfeit device, or for having violated section 301(fff)(3) if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the device was a counterfeit device’’ before the pe- riod.
(c) SEIZURE.—Section 304(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

334(a)(2)) is amended— (1) by striking ‘‘, and (E)’’ and inserting ‘‘, (E)’’; and (2) by inserting ‘‘, (F) Any device that is a counterfeit device, (G) Any container, packaging, or labeling of a counterfeit device, and (H) Any punch, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3465 die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit de- vice or devices’’ before the period.

SEC.

2514.

PREVENTING MEDICAL DEVICE SHORTAGES.

(a) NOTIFICATIONS.—Section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356j) is amend- ed— (1) in subsection (f), by inserting ‘‘or (h)’’ after ‘‘subsection (a)’’; (2) by redesignating subsections (h) and (i) as subsections (i) and (j), respectively; and (3) by inserting after subsection (g) the fol- lowing: ‘‘(h) ADDITIONAL NOTIFICATIONS.—The Secretary may receive voluntary notifications from a manufacturer of a device that is life-supporting, life-sustaining, or in- tended for use in emergency medical care or during sur- gery, or any other device the Secretary determines to be critical to the public health, pertaining to a permanent dis- continuance in the manufacture of the device (except for any discontinuance as a result of an approved modification of the device) or an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States, and the reasons for such discontinuance or interruption.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3466 (b) GUIDANCE ON VOLUNTARY NOTIFICATIONS OF DISCONTINUANCE OR INTERRUPTION OF DEVICE MANU- FACTURE.—Not later than 1 year after the date of enact- ment of this Act, the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection (h) of section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

356j), as added by subsection (a).


Such guidance shall include a description of circumstances in which a voluntary notification under such subsection (h) may be appropriate, recommended timeframes for such a notification, the process for receiving such a notification, and actions the Secretary may take to mitigate or prevent a shortage resulting from a discontinuance or interruption in the manufacture of a device for which such notification is received.
The Secretary shall issue final guidance not later than 1 year after the close of the comment period 17 for the draft guidance.

18 (c) GUIDANCE ON DEVICE SHORTAGE NOTIFICATION REQUIREMENT.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

356j).
356j).

Such guidance shall include a list of each device product code for which a manufacturer of such device is December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3467 required to notify the Secretary in accordance with section 506J.

SEC.

2515.

TECHNICAL CORRECTIONS.


(a) TECHNICAL CORRECTIONS TO THE CARES ACT.—Division A of the CARES Act (Public Law 116– 136) is amended— (1) in section 3111(1), by striking ‘‘in para- graph (1)’’ and inserting ‘‘in the matter preceding paragraph (1)’’; (2) in section 3112(d)(1), by striking ‘‘and sub- paragraphs (A) and (B)’’ and inserting ‘‘as subpara- graphs (A) and (B)’’; and (3) in section 3112(e), by striking ‘‘Federal Food, Drug, Cosmetic Act’’ and inserting ‘‘Federal Food, Drug, and Cosmetic Act’’.
(b) TECHNICAL CORRECTIONS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT RELATED TO THE CARES ACT.— (1) SECTION 506C.—Section 506C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

356c(a)) is amended, in the flush text at the end, by striking the second comma after ‘‘in the United States’’.
(2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall take effect as if included in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3468 section 3112 of division A of the CARES Act (Pub- lic Law 116–136).

(c) OTHER TECHNICAL CORRECTION TO THE FED- ERAL FOOD, DRUG, AND COSMETIC ACT.—Section 505B(f)(6)(I) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c(f)(6)(I)) is amended by striking ‘‘subsection (a)(3)(B)’’ and inserting ‘‘subsection (a)(4)(C)’’.

TITLE III—FOOD AND DRUG ADMINISTRATION SEC.

3001.

SHORT TITLE.

This title may be cited as the ‘‘Food and Drug Omni- 13 bus Reform Act of 2022’’.

14 15 16 SEC.

3002.

DEFINITION.

In this title, except as otherwise specified, the term ‘‘Secretary’’ means the Secretary of Health and Human 17 Services.

18 Subtitle A—Reauthorizations SEC.

3101.
3101.

REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIP.

Section 566(f) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

360bbb–5(f)) is amended by striking ‘‘$1,265,753 for the period beginning on October 1, 2022 and ending on December 23, 2022’’ and inserting ‘‘$6,000,000 for each of fiscal years 2023 through 2027’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3469 SEC.

3102.

REAUTHORIZATION OF THE BEST PHARMA- CEUTICALS FOR CHILDREN PROGRAM.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.

284m(d)(1)) is amended by striking ‘‘$5,273,973 for the period beginning on October 1, 2022 and ending on December 23, 2022’’ and inserting ‘‘$25,000,000 for each of fiscal years 2023 through 2027’’.

SEC.

3103.

REAUTHORIZATION OF THE HUMANITARIAN DE- VICE EXEMPTION INCENTIVE.

Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(m)(6)(A)(iv)) is amended by striking ‘‘December 24, 2022’’ and inserting ‘‘October 1, 2027’’.

15 SEC.

3104.

REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA PROGRAM.

Section 305(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85; 42 U.S.C.
282 note) is amended by striking ‘‘$1,107,534 for the pe- riod beginning on October 1, 2022, and ending on Decem- ber 23, 2022’’ and inserting ‘‘$7,000,000 for each of fiscal 22 years 2023 through 2027’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3470 SEC.

3105.

REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS CONTAINING SINGLE ENANTIOMERS.

Section 505(u) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
355(u)) is amended— (1) in paragraph (1)(A)(ii)(II), by adding ‘‘(other than bioavailability studies)’’ after ‘‘any clin- ical investigations’’; and (2) in paragraph (4), by striking ‘‘December 24, 2022’’ and inserting ‘‘October 1, 2027’’.

SEC.

3106.

REAUTHORIZATION OF CERTAIN DEVICE IN- SPECTIONS.

Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

374(g)(11)) is amended by strik- ing ‘‘December 24, 2022’’ and inserting ‘‘October 1, 16 2027’’.

17 18 SEC.

3107.
17 18 SEC.

3107.

REAUTHORIZATION OF ORPHAN DRUG GRANTS.

Section 5 of the Orphan Drug Act (21 U.S.C.

360ee) 19 is amended— 26 (1) in subsection (a)— (A) by striking ‘‘and (3)’’ and inserting ‘‘(3)’’; and (B) by inserting before the period at the end the following: ‘‘, and (4) developing regu- latory science pertaining to the chemistry, man- ufacturing, and controls of individualized med- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3471 ical products to treat individuals with rare dis- eases or conditions’’; and (2) in subsection (c), by striking ‘‘$6,328,767 for the period beginning on October 1, 2022, and ending on December 23, 2022’’ and inserting ‘‘$30,000,000 for each of fiscal years 2023 through 2027’’.

SEC.

3108.

REAUTHORIZATION OF REPORTING REQUIRE- MENTS RELATED TO PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS.
Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115–52) is amended, in the matter preceding paragraph (1), by striking ‘‘December 23, 2022’’ and in- serting ‘‘October 1, 2027’’.

16 17 18 19 20 SEC.

3109.

REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.

Section 523(c) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

360m(c)) is amended by striking ‘‘December 24, 2022’’ and inserting ‘‘on October 1, 2027’’ 21 .
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3472 Subtitle B—Drugs and Biologics CHAPTER 1—RESEARCH, DEVELOPMENT, AND COMPETITION IMPROVEMENTS SEC.

3201.

PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF APPROVED APPLICATIONS FOR BIOLOGICAL PRODUCTS.

(a) IN GENERAL.—Section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356i) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1), by striking ‘‘The holder of an application ap- proved under subsection (c) or (j) of section 505’’ and inserting ‘‘The holder of an applica- tion approved under subsection (c) or (j) of sec- tion 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act’’; (B) in paragraph (2), by striking ‘‘estab- lished name’’ and inserting ‘‘established name (or, in the case of a biological product, the proper name)’’; and (C) in paragraph (3), by striking ‘‘or ab- breviated application number’’ and inserting ‘‘, abbreviated application number, or biologics li- cense application number’’; and (2) in subsection (b)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3473 (A) in the matter preceding paragraph (1), by striking ‘‘The holder of an application ap- proved under subsection (c) or (j)’’ and insert- ing ‘‘The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act’’; (B) in paragraph (1), by striking ‘‘estab- lished name’’ and inserting ‘‘established name (or, in the case of a biological product, the proper name)’’; and (C) in paragraph (2), by striking ‘‘or ab- breviated application number’’ and inserting ‘‘, abbreviated application number, or biologics li- cense application number’’.
(b) ADDITIONAL ONE-TIME REPORT.—Subsection (c) of section 506I of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
356i) is amended to read as follows: ‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 days of the date of enactment of the Food and Drug Om- nibus Reform Act of 2022, all holders of applications ap- proved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A) of the Public December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3474 Health Service Act and shall submit a written notice to the Secretary— ‘‘(1) stating that all of the application holder’s biological products in the list published under such section 351(k)(9)(A) that are not listed as discon- tinued are available for sale; or ‘‘(2) including the information required pursu- ant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under such section 351(k)(9)(A) and not listed as discontinued, but have been discontinued from sale or never have been available for sale.’’.
(c) PURPLE BOOK.—Section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356i) is amend- ed— (1) by striking subsection (d) and inserting the following: ‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a hold- er of an approved application fails to submit the informa- tion required under subsection (a), (b), or (c), the Sec- 22 retary may— 23 24 25 ‘‘(1) move the application holder’s drugs from the active section of the list published under section 505(j)(7)(A) to the discontinued section of the list, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3475 except that the Secretary shall remove from the list in accordance with section 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness; and ‘‘(2) identify the application holder’s biological products as discontinued in the list published under section 351(k)(9)(A) of the Public Health Service Act, except that the Secretary shall remove from the list in accordance with section 351(k)(9)(B) of such Act biological products for which the license has been revoked or suspended for reasons of safety, pu- rity, or potency.’’; and (2) in subsection (e)— (A) by inserting after the first sentence the following: ‘‘The Secretary shall update the list published under section 351(k)(9)(A) of the Public Health Service Act based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that bio- logical products for which the license has been revoked or suspended for safety, purity, or po- tency reasons shall be removed from the list in accordance with section 351(k)(9)(B) of the Public Health Service Act.’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3476 (B) by striking ‘‘monthly updates to the list’’ and inserting ‘‘monthly updates to the lists referred to in the preceding sentences’’; and (C) by striking ‘‘and shall update the list based on’’ and inserting ‘‘and shall update such lists based on’’.

(d) TECHNICAL CORRECTIONS.—Section 506I(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356i(e)) is amended— (1) by striking ‘‘subsection 505(j)(7)(A)’’ and inserting ‘‘section 505(j)(7)(A)’’; and (2) by striking ‘‘subsection 505(j)(7)(C)’’ and inserting ‘‘section 505(j)(7)(C)’’.

SEC.

3202.

IMPROVING THE TREATMENT OF RARE DIS- EASES AND CONDITIONS.
(a) REPORT ON ORPHAN DRUG PROGRAM.— (1) IN GENERAL.—Not later than September 30, 2026, the Secretary shall submit to the Com- mittee on Energy and Commerce of the House of Representatives and the Committee on Health, Edu- cation, Labor, and Pensions of the Senate a report summarizing the activities of the Food and Drug Administration, with respect to the period of fiscal years 2023 through fiscal year 2025, related to des- ignating drugs under section 526 of the Federal December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3477 Food, Drug, and Cosmetic Act (21 U.S.C.

360bb) for a rare disease or condition and approving such drugs under section 505 of such Act (21 U.S.C.

355) or licensing such drugs under section 351 of the Public Health Service Act (42 U.S.C.

262), in- cluding— (A) the number of applications for such drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355) or section 351 of the Public Health Service Act (42 U.S.C.
262) received by the Food and Drug Administration, the number of such applica- tions accepted and rejected for filing, and the numbers of such applications pending, ap- proved, and for which a complete response let- ter has been issued by the Food and Drug Ad- ministration; (B) the number of applications for which the sponsor requested written recommendations pursuant to section 525 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360aa) and the number of such applications for which the sponsor received such written recommendations; (C) a description of trends in drug approv- als for rare diseases and conditions across re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3478 view divisions at the Food and Drug Adminis- tration; (D) the extent to which the Food and Drug Administration is consulting with external experts pursuant to section 569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–8(a)(2)) on topics pertaining to drugs for a rare disease or condition, including how and when any such consultation is occur- ring; (E) the number of applications for which the Secretary allowed the sponsor to rely upon data and information pursuant to section 529A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff–1); and (F) a description of the Food and Drug Administration’s efforts to promote best prac- tices in the development of novel treatments for rare diseases or conditions, including— (i) reviewer training on policies, meth- ods, and tools related to rare diseases and conditions; and (ii) new regulatory science and coordi- nated support for patient and stakeholder engagement.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3479 (2) PUBLIC AVAILABILITY.—The Secretary shall make the report under paragraph (1) available to the public, including by posting the report on the website of the Food and Drug Administration.

(3) INFORMATION DISCLOSURE.—Nothing in this subsection shall be construed to authorize the disclosure of information that is prohibited from dis- closure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331(j)) or sec- tion 1905 of title 18, United States Code, or subject to withholding under paragraph (4) of section 552(b) of title 5, United States Code (commonly re- ferred to as the ‘‘Freedom of Information Act’’).

(b) GUIDANCE.—Not later than 9 months after the date of enactment of this Act, the Secretary shall publish final guidance related to the draft guidance titled, ‘‘Rare Diseases: Common Issues in Drug Development’’, issued on February 1, 2019.
19 20 (c) STUDY ON EUROPEAN UNION SAFETY AND EFFI- CACY REVIEWS OF DRUGS FOR RARE DISEASES AND CON- 21 DITIONS.— 22 23 24 25 (1) IN GENERAL.—The Secretary shall enter into a contract with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the ‘‘National Academies’’) to con- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3480 duct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union, in- cluding— (A) flexibilities, authorities, or mechanisms available to regulators in the United States and the European Union specific to rare diseases or conditions; (B) the consideration and use of supple- mental data submitted during review processes in the United States and the European Union, including data associated with open label exten- sion studies and expanded access programs spe- cific to rare diseases or conditions; (C) an assessment of collaborative efforts between United States and European Union regulators related to— (i) product development programs under review; (ii) policies under development and those recently issued; and (iii) scientific information related to product development or regulation; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3481 (D) recommendations for how Congress can support collaborative efforts described in subparagraph (C).

(2) CONSULTATION.—The contract under para- graph (1) shall provide for consultation with relevant stakeholders, including— (A) representatives from the Food and Drug Administration and the European Medi- cines Agency; (B) patients with rare diseases or condi- tions; and (C) patient groups that— (i) represent patients with rare dis- eases or conditions; and (ii) have international patient out- reach.
(3) REPORT.—The contract under paragraph (1) shall provide for, not later than 2 years after the date of entering into such contract— (A) the completion of the study under paragraph (1); and (B) the submission of a report on the re- sults of such study to the Committee on Energy and Commerce of the House of Representatives December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3482 and the Committee on Health, Education, Labor, and Pensions of the Senate.

(4) PUBLIC AVAILABILITY.—The contract under paragraph (1) shall provide for the National Acad- emies to make the report under paragraph (3) avail- able to the public, including by posting the report on the website of the National Academies.
(d) PUBLIC MEETING.— (1) IN GENERAL.—Not later than December 31, 2023, the Secretary, acting through the Commis- sioner of Food and Drugs, shall convene one or more public meetings to solicit input from stakeholders re- garding the approaches described in paragraph (2).
(2) APPROACHES.—The public meeting or meetings under paragraph (1) shall address ap- proaches to increasing and improving engagement with rare disease or condition patients, groups rep- resenting such patients, rare disease or condition ex- perts, and experts on small population studies, in order to improve the understanding with respect to rare diseases or conditions of— (A) patient burden; (B) treatment options; and (C) side effects of treatments, including understanding the risks of side effects relative December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3483 to the health status of the patient and the pro- gression of the disease or condition.

(3) PUBLIC DOCKET.—The Secretary shall es- tablish a public docket to receive written comments related to the approaches addressed during each public meeting under paragraph (1).

Such public docket shall remain open for 60 days following the date of each such public meeting.
(4) REPORTS.—Not later than 180 days after each public meeting under paragraph (1), the Com- missioner of Food and Drugs shall develop and pub- lish on the website of the Food and Drug Adminis- tration a report on— (A) the approaches discussed at the public meeting; and (B) any related recommendations.

(e) CONSULTATION ON THE SCIENCE OF SMALL POP- ULATION STUDIES.—Section 569(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–8(b)) is amended— (1) in paragraph (6), by striking ‘‘; and’’ and inserting a semicolon; (2) in paragraph (7), by striking the period and inserting ‘‘; and’’; and (3) by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3484 ‘‘(8) the science of small population studies.’’.
(f) GAO REPORT.— (1) IN GENERAL.—Not later than 18 months after the date of enactment of this Act, the Comp- troller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on En- ergy and Commerce of the House of Representa- tives, a report assessing the policies, practices, and programs of the Food and Drug Administration with respect to the review of applications for approval of drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) and licensing of biological products under section 351 of the Public Health Service Act (42 U.S.C.

262) intended to treat rare diseases and conditions.

(2) CONTENT OF REPORT.—The report under paragraph (1) shall— (A) describe the activities of the Food and Drug Administration dedicated to the develop- ment and review of drugs and biological prod- ucts intended to treat rare diseases and condi- tions under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3485 section 351 of the Public Health Service Act (42 U.S.C.
262); (B) describe challenges with developing and obtaining approval or licensure of drugs and biological products intended to treat rare diseases and conditions, such as challenges re- lated to designing and conducting clinical trials, clinical trial subject recruitment and enroll- ment, study endpoints, and ensuring data qual- ity, assessing the benefit-risk profile of drugs and biological products intended to treat rare diseases and conditions, and meeting require- ments for approval or licensure; (C) assess the effectiveness of policies and practices of the Food and Drug Administration related to the review of applications for drugs and biological products intended to treat rare diseases and conditions, including— (i) initiatives to support the develop- ment and review of drugs and biological products intended to treat rare diseases and conditions, including initiatives related to regulatory science, clinical trial design, statistical analysis, and other relevant top- ics; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3486 (ii) consideration of relevant patient- focused drug development data and infor- mation, including patient experience data and the views of patients, pursuant to sec- tion 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–8c); (iii) training and other efforts to en- sure the expertise of personnel of the Food and Drug Administration regarding the re- view of applications for drugs and biologi- cal products intended to treat rare diseases and conditions; and (iv) consultations and engagement with stakeholders and external experts pur- suant to section 569 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–8); (D) assess the extent to which the Food and Drug Administration is applying the poli- cies and practices described in subparagraph (C) consistently across review divisions, and the factors that influence the extent to which such application is consistent; and (E) include recommendations to address challenges and deficiencies identified, including December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3487 recommendations to improve the effectiveness, consistency, and coordination of policies, prac- tices, and programs of the Food and Drug Ad- ministration related to the review of applica- tions for drugs and biological products intended to treat rare diseases and conditions.
(g) DEFINITION.—In this section, the terms ‘‘rare disease or condition’’, ‘‘rare diseases or conditions’’, and ‘‘rare diseases and conditions’’ have the meaning given the term ‘‘rare disease or condition’’ in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

1 360bbb(a)(2)).

13 14 15 16 SEC.

3203.

EMERGING TECHNOLOGY PROGRAM.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

201 et seq.)
201 et seq.)

is amended by inserting after section 566 of such Act (21 U.S.C.

360bbb–5) the fol- 17 lowing: ‘‘SEC.

566A.

EMERGING TECHNOLOGY PROGRAM.

‘‘(a) PROGRAM ESTABLISHMENT.— ‘‘(1) IN GENERAL.—The Secretary shall estab- lish a program to support the adoption of, and im- prove the development of, innovative approaches to drug design and manufacturing.
‘‘(2) ACTIONS.—In carrying out the program under paragraph (1), the Secretary may— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3488 ‘‘(A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative drug product design and manufacturing; ‘‘(B) solicit information regarding, and conduct or support research on, innovative ap- proaches to drug product design and manufac- turing; ‘‘(C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested per- sons, as appropriate; ‘‘(D) convene working groups to support drug product design and manufacturing re- search and development; ‘‘(E) support education and training for regulatory staff and scientists related to innova- tive approaches to drug product design and manufacturing; ‘‘(F) advance regulatory science related to the development and review of innovative ap- proaches to drug product design and manufac- turing; ‘‘(G) convene or participate in working groups to support the harmonization of inter- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3489 national regulatory requirements related to in- novative approaches to drug product design and manufacturing; and ‘‘(H) award grants or contracts to carry out or support the program under paragraph (1).
‘‘(3) GRANTS AND CONTRACTS.—To seek a grant or contract under this section, an entity shall submit an application— ‘‘(A) in such form and manner as the Sec- retary may require; and ‘‘(B) containing such information as the Secretary may require, including a description of— ‘‘(i) how the entity will conduct the activities to be supported through the grant or contract; and ‘‘(ii) how such activities will further research and development related to, or adoption of, innovative approaches to drug product design and manufacturing.
‘‘(b) GUIDANCE.—The Secretary shall— ‘‘(1) issue or update guidance to help facilitate the adoption of, and advance the development of, in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3490 novative approaches to drug product design and manufacturing; and ‘‘(2) include in such guidance descriptions of— ‘‘(A) any regulatory requirements related to the development or review of technologies re- lated to innovative approaches to drug product design and manufacturing, including updates and improvements to such technologies after product approval; and ‘‘(B) data that can be used to demonstrate the identity, safety, purity, and potency of drugs manufactured using such technologies.
‘‘(c) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of this section, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing— ‘‘(1) an annual accounting of the allocation of funds made available to carry out this section; ‘‘(2) a description of how Food and Drug Ad- ministration staff were utilized to carry out this sec- tion and, as applicable, any challenges or limitations related to staffing; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3491 ‘‘(3) the number of public meetings held or par- ticipated in by the Food and Drug Administration pursuant to this section, including meetings con- vened as part of a working group described in sub- paragraph (D) or (G) of subsection (a)(2), and the topics of each such meeting; and ‘‘(4) the number of drug products approved or licensed, after the date of enactment of this section, using an innovative approach to drug product design and manufacturing.’’.

SEC.

3204.
SEC.

3204.

NATIONAL CENTERS OF EXCELLENCE IN AD- VANCED AND CONTINUOUS PHARMA- CEUTICAL MANUFACTURING.

(a) IN GENERAL.—Section 3016 of the 21st Century Cures Act (21 U.S.C.

399h) is amended to read as follows: ‘‘SEC.

3016.

NATIONAL CENTERS OF EXCELLENCE IN AD- VANCED AND CONTINUOUS PHARMA- CEUTICAL MANUFACTURING.
‘‘(a) IN GENERAL.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs— 22 23 24 ‘‘(1) may, to support the advancement, develop- ment, and implementation of advanced and contin- uous pharmaceutical manufacturing— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3492 ‘‘(A) solicit requests for designation as Na- tional Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing (in this section referred to as a ‘National Center of Excellence’); ‘‘(B) beginning not later than one year after the date of enactment of the Food and Drug Omnibus Reform Act of 2022, designate as National Centers of Excellence institutions of higher education or consortia of institutions of higher education that— ‘‘(i) request such designation; and ‘‘(ii) meet the eligibility criteria speci- fied in subsection (c); and ‘‘(C) award grants to such institutions or consortia of institutions; and ‘‘(2) shall so designate not more than 5 institu- tions of higher education or consortia of such insti- tutions.
‘‘(b) REQUEST FOR DESIGNATION.—A request for designation under subsection (a) shall be made to the Sec- retary at such time, in such manner, and containing such information as the Secretary may require.

‘‘(c) ELIGIBILITY CRITERIA FOR DESIGNATION.—To be eligible to receive a designation under this section, an December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3493 institution of higher education or consortium of institu- tions of higher education shall include in its request for designation a description of the institution’s or consor- tium’s— ‘‘(1) physical capacity and technical capabilities to conduct advanced research on, and to develop and implement, advanced and continuous pharmaceutical manufacturing; ‘‘(2) collaboration or partnerships with other in- stitutions of higher education, nonprofit organiza- tions, and large and small pharmaceutical manufac- turers, including generic and nonprescription manu- facturers, contract manufacturers, and other rel- evant entities; ‘‘(3) proven capacity to design, develop, imple- ment, and demonstrate new, highly effective tech- nologies for use in advanced and continuous phar- maceutical manufacturing; ‘‘(4) proven ability to facilitate training of a qualified workforce for advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing; and ‘‘(5)(A) experience in participating in and lead- ing advanced and continuous pharmaceutical manu- facturing technology partnerships with other institu- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3494 tions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufactur- ers, contract manufacturers, and other relevant enti- ties to— ‘‘(i) support the implementation of ad- vanced or continuous pharmaceutical manufac- turing for companies manufacturing or seeking to manufacture in the United States; ‘‘(ii) support Federal agencies with tech- nical assistance and workforce training, which may include regulatory and quality metric guid- ance as applicable, and hands-on training, for advanced and continuous pharmaceutical manu- facturing; ‘‘(iii) organize and conduct advanced re- search and development activities, with respect to advanced or continuous pharmaceutical man- ufacturing, needed to develop new and more ef- fective technology, and to develop and support technological leadership; ‘‘(iv) develop best practices for designing, developing, and implementing advanced and continuous pharmaceutical manufacturing proc- esses; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3495 ‘‘(v) identify and assess workforce needs for advanced and continuous pharmaceutical manufacturing, and address such workforce needs, which may include the development and implementing of training programs; or ‘‘(B) a plan, to be implemented within 2 years, to establish partnerships described in subparagraph (A).
‘‘(d) TERMINATION OF DESIGNATION.—The Sec- retary may terminate the designation of any National Cen- ter of Excellence designated under this section if the Sec- retary determines such National Center of Excellence no longer meets the criteria specified in subsection (c).
Not later than 90 days before the effective date of such a ter- mination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.
‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi- tion of designation as a National Center of Excellence under this section, the Secretary shall require that an in- stitution of higher education or consortium of institutions of higher education enter into an agreement with the Sec- retary under which the institution or consortium agrees— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3496 ‘‘(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g); ‘‘(2) to share data with the Food and Drug Ad- ministration regarding best practices and research generated through the funding under subsection (f); ‘‘(3) to develop, along with industry partners (which may include large and small pharmaceutical manufacturers, including generic and nonprescrip- tion manufacturers, and contract research organiza- tions or contract manufacturers that carry out drug development and manufacturing activities) and an- other institution or consortium designated under this section, if any, a strategic plan for developing an ad- vanced and continuous pharmaceutical manufac- turing workforce; ‘‘(4) to develop, along with industry partners and other institutions or consortia of such institu- tions designated under this section, a strategic plan for strengthening existing, and developing new, part- nerships with other institutions of higher education or consortia thereof, or nonprofit organizations; and ‘‘(5) to provide an annual report to the Food and Drug Administration regarding the designee’s activities under this section, including a description December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3497 of how the designee continues to meet and make progress on the criteria specified in subsection (c).
‘‘(f) FUNDING.— ‘‘(1) IN GENERAL.—The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the entities designated as National Centers of Excellence under this section for the pur- poses of supporting the advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing, and rec- ommending improvements to advanced and contin- uous pharmaceutical manufacturing, including— ‘‘(A) expanding capacity for advanced re- search on, and development of, advanced and continuous pharmaceutical manufacturing; and ‘‘(B) implementing advanced research ca- pacity and capabilities in advanced and contin- uous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to public health threats, miti- gate or prevent drug shortages, address drug quality issues and supply chain disruptions, and other circumstances with respect to which the Secretary may determine the rapid development December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3498 of new products or new manufacturing proc- esses may be appropriate.
‘‘(2) CONSISTENCY WITH FDA MISSION.—As a condition on receipt of funding under this sub- section, a National Center of Excellence shall con- sider any input from the Secretary regarding the use of funding related to— ‘‘(A) best practices to increase, and provide for the advancement of, advanced and contin- uous pharmaceutical manufacturing through the National Center of Excellence; and ‘‘(B) the extent to which activities con- ducted by the National Center of Excellence are consistent with the mission of the Food and Drug Administration.
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as precluding a Na- tional Center for Excellence designated under this section from receiving funds under any other provi- sion of this Act or any other Federal law.
‘‘(g) ANNUAL REVIEW AND REPORTS.— ‘‘(1) ANNUAL REPORT TO CONGRESS.—Begin- ning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3499 ‘‘(A) submit to Congress a report describ- ing the activities, partnerships and collabora- tions, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the Na- tional Centers of Excellence designated under this section; ‘‘(B) include in such report an accounting of the Federal administrative expenses de- scribed in subsection (i)(2) over the reporting period; and ‘‘(C) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Adminis- tration.
‘‘(2) CENTER OF EXCELLENCE REPORT.—An entity receiving a grant under this section shall, not later than 1 year after receiving such grant, and an- nually thereafter for the duration of the grant pe- riod, submit to the Secretary a summary of pro- grams and activities funded under the grant.
‘‘(3) PERIODIC REVIEW.—The Secretary shall periodically review the National Centers of Excel- lence designated under this section to ensure that December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3500 such National Centers of Excellence continue to meet the criteria for designation under this section.
‘‘(4) ADDITIONAL REPORT TO CONGRESS.—Not later than 1 year after the date on which the first designation is made under subsection (a), the Sec- retary, in consultation with the National Centers of Excellence designated under this section, shall sub- mit a report to the Congress on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, in- cluding— ‘‘(A) a national framework of principles re- lated to the implementation of advanced and continuous pharmaceutical manufacturing; ‘‘(B) a plan for the development of Federal regulations and guidance to support and facili- tate the incorporation of advanced or contin- uous manufacturing into the development of pharmaceuticals; ‘‘(C) a plan for development of Federal regulations or guidance related to the review of advanced and continuous pharmaceutical manu- facturing, including how such manufacturing practices may be incorporated into the review of medical product applications; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3501 ‘‘(D) a summary of relevant feedback re- lated to improving advanced and continuous pharmaceutical manufacturing solicited from the public, which may include other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufac- turers, including generic and nonprescription manufacturers, and contract manufacturers, and other relevant entities.
‘‘(h) DEFINITIONS.—In this section: ‘‘(1) ADVANCED AND CONTINUOUS PHARMA- CEUTICAL MANUFACTURING.—The term ‘advanced and continuous pharmaceutical manufacturing’ re- fers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods— ‘‘(A) that incorporates a novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the manufacturing process for a drug, including processes that may apply to advanced therapies and the production of bi- ological products, such as cell and gene thera- pies; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3502 ‘‘(B) for which the input materials are con- tinuously fed into and transformed within the process, and the output materials are continu- ously removed from the system, utilizing an in- tegrated manufacturing process that consists of a series of 2 or more simultaneous unit oper- ations.

‘‘(2) BIOLOGICAL PRODUCT.—The term ‘bio- logical product’ has the meaning given such term in section 351(i) of the Public Health Service Act (42 U.S.C.

262(i)).
262(i)).

‘‘(3) DRUG.—The term ‘drug’ has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

321(g)).

‘‘(4) INSTITUTION OF HIGHER EDUCATION.— The term ‘institution of higher education’ has the meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C.

1001(a)).

‘‘(5) SECRETARY.—The term ‘Secretary’ means the Secretary of Health and Human Services.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.— ‘‘(1) IN GENERAL.—There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3503 ‘‘(2) FEDERAL ADMINISTRATIVE EXPENSES.— Of the amounts made available to carry out this sec- tion for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative ex- penses, including training, technical assistance, re- porting, and evaluation.’’.

(b) TRANSITION RULE.—Section 3016 of the 21st Century Cures Act (21 U.S.C.
399h), as in effect on the day before the date of the enactment of this section, shall apply with respect to grants awarded under such section before such date of enactment.

(c) CLERICAL AMENDMENT.—The item relating to section 3016 in the table of contents in section 1(b) of the 21st Century Cures Act (Public Law 114–255) is amended to read as follows: ‘‘Sec.

3016.

National Centers of Excellence in Advanced and Continuous Phar- maceutical Manufacturing.’’.
SEC.

3205.

PUBLIC WORKSHOP ON CELL THERAPIES.
Not later than 3 years after the date of the enact- ment of this Act, the Secretary, acting through the Com- missioner of Food and Drugs, shall convene a public work- shop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of certain human cell-, tissue-, and cel- lular-based medical products (and the latest scientific in- formation about such products) that are regulated as December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3504 drugs under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.)

and biological products under sec- tion 351 of the Public Health Service Act (42 U.S.C.

262), namely, stem cell and other cellular therapies.

SEC.

3206.

CLARIFICATIONS TO EXCLUSIVITY PROVISIONS FOR FIRST INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCTS.

Section 351(k)(6) of the Public Health Service Act (42 U.S.C.
262(k)(6)) is amended— (1) in the matter preceding subparagraph (A)— (A) by striking ‘‘Upon review of’’ and in- serting ‘‘The Secretary shall not make approval as an interchangeable biological product effec- tive with respect to’’; (B) by striking ‘‘relying on’’ and inserting ‘‘that relies on’’; and (C) by striking ‘‘the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use’’; and (2) in the flush text that follows subparagraph (C)(ii), by striking ‘‘taken.’’ and inserting ‘‘taken, and the term ‘first interchangeable biosimilar bio- logical product’ means any interchangeable bio- similar biological product that is approved on the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3505 first day on which such a product is approved as interchangeable with the reference product.’’.

SEC.

3207.

GAO REPORT ON NONPROFIT PHARMACEUTICAL ORGANIZATIONS.
(a) GAO REVIEW.—The Comptroller General of the United States (referred to in this section as the ‘‘Comp- troller General’’) shall prepare a report on— (1) what is known about nonprofit pharma- ceutical manufacturing organizations, including the impact of such organizations on the development, availability, and cost of prescription drugs in the United States, which may include information with respect to the capacity and capability to help prevent or mitigate shortages of such drugs, and any chal- lenges to manufacturing or other operations; and (2) recommendations to address such chal- lenges.
(b) REPORT.—Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit the report described in subsection (a) to the Com- mittee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3506 SEC.

3208.

RARE DISEASE ENDPOINT ADVANCEMENT PILOT PROGRAM.
(a) IN GENERAL.—The Secretary shall establish a pilot program under which the Secretary establishes proce- dures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases, including through— (1) determining eligibility of participants for such program; and (2) developing and implementing a process for applying to, and participating in, such a program.
(b) PUBLIC WORKSHOPS.—The Secretary shall con- duct up to 3 public workshops, which shall be completed not later than September 30, 2026, to discuss topics rel- evant to the development of endpoints for rare diseases, which may include discussions about— (1) novel endpoints developed through the pilot program established under this section; and (2) as appropriate, the use of real world evi- dence and real world data to support the validation of efficacy endpoints, including surrogate and inter- mediate endpoints, for rare diseases.
(c) REPORTS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3507 (1) INTERIM REPORT.—Not later than Sep- tember 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Commerce of the House of Representatives a re- port describing the completed and ongoing activities in the pilot program established under this section and public workshops described in subsection (b).
(2) FINAL REPORT.—Not later than September 30, 2027, the Secretary shall submit to the Com- mittee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the outcomes of the pilot program estab- lished under this section.
(d) GUIDANCE.—Not later than September 30, 2027, the Secretary shall issue guidance describing best prac- tices and strategies for development of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

21 22 23 (e) SUNSET.—The Secretary may not accept any new application or request to participate in the program estab- lished by this section on or after October 1, 2027.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3508 SEC.

3209.

ANIMAL TESTING ALTERNATIVES.

(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended— (1) in subsection (i)— (A) in paragraph (1)(A), by striking ‘‘pre- clinical tests (including tests on animals)’’ and inserting ‘‘nonclinical tests’’; and (B) in paragraph (2)(B), by striking ‘‘ani- mal’’ and inserting ‘‘nonclinical tests’’; and (2) by inserting after subsection (y) the fol- lowing: ‘‘(z) NONCLINICAL TEST DEFINED.—For purposes of this section, the term ‘nonclinical test’ means a test con- ducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.
Such test may include the following: ‘‘(1) Cell-based assays.

‘‘(2) Organ chips and microphysiological sys- tems.

‘‘(3) Computer modeling.

‘‘(4) Other nonhuman or human biology-based test methods, such as bioprinting.

‘‘(5) Animal tests.’’.

(b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA- TIONS.—Item (bb) of section 351(k)(2)(A)(i)(I) of the 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3509 Public Health Service Act (42 U.S.C.

262(k)(2)(A)(i)(I)) is amended to read as follows: ‘‘(bb) an assessment of tox- icity (which may rely on, or con- sist of, a study or studies de- scribed in item (aa) or (cc)); and’’.

SEC.

3210.

MODERNIZING ACCELERATED APPROVAL.

(a) IN GENERAL.—Section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(c)) is 11 amended— (1) in paragraph (2)— (A) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly; (B) by striking ‘‘Approval of a product’’ and inserting the following: ‘‘(A) IN GENERAL.—Approval of a prod- uct’’; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking ‘‘appropriate postapproval studies’’ and inserting ‘‘an appro- priate postapproval study or studies’’; and (D) by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3510 ‘‘(B) STUDIES NOT REQUIRED.—If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this para- graph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appro- priate or necessary.
‘‘(C) POSTAPPROVAL STUDY CONDI- TIONS.—Not later than the date of approval of a product under accelerated approval, the Sec- retary shall specify the conditions for a post- approval study or studies required to be con- ducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, in- cluding the target date of study completion.
‘‘(D) STUDIES BEGUN BEFORE AP- PROVAL.—The Secretary may require, as appro- priate, a study or studies to be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.’’; and (2) in paragraph (3)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3511 (A) in the matter preceding subparagraph (A), by striking ‘‘(as prescribed by the Sec- retary in regulations which shall include an op- portunity for an informal hearing)’’ and insert- ing ‘‘described in subparagraph (B)’’; (B) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respec- tively and adjusting the margins accordingly; (C) by striking ‘‘The Secretary may’’ and inserting the following: ‘‘(A) IN GENERAL.—The Secretary may’’; (D) in clause (i) of such subparagraph (A), as so redesignated, by striking ‘‘drug with due diligence’’ and inserting ‘‘product with due dili- gence, including with respect to conditions spec- ified by the Secretary under paragraph (2)(C)’’; (E) in clause (iii) of such subparagraph (A), as so redesignated, by inserting ‘‘shown to be’’ after ‘‘product is not’’; and (F) by adding at the end the following: ‘‘(B) EXPEDITED PROCEDURES DE- SCRIBED.—Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval— ‘‘(i) providing the sponsor with— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3512 ‘‘(I) due notice; ‘‘(II) an explanation for the pro- posed withdrawal; ‘‘(III) an opportunity for a meet- ing with the Commissioner or the Commissioner’s designee; and ‘‘(IV) an opportunity for written appeal to— ‘‘(aa) the Commissioner; or ‘‘(bb) a designee of the Commissioner who has not par- ticipated in the proposed with- drawal of approval (other than a meeting pursuant to subclause (III)) and is not subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal; ‘‘(ii) providing an opportunity for public comment on the proposal to with- draw approval; ‘‘(iii) the publication of a summary of the public comments received, and the Sec- retary’s response to such comments, on the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3513 website of the Food and Drug Administra- tion; and ‘‘(iv) convening and consulting an ad- visory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s re- quest.’’.

(b) REPORTS OF POSTMARKETING STUDIES.—Sec- tion 506B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356b(a)) is amended— (1) by redesignating paragraph (2) as para- graph (3); and (2) by inserting after paragraph (1) the fol- lowing: ‘‘(2) ACCELERATED APPROVAL.—Notwith- standing paragraph (1), a sponsor of a drug ap- proved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under section 506(c), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3514 and not less frequently than every 180 days there- after, until the study is completed or terminated.

The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.’’.

(c) ENFORCEMENT.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331), as amended by title II, is further amended by adding at the end the following: ‘‘(ggg) The failure of a sponsor of a product approved under accelerated approval pursuant to section 506(c)— ‘‘(1) to conduct with due diligence any post- approval study required under section 506(c) with respect to such product; or ‘‘(2) to submit timely reports with respect to such product in accordance with section 506B(a)(2).’’.
(d) GUIDANCE.— (1) IN GENERAL.—The Secretary shall issue guidance describing— (A) how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3515 stage development meetings with the Food and Drug Administration; (B) the use of novel clinical trial designs that may be used to conduct appropriate post- approval studies as may be required under sec- tion 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

356(c)(2)(A)), as amended by subsection (a); (C) the expedited procedures described in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(c)(3)(B)); and (D) considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under 506(c)(1)(A) of such Act (21 U.S.C.

356(c)(1)(A)), including considerations in evaluating the evidence related to any such endpoints.
(2) FINAL GUIDANCE.—The Secretary shall issue— (A) draft guidance under paragraph (1) not later than 18 months after the date of en- actment of this Act; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3516 (B) final guidance not later than 1 year after the close of the public comment period on such draft guidance.
(e) ACCELERATED APPROVAL COUNCIL.— (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the ‘‘Council’’) within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated ap- proval across the Food and Drug Administration, pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

356(c)).
356(c)).

(2) MEMBERSHIP.—The members of the Coun- cil shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers: (A) The Director of the Center for Drug Evaluation and Research.

(B) The Director of the Center for Bio- logics Evaluation and Research.

(C) The Director of the Oncology Center of Excellence.

(D) The Director of the Office of New Drugs.


1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3517 (E) The Director of the Office of Orphan Products Development.

(F) The Director of the Office of Tissues and Advanced Therapies.

(G) The Director of the Office of Medical Policy.


(H) At least 3 directors of review divisions or offices overseeing products approved under accelerated approval, including at least one di- rector within the Office of Neuroscience.
(3) DUTIES OF THE COUNCIL.— (A) MEETINGS.—The Council shall con- vene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary ap- proaches related to product review with respect to accelerated approval.

(B) POLICY DEVELOPMENT.—The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration.
Such engagement may in- clude— (i) developing guidance for Food and Drug Administration staff and best prac- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3518 tices for, and across, product review teams, including with respect to communication between sponsors and the Food and Drug Administration and the review of products under accelerated approval; (ii) providing training for product re- view teams; and (iii) advising review divisions on best practices with respect to product-specific development, review, and withdrawal of products under accelerated approval.
(4) PUBLICATION OF A REPORT.—Not later than 1 year after the date of enactment of this Act, and annually thereafter, the Council shall publish on the public website of the Food and Drug Adminis- tration a report on the activities of the Council.

(f) RULE OF CONSTRUCTION.—Nothing in this sec- tion (including the amendments made by this section) shall be construed to affect ongoing withdrawal pro- ceedings for products approved pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(c)) for which a notice of proposed withdrawal has been published in the Federal Register prior to the date of enactment of this Act.

Such proceedings may continue December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3519 under procedures in effect prior to the date of enactment of this Act.

SEC.

3211.

ANTIFUNGAL RESEARCH AND DEVELOPMENT.


(a) DRAFT GUIDANCE.—Not later than 3 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance for industry for the purposes of assisting entities seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355) or licen- sure under section 351 of the Public Health Service Act (42 U.S.C.
262) of antifungal therapies designed to treat coccidioidomycosis (commonly known as Valley Fever).

(b) FINAL GUIDANCE.—Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance.

(c) WORKSHOP.—To assist entities developing pre- ventive vaccines for fungal infections and coccidioidomy- cosis, the Secretary shall hold a public workshop.
SEC.

3212.

ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.

(a) IN GENERAL.—Section 505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355f) is amend- ed— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3520 (1) in subsection (c)— (A) in paragraph (2), by striking ‘‘; or’’ and inserting ‘‘;’’; (B) in paragraph (3), by striking the pe- riod and inserting ‘‘; or’’; and (C) by adding at the end the following: ‘‘(4) an application pursuant to section 351(a) of the Public Health Service Act.’’; (2) in subsection (d)(1), by inserting ‘‘of this Act or section 351(a) of the Public Health Service Act’’ after ‘‘section 505(b)’’; and (3) by amending subsection (g) to read as fol- lows: ‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— The term ‘qualified infectious disease product’ means a drug (including a biological product), including an anti- bacterial or antifungal drug, for human use that— ‘‘(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and ‘‘(2) is intended to treat a serious or life-threat- ening infection, including such an infection caused by— ‘‘(A) an antibacterial or antifungal resist- ant pathogen, including novel or emerging in- fectious pathogens; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3521 ‘‘(B) qualifying pathogens listed by the Secretary under subsection (f).’’.

(b) PRIORITY REVIEW.—Section 524A(a) of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.

360n–1(a)) is amended by inserting ‘‘of this Act, or section 351(a) of the Public Health Service Act, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness’’ before the period.

SEC.

3213.

ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PROGRAM.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

351 et seq.

), as amended by title II, is further amended by inserting after 14 section 506K the following: ‘‘SEC.

506L.

ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PROGRAM.
‘‘(a) IN GENERAL.—Not later than 1 year after the date of enactment of this section, the Secretary shall ini- tiate a program under which persons may request designa- tion of an advanced manufacturing technology as de- 21 scribed in subsection (b).
22 23 24 25 ‘‘(b) DESIGNATION PROCESS.—The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3522 drugs, as advanced manufacturing technologies.
A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manu- facturing technology if such method or combination of methods incorporates a novel technology, or uses an estab- lished technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by— ‘‘(1) reducing development time for a drug using the designated manufacturing method; or ‘‘(2) increasing or maintaining the supply of— ‘‘(A) a drug that is life-supporting, life- sustaining, or of critical importance to pro- viding health care; or ‘‘(B) a drug that is on the drug shortage list under section 506E.
‘‘(c) EVALUATION AND DESIGNATION OF AN AD- VANCED MANUFACTURING TECHNOLOGY.— ‘‘(1) SUBMISSION.—A person who requests des- ignation of a method of manufacturing as an ad- vanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3523 particular context of use.

The Secretary may facili- tate the development and review of such data or in- formation by— ‘‘(A) providing timely advice to, and inter- active communication with, such person regard- ing the development of the method of manufac- turing; and ‘‘(B) involving senior managers and experi- enced staff of the Food and Drug Administra- tion, as appropriate, in a collaborative, cross- disciplinary review of the method of manufac- turing, as applicable.
‘‘(2) EVALUATION AND DESIGNATION.—Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall de- termine whether to designate such method of manu- facturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b).
‘‘(d) REVIEW OF ADVANCED MANUFACTURING TECHNOLOGIES.—If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3524 ‘‘(1) expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, in- cluding supplemental applications, for drugs that are manufactured using a designated advanced manufac- turing technology; and ‘‘(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to ref- erence or rely upon, in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including a supplemental application, data and information about the des- ignated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.
‘‘(e) IMPLEMENTATION AND EVALUATION OF AD- VANCED MANUFACTURING TECHNOLOGIES PROGRAM.— ‘‘(1) PUBLIC MEETING.—The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after the date of enactment of this section, to discuss, and ob- tain input and recommendations from relevant stakeholders regarding— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3525 ‘‘(A) the goals and scope of the program under this section, and the framework, proce- dures, and requirements suitable for such pro- gram; and ‘‘(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innova- tive manufacturing approaches for drugs.
‘‘(2) PROGRAM GUIDANCE.— ‘‘(A) IN GENERAL.—The Secretary shall— ‘‘(i) not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and im- plementation of the program under this section; and ‘‘(ii) not later than 2 years after the date of enactment of this section, issue final guidance regarding the implementa- tion of such program.
‘‘(B) CONTENT.—The guidance described in subparagraph (A) shall address— ‘‘(i) the process by which a person may request a designation under sub- section (b); December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3526 ‘‘(ii) the data and information that a person requesting such a designation is re- quired to submit under subsection (c), and how the Secretary intends to evaluate such submissions; ‘‘(iii) the process to expedite the de- velopment and review of applications under subsection (d); and ‘‘(iv) the criteria described in sub- section (b) for eligibility for such a des- ignation.
‘‘(3) REPORT.—Not later than 3 years after the date of enactment of this section and annually there- after, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on En- ergy and Commerce of the House of Representatives a report containing a description and evaluation of the program being conducted under this section, in- cluding the types of innovative manufacturing ap- proaches supported under the program.
Such report shall include the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3527 ‘‘(A) The number of persons that have re- quested designations and that have been grant- ed designations.

‘‘(B) The number of methods of manufac- turing that have been the subject of designation requests and that have been granted designa- tions.
‘‘(C) The average number of calendar days for completion of evaluations under subsection (c)(2).

‘‘(D) An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection (c)(2).
‘‘(E) The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, including supple- mental applications, that have included an ad- vanced manufacturing technology designated under this section, and the number of such ap- plications approved.
‘‘(f) SUNSET.—The Secretary— ‘‘(1) may not consider any requests for designa- tion submitted under subsection (c) after October 1, 2032; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3528 ‘‘(2) may continue all activities under this sec- tion with respect to advanced manufacturing tech- nologies that were designated pursuant to subsection (b) prior to such date, if the Secretary determines such activities are in the interest of the public health.’’.

CHAPTER 2—TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY IM- PROVEMENTS SEC.

3221.

SAFER DISPOSAL OF OPIOIDS.

Section 505–1(e)(4)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355–1(e)(4)(B)) is amended by striking ‘‘for purposes of rendering drugs nonretriev- able (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation))’’.

SEC.

3222.

THERAPEUTIC EQUIVALENCE EVALUATIONS.

Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)(A)) is amended by adding at the end the following: ‘‘(v)(I) With respect to an application submitted pur- suant to subsection (b)(2) for a drug that is subject to section 503(b) for which the sole difference from a listed drug relied upon in the application is a difference in inac- tive ingredients not permitted under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of Federal Regula- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3529 tions (or any successor regulations), the Secretary shall make an evaluation with respect to whether such drug is a therapeutic equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to another approved drug product in the pre- scription drug product section of the list under this para- graph as follows: ‘‘(aa) With respect to such an application sub- mitted after the date of enactment of the Food and Drug Omnibus Reform Act of 2022, the evaluation shall be made with respect to a listed drug relied upon in the application pursuant to subsection (b)(2) that is a pharmaceutical equivalent (as de- fined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug in the application pursuant to subsection (b)(2) at the time of approval of such application or not later than 180 days after the date of such approval, provided that the request for such an evaluation is made in the original application (or in a resubmis- sion to a complete response letter), and all necessary data and information are submitted in the original application (or in a resubmission in response to a complete response letter) for the therapeutic equiva- lence evaluation, including information to dem- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3530 onstrate bioequivalence, in a form and manner pre- scribed by the Secretary.
‘‘(bb) With respect to such an application ap- proved prior to or on the date of enactment of the Food and Drug Omnibus Reform Act of 2022, the evaluation shall be made not later than 180 days after receipt of a request for a therapeutic equiva- lence evaluation submitted as part of a supplement to such application; or with respect to an application that was submitted prior to the date of enactment of the Food and Drug Omnibus Reform Act of 2022 but not approved as of the date of enactment of such Act, the evaluation shall be made not later than 180 days after the date of approval of such ap- plication if a request for such evaluation is sub- mitted as an amendment to the application, provided that— ‘‘(AA) such request for a therapeutic equivalence evaluation is being sought with re- spect to a listed drug relied upon in the applica- tion, and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any suc- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3531 cessor regulations)) to the drug for which a therapeutic equivalence evaluation is sought; and ‘‘(BB) the amendment or supplement, as applicable, containing such request, or the rel- evant application, includes all necessary data and information for the therapeutic equivalence evaluation, including information to dem- onstrate bioequivalence, in a form and manner prescribed by the Secretary.
‘‘(II) When the Secretary makes an evaluation under subclause (I), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug.’’.

15 SEC.

3223.

PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY VENDORS.
(a) IN GENERAL.— (1) OPENING PUBLIC DOCKET.—Not later than 90 days after the date of enactment of this Act, the Secretary shall open a single public docket to solicit comments on factors that generally should be consid- ered by the Secretary when reviewing requests from sponsors of drugs subject to risk evaluation and mitigation strategies to change third-party vendors December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3532 engaged by sponsors to aid in implementation and management of the strategies.

(2) FACTORS.—Such factors include the poten- tial effects of changes in third-party vendors on— (A) patient access; and (B) prescribing and administration of the drugs by health care providers.

(3) CLOSING PUBLIC DOCKET.—The Secretary may close such public docket not earlier than 90 days after such docket is opened.
(4) NO DELAY.—Nothing in this section shall delay agency action on any modification to a risk evaluation and mitigation strategy.
(b) GAO REPORT.—Not later than December 31, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on— (1) the number of changes in third-party ven- dors (engaged by sponsors to aid implementation and management of risk evaluation and mitigation strategies) for an approved risk evaluation and miti- gation strategy the Secretary has approved under December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3533 section 505–1(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355–1(h)); (2) any issues affecting patient access to the drug that is subject to the strategy or considerations with respect to the administration or prescribing of such drug by health care providers that arose as a result of such changes; and (3) how such issues were resolved, as applica- ble.

SEC.

3224.

ENHANCING ACCESS TO AFFORDABLE MEDI- CINES.

Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(10)(A)) is amended by striking clauses (i) through (iii) and inserting the fol- lowing: ‘‘(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for ap- proval under this subsection; ‘‘(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the sub- ject of the application not later than 60 days after approval under this subsection of the application; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3534 ‘‘(iii) the labeling revision described under clause (i) does not include a change to the ‘Warn- ings’ section of the labeling; and’’.

Subtitle C—Medical Devices SEC.

3301.

DUAL SUBMISSION FOR CERTAIN DEVICES.

Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360c) is amended by adding at the end the following: ‘‘(k) For a device authorized for emergency use under section 564 for which, in accordance with section 564(m), the Secretary has deemed a laboratory examination or pro- cedure associated with such device to be in the category of examinations and procedures described in section 353(d)(3) of the Public Health Service Act, the sponsor of such device may, when submitting a request for classi- fication under section 513(f)(2), submit a single submis- sion containing— ‘‘(1) the information needed for such a request; and ‘‘(2) sufficient information to enable the Sec- retary to determine whether such laboratory exam- ination or procedure satisfies the criteria to be cat- egorized under section 353(d)(3) of the Public Health Service Act.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3535 SEC.

3302.

MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.

(a) IN GENERAL.—The Secretary shall convene one or more panels of the Medical Devices Advisory Committee not less than once per year for the purpose of providing advice to the Secretary on topics related to medical devices used in pandemic preparedness and response, including topics related to in vitro diagnostics.
(b) REQUIRED PANEL MEMBER.—A panel convened 10 under subsection (a) shall include at least 1 population 11 health-specific representative.

12 (c) SUNSET.—This section shall cease to be effective 13 on October 1, 2027.

14 SEC.

3303.

GAO REPORT ON THIRD-PARTY REVIEW.


Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Com- mittee on Energy and Commerce of the House of Rep- resentatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the third- party review program under section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360m).
360m).

Such 22 report shall include— 23 24 25 26 (1) a description of the financial and staffing resources used to carry out such program; (2) a description of actions taken by the Sec- retary pursuant section 523(b)(2)(C) of the Federal December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3536 Food, Drug, and Cosmetic Act (21 U.S.C.

360m(b)(2)(C)); and (3) the results of an audit of the performance of select persons accredited under such program.

SEC.

3304.
SEC.

3304.

CERTIFICATES TO FOREIGN GOVERNMENTS.

Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(e)(4)) is amended— (1) in subparagraph (E), by striking clause (iii); and (2) by adding at the end the following: ‘‘(F)(i) This paragraph applies to requests for certifi- cation under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 510, if the device is listed pursuant to section 510(j), the device has been cleared, approved, or is not required to submit a pre- market report pursuant to subsection (l) or (m) of section 510, and the device is imported or offered for import into the United States.
20 21 22 23 ‘‘(ii) The Secretary shall issue the certification as de- scribed in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this Act.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3537 ‘‘(iii)(I) A certification for a device described in clause (i) shall be subject to the fee described in subpara- graph (B).
‘‘(II) Notwithstanding subparagraph (C), a certifi- cation for a device described in clause (i) shall address and include the same material information as a ‘Certifi- cate to Foreign Government’ and shall have a document title including the words ‘Certificate to Foreign Govern- ment’.

‘‘(iv) The requirements and procedures of subpara- graph (E) shall apply to a denial of a certification under this subparagraph.’’.

13 SEC.

3305.
SEC.

3305.

ENSURING CYBERSECURITY OF MEDICAL DE- VICES.

(a) IN GENERAL.—Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

351 et seq.)

is amended by adding at the end the following: ‘‘SEC.

524B.

ENSURING CYBERSECURITY OF DEVICES.


‘‘(a) IN GENERAL.—A person who submits an appli- cation or submission under section 510(k), 513, 515(c), 515(f), or 520(m) for a device that meets the definition of a cyber device under this section shall include such in- formation as the Secretary may require to ensure that such cyber device meets the cybersecurity requirements 25 under subsection (b).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3538 ‘‘(b) CYBERSECURITY REQUIREMENTS.—The spon- sor of an application or submission described in subsection (a) shall— ‘‘(1) submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclo- sure and related procedures; ‘‘(2) design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available postmarket updates and patches to the device and related systems to address— ‘‘(A) on a reasonably justified regular cycle, known unacceptable vulnerabilities; and ‘‘(B) as soon as possible out of cycle, crit- ical vulnerabilities that could cause uncontrolled risks; ‘‘(3) provide to the Secretary a software bill of materials, including commercial, open-source, and off-the-shelf software components; and ‘‘(4) comply with such other requirements as the Secretary may require through regulation to demonstrate reasonable assurance that the device and related systems are cybersecure.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3539 ‘‘(c) DEFINITION.—In this section, the term ‘cyber device’ means a device that— ‘‘(1) includes software validated, installed, or authorized by the sponsor as a device or in a device; ‘‘(2) has the ability to connect to the internet; and ‘‘(3) contains any such technological character- istics validated, installed, or authorized by the spon- sor that could be vulnerable to cybersecurity threats.
‘‘(d) EXEMPTION.—The Secretary may identify de- vices, or categories or types of devices, that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section.

The Secretary shall publish in the Federal Register, and update, as appropriate, a list of the devices, or categories or types of devices, so identified by the Sec- retary.’’.
(b) PROHIBITED ACT.—Section 301(q) of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.

331(q)) is amended by adding at the end the following: ‘‘(3) The failure to comply with any requirement under section 524B(b)(2) (relating to ensuring device cy- 23 bersecurity).’’.

24 25 (c) RULE OF CONSTRUCTION.—Nothing in this sec- tion, including the amendments made by this section, shall December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3540 be construed to affect the Secretary’s authority related to ensuring that there is a reasonable assurance of the safety and effectiveness of devices, which may include ensuring that there is a reasonable assurance of the cybersecurity of certain cyber devices, including for devices approved or cleared prior to the date of enactment of this Act.
(d) EFFECTIVE DATE.—The amendments made by subsections (a) and (b) shall take effect 90 days after the date of enactment of this Act.

An application or submis- sion submitted before such effective date shall not be sub- ject to the requirements under subsection (a) or (b) of sec- tion 524B of the Federal Food, Drug, and Cosmetic Act, 13 as added by this section.
(e) GUIDANCE FOR INDUSTRY AND FDA STAFF ON DEVICE CYBERSECURITY.—Not later than 2 years after the date of enactment of this Act, and periodically there- after as appropriate, the Secretary, in consultation with the Director of the Cybersecurity and Infrastructure Secu- rity Agency, shall review and, as appropriate and after so- liciting and receiving feedback from device manufacturers, health care providers, third-party-device servicers, patient advocates, and other appropriate stakeholders, update the guidance entitled ‘‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices’’ (or a 25 successor document).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3541 (f) RESOURCES REGARDING CYBERSECURITY OF DE- VICES.—Not later than 180 days after the date of enact- ment of this Act, and not less than annually thereafter, the Secretary shall update public information provided by the Food and Drug Administration, including on the website of the Food and Drug Administration, with infor- mation regarding improving cybersecurity of devices.
Such information shall include information on identifying and addressing cyber vulnerabilities for health care providers, health systems, and device manufacturers, and how such entities may access support through the Cybersecurity and Infrastructure Security Agency and other Federal entities, including the Department of Health and Human Services, to improve the cybersecurity of devices.
(g) GAO REPORT.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall publish a report identifying challenges in cybersecurity for devices, including legacy devices that may not support certain software security up- dates.
Through such report, the Comptroller General shall 21 examine— 22 23 24 25 (1) challenges for device manufacturers, health care providers, health systems, and patients in ac- cessing Federal support to address vulnerabilities across Federal agencies; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3542 (2) how Federal agencies can strengthen coordi- nation to better support cybersecurity for devices; and (3) statutory limitations and opportunities for improving cybersecurity for devices.

(h) DEFINITION.—In this section, the term ‘‘device’’ has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

321(h)).

SEC.

3306.

BANS OF DEVICES FOR ONE OR MORE INTENDED USES.

(a) IN GENERAL.—Section 516(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360f(a)) is amended— (1) in paragraph (1), by inserting ‘‘for one or more intended uses’’ before the semicolon at the end; and (2) in the matter following paragraph (2), by inserting ‘‘or to make such intended use or uses a banned intended use or uses.

A device that is banned for one or more intended uses is not a le- gally marketed device under section 1006 when in- tended for such use or uses’’ after ‘‘banned device’’.
(b) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to limit the authority of the Sec- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3543 retary to amend, in accordance with section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360f), as amended by this section, and chapter 5 of title 5, United States Code, regulations promulgated pursuant to such section 516, as amended by this section.

SEC.

3307.

THIRD PARTY DATA TRANSPARENCY.
(a) IN GENERAL.—To the extent the Secretary relies on any data, analysis, or other information or findings provided by entities that has been funded in whole or in part by, or otherwise performed under contract with, the Food and Drug Administration, in regulatory decision- making with respect to devices, the Secretary shall— (1) request access to the datasets, inputs, clin- ical or other assumptions, methods, analytical code, results, and other components underlying or com- prising the analysis, conclusions, or other findings upon which the Secretary seeks to rely; and (2) in the event that information described in paragraph (1) is used to support regulatory decision- making, and as otherwise appropriate, to the extent practicable, provide the manufacturer or manufac- turers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or personally identifiable information.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3544 (b) REPORT.—Not later than September 30, 2023, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and publish on the website of the Food and Drug Administration, a report on the number of postmarket device signals communica- tions issued by the Secretary, the sources of data for such signals, and how such signals were revised or resolved.
(c) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to require the delay of any regu- latory decision-making or other action of the Food and 13 Drug Administration.

14 15 16 17 18 SEC.

3308.

PREDETERMINED CHANGE CONTROL PLANS FOR DEVICES.

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

351 et seq.)

is amend- ed by inserting after section 515B (21 U.S.C.

360e–3) the 19 following: ‘‘SEC.

515C.
515C.

PREDETERMINED CHANGE CONTROL PLANS FOR DEVICES.

‘‘(a) APPROVED DEVICES.— ‘‘(1) IN GENERAL.—Notwithstanding section 515(d)(5)(A), a supplemental application shall not be required for a change to a device approved under December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3545 section 515, if such change is consistent with a pre- determined change control plan that is approved pursuant to paragraph (2).
‘‘(2) PREDETERMINED CHANGE CONTROL PLAN.—The Secretary may approve a predetermined change control plan submitted in an application, in- cluding a supplemental application, under section 515 that describes planned changes that may be made to the device (and that would otherwise re- quire a supplemental application under section 515), if the device remains safe and effective without any change.
‘‘(3) SCOPE.—The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification require- ments if the device does not function as intended pursuant to such plan, and performance require- ments for changes made under the plan.
‘‘(b) CLEARED DEVICES.— ‘‘(1) IN GENERAL.—Notwithstanding section 510(k), a premarket notification shall not be re- quired for a change to a device cleared under section 510(k), if such change is consistent with an estab- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3546 lished predetermined change control plan granted pursuant to paragraph (2).
‘‘(2) PREDETERMINED CHANGE CONTROL PLAN.—The Secretary may clear a predetermined change control plan submitted in a notification sub- mitted under section 510(k) that describes planned changes that may be made to the device (and that would otherwise require a new notification), if— ‘‘(A) the device remains safe and effective without any such change; and ‘‘(B) the device would remain substantially equivalent to the predicate.
‘‘(3) SCOPE.—The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification require- ments if the device does not function as intended pursuant to such plan, and performance require- ments for changes made under the plan.
‘‘(c) PREDICATE DEVICES.—In making a determina- tion of substantial equivalence pursuant to section 513(i), the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predi- cate device.

Only the version of the device cleared or ap- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3547 proved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predi- cate device.’’.

(b) CONFORMING AMENDMENTS.— (1) CLEARED DEVICES.—Section 510(l)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360(l)(1)) is amended, in the first sentence, by inserting ‘‘, or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C’’ before the period at the end.
(2) APPROVED DEVICES.—Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

360e(d)(5)(A)(i)) is amended by striking ‘‘A supplemental’’ and inserting ‘‘Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental’’.

(3) DOCUMENTATION OF RATIONALE FOR SIG- NIFICANT DECISIONS.—Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360g–1(a)(1)) is amended to read as follows: ‘‘(1) IN GENERAL.—The Secretary shall provide a substantive summary of the scientific and regu- latory rationale for any significant decision of the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3548 Center for Devices and Radiological Health regard- ing submission or review of a report under section 510(k), a petition for classification under section 513(f), an application under section 515, or an ap- plication for an exemption under section 520(g), in- cluding documentation of significant controversies or differences of opinion and the resolution of such con- troversies or differences of opinion.’’.

SEC.

3309.

SMALL BUSINESS FEE WAIVER.


(a) IN GENERAL.—Section 738(a)(3)(B) of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.
379j) is amended— (1) by striking ‘‘No fee’’ and inserting the fol- lowing: ‘‘(i) IN GENERAL.—No fee’’; and (2) by adding at the end the following: ‘‘(ii) SMALL BUSINESSES FEE WAIV- ER.— ‘‘(I) DEFINITION OF SMALL BUSINESS.—For purposes of this clause, the term ‘small business’ means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal in- come tax return for a taxable year, in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3549 cluding such returns of all of its affili- ates.

‘‘(II) WAIVER.—The Secretary may grant a waiver of the fee required under subparagraph (A) for the an- nual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establish- ment is a small business and paying the fee for such year represents a fi- nancial hardship to the establishment as determined by the Secretary.
‘‘(III) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES IN- TERNAL REVENUE SERVICE.—The es- tablishment shall support its claim that it meets the definition under sub- clause (I) by submission of a copy of its most recent Federal income tax re- turn for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or re- ceipts that is less than the maximum established in subclause (I).
The es- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3550 tablishment, and each of such affili- ates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service.

If no tax forms are submitted for any affil- iate, the establishment shall certify that the establishment has no affili- ates.
‘‘(IV) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERV- ICE.—In the case of an establishment that has not previously submitted a Federal income tax return, the estab- lishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by sub- mission of a signed certification, in such form as the Secretary may direct through a notice published in the Fed- eral Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing au- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3551 thority, if extant, of the country in which the establishment or, if applica- ble, affiliate is headquartered.
The certification from such taxing author- ity shall bear the official seal of such taxing authority and shall provide the establishment’s or affiliate’s gross re- ceipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected.
The establish- ment shall also submit a statement signed by the head of the establish- ment’s firm or by its chief financial officer that the establishment has sub- mitted certifications for all of its af- filiates, or that the establishment has no affiliates.
‘‘(V) REQUEST FOR WAIVER.— An establishment seeking a fee waiver for a year under this clause shall sub- mit supporting information to the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3552 Secretary at least 60 days before the fee is required pursuant to subpara- graph (C).

The decision of the Sec- retary regarding whether an entity may receive the waiver for such year is not reviewable.’’.
(b) TAXING AUTHORITY.—Section 738(d)(2)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

379j(d)(2)(B)(iii)) is amended by inserting ‘‘, if extant,’’ after ‘‘national taxing authority’’.

Subtitle D—Infant Formula SEC.

3401.

PROTECTING INFANTS AND IMPROVING FOR- MULA SUPPLY.

(a) DEFINITIONS.— (1) IN GENERAL.—In this section, the term ‘‘in- fant formula’’ has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

321(z)).
321(z)).

(2) CRITICAL FOOD.—Section 201 of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.

321) is amended by adding at the end the following: ‘‘(ss) The term ‘critical food’ means a food that is— ‘‘(1) an infant formula; or ‘‘(2) a medical food, as defined in section 5(b)(3) of the Orphan Drug Act.’’.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3553 (b) OFFICE OF CRITICAL FOODS.— (1) IN GENERAL.—The Secretary shall establish within the Center for Food Safety and Applied Nu- trition an office to be known as the Office of Critical Foods.

The Secretary shall appoint a Director to lead such Office.
(2) DUTIES.—The Office of Critical Foods shall be responsible for oversight, coordination, and facili- tation of activities related to critical foods, as de- fined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)(2).

(c) PREMARKET SUBMISSIONS OF INFANT FORMULA TO ADDRESS SHORTAGES.—Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a) is amended by adding at the end the following: ‘‘(j) PREMARKET SUBMISSIONS TO ADDRESS SHORT- AGES.— ‘‘(1) IN GENERAL.—The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket sub- mission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula.
‘‘(2) EFFECTIVE PERIOD.—The waiver author- ity under this subsection shall remain in effect— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3554 ‘‘(A) for 90 days beginning on the date that the Secretary distributes information under section 424(a)(2) with respect to a short- age of infant formula; or ‘‘(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.’’.
(d) REPORT.—Not later than one year after the date of enactment of this Act, the Secretary shall submit a re- port to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that in- cludes— (1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
350a(d)) each year since 2012; (2) how many of such submissions received re- quests from the Secretary for additional information; (3) how long after receiving such submissions the Secretary sent such requests for additional infor- mation; (4) what additional information the Secretary requested of the persons submitting such submis- sions; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3555 (5) the date each new infant formula described in subparagraph (A) was first marketed, if available.

(e) INFANT FORMULA FLEXIBILITIES.—The Sec- retary shall publish a list on the website of the Depart- ment of Health and Human Services providing informa- tion on how to identify appropriate substitutes for infant formula products in shortage that are relied upon by in- fants and other individuals with inborn errors of metabo- lism or other serious health conditions.
10 (f) INTERNATIONAL HARMONIZATION OF INFANT 11 FORMULA REQUIREMENTS.— (1) IN GENERAL.—The Secretary— (A) shall participate in meetings with rep- resentatives from other countries to discuss methods and approaches to harmonizing regu- latory requirements for infant formula, includ- ing with respect to inspections, labeling, and nutritional requirements; and (B) may enter into arrangements or agree- ments regarding such requirements with other countries, as appropriate, including arrange- ments or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3556 manufacture infant formula for export to the United States.
(2) STUDY ON INFANT FORMULA.— (A) IN GENERAL.—Not later than 60 days after the date of enactment of this Act, the Sec- retary shall seek to enter into an agreement with the National Academies of Sciences, Engi- neering, and Medicine (referred to in this para- graph as the ‘‘National Academies’’) to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States.
(B) CONTENTS OF THE REPORT.—The re- port developed pursuant to the agreement under subparagraph (A) shall— (i) assess and evaluate— (I) infant formula marketed in the United States; (II) any challenges in supply, or market competition with respect to such infant formula; and (III) any differences between in- fant formula marketed in the United States and infant formula marketed in the European Union, including December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3557 with respect to nutritional content and applicable labeling and other reg- ulatory requirements; and (ii) include recommendations, includ- ing for infant formula manufacturers, on measures to address supply and market competition in the United States.
(C) FINAL REPORT.—The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after the date of enactment of this Act, com- plete such study and submit a report on the re- sults of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
(g) TRANSPARENCY AND ACCOUNTABILITY TO SUP- PORT INFANT FORMULA INNOVATION.— (1) CONGRESSIONAL NOTIFICATION OF RE- CALL.—Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

350a), as amended by sub- section (c), is further amended by adding at the end the following: ‘‘(k) CONGRESSIONAL NOTIFICATION OF RECALL.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3558 ‘‘(1) IN GENERAL.—Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall sub- mit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representa- tives a notification of such recall.
‘‘(2) CONTENTS.—A notification under para- graph (1) shall include the following: ‘‘(A) If the recall is required by the Food and Drug Administration, a summary of the in- formation supporting a determination that the adulterated or misbranded infant formula pre- sents a risk to human health.
‘‘(B) If the recall is voluntarily initiated by the manufacturer, a summary of the informa- tion provided to the Food and Drug Adminis- tration by the manufacturer regarding infant formula that has left the control of the manu- facturer that may be adulterated or mis- branded.

‘‘(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3559 ‘‘(D) An initial estimate of the disruption in domestic production that may result from the recall.’’.

(2) ANNUAL REPORT TO CONGRESS.—Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a), as amended by paragraph (1), is further amended by adding at the end the following: ‘‘(l) ANNUAL REPORT TO CONGRESS.— ‘‘(1) IN GENERAL.—Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information: ‘‘(A) The number of submissions received by the Secretary under subsection (d).
‘‘(B) The number of such submissions that included any new ingredients that were not in- cluded in any infant formula already on the market.

‘‘(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under sub- section (b).
‘‘(D) The time between any inspection re- ferred to in subparagraph (C) and any nec- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3560 essary reinspection to evaluate compliance with the requirements for infant formulas under sub- section (b).

‘‘(E) A breakdown of the information de- scribed in subparagraphs (A) through (D) be- tween foreign and domestic manufacturers and facilities.
‘‘(2) CONFIDENTIALITY.—The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.’’.

(3) NEW INFANT FORMULA SUBMISSIONS.— Section 412(d) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
350a(d)) is amended by add- ing at the end the following: ‘‘(4) The Secretary shall provide a response to a sub- mission under this subsection not later than 45 days after receiving such submission.’’.

21 22 23 24 25 (4) LIST OF NUTRIENTS.—Section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a(i)) is amended by striking ‘‘or, if re- vised by the Secretary under paragraph (2), as so revised’’ and inserting the following: ‘‘, which shall December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3561 be reviewed by the Secretary every 4 years as appro- priate.

In reviewing such table, the Secretary shall consider any new scientific data or information re- lated to infant formula nutrients, including inter- national infant formula standards.
The Secretary may revise the list of nutrients and the required level for any nutrient required by the table’’.

(5) GUIDANCE.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance regarding information sponsors may consider including in submissions required under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

350a(d)), including considerations for meeting each of the requirements of paragraphs (1), (2), and (3) of subsection (d).
(6) TECHNICAL CORRECTION.—Section 412(c)(1)(B) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

350a(c)(1)(B)) is amended by striking ‘‘subsection (c)(1)’’ and inserting ‘‘sub- section (d)(1)’’.
(h) RESPONSE TO RECALL.— (1) MANUFACTURER SUBMISSION.— (A) IN GENERAL.—Promptly after the ini- tiation of a recall of infant formula, the manu- facturer of the recalled infant formula shall December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3562 submit information to the Secretary regarding such recall.
(B) CONTENTS.—A submission under sub- paragraph (A) shall include the following: (i) A plan (including an estimated timeline, as applicable) of actions the man- ufacturer will take, suited to the individual circumstances of the particular recall, in- cluding— (I) to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and (II) if appropriate, to restore op- eration of the impacted facilities.
(ii) In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the pro- duction of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer’s infant formula supply if the current domestic supply of such infant formula has fallen, or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3563 is expected to fall, below the expected de- mand for the formula.

(2) REPORT TO CONGRESS.— (A) IN GENERAL.—Promptly after a sub- mission under paragraph (1) is received, the Secretary shall provide such submission, to- gether with the information specified in sub- paragraph (B), in a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Com- merce of the House of Representatives.
(B) CONTENTS.—A report under subpara- graph (A) shall include the following: (i) Information concerning the current domestic supply of infant formula, includ- ing— (I) a breakdown of the specific types of formula involved; and (II) an estimate of how long cur- rent supplies will last.
(ii) If a submission or submissions under paragraph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domes- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3564 tic production of infant formula intended for sale in the United States— (I) actions to work with the im- pacted manufacturer or other manu- facturers to increase production; and (II) specification of— (aa) any additional authori- ties needed regarding production or importation to fill a supply gap; and (bb) any supplemental fund- ing necessary to address the shortage.

(3) SUNSET.—This subsection shall cease to have force or effect on September 30, 2026.
(i) COORDINATION WITH MANUFACTURER.— (1) IN GENERAL.— (A) COMMUNICATION FOLLOWING INSPEC- TION.—Upon completing an inspection of an in- fant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3565 (i) address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and (ii) safely restart production at the fa- cility.
(B) RESPONSE TO MANUFACTURER.—Not later than 7 days after receiving a written com- munication from a manufacturer of infant for- mula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufac- turing of an infant formula impacted by a re- call, the Secretary, acting through the Commis- sioner of Food and Drugs, shall provide a sub- stantive response to such communication con- cerning the sufficiency of the proposed correc- tive actions.
(2) INSPECTIONS.—The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consump- tion in the United States.
If a reinspection of a manufacturer of an infant formula is required to en- sure that such manufacturer completed any remedi- ation actions or addressed any deficiencies, the Sec- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3566 retary shall reinspect such facility in a timely man- ner.
The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an in- fant formula.
(3) ANNUAL INSPECTIONS.—Not later than 6 months after the date of enactment of this Act, and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unan- nounced inspections, of the facilities (including for- eign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
350a(c)(1)(A)), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition.

In meeting the inspection requirements under this subsection, the Secretary may rely on inspections conducted by for- eign regulatory authorities, under arrangements or agreements, and conducted by State agencies under contract, memoranda of understanding, or any other obligation.
(j) NATIONAL STRATEGY ON INFANT FORMULA.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3567 (1) IN GENERAL.—The Secretary, in consulta- tion with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after the date of enactment of this Act, a national strategy on infant formula to increase the resiliency of the in- fant formula supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and infor- mation they need.
(2) IMMEDIATE NATIONAL STRATEGY.—The na- tional strategy under paragraph (1) shall include ef- forts— (A) to increase the resiliency of the infant formula supply chain in the short-term by— (i) assessing causes of any supply dis- ruption or shortage of infant formula in existence as of the date of enactment of this Act and potential causes of future supply disruptions and shortages; (ii) assessing and addressing imme- diate infant formula needs associated with the shortage; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3568 (iii) developing a plan to increase in- fant formula supply, including through in- creased competition; and (B) to ensure the development and updat- ing of education and communication materials for parents and caregivers that cover— (i) where and how to find infant for- mula; (ii) comparable infant formulas on the market; (iii) what to do if a specialty infant formula is unavailable; (iv) safe practices for handling infant formula; and (v) other topics, as appropriate.
(3) LONG-TERM STRATEGY.—Not later than 90 days after the submission of the report described in subsection (f)(2), the Secretary shall update the na- tional strategy under paragraph (1) to include ef- forts to improve preparedness against infant formula shortages in the long-term by— (A) outlining methods to improve informa- tion-sharing between the Federal Government and State and local governments, and other en- tities as appropriate, regarding shortages; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3569 (B) recommending measures for protecting the integrity of the infant formula supply and preventing contamination; (C) outlining methods to incentivize new infant formula manufacturers to increase sup- ply and mitigate future shortages; and (D) recommending other necessary au- thorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers.
(k) MEANINGFUL DISRUPTION IN THE PRODUCTION OF CRITICAL FOOD.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

341 et seq.)

is amend- ed by adding at the end the following: ‘‘SEC.

424.

REQUIREMENTS FOR CRITICAL FOOD.
‘‘(a) NOTIFICATION OF MEANINGFUL DISRUPTION FOR CRITICAL FOOD.— ‘‘(1) IN GENERAL.—A manufacturer of a crit- ical food (as defined in section 201(ss)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3570 than 5 business days after such discontinuance or such interruption.
‘‘(2) DISTRIBUTION OF INFORMATION.—Not later than 5 calendar days after receiving a notifica- tion under paragraph (1), if the Secretary has deter- mined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Sec- retary determines appropriate, information on such shortage.
‘‘(3) CONFIDENTIALITY.—Nothing in this sub- section authorizes the Secretary to disclose any in- formation that is a trade secret or confidential infor- mation subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
‘‘(4) MEANINGFUL DISRUPTION.—In this sub- section, the term ‘meaningful disruption’— ‘‘(A) means a change in production that is reasonably likely to lead to a significant reduc- tion in the supply of a critical food by a manu- facturer that affects the ability of the manufac- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3571 turer to meet expected demand for its product; and ‘‘(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of fla- vors, colors, or other insignificant formulation characteristics, or insignificant changes in man- ufacturing so long as the manufacturer expects to resume operations in a short period of time.
‘‘(b) RISK MANAGEMENT PLANS.—Each manufac- turer of a critical food shall develop, maintain, and imple- ment, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured.
A risk management plan under this subsection— ‘‘(1) may identify and evaluate risks to the sup- ply of more than one critical food, or critical food category, manufactured at the same establishment; ‘‘(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, al- ternative suppliers, stockpiling of inventory, or other means; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3572 ‘‘(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 704.
‘‘(c) FAILURE TO MEET REQUIREMENTS.— ‘‘(1) IN GENERAL.—If a person fails to submit information required under, and in accordance with, subsection (a)— ‘‘(A) the Secretary shall issue a letter to such person informing such person of such fail- ure; and ‘‘(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)— ‘‘(i) the letter issued under subpara- graph (A); and ‘‘(ii) at the request of such person, any response to such letter such person submitted to the Secretary.
‘‘(2) EXCEPTION.—If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3573 had a reasonable basis for not submitting a notifica- tion as required under subsection (a), the require- ments of paragraph (1)(B) shall not apply.’’.
(l) SPECIALTY INFANT FORMULA FOR IMPORTA- TION.—Section 412 of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
350a), as amended by subsection (f)(2), is further amended by adding at the end the fol- lowing: ‘‘(m) WAIVER OF REQUIREMENTS FOR IMPORTATION OF SPECIALTY INFANT FORMULA.— ‘‘(1) IN GENERAL.—The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this Act applicable to facilitate the importation of spe- cialty infant formula.
Such a waiver may be applica- ble to— ‘‘(A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional ade- quacy as the requirements of this Act; or ‘‘(B) the distribution and sale of such im- ported specialty infant formula.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3574 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) shall be construed to limit the author- ity of the Secretary to require a recall of, or other- wise impose restrictions and requirements under this Act with respect to, specialty infant formula that is subject to a waiver under paragraph (1).
‘‘(3) DEFINITION OF SPECIALTY INFANT FOR- MULA.—In this subsection, the term ‘specialty infant formula’ means infant formula described in sub- section (h)(1).’’.

(m) IMPORTATION FOR PERSONAL USE.— (1) IN GENERAL.—Notwithstanding any provi- sion of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.
), during the 90-day period beginning on the date of enactment of this Act, an individual may, without prior notice to the Food and Drug Administration, import up to a 3-month sup- ply of infant formula for personal use from— (A) Canada; (B) any country in the European Union; or (C) any other country that is determined by the Secretary to be implementing and en- forcing requirements for infant formula that provide a similar assurance of safety and nutri- tional adequacy as the requirements of the Fed- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3575 eral Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.).

(2) LIMITATIONS.—Infant formula may be im- ported pursuant to paragraph (1) only if the infant formula— (A) is exclusively for personal use and will not be commercialized or promoted; and (B) does not present an unreasonable risk to human health.
(3) REPORTING OF ADVERSE EVENTS.—If a health care provider becomes aware of any adverse event which the health care provider reasonably sus- pects to be associated with infant formula imported pursuant to paragraph (1), the health care provider shall report such adverse event to the Commissioner of Food and Drugs.
(4) PUBLIC NOTICE.—The Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Ad- ministration notice that— (A) infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3576 (B) the labeling of such infant formula may not meet the standards and other require- ments applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.

); and (C) the nutritional content of infant for- mula imported pursuant to paragraph (1) may vary from that of infant formula meeting such standards and other requirements.
(5) SENSE OF CONGRESS.—It is the sense of Congress that persons considering the personal im- portation of infant formula should consult with their pediatrician about such importation.

Subtitle E—Cosmetics SEC.

3501.

SHORT TITLE.

This subtitle may be cited as the ‘‘Modernization of Cosmetics Regulation Act of 2022’’.

SEC.

3502.

AMENDMENTS TO COSMETIC REQUIREMENTS.

Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

361 et seq.)
361 et seq.)

is amended by adding at the end the following: 22 23 ‘‘SEC.

604.

DEFINITIONS.

‘‘In this chapter: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3577 ‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ means any health-related event associated with the use of a cosmetic product that is adverse.
‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic product’ means a preparation of cosmetic ingredi- ents with a qualitatively and quantitatively set com- position for use in a finished product.

‘‘(3) FACILITY.— ‘‘(A) IN GENERAL.—The term ‘facility’ in- cludes any establishment (including an estab- lishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
‘‘(B) Such term does not include any of the following: ‘‘(i) Beauty shops and salons, unless such establishment manufactures or proc- esses cosmetic products at that location.
‘‘(ii) Cosmetic product retailers, in- cluding individual sales representatives, di- rect sellers (as defined in section 3508(b)(2) of the Internal Revenue Code of 1986), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic prod- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3578 ucts that are not sold directly to con- sumers at that location.

‘‘(iii) Hospitals, physicians’ offices, and health care clinics.

‘‘(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.

‘‘(v) Entities (such as hotels and air- lines) that provide complimentary cosmetic products to customers incidental to other services.
‘‘(vi) Trade shows and other venues where cosmetic product samples are pro- vided free of charge.

‘‘(vii) An establishment that manufac- tures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not of- fered for retail sale.

‘‘(viii) An establishment that solely performs one or more of the following with respect to cosmetic products: ‘‘(I) Labeling.

‘‘(II) Relabeling.

‘‘(III) Packaging.


December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3579 ‘‘(IV) Repackaging.

‘‘(V) Holding.

‘‘(VI) Distributing.

‘‘(C) CLARIFICATION.—For the purposes of subparagraph (B)(viii), the terms ‘packaging’ and ‘repackaging’ do not include filling a prod- uct container with a cosmetic product.
‘‘(4) RESPONSIBLE PERSON.—The term ‘re- sponsible person’ means the manufacturer, packer, or distributor of a cosmetic product whose name ap- pears on the label of such cosmetic product in ac- cordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act.
‘‘(5) SERIOUS ADVERSE EVENT.—The term ‘se- rious adverse event’ means an adverse event that— ‘‘(A) results in— ‘‘(i) death; ‘‘(ii) a life-threatening experience; ‘‘(iii) inpatient hospitalization; ‘‘(iv) a persistent or significant dis- ability or incapacity; ‘‘(v) a congenital anomaly or birth de- fect; ‘‘(vi) an infection; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3580 ‘‘(vii) significant disfigurement (in- cluding serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alter- ation of appearance), other than as in- tended, under conditions of use that are customary or usual; or ‘‘(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).

‘‘SEC.

605.

ADVERSE EVENTS.


‘‘(a) SERIOUS ADVERSE EVENT REPORTING RE- QUIREMENTS.—The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such per- son.
‘‘(b) SUBMISSION OF REPORTS.— ‘‘(1) SERIOUS ADVERSE EVENT REPORT.—The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3581 after the report is received by the responsible per- son.
‘‘(2) NEW MEDICAL INFORMATION.—The re- sponsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Sec- retary in accordance with paragraph (1), that is re- ceived by the responsible person within 1 year of the initial report to the Secretary, no later than 15 busi- ness days after such information is received by such responsible person.
‘‘(3) CONSOLIDATION OF REPORTS.—The Sec- retary shall develop systems to enable responsible persons to submit a single report that includes du- plicate reports of, or new medical information re- lated to, a serious adverse event.

‘‘(c) EXEMPTIONS.—The Secretary may establish by regulation an exemption to any of the requirements of this section if the Secretary determines that such exemption would have no significant adverse effect on public health.
‘‘(d) CONTACT INFORMATION.—The responsible per- son shall receive reports of adverse events through the do- mestic address, domestic telephone number, or electronic contact information included on the label in accordance with section 609(a).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3582 ‘‘(e) MAINTENANCE AND INSPECTION OF ADVERSE EVENT RECORDS.— ‘‘(1) MAINTENANCE.—The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or dis- tributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 612, who does not engage in the manufac- turing or processing of the cosmetic products de- scribed in subsection 612(b), shall maintain such records for a period of 3 years.
‘‘(2) INSPECTION.— ‘‘(A) IN GENERAL.— The responsible per- son shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursu- ant to section 704.
‘‘(B) AUTHORIZED PERSON.—For pur- poses of this paragraph, the term ‘authorized person’ means an officer or employee of the De- partment of Health and Human Services who has— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3583 ‘‘(i) appropriate credentials, as deter- mined by the Secretary; and ‘‘(ii) been duly designated by the Sec- retary to have access to the records re- quired under this section.
‘‘(f) FRAGRANCE AND FLAVOR INGREDIENTS.—If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a list of such ingredients or cat- egories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person.
The responsible person shall ensure that the requested infor- mation is submitted to the Secretary within 30 days of such request.

In response to a request under section 552 of title 5, United States Code, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5, United States Code.
‘‘(g) PROTECTED INFORMATION.—A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3584 ‘‘(1) a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclo- sure, that denies that the report or the records con- stitute an admission that the product involved caused or contributed to the adverse event; and ‘‘(2) a record about an individual under section 552a of title 5, United States Code (commonly re- ferred to as the ‘Privacy Act of 1974’) and a med- ical or similar file the disclosure of which would con- stitute a violation of section 552 of such title 5 (commonly referred to as the ‘Freedom of Informa- tion Act’), and shall not be publicly disclosed unless all personally identifiable information is redacted.
‘‘(h) EFFECT OF SECTION.— ‘‘(1) IN GENERAL.—Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, terri- tory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political sub- division.
‘‘(2) PERSONALLY IDENTIFIABLE INFORMA- TION.—Notwithstanding any other provision of law, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3585 personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, terri- tory, or political subdivision of a State or territory, shall not— ‘‘(A) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or ‘‘(B) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such infor- mation to the Secretary.
‘‘(3) USE OF REPORTS.—Nothing in this sec- tion shall permit a State, territory, or political sub- division of a State or territory, to use any safety re- port received from the Secretary in a manner incon- sistent with this section.

‘‘(4) RULE OF CONSTRUCTION.—The submis- sion of any report in compliance with this section shall not be construed as an admission that the cos- metic product involved caused or contributed to the relevant adverse event.

‘‘SEC.

606.

GOOD MANUFACTURING PRACTICE.


‘‘(a) IN GENERAL.—The Secretary shall by regula- tion establish good manufacturing practices for facilities December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3586 that are consistent, to the extent practicable, and appro- priate, with national and international standards, in ac- cordance with section 601.
Any such regulations shall be intended to protect the public health and ensure that cos- metic products are not adulterated.

Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing prac- tices prescribed by the Secretary under this paragraph during an inspection conducted under section 704.
‘‘(b) CONSIDERATIONS.—In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply.
Such regulations shall include simplified good manufac- turing practice requirements for smaller businesses, as ap- propriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses.

Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3587 ‘‘(c) TIMEFRAME.—The Secretary shall publish a no- tice of proposed rulemaking not later than 2 years after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 and shall publish a final such rule not later than 3 years after such date of enactment.

‘‘SEC.

607.

REGISTRATION AND PRODUCT LISTING.


‘‘(a) SUBMISSION OF REGISTRATION.— ‘‘(1) INITIAL REGISTRATION.— ‘‘(A) EXISTING FACILITIES.—Every person that, on the date of enactment of the Mod- ernization of Cosmetics Regulation Act of 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after date of enactment of such Act.
‘‘(B) NEW FACILITIES.—Every person that owns or operates a facility that first engages, after the date of enactment of the Moderniza- tion of Cosmetics Regulation Act of 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3588 or 60 days after the deadline for registration under subparagraph (A), whichever is later.

‘‘(2) BIENNIAL RENEWAL OF REGISTRATION.— A person required to register a facility under para- graph (1) shall renew such registrations with the Secretary biennially.
‘‘(3) CONTRACT MANUFACTURERS.—If a facility manufactures or processes cosmetic products on be- half of a responsible person, the Secretary shall re- quire only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on be- half of more than one responsible person.
Such sin- gle registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such fa- cility.

‘‘(4) UPDATES TO CONTENT.—A person that is required to register under subsection (a)(1) shall no- tify the Secretary within 60 days of any changes to information required under subsection (b)(2).
‘‘(5) ABBREVIATED RENEWAL REGISTRA- TIONS.—The Secretary shall provide for an abbre- viated registration renewal process for any person that owns or operates a facility that has not been re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3589 quired to submit updates under paragraph (4) for a registered facility since submission of the most re- cent registration of such facility under paragraph (1) or (2).
‘‘(b) FORMAT; CONTENTS OF REGISTRATION.— ‘‘(1) IN GENERAL.—Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe.
‘‘(2) CONTENTS.—The registration under sub- section (a) shall contain— ‘‘(A) the facility’s name, physical address, email address, and telephone number; ‘‘(B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information; ‘‘(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d); ‘‘(D) all brand names under which cos- metic products manufactured or processed in the facility are sold; and ‘‘(E) the product category or categories and responsible person for each cosmetic prod- uct manufactured or processed at the facility.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3590 ‘‘(c) COSMETIC PRODUCT LISTING.— ‘‘(1) IN GENERAL.—For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such sub- mission is made, at such time and in such manner as the Secretary may prescribe.
‘‘(2) COSMETIC PRODUCT LISTING.—The re- sponsible person of a cosmetic product that is mar- keted on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 shall submit to the Secretary a cosmetic product listing not later than 1 year after the date of enactment of the Mod- ernization of Cosmetics Regulation Act of 2022, or for a cosmetic product that is first marketed after the date of enactment of such Act, within 120 days of marketing such product in interstate commerce.
Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5).

‘‘(3) ABBREVIATED RENEWAL.—The Secretary shall provide for an abbreviated process for the re- newal of any cosmetic product listing under this sub- section with respect to which there has been no change since the responsible person submitted the previous listing.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3591 ‘‘(4) CONTENTS OF LISTING.— ‘‘(A) IN GENERAL.—Each such cosmetic product listing shall include— ‘‘(i) the facility registration number of each facility where the cosmetic product is manufactured or processed; ‘‘(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name ap- pears on the label; ‘‘(iii) the applicable cosmetic category or categories for the cosmetic product; ‘‘(iv) a list of ingredients in the cos- metic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the in- gredient; and ‘‘(v) the product listing number, if any previously assigned by the Secretary under subsection (d).
‘‘(B) FLEXIBLE LISTINGS.—A single list- ing submission for a cosmetic product may in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3592 clude multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

‘‘(5) UPDATES TO CONTENT.—A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.
‘‘(6) SUBMISSION.—A responsible person may submit product listing information as part of a facil- ity registration or separately.

‘‘(d) FACILITY REGISTRATION AND PRODUCT LIST- ING NUMBERS.—At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1), the Secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product.
The Secretary shall not make such product listing number publicly avail- able.

20 21 22 23 24 ‘‘(e) CONFIDENTIALITY.—In response to a request under section 552 of title 5, United States Code, informa- tion described in subsection (b)(2)(D) or (c)(4)(A)(i) that is derived from a registration or listing under this section shall be withheld under section 552(b)(3) of title 5, United 25 States Code.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3593 ‘‘(f) SUSPENSIONS.— ‘‘(1) SUSPENSION OF REGISTRATION OF A FA- CILITY.—The Secretary may suspend the registra- tion of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing seri- ous adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
‘‘(2) NOTICE OF SUSPENSION.—Before sus- pending a facility registration under this section, the Secretary shall provide— ‘‘(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and ‘‘(B) an opportunity, within 5 business days of the notice provided under subparagraph December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3594 (A), for the responsible person to provide a plan for addressing the reasons for possible suspen- sion of the facility registration.
‘‘(3) HEARING ON SUSPENSION.—The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated.
The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.
‘‘(4) POST-HEARING CORRECTIVE ACTION PLAN.—If, after providing opportunity for an infor- mal hearing under paragraph (3), the Secretary de- termines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary.
The Secretary shall review such plan not later than 14 business days after the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3595 submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant.
‘‘(5) VACATING OF ORDER; REINSTATEMENT.— Upon a determination by the Secretary that ade- quate grounds do not exist to continue the suspen- sion actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facil- ity.

‘‘(6) EFFECT OF SUSPENSION.—If the registra- tion of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic prod- ucts from such facility.
‘‘(7) NO DELEGATION.—The authority con- ferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.

‘‘SEC.

608.

SAFETY SUBSTANTIATION.

‘‘(a) SUBSTANTIATION OF SAFETY.—A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3596 ‘‘(b) COAL-TAR HAIR DYE.—Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 601(a).

A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
‘‘(c) DEFINITIONS.—For purposes of this section: ‘‘(1) ADEQUATE SUBSTANTIATION OF SAFE- TY.—The term ‘adequate substantiation of safety’ means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experi- ence to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
‘‘(2) SAFE.—The term ‘safe’ means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such con- ditions of use as are customary or usual.

The Sec- retary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users.
In de- termining for purposes of this section whether a cos- metic product is safe, the Secretary may consider, as December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3597 appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.

‘‘SEC.

609.

LABELING.


‘‘(a) GENERAL REQUIREMENT.—Each cosmetic prod- uct shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the respon- sible person can receive adverse event reports with respect to such cosmetic product.
‘‘(b) FRAGRANCE ALLERGENS.—The responsible per- son shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product.

Sub- stances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regula- tion.
The Secretary shall issue a notice of proposed rule- making promulgating the regulation implementing this re- quirement not later than 18 months after the date of en- actment of the Modernization of Cosmetics Regulation Act of 2022, and not later than 180 days after the date on which the public comment period on the proposed rule- making closes, shall issue a final rulemaking.
In promul- gating regulations implementing this subsection, the Sec- retary shall consider international, State, and local re- quirements for allergen disclosure, including the substance December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3598 and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
‘‘(c) COSMETIC PRODUCTS FOR PROFESSIONAL USE.— ‘‘(1) DEFINITION OF PROFESSIONAL.—For pur- poses of this subsection, the term ‘professional’ means an individual who is licensed by an official State authority to practice in the field of cosme- tology, nail care, barbering, or esthetics.
‘‘(2) PROFESSIONAL USE LABELING.—A cos- metic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that— ‘‘(A) contains a clear and prominent state- ment that the product shall be administered or used only by licensed professionals; and ‘‘(B) is in conformity with the require- ments of the Secretary for cosmetics labeling under this Act and section 4(a) of the Fair Packaging and Labeling Act.

‘‘SEC.

610.

RECORDS.


‘‘(a) IN GENERAL.—If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3599 that the Secretary reasonably believes is likely to be af- fected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to hu- mans, each responsible person and facility shall, at the re- quest of an officer or employee duly designated by the Sec- retary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably be- lieves is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to hu- mans.
This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing func- tions subject to this Act), research data (other than safety substantiation data for cosmetic products and their ingre- dients), or sales data (other than shipment data regarding 24 sales).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3600 ‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to limit the authority of the Sec- retary to inspect records or require establishment and maintenance of records under any other provision of this Act, including section 605 or 606.

‘‘SEC.

611.

MANDATORY RECALL AUTHORITY.


‘‘(a) IN GENERAL.—If the Secretary determines that there is a reasonable probability that a cosmetic is adulter- ated under section 601 or misbranded under section 602 and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Sec- retary shall provide the responsible person with an oppor- tunity to voluntarily cease distribution and recall such ar- ticle.
If the responsible person refuses to or does not vol- untarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to imme- diately cease distribution of such article.
‘‘(b) HEARING.—The Secretary shall provide the re- sponsible person who is subject to an order under sub- section (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify 25 the order.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3601 ‘‘(c) ORDER RESOLUTION.—After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)— ‘‘(1) vacate the order, if the Secretary deter- mines that inadequate grounds exist to support the actions required by the order; ‘‘(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or ‘‘(3) amend the order to require a recall of the cosmetic, including any requirements to notify ap- propriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.
‘‘(d) ACTION FOLLOWING ORDER.—Any person who is subject to an order pursuant to paragraph (2) or (3) of subsection (c) shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notifica- tion as required by such order.
‘‘(e) NOTICE TO PERSONS AFFECTED.—If the Sec- retary determines necessary, the Secretary may require the person subject to an order pursuant to subsection (a) or an amended order pursuant to paragraph (2) or (3) of subsection (c) to provide either a notice of a recall order for, or an order to cease distribution of, such cosmetic, as applicable, under this section to appropriate persons, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3602 including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public.
‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall under this section, the Secretary shall— ‘‘(1) ensure that a press release is published re- garding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notifi- cation— ‘‘(A) of the recall to consumers and retail- ers to whom such cosmetic was, or may have been, distributed; and ‘‘(B) that includes, at a minimum— ‘‘(i) the name of the cosmetic subject to the recall; ‘‘(ii) a description of the risk associ- ated with such article; and ‘‘(iii) to the extent practicable, infor- mation for consumers about similar cos- metics that are not affected by the recall; and ‘‘(2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3603 ‘‘(g) NO DELEGATION.—The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.
‘‘(h) EFFECT.—Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribu- tion or to recall under any other provision of this chapter.

‘‘SEC.

612.

SMALL BUSINESSES.


‘‘(a) IN GENERAL.—Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in sub- section (b), shall be considered small businesses and not subject to the requirements of section 606 or 607.
‘‘(b) REQUIREMENTS APPLICABLE TO ALL MANU- FACTURERS AND PROCESSORS OF COSMETICS.—The ex- emptions under subsection (a) shall not apply to any re- sponsible person or facility engaged in the manufacturing or processing of any of the following products: ‘‘(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under con- ditions of use that are customary or usual.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3604 ‘‘(2) Cosmetic products that are injected.

‘‘(3) Cosmetic products that are intended for internal use.

‘‘(4) Cosmetic products that are intended to alter appearance for more than 24 hours under con- ditions of use that are customary or usual and re- moval by the consumer is not part of such conditions of use that are customary or usual.

‘‘SEC.

613.

EXEMPTION FOR CERTAIN PRODUCTS AND FA- CILITIES.


‘‘(a) IN GENERAL.—Notwithstanding any other pro- vision of law, except as provided in subsection (b), a cos- metic product or facility that is also subject to the require- ments of chapter V shall be exempt from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611.
‘‘(b) EXCEPTION.—A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of chapter V shall not be exempt from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611, with respect to such cos- metic products.

22 23 24 25 ‘‘SEC.

614.

PREEMPTION.


‘‘(a) IN GENERAL.—No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3605 is different from or in addition to, or otherwise not iden- tical with, any requirement applicable under this chapter with respect to registration and product listing, good man- ufacturing practice, records, recalls, adverse event report- ing, or safety substantiation.
‘‘(b) LIMITATION.—Nothing in the amendments to this Act made by the Modernization of Cosmetics Regula- tion Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a).
Notwithstanding subsection (a), nothing in this sec- tion shall be construed to prevent any State from prohib- iting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a require- ment of any State that is in effect at the time of enact- ment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient 18 in a cosmetic product.
‘‘(c) SAVINGS.—Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regula- tion, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liabil- ity of any person under the law of any State, whether stat- utory or based in common law.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3606 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to amend, expand, or limit the pro- visions under section 752.’’.

SEC.

3503.

ENFORCEMENT AND CONFORMING AMEND- MENTS.

(a) IN GENERAL.— (1) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

331), as amended by section 3210, is further amended— (A) by adding at the end the following: ‘‘(hhh) The failure to register or submit listing infor- mation in accordance with section 607.
‘‘(iii) The refusal or failure to follow an order under section 611.’’; and (B) in paragraph (d), by striking ‘‘or 564’’ and inserting ‘‘, 564, or 607’’.

(2) ADULTERATED PRODUCTS.—Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

361) is amended by adding at the end the following: ‘‘(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing prac- tice requirements of section 606.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3607 ‘‘(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as de- fined in section 608(c).’’.

(3) MISBRANDED COSMETICS.—Section 602(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
362(b)) is amended— (A) by striking ‘‘and (2)’’ and inserting ‘‘(2)’’; and (B) by inserting after ‘‘numerical count’’ the following: ‘‘; and (3) the information re- quired under section 609’’.

(4) ADVERSE EVENT REPORTING.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.)

is amended— (A) in section 301(e) (21 U.S.C.


331(e))— (i) by striking ‘‘564, 703’’ and insert- ing ‘‘564, 605, 703’’; and (ii) by striking ‘‘564, 760’’ and insert- ing ‘‘564, 605, 611, 760’’; (B) in section 301(ii) (21 U.S.C.

331(ii))— (i) by striking ‘‘760 or 761) or’’ and inserting ‘‘604, 760, or 761) or’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3608 (ii) by inserting ‘‘or required under section 605(a)’’ after ‘‘report (as defined under section 760 or 761’’; (C) in section 801(a) (21 U.S.C.
381(a))— (i) by striking ‘‘under section 760 or 761’’ and inserting ‘‘under section 605, 760, or 761’’; (ii) by striking ‘‘defined in such sec- tion 760 or 761’’ and inserting ‘‘defined in section 604, 760, or 761’’; (iii) by striking ‘‘of such section 760 or 761’’ and inserting ‘‘of such section 605, 760, or 761’’; and (iv) by striking ‘‘described in such section 760 or 761’’ and inserting ‘‘de- scribed in such section 605, 760, or 761’’; and (D) in section 801(b) (21 U.S.C.
381(b))— (i) by striking ‘‘requirements of sec- tions 760 or 761,’’ and inserting ‘‘require- ments of section 605, 760, or 761’’; (ii) by striking ‘‘as defined in section 760 or 761’’ and inserting ‘‘as defined in section 604, 760, or 761’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3609 (iii) by striking ‘‘with section 760 or 761’’ and inserting ‘‘with section 605, 760, or 761’’.
(b) EFFECTIVE DATES.— (1) IN GENERAL.—The amendments made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act.

(2) LABELING REQUIREMENT.—Section 609(a) of the Federal Food, Drug, and Cosmetic Act, as added by section 802, shall take effect on the date that is 2 years after the date of enactment of this Act.
(c) CONFIDENTIALITY.— (1) IN GENERAL.—The Secretary shall take ap- propriate measures to ensure that there are in effect effective procedures to prevent the unauthorized dis- closure of any trade secret or confidential commer- cial information that is obtained by the Secretary of Health and Human Services pursuant to this sub- title, including the amendments made by this sub- title.
(2) CLARIFICATION.—Nothing in this subtitle, including the amendments made by this subtitle, shall be construed to authorize the disclosure of in- formation that is prohibited from disclosure under December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3610 section 301(j) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
331(j)) or section 1905 of title 18, United States Code, or that is subject to with- holding under section 552(b)(4) of title 5, United States Code.

SEC.

3504.

RECORDS INSPECTION.

Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374(a)(1)) is amended by insert- ing after the second sentence the following: ‘‘In the case of a facility (as defined in section 604) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 605, 606, and 610, when the standard for records inspec- tion under such section applies.’’.

SEC.

3505.

TALC-CONTAINING COSMETICS.


The Secretary of Health and Human Services— (1) not later than one year after the date of en- actment of this Act, shall promulgate proposed regu- lations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and (2) not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

SEC.

3506.

PFAS IN COSMETICS.


3611 (a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Sec- retary’’) shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cos- metic products, including any risks associated with such use.
In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxi- cological Research.

11 12 13 14 (b) REPORT.—Not later than 3 years after enactment of this Act, the Secretary shall publish on the website of the Food and Drug Administration a report summarizing the results of the assessment conducted under subsection 15 (a).

16 26 SEC.

3507.

SENSE OF THE CONGRESS ON ANIMAL TESTING.


It is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the ex- ception of appropriate allowances.

SEC.

3508.

FUNDING.


There is authorized to be appropriated $14,200,000 for fiscal year 2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of fiscal years 2025 through 2027, for purposes of conducting the activities under this sub- title (including the amendments made by this subtitle) and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3612 hiring personnel required to carry out this subtitle (includ- ing the amendments made by this subtitle).

Subtitle F—Cross-Cutting Provisions CHAPTER 1—CLINICAL TRIAL DIVERSITY AND MODERNIZATION SEC.

3601.

DIVERSITY ACTION PLANS FOR CLINICAL STUD- IES.

(a) DRUGS.—Section 505 of the Federal Food, Drug, 10 and Cosmetic Act (21 U.S.C.
355) is amended by adding 11 at the end the following: ‘‘(z)(1) With respect to a clinical investigation of a new drug that is a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or suc- cessor regulations), or, as appropriate, another pivotal study of a new drug (other than bioavailability or bio- equivalence studies), the sponsor of such drug shall submit to the Secretary a diversity action plan.
‘‘(2) Such diversity action plan shall include— ‘‘(A) the sponsor’s goals for enrollment in such clinical study; ‘‘(B) the sponsor’s rationale for such goals; and ‘‘(C) an explanation of how the sponsor intends to meet such goals.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3613 ‘‘(3) The sponsor shall submit to the Secretary such diversity action plan, in the form and manner specified by the Secretary in guidance, as soon as practicable but not later than the date on which the sponsor submits the protocol to the Secretary for such a phase 3 study or other pivotal study of the drug.

The sponsor may submit modi- fications to the diversity action plan.
Any such modifica- tions shall be in the form and manner specified by the Secretary in guidance.
‘‘(4)(A) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any require- ment in paragraph (1), (2), or (3) if the Secretary deter- mines that a waiver is necessary based on what is known or what can be determined about the prevalence or inci- dence of the disease or condition for which the new drug is under investigation (including in terms of the patient population that may use the drug), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is nec- essary to protect public health during a public health 21 emergency.
22 23 24 ‘‘(B) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3614 ‘‘(5) No diversity action plan shall be required for a submission described in section 561.’’.

(b) DEVICES.—Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(g)) is amended by adding at the end the following: ‘‘(9)(A)(i) The sponsor of a device for which submis- sion of an application for an investigational device exemp- tion is required shall submit to the Secretary in such ap- plication a diversity action plan for clinical studies of the 10 device, in the form and manner specified in guidance 11 issued by the Secretary.
‘‘(ii) The sponsor of a device for which submission of an application for an investigational device exemption is not required, except for a device being studied as de- scribed in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), shall develop a di- versity action plan for any clinical study with respect to the device.
Such diversity action plan shall be submitted to the Secretary in any premarket notification under sec- tion 510(k), request for classification under section 513(f)(2), or application for premarket approval under 22 section 515 for such device.

23 24 ‘‘(B) A diversity action plan under clause (i) or (ii) of subparagraph (A) shall include— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3615 ‘‘(i) the sponsor’s goals for enrollment in the clinical study; ‘‘(ii) the sponsor’s rationale for such goals; and ‘‘(iii) an explanation of how the sponsor intends to meet such goals.
‘‘(C)(i) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any require- ment in subparagraph (A) or (B) if the Secretary deter- mines that a waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the device is under investigation (including in terms of the patient population that may use the device), if conducting a clinical investiga- tion in accordance with a diversity action plan would oth- erwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.
‘‘(ii) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

‘‘(D) No diversity action plan shall be required for a submission described in section 561.’’.

SEC.

3602.

GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.
(a) IN GENERAL.—The Secretary shall update or issue guidance relating to— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3616 (1) the format and content of the diversity ac- tion plans required by sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(z); 360j(g)(9)) (as amended by section 3601) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations, and may in- clude characteristics such as geographic location and socioeconomic status, including with respect to— (A) the rationale for the sponsor’s enroll- ment goals, which may include— (i) the estimated prevalence or inci- dence in the United States of the disease or condition for which the drug or device is being investigated in the relevant clinical trial, if such estimated prevalence or inci- dence is known or can be determined based on available data; (ii) what is known about the disease or condition for which the drug or device is being investigated; (iii) any relevant pharmacokinetic or pharmacogenomic data; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3617 (iv) what is known about the patient population for such disease or condition, including, to the extent data is available— (I) demographic information, which may include age group, sex, race, geographic location, socio- economic status, and ethnicity; (II) non-demographic factors, in- cluding co-morbidities affecting the patient population; and (III) potential barriers to enroll- ing diverse participants, such as pa- tient population size, geographic loca- tion, and socioeconomic status; and (v) any other data or information rel- evant to selecting appropriate enrollment goals, disaggregated by demographic sub- group, such as the inclusion of pregnant and lactating women; and (B) an explanation for how the sponsor in- tends to meet such goals, including demo- graphic-specific outreach and enrollment strate- gies, study-site selection, clinical study inclusion and exclusion practices, and any diversity train- ing for study personnel; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3618 (2) submission of any modifications to the di- versity action plan; (3) considerations for the public posting by a sponsor of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate; (4) criteria that the Secretary will consider in assessing whether to grant a sponsor’s request to waive the requirement to submit a diversity action plan under section 505(z)(4) or 520(g)(9)(C) of the Federal Food, Drug, and Cosmetic Act (as amended by section 3601); and (5) how sponsors may include in regular reports otherwise required by the Secretary— (A) the sponsor’s progress in meeting the goals referred to in paragraph (1)(A); and (B) any updates needed to be made to a diversity action plan referred to in paragraph (1) to help meet goals referred to in paragraph (1)(A); and (C) if the sponsor does not expect to meet goals referred to in paragraph (1)(A), the spon- sor’s reasons for why the sponsor does not ex- pect to meet such goals.
(b) ISSUANCE.—The Secretary shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3619 (1) not later than 12 months after the date of enactment of this Act, issue new draft guidance or update existing draft guidance described in sub- section (a); and (2) not later than 9 months after closing the comment period on such draft guidance, finalize such guidance.
(c) APPLICABILITY.—Sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by section 3601, shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guid- ance required under this section.

SEC.

3603.

PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY DIVERSITY.
(a) IN GENERAL.—Not later than one year after the date of enactment of this Act, the Secretary, in consulta- tion with drug sponsors, medical device sponsors, clinical research organizations, academia, patients, and other stakeholders, shall convene one or more public workshops to solicit input from stakeholders on increasing the enroll- ment of historically underrepresented populations in clin- ical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3620 among demographic subgroups, where appropriate, and other topics, including— (1) how and when to collect and present the prevalence or incidence data on a disease or condi- tion by demographic subgroup, including possible sources for such data and methodologies for assess- ing such data; (2) considerations for the dissemination, as ap- propriate, after approval, of information to the pub- lic on clinical study enrollment demographic data; (3) the establishment of goals for enrollment in clinical trials, including the relevance of the esti- mated prevalence or incidence, as applicable, in the United States of the disease or condition for which the drug or device is being developed; and (4) approaches to support inclusion of under- represented populations and to encourage clinical study participation that reflects the population ex- pected to use the drug or device under study, includ- ing with respect to— (A) the establishment of inclusion and ex- clusion criteria for certain subgroups, such as pregnant and lactating women and individuals with disabilities, including intellectual or devel- opmental disabilities or mental illness; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3621 (B) considerations regarding informed con- sent with respect to individuals with intellectual or developmental disabilities or mental illness, including ethical and scientific considerations; (C) the appropriate use of decentralized trials or digital health tools; (D) clinical endpoints; (E) biomarker selection; and (F) studying analysis.
(b) PUBLIC DOCKET.—The Secretary shall establish a public comment period to receive written comments re- lated to the topics addressed during each public workshop convened under this section.

The public comment period shall remain open for 60 days following the date on which each public workshop is convened.
(c) REPORT.—Not later than 180 days after the close of the public comment period for each public workshop convened under this section, the Secretary shall make available on the public website of the Food and Drug Ad- ministration a report on the topics discussed at such work- shop.

The report shall include a summary of topics and responses to any recommendations raised in such work- shop.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3622 SEC.

3604.

ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE DIVERSITY IN CLINICAL STUDIES.
(a) IN GENERAL.—Beginning not later than 2 years after the date of enactment of this Act, and each year thereafter, the Secretary shall submit to the Congress, and publish on the public website of the Food and Drug Ad- ministration, a report that— (1) summarizes, in aggregate, the diversity ac- tion plans received pursuant to section 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by section 3601; and (2) contains information, in the aggregate, on— (A) for drugs, biological products, and de- vices approved, licensed, cleared, or classified under section 505, 515, 510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355; 360e; 360(k); and 360(f)(2)), or section 351(a) of the Public Health Service Act (42 U.S.C.

262(a)), whether the clinical studies conducted with respect to such applications met the demographic subgroup enrollment goals from the diversity action plan submitted for such applications; and (B) the reasons provided, if any, for why enrollment goals from submitted diversity ac- tion plans were not met.
26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3623 (b) CONFIDENTIALITY.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential informa- tion subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

SEC.
SEC.

3605.

PUBLIC MEETING ON CLINICAL STUDY FLEXI- BILITIES INITIATED IN RESPONSE TO COVID– 19 PANDEMIC.
(a) IN GENERAL.—Not later than 180 days after the date on which the COVID–19 emergency period ends, the Secretary shall convene a public meeting to discuss the recommendations provided by the Food and Drug Admin- istration during the COVID–19 emergency period to miti- gate disruption of clinical studies, including recommenda- tions detailed in the guidance entitled ‘‘Conduct of Clinical Trials of Medical Products During the COVID–19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards’’, as updated on August 8, 2021, and by any subsequent updates to such guidance.
The Secretary shall invite to such meeting representatives from the pharmaceutical and medical device industries who sponsored clinical studies during the COVID–19 emergency period and organizations representing patients.

(b) TOPICS.—Not later than 90 days after the date on which the public meeting under subsection (a) is con- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3624 vened, the Secretary shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such meeting.
Such topics shall in- clude discussion of— (1) the actions sponsors took to utilize such rec- ommendations and the frequency at which such rec- ommendations were employed; (2) the characteristics of the sponsors, studies, and patient populations impacted by such rec- ommendations; (3) a consideration of how recommendations in- tended to mitigate disruption of clinical studies dur- ing the COVID–19 emergency period, including any recommendations to consider decentralized clinical studies when appropriate, may have affected access to clinical studies for certain patient populations, es- pecially unrepresented or underrepresented racial and ethnic minorities; and (4) recommendations for incorporating certain clinical study disruption mitigation recommendations into current or additional guidance to improve clin- ical study access and enrollment of diverse patient populations.
(c) COVID–19 EMERGENCY PERIOD DEFINED.—In this section, the term ‘‘COVID–19 emergency period’’ has December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3625 the meaning given the term ‘‘emergency period’’ in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C.

1320b–5(g)(1)(B)).

SEC.

3606.

DECENTRALIZED CLINICAL STUDIES.
(a) GUIDANCE.—The Secretary shall— (1) not later than 1 year after the date of en- actment of this Act, issue or revise draft guidance that includes recommendations to clarify and ad- vance the use of decentralized clinical studies to sup- port the development of drugs and devices, including recommendations for how to advance the use of flexible and novel clinical trial designs and to help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse clinical population, including with respect to race, ethnicity, age, sex, and geographic location, when appropriate; and (2) not later than 1 year after closing the com- ment period on such draft guidance, finalize such guidance.
(b) CONTENT OF GUIDANCE.—The guidance under subsection (a) shall address the following: (1) Recommendations related to digital health technology or other assessment options, such as tele- health, local laboratories, local health care providers, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3626 or other options for remote data collection, could support decentralized clinical studies, including guid- ance on considerations for selecting technological platforms and mediums, data collection and use, data integrity and security, and communication to study participants through digital technology.
(2) Recommendations for subject recruitment, retention, and engagement, including considerations for sponsors to minimize or reduce burdens for clin- ical study participants through the use of digital health technology, telehealth, local health care pro- viders and laboratories, health care provider home visits, direct-to-participant engagement, electronic informed consent, or other means, as appropriate.
(3) Recommendations with respect to the eval- uation of data collected within a decentralized clin- ical study setting.

(4) Recommendations for methods of remote data collection, including clinical trial participant ex- perience data, through the use of digital health tech- nologies, telemedicine, local laboratories, local health care providers, or other options for data collection.
(5) Considerations for sponsors to minimize or reduce burdens for clinical trial participants associ- ated with participating in a clinical trial, such as the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3627 use of digital technologies, telemedicine, local labora- tories, local health care providers, or other data col- lection or assessment options, health care provider home visits, direct-to-participant shipping of inves- tigational drugs and devices, and electronic informed consent, as appropriate.
(6) Recommendations regarding conducting de- centralized clinical trials to facilitate and encourage meaningful diversity among clinical trial partici- pants, including with respect to race, ethnicity, age, sex, and geographic location, as appropriate.
(7) Recommendations for strategies and meth- ods for recruiting, retaining, and engaging with clin- ical trial participants, including communication re- garding the role of clinical trial participants and community partners to facilitate clinical trial recruit- ment and engagement, including with respect to di- verse and underrepresented populations, as appro- priate.

(8) Considerations for review and oversight by sponsors and institutional review boards, including remote trial oversight.
(9) Recommendations for decentralized clinical trial protocol designs and processes for evaluating such proposed clinical trial designs.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3628 (10) Recommendations related to digital health technology and other remote assessment tools that may support decentralized clinical trials, including guidance on appropriate technological platforms and tools, data collection and use, data integrity, and communication to clinical trial participants through such technology.
(11) A description of the manner in which the Secretary will assess or evaluate data collected with- in a decentralized clinical trial to support the devel- opment of the drug or device, if the manner is dif- ferent from that used for a nondecentralized trial.

(12) Considerations for sponsors to validate digital technologies and establish appropriate clinical endpoints for use in decentralized trials.
(13) Considerations for privacy and security of personally identifiable information of trial partici- pants.

(14) Considerations for conducting clinical trials using centralized approaches in conjunction with decentralized approaches.

(c) DEFINITION.—In this section, the term ‘‘decen- tralized clinical study’’ means a clinical study in which some or all of the study-related activities occur at a loca- tion separate from the investigator’s location.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

SEC.

3607.

MODERNIZING CLINICAL TRIALS.
3629 (a) CLARIFYING THE USE OF DIGITAL HEALTH TECHNOLOGIES IN CLINICAL TRIALS.— (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance regarding the ap- propriate use of digital health technologies in clinical trials to help improve recruitment for, retention in, participation in, and data collection during, clinical trials, and provide for novel clinical trial designs uti- lizing such technology for purposes of supporting the development of, and review of applications for, drugs and devices.
Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.
(2) CONTENT.—The guidance described in paragraph (1) shall include— (A) recommendations for data collection methodologies by which sponsors may incor- porate the use of digital health technologies in clinical trials to collect data remotely from trial participants; (B) considerations for privacy and security protections for data collected during a clinical trial, including— 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3630 (i) recommendations for the protec- tion of trial participant data that are col- lected or used in research using digital health technologies; (ii) compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Account- ability Act of 1996 (42 U.S.C.
1320d–2 note), subpart B of part 50 of title 21, Code of Federal Regulations, subpart C of part 56 of title 21, Code of Federal Regu- lations, the Federal policy for the protec- tion of human subjects under subpart A of part 46 of title 45, Code of Federal Regu- lations (commonly known as the ‘‘Common Rule’’), and part 2 of title 42, Code of Federal Regulations (or any successor reg- ulations); and (iii) recommendations for the protec- tion of clinical trial participant data against cybersecurity threats, as applica- ble; (C) considerations on data collection meth- ods to help increase recruitment of clinical trial participants and the level of participation of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3631 such participants, reduce burden on clinical trial participants, and optimize data quality; (D) recommendations for the use of elec- tronic methods to obtain informed consent from clinical trial participants, taking into consider- ation applicable Federal law, including subpart B of part 50 of title 21, Code of Federal Regu- lations (or successor regulations), and, as ap- propriate, State law; (E) best practices for communication be- tween sponsors and the Secretary on the devel- opment of data collection methods; (F) the appropriate format to submit such data to the Secretary; (G) a description of the manner in which the Secretary may assess or evaluate data col- lected through digital health technologies to support the development of the drug or device; (H) recommendations regarding the data and information needed to demonstrate that a digital health technology is fit-for-purpose for a clinical trial, and a description of how the Sec- retary will evaluate such data and information; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3632 (I) recommendations for increasing access to, and the use of, digital health technologies in clinical trials to facilitate the inclusion of di- verse and underrepresented populations, as ap- propriate, including considerations for access to, and the use of, digital health technologies in clinical trials by people with disabilities and pe- diatric populations.
(b) SEAMLESS AND CONCURRENT CLINICAL TRIALS.— (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance on the use of seamless, concurrent, and other innovative clinical trial designs to support the expedited development and review of applications for drugs, as appropriate.
Not later than 18 months after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guid- ance.

(2) CONTENT.—The guidance described in paragraph (1) shall include— (A) recommendations on the use of expan- sion cohorts and other seamless clinical trial de- signs to assess different aspects of product can- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3633 didates in one continuous trial, including how such clinical trial designs can be used as part of meeting the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(d)); (B) recommendations on the use of clinical trial designs that involve the concurrent con- duct of different or multiple clinical trial phases, and the concurrent conduct of pre- clinical testing, to expedite the development of new drugs and facilitate the timely collection of data; (C) recommendations for how to streamline trial logistics and facilitate the efficient collec- tion and analysis of clinical trial data, including any planned interim analyses and how such analyses could be used to streamline the prod- uct development and review processes; (D) considerations to assist sponsors in en- suring the rights, safety, and welfare of clinical trial participants, maintaining compliance with good clinical practice regulations, minimizing risks to clinical trial data integrity, and ensur- ing the reliability of clinical trial results; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3634 (E) recommendations for communication between sponsors and the Food and Drug Ad- ministration on the development of seamless, concurrent, or other adaptive clinical trial de- signs, including review of, and feedback on, clinical trial protocols; and (F) a description of the manner in which the Secretary will assess or evaluate data col- lected through seamless, concurrent, or other adaptive clinical trial designs to support the de- velopment of drugs.
(c) INTERNATIONAL HARMONIZATION.—The Sec- retary shall, as appropriate, work with foreign regulators pursuant to memoranda of understanding or other ar- rangements governing the exchange of information to fa- cilitate international harmonization of the regulation and use of decentralized clinical trials, digital technology in clinical trials, and seamless, concurrent, and other adapt- ive or innovative clinical trial designs.

CHAPTER 2—INSPECTIONS SEC.

3611.

DEVICE INSPECTIONS.


(a) IN GENERAL.—Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

374(a)(1)) is amended by striking ‘‘restricted devices’’ each place it ap- pears and inserting ‘‘devices’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3635 (b) RECORDS OR OTHER INFORMATION.— (1) ESTABLISHMENTS.—Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374(a)(4)(A)) is amended— (A) by striking ‘‘an establishment that is engaged in the manufacture, preparation, prop- agation, compounding, or processing of a drug’’ and inserting ‘‘an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),’’; and (B) by striking ‘‘records requested.’’ and inserting the following: ‘‘records or other infor- mation requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.’’.
(2) GUIDANCE.— (A) IN GENERAL.—The Secretary shall issue or update guidance describing— (i) circumstances in which the Sec- retary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3636 Cosmetic Act, as amended by paragraph (1); (ii) processes for responding to such requests electronically or in physical form; and (iii) factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within rea- sonable limits, and in a reasonable man- ner, accounting for resource and other lim- itations that may exist, including for small businesses.
(B) TIMING.—The Secretary shall— (i) not later than 1 year after the date of enactment of this Act, issue draft guid- ance under subparagraph (A); and (ii) not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under sub- paragraph (A).

SEC.

3612.

BIORESEARCH MONITORING INSPECTIONS.

(a) IN GENERAL.—Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374(a)) is amended by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3637 ‘‘(5)(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this Act or the Public Health Service Act, enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.
‘‘(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.
‘‘(C)(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with— ‘‘(I) developing an application or other submis- sion to the Secretary under this Act or the Public Health Service Act related to marketing authoriza- tion for a product described in paragraph (1); ‘‘(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or ‘‘(III) holding any records or other information described in subparagraph (B).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3638 ‘‘(ii) A person described in this clause is— ‘‘(I) the sponsor of an application or submission specified in subparagraph (E); ‘‘(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor; ‘‘(III) an institutional review board, or other in- dividual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or ‘‘(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).
‘‘(D)(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including— 23 24 ‘‘(I) permitting the Secretary to record or copy such information for purposes of this paragraph; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3639 ‘‘(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and ‘‘(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other infor- mation described in subparagraph (B) is or was gen- erated, held, processed, analyzed, or transferred.
‘‘(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.

‘‘(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable lim- its and in a reasonable manner.
‘‘(E) The studies and submissions described in this subparagraph are each of the following: ‘‘(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Sec- retary under this Act or the Public Health Service December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3640 Act for marketing authorization of a product de- scribed in paragraph (1).

‘‘(ii) Postmarket safety activities conducted under this Act or the Public Health Service Act.

‘‘(iii) Any other clinical investigation of— ‘‘(I) a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or ‘‘(II) a device subject to section 520(g).
‘‘(iv) Any other submissions made under this Act or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.
‘‘(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to the date of enactment of this para- graph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.’’.
22 (b) REVIEW OF PROCESSES AND PRACTICES; GUID- 23 ANCE FOR INDUSTRY.— 24 (1) IN GENERAL.—The Secretary shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3641 (A) review processes and practices in effect as of the date of enactment of this Act applica- ble to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and (B) evaluate whether any updates are needed to facilitate the consistency of such processes and practices.
(2) GUIDANCE.— (A) IN GENERAL.—The Secretary shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in ad- vance of or during an inspection or request for records or other information, and other inspec- tions-related conduct, to the extent not specified in existing publicly available Food and Drug December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3642 Administration guides and manuals for such in- spections.

(B) TIMING.—The Secretary shall— (i) not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and (ii) not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A).

SEC.

3613.

IMPROVING FOOD AND DRUG ADMINISTRATION INSPECTIONS.
(a) RISK FACTORS FOR ESTABLISHMENTS.—Section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(h)(4)) is amended— (1) by redesignating subparagraph (F) as sub- paragraph (G); and (2) by inserting after subparagraph (E) the fol- lowing: ‘‘(F) The compliance history of establish- ments in the country or region in which the es- tablishment is located that are subject to regu- lation under this Act, including the history of violations related to products exported from December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3643 such country or region that are subject to such regulation.’’.

(b) USE OF RECORDS.—Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374(a)(4)) is amended— (1) by redesignating subparagraph (C) as sub- paragraph (D); and (2) by inserting after subparagraph (B) the fol- lowing: ‘‘(C) The Secretary may rely on any records or other information that the Secretary may inspect under this sec- tion to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to re- solve deficiencies identified during such inspections, if ap- plicable and appropriate.’’.
(c) RECOGNITION OF FOREIGN GOVERNMENT IN- SPECTIONS.—Section 809 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

384e) is amended— (1) in subsection (a)(1), by inserting ‘‘preapproval or’’ before ‘‘risk-based inspections’’; and (2) by adding at the end the following: ‘‘(c) PERIODIC REVIEW.— ‘‘(1) IN GENERAL.—Beginning not later than 1 year after the date of the enactment of the Food December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3644 and Drug Omnibus Reform Act of 2022, the Sec- retary shall periodically assess whether additional arrangements and agreements with a foreign govern- ment or an agency of a foreign government, as al- lowed under this section, are appropriate.
‘‘(2) REPORTS TO CONGRESS.—Beginning not later than 4 years after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Com- merce of the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under para- graph (1).’’.

SEC.

3614.
SEC.

3614.

GAO REPORT ON INSPECTIONS OF FOREIGN ES- TABLISHMENTS MANUFACTURING DRUGS.
(a) IN GENERAL.—Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Com- mittee on Energy and Commerce of the House of Rep- resentatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on inspections conducted by— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3645 (1) the Secretary of foreign establishments pur- suant to subsections (h) and (i) of section 510 and section 704 of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

360; 374); or (2) a foreign government or an agency of a for- eign government pursuant to section 809 of such Act (21 U.S.C.

384e).
(b) CONTENTS.—The report conducted under sub- section (a) shall include— (1) what alternative tools, including remote in- spections or remote evaluations, other countries are utilizing to facilitate inspections of foreign establish- ments; (2) how frequently trusted foreign regulators conduct inspections of foreign facilities that could be useful to the Food and Drug Administration to re- view in lieu of its own inspections; (3) how frequently and under what cir- cumstances, including for what types of inspections, the Secretary utilizes existing agreements or ar- rangements under section 809 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384e) and whether the use of such agreements could be appro- priately expanded; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3646 (4) whether the Secretary has accepted reports of inspections of facilities in China and India con- ducted by entities with which they have entered into such an agreement or arrangement; (5) what additional foreign governments or agencies of foreign governments the Secretary has considered entering into a mutual recognition agree- ment with and, if applicable, reasons why the Sec- retary declined to enter into a mutual recognition agreement with such foreign governments or agen- cies; (6) what tools, if any, the Secretary used to fa- cilitate inspections of domestic facilities that could also be effectively utilized to appropriately inspect foreign facilities; (7) what steps the Secretary has taken to iden- tify and evaluate tools and strategies the Secretary may use to continue oversight with respect to inspec- tions when in-person inspections are disrupted; (8) how the Secretary is considering incor- porating alternative tools into the inspection activi- ties conducted pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.

); and (9) what steps the Secretary has taken to iden- tify and evaluate how the Secretary may use alter- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3647 native tools to address workforce shortages to carry out such inspection activities.

SEC.

3615.

UNANNOUNCED FOREIGN FACILITY INSPEC- TIONS PILOT PROGRAM.
(a) IN GENERAL.—The Secretary shall conduct a pilot program under which the Secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.
Such pilot program shall evaluate— (1) differences in the number and type of viola- tions of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(a)(2)(B)) identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection; (2) costs and benefits associated with con- ducting announced and unannounced inspections of foreign human drug establishments; (3) barriers to conducting unannounced inspec- tions of foreign human drug establishments and any December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3648 challenges to achieving parity between domestic and foreign human drug establishment inspections; and (4) approaches for mitigating any negative ef- fects of conducting announced inspections of foreign human drug establishments.
(b) PILOT PROGRAM SCOPE.—The inspections evalu- ated under the pilot program under this section shall be routine surveillance inspections and shall not include in- spections conducted as part of the Secretary’s evaluation of a request for approval to market a drug submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.)

or the Public Health Service Act (42 U.S.C.

201 et seq.).
201 et seq.).

14 (c) PILOT PROGRAM INITIATION.—The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act.
(d) REPORT.—The Secretary shall, not later than 180 days following the completion of the pilot program under this section, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including— (1) findings and any associated recommenda- tions with respect to the evaluation under subsection (a), including any recommendations to address iden- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3649 tified barriers to conducting unannounced inspec- tions of foreign human drug establishments; (2) findings and any associated recommenda- tions regarding how the Secretary may achieve par- ity between domestic and foreign human drug in- spections; and (3) the number of unannounced inspections during the pilot program that would not be unan- nounced under practices in use as of the date of the enactment of this Act.

SEC.

3616.

ENHANCING COORDINATION AND TRANS- PARENCY ON INSPECTIONS.
(a) COORDINATION.—Section 506D of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356d) is amended— (1) by adding at the end the following: ‘‘(g) COORDINATION.—The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Ad- ministration and the staff of the Center for Drug Evalua- tion and Research’s Office of Compliance and Drug Short- 22 age Program regarding— 23 24 ‘‘(1) the reviews of reports shared pursuant to section 704(b)(2); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3650 ‘‘(2) any feedback or corrective or preventive actions in response to such reports.’’; and (2) by amending subsection (f) to read as fol- lows: ‘‘(f) TEMPORARY SUNSET.—Subsection (a) shall cease to be effective on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act.
Subsections (b), (c), and (e) shall not be in effect during the period beginning 5 years after the date of enactment of the Food and Drug Admin- istration Safety and Innovation Act and ending on the date of enactment of the Food and Drug Omnibus Reform Act of 2022.

Subsections (b), (c), and (e) shall be in effect beginning on the date of enactment of the Food and Drug Omnibus Reform Act of 2022.’’.

(b) REPORTING.— (1) AMENDMENTS.—Section 506C–1(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356c–1(a)) is amended— (A) by redesignating paragraphs (3) through (7) as paragraphs (5) through (9), re- spectively; (B) by inserting after paragraph (2) the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3651 ‘‘(3) describes the coordination and alignment activities undertaken pursuant to section 506D(g); ‘‘(4) provides the number of reports that were required under section 704(b)(2) to be sent to the appropriate offices of the Food and Drug Adminis- tration with expertise regarding drug shortages, and the number of such reports that were sent;’’; and (C) in paragraph (5)(A), as so redesig- nated, by striking ‘‘paragraph (7)’’ and insert- ing ‘‘paragraph (9)’’.
(2) APPLICABILITY.—The amendments made by paragraph (1) shall apply with respect to reports submitted under section 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

356c–1) on or after March 31, 2024.

(c) REPORTING OF MUTUAL RECOGNITION AGREE- MENTS FOR INSPECTIONS AND REVIEW ACTIVITIES.— Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(h)) is amended— (1) in paragraph (6)— (A) in the matter preceding subparagraph (A), by striking ‘‘Beginning in 2014, not’’ and inserting ‘‘Not’’; (B) by amending subparagraph (A) to read as follows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3652 ‘‘(A)(i) the number of domestic and foreign establishments registered pursuant to this sec- tion in the previous fiscal year; ‘‘(ii) the number of such registered estab- lishments in each region of interest; ‘‘(iii) the number of such domestic estab- lishments and the number of such foreign es- tablishments, including the number of establish- ments in each region of interest, that the Sec- retary inspected in the previous fiscal year; ‘‘(iv) the number of inspections to support actions by the Secretary on applications under section 505 of this Act or section 351 of the Public Health Service Act, including the num- ber of inspections to support actions by the Sec- retary on supplemental applications, including changes to manufacturing processes, the Sec- retary conducted in the previous fiscal year; ‘‘(v) the number of routine surveillance in- spections the Secretary conducted in the pre- vious fiscal year, including in each region of in- terest; ‘‘(vi) the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3653 clause (iv), including in each region of interest; and ‘‘(vii) the number of inspections the Sec- retary has recognized pursuant to an agreement entered into pursuant to section 809, or other- wise recognized, for each of the types of inspec- tions described in clauses (v) and (vi), including for inspections of establishments in each region of interest.’’; (C) in subparagraph (B), by striking ‘‘; and’’ and inserting a semicolon; (D) in subparagraph (C), by striking the period and inserting ‘‘; and’’; and (E) by adding at the end the following: ‘‘(D) the status of the efforts of the Food and Drug Administration to expand its recogni- tion of inspections conducted or recognized by foreign regulatory authorities under section 809, including any obstacles to expanding the use of such recognition.’’; and (2) by adding at the end the following: ‘‘(7) REGION OF INTEREST.—For purposes of paragraph (6)(A), the term ‘region of interest’ means a foreign geographic region or country, in- cluding the People’s Republic of China, India, the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3654 European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate.’’.

SEC.

3617.

ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION TIMELINES.

Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C.

355 note) is amended to read as follows: ‘‘SEC.

902.

ANNUAL REPORT ON INSPECTIONS.


‘‘Not later than 120 days after the end of each fiscal year, the Secretary of Health and Human Services shall post on the website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under subsection (c) or (j) of sec- tion 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355) or approval of a device under section 515 of such Act (21 U.S.C.
360e) that were conducted during the previous fiscal year.

Such information shall include the 18 following: ‘‘(1) The median time following a request from staff of the Food and Drug Administration review- ing an application or report to the beginning of the inspection, including— ‘‘(A) the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(11)(A)(i)); December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3655 ‘‘(B) the median time for drugs for which a notification has been submitted in accordance with section 506C(a) of such Act (21 U.S.C.

356c(a)) during the previous fiscal year; and ‘‘(C) the median time for drugs on the drug shortage list in effect under section 506E of such Act (21 U.S.C.

356e) at the time of such request.


‘‘(2) The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

374(b)) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, in- cluding the median time for each category of drugs listed in subparagraphs (A) through (C) of para- graph (1).
‘‘(3) The median time from the sending of a warning letter, issuance of an import alert, or hold- ing of a regulatory meeting related to conditions ob- served by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3656 ‘‘(4) The number of facilities that failed to im- plement adequate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation for an application under review, including the number of such facilities manufacturing each category of drugs listed in subparagraphs (A) through (C) of para- graph (1).’’.

CHAPTER 3—MISCELLANEOUS SEC.

3621.

REGULATION OF CERTAIN PRODUCTS AS DRUGS.


Section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

353) is amended by adding at the end the following: ‘‘(h)(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under sec- tion 201(g) and not a device under section 201(h).
‘‘(2) For purposes of this subsection: ‘‘(A) The term ‘contrast agent’ means an arti- cle that is intended for use in conjunction with a medical imaging device, and— ‘‘(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any suc- cessor regulations); or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3657 ‘‘(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, struc- ture, or fluid.
‘‘(B) The term ‘radioactive drug’ has the mean- ing given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regu- lations), except that such term does not include— ‘‘(i) an implant or article similar to an im- plant; ‘‘(ii) an article that applies radiation from outside of the body; or ‘‘(iii) the radiation source of an article de- scribed in clause (i) or (ii).

‘‘(C) The term ‘OTC monograph drug’ has the meaning given such term in section 744L.
‘‘(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 201(g)) if such product— ‘‘(A) is not described in paragraph (1); and ‘‘(B) meets the definition of a device under sec- tion 201(h), unless another provision of this Act otherwise indicates a different classification.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3658 ‘‘(4) The Secretary shall waive the application fee under sections 736 and 744B for applications for drugs that are— ‘‘(A) on the date of enactment of the Prescrip- tion Drug User Fee Amendments of 2022, legally marketed as devices; and ‘‘(B) deemed drugs pursuant to paragraph (1)’’.

SEC.

3622.

WOMEN’S HEALTH RESEARCH ROADMAP.


Not later than 2 years after the date of enactment of this Act, the Office of Women’s Health of the Food and Drug Administration, established under section 1011 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
399b), shall— (1) review and, as appropriate, update the Women’s Health Research Roadmap issued in De- cember 2015; and (2) brief the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Representatives on the review and, as appropriate, any resulting update.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3659 SEC.

3623.

STRATEGIC WORKFORCE PLAN AND REPORT.

Chapter VII of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

371 et seq.)

is amended by inserting after section 714A the following: ‘‘SEC.

714B.

STRATEGIC WORKFORCE PLAN AND REPORT.
‘‘(a) IN GENERAL.—Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop, begin implementation of, and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordi- nated strategy and report to provide direction for the ac- tivities and programs of the Secretary to recruit, hire, train, develop, and retain the workforce needed to fulfill the public health mission of the Food and Drug Adminis- tration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and sci- entific advancements, and support the development, re- view, and regulation of medical products.
Each such report shall be known as the ‘Food and Drug Administration 20 Strategic Workforce Plan’.

21 22 23 24 25 26 ‘‘(b) USE OF THE FOOD AND DRUG ADMINISTRATION STRATEGIC WORKFORCE PLAN.—Each center within the Food and Drug Administration shall develop and update, as appropriate, a strategic plan that will be informed by the Food and Drug Administration Strategic Workforce Plans developed under subsection (a).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3660 ‘‘(c) CONTENTS OF THE FOOD AND DRUG ADMINIS- TRATION STRATEGIC WORKFORCE PLAN.—Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall— ‘‘(1) include agency-wide human capital stra- tegic goals and priorities for recruiting, hiring, train- ing, developing, and retaining a qualified workforce for the Food and Drug Administration; ‘‘(2) establish specific actions the Secretary will take to achieve such strategic goals and priorities and address the workforce needs of the Food and Drug Administration in the forthcoming fiscal years; ‘‘(3) identify challenges and risks the Secretary will face in meeting its strategic goals and priorities, and the actions the Secretary will take to overcome those challenges and mitigate those risks; ‘‘(4) establish performance measures, bench- marks, or other elements that the Secretary will use to measure and evaluate progress in achieving such strategic goals and priorities and the effectiveness of such strategic goals and priorities; and ‘‘(5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3661 ‘‘(d) CONSIDERATIONS.—In developing each Food and Drug Administration Strategic Workforce Plan under subsection (a), the Secretary shall consider— ‘‘(1) the number of employees (including senior leadership and non-senior leadership employees) eli- gible for retirement, the expertise of such employees, and the employing center of such employees; ‘‘(2) the vacancy and turnover rates for employ- ees with different types of expertise and from dif- ferent centers, including any changes or trends re- lated to such rates; ‘‘(3) the results of the Federal Employee View- point Survey for employees of the Food and Drug Administration, including any changes or trends re- lated to such results; ‘‘(4) rates of pay for different types of posi- tions, including rates for different types of expertise within the same field (such as differences in pay be- tween different medical specialists), and how such rates of pay impact the ability of the Secretary to achieve the strategic goals and priorities described in subsection (c); ‘‘(5) the statutory hiring authorities used to hire Food and Drug Administration employees, and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3662 the time to hire across different hiring authorities; and ‘‘(6) any other timely and relevant information, as the Secretary determines appropriate.
‘‘(e) EVALUATION OF PROGRESS.—Each Food and Drug Administration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administration Strategic Workforce Plan, shall include an evaluation of— ‘‘(1) the progress the Secretary has made, based on the performance measures, benchmarks, and other elements that measure successful recruit- ment, hiring, training, development, and retention activities; and ‘‘(2) whether actions taken in response to the Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities described in subsection (c)(1).
‘‘(f) ADDITIONAL CONSIDERATIONS.—The Food and Drug Administration Strategic Workforce Plan issued in fiscal year 2023 shall address the effect of the COVID– 19 pandemic on hiring, retention, and other workforce challenges for the Food and Drug Administration, includ- ing protecting such workforce during public health emer- gencies.’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3663 SEC.

3624.
3663 SEC.

3624.

ENHANCING FOOD AND DRUG ADMINISTRATION HIRING AUTHORITY FOR SCIENTIFIC, TECH- NICAL, AND PROFESSIONAL PERSONNEL.

Section 714A of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
379d–3a) is amended— (1) in subsection (a)— (A) by inserting ‘‘, including cross-cutting operational positions,’’ after ‘‘professional posi- tions’’; and (B) by inserting ‘‘and the regulation of food and cosmetics’’ after ‘‘medical products’’; and (2) in subsection (d)(1)— (A) in the matter preceding subparagraph (A)— (i) by striking ‘‘the 21st Century Cures Act’’ and inserting ‘‘the Food and Drug Omnibus Reform Act of 2022’’; and (ii) by striking ‘‘that examines the ex- tent’’ and all that follows through ‘‘, in- cluding’’ and inserting ‘‘that includes’’; (B) in subparagraph (A)— (i) by inserting ‘‘updated’’ before ‘‘analysis’’; and (ii) by striking ‘‘; and’’ and inserting a semicolon; 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3664 (C) by redesignating subparagraph (B) as subparagraph (C); (D) by inserting after subparagraph (A) the following: ‘‘(B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applica- ble hiring authorities, for employees of the Food and Drug Administration; and’’; and (E) in the matter preceding clause (i) of subparagraph (C), as so redesignated, by strik- ing ‘‘a recruitment’’ and inserting ‘‘an updated recruitment’’.
SEC.

3625.

FACILITIES MANAGEMENT.

(a) PDUFA AUTHORITY.—Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

1 379h(g)(2)) is amended— (1) in subparagraph (A)(ii)— (A) by striking ‘‘shall be available to de- fray’’ and inserting the following: ‘‘shall be available— ‘‘(I) for fiscal year 2023, to de- fray’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3665 (B) by striking the period and inserting ‘‘; and’’; and (C) by adding at the end the following: ‘‘(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full- time equivalent positions in the De- partment of Health and Human Serv- ices to be engaged in such process), only if the sum of the amounts allo- cated by the Secretary for such costs, excluding costs paid from fees col- lected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary mate- rials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, ex- cluding any such costs paid from fees December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3666 collected under this section, for fiscal year 1997, multiplied by the adjust- ment factor.’’; and (2) in subparagraph (B), by striking ‘‘for the process for the review of human drug applications’’ and inserting ‘‘as described in subclause (I) or (II) of such subparagraph, as applicable’’.

(b) BSUFA AUTHORITY.—Section 744H(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j– 52(f)(2)) is amended— (1) in subparagraph (B)(i)— (A) by striking ‘‘available for a fiscal year beginning after fiscal year 2012’’ and inserting the following: ‘‘available— ‘‘(I) for fiscal year 2023,’’; (B) by striking ‘‘the fiscal year involved.’’ and inserting ‘‘such fiscal year; and’’; and (C) by adding at the end the following: ‘‘(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product appli- cations (including such costs for an additional number of full-time equiva- lent positions in the Department of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3667 Health and Human Services to be en- gaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, mainte- nance, and repair of fixtures, fur- niture, and other necessary materials and supplies in connection with the process for the review of biosimilar bi- ological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.’’; and (2) in subparagraph (C), by striking ‘‘subpara- graph (B) in any fiscal year if the costs described in such subparagraph’’ and inserting ‘‘subparagraph (B)(i) in any fiscal year if the costs allocated as de- scribed in subclause (I) or (II) of such subpara- graph, as applicable,’’.
(c) GDUFA AUTHORITY.—Section 744B of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.

379j–42) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3668 (1) in subsection (e)(2), by striking ‘‘744A(11)(C)’’ and inserting ‘‘744A(12)(C)’’; and (2) in subsection (i)(2)— (A) in subparagraph (A)(ii)— (i) by striking ‘‘available for a fiscal year beginning after fiscal year 2012’’ and inserting the following: ‘‘available— ‘‘(I) for fiscal year 2023,’’; (ii) by striking ‘‘the fiscal year in- volved.’’ and inserting ‘‘such fiscal year; and’’; and (iii) by adding at the end the fol- lowing: ‘‘(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug ac- tivities (including such costs for an additional number of full-time equiva- lent positions in the Department of Health and Human Services to be en- gaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3669 maintenance, renovation, and repair of facilities and acquisition, mainte- nance, and repair of fixtures, fur- niture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in sec- tion 744A(3) applicable to the fiscal year involved.’’; and (B) in subparagraph (B), by striking ‘‘for human generic activities’’ and inserting ‘‘as de- scribed in subclause (I) or (II) of such subpara- graph, as applicable,’’.
(d) MDUFA AUTHORITY.—Section 738 of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.
379j), as amended by section 3309, is further amended— (1) in subsection (e)(2)(B)(iii), by inserting ‘‘, if extant,’’ after ‘‘national taxing authority’’; (2) in subsection (h)(2)— (A) in subparagraph (A)(ii)— (i) by striking ‘‘shall be available to defray’’ and inserting the following: ‘‘shall be available— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3670 ‘‘(I) for fiscal year 2023, to de- fray’’; (ii) by striking the period and insert- ing ‘‘; and’’; and (iii) by adding at the end the fol- lowing: ‘‘(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Depart- ment of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, mainte- nance, and repair of fixtures, fur- niture and other necessary materials and supplies in connection with the process for the review of device appli- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3671 cations, is no less than the amount al- located for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.’’; and (B) in subparagraph (B)(i), in the matter preceding subclause (I), by striking ‘‘for the process for the review of device applications’’ and inserting ‘‘as described in subclause (I) or (II) of such subparagraph, as applicable’’; and (3) in subsection (g)(3), by striking ‘‘737(9)(C)’’ and inserting ‘‘737(10)(C)’’.
(e) TECHNICAL CORRECTION.— (1) IN GENERAL.—Section 905(b)(2) of the FDA Reauthorization Act of 2017 (Public Law 115– 52) is amended by striking ‘‘Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

379j(h)) is amended’’ and inserting ‘‘Subsection (g) of section 738 of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.

379j), as so redesignated by section 203(f)(2)(B)(i), is amended’’.
(2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall take effect as though in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3672 cluded in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52).

SEC.

3626.

USER FEE PROGRAM TRANSPARENCY AND AC- COUNTABILITY.
(a) PDUFA.— (1) REAUTHORIZATION; REPORTING REQUIRE- MENTS.—Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h–2(a)) is amended— (A) in paragraph (1)— (i) in subparagraph (B)— (I) in clause (vii), by striking ‘‘; and’’ and inserting a semicolon; (II) in clause (viii), by striking the period and inserting ‘‘; and’’; and (III) by adding at the end the following: ‘‘(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.’’; and (ii) by adding at the end the following flush text: ‘‘Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is pro- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3673 hibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.’’; (B) by adding at the end of paragraph (3)(B) the following: ‘‘(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall pre- scribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency cen- ter.’’; and (C) in paragraph (4)— (i) by amending subparagraph (A) to read as follows: ‘‘(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3674 1001(b) of the Prescription Drug User Fee Amendments of 2022 and the number of re- maining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 736, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Re- search, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;’’; (ii) by amending subparagraph (B) to read as follows: ‘‘(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying— ‘‘(i) drivers of such changes; and ‘‘(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;’’; (iii) in subparagraph (C), by striking the period and inserting ‘‘; and’’; and (iv) by adding at the end the fol- lowing: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3675 ‘‘(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.’’.

(2) REAUTHORIZATION.—Section 736B(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h–2(f)) is amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), re- spectively; (B) by inserting after paragraph (3) the following: ‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthoriza- tion of this part to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.’’; and (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking ‘‘Before pre- senting the recommendations devel- oped under paragraphs (1) through December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3676 (5) to the Congress, the’’ and insert- ing ‘‘The’’; and (II) by inserting ‘‘, not later than 30 days after each such negotiation meeting’’ before the period at the end; and (ii) in subparagraph (B), by inserting ‘‘, in sufficient detail,’’ after ‘‘shall sum- marize’’.

(b) MDUFA.— (1) REAUTHORIZATION; REPORTING REQUIRE- MENTS.—Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j– 1(a)(1)(A)) is amended— (A) in clause (ii)— (i) in subclause (II), by striking ‘‘; and’’ and inserting a semicolon; (ii) in subclause (III), by striking the period and inserting a semicolon; and (iii) by adding at the end the fol- lowing: ‘‘(IV) the number of investiga- tional device exemption applications submitted under section 520(g) per December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3677 fiscal year, including for each review division; and ‘‘(V) the number of expedited de- velopment and priority review requests and designations under section 515B per fiscal year, including for each re- view division.
Nothing in this clause shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.’’; and (B) in clause (iv) (relating to rationale for MDUFA program changes)— (i) by amending subclause (I) to read as follows: ‘‘(I) data, analysis, and discus- sion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3678 number of remaining vacancies, the number of full-time equivalents fund- ed by fees collected pursuant to sec- tion 738, and the number of full time equivalents funded by budget author- ity at the Food and Drug Administra- tion by each division within the Cen- ter for Devices and Radiological Health, the Center for Biologics Eval- uation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;’’; (ii) by amending subclause (II) to read as follows: ‘‘(II) data, analysis, and discus- sion of the changes in the fee revenue amounts and costs for the process for the review of device applications, in- cluding identifying— ‘‘(aa) drivers of such changes; and ‘‘(bb) changes in the average total cost per full-time equivalent in the medical device review pro- gram;’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3679 (iii) in subclause (III), by striking the period and inserting ‘‘; and’’; and (iv) by adding at the end the fol- lowing: ‘‘(IV) data, analysis, and discus- sion of the changes in the average full-time equivalent hours required to complete review of medical device ap- plication types.’’.

(2) REAUTHORIZATION.—Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–1(b)) is amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), re- spectively; (B) by inserting after paragraph (3) the following: ‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthoriza- tion of this part to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.’’; and (C) in paragraph (7), as so redesignated— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3680 (i) in subparagraph (A)— (I) by striking ‘‘Before pre- senting the recommendations devel- oped under paragraphs (1) through (5) to the Congress, the’’ and insert- ing ‘‘The’’; and (II) by inserting ‘‘, not later than 30 days after each such negotiation meeting’’ before the period at the end; and (ii) in subparagraph (B), by inserting ‘‘, in sufficient detail,’’ after ‘‘shall sum- marize’’.
(c) GDUFA.— (1) REAUTHORIZATION; REPORTING REQUIRE- MENTS.—Section 744C(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–43(a)(3)) is amended— (A) by amending subparagraph (A) to read as follows: ‘‘(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amend- ments of 2022 and the number of remaining va- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3681 cancies, the number of full-time equivalents funded by fees collected pursuant to section 744B, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Re- search, the Office of Regulatory Affairs, and the Office of the Commissioner;’’; (B) by amending subparagraph (B) to read as follows: ‘‘(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including— ‘‘(i) identifying drivers of such changes; and ‘‘(ii) changes in the total average cost per full-time equivalent in the generic drug review program;’’; (C) in subparagraph (C), by striking the period at the end and inserting ‘‘; and’’; and (D) by adding at the end the following: ‘‘(D) data, analysis, and discussion of the changes in the average full-time equivalent December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3682 hours required to complete review of each type of abbreviated new drug application.’’.

(2) REAUTHORIZATION.—Section 744C(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–43(f)) is amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), re- spectively; (B) by inserting after paragraph (3) the following: ‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthoriza- tion of this part to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.’’; and (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking ‘‘Before pre- senting the recommendations devel- oped under paragraphs (1) through (5) to the Congress, the’’ and insert- ing ‘‘The’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3683 (II) by inserting ‘‘, not later than 30 days after each such negotiation meeting’’ before the period at the end; and (ii) in subparagraph (B), by inserting ‘‘, in sufficient detail,’’ after ‘‘shall sum- marize’’.

(d) BSUFA.— (1) REAUTHORIZATION; REPORTING REQUIRE- MENTS.—Section 744I(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–53(a)(4)) is amended— (A) by amending subparagraph (A) to read as follows: ‘‘(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 4001(b) of the Biosimilar User Fee Amend- ments of 2022 and the number of remaining va- cancies, the number of full-time equivalents funded by fees collected pursuant to section 744H, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3684 the Center for Biologics Evaluation and Re- search, the Office of Regulatory Affairs, and the Office of the Commissioner;’’; (B) by amending subparagraph (B) to read as follows: ‘‘(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar bio- logical product applications, including identi- fying— ‘‘(i) drivers of such changes; and ‘‘(ii) changes in the average total cost per full-time equivalent in the biosimilar biological product review program;’’; (C) in subparagraph (C), by striking the period at the end and inserting ‘‘; and’’; and (D) by adding at the end the following: ‘‘(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application.’’.
(2) REAUTHORIZATION.—Section 744I(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

379j–53(f)) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3685 (A) by redesignating paragraphs (2) and (3) as paragraphs (5) and (6), respectively; (B) by inserting after paragraph (1) the following: ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reau- thorization of this part, the Secretary shall— ‘‘(A) publish a notice in the Federal Reg- ister requesting public input on the reauthoriza- tion; ‘‘(B) hold a public meeting at which the public may present its views on the reauthoriza- tion; ‘‘(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and ‘‘(D) publish the comments on the Food and Drug Administration’s website.
‘‘(3) PERIODIC CONSULTATION.—Not less fre- quently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and con- sumer advocacy groups to continue discussions of their views on the reauthorization and their sugges- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3686 tions for changes to this part as expressed under paragraph (2).
‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthoriza- tion of this part to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.’’; and (C) by adding at the end the following: ‘‘(7) MINUTES OF NEGOTIATION MEETINGS.— ‘‘(A) PUBLIC AVAILABILITY.—The Sec- retary shall make publicly available, on the pub- lic website of the Food and Drug Administra- tion, minutes of all negotiation meetings con- ducted under this subsection between the Food and Drug Administration and the regulated in- dustry, not later than 30 days after each such negotiation meeting.
‘‘(B) CONTENT.—The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as sig- nificant controversies or differences of opinion during the negotiations and their resolution.’’.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3687 SEC.

3627.
3687 SEC.

3627.

IMPROVING INFORMATION TECHNOLOGY SYS- TEMS OF THE FOOD AND DRUG ADMINISTRA- TION.
(a) FDA STRATEGIC INFORMATION TECHNOLOGY PLAN.— (1) IN GENERAL.—Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop and submit to the appro- priate committees of Congress and post on the website of the Food and Drug Administration, a co- ordinated information technology strategic plan to modernize the information technology systems of the Food and Drug Administration.
Each such report shall be known as the ‘‘Food and Drug Administra- tion Strategic Information Technology Plan’’.

The first such report may include the Data and Tech- nology Modernization Strategy, as set forth in the letters described in section 1001(b) of the FDA User Fee Reauthorization Act of 2022 (division F of Pub- lic Law 117–180).
(2) CONTENT OF STRATEGIC PLAN.—The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall in- clude— (A) agency-wide strategic goals and prior- ities for modernizing the information technology 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3688 systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mis- sion; (B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific mile- stones, metrics, and performance measures for assessing progress against such strategic goals and priorities; (C) specific activities and strategies for im- proving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns; (D) challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will under- take to overcome those challenges and mitigate those risks; (E) the ways in which the Food and Drug Administration will use the Plan to guide and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3689 coordinate the projects and activities of the Food and Drug Administration across its of- fices and centers; and (F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to informa- tion technology human capital planning.
(3) EVALUATION OF PROGRESS.—Each Food and Drug Administration Strategic Information Technology Plan issued pursuant to this subsection, with the exception of the first such Food and Drug Administration Strategic Information Technology Plan, shall include an evaluation of— (A) the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and (B) whether actions taken in response to the previous Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in such previous Plans.
(b) GAO REPORT.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3690 (1) IN GENERAL.—Not later than September 30, 2026, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the im- plementation of the Food and Drug Administration Strategic Information Technology Plan adopted pur- suant to subsection (a).
(2) CONTENT OF REPORT.—The report re- quired under paragraph (1) shall include an assess- ment of— (A) the development and implementation of the Food and Drug Administration Strategic Information Technology Plan, including the suf- ficiency of the plan, progress of the Food and Drug Administration in meeting the results-ori- ented goals, milestones, and performance meas- ures identified in such plan and any gaps in such implementation; (B) the efficiency and effectiveness of the Food and Drug Administration’s expenditures on information technology systems over the pre- ceding 10 fiscal years, including the implemen- tation by the Food and Drug Administration of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3691 the Technology Modernization Action Plan and Data Modernization Action Plan; (C) challenges posed by the information technology systems of the Food and Drug Ad- ministration for carrying out the Food and Drug Administration’s public health mission, including on meeting user fee agreement per- formance goals, conducting inspections, re- sponding to identified safety concerns, and keeping pace with new scientific and medical advances; and (D) recommendations for the Food and Drug Administration to address the identified challenges, improve its implementation of the Food and Drug Administration Strategic Infor- mation Technology Plan, and to otherwise im- prove the Food and Drug Administration’s in- formation technology systems.
SEC.

3628.

REPORTING ON MAILROOM AND OFFICE OF THE EXECUTIVE SECRETARIAT OF THE FOOD AND DRUG ADMINISTRATION.

(a) REPORT.—Not later than 90 days after the date of enactment of this Act, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3692 the Senate and the Committee on Energy and Commerce of the House of Representatives on— (1) information related to policies, procedures, and activities of the mailroom and the Office of the Executive Secretariat of the Food and Drug Admin- istration, including— (A) taking receipt, tracking, managing, and prioritizing confidential informant com- plaints; (B) taking receipt of common carrier pack- ages to the Food and Drug Administration; (C) the organizational structure and man- agement of the mailroom; (D) the organizational structure and man- agement of the Office of the Executive Secre- tariat; (E) the total number of employees and contractors in the mailroom including those working remotely and those working in person; (F) the total number of employees and contractors in the Office of the Executive Secre- tariat; (G) the number of vacant positions in the mailroom; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3693 (H) the number of vacant positions in the Office of the Executive Secretariat; (I) the average number of days for re- sponse to correspondence received by the Office of the Secretariat; (J) the extent to which there is a backlog of common carrier packages received by the mailroom and the number of common carrier packages in any backlog; (K) the extent to which there is a backlog of correspondence in the Office of the Executive Secretariat that has not been appropriately re- sponded to by the Food and Drug Administra- tion and the number of correspondence or com- mon carrier packages in any backlog; (L) a rationale for the failure of the Office of the Executive Secretariat to respond to cor- respondence in any backlog and the position of the decision-making official who determined not to respond to such correspondence; (M) the number of whistleblower cor- respondence received, including within each agency center; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3694 (N) the amount of resources expended for the mailroom, including a breakdown of budget authority and user fee dollars; (O) the amount of resources expended for the Office of the Executive Secretariat and cor- respondence-related activities, including a breakdown of budget authority and user fee dol- lars; and (P) the performance of third-party con- tractors responsible for correspondence-related activities with respect to the receipt and track- ing of correspondence, and efforts by the Food and Drug Administration to improve perform- ance by such contractors; and (2) the development and implementation of new or revised policies and procedures of the Food and Drug Administration to monitor and ensure— (A) the effective receipt, tracking, man- aging, and prioritization of such complaints; and (B) the effective receipt of common carrier packages to the Food and Drug Administration.
(b) ANNUAL REPORT.—Not later than the end of each of fiscal years 2023 and 2024, the Secretary shall issue a report to the Committee on Health, Education, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3695 Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the implementation of the new or revised policies of the Food and Drug Administration reported under sub- section (a)(2), and since such implementation— (1) the volume of incoming common carrier packages to the mailroom; (2) the volume of incoming correspondence to the Office of the Executive Secretariat; (3) the extent to which new backlogs occur in the processing of common carrier packages received by the mailroom; (4) the extent to which new backlogs occur in the processing of correspondence received by the Of- fice of the Executive Secretariat; (5) the length of time required to resolve each such backlog; (6) any known issues of unreasonable delays in correspondence being provided to the intended re- cipient, or in correspondence being lost, and the measures taken to remedy such delays or lost items; (7) the average number of days it takes to re- spond to correspondence received by the Office of the Executive Secretariat; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3696 (8) the resources expended by the mailroom, in- cluding a breakdown of budget authority and user fee dollars; and (9) the resources expended by the Office of the Executive Secretariat on correspondence-related ac- tivities, including a breakdown of budget authority and user fee dollars.
(c) GAO REPORT.—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the policies and practices of the Division of Executive Operations of the Office of the Executive Secretariat of the Food and Drug Administration with respect to the receipt, tracking, man- aging, and prioritization of correspondence.
SEC.

3629.

FACILITATING THE USE OF REAL WORLD EVI- DENCE.

(a) GUIDANCE.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise existing guidance on considerations for the use of real world data and real world evidence to support regulatory 24 decision-making, as follows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3697 (1) With respect to drugs, such guidance shall address the use of such data and evidence to support the approval of a drug application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355) or a biological product application under section 351 of the Public Health Service Act (42 U.S.C.

262), and to support an investigational use exemption submission under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C.

262(a)(3)).

Such guidance shall include considerations for the inclu- sion, in such applications and submissions, of real world data and real world evidence obtained as a re- sult of the use of drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–3), and con- siderations for standards and methodologies for col- lection and analysis of real world evidence included in such applications and submissions, as appro- priate.
(2) With respect to devices, such guidance shall address the use of such data and evidence to support the approval, clearance, or classification of a device pursuant to an application or submission submitted December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3698 under section 510(k), 513(f)(2), or 515 of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.
360(k), 360c(f)(2), 360e), to support an investiga- tional use exemption submission under section 520(g) of such Act (21 U.S.C.

360j(g)), and to sup- port a determination by the Secretary for purposes of section 353 of the Public Health Service Act (42 U.S.C.

263a) (including the category described under subsection (d)(3) of such section).
Such guid- ance shall include considerations for the inclusion, in such applications and submissions, of real world data and real world evidence obtained as a result of the use of devices authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360bbb–3), including con- siderations related to a determination under section 353(d)(3) of the Public Health Service Act (42 U.S.C.
263a(d)(3)), and considerations for stand- ards and methodologies for collection and analysis of real world evidence included in such applications, submissions, or determinations, as appropriate.

(b) REPORT TO CONGRESS.—Not later than 2 years after the end of the public health emergency declared by the Secretary under section 319 of the Public Health Serv- ice Act (42 U.S.C.
247d) on January 31, 2020, with re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3699 spect to COVID–19, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Commerce of the House of Representatives on— (1) the number of applications, submissions, or requests submitted for clearance, approval, or au- thorization under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355, 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act (42 U.S.C.

262), for which an authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–3) was previously granted; (2) of the number of applications so submitted, the number of such applications— (A) for which real world evidence was sub- mitted and used to support a regulatory deci- sion; and (B) for which real world evidence was sub- mitted and determined to be insufficient to sup- port a regulatory decision; and (3) a summary explanation of why, in the case of applications described in paragraph (2)(B), real world evidence could not be used to support regu- latory decisions.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3700 (c) INFORMATION DISCLOSURE.—Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under sec- tion 1905 of title 18, United States Code, or subject to withholding under subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the ‘‘Freedom of Information Act’’).
SEC.

3630.

FACILITATING EXCHANGE OF PRODUCT INFOR- MATION PRIOR TO APPROVAL.

(a) IN GENERAL.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended— (1) in paragraph (a)— (A) by striking ‘‘drugs for coverage’’ and inserting ‘‘drugs or devices for coverage’’; and (B) by striking ‘‘drug’’ each place it ap- pears and inserting ‘‘drug or device’’, respec- tively; (2) in paragraphs (a)(1) and (a)(2)(B), by striking ‘‘under section 505 or under section 351 of the Public Health Service Act’’ and inserting ‘‘under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act’’; (3) in paragraph (a)(1)— (A) by striking ‘‘under section 505 or under section 351(a) of the Public Health Serv- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3701 ice Act’’ and inserting ‘‘under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act’’; and (B) by striking ‘‘in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act’’ and inserting ‘‘in section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act’’; and (4) by adding at the end the following: ‘‘(gg)(1) Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product infor- mation to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimburse- ment if the product information relates to an investiga- tional drug or device or investigational use of a drug or device that is approved, cleared, granted marketing au- thorization, or licensed under section 505, 510(k), December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3702 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable), provided— ‘‘(A) the product information includes— ‘‘(i) a clear statement that the investiga- tional drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable) and that the safety and effectiveness of such drug or device for such use has not been established; ‘‘(ii) information related to the stage of de- velopment of the drug or device involved, such as— ‘‘(I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated; ‘‘(II) how the study or studies relate to the overall plan for the development of the drug or device; and ‘‘(III) whether an application, pre- market notification, or request for classi- fication for the investigational drug or de- vice or investigational use has been sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3703 mitted to the Secretary and when such a submission is planned; ‘‘(iii) in the case of information that in- cludes factual presentations of results from studies, which shall not be selectively presented, a description of— ‘‘(I) all material aspects of study de- sign, methodology, and results; and ‘‘(II) all material limitations related to the study design, methodology, and re- sults; ‘‘(iv) where applicable, a prominent state- ment disclosing the indication or indications for which the Secretary has approved, granted mar- keting authorization, cleared, or licensed the product pursuant to section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act, and a copy of the most current required labeling; and ‘‘(v) updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the prod- uct or its review status; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3704 ‘‘(B) the product information does not in- clude— ‘‘(i) information that represents that an unapproved product— ‘‘(I) has been approved, cleared, granted marketing authorization, or li- censed under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act (as applicable); or ‘‘(II) has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or ‘‘(ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authoriza- tion, cleared, or licensed— ‘‘(I) is so approved, granted mar- keting authorization, cleared, or licensed; or ‘‘(II) that the product is safe or effec- tive for the use or uses for which the drug or device is being studied.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3705 ‘‘(2) For purposes of this paragraph, the term ‘prod- uct information’ includes— ‘‘(A) information describing the drug or device (such as drug class, device description, and fea- tures); ‘‘(B) information about the indication or indica- tions being investigated; ‘‘(C) the anticipated timeline for a possible ap- proval, clearance, marketing authorization, or licen- sure pursuant to section 505, 510(k), 513, or 515 of this Act or section 351 of the Public Health Serv- ice Act; ‘‘(D) drug or device pricing information; ‘‘(E) patient utilization projections; ‘‘(F) product-related programs or services; and ‘‘(G) factual presentations of results from stud- ies that do not characterize or make conclusions re- garding safety or efficacy.’’.
(b) GAO STUDY AND REPORT.—Beginning on the date that is 5 years and 6 months after the date of enact- ment of this Act, the Comptroller General of the United States shall conduct a study on the provision and use of information pursuant to section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by this sub- section (a), between manufacturers of drugs and devices December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3706 (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

321)) and entities described in such section 502(gg).

Such study shall include an analysis of the following: (1) The types of information communicated be- tween such manufacturers and payors.

(2) The manner of communication between such manufacturers and payors.
(3)(A) Whether such manufacturers file an ap- plication for approval, marketing authorization, clearance, or licensing of a new drug or device or the new use of a drug or device that is the subject of communication between such manufacturers and payors under section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

(B) How frequently the Food and Drug Admin- istration approves, grants marketing authorization, clears, or licenses the new drug or device or new use.
(C) The timeframe between the initial commu- nications permitted under section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), regarding an investigational drug or device or investigational use, and the initial mar- keting of such drug or device.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3707 SEC.

3631.

STREAMLINING BLOOD DONOR INPUT.


Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary and that is initiated by the Secretary to solicit information from blood donors or potential blood donors to support the development of recommendations by the Secretary, acting through the Commissioner of Food and Drugs, concerning blood donation.

TITLE IV—MEDICARE PROVISIONS Subtitle A—Medicare Extenders SEC.

4101.
4101.

EXTENSION OF INCREASED INPATIENT HOS- PITAL PAYMENT ADJUSTMENT FOR CERTAIN LOW-VOLUME HOSPITALS.

(a) IN GENERAL.—Section 1886(d)(12) of the Social Security Act (42 U.S.C.
1395ww(d)(12)) is amended— (1) in subparagraph (B), in the matter pre- ceding clause (i), by striking ‘‘during the portion of fiscal year 2023 beginning on December 24, 2022, and ending on September 30, 2023, and in fiscal year 2024’’ and inserting ‘‘in fiscal year 2025’’; (2) in subparagraph (C)(i)— (A) in the matter preceding subclause (I)— (i) by striking ‘‘or portion of a fiscal year’’; and 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3708 (ii) by striking ‘‘through 2022 and the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ’’ and inserting ‘‘through 2024’’; (B) in subclause (III), by striking ‘‘through 2022 and the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ’’ and inserting ‘‘through 2024’’; and (C) in subclause (IV), by striking ‘‘the por- tion of fiscal year 2023 beginning on December 24, 2022, and ending on September 30, 2023, and fiscal year 2024’’ and inserting ‘‘fiscal year 2025’’; and (3) in subparagraph (D)— (A) in the matter preceding clause (i), by striking ‘‘through 2022 or during the portion of fiscal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’ ’’ and in- serting ‘‘through 2024’’; and (B) in clause (ii), by striking ‘‘through 2022 and the portion of fiscal year 2023 begin- ning on October 1, 2022, and ending on De- cember 23, 2022’ ’’ and inserting ‘‘through 2024’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3709 (b) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, including the amendments made by, this section by program instruction or otherwise.

SEC.

4102.

EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL PROGRAM.

(a) IN GENERAL.—Section 1886(d)(5)(G) of the So- cial Security Act (42 U.S.C.
1395ww(d)(5)(G)) is amend- ed— (1) in clause (i), by striking ‘‘December 24, 2022’’ and inserting ‘‘October 1, 2024’’; and (2) in clause (ii)(II), by striking ‘‘December 24, 2022’’ and inserting ‘‘October 1, 2024’’.

(b) CONFORMING AMENDMENTS.— (1) EXTENSION OF TARGET AMOUNTS.—Section 1886(b)(3)(D) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(D)) is amended— (A) in the matter preceding clause (i), by striking ‘‘December 24, 2022’’ and inserting ‘‘October 1, 2024’’; and (B) in clause (iv), by striking ‘‘fiscal year 2022 and the portion of fiscal year 2023 begin- ning on October 1, 2022, and ending on De- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3710 cember 23, 2022,’’ and inserting ‘‘fiscal year 2024’’.
(2) PERMITTING HOSPITALS TO DECLINE RE- CLASSIFICATION.—Section 13501(e)(2) of the Omni- bus Budget Reconciliation Act of 1993 (42 U.S.C.

1395ww note) is amended by striking ‘‘fiscal year 2000 through fiscal year 2022, or the portion of fis- cal year 2023 beginning on October 1, 2022, and ending on December 23, 2022’’ and inserting ‘‘or fiscal year 2000 through fiscal year 2024’’.

SEC.

4103.

EXTENSION OF ADD-ON PAYMENTS FOR AMBU- LANCE SERVICES.

Section 1834(l) of the Social Security Act (42 U.S.C.
1395m(l)) is amended— (1) in paragraph (12)(A), by striking ‘‘January 1, 2023’’ and inserting ‘‘January 1, 2025’’; and (2) in paragraph (13), by striking ‘‘January 1, 2023’’ in each place it appears and inserting ‘‘Janu- ary 1, 2025’’ in each such place.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3711 Subtitle B—Other Expiring Medicare Provisions SEC.

4111.
4111.

EXTENDING INCENTIVE PAYMENTS FOR PAR- TICIPATION IN ELIGIBLE ALTERNATIVE PAY- MENT MODELS.

(a) IN GENERAL.—Section 1833(z) of the Social Se- curity Act (42 U.S.C.
1395l(z)) is amended— (1) in paragraph (1)(A)— (A) by striking ‘‘2024’’ and inserting ‘‘2025’’; and (B) by inserting ‘‘(or, with respect to 2025, 3.5 percent)’’ after ‘‘5 percent’’; (2) in paragraph (2)— (A) in subparagraph (B)— (i) in the header, by striking ‘‘2024’’ and inserting ‘‘2025’’; and (ii) in the matter preceding clause (i), by striking ‘‘2024’’ and inserting ‘‘2025’’; (B) in subparagraph (C)— (i) in the header, by striking ‘‘2025’’ and inserting ‘‘2026’’; and (ii) in the matter preceding clause (i), by striking ‘‘2025’’ and inserting ‘‘2026’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3712 (C) in subparagraph (D), by striking ‘‘2023 and 2024’’ and inserting ‘‘2023, 2024, and 2025’’; and (3) in paragraph (4)(B), by inserting ‘‘(or, with respect to 2025, 3.5 percent)’’ after ‘‘5 percent’’.

(b) CONFORMING AMENDMENTS.—Section 1848(q)(1)(C)(iii) of the Social Security Act (42 U.S.C.

1395w–4(q)(1)(C)(iii)) is amended— (1) in subclause (II), by striking ‘‘2024’’ and inserting ‘‘2025’’; and (2) in subclause (III), by striking ‘‘2025’’ and inserting ‘‘2026’’.

SEC.

4112.
SEC.

4112.

EXTENSION OF SUPPORT FOR PHYSICIANS AND OTHER PROFESSIONALS IN ADJUSTING TO MEDICARE PAYMENT CHANGES.

Section 1848 of the Social Security Act (42 U.S.C.


1 1395w–4) is amended— (1) in subsection (c)(2)(B)(iv)(V), by striking ‘‘2021 or 2022’’ and inserting ‘‘2021, 2022, 2023, or 2024’’; and (2) in subsection (t)— (A) in the subsection header, by striking ‘‘2021 AND 2022’’ and inserting ‘‘2021 THROUGH 2024’’; (B) in paragraph (1)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3713 (i) in the matter preceding subpara- graph (A), by striking ‘‘during 2021 and 2022’’ and inserting ‘‘during 2021, 2022, 2023, and 2024’’; and (ii) in subparagraph (A), by striking at the end ‘‘and’’; (iii) in subparagraph (B), by striking at the end the period and inserting a semi- colon; and (iv) by adding at the end the following new subparagraphs: ‘‘(C) such services furnished on or after January 1, 2023, and before January 1, 2024, by 2.5 percent; and ‘‘(D) such services furnished on or after January, 1, 2024, and before January 1, 2025, by 1.25 percent.’’; and (C) in paragraph (2)(C)— (i) in the subparagraph header, by striking ‘‘2021 AND 2022’’ and inserting ‘‘2021 THROUGH 2024’’; (ii) by striking ‘‘for services furnished in 2021 or 2022’’ and inserting ‘‘for serv- ices furnished in 2021, 2022, 2023, or 2024’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3714 (iii) by striking ‘‘or 2022, respec- tively’’ and inserting ‘‘, 2022, 2023, or 2024, respectively’’.

SEC.

4113.

ADVANCING TELEHEALTH BEYOND COVID–19.

(a) REMOVING GEOGRAPHIC REQUIREMENTS AND EXPANDING ORIGINATING SITES FOR TELEHEALTH SERVICES.—Section 1834(m) of the Social Security Act (42 U.S.C.
1395m(m)) is amended— (1) in paragraph (2)(B)(iii)— (A) by striking ‘‘With’’ and inserting ‘‘In the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, with’’; and (B) by striking ‘‘that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)’’ and inserting ‘‘that are furnished during the period beginning on the first day after the end of such emergency period and ending December 31, 2024’’; and (2) in paragraph (4)(C)(iii)— (A) by striking ‘‘With’’ and inserting ‘‘In the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, with’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3715 (B) by striking ‘‘that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)’’ and inserting ‘‘that are furnished during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024’’.

(b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR- NISH TELEHEALTH SERVICES.—Section 1834(m)(4)(E) of the Social Security Act (42 U.S.C.
1395m(m)(4)(E)) is amended by striking ‘‘and, for the 151-day period begin- ning on the first day after the end of the emergency period described in section 1135(g)(1)(B)’’ and inserting ‘‘and, in the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, for the pe- riod beginning on the first day after the end of such emer- gency period and ending on December 31, 2024’’.
(c) EXTENDING TELEHEALTH SERVICES FOR FED- ERALLY QUALIFIED HEALTH CENTERS AND RURAL HEALTH CLINICS.—Section 1834(m)(8)(A) of the Social Security Act (42 U.S.C.
1395m(m)(8)(A)) is amended by striking ‘‘during the 151-day period beginning on the first day after the end of such emergency period’’ and inserting ‘‘in the case that such emergency period ends before De- cember 31, 2024, during the period beginning on the first December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3716 day after the end of such emergency period and ending on December 31, 2024’’.
(d) DELAYING THE IN-PERSON REQUIREMENTS UNDER MEDICARE FOR MENTAL HEALTH SERVICES FURNISHED THROUGH TELEHEALTH AND TELE- COMMUNICATIONS TECHNOLOGY.— (1) DELAY IN REQUIREMENTS FOR MENTAL HEALTH SERVICES FURNISHED THROUGH TELE- HEALTH.—Section 1834(m)(7)(B)(i) of the Social Security Act (42 U.S.C.
1395m(m)(7)(B)(i)) is amended, in the matter preceding subclause (I), by striking ‘‘on or after the day that is the 152nd day after the end of the period at the end of the emer- gency sentence described in section 1135(g)(1)(B))’’ and inserting ‘‘on or after January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1135(g)(1)(B))’’.

(2) MENTAL HEALTH VISITS FURNISHED BY RURAL HEALTH CLINICS.—Section 1834(y) of the Social Security Act (42 U.S.C.
1395m(y)) is amend- ed— (A) in the heading, by striking ‘‘TO HOS- PICE PATIENTS’’; and (B) in paragraph (2), by striking ‘‘prior to the day that is the 152nd day after the end of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3717 the emergency period described in section 1135(g)(1)(B))’’ and inserting ‘‘prior to Janu- ary 1, 2025 (or, if later, the first day after the end of the emergency period described in sec- tion 1135(g)(1)(B))’’.

(3) MENTAL HEALTH VISITS FURNISHED BY FEDERALLY QUALIFIED HEALTH CENTERS.—Section 1834(o)(4) of the Social Security Act (42 U.S.C.
1395m(o)(4) is amended— (A) in the heading, by striking ‘‘TO HOS- PICE PATIENTS’’; and (B) in subparagraph (B), by striking ‘‘prior to the day that is the 152nd day after the end of the emergency period described in section 1135(g)(1)(B))’’ and inserting ‘‘prior to January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1135(g)(1)(B))’’.
(e) ALLOWING FOR THE FURNISHING OF AUDIO- ONLY TELEHEALTH SERVICES.—Section 1834(m)(9) of the Social Security Act (42 U.S.C.
1395m(m)(9)) is amended by striking ‘‘The Secretary shall continue to pro- vide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of the date of the enactment of this paragraph that are furnished via December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3718 an audio-only telecommunications system during the 151- day period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B)’’ and inserting ‘‘In the case that the emergency period described in section 1135(g)(1)(B) ends before December 31, 2024, the Secretary shall continue to provide coverage and pay- ment under this part for telehealth services identified in paragraph (4)(F)(i) as of the date of the enactment of this paragraph that are furnished via an audio-only com- munications system during the period beginning on the first day after the end of such emergency period and end- 12 ing on December 31, 2024’’.
(f) USE OF TELEHEALTH TO CONDUCT FACE-TO- FACE ENCOUNTER PRIOR TO RECERTIFICATION OF ELI- GIBILITY FOR HOSPICE CARE DURING EMERGENCY PE- RIOD.—Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
1395f(a)(7)(D)(i)(II)) is amended by striking ‘‘and during the 151-day period beginning on the first day after the end of such emergency period’’ and in- serting ‘‘and, in the case that such emergency period ends before December 31, 2024, during the period beginning on the first day after the end of such emergency period described in such section 1135(g)(1)(B) and ending on 24 December 31, 2024’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3719 (g) STUDY ON TELEHEALTH AND MEDICARE PRO- GRAM INTEGRITY.— (1) IN GENERAL.— (A) STUDY.—The Secretary shall conduct a study using medical record review, as de- scribed in subparagraph (C), on program integ- rity related to telehealth services under part B of title XVIII of the Social Security Act (42 U.S.C.

1395j et seq.).
(B) SCOPE OF STUDY.—In conducting the study under subparagraph (A), the Secretary shall review and analyze information (to the ex- tent that such information is available) on the duration of telehealth services furnished, the types of telehealth services furnished, and, to the extent feasible, the impact of the telehealth services furnished on future utilization of health care services by Medicare beneficiaries, such as the utilization of additional telehealth services or in-person services, including hospitalizations and emergency department visits.
The Sec- retary may also review and analyze information on— (i) any geographic differences in utili- zation of telehealth services; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3720 (ii) documentation of the care and methods of delivery associated with tele- health services; and (iii) other areas, as determined appro- priate by the Secretary.
(C) MEDICAL RECORD REVIEW.—In con- ducting the study under subparagraph (A), the Secretary shall conduct medical record review of a sample of claims for telehealth services with dates of service during the period beginning on January 1, 2022, and ending on December 31, 2024.

For such claims with a date of service during the emergency period described in sec- tion 1135(g)(1)(B) of the Social Security Act (42 U.S.C.
1320b–5(g)(1)(B)), the Secretary shall only conduct medical record review of those claims that have undergone standard pro- gram integrity review (as defined in paragraph (2)(B)), as determined appropriate by the Sec- retary.

(D) REPORTS.— (i) INTERIM REPORT.—Not later than October 1, 2024, the Secretary shall sub- mit to the Committee on Finance of the Senate and the Committee on Energy and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3721 Commerce and the Committee on Ways and Means of the House of Representa- tives an interim report on the study con- ducted under subparagraph (A).

(ii) FINAL REPORT.—Not later than April 1, 2026, the Secretary shall submit to the Committee on Finance of the Senate and the Committee on Energy and Com- merce and the Committee on Ways and Means of the House of Representatives a final report on the study conducted under subparagraph (A).
(2) DEFINITIONS.—In this subsection: (A) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Health and Human Services.

(B) STANDARD PROGRAM INTEGRITY RE- VIEW.—The term ‘‘standard program integrity review’’ refers to the review of any claim that requires a review of the associated medical record by the Secretary to determine the med- ical necessity of the services furnished or to identify potential fraud.
(C) TELEHEALTH SERVICE.—The term ‘‘telehealth service’’ has the meaning given that December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3722 term in section 1834(m)(4)(F) of the Social Se- curity Act (42 U.S.C.

1395(m)(4)(F)).
1395(m)(4)(F)).

(3) FUNDING.—In addition to amounts other- wise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Manage- ment Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $10,000,000, to remain available until expended, for purposes of carrying out this subsection.
(h) PROGRAM INSTRUCTION AUTHORITY.—Notwith- standing any other provision of law, the Secretary of Health and Human Services may implement the provisions of, including amendments made by, this section through program instruction or otherwise.

SEC.

4114.

REVISED PHASE-IN OF MEDICARE CLINICAL LAB- ORATORY TEST PAYMENT CHANGES.

(a) REVISED PHASE-IN OF REDUCTIONS FROM PRI- VATE PAYOR RATE IMPLEMENTATION.—Section 1834A(b)(3) of the Social Security Act (42 U.S.C.
1395m–1(b)(3)) is amended— (1) in subparagraph (A), by striking ‘‘through 2025’’ and inserting ‘‘through 2026’’; and (2) in subparagraph (B)— (A) in clause (ii), by striking ‘‘and 2022’’ and inserting ‘‘through 2023’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3723 (B) in clause (iii), by striking ‘‘2023 through 2025’’ and inserting ‘‘2024 through 2026’’.
(b) REVISED REPORTING PERIOD FOR REPORTING OF PRIVATE SECTOR PAYMENT RATES FOR ESTABLISH- MENT OF MEDICARE PAYMENT RATES.—Section 1834A(a)(1)(B) of the Social Security Act (42 U.S.C.

1395m–1(a)(1)(B)) is amended— (1) in clause (i), by striking ‘‘December 31, 2022’’ and inserting ‘‘December 31, 2023’’; and (2) in clause (ii)— (A) by striking ‘‘January 1, 2023’’ and in- serting ‘‘January 1, 2024’’; and (B) by striking ‘‘March 31, 2023’’ and in- serting ‘‘March 31, 2024’’.
Subtitle C—Medicare Mental Health Provisions SEC.

4121.

COVERAGE OF MARRIAGE AND FAMILY THERA- PIST SERVICES AND MENTAL HEALTH COUN- SELOR SERVICES UNDER PART B OF THE MEDICARE PROGRAM.

(a) COVERAGE OF SERVICES.— (1) IN GENERAL.—Section 1861(s)(2) of the Social Security Act (42 U.S.C.

1395x(s)(2)) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3724 (A) in subparagraph (GG), by striking ‘‘and’’ after the semicolon at the end; (B) in subparagraph (HH), by striking the period at the end and inserting ‘‘; and’’; and (C) by adding at the end the following new subparagraph: ‘‘(II) marriage and family therapist services (as defined in subsection (lll)(1)) and mental health counselor services (as defined in subsection (lll)(3));’’.

(2) DEFINITIONS.—Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended by add- ing at the end the following new subsection: ‘‘(lll) MARRIAGE AND FAMILY THERAPIST SERVICES; MARRIAGE AND FAMILY THERAPIST; MENTAL HEALTH COUNSELOR SERVICES; MENTAL HEALTH COUNSELOR.— ‘‘(1) MARRIAGE AND FAMILY THERAPIST SERV- ICES.—The term ‘marriage and family therapist services’ means services furnished by a marriage and family therapist (as defined in paragraph (2)) for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital), which the marriage and family therapist is legally authorized to perform under State law (or the State regulatory mechanism provided by State December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3725 law) of the State in which such services are fur- nished, as would otherwise be covered if furnished by a physician or as an incident to a physician’s profes- sional service.
‘‘(2) MARRIAGE AND FAMILY THERAPIST.—The term ‘marriage and family therapist’ means an indi- vidual who— ‘‘(A) possesses a master’s or doctor’s de- gree which qualifies for licensure or certification as a marriage and family therapist pursuant to State law of the State in which such individual furnishes the services described in paragraph (1); ‘‘(B) is licensed or certified as a marriage and family therapist by the State in which such individual furnishes such services; ‘‘(C) after obtaining such degree has per- formed at least 2 years of clinical supervised ex- perience in marriage and family therapy; and ‘‘(D) meets such other requirements as specified by the Secretary.
‘‘(3) MENTAL HEALTH COUNSELOR SERV- ICES.—The term ‘mental health counselor services’ means services furnished by a mental health coun- selor (as defined in paragraph (4)) for the diagnosis December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3726 and treatment of mental illnesses (other than serv- ices furnished to an inpatient of a hospital), which the mental health counselor is legally authorized to perform under State law (or the State regulatory mechanism provided by the State law) of the State in which such services are furnished, as would other- wise be covered if furnished by a physician or as in- cident to a physician’s professional service.
‘‘(4) MENTAL HEALTH COUNSELOR.—The term ‘mental health counselor’ means an individual who— ‘‘(A) possesses a master’s or doctor’s de- gree which qualifies for licensure or certification as a mental health counselor, clinical profes- sional counselor, or professional counselor under the State law of the State in which such individual furnishes the services described in paragraph (3); ‘‘(B) is licensed or certified as a mental health counselor, clinical professional counselor, or professional counselor by the State in which the services are furnished; ‘‘(C) after obtaining such a degree has per- formed at least 2 years of clinical supervised ex- perience in mental health counseling; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3727 ‘‘(D) meets such other requirements as specified by the Secretary.’’.

(3) AMOUNT OF PAYMENT.—Section 1833(a)(1) of the Social Security Act (42 U.S.C.
1395l(a)(1)), as amended by section 11101(b) of Public Law 117– 169, is further amended— (A) by striking ‘‘, and (EE)’’ and inserting ‘‘(EE)’’; and (B) by inserting before the semicolon at the end the following: ‘‘and (FF) with respect to marriage and family therapist services and mental health counselor services under section 1861(s)(2)(II), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or 75 percent of the amount deter- mined for payment of a psychologist under sub- paragraph (L)’’.
(4) EXCLUSION OF MARRIAGE AND FAMILY THERAPIST SERVICES AND MENTAL HEALTH COUN- SELOR SERVICES FROM SKILLED NURSING FACILITY PROSPECTIVE PAYMENT SYSTEM.—Section 1888(e)(2)(A)(ii) of the Social Security Act (42 U.S.C.

1395yy(e)(2)(A)(ii)) is amended by inserting ‘‘marriage and family therapist services (as defined in section 1861(lll)(1)), mental health counselor December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3728 services (as defined in section 1861(lll)(3)),’’ after ‘‘qualified psychologist services,’’.

(5) INCLUSION OF MARRIAGE AND FAMILY THERAPISTS AND MENTAL HEALTH COUNSELORS AS PRACTITIONERS FOR ASSIGNMENT OF CLAIMS.—Sec- tion 1842(b)(18)(C) of the Social Security Act (42 U.S.C.

1395u(b)(18)(C)) is amended by adding at the end the following new clauses: ‘‘(vii) A marriage and family therapist (as de- fined in section 1861(lll)(2)).
‘‘(viii) A mental health counselor (as defined in section 1861(lll)(4)).’’.

(b) COVERAGE OF CERTAIN MENTAL HEALTH SERV- ICES PROVIDED IN CERTAIN SETTINGS.— (1) RURAL HEALTH CLINICS AND FEDERALLY QUALIFIED HEALTH CENTERS.—Section 1861(aa)(1)(B) of the Social Security Act (42 U.S.C.
1395x(aa)(1)(B)) is amended by striking ‘‘or by a clinical social worker (as defined in subsection (hh)(1))’’ and inserting ‘‘, by a clinical social worker (as defined in subsection (hh)(1)), by a marriage and family therapist (as defined in subsection (lll)(2)), or by a mental health counselor (as defined in subsection (lll)(4))’’.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3729 (2) HOSPICE PROGRAMS.—Section 1861(dd)(2)(B)(i)(III) of the Social Security Act (42 U.S.C.

1395x(dd)(2)(B)(i)(III)) is amended by in- serting ‘‘, marriage and family therapist, or mental health counselor’’ after ‘‘social worker’’.

(c) EFFECTIVE DATE.—The amendments made by this section shall apply with respect to services furnished on or after January 1, 2024.

SEC.

4122.

ADDITIONAL RESIDENCY POSITIONS.

(a) IN GENERAL.—Section 1886(h) of the Social Se- curity Act (42 U.S.C.
1395ww(h)) is amended— (1) in paragraph (4)(F)(i), by striking ‘‘and (9)’’ and inserting ‘‘(9), and (10)’’; (2) in paragraph (4)(H)(i), by striking ‘‘and (9)’’ and inserting ‘‘(9), and (10)’’; and (3) by adding at the end the following new paragraph: ‘‘(10) DISTRIBUTION OF ADDITIONAL RESI- DENCY POSITIONS IN PSYCHIATRY AND PSYCHIATRY SUBSPECIALTIES.— ‘‘(A) ADDITIONAL RESIDENCY POSI- TIONS.— ‘‘(i) IN GENERAL.—For fiscal year 2026, the Secretary shall, subject to the succeeding provisions of this paragraph, in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3730 crease the otherwise applicable resident limit for each qualifying hospital (as de- fined in subparagraph (F)) that submits a timely application under this subparagraph by such number as the Secretary may ap- prove effective beginning July 1 of the fis- cal year of the increase.

‘‘(ii) NUMBER AVAILABLE FOR DIS- TRIBUTION.—The aggregate number of such positions made available under this paragraph shall be equal to 200.
‘‘(iii) DISTRIBUTION FOR PSYCHIATRY OR PSYCHIATRY SUBSPECIALTY RESIDENCIES.—At least 100 of the posi- tions made available under this paragraph shall be distributed for a psychiatry or psy- chiatry subspecialty residency (as defined in subparagraph (F)).

‘‘(iv) TIMING.—The Secretary shall notify hospitals of the number of positions distributed to the hospital under this para- graph as a result of an increase in the oth- erwise applicable resident limit by January 31 of the fiscal year of the increase.
Such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3731 increase shall be effective beginning July 1 of such fiscal year.
‘‘(B) DISTRIBUTION.—For purposes of providing an increase in the otherwise applica- ble resident limit under subparagraph (A), the following shall apply: ‘‘(i) CONSIDERATIONS IN DISTRIBU- TION.—In determining for which qualifying hospitals such an increase is provided under subparagraph (A), the Secretary shall take into account the demonstrated likelihood of the hospital filling the posi- tions made available under this paragraph within the first 5 training years beginning after the date the increase would be effec- tive, as determined by the Secretary.
‘‘(ii) MINIMUM DISTRIBUTION FOR CERTAIN CATEGORIES OF HOSPITALS.— With respect to the aggregate number of such positions available for distribution under this paragraph, the Secretary shall distribute not less than 10 percent of such aggregate number to each of the following categories of hospitals: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3732 ‘‘(I) Hospitals that are located in a rural area (as defined in section 1886(d)(2)(D)) or are treated as being located in a rural area pursuant to section 1886(d)(8)(E).

‘‘(II) Hospitals in which the ref- erence resident level of the hospital (as specified in subparagraph (F)(iii)) is greater than the otherwise applica- ble resident limit.
‘‘(III) Hospitals in States with— ‘‘(aa) new medical schools that received ‘Candidate School’ status from the Liaison Com- mittee on Medical Education or that received ‘Pre-Accreditation’ status from the American Osteo- pathic Association Commission on Osteopathic College Accredita- tion on or after January 1, 2000, and that have achieved or con- tinue to progress toward ‘Full Accreditation’ status (as such term is defined by the Liaison Committee on Medical Edu- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3733 cation) or toward ‘Accreditation’ status (as such term is defined by the American Osteopathic As- sociation Commission on Osteo- pathic College Accreditation); or ‘‘(bb) additional locations and branch campuses established on or after January 1, 2000, by medical schools with ‘Full Ac- creditation’ status (as such term is defined by the Liaison Com- mittee on Medical Education) or ‘Accreditation’ status (as such term is defined by the American Osteopathic Association Commis- sion on Osteopathic College Ac- creditation).
‘‘(IV) Hospitals that serve areas designated as health professional shortage areas under section 332(a)(1)(A) of the Public Health Service Act, as determined by the Sec- retary.

‘‘(iii) PRO RATA APPLICATION.—The Secretary shall ensure that each qualifying December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3734 hospital that submits a timely application under subparagraph (A) receives at least 1 (or a fraction of 1) of the positions made available under this paragraph before any qualifying hospital receives more than 1 of such positions.

‘‘(C) REQUIREMENTS.— ‘‘(i) LIMITATION.—A hospital may not receive more than 10 additional full-time equivalent residency positions under this paragraph.
‘‘(ii) PROHIBITION ON DISTRIBUTION TO HOSPITALS WITHOUT AN INCREASE AGREEMENT.—No increase in the other- wise applicable resident limit of a hospital may be made under this paragraph unless such hospital agrees to increase the total number of full-time equivalent residency positions under the approved medical resi- dency training program of such hospital by the number of such positions made avail- able by such increase under this para- graph.
‘‘(iii) REQUIREMENT FOR HOSPITALS TO EXPAND PROGRAMS.—If a hospital that December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3735 receives an increase in the otherwise appli- cable resident limit under this paragraph would be eligible for an adjustment to the otherwise applicable resident limit for par- ticipation in a new medical residency train- ing program under section 413.79(e)(3) of title 42, Code of Federal Regulations (or any successor regulation), the hospital shall ensure that any positions made avail- able under this paragraph are used to ex- pand an existing program of the hospital, and not for participation in a new medical residency training program.
‘‘(D) APPLICATION OF PER RESIDENT AMOUNTS FOR NONPRIMARY CARE.—With re- spect to additional residency positions in a hos- pital attributable to the increase provided under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for nonprimary care com- puted under paragraph (2)(D) for that hospital.
‘‘(E) PERMITTING FACILITIES TO APPLY AGGREGATION RULES.—The Secretary shall permit hospitals receiving additional residency positions attributable to the increase provided December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3736 under this paragraph to, beginning in the fifth year after the effective date of such increase, apply such positions to the limitation amount under paragraph (4)(F) that may be aggre- gated pursuant to paragraph (4)(H) among members of the same affiliated group.
‘‘(F) DEFINITIONS.—In this paragraph: ‘‘(i) OTHERWISE APPLICABLE RESI- DENT LIMIT.—The term ‘otherwise appli- cable resident limit’ means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph but taking into account para- graphs (7)(A), (7)(B), (8)(A), (8)(B), and (9)(A).
‘‘(ii) PSYCHIATRY OR PSYCHIATRY SUBSPECIALTY RESIDENCY.—The term ‘psychiatry or psychiatry subspecialty resi- dency’ means a residency in psychiatry as accredited by the Accreditation Council for Graduate Medical Education for the pur- pose of preventing, diagnosing, and treat- ing mental health disorders.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3737 ‘‘(iii) QUALIFYING HOSPITAL.—The term ‘qualifying hospital’ means a hospital described in any of subclauses (I) through (IV) of subparagraph (B)(ii).
‘‘(iv) REFERENCE RESIDENT LEVEL.—The term ‘reference resident level’ means, with respect to a hospital, the resident level for the most recent cost re- porting period of the hospital ending on or before the date of enactment of this para- graph, for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.

‘‘(v) RESIDENT LEVEL.—The term ‘resident level’ has the meaning given such term in paragraph (7)(C)(i).’’.
(b) IME.—Section 1886(d)(5)(B) of the Social Secu- rity Act (42 U.S.C.

1395ww(d)(5)(B)) is amended— (1) in clause (v), in the third sentence, by strik- ing ‘‘and (h)(9)’’ and inserting ‘‘(h)(9), and (h)(10)’’; (2) by moving clause (xii) 4 ems to the left; and (3) by adding at the end the following new clause: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3738 ‘‘(xiii) For discharges occurring on or after July 1, 2026, insofar as an additional payment amount under this subparagraph is attributable to resident positions distributed to a hospital under subsection (h)(10), the indirect teaching adjustment factor shall be computed in the same manner as pro- vided under clause (ii) with respect to such resident positions.’’.

(c) PROHIBITION ON JUDICIAL REVIEW.—Section 1886(h)(7)(E) of the Social Security Act (42 U.S.C.
1395ww—4(h)(7)(E)) is amended by inserting ‘‘para- graph (10),’’ after ‘‘paragraph (8),’’.

SEC.

4123.

IMPROVING MOBILE CRISIS CARE IN MEDICARE.

(a) PAYMENT FOR PSYCHOTHERAPY FOR CRISIS SERVICES FURNISHED IN AN APPLICABLE SITE OF SERV- ICE.— (1) IN GENERAL.—Section 1848(b) of the So- cial Security Act (42 U.S.C.
1395w–4(b)) is amend- ed by adding at the end the following new para- graph: ‘‘(12) PAYMENT FOR PSYCHOTHERAPY FOR CRI- SIS SERVICES FURNISHED IN AN APPLICABLE SITE OF SERVICE.— ‘‘(A) IN GENERAL.—The Secretary shall establish new HCPCS codes under the fee December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3739 schedule established under this subsection for services described in subparagraph (B) that are furnished on or after January 1, 2024.

‘‘(B) SERVICES DESCRIBED.—The services described in this subparagraph are psycho- therapy for crisis services that are a furnished in an applicable site of service.
‘‘(C) AMOUNT OF PAYMENT.—For services described in subparagraph (B) that are fur- nished to an individual in a year (beginning with 2024), in lieu of the fee schedule amount that would otherwise be determined under this subsection for such year, the fee schedule amount for such services for such year shall be equal to 150 percent of the fee schedule amount for non-facility sites of service for such year de- termined for services identified, as of January 1, 2022, by HCPCS codes 90839 and 90840 (and any succeeding codes).
‘‘(D) DEFINITIONS.—In this paragraph: ‘‘(i) APPLICABLE SITE OF SERVICE.— The term ‘applicable site of service’ means a site of service other than a site where the facility rate under the fee schedule under December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3740 this subsection applies and other than an office setting.
‘‘(ii) PSYCHOTHERAPY FOR CRISIS SERVICES.—The code descriptions for serv- ices described in subparagraph (B) shall be the same as the code descriptions for serv- ices identified, as of January 1, 2022, by HCPCS codes 90839 and 90840 (and any succeeding codes), except that such new codes shall be limited to services furnished in an applicable site of service.’’.

(2) WAIVER OF BUDGET NEUTRALITY.—Section 1848(c)(2)(B)(iv) of such Act (42 U.S.C.
1395w– 4(c)(2)(B)(iv)) is amended— (A) in subclause (IV), by striking ‘‘and’’ at the end; (B) in subclause (V), by striking the period at the end and inserting ‘‘; and’’ and (C) by adding at the end the following new subclause: ‘‘(VI) subsection (b)(12) shall not be taken into account in applying clause (ii)(II) for 2024.’’.
(b) EDUCATION AND OUTREACH.—Not later than January 1, 2024, the Secretary shall use existing commu- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3741 nications mechanisms to provide education and outreach to stakeholders with respect to the ability of health profes- sionals to bill for psychotherapy for crisis services under the Medicare physician fee schedule under section 1848 of the Social Security Act (42 U.S.C.

1395w–4) when such services are furnished in an applicable site of service to a Medicare beneficiary who is experiencing a mental or behavioral health crisis.
(c) OPEN DOOR FORUM.—Not later than January 1, 2024, the Secretary shall convene stakeholders and ex- perts for an open door forum or other appropriate mecha- nism to discuss current Medicare program coverage and payment policies for services that can be furnished to pro- vide care to a Medicare beneficiary who is experiencing a mental or behavioral health crisis.
(d) EDUCATION AND OUTREACH ON THE USE OF PEER SUPPORT SPECIALISTS AND OTHER AUXILIARY PERSONNEL IN FURNISHING OF PSYCHOTHERAPY FOR CRISIS SERVICES AND BEHAVIORAL HEALTH INTEGRA- TION SERVICES.—Not later than January 1, 2024, the Secretary shall use existing communication mechanisms to provide education and outreach to providers of services, physicians, and practitioners with respect to the ability of auxiliary personnel, including peer support specialists, to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3742 participate, consistent with applicable requirements for auxiliary personnel, in the furnishing of— (1) psychotherapy for crisis services billed under the Medicare physician fee schedule under section 1848 of the Social Security Act (42 U.S.C.

1395w–4), as well as other services that can be fur- nished to a Medicare beneficiary experiencing a men- tal or behavioral health crisis; and (2) behavioral health integration services.
(e) DEFINITIONS.—In this section: (1) APPLICABLE SITE OF SERVICE.—The term ‘‘applicable site of service’’ has the meaning given that term in section 1848(b)(12)(D)(i) of the Social Security Act, as added by subsection (a).

(2) BEHAVIORAL HEALTH INTEGRATION SERV- ICES.—The term ‘‘behavioral health integration serv- ices’’ means services identified, as of January 1, 2022, by HCPCS codes 99484, 99492, 99493, 99494, and G2214 (and any successor or similar codes as determined appropriate by the Secretary).
(3) PSYCHOTHERAPY FOR CRISIS SERVICES.— The term ‘‘psychotherapy for crisis services’’ means services described in 1848(b)(12)(D)(ii) of the Social Security Act, as added by subsection (a).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3743 (4) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Health and Human Services.

SEC.

4124.
SEC.

4124.

ENSURING ADEQUATE COVERAGE OF OUT- PATIENT MENTAL HEALTH SERVICES UNDER THE MEDICARE PROGRAM.

(a) MODIFICATION OF DEFINITION OF PARTIAL HOS- PITALIZATION SERVICES.—Section 1861(ff)(1) of the So- cial Security Act (42 U.S.C.

1395x(ff)(1)) is amended by inserting ‘‘for an individual determined (not less fre- quently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week’’ after 12 ‘‘prescribed by a physician’’.
13 (b) COVERAGE OF INTENSIVE OUTPATIENT SERV- 14 ICES.— (1) SCOPE OF BENEFITS.— (A) COMMUNITY MENTAL HEALTH CEN- TERS.—Section 1832(a)(2)(J) of the Social Se- curity Act (42 U.S.C.

1395k(a)(2)(J)) is amended by inserting ‘‘and intensive outpatient services’’ after ‘‘partial hospitalization serv- ices’’.

(B) INCIDENT-TO SERVICES.—Section 1861(s)(2)(B) is amended by inserting ‘‘or in- tensive outpatient services’’ after ‘‘partial hos- pitalization services’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3744 (2) DEFINITION.—Section 1861(ff) of the So- cial Security Act (42 U.S.C.
1395x(ff)) is amend- ed— (A) in the header, by inserting ‘‘; Intensive Outpatient Services’’ after ‘‘Partial Hospitaliza- tion Services’’; and (B) by adding at the end the following new paragraph: ‘‘(4) The term ‘intensive outpatient services’ has the meaning given the term ‘partial hospitalization services’ in paragraph (1), except that— ‘‘(A) section 1835(a)(2)(F)(i) shall not apply; ‘‘(B) the reference in such paragraph to an in- dividual ‘determined (not less frequently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week’ shall be treated as a reference to an individual ‘deter- mined (not less frequently than once every other month) by a physician to have a need for such serv- ices for a minimum of 9 hours per week’; and ‘‘(C) the reference to ‘a community mental health center (as defined in subparagraph (B))’ in paragraph (3) shall be treated as a reference to ‘a community mental health center (as defined in sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3745 paragraph (B)), a Federally qualified health center, or a rural health clinic’.’’.

(3) EXCLUSION FROM CALCULATION OF CER- TAIN TREATMENT COSTS.—Section 1833(c)(2) of the Social Security Act (42 U.S.C.

1395l(c)(2)) is amended by inserting ‘‘or intensive outpatient serv- ices’’ after ‘‘partial hospitalization services’’.

(4) CONFORMING AMENDMENTS.— (A) INTENSIVE OUTPATIENT SERVICES.— Section 1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa)) is amended— (i) in paragraph (1)— (I) in subparagraph (B), by striking ‘‘and’’ at the end; (II) in subparagraph (C), by add- ing ‘‘and’’ at the end; and (III) by inserting after subpara- graph (C) the following new subpara- graph: ‘‘(D) intensive outpatient services (as defined in section 1861(ff)(4)),’’; and (ii) in paragraph (3), by striking ‘‘through (C)’’ and inserting ‘‘through (D)’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3746 (B) PROVIDER OF SERVICES.—Section 1866(e)(2) of the Social Security Act (42 U.S.C.

1395cc(e)(2)) is amended by inserting ‘‘, or intensive outpatient services (as described in section 1861(ff)(4))’’ after ‘‘partial hospitaliza- tion services (as described in section 1861(ff)(1))’’.
(c) SPECIAL PAYMENT RULE FOR FQHCS AND RHCS.—Section 1834 of the Social Security Act (42 U.S.C.
1395m) is amended— (1) in subsection (o), by adding at the end the following new paragraph: ‘‘(5) SPECIAL PAYMENT RULE FOR INTENSIVE OUTPATIENT SERVICES.— ‘‘(A) IN GENERAL.—In the case of inten- sive outpatient services furnished by a Federally qualified health center, the payment amount for such services shall be equal to the amount that would have been paid under this title for such services had such services been covered OPD services furnished by a hospital.
‘‘(B) EXCLUSION.—Costs associated with intensive outpatient services shall not be used to determine the amount of payment for Feder- ally qualified health center services under the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3747 prospective payment system under this sub- section.’’; and (2) in subsection (y)— (A) in the header, by striking ‘‘TO HOS- PICE PATIENTS’’; and (B) by adding at the end the following new paragraph: ‘‘(3) SPECIAL PAYMENT RULE FOR INTENSIVE OUTPATIENT SERVICES.— ‘‘(A) IN GENERAL.—In the case of inten- sive outpatient services furnished by a rural health clinic, the payment amount for such services shall be equal to the amount that would have been paid under this title for such services had such services been covered OPD services furnished by a hospital.
‘‘(B) EXCLUSION.—Costs associated with intensive outpatient services shall not be used to determine the amount of payment for rural health clinic services under the methodology for all-inclusive rates (established by the Secretary) under section 1833(a)(3).’’.

(d) EFFECTIVE DATE.—The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2024.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3748 SEC.

4125.

IMPROVEMENTS TO MEDICARE PROSPECTIVE PAYMENT SYSTEM FOR PSYCHIATRIC HOS- PITALS AND PSYCHIATRIC UNITS.

(a) IMPROVEMENTS THROUGH ADDITIONAL CLAIMS DATA.—Section 1886(s) of the Social Security Act (42 U.S.C.
1395ww(s)) is amended by adding at the end the following new paragraph: ‘‘(5) ADDITIONAL DATA AND INFORMATION.— ‘‘(A) IN GENERAL.—The Secretary shall collect data and information as the Secretary determines appropriate to revise payments under the system described in paragraph (1) for psychiatric hospitals and psychiatric units pur- suant to subparagraph (D) and for other pur- poses as determined appropriate by the Sec- retary.
The Secretary shall begin to collect such data by not later than October 1, 2023.
‘‘(B) DATA AND INFORMATION.—The data and information to be collected under subpara- graph (A) may include— ‘‘(i) charges, including those related to ancillary services; ‘‘(ii) the required intensity of behav- ioral monitoring, such as cognitive deficit, suicide ideations, violent behavior, and need for physical restraint; and 26 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3749 ‘‘(iii) interventions, such as detoxifica- tion services for substance abuse, depend- ence on respirator, total parenteral nutri- tional support, dependence on renal dialy- sis, and burn care.

‘‘(C) METHOD OF COLLECTION.—The Sec- retary may collect the additional data and infor- mation under subparagraph (A) on cost reports, on claims, or otherwise.
‘‘(D) REVISIONS TO PAYMENT RATES.— ‘‘(i) IN GENERAL.—Notwithstanding the preceding paragraphs of this sub- section or section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, for rate year 2025 (and for any subsequent rate year, if determined appropriate by the Secretary), the Secretary shall, by regulation, imple- ment revisions to the methodology for de- termining the payment rates under the system described in paragraph (1) for psy- chiatric hospitals and psychiatric units, as the Secretary determines to be appropriate.
Such revisions may be based on a review of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3750 data and information collected under sub- paragraph (A).
‘‘(ii) REVIEW.—The Secretary may make revisions to the diagnosis-related group classifications, in accordance with subsection (d)(4)(C), to reflect nursing and staff resource use and costs involved in furnishing services at such hospitals and units, including considerations for patient complexity and prior admission to an inpa- tient psychiatric facility, which may be based on review of data and information collected under subparagraph (A), as the Secretary determines to be appropriate.
‘‘(iii) BUDGET NEUTRALITY.—Revi- sions in payment implemented pursuant to clause (i) for a rate year shall result in the same estimated amount of aggregate ex- penditures under this title for psychiatric hospitals and psychiatric units furnished in the rate year as would have been made under this title for such care in such rate year if such revisions had not been imple- mented.’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3751 (b) IMPROVEMENTS THROUGH STANDARDIZED PA- TIENT ASSESSMENT DATA.—Section 1886(s) of the Social Security Act (42 U.S.C.
1395ww(s)), as amended by sub- section (a), is further amended— (1) in paragraph (4)— (A) in subparagraph (A)(i), by striking ‘‘subparagraph (C)’’ and inserting ‘‘subpara- graphs (C) and (E)’’; (B) by redesignating subparagraph (E) as subparagraph (F); (C) by inserting after subparagraph (D) the following new subparagraph: ‘‘(E) STANDARDIZED PATIENT ASSESS- MENT DATA.— ‘‘(i) IN GENERAL.—For rate year 2028 and each subsequent rate year, in ad- dition to such data on the quality measures described in subparagraph (C), each psy- chiatric hospital and psychiatric unit shall submit to the Secretary, through the use of a standardized assessment instrument im- plemented under clause (iii), the standard- ized patient assessment data described in clause (ii).
Such data shall be submitted with respect to admission and discharge of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3752 an individual (and may be submitted more frequently as the Secretary determines ap- propriate).
‘‘(ii) STANDARDIZED PATIENT AS- SESSMENT DATA DESCRIBED.—For pur- poses of clause (i), the standardized pa- tient assessment data described in this clause, with respect to a psychiatric hos- pital or psychiatric unit, is data with re- spect to the following categories: ‘‘(I) Functional status, such as mobility and self-care at admission to a psychiatric hospital or unit and be- fore discharge from a psychiatric hos- pital or unit.
‘‘(II) Cognitive function, such as ability to express ideas and to under- stand, and mental status, such as de- pression and dementia.

‘‘(III) Special services, treat- ments, and interventions for psy- chiatric conditions.

‘‘(IV) Medical conditions and co- morbidities, such as diabetes, conges- tive heart failure, and pressure ulcers.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3753 ‘‘(V) Impairments, such as incon- tinence and an impaired ability to hear, see, or swallow.

‘‘(VI) Other categories as deter- mined appropriate by the Secretary.
‘‘(iii) STANDARDIZED ASSESSMENT IN- STRUMENT.— ‘‘(I) IN GENERAL.—For purposes of clause (i), the Secretary shall im- plement a standardized assessment in- strument that provides for the sub- mission of standardized patient as- sessment data under this title with re- spect to psychiatric hospitals and psy- chiatric units which enables compari- son of such assessment data across all such hospitals and units to which such data are applicable.
‘‘(II) FUNDING.—The Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1817 to the Cen- ters for Medicare & Medicaid Services Program Management Account, of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3754 $10,000,000 for purposes of carrying out subclause (I).’’; and (D) in subparagraph (F), as redesignated by subparagraph (B) of this paragraph, by striking ‘‘subparagraph (C)’’ and inserting ‘‘subparagraphs (C) and (F)’’; and (2) by adding at the end the following new paragraph: ‘‘(6) ADDITIONAL CONSIDERATIONS FOR DIAG- NOSIS-RELATED GROUP CLASSIFICATIONS.— ‘‘(A) IN GENERAL.—Notwithstanding the preceding paragraphs of this subsection (other than paragraph (5)) or section 124 of the Medi- care, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, beginning not later than rate year 2031, in addition to any revi- sions pursuant to paragraph (5), the Secretary shall, by regulation, implement revisions to the methodology for determining the payment rates under the system described in paragraph (1) for psychiatric hospitals and psychiatric units, as the Secretary determines to be appropriate, to take into account the patient assessment data described in paragraph (4)(E)(ii).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3755 ‘‘(B) BUDGET NEUTRALITY.—Revisions in payment implemented pursuant to subpara- graph (A) for a rate year shall result in the same estimated amount of aggregate expendi- tures under this title for psychiatric hospitals and psychiatric units furnished in the rate year as would have been made under this title for such care in such rate year if such revisions had not been implemented.’’.
(c) IMPROVEMENTS THROUGH INCLUSION OF PA- TIENTS’ PERSPECTIVE ON CARE QUALITY MEASURE.— Section 1886(s)(4) of the Social Security Act (42 U.S.C.
1395ww(s)(4)) is amended— (1) in subparagraph (D), by adding at the end the following new clause: ‘‘(iv) PATIENTS’ PERSPECTIVE ON CARE.—Not later than for rate year 2031, the quality measures specified under this subparagraph shall include a quality meas- ure of patients’ perspective on care.’’; and (2) in subparagraph (E), by inserting ‘‘, includ- ing the quality measure of patients’ perspective on care described in subparagraph (D)(iv),’’ after ‘‘shall report quality measures’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3756 SEC.

4126.

EXCEPTION FOR PHYSICIAN WELLNESS PRO- GRAMS.

(a) IN GENERAL.—Section 1877(e) of the Social Se- curity Act (42 U.S.C.
1395nn(e)) is amended by adding at the end the following: ‘‘(9) PHYSICIAN WELLNESS PROGRAMS.—A bona fide mental health or behavioral health im- provement or maintenance program offered to a phy- sician by an entity, if— ‘‘(A) such program— ‘‘(i) consists of counseling, mental health services, a suicide prevention pro- gram, or a substance use disorder preven- tion and treatment program; ‘‘(ii) is made available to a physician for the primary purpose of preventing sui- cide, improving mental health and resil- iency, or providing training in appropriate strategies to promote the mental health and resiliency of such physician; ‘‘(iii) is set out in a written policy, ap- proved in advance of the operation of the program by the governing body of the enti- ty providing such program (and which shall be updated accordingly in advance to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3757 substantial changes to the operation of such program), that includes— ‘‘(I) a description of the content and duration of the program; ‘‘(II) a description of the evi- dence-based support for the design of the program; ‘‘(III) the estimated cost of the program; ‘‘(IV) the personnel (including the qualifications of such personnel) conducting the program; and ‘‘(V) the method by which such entity will evaluate the use and suc- cess of the program; ‘‘(iv) is offered by an entity described in subparagraph (B) with a formal medical staff to all physicians who practice in the geographic area served by such entity, in- cluding physicians who hold bona fide ap- pointments to the medical staff of such en- tity or otherwise have clinical privileges at such entity; ‘‘(v) is offered to all such physicians on the same terms and conditions and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3758 without regard to the volume or value of referrals or other business generated by a physician for such entity; ‘‘(vi) is evidence-based and conducted by a qualified health professional; and ‘‘(vii) meets such other requirements the Secretary may impose by regulation as needed to protect against program or pa- tient abuse; ‘‘(B) such entity is— ‘‘(i) a hospital; ‘‘(ii) an ambulatory surgical center; ‘‘(iii) a community health center; ‘‘(iv) a rural emergency hospital; ‘‘(v) a rural health clinic; ‘‘(vi) a skilled nursing facility; or ‘‘(vii) a similar entity, as determined by the Secretary; and ‘‘(C) neither the provision of such pro- gram, nor the value of such program, are con- tingent upon the number or value of referrals made by a physician to such entity or the amount or value of other business generated by such physician for the entity.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3759 (b) EXCEPTION UNDER THE ANTI-KICKBACK STAT- UTE.—Section 1128B(b)(3) of the Social Security Act (42 U.S.C.
1320a–7b(b)(3)) is amended— (1) in subparagraph (J), by striking ‘‘and’’ at the end; (2) in subparagraph (K), by striking the period at the end and inserting ‘‘; and’’; and (3) by adding at the end the following: ‘‘(L) a bona fide mental health or behavioral health improvement or maintenance program, if— ‘‘(i) such program— ‘‘(I) consists of counseling, mental health services, a suicide prevention pro- gram, or a substance use disorder preven- tion and treatment program; ‘‘(II) is made available to a physician or other clinician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in appropriate strategies to promote the mental health and resiliency of such physi- cian or other clinician; ‘‘(III) is set out in a written policy, approved in advance of the operation of the program by the governing body of the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3760 entity providing such program (and which shall be updated accordingly in advance to substantial changes to the operation of such program), that includes— ‘‘(aa) a description of the content and duration of the program; ‘‘(bb) a description of the evi- dence-based support for the design of the program; ‘‘(cc) the estimated cost of the program; ‘‘(dd) the personnel (including the qualifications of such personnel) implementing the program; and ‘‘(ee) the method by which such entity will evaluate the use and suc- cess of the program; ‘‘(IV) is offered by an entity described in clause (ii) with a formal medical staff to all physicians and other clinicians who practice in the geographic area served by such entity, including physicians who hold bona fide appointments to the medical staff of such entity or otherwise have clin- ical privileges at such entity; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3761 ‘‘(V) is offered to all such physicians and clinicians on the same terms and con- ditions and without regard to the volume or value of referrals or other business gen- erated by a physician or clinician for such entity; ‘‘(VI) is evidence-based and conducted by a qualified health professional; and ‘‘(VII) meets such other requirements the Secretary may impose by regulation as needed to protect against program or pa- tient abuse; ‘‘(ii) such entity is— ‘‘(I) a hospital; ‘‘(II) an ambulatory surgical center; ‘‘(III) a community health center; ‘‘(IV) a rural emergency hospital; ‘‘(V) a skilled nursing facility; or ‘‘(VI) any similar entity, as deter- mined by the Secretary; and ‘‘(iii) neither the provision of such pro- gram, nor the value of such program, are con- tingent upon the number or value of referrals made by a physician or other clinician to such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3762 entity or the amount or value of other business generated by such physician for the entity.’’.

SEC.

4127.

CONSIDERATION OF SAFE HARBOR UNDER THE ANTI-KICKBACK STATUTE FOR CERTAIN CON- TINGENCY MANAGEMENT INTERVENTIONS.

Section 1128D(a) of the Social Security Act (42 U.S.C.
1320a–7d(a)) is amended by adding at the end the following new paragraph: ‘‘(3) CONSIDERATION OF SAFE HARBOR FOR CERTAIN CONTINGENCY MANAGEMENT INTERVEN- TIONS.— ‘‘(A) IN GENERAL.—Not later than one year after the date of the enactment of this paragraph, the Inspector General shall conduct a review on whether to establish a safe harbor described in paragraph (1)(A)(ii) for evidence- based contingency management incentives and the parameters for such a safe harbor.
In con- ducting the review under the previous sentence, the Inspector General shall consider the extent to which providing such a safe harbor for evi- dence-based contingency management incentives may result in any of the factors described in paragraph (2).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3763 ‘‘(B) REPORT.—Not later than two years after the date of the enactment of this para- graph, the Secretary and the Inspector General shall submit to Congress recommendations, in- cluding based on the review conducted under subparagraph (A), for improving access to evi- dence-based contingency management interven- tions while ensuring quality of care, ensuring fi- delity to evidence-based practices, and including strong program integrity safeguards that pre- vent increased waste, fraud, and abuse and pre- vent medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care program.’’.
SEC.

4128.

PROVIDER OUTREACH AND REPORTING ON CER- TAIN BEHAVIORAL HEALTH INTEGRATION SERVICES.

(a) OUTREACH.—The Secretary of Health and Human Services (in this section referred to as the ‘‘Sec- retary’’) shall conduct outreach to physicians and appro- priate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C.

1395 et seq.)
1395 et seq.)

with respect to behavioral health integration services described by any of HCPCS codes 99492 through 99494 or 99484 (or any successor December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3764 code).
3764 code).

Such outreach shall include a comprehensive, one- time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements to bill for such codes and the require- ments for beneficiary eligibility for such services.
(b) REPORTS TO CONGRESS.— (1) PROVIDER OUTREACH.—Not later than 1 year after the date of the completion of the edu- cation initiative described in subsection (a), the Sec- retary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection.

Such report shall include a description of the methods used for such outreach.
(2) UTILIZATION RATES.—Not later than 18 months after the date of the completion of the edu- cation initiative described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Rep- resentatives and the Committee on Finance of the Senate a report on the number of Medicare bene- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3765 ficiaries (including those beneficiaries accessing serv- ices in rural and underserved areas) who, during the preceding year, were furnished services described in subsection (a) for which payment was made under title XVIII of the Social Security Act (42 U.S.C.

1395 et seq.).

SEC.

4129.

OUTREACH AND REPORTING ON OPIOID USE DISORDER TREATMENT SERVICES FUR- NISHED BY OPIOID TREATMENT PROGRAMS.
(a) OUTREACH.— (1) PROVIDER OUTREACH.—The Secretary of Health and Human Services (in this section referred to as the ‘‘Secretary’’) shall conduct outreach to physicians and appropriate non-physician practi- tioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C.

1395 et seq.)

with respect to opioid use dis- order treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C.

1395x(jjj))).
1395x(jjj))).

Such outreach shall include a comprehensive, one- time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, in- cluding describing the requirements for billing and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3766 the requirements for beneficiary eligibility for such services.
(2) BENEFICIARY OUTREACH.—The Secretary shall conduct outreach to Medicare beneficiaries with respect to opioid use disorder treatment services fur- nished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C.

1395x(jjj))), including a comprehensive, one- time education initiative informing such beneficiaries about the eligibility requirements to receive such services.
(b) REPORTS TO CONGRESS.— (1) OUTREACH.—Not later than 1 year after the date of the completion of the education initia- tives described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Fi- nance of the Senate a report on the outreach con- ducted under such subsection.

Such report shall in- clude a description of the methods used for such outreach.
(2) UTILIZATION RATES.—Not later than 18 months after the date of the completion of the edu- cation initiatives described in subsection (a), and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3767 two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Com- mittee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who, during the preceding year, were furnished opioid use disorder treatment services by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C.
1395x(jjj))) for which payment was made under title XVIII of such Act (42 U.S.C.

1395 et seq.).

SEC.

4130.

GAO STUDY AND REPORT COMPARING COV- ERAGE OF MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS AND NON-MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS.
(a) STUDY.— (1) IN GENERAL.—The Comptroller General of the United States (in this section referred to as the ‘‘Comptroller General’’) shall conduct a study that compares the mental health and substance use dis- order benefits offered by Medicare Advantage plans (including specialized MA plans for special needs in- dividuals, as defined in section 1859(b)(6) of the So- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3768 cial Security Act (42 U.S.C.

1395w–28(b)(6)) under part C of title XVIII of such Act with— (A) benefits (other than mental health and substance use disorder benefits) offered by such Medicare Advantage plans; and (B) the mental health and substance use disorder benefits under the original Medicare fee-for-service program under parts A and B of such title XVIII.
(2) ANALYSIS.—To the extent data is available and reliable, the study under paragraph (1) shall in- clude an analysis of— (A) out-of-pocket expenses for in-network care; (B) the use of prior authorization and other utilization management tools; (C) the mental health and substance use disorder benefits offered; and (D) other items determined appropriate by the Comptroller General.
(3) PLAN AND SERVICE SPECIFIC.—To the ex- tent practicable, the study under paragraph (1) shall examine differences by type of Medicare Advantage plan and type of item or service.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3769 (4) BOTH REQUIRED AND SUPPLEMENTAL BEN- EFITS.—For purposes of the study under paragraph (1), benefits offered by Medicare Advantage plans (including specialized MA plans for special needs in- dividuals) under part C of title XVIII of the Social Security Act shall include both and differentiate be- tween— (A) benefits under the original Medicare fee-for-service program, as described in section 1852(a)(1)(B) of such Act (42 U.S.C.
1395w– 22(a)(1)(B)); and (B) supplemental health care benefits, as described in section 1852(a)(3)(A) of such Act (42 U.S.C.

1395w–22(a)(3)(A)).

(b) REPORT.—Not later than 30 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under subsection (a).

19 Subtitle D—Other Medicare Provisions SEC.

4131.
4131.

TEMPORARY INCLUSION OF AUTHORIZED ORAL ANTIVIRAL DRUGS AS COVERED PART D DRUG.

Section 1860D–2(e)(1) of the Social Security Act (42 U.S.C.

1395w–102(e)(1)) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3770 (1) in subparagraph (A), by striking at the end ‘‘or’’; (2) in subparagraph (B), by striking the comma at the end and inserting ‘‘; or’’; and (3) by inserting after subparagraph (B) the fol- lowing new subparagraph: ‘‘(C) for the period beginning on the date of the enactment of this subparagraph and end- ing on December 31, 2024, an oral antiviral drug that may be dispensed only upon a pre- scription and is authorized under section 564 of the Federal Food, Drug, and Cosmetic Act, on the basis of the declaration published in the Federal Register by the Secretary of Health and Human Services on April 1, 2020 (85 Fed.
Reg.

18250 et seq.),’’.

SEC.

4132.

RESTORATION OF CBO ACCESS TO CERTAIN PART D PAYMENT DATA.

Section 1860D–15(f)(2) of the Social Security Act (42 U.S.C.

1395w–115(f)(2)) is amended— (1) in subparagraph (B), by striking at the end ‘‘and’’; (2) in subparagraph (C), by striking at the end the period and inserting ‘‘; and’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3771 (3) by adding at the end the following new sub- paragraph: ‘‘(D) by the Director of the Congressional Budget Office for the purposes of analysis of programs authorized under the Social Security Act, as applicable, and the fulfilment of such Director’s duties under the Congressional Budget and Impoundment Control Act of 1974.’’.

SEC.

4133.

MEDICARE COVERAGE OF CERTAIN LYMPHEDEMA COMPRESSION TREATMENT ITEMS.

(a) COVERAGE.— (1) IN GENERAL.—Section 1861 of the Social Security Act (42 U.S.C.
1395x), as amended by sec- tion 4121(a), is amended— (A) in subsection (s)(2)— (i) in subparagraph (HH), by striking ‘‘and’’ after the semicolon at the end; (ii) in subparagraph (II), by striking the period at the end and inserting ‘‘; and’’; and (iii) by adding at the end the fol- lowing new subparagraph: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3772 ‘‘(JJ) lymphedema compression treatment items (as defined in subsection (mmm));’’; and (B) by adding at the end the following new subsection: ‘‘(mmm) LYMPHEDEMA COMPRESSION TREATMENT ITEMS.—The term ‘lymphedema compression treatment items’ means standard and custom fitted gradient com- pression garments and other items determined by the Sec- retary that are— ‘‘(1) furnished on or after January 1, 2024, to an individual with a diagnosis of lymphedema for the treatment of such condition; ‘‘(2) primarily and customarily used to serve a medical purpose and for the treatment of lymphedema, as determined by the Secretary; and ‘‘(3) prescribed by a physician (or a physician assistant, nurse practitioner, or a clinical nurse spe- cialist (as those terms are defined in section 1861(aa)(5)) to the extent authorized under State law).’’.
(2) PAYMENT.— (A) IN GENERAL.—Section 1833(a)(1) of the Social Security Act (42 U.S.C.

1395l(a)(1)) , as amended by section 4121(a), is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3773 (i) by striking ‘‘and’’ before ‘‘(FF)’’; and (ii) by inserting before the semicolon at the end the following: ‘‘, and (GG) with respect to lymphedema compression treat- ment items (as defined in section 1861(mmm)), the amount paid shall be equal to 80 percent of the lesser of the ac- tual charge or the amount determined under the payment basis determined under section 1834(z)’’.

(B) PAYMENT BASIS AND LIMITATIONS.— Section 1834 of the Social Security Act (42 U.S.C.
1395m) is amended by adding at the end the following new subsection: ‘‘(z) PAYMENT FOR LYMPHEDEMA COMPRESSION TREATMENT ITEMS.— ‘‘(1) IN GENERAL.—The Secretary shall deter- mine an appropriate payment basis for lymphedema compression treatment items (as defined in section 1861(mmm)).
In making such a determination, the Secretary may take into account payment rates for such items under State plans (or waivers of such plans) under title XIX, the Veterans Health Admin- istration, and group health plans and health insur- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3774 ance coverage (as such terms are defined in section 2791 of the Public Health Service Act), and such other information as the Secretary determines ap- propriate.
‘‘(2) FREQUENCY LIMITATION.—No payment may be made under this part for lymphedema com- pression treatment items furnished other than at such frequency as the Secretary may establish.
‘‘(3) APPLICATION OF COMPETITIVE ACQUISI- TION.—In the case of lymphedema compression treatment items that are included in a competitive acquisition program in a competitive acquisition area under section 1847(a)— ‘‘(A) the payment basis under this sub- section for such items furnished in such area shall be the payment basis determined under such competitive acquisition program; and ‘‘(B) the Secretary may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise determined under this sub- section for an area that is not a competitive ac- quisition area under section 1847, and in the case of such adjustment, paragraphs (8) and (9) of section 1842(b) shall not be applied.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3775 (3) CONFORMING AMENDMENT.—Section 1847(a)(2) of the Social Security Act (42 U.S.C.

1395w–3(a)(2)) is amended by adding at the end the following new subparagraph: ‘‘(D) LYMPHEDEMA COMPRESSION TREAT- MENT ITEMS.—Lymphedema compression treat- ment items (as defined in section 1861(mmm)) for which payment would otherwise be made under section 1834(z).’’.
(b) INCLUSION IN REQUIREMENTS FOR SUPPLIERS OF MEDICAL EQUIPMENT AND SUPPLIES.—Section 1834 of the Social Security Act (42 U.S.C.

1395m) is amend- ed— (1) in subsection (a)(20)(D), by adding at the end the following new clause: ‘‘(iv) Lymphedema compression treat- ment items (as defined in section 1861(mmm)).’’.
(2) in subsection (j)(5)— (A) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respec- tively; and (B) by inserting after subparagraph (D) the following new subparagraph: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3776 ‘‘(E) lymphedema compression treatment items (as defined in section 1861(mmm));’’.

SEC.

4134.

PERMANENT IN-HOME BENEFIT FOR IVIG SERV- ICES.

(a) COVERAGE.—Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended— (1) in subsection (s)(2)(Z) by inserting ‘‘, and items and services furnished on or after January 1, 2024, related to the administration of intravenous immune globulin,’’ after ‘‘globulin’’; and (2) in subsection (zz), by inserting ‘‘furnished before January 1, 2024,’’ after ‘‘but not including items or services’’.

(b) PAYMENT.—Section 1842(o) of the Social Secu- rity Act (42 U.S.C.
1395u(o)) is amended by adding at the end the following new paragraph: ‘‘(8) In the case of intravenous immune glob- ulin described in section 1861(s)(2)(Z) that are fur- nished on or after January 1, 2024, to an individual by a supplier in the patient’s home, the Secretary shall provide for a separate bundled payment to the supplier for all items and services related to the ad- ministration of such intravenous immune globulin to such individual in the patient’s home during a cal- endar day in an amount that the Secretary deter- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3777 mines to be appropriate, which may be based on the payment established pursuant to subsection (d) of section 101 of the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012.

For purposes of the preceding sen- tence, such separate bundled payment shall not apply in the case of an individual receiving home health services under section 1895.’’.
(c) CLARIFICATION WITH RESPECT TO PAYMENT FOR THE IN-HOME ADMINISTRATION OF IVIG ITEMS AND SERVICES.—Section 1834(j)(5) of the Social Security Act (42 U.S.C.
1395m(j)(5)) is amended— (1) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and (2) by inserting after subparagraph (D) the fol- lowing new subparagraph: ‘‘(E) items and services related to the ad- ministration of intravenous immune globulin furnished on or after January 1, 2024, as de- scribed in section 1861(zz);’’.

(d) COINSURANCE.—Section 1833(a)(1) of the Social Security Act (42 U.S.C.
1395l(a)(1), as amended by sec- tion 4121(a) and section 4133(a), is amended— (1) by striking ‘‘and’’ before ‘‘(GG)’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3778 (2) by inserting before the semicolon at the end the following: ‘‘, and (HH) with respect to items and services related to the administration of intravenous immune globulin furnished on or after January 1, 2024, as described in section 1861(zz), the amounts paid shall be the lesser of the 80 percent of the ac- tual charge or the payment amount established under section 1842(o)(8)’’.
(e) ADDITIONAL FUNDING FOR MEDICARE IVIG DEMONSTRATION PROJECT.— (1) FUNDING.—There is authorized to be ap- propriated, and there is hereby appropriated, out of any monies in the Treasury not otherwise appro- priated, $4,300,000 for purposes of paying for items and services furnished under the demonstration project established by the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C.

1395l note).
1395l note).

(2) SUPPLEMENT, NOT SUPPLANT.—Any amounts appropriated pursuant to this subsection shall be in addition to any other amounts otherwise appropriated pursuant to any other provision of law.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3779 SEC.

4135.

ACCESS TO NON-OPIOID TREATMENTS FOR PAIN RELIEF.

(a) IN GENERAL.—Section 1833(t) of the Social Se- curity Act (42 U.S.C.
1395l(t)) is amended— (1) in paragraph (2)(E), by inserting ‘‘and tem- porary additional payments for non-opioid treat- ments for pain relief under paragraph (16)(G),’’ after ‘‘payments under paragraph (6)’’; and (2) in paragraph (16), by adding at the end the following new subparagraph: ‘‘(G) TEMPORARY ADDITIONAL PAYMENTS FOR NON-OPIOID TREATMENTS FOR PAIN RE- LIEF.— ‘‘(i) IN GENERAL.—Notwithstanding any other provision of this subsection, with respect to a non-opioid treatment for pain relief (as defined in clause (iv)) furnished on or after January 1, 2025, and before January 1, 2028, the Secretary shall not package payment for such non-opioid treatment for pain relief into a payment for a covered OPD service (or group of services), and shall make an additional payment as specified in clause (ii) for such non-opioid treatment for pain relief.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3780 ‘‘(ii) AMOUNT OF PAYMENT.—Subject to the limitation under clause (iii), the amount of the payment specified in this clause is, with respect to a non-opioid treatment for pain relief that is— ‘‘(I) a drug or biological product, the amount of payment for such drug or biological determined under section 1847A that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary deter- mines is associated with the drug or biological; or ‘‘(II) a medical device, the amount of the hospital’s charges for the device, adjusted to cost, that ex- ceeds the portion of the otherwise ap- plicable Medicare OPD fee schedule that the Secretary determines is asso- ciated with the device.
‘‘(iii) LIMITATION.—The additional payment amount specified in clause (ii) shall not exceed the estimated average of 18 percent of the OPD fee schedule amount for the OPD service (or group of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3781 services) with which the non-opioid treat- ment for pain relief is furnished, as deter- mined by the Secretary.
‘‘(iv) DEFINITION OF NON-OPIOID TREATMENT FOR PAIN RELIEF.—In this subparagraph, the term ‘non-opioid treat- ment for pain relief’ means a drug, biologi- cal product, or medical device that— ‘‘(I) in the case of a drug or bio- logical product, has a label indication approved by the Food and Drug Ad- ministration to reduce postoperative pain, or produce postsurgical or re- gional analgesia, without acting upon the body’s opioid receptors; ‘‘(II) in case of a medical device, is used to deliver a therapy to reduce postoperative pain, or produce post- surgical or regional analgesia, and has— ‘‘(aa) an application under section 515 of the Federal Food, Drug, and Cosmetic Act that has been approved with respect to the device, been cleared for market December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3782 under section 510(k) of such Act, or is exempt from the require- ments of section 510(k) of such Act pursuant to subsection (l) or (m) or section 510 of such Act or section 520(g) of such Act; and ‘‘(bb) demonstrated the abil- ity to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal; ‘‘(III) does not receive transi- tional pass-through payment under paragraph (6); and ‘‘(IV) has payment that is pack- aged into a payment for a covered OPD service (or group of services).’’.
(b) AMBULATORY SURGICAL CENTER PAYMENT SYS- TEM.—Section 1833(i) of the Social Security Act (42 U.S.C.

1395l(i)) is amended by adding at the end the fol- lowing new paragraph: 24 25 ‘‘(10) TEMPORARY ADDITIONAL PAYMENTS FOR NON-OPIOID TREATMENTS FOR PAIN RELIEF.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3783 ‘‘(A) IN GENERAL.—In the case of surgical services furnished on or after January 1, 2025, and before January 1, 2028, the payment sys- tem described in paragraph (2)(D)(i) shall pro- vide, in a budget-neutral manner, for an addi- tional payment for a non-opioid treatment for pain relief (as defined in clause (iv) of sub- section (t)(16)(G)) furnished as part of such services in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.
‘‘(B) TRANSITION.—A drug or biological that meets the requirements of section 416.174 of title 42, Code of Federal Regulations (or any successor regulation) and is a non-opioid treat- ment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) shall receive additional payment in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.’’.
(c) EVALUATION OF COVERAGE AND PAYMENT FOR NON-OPIOID THERAPIES AND THERAPEUTIC SERVICES FOR PAIN MANAGEMENT.— 24 25 (1) REPORT TO CONGRESS.—Not later than January 1, 2028, the Secretary of Health and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3784 Human Services (in this subsection referred to as the ‘‘Secretary’’) shall submit to Congress a re- port— (A) identifying limitations, gaps, barriers to access, or deficits in Medicare coverage or re- imbursement for restorative therapies, behav- ioral approaches, and complementary and inte- grative health services that are identified in the Pain Management Best Practices Inter-Agency Task Force Report and that have demonstrated the ability to replace or reduce opioid consump- tion; (B) recommending actions to address the limitations, gaps, barriers to access, or deficits identified under subparagraph (A) to improve Medicare coverage and reimbursement for such therapies, approaches, and services; and (C) comparing, for the 12-month period following the first 6 months in which additional payment for non-opioid treatments for pain re- lief (as defined in clause (iv) of section 1833(t)(16)(G) of the Social Security Act, as added by subsection (a)) is made under such section 1833(t)(16)(G)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3785 (i) with respect to Medicare bene- ficiaries who received a non-opioid treat- ment for pain relief (as so defined) as part of a covered OPD service, the quantity of opioids administered, dispensed, and pre- scribed for the same covered OPD service, including postoperative management; and (ii) with respect to Medicare bene- ficiaries who did not receive a non-opioid treatment for pain relief (as so defined) as part of the same covered OPD service in clause (i)), the quantity of opioids adminis- tered, dispensed, and prescribed for the same covered OPD service, including post- operative management.
(2) REPORTING STANDARD AND PUBLIC CON- SULTATION.—In developing the report described in paragraph (1), the Secretary shall compare results from nationally represented samples of beneficiaries and consult with relevant stakeholders as determined appropriate by the Secretary.
(3) EXCLUSIVE TREATMENT.—Any drug, bio- logical product, or medical device that is a non- opioid treatment for pain relief (as defined in section 1833(t)(16)(G)(iv) of the Social Security Act, as December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3786 added by subsection (a)) shall not be considered a therapeutic service for purposes of the report under paragraph (1).

SEC.

4136.
SEC.

4136.

TECHNICAL AMENDMENTS TO MEDICARE SEPA- RATE PAYMENT FOR DISPOSABLE NEGATIVE PRESSURE WOUND THERAPY DEVICES.

(a) IN GENERAL.—Section 1834(s) of the Social Se- curity Act (42 U.S.C.
1395m(s)) is amended— (1) by amending paragraph (3) to read as fol- lows: ‘‘(3) PAYMENT.— ‘‘(A) IN GENERAL.—The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to— ‘‘(i) for a year before 2024, the amount of the payment that would be made under section 1833(t) (relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such de- vice; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3787 ‘‘(ii) for 2024, the supply price used to determine the relative value for the serv- ice under the fee schedule under section 1848 (as of January 1, 2022) for the ap- plicable disposable device, updated by the specified adjustment described in subpara- graph (B) for such year; and ‘‘(iii) for 2025 and each subsequent year, the payment amount established under this paragraph for such device for the previous year, updated by the specified adjustment described in subparagraph (B) for such year.
‘‘(B) SPECIFIED ADJUSTMENT.— ‘‘(i) IN GENERAL.—For purposes of subparagraph (A), the specified adjustment described in this subparagraph for a year is equal to— ‘‘(I) the percentage increase in the consumer price index for all urban consumers (United States city aver- age) for the 12-month period ending in June of the previous year; minus December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3788 ‘‘(II) the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) for such year.

‘‘(ii) CLARIFICATION ON APPLICATION OF THE PRODUCTIVITY ADJUSTMENT.— The application of clause (i)(II) may result in a specified adjustment of less than 0.0 for a year, and may result in the separate payment amount under this subsection for an applicable device for a year being less than such separate payment amount for such device for the preceding year.
‘‘(C) EXCLUSION OF NURSING AND THER- APY SERVICES FROM SEPARATE PAYMENT.— With respect to applicable devices furnished on or after January 1, 2024, the separate payment amount determined under this paragraph shall not include payment for nursing or therapy services described in section 1861(m).
Payment for such nursing or therapy services shall be made under the prospective payment system es- tablished under section 1895 and shall not be separately billable.’’; and (2) by adding at the end the following new paragraph: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3789 ‘‘(4) IMPLEMENTATION.—As part of submitting claims for the separate payment established under this subsection, beginning with 2024, the Secretary shall accept and process claims submitted using the type of bill that is most commonly used by home health agencies to bill services under a home health plan of care.’’.

SEC.

4137.

EXTENSION OF CERTAIN HOME HEALTH RURAL ADD-ON PAYMENTS.
Subsection (b)(1)(B) of section 421 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173; 117 Stat.

2283; 42 U.S.C.

1395fff note), as amended by section 5201(b) of the Def- icit Reduction Act of 2005 (Public Law 109–171; 120 Stat.

46), section 3131(c) of the Patient Protection and Affordable Care Act (Public Law 111–148; 124 Stat.

428), section 210 of the Medicare Access and CHIP Reau- thorization Act of 2015 (Public Law 114–10; 129 Stat.
151), and section 50208 of the Bipartisan Budget Act of 2018 (Public Law 115–123; 132 Stat.

187) is amended— (1) in clause (iii), by striking ‘‘and’’ at the end; and (2) by adding at the end the following new clause: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3790 ‘‘(v) in the case of episodes and visits ending during 2023, by 1 percent; and’’.

SEC.

4138.
SEC.

4138.

REMEDYING ELECTION REVOCATIONS RELAT- ING TO ADMINISTRATION OF COVID–19 VAC- CINES.

(a) IN GENERAL.—Section 1821(b)(5)(A) of the So- cial Security Act (42 U.S.C.
1395i–5(b)(5)(A)) is amend- ed— (1) in clause (i), by striking ‘‘or’’ or at the end; (2) in clause (ii), by striking the period at the end and inserting ‘‘, or’’; and (3) by adding at the end the following new clause: ‘‘(iii) effective beginning on the date of the enactment of this clause, that is a COVID–19 vaccine and its administration described in section 1861(s)(10)(A).’’.
(b) SPECIAL RULES FOR COVID–19 VACCINES RE- LATING TO REVOCATION OF ELECTION.—Notwith- standing paragraphs (3) and (4) of section 1821(b) of the Social Security Act (42 U.S.C.
1395i–5(b)), in the case of an individual with a revocation of an election under such section prior to the date of enactment of this Act by reason of receiving a COVID–19 vaccine and its admin- istration described in section 1861(s)(10)(A) of such Act December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3791 (42 U.S.C.
3791 (42 U.S.C.

1395x(s)(10)(A)), the following rules shall apply: (1) Beginning on such date of enactment, such individual may make an election under such section, which shall take effect immediately upon its execu- tion, if such individual would be eligible to make such an election if they had not received such COVID–19 vaccine and its administration.
(2) Such revoked election shall not be taken into account for purposes of determining the effec- tive date for an election described in subparagraph (A) or (B) of such paragraph (4).

SEC.

4139.

PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PRO- GRAM.
(a) AREAS OTHER THAN RURAL AND NONCONTIG- UOUS AREAS.—The Secretary shall implement section 414.210(g)(9)(v) of title 42, Code of Federal Regulations (or any successor regulation), to apply the transition rule described in the first sentence of such section to all appli- cable items and services furnished in areas other than rural or noncontiguous areas (as such terms are defined for purposes of such section) through the remainder of the duration of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3792 1320b–5(g)(1)(B)) or December 31, 2023, whichever is later.

(b) ALL AREAS.—The Secretary shall not implement section 414.210(g)(9)(vi) of title 42, Code of Federal Reg- ulations (or any successor regulation) until the date imme- diately following the last day of the emergency period de- scribed in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C.
1320b–5(g)(1)(B)), or January 1, 2024, whichever is later.

(c) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary may implement the provi- sions of this section by program instruction or otherwise.

SEC.

4140.

EXTENDING ACUTE HOSPITAL CARE AT HOME WAIVERS AND FLEXIBILITIES.

Title XVIII of the Social Security Act (42 U.S.C.

1395 et seq.)

is amended by inserting after section 1866F the following new section: ‘‘SEC.
1866G.

EXTENSION OF ACUTE HOSPITAL CARE AT HOME INITIATIVE.

‘‘(a) IN GENERAL.— ‘‘(1) EXTENSION.—With respect to inpatient hospital admissions occurring during the period be- ginning on the first day after the end of the emer- gency period described in section 1135(g)(1)(B) and ending on December, 31, 2024, the Secretary of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3793 Health and Human Services shall grant waivers and flexibilities (as described in paragraph (2)) to an in- dividual hospital that submits a request for such waivers and flexibilities and meets specified criteria (as described in paragraph (3)) in order to partici- pate in the Acute Hospital Care at Home initiative of the Secretary.
‘‘(2) ACUTE HOSPITAL CARE AT HOME WAIVERS AND FLEXIBILITIES.—For the purposes of para- graph (1), the waivers and flexibilities described in this paragraph are the following waivers and flexi- bilities that were made available to individual hos- pitals under the Acute Hospital Care at Home ini- tiative of the Secretary during the emergency period described in section 1135(g)(1)(B): ‘‘(A) Subject to paragraph (3)(D), waiver of the requirements to provide 24-hour nursing services on premises and for the immediate availability of a registered nurse under section 482.23(b) of title 42, Code of Federal Regula- tions (or any successor regulation), and the waivers of the physical environment and Life Safety Code requirements under section 482.41 of title 42, Code of Federal Regulations (or any successor regulation).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3794 ‘‘(B) Flexibility to allow a hospital to fur- nish inpatient services, including routine serv- ices, outside the hospital under arrangements, as described in Medicare Program: Hospital Outpatient Prospective Payment and Ambula- tory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisi- tion; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Serv- ice Category for Hospital Outpatient Depart- ment Prior Authorization Process; Overall Hos- pital Quality Star Rating; COVID–19 (87 Fed.
Reg.

71748 et seq.).

‘‘(C) Waiver of the telehealth requirements under clause (i) of section 1834(m)(4)(C), as amended by section 4113(a) of the Health Ex- tenders, Improving Access to Medicare, Med- icaid, and CHIP, and Strengthening Public Health Act of 2022, such that the originating sites described in clause (ii) of such section shall include the home or temporary residence of the individual.
‘‘(D) Other waivers and flexibilities that, as of the date of enactment of this section, were December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3795 in place for such initiative during such emer- gency period.
‘‘(3) SPECIFIED CRITERIA.—For purposes of paragraph (1), the specified criteria for granting such waivers and flexibilities to individual hospitals are: ‘‘(A) The hospital shall indicate to the Sec- retary the criteria it would use to ensure that hospital services be furnished only to an indi- vidual who requires an inpatient level of care, and shall require that a physician document in the medical record of each such individual that the individual meets such criteria.
‘‘(B) The hospital and any other entities providing services under arrangements with the hospital shall ensure that the standard of care to treat an individual at home is the same as the standard of care to treat such individual as an inpatient of the hospital.
‘‘(C) The hospital shall ensure that an in- dividual is only eligible for services under para- graph (1) if the individual is a hospital inpa- tient or is a patient of the hospital’s emergency department for whom the hospital determines December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3796 that an inpatient level of care is required (as described in subparagraph (A)).
‘‘(D) The hospital shall meet all patient safety standards determined appropriate by the Secretary, in addition to those that otherwise apply to the hospital, except those for which the waivers and flexibilities under this subsection apply.
‘‘(E) The hospital shall provide to the Sec- retary, at a time, form and manner determined by the Secretary, any data and information the Secretary determines necessary to do the fol- lowing: ‘‘(i) Monitor the quality of care fur- nished, and to the extent practicable, en- sure the safety of individuals and analyze costs of such care.

‘‘(ii) Undertake the study described in subsection (b).

‘‘(F) The hospital meets such other re- quirements and conditions as the Secretary de- termines appropriate.
‘‘(4) TERMINATION.—The Secretary may termi- nate a hospital from participation in such initiative (and the waivers and flexibilities applicable to such December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3797 hospital) if the Secretary determines that the hos- pital no longer meets the criteria described in para- graph (3).
‘‘(b) STUDY AND REPORT.— ‘‘(1) IN GENERAL.—The Secretary shall con- duct a study to— ‘‘(A) analyze, to the extent practicable, the criteria established by hospitals under the Acute Hospital Care at Home initiative of the Sec- retary to determine which individuals may be furnished services under such initiative; and ‘‘(B) analyze and compare, to the extent practicable— ‘‘(i) quality of care furnished to indi- viduals with similar conditions and charac- teristics in the inpatient setting and through the Acute Hospital Care at Home initiative, including health outcomes, hos- pital readmission rates, hospital mortality rates, length of stay, infection rates, and patient experience of care; ‘‘(ii) clinical conditions treated and di- agnosis-related groups of discharges from the inpatient setting and under the Acute Hospital Care at Home initiative; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3798 ‘‘(iii) costs incurred by furnishing care in the inpatient setting and through the Acute Hospital Care at Home initiative; ‘‘(iv) the quantity, mix and intensity of such services (such as in-person visits and virtual contacts with patients) fur- nished in the Acute Hospital Care at Home initiative and furnished in the inpa- tient setting; and ‘‘(v) socioeconomic information on beneficiaries treated under the initiative, including racial and ethnic data, income, and whether such beneficiaries are dually eligible for benefits under this title and title XIX.
‘‘(2) REPORT.—Not later than September 30, 2024, the Secretary of Health and Human Services shall post on a website of the Centers for Medicare & Medicaid Services a report on the study conducted under paragraph (1).
‘‘(3) FUNDING.—In addition to amounts other- wise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Manage- ment Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3799 $5,000,000, to remain available until expended, for purposes of carrying out this subsection.
‘‘(c) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary may implement this section by program instruction or otherwise.

‘‘(d) PUBLICLY AVAILABLE INFORMATION.—The Secretary shall, as feasible, make the information collected under subsections (a)(3)(E) and (b)(1) available on the Medicare.gov internet website (or a successor website).’’.

SEC.

4141.

EXTENSION OF PASS-THROUGH STATUS UNDER THE MEDICARE PROGRAM FOR CERTAIN DE- VICES IMPACTED BY COVID–19.
(a) IN GENERAL.—Section 1833(t)(6) of the Social Security Act (42 U.S.C.
1395l(t)(6)) is amended— (1) in subparagraph (B)(iii), in the matter pre- ceding subclause (I), by striking ‘‘A category’’ and inserting ‘‘Subject to subparagraph (K), a cat- egory’’; and (2) by adding at the end the following new sub- paragraph: ‘‘(K) PASS-THROUGH EXTENSION FOR CERTAIN DEVICES.— ‘‘(i) IN GENERAL.—In the case of a device whose period of pass-through status under this paragraph will end on Decem- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3800 ber 31, 2022, such pass-through status shall be extended for a 1–year period be- ginning on January 1, 2023.

‘‘(ii) NO ADJUSTMENT FOR PACKAGED COSTS.—For purposes of the 1–year period described in clause (i), the Secretary shall not remove the packaged costs of such de- vice (as determined by the Secretary) from the payment amount under this subsection for a covered OPD service (or group of services) with which it is packaged.
‘‘(iii) NO APPLICATION OF AGGRE- GATE LIMIT OR BUDGET NEUTRALITY.— Notwithstanding any other provision of this subsection, this subparagraph shall not be taken into account— ‘‘(I) in applying the limit on an- nual aggregate adjustments under subparagraph (E) for 2023; or ‘‘(II) in making any budget neu- trality adjustments under this sub- section for 2023.’’.
(b) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary of Health and Human December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3801 Service may implement the amendments made by sub- section (a) by program instruction or otherwise.

SEC.

4142.

INCREASING TRANSPARENCY FOR HOME HEALTH PAYMENTS UNDER THE MEDICARE PROGRAM.
(a) TRANSPARENCY.—In notice and comment rule- making used to implement section 1895(b)(3)(D) of the Social Security Act (42 U.S.C.
1395fff(b)(3)(D), the Sec- retary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall, on the date of the notice of proposed rulemaking, make available through the inter- net website of the Centers for Medicare & Medicaid Serv- 13 ices the following: (1) Electronic data files showing the Centers for Medicare & Medicaid Services simulation of 60- day episodes under the home health prospective pay- ment system in effect prior to the Patient Driven Groupings Model using data from 30-day periods paid under such Model, if such data are used in de- termining payment adjustments under clauses (ii) or (iii) of such section 1895(b)(3)(D).
(2) To the extent practicable, a description of actual behavior changes, as described in clause (i) of such section 1895(b)(3)(D), including behavior changes as a result of the implementation of sections December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3802 1895(b)(2)(B) and 1895(b)(4)(B) of the Social Se- curity Act (42 U.S.C.

1395fff(b)(2)(B) and 1395(b)(4)(B)) that occurred in calendar years 2020 through 2026.
(b) ENGAGEMENT WITH STAKEHOLDERS.— (1) IN GENERAL.—Not later than 90 days after the date of enactment of this section, the Secretary shall use an open door forum, a town hall meeting, a web-based forum, or other appropriate mechanism to receive input from home health stakeholders and interested parties on Medicare home health payment rate development, including the items described in paragraphs (1) and (2) of subsection (a) with re- spect to the home health prospective payment sys- tem rate for calendar year 2023.
(2) REQUIREMENT.—At least 30 days before the forum, meeting, or other mechanism referred to in paragraph (1), the Secretary shall make available through the internet website of the Centers for Medicare & Medicaid Services the items described in paragraphs (1) and (2) of subsection (a) with re- spect to the home health prospective payment sys- tem rate for calendar year 2023 as finalized in the final rule entitled ‘‘Medicare Program; Calendar Year 2023 Home Health Prospective Payment Sys- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3803 tem Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements’’ published in the Federal Register on November 4, 2022 (87 Fed.

Reg.

66790).
(c) CONSTRUCTION.—Nothing in this section shall be construed to require any change in the methodology used by the Secretary to implement such section 1895(b)(3)(D), to restrict the Secretary’s discretion in es- tablishing the methodology to implement such section, or to suggest that the Secretary’s promulgation of the meth- odology implementing such Calendar Year 2023 home health final rule was inadequate under Chapter 5 of title 5, United States Code (commonly known as the ‘‘Adminis- trative Procedures Act’’) or any other provision of law.
SEC.

4143.

WAIVER OF CAP ON ANNUAL PAYMENTS FOR NURSING AND ALLIED HEALTH EDUCATION PAYMENTS.

(a) IN GENERAL.—Section 1886(l)(2)(B) of the So- cial Security Act (42 U.S.C.

1395ww(l)(2)(B)) is amend- ed— 23 24 (1) by striking ‘‘PAYMENTS.—Such ratio’’ and inserting ‘‘PAYMENTS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3804 ‘‘(i) IN GENERAL.—Subject to clause (ii), such ratio’’; and (2) by adding at the end the following new clause: ‘‘(ii) EXCEPTION TO ANNUAL LIMITA- TION FOR EACH OF 2010 THROUGH 2019.— For each of 2010 through 2019, the limi- tation under clause (i) on the total amount of additional payments for nursing and al- lied health education to be distributed to hospitals under this subsection for portions of cost reporting periods occurring in the year shall not apply to such payments made in such year to those hospitals that, as of the date of the enactment of this clause, are operating a school of nursing, a school of allied health, or a school of nurs- ing and allied health.’’.
(b) NO AFFECT ON PAYMENTS FOR DIRECT GRAD- UATE MEDICAL EDUCATION.—Section 1886(h)(3)(D)(iii) of the Social Security Act (42 U.S.C.

22 23 24 25 1395ww(h)(3)(D)(iii)) is amended by adding at the end the following sentence: ‘‘In applying the preceding sen- tence for each of 2010 through 2019, the Secretary shall not take into account any increase in the total amount December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3805 of such additional payment amounts for such nursing and allied health education for portions of cost reporting peri- ods occurring in the year pursuant to the application of paragraph (2)(B)(ii) of such subsection.’’.

(c) RETROACTIVE APPLICATION.—The amendments made by this section shall apply to payments made for portions of cost reporting periods occurring in 2010 through 2019.
(d) FUNDING.—In addition to amounts otherwise available, there is appropriated to the Centers for Medi- care & Medicaid Services Program Management Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $3,000,000, to remain avail- able until expended, for purposes of carrying out the amendments made by this section.

Subtitle E—Health Care Tax Provisions SEC.

4151.

EXTENSION OF SAFE HARBOR FOR ABSENCE OF DEDUCTIBLE FOR TELEHEALTH.
(a) IN GENERAL.—Section 223(c)(2)(E) of the Inter- nal Revenue Code of 1986 is amended by striking ‘‘In the case of plan years’’ and all that follows through ‘‘a plan’’ and inserting ‘‘In the case of— ‘‘(i) months beginning after March 31, 2022, and before January 1, 2023, and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3806 ‘‘(ii) plan years beginning on or before December 31, 2021, or after December 31, 2022, and before January 1, 2025, a plan’’.
(b) CERTAIN COVERAGE DISREGARDED.—Section 223(c)(1)(B)(ii) of the Internal Revenue Code of 1986 is amended by striking ‘‘(in the case of plan years beginning on or before December 31, 2021, or in the case of months beginning after March 31, 2022, and before January 1, 2023)’’ and inserting ‘‘(in the case of months or plan years to which paragraph (2)(E) applies)’’.
(c) EFFECTIVE DATE.—The amendments made by this section shall apply to plan years beginning after De- cember 31, 2022.

15 16 17 18 Subtitle F—Offsets SEC.

4161.

REDUCTION OF MEDICARE IMPROVEMENT FUND.

Section 1898(b)(1) of the Social Security Act (42 19 U.S.C.

1395iii(b)(1)) is amended by striking ‘‘$7,278,000,000’’ and inserting ‘‘$180,000,000’’.

SEC.

4162.

EXTENSION OF ADJUSTMENT TO CALCULATION OF HOSPICE CAP AMOUNT UNDER MEDI- CARE.
Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C.

1395f(i)(2)(B)) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3807 (1) in clause (ii), by striking ‘‘2031’’ and in- serting ‘‘2032’’; and (2) in clause (iii), by striking ‘‘2031’’ and in- serting ‘‘2032’’.

SEC.

4163.

MEDICARE DIRECT SPENDING REDUCTIONS.

Section 251A(6) of the Balanced Budget and Emer- gency Deficit Control Act of 1985 (2 U.S.C.
901a(6)) is amended— (1) in subparagraph (B), in the matter pre- ceding clause (i)— (A) by striking ‘‘On the dates OMB issues its sequestration preview reports’’ and inserting ‘‘On the date on which the President submits the budget under section 1105 of title 31, United States Code,’’; and (B) by striking ‘‘pursuant to section 254(c),’’; (2) in subparagraph (C), by moving the margin 2 ems to the left; (3) by striking subparagraphs (D) and (E); and (4) by adding at the end the following: ‘‘(D) On the date on which the President sub- mits the budget under section 1105 of title 31, United States Code, for fiscal year 2032, the Presi- dent shall order a sequestration of payments for the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3808 Medicare programs specified in section 256(d), effec- tive upon issuance, such that, notwithstanding the 2 percent limit specified in subparagraph (A) for such payments— ‘‘(i) with respect to the first 6 months in which such order is effective for such fiscal year, the payment reduction shall be 2.0 per- cent; and ‘‘(ii) with respect to the second 6 months in which such order is effective for such fiscal year, the payment reduction shall be 0 per- cent.’’.
TITLE V—MEDICAID AND CHIP PROVISIONS Subtitle A—Territories SEC.

5101.

MEDICAID ADJUSTMENTS FOR THE TERRI- TORIES.

(a) REVISING ALLOTMENTS FOR PUERTO RICO.— Section 1108(g) of the Social Security Act (42 U.S.C.
1308(g)) is amended— (1) in paragraph (2)— (A) in subparagraph (A)— (i) in clause (i)— (I) by striking ‘‘clause (ii)’’ and inserting ‘‘clause (ii) or (iii)’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3809 (II) by striking ‘‘and’’ at the end; (ii) in clause (ii), by striking the semi- colon and inserting ‘‘; and’’; and (iii) by adding at the end the fol- lowing new clause: ‘‘(iii) for fiscal year 2023 and each subsequent fiscal year, the amount speci- fied in paragraph (11) for such fiscal year;’’; and (B) in the matter following subparagraph (E), by striking ‘‘each fiscal year after fiscal year 2021’’ and inserting ‘‘fiscal year 2022 (and, in the case of a territory other than Puer- to Rico, for each subsequent fiscal year)’’; and (2) by adding at the end the following new paragraphs: ‘‘(11) ALLOTMENT AMOUNTS FOR PUERTO RICO FOR FISCAL YEAR 2023 AND SUBSEQUENT FISCAL YEARS.—For purposes of paragraph (2)(A)(iii), sub- ject to paragraphs (12) and (13), the amounts speci- fied in this paragraph are the following: ‘‘(A) For fiscal year 2023, $3,275,000,000.
‘‘(B) For fiscal year 2024, $3,325,000,000.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3810 ‘‘(C) For fiscal year 2025, $3,475,000,000.

‘‘(D) For fiscal year 2026, $3,645,000,000.

‘‘(E) For fiscal year 2027, $3,825,000,000.
‘‘(F) For fiscal year 2028, the sum of the amount that would have been provided under this subsection for Puerto Rico for such fiscal year in accordance with clause (i) of paragraph (2)(A) (without regard to clause (iii) of such paragraph) had the amount provided under this subsection for Puerto Rico for each of fiscal years 2020 through 2027 been equal to the fol- lowing: ‘‘(i) For fiscal year 2020, the sum of the amount provided under this subsection for Puerto Rico for fiscal year 2019, in- creased by the percentage increase in the medical care component of the Consumer Price Index for all urban consumers (as published by the Bureau of Labor Statis- tics) for the 12-month period ending in March preceding the beginning of the fiscal year, rounded to the nearest $100,000.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3811 ‘‘(ii) For each of fiscal years 2021 through 2027, the sum of the amount pro- vided under this subparagraph for the pre- ceding fiscal year, increased in accordance with the percentage increase described in clause (i), rounded to the nearest $100,000.
‘‘(G) For fiscal year 2029 and each subse- quent fiscal year, the sum of the amount speci- fied in this paragraph for the preceding fiscal year, increased by the percentage increase in the medical care component of the Consumer Price Index for all urban consumers (as pub- lished by the Bureau of Labor Statistics) for the 12-month period ending in March preceding the beginning of the fiscal year, rounded to the nearest $100,000.
In determining the amount specified under subpara- graph (F) for fiscal year 2028 or under subpara- graph (G) for fiscal year 2029 or a subsequent fiscal year, the Secretary may in no way take into account the amount that was provided under this subsection for Puerto Rico for fiscal year 2022 that was based on the Centers for Medicare & Medicaid Services’ in- terpretation of the flush language following para- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3812 graph (2)(E) (as described in the letters sent by the Centers for Medicare & Medicaid Services to the Di- rector of the Medicaid Program for Puerto Rico dated September 24, 2021, and November 18, 2021, respectively).
‘‘(12) ADDITIONAL INCREASE FOR PUERTO RICO.— ‘‘(A) IN GENERAL.—For fiscal year 2023 and each subsequent fiscal year through fiscal year 2027, the amount specified in paragraph (11) for the fiscal year shall be equal to the amount specified for such fiscal year under such paragraph increased by $300,000,000 if the Secretary certifies that, with respect to such fiscal year, Puerto Rico’s State plan under title XIX (or waiver of such plan) establishes a re- imbursement floor, implemented through a di- rected payment arrangement plan, for physician services that are covered under the Medicare part B fee schedule in the Puerto Rico locality established under section 1848(b) that is not less than 75 percent of the payment that would apply to such services if they were furnished under part B of title XVIII during such fiscal year.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3813 ‘‘(B) APPLICATION TO MANAGED CARE.— In certifying whether Puerto Rico has estab- lished a reimbursement floor under a directed payment arrangement plan that satisfies the re- quirements of subparagraph (A)— ‘‘(i) for fiscal year 2023, the Sec- retary shall apply such requirements to payments for physician services under a managed care contract entered into or re- newed after the date of enactment of this paragraph and disregard payments for physician services under any managed care contract that was entered into prior to such date; and ‘‘(ii) for each subsequent fiscal year through fiscal year 2027— ‘‘(I) the Secretary shall disregard payments made under subcapitated arrangements for services such as pri- mary care case management; and ‘‘(II) if the reimbursement floor for physician services applicable under a managed care contract satisfies the requirements of subparagraph (A) for the fiscal year in which the contract is December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3814 entered into or renewed, such reim- bursement floor shall be deemed to satisfy such requirements for the sub- sequent fiscal year.

‘‘(C) NONAPPLICATION OF INCREASE IN DETERMINING ALLOTMENTS FOR SUBSEQUENT FISCAL YEARS.—An increase under this para- graph for a fiscal year may not be taken into account in calculating the amount specified under paragraph (11) for the succeeding fiscal year.
‘‘(13) FURTHER INCREASE FOR PUERTO RICO.— ‘‘(A) IN GENERAL.—For each of fiscal years 2023 through 2027, the amount specified in paragraph (11) for the fiscal year shall be equal to the amount specified for such fiscal year under such paragraph (increased, if appli- cable, in accordance with paragraph (12)) and further increased— ‘‘(i) in the case of each of fiscal years 2023 through 2025, by $75,000,000 if the Secretary determines that Puerto Rico fully satisfies the requirements described in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3815 paragraph (7)(A)(i) for such fiscal year; and ‘‘(ii) in the case of each of fiscal years 2026 and 2027, by $75,000,000 if the Sec- retary determines that Puerto Rico fully satisfies the requirements described in— ‘‘(I) paragraph (7)(A)(i) for such fiscal year; and ‘‘(II) paragraph (7)(A)(v) for such fiscal year.
‘‘(B) NONAPPLICATION OF INCREASE IN DETERMINING ALLOTMENTS FOR SUBSEQUENT FISCAL YEARS.—An increase under this para- graph for a fiscal year may not be taken into account in calculating the amount specified under paragraph (11) for the succeeding fiscal year.’’.

(b) EXTENSION OF INCREASED FMAPS.—Section 1905(ff) of the Social Security Act (42 U.S.C.
1396d(ff)) is amended— 21 22 23 24 (1) in the header, by striking ‘‘TEMPORARY’’; (2) in paragraph (2)— (A) by striking ‘‘subject to section 1108(g)(7)(C),’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3816 (B) by striking ‘‘December 23, 2022’’ and inserting ‘‘September 30, 2027,’’; and (3) in paragraph (3), by striking ‘‘for the pe- riod beginning December 21, 2019, and ending De- cember 23, 2022’’ and inserting ‘‘beginning Decem- ber 21, 2019’’.

(c) APPLICATION OF ASSET VERIFICATION PROGRAM REQUIREMENTS TO PUERTO RICO.—Section 1940 of the Social Security Act (42 U.S.C.
1396w) is amended— (1) in subsection (a)— (A) in paragraph (3)(A), by adding at the end the following new clause: ‘‘(iii) IMPLEMENTATION IN PUERTO RICO.—The Secretary shall require Puerto Rico to implement an asset verification program under this subsection by January 1, 2026.’’; and (B) in paragraph (4)— (i) in the paragraph heading, by strik- ing ‘‘EXEMPTION OF TERRITORIES’’ and inserting ‘‘EXEMPTION OF CERTAIN TERRI- TORIES’’; and (ii) by striking ‘‘and the District of Columbia’’ and inserting ‘‘, the District of Columbia, and Puerto Rico’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3817 (2) in subsection (k)— (A) in paragraph (1)— (i) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively, and adjusting the mar- gins accordingly; (ii) in the matter preceding clause (i), as so redesignated— (I) by striking ‘‘beginning on or after January 1, 2021’’; and (II) by striking ‘‘for a non-com- pliant State shall be reduced—’’ and inserting the following: ‘‘for— ‘‘(A) a non-compliant State that is one of the 50 States or the District of Columbia shall be reduced—’’; (iii) in clause (iv), as so redesignated, by striking the period at the end and in- serting ‘‘; and’’; and (iv) by adding at the end the following new subparagraph: ‘‘(B) a non-compliant State that is Puerto Rico shall be reduced— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3818 ‘‘(i) for calendar quarters in fiscal year 2026 beginning on or after January 1, 2026, by 0.12 percentage points; ‘‘(ii) for calendar quarters in fiscal year 2027, by 0.25 percentage points; ‘‘(iii) for calendar quarters in fiscal year 2028, by 0.35 percentage points; and ‘‘(iv) for calendar quarters in fiscal year 2029 and each fiscal year thereafter, by 0.5 percentage points.’’; and (B) in paragraph (2)(A), by striking ‘‘or the District of Columbia’’ and inserting ‘‘, the District of Columbia, or Puerto Rico’’.
(d) EXTENSION OF REPORTING REQUIREMENT.— Section 1108(g)(9) of the Social Security Act (42 U.S.C.
1308(g)(9)) is amended— (1) in subparagraph (A), by inserting ‘‘and for fiscal year 2023 and each subsequent fiscal year (or, in the case of Puerto Rico, and for fiscal year 2023 and each subsequent fiscal year before fiscal year 2028)’’ after ‘‘fiscal year 2021)’’; and (2) in subparagraph (B)(i), by inserting ‘‘or by reason of the amendments made by section 5101 of the Health Extenders, Improving Access to Medi- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3819 care, Medicaid, and CHIP, and Strengthening Pub- lic Health Act of 2022’’ before the period at the end.

(e) PUERTO RICO PROGRAM INTEGRITY.—Section 1108(g)(7)(A) of the Social Security Act (42 U.S.C.
1308(g)(7)(A)) is amended— (1) in clause (iii), in the header, by inserting ‘‘REPORTING’’ after ‘‘REFORM’’; and (2) by adding at the end the following new clause: ‘‘(v) CONTRACTING AND PROCURE- MENT OVERSIGHT LEAD REQUIREMENT.— ‘‘(I) IN GENERAL.—Not later than 6 months after the date of the enactment of this clause, the agency responsible for the administration of Puerto Rico’s Medicaid program under title XIX shall designate an of- ficer (other than the director of such agency) to serve as the Contracting and Procurement Oversight Lead to carry out the duties specified in sub- clause (II).
‘‘(II) DUTIES.—Not later than 60 days after the end of each fiscal quarter (beginning with the first fiscal December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3820 quarter beginning on or after the date that is 1 year after the date of the en- actment of this clause), the officer designated pursuant to subclause (I) shall, with respect to each contract described in clause (iii) with an an- nual value exceeding $150,000 en- tered into during such quarter, certify to the Secretary either— ‘‘(aa) that such contract has met the procurement standards identified under any of sections 75.327, 75.328, and 75.329 of title 45, Code of Federal Regula- tions (or successor regulations); or ‘‘(bb) that extenuating cir- cumstances (including a lack of multiple entities competing for such contract) prevented the compliance of such contract with such standards.
‘‘(III) PUBLICATION.—The offi- cer designated pursuant to subclause (I) shall make public each certification December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3821 containing extenuating circumstances described in subclause (II)(bb) not later than 30 days after such certifi- cation is made, including a description of, and justification of, such extenu- ating circumstances.
‘‘(IV) REVIEW OF COMPLI- ANCE.—Not later than 2 years after the date of the enactment of this clause, the Inspector General of the Department of Health and Human Services shall submit to Congress a report on the compliance of Puerto Rico with the provisions of this clause.’’.

(f) MEDICAID DATA SYSTEMS IMPROVEMENT PAY- MENTS.—Section 1108 of the Social Security Act (42 U.S.C.
1308) is amended by adding at the end the fol- lowing new subsection: ‘‘(i) DATA SYSTEMS IMPROVEMENT PAYMENTS.— ‘‘(1) IN GENERAL.—Subject to paragraphs (2) and (3), the Secretary shall pay to each eligible ter- ritory an amount equal to 100 percent of the quali- fying data system improvement expenditures in- curred by such territory on or after October 1, 2023.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3822 ‘‘(2) TREATMENT AS MEDICAID PAYMENTS.— ‘‘(A) IN GENERAL.—Payments to eligible territories made under this paragraph shall be considered to have been made under, and are subject to the requirements of, section 1903.

‘‘(B) NONDUPLICATION.—No payment shall be made under title XIX (other than as provided under paragraph (1)), title XXI, or any other provision of law with respect to an expenditure for which payment is made under such paragraph.
‘‘(3) ALLOTMENTS.—The Secretary shall speci- fy an allotment for each eligible territory for pay- ments made under paragraph (1) in a manner such that— ‘‘(A) the total amount of payments made under such paragraph for all eligible territories does not exceed $20,000,000; and ‘‘(B) each eligible territory receives an eq- uitable allotment of such payments.
‘‘(4) NO EFFECT ON TERRITORIAL CAPS.—A payment to an eligible territory under this sub- section shall not be taken into account for purposes of applying the payment limits under subsections (f) and (g).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3823 ‘‘(5) DEFINITIONS.—In this subsection: ‘‘(A) ELIGIBLE TERRITORY.—The term ‘el- igible territory’ means American Samoa, Guam, the Northern Mariana Islands, and the Virgin Islands.
‘‘(B) QUALIFYING DATA SYSTEM IMPROVE- MENT EXPENDITURE.—The term ‘qualifying data system improvement expenditure’ means an expenditure by an eligible territory to im- prove, update, or enhance a data system that is used by the territory to carry out an adminis- trative activity for which Federal financial par- ticipation is available under section 1903(a).’’.
(g) STRATEGIC PLAN AND EVALUATION.— (1) IN GENERAL.—Each territory described in paragraph (2) shall— (A) not later than September 30, 2023, submit to the Secretary of Health and Human Services a 4-year strategic plan that outlines the territory’s goals relating to workforce devel- opment, financing, systems implementation and operation, and program integrity with respect to the territory’s Medicaid program under title XIX of the Social Security Act (42 U.S.C.

1396 et seq.
1396 et seq.

); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3824 (B) not later than September 30, 2027, submit to the Secretary of Health and Human Services an analysis of the extent to which the territory has achieved, or is making progress to- ward achieving, the goals described in such strategic plan, and any policy changes relating to such goals that were adopted by the territory after the submission of the plan.
(2) TERRITORIES DESCRIBED.—The territories described in this paragraph are American Samoa, Guam, the Northern Mariana Islands, and the Vir- gin Islands.

Subtitle B—Medicaid and CHIP Coverage SEC.

5111.

FUNDING EXTENSION OF THE CHILDREN’S HEALTH INSURANCE PROGRAM AND RE- LATED PROVISIONS.

(a) IN GENERAL.—Section 2104(a) of the Social Se- curity Act (42 U.S.C.
1397dd(a)) is amended— (1) in paragraph (27), by striking ‘‘through 2026’’ and inserting ‘‘through 2028’’; and (2) in paragraph (28)— (A) in the matter preceding subparagraph (A), by striking ‘‘for fiscal year 2027’’ and in- serting ‘‘for fiscal year 2029’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3825 (B) in subparagraph (A), by striking ‘‘be- ginning on October 1, 2026, and ending on March 31, 2027’’ and inserting ‘‘beginning on October 1, 2028, and ending on March 31, 2029’’; and (C) in subparagraph (B), by striking ‘‘be- ginning on April 1, 2027, and ending on Sep- tember 30, 2027’’ and inserting ‘‘beginning on April 1, 2029, and ending on September 30, 2029’’.

(b) CHIP ALLOTMENTS.— (1) IN GENERAL.—Section 2104(m) of the So- cial Security Act (42 U.S.C.
1397dd(m)) is amend- ed— (A) in paragraph (2)(B)(i), by striking ‘‘, 2023, and 2027’’ and inserting ‘‘2023, and 2029’’; (B) in paragraph (5), by striking ‘‘or 2027’’ and inserting ‘‘or 2029’’; (C) in paragraph (7)— (i) in subparagraph (A), by striking ‘‘fiscal year 2027,’’ and inserting ‘‘fiscal year 2029’’; and (ii) in the flush left matter at the end, by striking ‘‘or fiscal year 2026.’’ and in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3826 serting ‘‘fiscal year 2026, or fiscal year 2028.’’; (D) in paragraph (9), by striking ‘‘or 2027’’ and inserting ‘‘or 2029’’; and (E) in paragraph (11)— (i) in the paragraph header, by strik- ing ‘‘FISCAL YEAR 2027’’ and inserting ‘‘FISCAL YEAR 2029’’; and (ii) in subparagraph (C)— (I) by striking ‘‘fiscal year 2026’’ each place it appears and inserting ‘‘fiscal year 2028’’; and (II) by striking ‘‘fiscal year 2027’’ and inserting ‘‘fiscal year 2029’’.
(2) CONFORMING AMENDMENTS.—Section 50101(b)(2) of the Bipartisan Budget Act of 2018 (Public Law 115–123) is amended— (A) in the paragraph header, by striking ‘‘FISCAL YEAR 2027’’ and inserting ‘‘FISCAL YEAR 2029’’; (B) by striking ‘‘fiscal year 2027’’ each place it appears and inserting ‘‘fiscal year 2029’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3827 (C) by striking ‘‘beginning on October 1, 2026, and ending on March 31, 2027’’ and in- serting ‘‘beginning on October 1, 2028, and ending on March 31, 2029’’.

(c) OTHER RELATED CHIP POLICIES.— (1) PEDIATRIC QUALITY MEASURES PRO- GRAM.—Section 1139A(i)(1) of the Social Security Act (42 U.S.C.
1320b–9a(i)(1)) is amended— (A) in subparagraph (C), by striking at the end ‘‘and’’; (B) in subparagraph (D), by striking the period at the end and inserting ‘‘; and’’; and (C) by adding at the end the following new subparagraph: ‘‘(E) for each of fiscal years 2028 and 2029, $15,000,000 for the purpose of carrying out this section (other than subsections (e), (f), and (g)).’’.

(2) ASSURANCE OF ELIGIBILITY STANDARDS FOR CHILDREN.—Section 2105(d)(3) of the Social Security Act (42 U.S.C.
1397ee(d)(3)) is amended— (A) in the paragraph heading, by striking ‘‘THROUGH SEPTEMBER 30, 2027’’ and inserting ‘‘THROUGH SEPTEMBER 30, 2029’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3828 (B) in subparagraph (A) by striking ‘‘Sep- tember 30, 2027’’ each place it appears and in- serting ‘‘September 30, 2029’’.

(3) QUALIFYING STATES OPTION.—Section 2105(g)(4) of the Social Security Act (42 U.S.C.
1397ee(g)(4)) is amended— (A) in the paragraph heading, by striking ‘‘THROUGH 2027’’ and inserting ‘‘THROUGH 2029’’; and (B) in subparagraph (A), by striking ‘‘through 2027’’ and inserting ‘‘through 2029’’.

(4) OUTREACH AND ENROLLMENT PROGRAM.— Section 2113 of the Social Security Act (42 U.S.C.
1397mm) is amended— (A) in subsection (a)— (i) in paragraph (1), by striking ‘‘through 2027’’ and inserting ‘‘through 2029’’; and (ii) in paragraph (3), by striking ‘‘through 2027’’ and inserting ‘‘through 2029’’; and (B) in subsection (g)— (i) by striking ‘‘2017,,’’ and inserting ‘‘2017,’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3829 (ii) by striking ‘‘and $48,000,000’’ and inserting ‘‘$48,000,000’’; and (iii) by inserting after ‘‘through 2027’’ the following: ‘‘, and $40,000,000 for the period of fiscal years 2028 and 2029’’.

(5) CHILD ENROLLMENT CONTINGENCY FUND.—Section 2104(n) of the Social Security Act (42 U.S.C.

1397dd(n)) is amended— (A) by striking ‘‘2024 through 2026’’ each place it appears and inserting ‘‘2024 through 2028’’; and (B) by striking ‘‘2023, and 2027’’ each place it appears and inserting ‘‘2023, and 2029’’.
(d) EXTENSION OF CERTAIN PROVISIONS.— (1) EXPRESS LANE ELIGIBILITY OPTION.—Sec- tion 1902(e)(13)(I) of the Social Security Act (42 U.S.C.

1396a(e)(13)(I)) is amended by striking ‘‘2027’’ and inserting ‘‘2029’’.

(2) CONFORMING AMENDMENTS FOR ASSUR- ANCE OF AFFORDABILITY STANDARD FOR CHILDREN AND FAMILIES.—Section 1902(gg)(2) of the Social Security Act (42 U.S.C.
1396a(gg)(2)) is amend- ed— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3830 (A) in the paragraph heading, by striking ‘‘THROUGH SEPTEMBER 30, 2027’’ and inserting ‘‘THROUGH SEPTEMBER 30, 2029’’; and (B) by striking ‘‘2027’’ each place it ap- pears and inserting ‘‘2029,’’.

SEC.

5112.

CONTINUOUS ELIGIBILITY FOR CHILDREN UNDER MEDICAID AND CHIP.
(a) UNDER THE MEDICAID PROGRAM.—Section 1902(e) of the Social Security Act (42 U.S.C.
1396a(e)) is amended by striking paragraph (12) and inserting the 11 following new paragraph: ‘‘(12) 1 YEAR OF CONTINUOUS ELIGIBILITY FOR CHILDREN.—The State plan (or waiver of such State plan) shall provide that an individual who is under the age of 19 and who is determined to be eli- gible for benefits under a State plan (or waiver of such plan) approved under this title under sub- section (a)(10)(A) shall remain eligible for such ben- efits until the earlier of— ‘‘(A) the end of the 12-month period begin- ning on the date of such determination; ‘‘(B) the time that such individual attains the age of 19; or ‘‘(C) the date that such individual ceases to be a resident of such State.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3831 (b) UNDER THE CHILDREN’S HEALTH INSURANCE PROGRAM.—Section 2107(e)(1) of the Social Security Act (42 U.S.C.
1397gg(e)(1)) is amended— (1) by redesignating subparagraphs (K) through (T) as subparagraphs (L) through (U), re- spectively; and (2) by inserting after subparagraph (J) the fol- lowing new subparagraph: ‘‘(K) Section 1902(e)(12) (relating to 1 year of continuous eligibility for children), ex- cept that a targeted low-income child enrolled under the State child health plan or waiver may be transferred to the Medicaid program under title XIX for the remaining duration of the 12- month continuous eligibility period, if the child becomes eligible for full benefits under title XIX during such period.’’.
(c) EFFECTIVE DATE.—The amendments made by this section shall take effect on the first day of the first fiscal quarter that begins on or after the date that is 1 year after the date of enactment of this Act.

SEC.

5113.

MODIFICATIONS TO POSTPARTUM COVERAGE UNDER MEDICAID AND CHIP.
Effective as if included in the enactment of sections 9812 and 9822 of the American Rescue Plan Act of 2021 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3832 (Public Law 117–2), subsection (b) of each such section is amended by striking ‘‘during the 5-year period’’.

SEC.

5114.

EXTENSION OF MONEY FOLLOWS THE PERSON REBALANCING DEMONSTRATION.
(a) IN GENERAL.—Subsection (h) of section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended— (1) in paragraph (1)— (A) in each of subparagraphs (F), (H), and (J), by striking ‘‘and’’ after the semicolon; (B) in subparagraph (K), by striking the period and inserting ‘‘; and’’; and (C) by adding at the end the following: ‘‘(L) $450,000,000 for each of fiscal years 2024 through 2027.’’; (2) in paragraph (2), by striking ‘‘September 30, 2023’’ and inserting ‘‘September 30 of the sub- sequent fiscal year’’; and (3) by adding at the end the following new paragraph: ‘‘(3) TECHNICAL ASSISTANCE.—In addition to amounts otherwise available, there is appropriated to the Secretary, out of any money in the Treasury not otherwise appropriated for fiscal 2023 and for each subsequent 3-year period through fiscal year 2029, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3833 $5,000,000, to remain available until expended, for carrying out subsections (f) and (g).’’.

(b) REDISTRIBUTION OF UNEXPENDED GRANT AWARDS.—Subsection (e)(2) of section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended by adding at the end the following new sentence: ‘‘Any portion of a State grant award for a fiscal year under this section that is unexpended by the State at the end of the fourth succeeding fiscal year shall be rescinded by the Sec- 10 retary and added to the appropriation for the fifth suc- 11 ceeding fiscal year.’’.

12 SEC.

5115.

EXTENSION OF MEDICAID PROTECTIONS AGAINST SPOUSAL IMPOVERISHMENT FOR RECIPIENTS OF HOME AND COMMUNITY- BASED SERVICES.
Section 2404 of the Patient Protection and Afford- able Care Act (42 U.S.C.

1396r–5 note) is amended by striking ‘‘September 30, 2023’’ and inserting ‘‘September 19 30, 2027’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3834 Subtitle C—Medicaid and CHIP Mental Health SEC.

5121.

MEDICAID AND CHIP REQUIREMENTS FOR HEALTH SCREENINGS, REFERRALS, AND CASE MANAGEMENT SERVICES FOR ELIGIBLE JUVENILES IN PUBLIC INSTITUTIONS.
(a) MEDICAID STATE PLAN REQUIREMENT.—Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended— (1) in subsection (a)(84)— (A) in subparagraph (A), by inserting ‘‘, subject to subparagraph (D),’’ after ‘‘but’’; (B) in subparagraph (B), by striking ‘‘and’’ at the end; (C) in subparagraph (C), by adding ‘‘and’’ at the end; and (D) by adding at the end the following new subparagraph: ‘‘(D) in the case of an individual who is an eligible juvenile described in subsection (nn)(2) and is within 30 days of the date on which such eligible juvenile is scheduled to be released from a public institution following adjudication, the State shall have in place a plan, and in accord- ance with such plan, provide for— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3835 ‘‘(i) in the 30 days prior to the release of such eligible juvenile from such public institution (or not later than one week, or as soon as practicable, after release from the public institution), and in coordination with such institution, any screening or di- agnostic service which meets reasonable standards of medical and dental practice, as determined by the State, or as indicated as medically necessary, in accordance with paragraphs (1)(A) and (5) of section 1905(r), including a behavioral health screening or diagnostic service; and ‘‘(ii) in the 30 days prior to the re- lease of such eligible juvenile from such public institution, and for at least 30 days following the release of such eligible juve- nile from such institution, targeted case management services, including referrals for such eligible juvenile to the appropriate care and services available in the geo- graphic region of the home or residence of such eligible juvenile (where feasible) under the State plan (or waiver of such plan);’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3836 (2) in subsection (nn)(3), by striking ‘‘(30)’’ and inserting ‘‘(31)’’.

(b) AUTHORIZATION OF FEDERAL FINANCIAL PAR- TICIPATION.—The subdivision (A) of section 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)) following paragraph (31) of such section is amended by inserting ‘‘, or in the case of an eligible juvenile described in section 1902(a)(84)(D) with respect to the screenings, diagnostic services, referrals, and targeted case management services required under such section’’ after ‘‘(except as a patient 11 in a medical institution’’.

12 13 14 15 16 (c) CHIP CONFORMING AMENDMENTS.— (1) Section 2102 of the Social Security Act (42 U.S.C.
1397bb) is amended by adding at the end the following new subsection: ‘‘(d) TREATMENT OF CHILDREN WHO ARE INMATES 17 OF A PUBLIC INSTITUTION.— ‘‘(1) IN GENERAL.—The State child health plan shall provide that— ‘‘(A) the State shall not terminate eligi- bility for child health assistance under the State child health plan for a targeted low-income child because the child is an inmate of a public institution, but may suspend coverage during the period the child is such an inmate; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3837 ‘‘(B) in the case of a targeted low-income child who was determined eligible for child health assistance under the State child health plan (or waiver of such plan) immediately be- fore becoming an inmate of a public institution, the State shall, prior to the child’s release from such public institution, conduct a redetermina- tion of eligibility for such child with respect to such child health assistance (without requiring a new application from the child) and, if the State determines pursuant to such redetermina- tion that the child continues to meet the eligi- bility requirements for such child health assist- ance, the State shall restore coverage for such child health assistance to such child upon the child’s release from such public institution; and ‘‘(C) in the case of a targeted low-income child who is determined eligible for child health assistance while an inmate of a public institu- tion (subject to the exception to the exclusion of children who are inmates of a public institution described in section 2110(b)(7)), the State shall process any application for child health assist- ance submitted by, or on behalf of, the child such that the State makes a determination of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3838 eligibility for the child with respect to child health assistance upon release of the child from the public institution.
‘‘(2) REQUIRED COVERAGE OF SCREENINGS, DI- AGNOSTIC SERVICES, REFERRALS, AND CASE MAN- AGEMENT FOR CERTAIN INMATES PRE-RELEASE.—A State child health plan shall provide that, in the case of a targeted low-income child who is within 30 days of the date on which such child is scheduled to be released from a public institution following adjudica- tion, the State shall have in place a plan for pro- viding, and shall provide in accordance with such plan, screenings, diagnostic services, referrals, and case management services otherwise covered under the State child health plan (or waiver of such plan) in the same manner as described in section 1902(a)(84)(D).’’.
(2) Section 2110(b) of the Social Security Act (42 U.S.C.

1397jj(b)) is amended— (A) in paragraph (2)(A), by inserting ‘‘ex- cept as provided in paragraph (7),’’ before ‘‘a child who is an inmate of a public institution’’; and (B) by adding at the end the following new paragraph: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3839 ‘‘(7) EXCEPTION TO EXCLUSION OF CHILDREN WHO ARE INMATES OF A PUBLIC INSTITUTION.—In the case of a child who is an inmate of a public in- stitution, during the 30 days prior to the release of the child from such institution the child shall not be considered to be described in paragraph (2)(A) with respect to the screenings, diagnostic services, refer- rals, and case management services otherwise cov- ered under the State child health plan (or waiver of such plan) that the State is required to provide under section 2102(d)(2).’’.
(d) EFFECTIVE DATE.—The amendments made by this section shall apply beginning on the first day of the first calendar quarter that begins on or after the date that is 24 months after the date of enactment of this Act.

SEC.

5122.

REMOVAL OF LIMITATIONS ON FEDERAL FINAN- CIAL PARTICIPATION FOR INMATES WHO ARE ELIGIBLE JUVENILES PENDING DISPOSITION OF CHARGES.

(a) MEDICAID.— (1) IN GENERAL.—The subdivision (A) of sec- tion 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)) following paragraph (31) of such section, as amended by section 5121(b), is further amended by inserting ‘‘, or, at the option of the State, for an December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3840 individual who is an eligible juvenile (as defined in section 1902(nn)(2)), while such individual is an in- mate of a public institution (as defined in section 1902(nn)(3)) pending disposition of charges’’ after ‘‘or in the case of an eligible juvenile described in section 1902(a)(84)(D) with respect to the screenings, diagnostic services, referrals, and case management required under such section’’.

(2) CONFORMING AMENDMENT.—Section 1902(a)(84)(A) of the Social Security Act (42 U.S.C.
1396a(a)(84)(A)) is amended by inserting ‘‘(or in the case of a State electing the option de- scribed in the subdivision (A) following paragraph (31) of section 1905(a), during such period begin- ning after the disposition of charges with respect to such individual)’’ after ‘‘is such an inmate’’.

(b) CHIP.—Section 2110(b)(7) of the Social Security Act (42 U.S.C.
13977jj(b)(7)), as added by section 5121(c)(2)(B), is amended— (1) in the heading, by striking ‘‘EXCEPTION’’ and inserting ‘‘EXCEPTIONS’’; and (2) by adding at the end the following new sen- tence: ‘‘At the option of the State, a child who is an inmate of a public institution shall not be considered to be described in paragraph (2)(A) during the pe- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3841 riod that the child is an inmate of such institution pending disposition of charges.’’.

(c) EFFECTIVE DATE.—The amendments made by this section shall take effect on the first day of the first calendar quarter that begins after the date that is 24 months after the date of enactment of this Act and shall apply to items and services furnished for periods beginning on or after such date.

SEC.

5123.

REQUIRING ACCURATE, UPDATED, AND SEARCH- ABLE PROVIDER DIRECTORIES.
(a) APPLICATION TO MANAGED CARE.—Section 1932(a)(5) of the Social Security Act (42 U.S.C.
1396u– 13 2(a)(5)) is amended— (1) in subparagraph (B)(i), by inserting ‘‘, in- cluding as required by subparagraph (E)’’ before the period at the end; and (2) by adding at the end the following new sub- paragraph: ‘‘(E) PROVIDER DIRECTORIES.— ‘‘(i) IN GENERAL.—Each managed care organization, prepaid inpatient health plan (as defined by the Secretary), prepaid ambulatory health plan (as defined by the Secretary), and, when appropriate, primary care case management entity (as defined December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3842 by the Secretary) with a contract with a State to enroll individuals who are eligible for medical assistance under the State plan under this title or under a waiver of such plan, shall publish (and update on at least a quarterly basis or more frequently as re- quired by the Secretary) on a public website, a searchable directory of network providers, which shall include physicians, hospitals, pharmacies, providers of mental health services, providers of substance use disorder services, providers of long term services and supports as appropriate, and such other providers as required by the Secretary, and that includes with respect to each such provider— ‘‘(I) the name of the provider; ‘‘(II) the specialty of the pro- vider; ‘‘(III) the address at which the provider provides services; ‘‘(IV) the telephone number of the provider; and ‘‘(V) information regarding— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3843 ‘‘(aa) the provider’s cultural and linguistic capabilities, includ- ing languages (including Amer- ican Sign Language) offered by the provider or by a skilled med- ical interpreter who provides in- terpretation services at the pro- vider’s office; ‘‘(bb) whether the provider is accepting as new patients, in- dividuals who receive medical as- sistance under this title; ‘‘(cc) whether the provider’s office or facility has accommoda- tions for individuals with physical disabilities, including offices, exam rooms, and equipment; ‘‘(dd) the Internet website of such provider, if applicable; and ‘‘(ee) whether the provider offers covered services via tele- health; and ‘‘(VI) other relevant information, as required by the Secretary.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3844 ‘‘(ii) NETWORK PROVIDER DE- FINED.—In this subparagraph, the term ‘network provider’ includes any provider, group of providers, or entity that has a network provider agreement with a man- aged care organization, a prepaid inpatient health plan (as defined by the Secretary), a prepaid ambulatory health plan (as de- fined by the Secretary), or a primary care case management entity (as defined by the Secretary) or a subcontractor of any such entity or plan, and receives payment under this title directly or indirectly to order, refer, or render covered services as a result of the State’s contract with the entity or plan.
For purposes of this subparagraph, a network provider shall not be considered to be a subcontractor by virtue of the network provider agreement.’’.

(b) CONFORMING AMENDMENTS TO STATE PLAN RE- QUIREMENTS.—Section 1902(a) of the Social Security Act (42 U.S.C.

1396a) is amended— (1) by striking paragraph (83) and inserting the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3845 ‘‘(83) provide that in the case of a State plan (or waiver of the plan) that provides medical assist- ance on a fee-for-service basis or through a primary care case-management system described in section 1915(b)(1), the State shall publish (and update on at least a quarterly basis or more frequently as re- quired by the Secretary) on the public website of the State agency administering the State plan, a search- able directory of the providers described in sub- section (mm) that, in addition to such other require- ments as the Secretary may specify, such as making paper directories available to enrollees, includes with respect to each such provider— ‘‘(A) the name of the provider; ‘‘(B) the specialty of the provider; ‘‘(C) the address at which the provider provides services; ‘‘(D) the telephone number of the provider; ‘‘(E) information regarding— ‘‘(i) the provider’s cultural and lin- guistic capabilities, including languages (including American Sign Language) of- fered by the provider or by a skilled med- ical interpreter who provides interpretation services at the provider’s office; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3846 ‘‘(ii) whether the provider is accepting as new patients individuals who receive medical assistance under this title; ‘‘(iii) whether the provider’s office or facility has accommodations for individuals with physical disabilities, including offices, exam rooms, and equipment; ‘‘(iv) the Internet website of such pro- vider, if applicable; and ‘‘(v) whether the provider offers cov- ered services via telehealth; and ‘‘(F) other relevant information as re- quired by the Secretary;’’; and (2) by striking subsection (mm) and inserting the following: ‘‘(mm) DIRECTORY PROVIDER DESCRIBED.— ‘‘(1) IN GENERAL.—A provider described in this subsection, at a minimum, includes physicians, hos- pitals, pharmacies, providers of mental health serv- ices, providers of substance use disorder services, providers of long term services and supports as ap- propriate, and such other providers as required by the Secretary, and— ‘‘(A) in the case of a provider or a provider type for which the State agency, as a condition December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3847 of receiving payment for items and services fur- nished by the provider to individuals eligible to receive medical assistance under the State plan (or a waiver of the plan), requires the enroll- ment of the provider with the State agency, in- cludes a provider that— ‘‘(i) is enrolled with the agency as of the date on which the directory is pub- lished or updated (as applicable) under subsection (a)(83); and ‘‘(ii) received payment under the State plan in the 12-month period preceding such date; and ‘‘(B) in the case of a provider or a provider type for which the State agency does not re- quire such enrollment, includes a provider that received payment under the State plan (or a waiver of the plan) in the 12-month period pre- ceding the date on which the directory is pub- lished or updated (as applicable) under sub- section (a)(83).
‘‘(2) STATE OPTION TO INCLUDE OTHER PAR- TICIPATING PROVIDERS.—At State option, a pro- vider described in this subsection may include any provider who furnishes services and is participating December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3848 under the State plan under this title or under a waiver of such plan.’’.
(c) GENERAL APPLICATION TO CHIP.—Section 2107(e)(1)(G) of the Social Security Act (42 U.S.C.

1397gg(e)(1)(G)) is amended by inserting ‘‘and subsection (a)(83) of section 1902 (relating to searchable directories of the providers described in subsection (mm) of such sec- tion)’’ before the period.

(d) EFFECTIVE DATE.—The amendments made by this section shall take effect on July 1, 2025.

SEC.

5124.

SUPPORTING ACCESS TO A CONTINUUM OF CRI- SIS RESPONSE SERVICES UNDER MEDICAID AND CHIP.
(a) GUIDANCE.—Not later than July 1, 2025, the Secretary, in coordination with the Administrator of the Centers for Medicare & Medicaid Services and the Assist- ant Secretary for Mental Health and Substance Use, shall issue guidance to States regarding Medicaid and CHIP 19 that includes the following: (1) Provides, in consultation with health care providers and stakeholders with expertise in mental health and substance use disorder crisis response services, recommendations for an effective con- tinuum of crisis response services that— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3849 (A) includes crisis call centers, including 988 crisis services hotlines, mobile crisis teams, crisis response services delivered in home, com- munity, residential facility, and hospital set- tings, and coordination with follow-on mental health and substance use disorder services, such as intensive outpatient and partial hospitaliza- tion programs, as well as connections to social services and supports; (B) promotes access to appropriate and timely mental health and substance use disorder crisis response services in the least restrictive setting appropriate to an individual’s needs; and (C) promotes culturally competent, trau- ma-informed care, and crisis de-escalation.
(2) Outlines the Federal authorities through which States may finance and enhance under Med- icaid and CHIP the availability of crisis response services across each stage of the continuum of crisis response services.
(3) Addresses how States under Medicaid and CHIP may support the ongoing implementation of crisis call centers, including 988 crisis services hot- lines, and how Medicaid administrative funding, in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3850 cluding enhanced matching, and the Medicaid Infor- mation Technology Architecture 3.0 framework, may be used to establish or enhance regional or statewide crisis call centers, including 988 crisis services hot- lines, that coordinate in real time.
(4) Identifies how States under Medicaid and CHIP may support access to crisis response services that are responsive to the needs of children, youth, and families, including through CHIP health serv- ices initiatives, behavioral disorder-specific crisis re- sponse, trained peer support services, and estab- lishing or enhancing crisis call centers that are youth-focused.
(5) Identifies policies and practices to meet the need for crisis response services with respect to dif- fering patient populations, including urban, rural, and frontier communities, differing age groups, cul- tural and linguistic minorities, individuals with co- occurring mental health and substance use disorder conditions, and individuals with disabilities.

(6) Identifies policies and practices to promote evidence-based suicide risk screenings and assess- ments.
(7) Identifies strategies to facilitate timely pro- vision of crisis response services, including how December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3851 States can enable access to crisis response services without requiring a diagnosis, the use of presump- tive eligibility at different stages of the continuum of crisis response services, the use of telehealth to de- liver crisis response services, strategies to make cri- sis response services available 24/7 in medically un- derserved regions, and best practices used by States and health providers for maximizing capacity to de- liver crisis response services, such as identifying and repurposing available beds, space, and staff for crisis response services.
(8) Describes best practices for coordinating Medicaid and CHIP funding with other payors and sources of Federal funding for mental health and substance use disorder crisis response services, and best practices for Medicaid and CHIP financing when the continuum of crisis response services serves individuals regardless of payor.
(9) Describes best practices for establishing ef- fective connections with follow-on mental health and substance use disorder services, as well as with so- cial services and supports.

(10) Describes best practices for coordinating and financing a continuum of crisis response services through Medicaid managed care organizations, pre- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3852 paid inpatient health plans, prepaid ambulatory health plans, and fee-for-service delivery systems, in- cluding when States carve-out from delivery through Medicaid managed care organizations, prepaid inpa- tient health plans, prepaid ambulatory health plans, or fee-for-service systems, mental health or sub- stance use disorder benefits or a subset of such serv- ices.
(11) Identifies strategies and best practices for measuring and monitoring utilization of, and out- comes related to, crisis response services.
(b) TECHNICAL ASSISTANCE CENTER.— (1) IN GENERAL.—Not later than July 1, 2025, the Secretary, in coordination with the Adminis- trator of the Centers for Medicare & Medicaid Serv- ices and the Assistant Secretary for Mental Health and Substance Use, shall establish a technical assist- ance center to help States under Medicaid and CHIP design, implement, or enhance a continuum of crisis response services for children, youth, and adults.
Such technical assistance shall, at least in part, provide support to States in— (A) leveraging the Federal authorities through which Medicaid and CHIP may finance December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3853 mental health and substance use disorder crisis response services; (B) coordinating Medicaid and CHIP funds with other sources of Federal funding for mental health and substance use disorder crisis response services; and (C) after the guidance described in sub- section (a) is issued, adopting the best practices and strategies identified in such guidance.
(2) COMPENDIUM OF BEST PRACTICES.—The Secretary shall develop and maintain a publicly available compendium of best practices for the suc- cessful operation under Medicaid and CHIP of a continuum of crisis response services.

The Secretary annually shall review the information available through the compendium and shall update such in- formation when appropriate.
(c) FUNDING.—There is appropriated to the Sec- retary, out of any funds in the Treasury not otherwise appropriated, to remain available until expended for pur- poses of carrying out subsections (a) and (b), $8,000,000.

(d) DEFINITIONS.—In this section: (1) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Health and Human Services.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3854 (2) STATE.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

Subtitle D—Transitioning From Medicaid FMAP Increase Re- quirements SEC.

5131.

TRANSITIONING FROM MEDICAID FMAP IN- CREASE REQUIREMENTS.

(a) IN GENERAL.—Section 6008 of the Families First Coronavirus Response Act (42 U.S.C.
1396d note) 13 is amended— (1) in subsection (a)— (A) by striking ‘‘Subject to subsection (b)’’ and inserting the following: ‘‘(1) TEMPORARY FMAP INCREASE.—Subject to subsections (b) and (f)’’; (B) by striking ‘‘the last day of the cal- endar quarter in which the last day of such emergency period occurs’’ and inserting ‘‘De- cember 31, 2023’’; (C) by striking ‘‘6.2 percentage points’’ and inserting ‘‘the applicable number of per- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3855 centage points for the quarter (as determined in paragraph (2))’’; and (D) by adding at the end the following new paragraph: ‘‘(2) APPLICABLE NUMBER OF PERCENTAGE POINTS.—For purposes of paragraph (1), the appli- cable number of percentage points for a calendar quarter is the following: ‘‘(A) For each calendar quarter that occurs during the portion of the period described in paragraph (1) that ends on March 31, 2023, 6.2 percentage points.
‘‘(B) For the calendar quarter that begins on April 1, 2023, and ends on June 30, 2023, 5 percentage points.

‘‘(C) For the calendar quarter that begins on July 1, 2023, and ends on September 30, 2023, 2.5 percentage points.
‘‘(D) For the calendar quarter that begins on October 1, 2023, and ends on December 31, 2023, 1.5 percentage points.’’; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking ‘‘subsection (a)’’ and inserting ‘‘sub- section (a)(1)’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3856 (B) in paragraph (2), by striking ‘‘, with respect to an individual enrolled under such plan (or waiver),’’; and (C) in paragraph (3)— (i) by striking ‘‘as of the date of en- actment of this section’’ and inserting ‘‘as of March 18, 2020,’’; (ii) by striking ‘‘such date of enact- ment’’ and inserting ‘‘March 18, 2020,’’; (iii) by striking ‘‘the last day of the month in which the emergency period de- scribed in subsection (a) ends’’ and insert- ing ‘‘March 31, 2023,’’; and (iv) by striking ‘‘the end of the month in which such emergency period ends’’ and inserting ‘‘March 31, 2023,’’; (3) by redesignating the subsection (d) added by section 11 of division X of the Consolidated Ap- propriations Act, 2021 (Public Law 116–260) as subsection (e); and (4) by adding at the end the following new sub- sections: ‘‘(f) ELIGIBILITY REDETERMINATIONS DURING TRANSITION PERIOD.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3857 ‘‘(1) IN GENERAL.— For each calendar quarter occurring during the portion of the period described in subsection (a)(1) that begins on April 1, 2023, and ends on December 31, 2023 (such portion to be referred to in this subsection as the ‘transition pe- riod’), if a State described in such subsection satis- fies the conditions of subsection (b) and paragraph (2) of this subsection, the State shall receive the in- crease to the Federal medical assistance percentage of the State applicable under subsection (a).
Nothing in this subsection shall be construed as prohibiting a State, following the expiration of the condition de- scribed in paragraph (3) of subsection (b), from ini- tiating renewals, post-enrollment verifications, and redeterminations over a 12-month period for all indi- viduals who are enrolled in such plan (or waiver) as of April 1, 2023.
‘‘(2) CONDITIONS FOR FMAP INCREASE DURING TRANSITION PERIOD.—The conditions of this para- graph with respect to a State and the transition pe- riod are the following: ‘‘(A) COMPLIANCE WITH FEDERAL RE- QUIREMENTS.—The State conducts eligibility redeterminations under title XIX of the Social Security Act in accordance with all Federal re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3858 quirements applicable to such redeterminations, including renewal strategies authorized under section 1902(e)(14)(A) of the Social Security Act (42 U.S.C.

1396a(e)(14)(A)) or other alter- native processes and procedures approved by the Secretary of Health and Human Services.
‘‘(B) MAINTENANCE OF UP-TO-DATE CON- TACT INFORMATION.—The State, using the Na- tional Change of Address Database Maintained by the United States Postal Service, State health and human services agencies, or other reliable sources of contact information, at- tempts to ensure that it has up-to-date contact information (including a mailing address, phone number, and email address) for each individual for whom the State conducts an eligibility rede- termination.
‘‘(C) REQUIREMENT TO ATTEMPT TO CON- TACT BENEFICIARIES PRIOR TO DISENROLLMENT.—The State does not disenroll from the State plan or waiver any individual who is determined ineligible for medical assist- ance under the State plan or waiver pursuant to such a redetermination on the basis of re- turned mail unless the State first undertakes a December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3859 good faith effort to contact the individual using more than one modality.

‘‘(g) APPLICABLE QUARTERS.—A State that ceases to meet the requirements of subsection (b) or (f) (as appli- cable) shall not qualify for the increase described in sub- section (a) in the Federal medical assistance percentage for such State for the calendar quarter in which the State ceases to meet such requirements.’’.
(b) REPORTING AND ENFORCEMENT AND CORREC- TIVE ACTION.—Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended by adding at the end the 12 following new subsection: 13 14 15 ‘‘(tt) REQUIREMENTS RELATING TO TRANSITION FROM FAMILIES FIRST CORONAVIRUS RESPONSE ACT FMAP INCREASE REQUIREMENTS; ENFORCEMENT AND 16 CORRECTIVE ACTION.— ‘‘(1) REPORTING REQUIREMENTS.—For each month occurring during the period that begins on April 1, 2023, and ends on June 30, 2024, each State shall submit to the Secretary, on a timely basis, a report, that the Secretary shall make pub- licly available, on the activities of the State relating to eligibility redeterminations conducted during such period, and which include, with respect to the month December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3860 for which the report is submitted, the following in- formation: ‘‘(A) The number of eligibility renewals initiated, beneficiaries renewed on a total and ex parte basis, and individuals whose coverage for medical assistance, child health assistance, or pregnancy-related assistance was terminated.

‘‘(B) The number of individuals whose cov- erage for medical assistance, child health assist- ance, or pregnancy-related assistance was so terminated for procedural reasons.
‘‘(C) Where applicable, the number of indi- viduals who were enrolled in a State child health plan or waiver in the form described in paragraph (1) of section 2101(a).
‘‘(D) Unless the Administrator of the Cen- ters for Medicare & Medicaid Services reports such information on behalf of the State: ‘‘(i) In a State with a Federal or State American Health Benefit Exchange established under title I of the Patient Protection and Affordable Care Act in which the systems used to determine eligi- bility for assistance under this title or title XXI are not integrated with the systems December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3861 used to determine eligibility for coverage under a qualified health plan with advance payment under section 1412(a) of the Pa- tient Protection and Affordable Care Act of any premium tax credit allowed under section 36B of the Internal Revenue Code of 1986— ‘‘(I) the number of individuals whose accounts were received via se- cure electronic transfer by the Federal or State American Health Benefit Ex- change, or a basic health program es- tablished under section 1331 of the Patient Protection and Affordable Care Act; ‘‘(II) the number of individuals identified in subclause (I) who were determined eligible for a qualified health plan, as defined in section 1301(a)(1) of the Patient Protection and Affordable Care Act, or (if appli- cable) the basic health program estab- lished under section 1331 of such Act; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3862 ‘‘(III) the number of individuals identified in subclause (II) who made a qualified health plan selection or were enrolled in a basic health pro- gram plan (if applicable).
‘‘(ii) In a State with a State American Health Benefit Exchange established under title I of the Patient Protection and Af- fordable Care Act in which the systems used to determine eligibility for assistance under this title or title XXI are integrated with the systems used to determine eligi- bility for coverage under a qualified health plan with advance payment under section 1412(a) of the Patient Protection and Af- fordable Care Act of any premium tax credit allowed under section 36B of the In- ternal Revenue Code of 1986— ‘‘(I) the number of individuals who were determined eligible for a qualified health plan, as defined in section 1301(a)(1) of the Patient Pro- tection and Affordable Care Act, or (if applicable) the basic health program December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3863 established under section 1331 of such Act; and ‘‘(II) the number of individuals identified in subclause (I) who made a qualified health plan selection or were enrolled in a basic health program plan (if applicable).

‘‘(E) The total call center volume, average wait times, and average abandonment rate (as determined by the Secretary) for each call cen- ter of the State agency responsible for admin- istering the State plan under this title (or a waiver of such plan) during such month.
‘‘(F) Such other information related to eli- gibility redeterminations and renewals during the period described in paragraph (1), as identi- fied by the Secretary.
‘‘(2) ENFORCEMENT AND CORRECTIVE AC- TION.— ‘‘(A) IN GENERAL.—For each fiscal quar- ter that occurs during the period that begins on July 1, 2023, and ends on June 30, 2024, if a State does not satisfy the requirements of para- graph (1), the Federal medical assistance per- centage determined for the State for the quar- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3864 ter under section 1905(b) shall be reduced by the number of percentage points (not to exceed 1 percentage point) equal to the product of 0.25 percentage points and the number of fiscal quarters during such period for which the State has failed to satisfy such requirements.
‘‘(B) CORRECTIVE ACTION PLAN; ADDI- TIONAL AUTHORITY.— ‘‘(i) IN GENERAL.—The Secretary may assess a State’s compliance with all Federal requirements applicable to eligi- bility redeterminations and the reporting requirements described in paragraph (1), and, if the Secretary determines that a State did not comply with any such re- quirements during the period that begins on April 1, 2023, and ends on June 30, 2024, the Secretary may require the State to submit and implement a corrective ac- tion plan in accordance with clause (ii).
‘‘(ii) CORRECTIVE ACTION PLAN.—A State that receives a written notice from the Secretary that the Secretary has deter- mined that the State is not in compliance December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3865 with a requirement described in clause (i) shall— ‘‘(I) not later than 14 days after receiving such notice, submit a correc- tive action plan to the Secretary; ‘‘(II) not later than 21 days after the date on which such corrective ac- tion plan is submitted to the Sec- retary, receive approval for the plan from the Secretary; and ‘‘(III) begin implementation of such corrective action plan not later than 14 days after such approval.
‘‘(iii) EFFECT OF FAILURE TO SUBMIT OR IMPLEMENT A CORRECTIVE ACTION PLAN.—If a State fails to submit or imple- ment an approved corrective action plan in accordance with clause (ii), the Secretary may, in addition to any reduction applied under subparagraph (A) to the Federal medical assistance percentage determined for the State and any other remedy avail- able to the Secretary for the purpose of carrying out this title, require the State to suspend making all or some terminations December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3866 of eligibility for medical assistance from the State plan under this title (including any waiver of such plan) that are for pro- cedural reasons until the State takes ap- propriate corrective action, as determined by the Secretary, and may impose a civil money penalty of not more than $100,000 for each day a State is not in compli- ance.’’.

(c) EFFECTIVE DATE.—The amendments made by this section take effect on April 1, 2023.

Subtitle E—Medicaid Improvement Fund SEC.

5141.

MEDICAID IMPROVEMENT FUND.


Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C.

1396w–1(b)(3)(A)) is amended by striking ‘‘for fis- cal year 2025 and thereafter, $0’’ and inserting ‘‘for fiscal year 2028 and thereafter, $7,000,000,000’’.

TITLE VI—HUMAN SERVICES SEC.

6101.

JACKIE WALORSKI MATERNAL AND CHILD HOME VISITING REAUTHORIZATION ACT OF 2022.
(a) SHORT TITLE.—This section may be cited as the ‘‘Jackie Walorski Maternal and Child Home Visiting Re- authorization Act of 2022’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3867 (b) OUTCOMES DASHBOARD.—Section 511(d)(1) of the Social Security Act (42 U.S.C.
711(d)(1)) is amend- ed— (1) in the paragraph heading, by striking ‘‘BENCHMARK AREAS’’ and inserting ‘‘BENCHMARK AREAS RELATED TO INDIVIDUAL FAMILY OUT- COMES’’; (2) in subparagraph (D)(i), by striking ‘‘(B)’’ and inserting ‘‘(C)’’; and (3) by redesignating subparagraphs (B) through (D) as subparagraphs (C) through (E), re- spectively, and inserting after subparagraph (A) the following: ‘‘(B) OUTCOMES DASHBOARDS.—The Sec- retary shall, directly or by grant or contract, es- tablish and operate a website accessible to the public that includes an annually updated dash- board that— ‘‘(i) provides easy-to-understand infor- mation on the outcomes achieved by each eligible entity with respect to each of the benchmarks described in subparagraph (A) of this paragraph that apply to the eligible entity, which shall be based on only the data elements or types of data collected be- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3868 fore the date of the enactment of this sec- tion unless administering agencies and the Secretary agree pursuant to subsection (h)(6) that additional data is required; ‘‘(ii) includes a template provided by the Secretary that will enable comparison among eligible entities not referred to in subsection (k)(2)(A) of— ‘‘(I) a profile of each eligible en- tity showing outcome indicators and how the outcomes compare to bench- marks described in subclause (II); ‘‘(II) information on the outcome indicators and requisite outcome levels established for each eligible entity; ‘‘(III) information on each model employed in the program operated by each eligible entity, and regarding each benchmark area described in subsection (d)(1)(A) in which the model used by the eligible entity is ex- pected to affect participant outcomes; ‘‘(IV) the most recently available information from the report required December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3869 by subparagraph (E) of this para- graph; ‘‘(V) an electronic link to the State needs assessment under sub- section (b)(1); and ‘‘(VI) information regarding any penalty imposed, or other corrective action taken, by the Secretary against a State for failing to achieve a req- uisite outcome level or any other re- quirement imposed by or under this section, and an indication as to whether the eligible entity is operating under a corrective action plan under subparagraph (E)(ii) of this para- graph, and if so, a link to the plan, an explanation of the reason for the im- plementation of the plan, and a report on any progress made in operating under the plan; ‘‘(iii) includes information relating to those eligible entities for which funding is reserved under subsection (k)(2)(A), with modifications as necessary to reflect tribal December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3870 sovereignty, data privacy, and participant confidentiality; and ‘‘(iv) protects data privacy and con- fidentiality of participant families.’’.

(c) FUNDING.— (1) GRANT AMOUNTS.— (A) IN GENERAL.—Section 511(c)(4) of the Social Security Act (42 U.S.C.
711(c)(4)) is amended to read as follows: ‘‘(4) GRANT AMOUNTS.— ‘‘(A) BASE GRANTS.— ‘‘(i) IN GENERAL.— ‘‘(I) GENERAL RULE.—With re- spect to each of fiscal years 2023 through 2027 for which an eligible en- tity not referred to in subsection (k)(2)(A) is awarded a base grant under this section, the amount of the grant payable to the eligible entity for the fiscal year is the amount described by clause (ii) of this subparagraph with respect to the eligible entity, ex- cept as provided in subclause (II) of this clause.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3871 ‘‘(II) SUBSTITUTION OF SUC- CESSOR ELIGIBLE ENTITY FOR PRED- ECESSOR.—If the 1st fiscal year for which an eligible entity is awarded a base grant under this section for a program operated in a State is among fiscal years 2024 through 2027, the amount described by clause (ii) with respect to the eligible entity is the amount of the base grant for which a program operated in the State was eli- gible under this subparagraph for fis- cal year 2023.
‘‘(ii) AMOUNT DESCRIBED.— ‘‘(I) GENERAL RULE.—Subject to the succeeding provisions of this clause, the amount described by this clause with respect to an eligible enti- ty is— ‘‘(aa) the amount made available under subsection (k) for base grants for fiscal year 2023 that remains after making the reservations required by sub- section (k)(2) or any other reduc- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3872 tions required by Federal law for fiscal year 2023; multiplied by ‘‘(bb) the percentage of chil- dren in all States who have not attained 5 years of age (as deter- mined by the Secretary on the basis of the data most recently available before fiscal year 2023) that is represented by the num- ber of such children in the State in which the eligible entity is op- erating a program pursuant to this section (as so determined).
‘‘(II) ADJUSTMENTS TO ENSURE STABLE FUNDING.—If the amount otherwise payable to an eligible entity under subclause (I) for fiscal year 2023 is less than 90 percent, or great- er than 110 percent, of the amount payable under this section to the eligi- ble entity for the program for fiscal year 2021, the Secretary shall in- crease the amount otherwise so pay- able to 90 percent, or decrease the amount otherwise so payable to 110 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3873 percent, as the case may be, of the amount otherwise so payable.
‘‘(III) ADJUSTMENT TO ENSURE ALL BASE GRANT FUNDS ARE ALLO- CATED.—If the amount described by subclause (I)(aa) is different than the total of the amounts otherwise de- scribed by subclause (I) after applying subclause (II), the Secretary shall in- crease or decrease the amounts other- wise so described after applying sub- clause (II) by such equal percentage as is necessary to reduce that dif- ference to zero.
‘‘(IV) MINIMUM BASE GRANT AMOUNT.—Notwithstanding the pre- ceding provisions of this clause, the amount described by this clause with respect to an eligible entity shall be not less than $1,000,000.

‘‘(B) MATCHING GRANTS.— ‘‘(i) AMOUNT OF GRANT.— ‘‘(I) GENERAL RULE.—With re- spect to each of fiscal years 2024 through 2027 for which an eligible en- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3874 tity not referred to in subsection (k)(2)(A) is awarded a grant under this section, the Secretary shall in- crease the amount of the grant pay- able to the eligible entity for the fiscal year under subparagraph (A) of this paragraph by the matching amount (if any) determined under subclause (II) of this clause with respect to the eligi- ble entity for the fiscal year and the additional matching amount (if any) determined under clause (iii) of this subparagraph with respect to the eli- gible entity for the fiscal year.
‘‘(II) MATCHING AMOUNT.— ‘‘(aa) IN GENERAL.—Sub- ject to item (bb) of this sub- clause, the matching amount with respect to an eligible entity for a fiscal year is 75 percent of the sum of— ‘‘(AA) the total amount obligated by the eligible enti- ty for home visiting services in the State for the fiscal December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3875 December 19, 2022 (11:48 p.m.) year, from Federal funds made available for the fiscal year under this subpara- graph; and ‘‘(BB) the total amount so obligated by the eligible entity from non-Federal funds, determined under subclause (III).
‘‘(bb) LIMITATION.—The matching amount with respect to an eligible entity for a fiscal year shall not exceed the allotment under subclause (IV) for the State in which the eligible entity is operating a program under this section for the fiscal year.
‘‘(III) DETERMINATION OF OBLI- GATIONS FROM NON-FEDERAL FUNDS.—For purposes of this clause, the total amount obligated by an eligi- ble entity from non-Federal funds is the total of the amounts that are obli- gated by the eligible entity from non- Federal sources, to the extent that— U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3876 ‘‘(aa) the services are deliv- ered in compliance with sub- sections (d)(2) and (d)(3); ‘‘(bb) the eligible entity has reported the obligations to the Secretary; and ‘‘(cc) the amount is not counted toward meeting the maintenance of effort require- ment in subsection (f).
‘‘(IV) STATE ALLOTMENTS.—The amount allotted under this subclause for a State in which an eligible entity is operating a program under this sec- tion for a fiscal year is— ‘‘(aa) the minimum match- ing grant allocation amount for the fiscal year; plus ‘‘(bb)(AA) the amount (if any) by which the amount made available under subsection (k) for matching grants for the fiscal year that remains after making the reservations required by sub- section (k)(2) or any other reduc- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3877 tion required by Federal law for the fiscal year exceeds the sum of the minimum matching grant al- location amounts for all eligible entities for the fiscal year; multi- plied by ‘‘(BB) the percentage of children in all States who have not attained 5 years of age and are members of families with in- come not exceeding the poverty line (as determined by the Sec- retary on the basis of the most recently available data) that is represented by the number of such children in the State (as so determined).
‘‘(V) MINIMUM MATCHING GRANT ALLOCATION AMOUNT.—Subject to subclause (VI), for purposes of sub- clause (IV), the minimum matching grant allocation amount for a fiscal year is— ‘‘(aa) in the case of fiscal year 2024, $776,000; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3878 ‘‘(bb) in the case of fiscal year 2025, $1,000,000; ‘‘(cc) in the case of fiscal year 2026, $1,500,000; and ‘‘(dd) in the case of fiscal year 2027, $2,000,000.
‘‘(VI) SPECIAL RULE.—If, after making any reductions otherwise re- quired by law for a fiscal year, the amount made available for matching grants under this clause for the fiscal year is insufficient to provide the min- imum matching grant allocation amount to each eligible entity oper- ating a program under this section for the fiscal year, the Secretary may make a proportionate adjustment to the minimum matching grant alloca- tion amount for the fiscal year to ac- commodate the reductions.
‘‘(ii) SUBMISSION OF STATEMENT EX- PRESSING INTEREST IN ADDITIONAL MATCHING FUNDS IF AVAILABLE.—Before the beginning of a fiscal year for which an eligible entity desires a matching grant December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3879 under this subparagraph for a program op- erated under this section, the eligible entity shall submit to the Secretary a statement as to whether the eligible entity desires ad- ditional matching grant funds that may be made available under clause (iii) for the fiscal year.
‘‘(iii) CARRYOVER AND REALLOCATION OF UNOBLIGATED FUNDS.— ‘‘(I) IN GENERAL.—If the Sec- retary determines that an amount al- lotted under clause (i)(IV) of this sub- paragraph for a fiscal year will not be awarded during the fiscal year, or that an amount made available under subsection (k)(1) for a fiscal year for matching grants will not be obligated by an eligible entity for the fiscal year, the amount shall be available for matching grants under this subpara- graph for the succeeding fiscal year for eligible entities that have made submissions under clause (ii) of this subparagraph for additional matching grant funds from the amount.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3880 ‘‘(II) STATE ALLOTMENTS.—The Secretary shall allot to each eligible entity that has made such a submis- sion for a fiscal year— ‘‘(aa) the total amount (if any) made available under sub- clause (I) for the fiscal year; multiplied by ‘‘(bb) the percentage of chil- dren who have not attained 5 years of age and are members of families with income not exceed- ing the poverty line (as deter- mined by the Secretary on the basis of the most recently avail- able data) in all of the States in which any eligible entity that has made such a submission is so op- erating a program, that is rep- resented by the number of such children in the State (as so deter- mined) in which the eligible enti- ty is operating such a program.
‘‘(III) ADDITIONAL MATCHING AMOUNT.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3881 ‘‘(aa) IN GENERAL.—Sub- ject to item (bb) of this sub- clause, the additional matching amount with respect to an eligi- ble entity for a fiscal year is 75 percent of the sum of— ‘‘(AA) the total amount obligated by the eligible enti- ty for home visiting services in the State for the fiscal year, from Federal funds made available for the fiscal year under this subpara- graph; and ‘‘(BB) the total amount so obligated by the eligible entity from non-Federal funds, determined under clause (i)(III), that are not taken into account in determining the matching amount with respect to the eligi- ble entity under clause (i).
‘‘(bb) LIMITATION.—The additional matching amount with December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3882 respect to an eligible entity for a fiscal year shall not exceed the allotment under subclause (II) for the State in which the eligible entity is operating a program under this section for the fiscal year.’’.

(B) MAINTENANCE OF EFFORT.—Section 511(f) of such Act (42 U.S.C.
711) is amended to read as follows: ‘‘(f) MAINTENANCE OF EFFORT.— ‘‘(1) IN GENERAL.—Notwithstanding any other provision of this section, the Secretary may not make a grant to an eligible entity under this section for a fiscal year if the total amount of non-Federal funds obligated by the eligible entity in the State in the fiscal year for a program operated pursuant to this section is less than the total amount of non- Federal funds reported to have been expended by any eligible entity for such a program in the State in fiscal year 2019 or 2021, whichever is the lesser.
‘‘(2) PUBLICATION OF AMOUNTS.—Not later than June 30, 2023, the Secretary shall cause to have published in the Federal Register the amount of non-Federal funds expended as described in this December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3883 section that has been reported by each eligible entity not referred to in subsection (k)(2)(A) for each of fiscal years 2019 and 2021.
‘‘(3) GRACE PERIOD.—The Secretary may, in exceptional circumstances, allow an eligible entity a period to come into compliance with this subsection.

The Secretary shall provide technical assistance to any eligible entity to assist the entity in doing so.’’.

(2) RESERVATIONS OF FUNDS FOR CERTAIN PURPOSES.—Section 511(j)(2) of such Act (42 U.S.C.
711(j)(2)) is amended— (A) in the matter preceding subparagraph (A), by striking ‘‘the amount’’ and inserting ‘‘each amount made available for base grants and each amount made available for matching grants’’; (B) in subparagraph (A)— (i) by striking ‘‘3’’ and inserting ‘‘6’’; (ii) by inserting ‘‘and administering’’ before ‘‘grants’’; and (iii) by striking ‘‘and’’ at the end; and (C) by striking subparagraph (B) and in- serting the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3884 ‘‘(B) 2 percent of such amount for pur- poses of providing technical assistance, directly or through grants or contracts— ‘‘(i) for purposes as otherwise de- scribed in subsections (c)(5), (d)(1)(C)(iii), (d)(1)(E)(iii), and (d)(4)(E); and ‘‘(ii) to entities referred to in subpara- graph (A) of this paragraph; ‘‘(C) 2 percent of such amount for pur- poses of the provision of workforce support, re- tention, and case management, including work- force-related technical assistance, to eligible en- tities, research and evaluation, and program ad- ministration, directly or through grants or con- tracts, of which the Secretary shall use not more than $1,500,000 to establish and operate the Jackie Walorski Center for Evidence-Based Case Management; and ‘‘(D) 3 percent of such amount for pur- poses of research and evaluation (directly or through grants or contracts), and for admin- istering this section (directly, through contracts, or otherwise).’’.
(3) APPROPRIATIONS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3885 (A) IN GENERAL.—Section 511(j)(1) of the Social Security Act (42 U.S.C.
711(j)(1)) is amended by striking subparagraphs (A) through (H) and inserting the following: ‘‘(A) for fiscal year 2023, $500,000,000 for base grants; ‘‘(B) for fiscal year 2024, $550,000,000, of which $500,000,000 shall be for base grants and $50,000,000 shall be for matching grants; ‘‘(C) for fiscal year 2025, $600,000,000, of which $500,000,000 shall be for base grants and $100,000,000 shall be for matching grants; ‘‘(D) for fiscal year 2026, $650,000,000, of which $500,000,000 shall be for base grants and $150,000,000 shall be for matching grants; and ‘‘(E) for fiscal year 2027, $800,000,000, of which $500,000,000 shall be for base grants and $300,000,000 shall be for matching grants.’’.
(B) SPECIAL RULE.—Obligations and ex- penditures made pursuant to section 201 of di- vision D of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (Public Law 117–180) and section 201 of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3886 division C of the Further Continuing Appro- priations and Extensions Act, 2023 shall be charged to the appropriation made by section 511(j)(1)(A) of the Social Security Act for fis- cal year 2023 (as added by subparagraph (A) of this paragraph).

(C) REPEAL.—Section 201 of title II of di- vision D of Public Law 117–180 and section 201 of division C of the Further Continuing Appropriations and Extensions Act, 2023 are hereby repealed.
(4) DISPOSITION OF EXCESS FUNDS RESERVED FOR RESEARCH, EVALUATION, AND ADMINISTRA- TION.—Section 511(j) of the Social Security Act (42 U.S.C.
711(j)) is amended by adding at the end the following: ‘‘(5) DISPOSITION OF EXCESS FUNDS RE- SERVED FOR RESEARCH, EVALUATION, AND ADMIN- ISTRATION.—To the extent that the amounts re- served under paragraph (2)(D) for a fiscal year are not obligated in the fiscal year, the Secretary may use the funds for any purpose described in this sec- tion or to offset any reduction with respect to this section that is required by Federal law.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3887 (d) REQUIREMENT THAT HOME VISITING PROGRAMS BE TARGETED AND INTENSIVE.—Section 511(d)(3) of the Social Security Act (42 U.S.C.
711(d)(3)) is amended by redesignating subparagraph (B) as subparagraph (C) and inserting after subparagraph (A) the following: ‘‘(B) USE OF GRANT TO PROVIDE OR SUP- PORT TARGETED, INTENSIVE HOME VISITING SERVICES.—The program uses the grant to pro- vide or support targeted, intensive home visiting services for the populations described in para- graph (5).’’.
(e) LIMITATION ON USE OF FUNDS FOR ADMINIS- TRATION.— (1) IN GENERAL.—Section 511(d) of the Social Security Act (42 U.S.C.
711(d)) is amended by add- ing at the end the following: ‘‘(5) LIMITATION ON USE OF FUNDS FOR AD- MINISTRATIVE COSTS.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B) of this paragraph, an eligible entity to which funds are provided under sub- section (c) or (h)(2)(B) shall not use more than 10 percent of the funds to cover the costs of ad- ministration.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3888 ‘‘(B) AUTHORITY TO GRANT EXCEP- TIONS.— ‘‘(i) IN GENERAL.—The Secretary may authorize an eligible entity that meets a condition of clause (ii) of this subpara- graph to exceed the percentage limitation in subparagraph (A) with respect to a pro- gram conducted under this subsection by not more than 5 percentage points, subject to such terms and conditions as the Sec- retary deems appropriate.
‘‘(ii) CONDITIONS.—An eligible entity meets a condition of this clause if the eligi- ble entity— ‘‘(I) conducts the program by di- rectly providing home visits to eligible families and without a sub-recipient; ‘‘(II) in the fiscal year for which the grant for the program is made under this section, proposes to expand services in 1 or more communities identified in the statewide needs as- sessment under subsection (b) and in which home visiting services are not provided; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3889 ‘‘(III) has conducted the program for fewer than 3 years.’’.

(2) CONFORMING AMENDMENTS.—Section 511(i)(2) of such Act (42 U.S.C.

711(i)(2)) is amended by striking subparagraph (C) and redesig- nating subparagraphs (D) through (G) as subpara- graphs (C) through (F), respectively.

(f) ANNUAL REPORT TO CONGRESS.— (1) IN GENERAL.—Section 511 of the Social Security Act (42 U.S.C.
711) is amended by redesig- nating subsections (j) and (k) as subsections (k) and (l), respectively, and inserting after subsection (i) the following: ‘‘(j) ANNUAL REPORT TO CONGRESS.—By December 31, 2023, and annually thereafter, the Secretary shall sub- mit to the Congress a written report on the grants made under this section for the then preceding fiscal year, which shall include— ‘‘(1) an eligible entity-by-eligible entity sum- mary of the outcomes measured by the entity with respect to each benchmark described in subsection (e)(5) that apply to the entity; ‘‘(2) information regarding any technical assist- ance funded under subparagraph (B) or (C) of sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3890 section (k)(2), including the type of any such assist- ance provided; ‘‘(3) information on the demographic makeup of families served by each such entity to the extent pos- sible while respecting participant confidentiality, in- cluding race, ethnicity, educational attainment at en- rollment, household income, and other demographic markers as determined by the Secretary; ‘‘(4) the information described in subsection (d)(1)(E); ‘‘(5) the estimated share of the eligible popu- lation served using grants made under this section; ‘‘(6) a description of each service delivery model funded under this section by the eligible entities in each State, and the share (if any) of the grants ex- pended on each model; ‘‘(7) a description of non-Federal expenditures by eligible entities to qualify for matching funds under subsection (c)(4); ‘‘(8) information on the uses of funds reserved under subsection (k)(2)(C); ‘‘(9) information relating to those eligible enti- ties for which funding is reserved under subsection (k)(2)(A), with modifications as necessary to reflect December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3891 tribal data sovereignty, data privacy, and participant confidentiality; and ‘‘(10) a list of data elements collected from eli- gible entities, and the purpose of each data element in measuring performance or enforcing requirements under this section.’’.

(2) CONFORMING AMENDMENTS.— (A) Section 511 of such Act (42 U.S.C.
711) is amended— (i) in subsection (b)(1)(B)(iii), by striking ‘‘(k)(2)’’ and inserting ‘‘(l)(2)’’; and (ii) in subsection (h)(2)(B)— (I) by striking ‘‘(j)’’ and insert- ing ‘‘(k)’’; and (II) by striking ‘‘(k)(1)(B)’’ and inserting ‘‘(l)(1)(B)’’.

(B) Section 511A(c) of such Act (42 U.S.C.

711a(c)) is amended in each of para- graphs (5) and (7) by striking ‘‘511(k)(2)’’ and inserting ‘‘511(l)(2)’’.

(g) REDUCTION OF ADMINISTRATIVE BURDEN.— Section 511(h) of the Social Security Act (42 U.S.C.
711(h)) is amended by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3892 ‘‘(6) REDUCTION OF ADMINISTRATIVE BUR- DEN.— ‘‘(A) IN GENERAL.—The Secretary shall reduce the burden, on States and public and private implementing agencies at the local level, of administering this section, by— ‘‘(i) reviewing and revising adminis- trative data collection instruments and forms to eliminate duplication and stream- line reporting requirements for States, eli- gible entities referred to in subsection (k)(2)(A), and nonprofit organizations re- ferred to in subsection (l)(1)(B), including timelines for submitting reports; ‘‘(ii) conducting an analysis of the total number of hours reported by admin- istering agencies on complying with paper- work requirements, and exploring, in con- sultation with administering agencies, ways to reduce the number of hours spent by at least 15 percent; ‘‘(iii) conducting a review of paper- work and data collection requirements for tribal grantees, and exploring, in consulta- tion with tribes and tribal organizations, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3893 ways to reduce administrative burden, re- spect sovereignty, and acknowledge the dif- ferent focus points for tribal grantees; ‘‘(iv) collecting input from relevant State fiscal officials to align fiscal require- ments and oversight for States and eligible entities to ensure consistency with stand- ards and guidelines for other Federal for- mula grant programs; and ‘‘(v) consulting with administering agencies and service delivery model rep- resentatives on needed and unneeded data elements regarding the dashboards pro- vided for in subsection (d)(1)(B), con- sistent with the data requirements of such subsection.
‘‘(B) FINDINGS ON PAPERWORK REDUC- TION.— ‘‘(i) INCLUSION IN REPORT.—In the 1st report submitted pursuant to sub- section (j) more than 18 months after the date of the enactment of this Act, the Sec- retary shall include the findings of the Sec- retary with respect to the matters de- scribed in subparagraph (A).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3894 ‘‘(ii) IMPLEMENTATION.—Within 2 years after complying with clause (i), the Secretary shall implement the findings re- ferred to in clause (i).’’.

(h) VIRTUAL HOME VISITING AUTHORIZATION AND RESTRICTIONS.— (1) VIRTUAL HOME VISITS.— (A) APPLICATION REQUIREMENTS.—Sec- tion 511(e) of the Social Security Act (42 U.S.C.
711(e)) is amended by redesignating paragraph (10) as paragraph (11) and inserting after paragraph (9) the following: ‘‘(10) At the option of the eligible entity— ‘‘(A) a description of any limitations or constraints on virtual home visits under the program, including— ‘‘(i) a description of the plan of the el- igible entity to encourage in-person home visits; and ‘‘(ii) a description of the consider- ations to be used in determining when a virtual home visit is appropriate, including client consent, client preference, geographic limitations, model fidelity, and hazardous conditions including public health emer- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3895 gencies, weather events, health concerns for home visitors and client families, and other local issues; ‘‘(B) an assurance that— ‘‘(i) the virtual home visit is imple- mented as a model enhancement; or ‘‘(ii) the Secretary has identified the home visit as part of an effective model or model adaptation, based on an evidence of effectiveness review conducted using the criteria established under subsection (d)(3)(A)(iii); and ‘‘(C) an assurance to the Secretary that at least 1 in-person home visit shall be conducted for each client family under the program during the 12-month period that begins with the entry of the client family into the program, and dur- ing each succeeding 12-month period, except that any such period in which a public health emergency declared under Federal law, or under the law of the State in which the pro- gram is conducted, is in effect shall be extended by the length of time in which the declaration is in effect.’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3896 (B) APPLICABLE RULES.—Section 511(d) of such Act (42 U.S.C.
711(d)) is amended by redesignating paragraph (4) and paragraph (5) (as added by subsection (e)(1) of this section) as paragraphs (5) and (6), respectively, and in- serting after paragraph (3) the following: ‘‘(4) VIRTUAL HOME VISITS.— ‘‘(A) IN GENERAL.—A virtual home visit conducted under the program shall be consid- ered a home visit for purposes of this section if the application for funding of the program sub- mitted pursuant to this section most recently after the effective date of this paragraph in- cludes the material described in subsection (e)(10).
‘‘(B) STANDARDS FOR TRAINING APPLICA- BLE TO VIRTUAL SERVICE DELIVERY.—The standards for training requirements applicable to virtual service delivery under a home visiting model shall be equivalent to those that apply to in-person service delivery under the model.
‘‘(C) REPORTING REQUIREMENT.—A grant made under this section for the program may not be used for any virtual home visit during a year, unless the eligible entity to which the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3897 grant is made submits the report described in subsection (e)(8)(A) for the year.
‘‘(D) VIRTUAL HOME VISIT DEFINED.—In this section, the term ‘virtual home visit’ means a visit conducted solely by use of electronic in- formation and telecommunications technologies.
‘‘(E) TECHNICAL ASSISTANCE.—If the Secretary finds that an eligible entity has not complied with the assurance described in sub- section (e)(10)(C), the Secretary shall, directly or through grants, contracts, or cooperative agreements, provide the eligible entity with such technical assistance as is necessary to assist the eligible entity in doing so.’’.

(C) PROGRAM REQUIREMENT.—Section 511(d)(3)(C) of such Act (42 U.S.C.
711(d)(3)(C)), as so redesignated by subsection (d) of this section, is amended by adding at the end the following: ‘‘(vii) If the application submitted by the eligible entity includes the assurance described in subsection (e)(10)(C) with re- spect to the program, the program pro- vides in-person service consistent with the assurances.’’.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3898 (D) REPORTS.—Section 511(e)(8)(A) of such Act (42 U.S.C.
711(e)(8)(A)) is amended by inserting ‘‘, including the number of virtual home visits conducted under the program in the year covered by the report, disaggregated with respect to each home visiting model under which the virtual home visits are conducted’’ before the semicolon.
(2) TRANSITION RULE.— (A) IN GENERAL.—A virtual home visit conducted before the effective date of the amendments made by this subsection under an early childhood home visitation program funded under section 511 of the Social Security Act shall be considered a home visit for purposes of such section.

(B) VIRTUAL HOME VISIT DEFINED.—In subparagraph (A), the term ‘‘virtual home visit’’ means a visit conducted solely by use of electronic information and telecommunications technologies.
(i) EFFECTIVE DATE.— (1) IN GENERAL.—Except as provided in para- graph (2), this section and the amendments made by this section shall take effect on October 1, 2022.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3899 (2) VIRTUAL HOME VISITING PROVISIONS.—The amendments made by subsection (h) shall take effect on October 1, 2023.

SEC.

6102.
SEC.

6102.

EXTENSION OF TEMPORARY ASSISTANCE FOR NEEDY FAMILIES PROGRAM.

Activities authorized by part A of title IV (other than under section 403(c) or 418) and section 1108(b) of the Social Security Act shall continue through September 30, 2023, in the manner authorized for fiscal year 2022, and out of any money in the Treasury of the United States not otherwise appropriated, there are hereby appropriated such sums as may be necessary for such purpose.

SEC.

6103.
SEC.

6103.

1-YEAR EXTENSION OF CHILD AND FAMILY SERV- ICES PROGRAMS.

(a) The following provisions of the Social Security Act are each amended by striking ‘‘2022’’ and inserting 17 ‘‘2023’’: (1) Section 436(a) (42 U.S.C.

629f(a)).

(2) Section 436(b)(4)(A) (42 U.S.C.

629f(b)(4)(A)).

(3) Section 436(b)(5) (42 U.S.C.

629f(b)(5)).

(4) Section 438(d) (42 U.S.C.

629h(d)).


(b) The following provisions of the Social Security Act are each amended by striking ‘‘2021’’ and inserting 25 ‘‘2023’’: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3900 (1) Section 425 (42 U.S.C.

625).

(2) Section 437(a) (42 U.S.C.

629g(a)).

(3) Section 437(f)(3)(A) (42 U.S.C.

629g(f)(3)(A)).

(4) Section 437(f)(10) (42 U.S.C.

629g(f)(10)).

DIVISION GG—MERGER FILING FEE MODERNIZATION SEC.

1.

SHORT TITLE.
1.

SHORT TITLE.

This division may be cited as the ‘‘Merger Filing Fee Modernization Act of 2022’’.

TITLE I—MODERNIZING MERG- ER FILING FEE COLLEC- TIONS; ACCOUNTABILITY RE- LIMITATION QUIREMENTS; ON FUNDING SEC.

101.

MODIFICATION OF PREMERGER NOTIFICATION FILING FEES.

(a) AMENDMENTS.—Section 605 of Public Law 101– 162 (15 U.S.C.
18a note) is amended— (1) in subsection (b)— (A) in paragraph (1)— (i) by striking ‘‘$45,000’’ and insert- ing ‘‘$30,000’’; (ii) by striking ‘‘$100,000,000’’ and inserting ‘‘$161,500,000’’; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3901 (iii) by striking ‘‘September 30, 2004, in the same manner as provided in section 8(a)(5) of the Clayton Act (15 U.S.C.
19(a)(5)) to reflect the percentage change in the gross national product for such fis- cal year compared to the gross national product for the year ending September 30, 2003’’ and inserting ‘‘September 30, 2023, in accordance with subsection (c)’’; (B) in paragraph (2)— (i) by striking ‘‘$125,000’’ and insert- ing ‘‘$100,000’’; (ii) by striking ‘‘$100,000,000’’ and inserting ‘‘$161,500,000’’; (iii) by striking ‘‘but less’’ and insert- ing ‘‘but is less’’; and (iv) by striking ‘‘and’’ at the end; (C) in paragraph (3)— (i) by striking ‘‘$280,000’’ and insert- ing ‘‘$250,000’’; and (ii) by striking the period at the end and inserting ‘‘but is less than $1,000,000,000 (as so adjusted and pub- lished);’’; and (D) by adding at the end the following: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3902 ‘‘(4) $400,000 if the aggregate total amount determined under section 7A(a)(2) of the Clayton Act (15 U.S.C.

18a(a)(2)) is not less than $1,000,000,000 (as so adjusted and published) but is less than $2,000,000,000 (as so adjusted and published); ‘‘(5) $800,000 if the aggregate total amount determined under section 7A(a)(2) of the Clayton Act (15 U.S.C.
18a(a)(2)) is not less than $2,000,000,000 (as so adjusted and published) but is less than $5,000,000,000 (as so adjusted and published); and ‘‘(6) $2,250,000 if the aggregate total amount determined under section 7A(a)(2) of the Clayton Act (15 U.S.C.
18a(a)(2)) is not less than $5,000,000,000 (as so adjusted and published).’’; and (2) by adding at the end the following: ‘‘(c)(1) For each fiscal year commencing after Sep- tember 30, 2023, the filing fees in this section shall be increased by an amount equal to the percentage increase, if any, in the Consumer Price Index, as determined by the Department of Labor or its successor, for the year then ended over the level so established for the year ending September 30, 2022.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3903 ‘‘(2) As soon as practicable, but not later than Janu- ary 31 of each year, the Federal Trade Commission shall publish the adjusted amounts required by paragraph (1).

‘‘(3) The Federal Trade Commission shall not adjust amounts required by paragraph (1) if the percentage in- crease described in paragraph (1) is less than 1 percent.
‘‘(4) An amount adjusted under this section shall be rounded to the nearest multiple of $5,000.’’.

(b) EFFECTIVE DATE.—The amendments made by subsection (a) shall take effect on October 1, 2024.

SEC.

102.

REPORTING REQUIREMENTS FOR MERGER FEE COLLECTIONS.

(a) FTC AND DOJ JOINT REPORT.—For each of fis- cal years 2024 through 2027, the Federal Trade Commis- sion and Department of Justice shall jointly and annually report to the Congress on the operation of section 7A of the Clayton Act (15 U.S.C.
18a) and shall include in such 18 report the following: (1) The amount of funds made available to the Federal Trade Commission and the Department of Justice, respectively, from the premerger notification filing fees under section 605 of Public Law 101–162 (15 U.S.C.

18a note), as amended by section 101(a) of this division, as compared to the funds made available to the Federal Trade Commission and the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3904 Department of Justice, respectively, from premerger notification filing fees as the fees were determined in fiscal year 2023.

(2) The total revenue derived from premerger notification filing fees, by tier, by the Federal Trade Commission and the Department of Justice, respec- tively.

(3) The gross cost of operations of the Federal Trade Commission, by Budget Activity, and the Antitrust Division of the Department of Justice, re- spectively.
(b) FTC REPORT.—The Federal Trade Commission shall include in the report required under subsection (a), in addition to the requirements under subsection (a), for the previous fiscal year— (1) for actions with respect to which the record of the vote of each member of the Federal Trade Commission is on the public record of the Federal Trade Commission, a list of each action with respect to which the Federal Trade Commission took or de- clined to take action on a 3 to 2 vote; and (2) for all actions for which the Federal Trade Commission took a vote, the percentage of such ac- tions that were decided on a 3 to 2 vote.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3905 (c) SUMMARY.—The Federal Trade Commission and the Department of Justice shall make the report required under subsection (a) available to the Committee on the Judiciary of the Senate and the Committee of the Judici- ary of the House of Representatives, and shall, for fiscal years 2024 through 2027, no later than July 1, present a summary of the joint annual report for the preceding fiscal year, including the information required in sub- sections (a) and (b) of this section, to such Committees.
TITLE II—DISCLOSURE OF SUB- SIDIES BY FOREIGN ADVER- SARIES SEC.

201.

FINDINGS AND PURPOSE.
(a) FINDINGS.—Congress finds the following: (1) Foreign subsidies, which can take the form of direct subsidies, grants, loans (including below- market loans), loan guarantees, tax concessions, preferential government procurement policies, or government ownership or control, can distort the competitive process by enabling the subsidized firm to submit a bid higher than other firms in the mar- ket, or otherwise change the incentives of the firm in ways that undermine competition following an ac- quisition.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3906 (2) Foreign subsidies are particularly problem- atic when granted by countries or entities that con- stitute a strategic or economic threat to United States interests.
(3) The Made in China 2025 plan, states that the Chinese Communist Party will ‘‘support enter- prises to carry out mergers and acquisitions (M&A), equity investment, and venture capital overseas’’.
(4) The 2020 report to Congress from the bi- partisan U.S.-China Economic and Security Review Commission concluded that the Chinese Government subsidizes companies with a goal of their expanding into the United States and other countries, finding that ‘‘[t]his process assists Chinese national cham- pions in surpassing and supplanting global market leaders’’.
The report warns that the risk is particu- larly acute when it comes to emerging technologies, where China seeks to ‘‘surpass and displace the United States altogether [and that] [f]ailure to ap- preciate the gravity of this challenge and defend U.S. competitiveness would be dire .

.

.

[and] risks setting back U.S. economic and technological progress for decades’’.
(5) In remarks before the Hudson Institute on December 8, 2020, FTC Commissioner Noah Phil- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3907 lips stated, ‘‘[O]ne area where antitrust needs to reckon with the strategic interests of other nations is when we scrutinize mergers or conduct involving state-owned entities .

.

.

companies that are con- trolled, to varying degrees, by the state .

.

.
.

.

[and] often are a government tool for implementing indus- trial policies or to protect national security’’.

(b) PURPOSE.—The purpose of this title is to require parties providing pre-merger notifications to include in the notification required under section 7A of the Clayton Act (15 U.S.C.

18a) information concerning subsidies they re- ceive from countries or entities that are strategic or eco- nomic threats to the United States.

SEC.

202.

MERGERS INVOLVING FOREIGN GOVERNMENT SUBSIDIES.


(a) DEFINITION.—In this section, the term ‘‘foreign entity of concern’’ has the meaning given the term in sec- tion 40207(a) of the Infrastructure Investment and Jobs Act (42 U.S.C.

18741(a)).

20 21 22 23 24 (b) ACCOUNTING FOR FOREIGN GOVERNMENT SUB- SIDIES.—A person required to file a notification under section 7A of the Clayton Act (15 U.S.C.
18a) that re- ceived a subsidy from a foreign entity of concern shall in- clude in such notification content regarding such subsidy.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3908 (c) AUTHORITY OF ANTITRUST REGULATORS.—The Federal Trade Commission, with the concurrence of the Assistant Attorney General in charge of the Antitrust Di- vision of the Department of Justice, and in consultation with the Chairperson of the Committee on Foreign Invest- ment in the United States, the Secretary of Commerce, the Chair of the United States International Trade Com- mission, the United States Trade Representative, and the heads of other appropriate agencies, and by rule in accord- ance with section 553 of title 5, United States Code, shall require that the notification required under subsection (b) be in such form and contain such documentary material and information relevant to a proposed acquisition as is necessary and appropriate to enable the Federal Trade Commission and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice to determine whether such acquisition may, if consummated, 18 violate the antitrust laws.
19 20 (d) EFFECTIVE DATE.—Subsection (b) shall take ef- fect on the date on which the rule described in subsection 21 (c) takes effect.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3909 TITLE III—VENUE FOR STATE ANTITRUST ENFORCEMENT SEC.

301.

VENUE FOR STATE ANTITRUST ENFORCEMENT.


(a) IN GENERAL.—Section 1407 of title 28, United States Code, is amended— (1) in subsection (g)— (A) by inserting ‘‘or a State’’ after ‘‘United States’’; and (B) by striking ‘‘; but shall not include sec- tion 4A of the Act of October 15, 1914, as added July 7, 1955 (69 Stat.

282; 15 U.S.C.

15a)’’; and (2) by striking subsection (h).


(b) APPLICABILITY.—The amendments made by sub- section (a) shall apply to any matter pending on, or filed on or after, the date of enactment of this Act.

DIVISION HH—AGRICULTURE SEC.

101.

DEFINITION.

In this division, the term ‘‘Secretary’’ means the Sec- retary of Agriculture.

21 22 23 24 25 TITLE I—CONSERVATION SEC.

201.

GREENHOUSE GAS TECHNICAL ASSISTANCE PRO- VIDER AND THIRD-PARTY VERIFIER PRO- GRAM.
(a) DEFINITIONS.—In this section: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3910 (1) ADVISORY COUNCIL.—The term ‘‘Advisory Council’’ means the Greenhouse Gas Technical As- sistance Provider and Third-Party Verifier Program Advisory Council established under subsection (f)(1).
(2) AGRICULTURE OR FORESTRY CREDIT.—The term ‘‘agriculture or forestry credit’’ means a credit representing an amount of greenhouse gas emissions from an agricultural or forestry activity that are prevented, reduced, or mitigated (including through the sequestration of carbon) as a result of an agri- cultural or forestry activity.
(3) BEGINNING, SOCIALLY DISADVANTAGED, LIMITED RESOURCE, OR VETERAN FARMER, RANCH- ER, OR PRIVATE FOREST LANDOWNER.—The term ‘‘beginning, socially disadvantaged, limited resource, or veteran farmer, rancher, or private forest land- owner’’ means a farmer, rancher, or private forest landowner who is— (A) a beginning farmer or rancher (as de- fined in section 2501(a) of the Food, Agri- culture, Conservation, and Trade Act of 1990 (7 U.S.C.
2279(a))); (B) a socially disadvantaged farmer or rancher (as defined in section 355(e) of the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3911 Consolidated Farm and Rural Development Act (7 U.S.C.
2003(e))); (C) a limited resource farmer or rancher (as defined in section 1470.3 of title 7, Code of Federal Regulations (or successor regulations)); or (D) a veteran farmer (as defined in section 2501 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C.

2279)).
(4) COVERED ENTITY.—The term ‘‘covered en- tity’’ means a person or entity, including a private business, non-profit organization, or public agency, that either— (A) is a provider of technical assistance to farmers, ranchers, or private forest landowners in carrying out sustainable land use manage- ment practices that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon); or (B) is a third-party verifier entity that conducts the verification of the processes de- scribed in protocols for voluntary environmental credit markets.
(5) GREENHOUSE GAS.—The term ‘‘greenhouse gas’’ means— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3912 (A) carbon dioxide; (B) methane; (C) nitrous oxide; and (D) any other gas that the Secretary, in consultation with the Advisory Council, deter- mines has been identified to have heat trapping qualities.
(6) PROGRAM.—The term ‘‘Program’’ means the Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program established under subsection (b).
(7) PROTOCOL.—The term ‘‘protocol’’ means a systematic approach for generating an agriculture or forestry credit, which follows a transparent and thorough science-based methodology (including 1 or more baseline scenarios)— (A) for the development of projects to pre- vent, reduce, or mitigate greenhouse gas emis- sions (including projects to sequester carbon); and (B) for demonstrating how to quantify, monitor, report, and verify the prevention, re- duction, or mitigation of greenhouse gas emis- sions by projects described in subparagraph (A).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3913 (8) SOCIALLY DISADVANTAGED GROUP.—The term ‘‘socially disadvantaged group’’ has the mean- ing given that term in section 355(e) of the Consoli- dated Farm and Rural Development Act (7 U.S.C.

2003(e)).
2003(e)).

(9) TECHNICAL ASSISTANCE.—The term ‘‘tech- nical assistance’’ means technical expertise, informa- tion, and tools to assist a farmer, rancher, or private forest landowner, who is engaged in or wants to en- gage in a project to prevent, reduce, or mitigate greenhouse gas emissions (including a project to se- quester carbon), as necessary to meet a protocol.
(10) VOLUNTARY ENVIRONMENTAL CREDIT MARKET.—The term ‘‘voluntary environmental cred- it market’’ means a voluntary market through which agriculture or forestry credits may be bought or sold.
(b) ESTABLISHMENT OF PROGRAM.— (1) DETERMINATION.— (A) IN GENERAL.—Not later than 270 days after the date of enactment of this Act, the Secretary shall make a determination of whether establishing a voluntary program to register covered entities that carry out activities December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3914 described in subsection (c)(2) will further each of the following purposes: (i) Facilitating the participation of farmers, ranchers, and private forest land- owners in voluntary environmental credit markets.

(ii) Facilitating the provision of tech- nical assistance, through covered entities, to farmers, ranchers, and private forest landowners to help overcome barriers to entry into voluntary environmental credit markets.
(iii) Ensuring that participating farm- ers, ranchers, and private forest land- owners receive fair distribution of revenues derived from the sale of an agriculture or forestry credit.

(iv) Increasing access for farmers, ranchers, and private forest landowners to resources relating to existing voluntary en- vironmental credit markets, including in- formation relating to the basic market structure and the various roles and quali- fications of different parties.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3915 (B) CONSIDERATIONS.—In making the de- termination under this paragraph, the Secretary shall consider the results of the assessment con- ducted under subsection (g)(2)(A) and any other relevant information.
(2) ESTABLISHMENT.—If the Secretary deter- mines under paragraph (1) that establishing such a program will further such purposes, the Secretary shall establish a voluntary program, to be known as the ‘‘Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program’’, to register cov- ered entities that carry out activities described in subsection (c).
(3) REPORT.—Not later than 90 days after making the determination under paragraph (1), the Secretary shall publish a report describing the rea- sons for such determination, including how estab- lishing a program under this subsection would or would not further each of the purposes described in paragraph (1)(A).
(c) PROTOCOLS, QUALIFICATIONS, AND ACTIVI- TIES.— 23 24 25 (1) WIDELY ACCEPTED PROTOCOLS AND QUALI- FICATIONS.—After providing public notice and at least a 60-day period for public comment, but not December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3916 later than 90 days after the date on which the Pro- gram is established, the Secretary shall publish— (A) a list of, and documents relating to, widely accepted protocols that are designed to ensure consistency, reliability, effectiveness, ef- ficiency, and transparency of voluntary environ- mental credit markets, including protocol docu- ments and details relating to— (i) calculations; (ii) sampling methodologies; (iii) voluntary environmental credit accounting principles; (iv) systems for verification, moni- toring, measurement, and reporting; and (v) methods to account for additionality, permanence, leakage, and, where appropriate, avoidance of double counting; and (B) descriptions of widely accepted quali- fications possessed by covered entities that pro- vide technical assistance to farmers, ranchers, and private forest landowners.
(2) ACTIVITIES.—A covered entity may register under the Program with respect to technical assist- ance or process verification the covered entity carries December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3917 out for activities that prevent, reduce, or mitigate greenhouse gas emissions, including— (A) land or soil carbon sequestration; (B) emissions reductions derived from fuel choice or reduced fuel use; (C) livestock emissions reductions, includ- ing emissions reductions achieved through— (i) feeds, feed additives, and the use of byproducts as feed sources; or (ii) manure management practices; (D) on-farm energy generation; (E) energy feedstock production; (F) fertilizer or nutrient use emissions re- ductions; (G) reforestation; (H) forest management, including improv- ing harvesting practices and thinning diseased trees; (I) prevention of the conversion of forests, grasslands, and wetlands; (J) restoration of wetlands or grasslands; (K) grassland management, including pre- scribed grazing; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3918 (L) current practices associated with pri- vate land conservation programs administered by the Secretary; and (M) such other activities, or combinations of activities, that the Secretary, in consultation with the Advisory Council, determines to be ap- propriate.
(3) INCLUSIONS.—In publishing the list of widely accepted protocols and the descriptions of widely accepted qualifications under paragraph (1), the Secretary, in consultation with the Advisory Council, shall include all relevant information relat- ing to market-based protocols, as appropriate, with regard to— (A) quantification; (B) verification; (C) additionality; (D) permanence; (E) reporting; and (F) other expertise, as determined by the Secretary.
(4) PERIODIC REVIEW.—As appropriate, the Secretary shall periodically review and revise the list and descriptions published under paragraph (1) to December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3919 include any additional protocols or qualifications de- scribed in paragraph (3).
(d) REGISTRATION, WEBSITE, AND PUBLICATION OF LISTS.— (1) REGISTRATION LIST.— (A) IN GENERAL.—Not later than 1 year after establishing the Program, the Secretary shall publish, through a website maintained by the Secretary, a registration list consisting of a list of covered entities that have submitted in- formation to the Secretary, which list the Sec- retary shall regularly update.
(B) REGISTRATION.—A covered entity may register under the Program to be included on the registration list by submitting to the Sec- retary, through a website maintained by the Secretary, information that— (i) shall include— (I) the region in which the cov- ered entity provides its services; (II) whether the covered entity is a technical assistance provider or a verifier; and (III) the protocols in which the covered entity has proficiency; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3920 (ii) may include additional informa- tion that— (I) has been identified by the Ad- visory Council in its initial assessment under subsection (g)(1) to ensure cer- tainty for producers in the market- place for agriculture or forestry cred- its; and (II) the Secretary determines is appropriate for inclusion.
(2) WEBSITE AND SOLICITATION.—During the 180-day period beginning on the date on which the Program is established, the Secretary shall publish, through an existing website maintained by the Sec- retary— (A) information describing how covered en- tities may register under the Program in ac- cordance with paragraph (1); (B) a list of the widely accepted protocols and qualifications published by the Secretary under subsection (c)(1); and (C) instructions and suggestions to assist farmers, ranchers, and private forest land- owners in facilitating the development of agri- culture or forestry credits and accessing vol- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3921 untary environmental credit markets, includ- ing— (i) through working with covered enti- ties registered under the Program; and (ii) by providing information relating to programs, registries, and protocols of programs and registries that provide mar- ket-based participation opportunities for working and conservation agricultural and forestry lands.
(3) PROGRAMMATIC INTEGRITY.—The Sec- retary shall ensure, to the maximum extent prac- ticable, that covered entities registered under the Program— (A) act in good faith to provide realistic es- timates of costs and revenues relating to activi- ties and verification of processes described in subsection (c)(2), as applicable to the covered entity; and (B) demonstrate expertise in, and are able to perform in accordance with, best manage- ment practices for agricultural and forestry ac- tivities that prevent, reduce, or mitigate green- house gas emissions (including through the se- questration of carbon).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3922 (4) REMOVAL FROM REGISTRATION LIST.— (A) IN GENERAL.— (i) REMOVAL.—The Secretary shall remove a covered entity from the registra- tion list under the Program if the Sec- retary determines that the covered entity has not acted in accordance with— (I) the information provided by the entity under paragraph (1)(B); or (II) best management practices for agricultural and forestry activities that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon).
(ii) DETERMINATION.—The Secretary may make a determination under clause (i)— (I) based on a periodic review of a representative sample of covered en- tities, which shall occur not less fre- quently than once each year; or (II) as necessary.

(B) APPEAL OF REMOVAL.— (i) IN GENERAL.—A covered entity that has been removed from the registra- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3923 tion list pursuant to subparagraph (A) may appeal the determination to the Sec- retary.
(ii) RE-REGISTRATION.—A covered entity that appeals a determination under clause (i) may re-register under the Pro- gram if the covered entity successfully proves, as determined by the Secretary, that the covered entity has acted in accord- ance with, as applicable— (I) the information provided by the entity under paragraph (1)(B); and (II) best management practices for agricultural and forestry activities that prevent, reduce, or mitigate greenhouse gas emissions (including through the sequestration of carbon).
(C) NOTIFICATION.—If the Secretary re- moves a covered entity from the registration list pursuant to subparagraph (A), to the extent practicable, the Secretary shall— (i) request from that covered entity contact information for all farmers, ranch- ers, and private forest landowners to which December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3924 the covered entity provided technical as- sistance or the verification of the processes described in protocols of voluntary environ- mental credit markets; and (ii) notify those farmers, ranchers, and private forest landowners of the re- moval.

(5) SAVINGS CLAUSE.—Nothing in this section authorizes the Secretary to compel a farmer, ranch- er, or private forest landowner to participate in a transaction or project facilitated by a covered entity certified under paragraph (1).
(e) SUBMISSION OF FRAUDULENT INFORMATION OR CLAIMS.— (1) IN GENERAL.—A person or entity, regard- less of whether the person or entity is registered under the Program, shall not make a fraudulent submission under subsection (d) or make a fraudu- lent claim regarding the presence of that person or entity on the registration list published under such subsection.
(2) PENALTY.—Any person or entity that vio- lates paragraph (1) shall be— (A) subject to a civil penalty equal to such amount as the Secretary determines to be ap- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3925 propriate, not to exceed $1,000 per violation; and (B) ineligible to register under the Pro- gram for the 5-year period beginning on the date of the violation.
(f) GREENHOUSE GAS TECHNICAL ASSISTANCE PRO- VIDER AND THIRD-PARTY VERIFIER PROGRAM ADVISORY COUNCIL.— (1) IN GENERAL.—During the 90-day period beginning on the date on which the Program is es- tablished, the Secretary shall establish an advisory council, to be known as the ‘‘Greenhouse Gas Tech- nical Assistance Provider and Third-Party Verifier Program Advisory Council’’.
(2) MEMBERSHIP.— (A) IN GENERAL.—The Advisory Council shall be composed of members appointed by the Secretary in accordance with this paragraph.

(B) GENERAL REPRESENTATION.—The Advisory Council shall— (i) be broadly representative of the ag- riculture and private forest sectors; (ii) include beginning, socially dis- advantaged, limited resource, and veteran December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3926 farmers, ranchers, and private forest land- owners; and (iii) be composed of not less than 51 percent farmers, ranchers, or private forest landowners.
(C) MEMBERS.—Members appointed under subparagraph (A) shall include— (i) not more than 2 representatives of the Department of Agriculture, as deter- mined by the Secretary; (ii) not more than 1 representative of the Environmental Protection Agency, as determined by the Administrator of the Environmental Protection Agency; (iii) not more than 1 representative of the National Institute of Standards and Technology; (iv) not fewer than 12 representatives of the agriculture industry, appointed in a manner that is broadly representative of the agriculture sector, including not fewer than 6 active farmers and ranchers; (v) not fewer than 4 representatives of private forest landowners or the forestry and forest products industry appointed in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3927 a manner that is broadly representative of the private forest sector; (vi) not more than 4 representatives of the relevant scientific research commu- nity, including not fewer than 2 represent- atives from land-grant colleges and univer- sities (as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C.
3103)), of which 1 shall be a representa- tive of a college or university eligible to re- ceive funds under the Act of August 30, 1890 (commonly known as the ‘‘Second Morrill Act’’) (26 Stat.

417, chapter 841; 7 U.S.C.

321 et seq.


), including Tuskegee University; (vii) not more than 2 experts or pro- fessionals familiar with voluntary environ- mental credit markets and the verification requirements in those markets; (viii) not more than 3 members of nongovernmental or civil society organiza- tions with relevant expertise, of which not fewer than 1 shall represent the interests of socially disadvantaged groups; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3928 (ix) not more than 3 members of pri- vate sector entities or organizations that participate in voluntary environmental credit markets; and (x) any other individual whom the Secretary determines to be necessary to ensure that the Advisory Council is com- posed of a diverse group of representatives of industry, academia, independent re- searchers, and public and private entities.
(D) CHAIR.—The Secretary shall designate a member of the Advisory Council to serve as the Chair.

(E) TERMS.— (i) IN GENERAL.—The term of a member of the Advisory Council shall be 2 years, except that, of the members first ap- pointed— (I) not fewer than 8 members shall serve for a term of 1 year; (II) not fewer than 12 members shall serve for a term of 2 years; and (III) not fewer than 12 members shall serve for a term of 3 years.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3929 (ii) ADDITIONAL TERMS.—After the initial term of a member of the Advisory Council, including the members first ap- pointed, the member may serve not more than 4 additional 2-year terms.

(3) MEETINGS.— (A) FREQUENCY.—The Advisory Council shall meet not less frequently than annually, at the call of the Chair.
(B) INITIAL MEETING.—During the 90-day period beginning on the date on which the members are appointed under paragraph (2)(A), the Advisory Council shall hold an ini- tial meeting.
(4) GENERAL DUTIES.—The Advisory Council shall— (A) periodically review and recommend any appropriate changes to— (i) the list of protocols and description of qualifications published by the Secretary under subsection (c)(1); and (ii) the activities described in sub- section (c)(1)(B); (B) make recommendations to the Sec- retary regarding the best practices that should December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3930 be included in the protocols, description of qualifications, and activities described in sub- paragraph (A); and (C) advise the Secretary regarding— (i) the current methods used by vol- untary environmental credit markets to quantify and verify the prevention, reduc- tion, or mitigation of greenhouse gas emis- sions (including the sequestration of car- bon); (ii) means to reduce barriers to entry in the business of providing technical as- sistance or the verification of the processes described in protocols of voluntary environ- mental credit markets for covered entities, including by improving technical assistance provided by the Secretary; (iii) means to reduce compliance and verification costs for farmers, ranchers, and private forest landowners in entering voluntary environmental credit markets, in- cluding through mechanisms and processes to aggregate the value of activities across land ownership; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3931 (iv) issues relating to land and asset ownership in light of evolving voluntary en- vironmental credit markets; and (v) additional means to reduce bar- riers to entry in voluntary environmental credit markets for farmers, ranchers, and private forest landowners, particularly for beginning, socially disadvantaged, limited resource, and veteran farmers, ranchers, and private forest landowners.

(5) COMPENSATION.—The members of the Ad- visory Council shall serve without compensation.
(6) CONFLICT OF INTEREST.—The Secretary shall prohibit any member of the Advisory Council from— (A) engaging in any determinations or ac- tivities of the Advisory Council that may result in the favoring of, or a direct and predictable effect on— (i) the member or a family member, as determined by the Secretary; (ii) stock owned by the member or a family member, as determined by the Sec- retary; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3932 (iii) the employer of, or a business owned in whole or in part by, the member or a family member, as determined by the Secretary; or (B) providing advice or recommendations regarding, or otherwise participating in, mat- ters of the Advisory Council that— (i) constitute a conflict of interest under section 208 of title 18, United States Code; or (ii) may call into question the integ- rity of the Advisory Council, the Program, or the technical assistance or verification activities described under subsection (c)(2).
(7) FACA APPLICABILITY.—The Advisory Council shall be subject to the Federal Advisory Committee Act (5 U.S.C.

App.

), except that section 14(a)(2) of that Act shall not apply.
(g) ASSESSMENT.— (1) INITIAL ASSESSMENT.—Not later than 90 days after the Advisory Council holds an initial meeting, the Advisory Council shall submit to the Secretary, the Committee on Agriculture of the House of Representatives, and the Committee on Agriculture, Nutrition, and Forestry of the Senate December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3933 an initial assessment that examines ways to ensure certainty for farmers, ranchers, or private forest landowners in the marketplace for agriculture or for- estry credits, including identification of any informa- tion that may be appropriate for entities to provide when registering under subsection (d)(1)(B).
(2) GENERAL ASSESSMENT.—Not later than 240 days after the date of enactment of this Act, the Secretary, in consultation with the Administrator of the Environmental Protection Agency, shall— (A) conduct an assessment, which incor- porates information from existing publications and reports of the Department of Agriculture and other entities with relevant expertise, re- garding— (i) the number and categories of non- Federal actors in the nonprofit and for- profit sectors involved in development, gen- eration, or sale of agriculture or forestry credits in voluntary environmental credit markets; (ii) the estimated overall domestic market demand for agriculture or forestry credits at the end of the preceding 4-cal- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3934 endar year period, and historically, in vol- untary environmental credit markets; (iii) the total number of agriculture or forestry credits (measured in metric tons of carbon dioxide equivalent) that were es- timated to be in development, generated, or sold in market transactions during the preceding 4-calendar year period, and his- torically, in voluntary environmental credit markets; (iv) the estimated supply and demand of metric tons of carbon dioxide equivalent of offsets in the global marketplace for the next 4 years; (v) the barriers to entry due to com- pliance and verification costs described in subsection (f)(4)(C)(iii); (vi) the state of monitoring and meas- urement technologies needed to quantify long-term carbon sequestration in soils and from other activities to prevent, reduce, or mitigate greenhouse gas emissions in the agriculture and forestry sectors; (vii) means to reduce barriers to entry into voluntary environmental credit mar- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3935 kets for beginning, socially disadvantaged, limited resource, and veteran farmers, ranchers, and private forest landowners, and the extent to which existing protocols of voluntary environmental credit markets allow for aggregation of projects among farmers, ranchers, and private forest land- owners; (viii) the extent to which the existing regimes for generating and selling agri- culture or forestry credits (as the regimes exist at the end of the preceding 4-cal- endar year period, and historically), and existing voluntary environmental credit markets, may be impeded or constricted, or achieve greater scale and reach, if the De- partment of Agriculture were involved, in- cluding involvement in education described in clause (ix); (ix) the extent to which Department of Agriculture education of stakeholders about voluntary environmental credit mar- kets would benefit those stakeholders, in- cluding whether that education would re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3936 duce barriers to entry identified under clause (v); (x) the extent to which existing proto- cols of voluntary environmental credit mar- kets, including verification, additionality, permanence, and reporting, adequately take into consideration and account for factors encountered by the agriculture and private forest sectors in preventing, reduc- ing, or mitigating greenhouse gas emis- sions (including by sequestering carbon) through agriculture and forestry practices, considering variances across regions, to- pography, soil types, crop or species vari- eties, and business models; (xi) the extent to which existing proto- cols of voluntary environmental credit mar- kets consider options to ensure the contin- ued valuation, through discounting or other means, of agriculture and forestry credits in the case of the practices under- lying those credits being disrupted due to unavoidable events, including production challenges and natural disasters; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3937 (xii) opportunities for other voluntary markets outside of voluntary environmental credit markets to foster the trading, buy- ing, or selling of credits that are derived from activities that provide other eco- system service benefits, including activities that improve water quality, water quantity, wildlife habitat enhancement, and other ecosystem services, as the Secretary deter- mines appropriate; (B) publish the assessment; and (C) submit the assessment to the Com- mittee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agri- culture of the House of Representatives.
(3) QUADRIENNIAL ASSESSMENT.—The Sec- retary, in consultation with the Administrator of the Environmental Protection Agency and the Advisory Council, shall conduct the assessment described in paragraph (2)(A) and publish and submit such as- sessment in accordance with subparagraphs (B) and (C) of paragraph (2) every 4 years after the publica- tion and submission of the first assessment under subparagraphs (B) and (C) of paragraph (2).
(h) CONFIDENTIALITY.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3938 (1) PROHIBITION.— (A) IN GENERAL.—Except as provided in paragraph (2), the Secretary, any other officer or employee of the Department of Agriculture or any agency of the Department of Agri- culture, or any other person may not disclose to the public the information held by the Secretary described in subparagraph (B).
(B) INFORMATION.— (i) IN GENERAL.—Except as provided in clause (ii), the information prohibited from disclosure under subparagraph (A) is— (I) personally identifiable infor- mation, including in a contract or service agreement, of a farmer, ranch- er, or private forest landowner, ob- tained by the Secretary under sub- section (d)(4)(C)(i); and (II) confidential business infor- mation in a contract or service agree- ment of a farmer, rancher, or private forest landowner obtained by the Sec- retary under subsection (d)(4)(C)(i).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3939 (ii) AGGREGATED RELEASE.—Infor- mation described in clause (i) may be re- leased to the public if the information has been transformed into a statistical or ag- gregate form that does not allow the iden- tification of the person who supplied or is the subject of the particular information.
(2) EXCEPTION.—Paragraph (1) shall not pro- hibit the disclosure by an officer or employee of the Federal Government of information described in paragraph (1)(B) as otherwise directed by the Sec- retary or the Attorney General for enforcement pur- poses.

(i) FUNDING.— (1) AUTHORIZATION OF APPROPRIATIONS.—In addition to the amount made available under para- graph (2), there is authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2023 through 2027.
(2) DIRECT FUNDING.— (A) RESCISSION.—There is rescinded $4,100,000 of the unobligated balance of amounts made available by section 1003 of the American Rescue Plan Act of 2021 (Public Law 117–2).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3940 (B) APPROPRIATION.—If such unobligated amounts are available to execute the rescission under subparagraph (A), on the day after the execution of the rescission, there is appro- priated to the Secretary, out of amounts in the Treasury not otherwise appropriated, $4,100,000 to carry out this section to remain available for fiscal years 2023 through 2027.

(3) PROHIBITION.—None of the funds of the Commodity Credit Corporation shall be used to carry out this section.
(j) RULE OF CONSTRUCTION.—Nothing in this sec- tion shall be construed to provide authority to the Sec- retary for the establishment or operation of a Federal market through which agriculture or forestry credits may be bought or sold.

17 SEC.

202.

ACCEPTANCE AND USE OF PRIVATE FUNDS FOR PUBLIC-PRIVATE PARTNERSHIPS.

Section 1241(f) of the Food Security Act of 1985 (16 U.S.C.
3841(f)) is amended— (1) in the subsection heading, by inserting ‘‘FOR PUBLIC-PRIVATE PARTNERSHIPS’’ after ‘‘CONTRIBUTIONS’’; (2) by amending paragraph (1) to read as fol- lows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3941 ‘‘(1) ESTABLISHMENT OF PUBLIC-PRIVATE PARTNERSHIP CONTRIBUTIONS ACCOUNTS.—The Secretary shall establish the necessary accounts and process to accept contributions of private funds for the purposes of addressing the changing climate, se- questering carbon, improving wildlife habitat, pro- tecting sources of drinking water, and addressing other natural resource priorities identified by the Secretary.’’; (3) in paragraph (2), by striking ‘‘a conserva- tion program administered by the Secretary under subtitle D shall be deposited into the sub-account’’ and inserting ‘‘a covered program shall be deposited into the account’’; and (4) by adding at the end the following: ‘‘(3) SECRETARIAL AUTHORITY.— ‘‘(A) IN GENERAL.—The Secretary may accept under this subsection contributions of such funds as the Secretary determines appro- priate, taking into consideration— ‘‘(i) the source of the funds to be con- tributed; ‘‘(ii) the natural resource concerns to be addressed through the use of the funds; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3942 ‘‘(iii) the amount of funds to be con- tributed; ‘‘(iv) whether the activities proposed to be carried out using the funds are con- sistent with the priorities of the Secretary; and ‘‘(v) any other factors the Secretary determines to be relevant.

‘‘(B) DETERMINATION.—A determination of whether to accept private funds under this subsection shall be at the sole discretion of the Secretary.
‘‘(4) MATCH OF CONTRIBUTED FUNDS.— ‘‘(A) IN GENERAL.—Subject to subpara- graph (B), the Secretary may provide matching Federal funds, and determine the level of such match, which shall not exceed 75 percent, for the private funds contributed under this sub- section, subject to the availability of funding for the applicable covered program.
‘‘(B) DISTRIBUTION OF FEDERAL FUND- ING FOR STATES.—The Secretary may not pro- vide any matching Federal funds pursuant to subparagraph (A) in a manner that would re- sult in a substantial reduction in the historical December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3943 distribution of Federal funding to any State for any covered program.
‘‘(C) LIMITATION.—No funds made avail- able pursuant to Public Law 117–169 may be used to provide matching Federal funds pursu- ant to subparagraph (A).
‘‘(5) ROLE OF CONTRIBUTING ENTITY.—An en- tity contributing funds under this subsection may— ‘‘(A) designate the covered program for which the contributed funds are intended to be used; ‘‘(B) specify the geographic area in which the contributed funds are intended to be used; ‘‘(C) identify a natural resource concern the contributed funds are intended to be used to address; ‘‘(D) with respect to an activity funded pursuant to this subsection that may result in environmental services benefits to be sold through an environmental services market, sub- ject to the approval of the Secretary, prescribe the terms for ownership of the entity’s share of such environmental services benefits resulting from such activity; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3944 ‘‘(E) work with the Secretary to promote the activities funded pursuant to this sub- section.

‘‘(6) PRODUCER PARTICIPATION.— ‘‘(A) NOTIFICATION.—The Secretary shall establish a process to provide notice to pro- ducers— ‘‘(i) of activities that may be carried out, through a covered program, pursuant to this section; and ‘‘(ii) any terms prescribed by the con- tributing entity under paragraph (5)(D) with respect to such activities.
‘‘(B) RETENTION OF ENVIRONMENTAL SERVICES BENEFITS.—The Secretary shall not claim or impede any action of a producer with respect to the environmental services benefits they accrue through activities funded pursuant to this subsection.
‘‘(7) CONSISTENCY WITH PROGRAM REQUIRE- MENTS.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), the Secretary shall ensure that the terms and conditions of activities car- ried out using funds contributed under this sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3945 section are consistent with the requirements of the applicable covered program.
‘‘(B) ADJUSTMENTS.— ‘‘(i) IN GENERAL.—The Secretary may, if the Secretary determines necessary, adjust a regulatory requirement of a cov- ered program, or related guidance, as it applies to an activity carried out using funds contributed under this subsection— ‘‘(I) to provide a simplified proc- ess; or ‘‘(II) to better reflect unique local circumstances and to address a specific priority of the contributing entity.
‘‘(ii) LIMITATION.—The Secretary shall not adjust the application of statu- tory requirements for a covered program, including requirements governing appeals, payment limits, and conservation compli- ance.
‘‘(8) REPORT.—Not later than December 31, 2024, and each year thereafter through December 31, 2031, the Secretary shall submit to the Com- mittee on Agriculture of the House of Representa- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3946 tives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that contains— ‘‘(A) the name and a description of each entity contributing private funds under this subsection that took an action under paragraph (5), and a description of each such action; ‘‘(B) the name and a description of each entity contributing private funds under this subsection for which the Secretary has provided matching Federal funds, and the level of that match, including the amount of such matching Federal funds; and ‘‘(C) the total amounts of— ‘‘(i) private funds contributed under this subsection; and ‘‘(ii) matching Federal funds provided by the Secretary under paragraph (4).
‘‘(9) COVERED PROGRAM DEFINED.—In this subsection, the term ‘covered program’ means a pro- gram carried out by the Secretary under— ‘‘(A) subtitle D (except for subchapter B of such subtitle), subtitle H, or subtitle I; ‘‘(B) section 403 of the Agricultural Credit Act of 1978 (16 U.S.C.

2203); December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3947 ‘‘(C) title V of the Healthy Forests Res- toration Act of 2003 (16 U.S.C.

6571 et seq.

); or ‘‘(D) the Watershed Protection and Flood Prevention Act (16 U.S.C.

1001 et seq.

), except for any program established by the Secretary to carry out section 14 of such Act (16 U.S.C.

1012).

‘‘(10) DURATION OF AUTHORITY.—The author- ity of the Secretary under this subsection shall ex- pire, with respect to each covered program, on the date on which the authority of the covered program expires.’’.
TITLE II—COMMODITY FUTURES TRADING COMMISSION WHIS- TLEBLOWER PROGRAM SEC.

301.

IN GENERAL.

Section 1(b) of Public Law 117–25 (135 Stat.

297; 136 Stat.
297; 136 Stat.

2133) is amended— (1) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; (2) by inserting after paragraph (1) the fol- lowing: ‘‘(2) ADDITIONAL TRANSFERS.—In addition to amounts transferred under paragraph (1), the Com- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3948 mission may transfer up to $10,000,000 from the Fund into the account.’’; (3) in paragraph (3) (as so redesignated)— (A) by striking ‘‘paragraph (1)’’ and in- serting ‘‘paragraphs (1) and (2)’’; and (B) by striking ‘‘until’’ and all that follows through the period at the end and inserting ‘‘until October 1, 2024.’’; and (4) in paragraph (4) (as so redesignated), by striking ‘‘on’’ and all that follows through ‘‘shall’’ and inserting ‘‘on October 1, 2024, shall’’.

TITLE III—FORESTRY SEC.

401.


MODIFICATION OR TERMINATION OF EASEMENTS UNDER THE HEALTHY FORESTS RESERVE PROGRAM.

Section 502 of the Healthy Forests Restoration Act of 2003 (16 U.S.C.
6572) is amended by adding at the end the following: ‘‘(g) EASEMENT MODIFICATION OR TERMINATION.— ‘‘(1) IN GENERAL.—The Secretary may modify or terminate an easement or other interest in land administered by the Secretary under this title if— ‘‘(A) the owner of the land agrees to the modification or termination; and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3949 ‘‘(B) the Secretary determines that the modification or termination— ‘‘(i) will address a compelling public need for which there is no practicable al- ternative; and ‘‘(ii) is in the public interest.
‘‘(2) CONSIDERATION; CONDITIONS.— ‘‘(A) TERMINATION.—As consideration for termination of an easement or other interest in land under this subsection, the Secretary shall enter into a compensatory arrangement, as the Secretary determines to be appropriate.
‘‘(B) MODIFICATION.—In the case of a modification of an easement or other interest in land under this subsection— ‘‘(i) as a condition of the modification, the owner of the land shall enter into a compensatory arrangement, as the Sec- retary determines to be appropriate, to incur the costs of modification; and ‘‘(ii) the Secretary shall ensure that— ‘‘(I) the modification will not ad- versely affect the forest ecosystem functions and values for which the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3950 easement or other interest in land was acquired; ‘‘(II) any adverse impacts will be mitigated by enrollment and restora- tion of other land that provides great- er forest ecosystem functions and val- ues at no additional cost to the Fed- eral Government; and ‘‘(III) the modification will result in equal or greater environmental and economic values to the United States.’’.

TITLE IV—NUTRITION SEC.

501.

EBT BENEFIT FRAUD PREVENTION.
(a) GUIDANCE; RULEMAKING.—The Secretary shall— (1) issue guidance to State agencies, on an on- going basis, as informed by the process outlined in paragraph (4), that describes security measures that— (A) are effective, as determined by the Sec- retary, in detecting and preventing theft of ben- efits, including through card skimming, card cloning, and other similar fraudulent methods; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3951 (B) are consistent with industry standards for detecting, identifying, and preventing debit and credit card skimming, card cloning, and other similar fraudulent methods; and (C) consider the feasibility of cost, avail- ability, and implementation for States; (2) promulgate regulations through notice-and- comment rulemaking to require State agencies to take the security measures described in the guidance issued under paragraph (1); (3) not later than December 1, 2023, promul- gate regulations (including an interim final rule) to require State agencies to implement procedures for the replacement of benefits consistent with sub- section (b); (4) coordinate with the Administrator of the Administration for Children and Families of the De- partment of Health and Human Services, the Attor- ney General of the United States, State agencies, re- tail food stores, and EBT contractors— (A) to determine— (i) how benefits are being stolen through card skimming, card cloning, and other similar fraudulent methods; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3952 (ii) how those stolen benefits are used; and (iii) to the maximum extent prac- ticable, the locations where card skimming, card cloning, and other similar fraudulent methods are taking place; (B) to establish measures, including equip- ment enhancements for retail food stores, to prevent benefits from being stolen through card skimming, card cloning, and other similar fraudulent methods; and (C) to establish standard reporting meth- ods for States to collect and share data with the Secretary on the scope of benefits being stolen through card skimming, card cloning, and other similar fraudulent methods; and (5) not later than October 1, 2024, submit to the Committee on Agriculture, Nutrition, and For- estry of the Senate and the Committee on Agri- culture of the House of Representatives a report that includes— (A) to the maximum extent practicable, in- formation on the frequency of theft of benefits and the location of those thefts, including bene- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3953 fits stolen through card skimming, card cloning, and other similar fraudulent methods; (B) a description of the determinations made under paragraph (4)(A), the measures es- tablished under paragraph (4)(B), and methods established in paragraph (4)(C); (C) a description of the industry standards described in paragraph (1)(B); and (D) recommendations on how to consist- ently detect, track, report, and prevent theft of benefits, including benefits stolen through card skimming, card cloning, and other similar fraudulent methods.
(b) REPLACEMENT OF BENEFITS.—The Secretary shall use funds appropriated under section 18 of the Food and Nutrition Act of 2008 (7 U.S.C.
2027) to require States to replace benefits that are determined by the State agency to have been stolen through card skimming, card cloning, or similar fraudulent methods, subject to the con- ditions that— 21 22 23 24 (1) the State agency shall submit to the Sec- retary not later than 60 days after the date of the enactment of this Act for prior approval a plan for the replacement of stolen benefits that— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3954 (A) includes appropriate procedures, as de- termined by the Secretary, for the timely sub- mission of claims to, timely validation of claims by, and replacement issuance by the State agency that includes— (i) a signed statement by the affected household on the benefit theft, consistent with the signature requirements and op- tions provided by section 11(e)(2)(C) of the Food and Nutrition Act of 2008, as amended (7 U.S.C.
2020(e)(2)(C)); (ii) criteria to determine if a sub- mitted claim is valid; (iii) procedures for the documentation of replacement issuances, including the submitted claims and findings from the validation; (iv) the submission of data reports on benefit theft and replacement activity to the Secretary; (v) procedures to inform households of their right to a fair hearing, consistent with those already established by section 11(e) of the Food and Nutrition Act of 2008 (7 U.S.C.
2020(e)) and cor- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3955 responding regulations concerning replace- ment issuances; and (vi) the State agency’s use and planned use of benefit theft prevention measures, including any additional guid- ance that may be issued under subsection (a)(1); (B) includes appropriate procedures, as de- termined by the Secretary, for reporting the scope and frequency of card skimming affecting households within the State to the Secretary; (C) upon approval shall be incorporated into the State plan of operation required under section 11(e) of the Food and Nutrition Act of 2008 (7 U.S.C.
2020(e)); and (D) the Secretary may approve after the date on which guidance is issued under sub- section (a)(1); (2) the replacement of stolen benefits for a household— (A) shall not exceed the lesser of— (i) the amount of benefits stolen from the household; or (ii) the amount equal to 2 months of the monthly allotment of the household im- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3956 mediately prior to the date on which the benefits were stolen; (B) shall not occur more than 2 times per Federal fiscal year per household by a single State agency; and (C) shall only apply to benefits stolen dur- ing the period beginning on October 1, 2022, and ending on September 30, 2024; (3) plans approved under paragraph (1) will re- main in effect until the effective date of the rule pro- mulgated pursuant to subsection (a)(3); and (4) replacements of benefits under this section shall not be regarded as losses for the purpose of section 7(e) of the Food and Nutrition Act of 2008 (7 U.S.C.
2016(e)) to the extent such replacements are made in accordance with an approved plan that complies with this subsection.

(c) DEFINITIONS.—In this section, the terms ‘‘allot- ment’’, ‘‘benefit’’, ‘‘household’’, ‘‘retail food store’’, and ‘‘State agency’’ have the meaning given those terms in sec- tion 3 of the Food and Nutrition Act of 2008 (7 U.S.C.

1 2012).
23 24 25 (d) RESCISSION.—Of the unobligated balances made available for the Supplemental Nutrition Assistance Pro- gram as authorized by section 1101(b)(1) of the American December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3957 Rescue Plan Act of 2021 (Public Law 117–2), $8,000,000 is hereby rescinded.

SEC.

502.

INCREASING ACCESS TO SUMMER MEALS FOR CHILDREN THROUGH EBT AND ALTERNATIVE DELIVERY OPTIONS.
(a) AGREEMENTS.—Section 12(b) of the Richard B. Russell National School Lunch Act (42 U.S.C.

1760(b)) is amended— (1) by inserting ‘‘and Indian Tribal organiza- tions’’ after ‘‘State agencies’’ each place it appears; and (2) in paragraph (2)(B), in the matter pre- ceding clause (i), by inserting ‘‘and Indian Tribal or- ganization’’ before ‘‘budget’’.

(b) NONCONGREGATE MEALS.—Section 13 of the Richard B. Russell National School Lunch Act (42 U.S.C.
1761) is amended— (1) in subsection (a), by adding at the end the following: ‘‘(13) NONCONGREGATE MEALS.— ‘‘(A) IN GENERAL.—Beginning not later than summer 2023, the Secretary shall make available an option to States to provide pro- gram meals under this section for noncon- gregate consumption in a rural area with no December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3958 congregate meal service, as determined by the Secretary.
‘‘(B) SUMMER 2023.—Notwithstanding any other provision in this paragraph, for summer 2023, the Secretary may allow States to use im- plementation models developed by the Secretary for demonstration projects carried out under section 749(g) of the Agriculture, Rural Devel- opment, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat.

2132), to carry out subparagraph (A).
‘‘(C) ELIGIBILITY DETERMINATION.—In administering this paragraph, the Secretary shall ensure that noncongregate meals are only available for a child— ‘‘(i) in an area in which poor eco- nomic conditions exist; and ‘‘(ii) in an area that is not an area in which poor economic conditions exist, if the child is determined to be eligible for a free or reduced price lunch under this Act or a free or reduced price breakfast under sec- tion 4 of the Child Nutrition Act of 1966 (42 U.S.C.

1773).
1773).

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3959 ‘‘(D) PRIORITIES.— ‘‘(i) IN GENERAL.—States shall— ‘‘(I) identify areas with no con- gregate meal service that could benefit the most from the provision of non- congregate meals; and ‘‘(II) encourage participating service institutions in those areas to provide noncongregate meals as ap- propriate.
‘‘(ii) AREAS.—Areas identified under clause (i) may include areas that are not areas in which poor economic conditions exist but that have children who are deter- mined to be eligible for free or reduced price lunch under this Act or free or re- duced price breakfast under section 4 of the Child Nutrition Act of 1966 (42 U.S.C.

1773).
1773).

‘‘(E) ADMINISTRATION.—In administering this paragraph, the Secretary shall ensure that— ‘‘(i) any meal served for noncon- gregate consumption— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3960 ‘‘(I) meets all applicable State and local health, safety, and sanita- tion standards; and ‘‘(II) meets the requirements under subsection (f)(1); ‘‘(ii) over a 10-day calendar period, the number of reimbursable meals provided to a child does not exceed the number of meals that could be provided over a 10-day calendar period, as established under sub- section (b)(2); and ‘‘(iii) States establish a process for identifying gaps in service and barriers in reaching needy children for congregate and noncongregate models.
‘‘(F) REGULATIONS.—Not later than 1 year after the date of enactment of this para- graph, the Secretary shall promulgate regula- tions (which shall include interim final regula- tions) to carry out this section, including provi- sions— ‘‘(i) to ensure the integrity of the al- ternative option for program delivery de- scribed in subparagraph (A); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3961 ‘‘(ii) to incorporate best practices and lessons learned from noncongregate dem- onstration projects under section 749(g) of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat.
2132).’’; and (2) in subsection (n)— (A) by striking ‘‘by January 1 of each year of its intent to administer the program and shall submit for approval by February 15’’ and inserting ‘‘of its intent to administer the pro- gram and shall submit for approval by April 1, 2023,’’; (B) by striking ‘‘(1)’’ and inserting ‘‘(A)’’; (C) by striking ‘‘(2)’’ and inserting ‘‘(B)’’; (D) by striking ‘‘(3)’’ and inserting ‘‘(C)’’; (E) by striking ‘‘(4)’’ and inserting ‘‘(D)’’; (F) by striking ‘‘(5)’’ and inserting ‘‘(E)’’; (G) by striking ‘‘and (6)’’ and inserting ‘‘(F)’’; (H) by striking the period at the end and inserting ‘‘; and (G) the State’s plan for using the alternative option for program delivery de- scribed in subsection (a)(13), if applicable, in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3962 cluding plans to provide a reasonable oppor- tunity to access meals across all areas of the State.’’; (I) by striking the subsection designation and all that follows through ‘‘Each State’’ and inserting the following: ‘‘(n) MANAGEMENT AND ADMINISTRATION STATE PLANS.— ‘‘(1) SUMMER 2023.—Each State’’; and (J) by adding at the end the following: ‘‘(2) SUMMER 2024 AND BEYOND.—Beginning in 2024, each State desiring to participate in the program under this section or in the summer EBT program under section 13A shall notify the Sec- retary by January 1 of each year of its intent to ad- minister the applicable program and shall submit for approval by February 15 a management and admin- istration plan for the applicable program for the fis- cal year, which shall include, as applicable— ‘‘(A) the requirements listed in subpara- graphs (A) through (G) of paragraph (1); ‘‘(B) the administrative budget of the State for administering the summer EBT pro- gram under section 13A; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3963 ‘‘(C) the State’s plan to comply with the State requirements in section 13A(c) and any other standards prescribed by the Secretary under section 13A; ‘‘(D) the State’s plan to identify areas with no congregate meal service; ‘‘(E) the State’s plan to target priority areas identified under subsection (a)(13)(D)(i)(I); and ‘‘(F) the State’s plan to ensure that sum- mer EBT benefits (as described in section 13A(a)) are issued to children based on their school attendance at the end of the instruc- tional year immediately preceding such sum- mer.’’.
(c) SUMMER EBT.—The Richard B. Russell National School Lunch Act is amended by inserting after section 13 (42 U.S.C.

1761) the following: ‘‘SEC.

13A.

SUMMER ELECTRONIC BENEFITS TRANSFER FOR CHILDREN PROGRAM.
‘‘(a) PROGRAM ESTABLISHED.—The Secretary shall establish a program under which States and covered In- dian Tribal organizations electing to participate in such program shall, beginning with summer 2024 and annually for each summer thereafter, issue to each eligible house- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3964 hold summer electronic benefit transfer benefits (referred to in this section as ‘summer EBT benefits’)— ‘‘(1) in accordance with this section; and ‘‘(2) for the purpose of providing nutrition as- sistance through electronic benefit transfer or meth- ods described in clauses (ii) and (iii) of subsection (b)(2)(B) during the summer months for each eligi- ble child, to ensure continued access to food when school is not in session for the summer.
‘‘(b) SUMMER EBT BENEFITS REQUIREMENTS.— ‘‘(1) PURCHASE OPTIONS.— ‘‘(A) BENEFITS ISSUED BY STATES.— Summer EBT benefits issued pursuant to sub- section (a) by a State may only be used by the eligible household that receives such summer EBT benefits to purchase food (as defined in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C.
2012)) from retail food stores that have been approved for participation in the supplemental nutrition assistance program es- tablished under such Act and in accordance with section 7(b) of such Act (7 U.S.C.

2016(b)) or in the nutrition assistance program in American Samoa, the Commonwealth of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3965 Puerto Rico, and the Commonwealth of the Northern Mariana Islands.
‘‘(B) BENEFITS ISSUED BY COVERED IN- DIAN TRIBAL ORGANIZATIONS.—Summer EBT benefits issued pursuant to subsection (a) by a covered Indian Tribal organization may only be used by the eligible household that receives such summer EBT benefits to purchase supple- mental foods from vendors that have been ap- proved for participation in the special supple- mental nutrition program for women, infants, and children under section 17 of the Child Nu- trition Act of 1966 (42 U.S.C.

1786).
‘‘(2) AMOUNT.—Summer EBT benefits issued pursuant to subsection (a)— ‘‘(A) shall be— ‘‘(i) for calendar year 2024, in an amount equal to $40, which may be pro- portionately higher consistent with the ad- justments established under section 12(f) for each eligible child in the eligible house- hold per month during the summer oper- ational period; and ‘‘(ii) for calendar year 2025 and each year thereafter, in an amount equal to the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3966 unrounded benefit amount from the prior year, adjusted to the nearest lower dollar increment to reflect changes to the cost of the diet described in section 3(u) of the Food and Nutrition Act of 2008 (7 U.S.C.
2012(u)) for the 12-month period ending on November 30 of the preceding calendar year and rounded to the nearest lower dol- lar increment; and ‘‘(B) may be issued— ‘‘(i) in the form of an EBT card; ‘‘(ii) through other electronic meth- ods, as determined by the Secretary; or ‘‘(iii) in the case of a State that does not issue nutrition assistance program ben- efits electronically, using the same methods by which that State issues benefits under the nutrition assistance program of that State.
‘‘(3) ENFORCEMENT.—Summer EBT benefits issued pursuant to subsection (a) shall— ‘‘(A) be subject to sections 12, 14, and 15 of the Food and Nutrition Act of 2008 (7 U.S.C.

2021, 2023, 2024) and subsections (n), (o), and (p) of section 17 of the Child Nutrition December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3967 Act of 1966 (42 U.S.C.


1786), as applicable; and ‘‘(B) to the maximum extent practicable, incorporate technology tools consistent with in- dustry standards that track or prevent theft of benefits, cloning, or other fraudulent activities.
‘‘(4) TIMING.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), summer EBT benefits issued pursuant to subsection (a) may only be issued for the purpose of purchasing food dur- ing the summer months, with appropriate issuance and expungement timelines as deter- mined by the Secretary (but with an expungement timeline not to exceed 4 months).
‘‘(B) CONTINUOUS SCHOOL CALENDAR.— In the case of children who are under a contin- uous school calendar, the Secretary shall estab- lish alternative plans for the period during which summer EBT benefits may be issued pursuant to subsection (a) and used.
‘‘(c) ENROLLMENT IN PROGRAM.— ‘‘(1) STATE REQUIREMENTS.—States that elect to participate in the program under this section shall— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3968 ‘‘(A) with respect to summer, automati- cally enroll each eligible child who is directly certified, is an identified student (as defined in section 11(a)(1)(F)(i)), or is otherwise deter- mined by a school food authority to be eligible to receive free or reduced price meals in the in- structional year immediately preceding the sum- mer or during the summer operational period in the program under this section, without further application from households; ‘‘(B) make an application available for children who do not meet the criteria described in subparagraph (A) and make eligibility deter- minations using the eligibility criteria for free or reduced price lunches under this Act; ‘‘(C) establish procedures to carry out the enrollment described in subparagraph (A); ‘‘(D) establish procedures for expunging summer EBT benefits from the account of a household, consistent with the requirements under subsection (b)(4); and ‘‘(E) allow eligible households to opt out of participation in the program under this section and establish procedures for opting out of such participation.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3969 ‘‘(2) COVERED INDIAN TRIBAL ORGANIZATION REQUIREMENTS.—Covered Indian Tribal organiza- tions participating in the program under this section shall, to the maximum extent practicable, meet the requirements under paragraph (1).
‘‘(d) ADMINISTRATIVE EXPENSES.—The Secretary shall pay to each State agency and covered Indian Tribal organization an amount equal to 50 percent of the admin- istrative expenses incurred by the State agency or covered Indian Tribal organization in operating the program under this section, including the administrative expenses of local educational agencies and other agencies in each State or covered Indian Tribal organization relating to the operation of the program under this section.
‘‘(e) SUMMER EBT AUTHORITY.—Beginning in sum- mer 2024, the Secretary shall not allow States to use the authority in section 749(g) of the Agriculture, Rural De- velopment, Food and Drug Administration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat.

2132), to provide access to food through elec- tronic benefit transfer benefits to children during the sum- mer months when schools are not in regular session.
‘‘(f) ISSUANCE OF INTERIM FINAL REGULATIONS.— Not later than 1 year after the date of enactment of this section, the Secretary shall promulgate regulations (which December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3970 shall include interim final regulations) to carry out this section, including provisions that— ‘‘(1) incorporate best practices and lessons learned from demonstration projects under— ‘‘(A) section 749(g) of the Agriculture, Rural Development, Food and Drug Adminis- tration, and Related Agencies Appropriations Act, 2010 (Public Law 111–80; 123 Stat.

2132); and ‘‘(B) the pandemic EBT program under section 1101 of the Families First Coronavirus Response Act (7 U.S.C.
2011 note; Public Law 116–127); ‘‘(2) ensure timely and fair service to applicants for and recipients of benefits under this section; ‘‘(3) establish quality assurance and program integrity procedures to ensure that States and local educational agencies have adequate processes— ‘‘(A) to correctly determine the eligibility of children for benefits under this section; and ‘‘(B) to reliably enroll and issue benefits to eligible children; and ‘‘(4) allow States and covered Indian Tribal or- ganizations to streamline program administration, including by— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3971 ‘‘(A) automatically enrolling each eligible child who is able to be directly certified; and ‘‘(B) establishing a single summer oper- ational period.

‘‘(g) ADMINISTRATIVE AND MANAGEMENT PLAN.— Beginning in 2024, each State desiring to participate in the program under this section shall comply with the re- quirements under section 13(n).
‘‘(h) DEFINITIONS.—In this section: ‘‘(1) COVERED INDIAN TRIBAL ORGANIZA- TION.—The term ‘covered Indian Tribal organiza- tion’ means an Indian Tribal organization that par- ticipates in the special supplemental nutrition pro- gram for women, infants, and children established under section 17 of the Child Nutrition Act of 1966 (42 U.S.C.

1786).
1786).

‘‘(2) ELIGIBLE CHILD.—The term ‘eligible child’ means, with respect to a summer, a child who— ‘‘(A) was, at the end of the instructional year immediately preceding such summer or during the summer operational period— ‘‘(i) certified to receive free or reduced price lunch under the school lunch pro- gram under this Act; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3972 ‘‘(ii) certified to receive free or re- duced price breakfast under the school breakfast program under section 4 of the Child Nutrition Act of 1966 (42 U.S.C.
1773); or ‘‘(iii) able to be directly certified; ‘‘(B) was, at the end of the instructional year immediately preceding such summer— ‘‘(i) enrolled in a school described in subparagraph (B), (C), (D), (E), or (F) of section 11(a)(1); and ‘‘(ii)(I) an identified student (as de- fined in section 11(a)(1)(F)(i)); or ‘‘(II) a child who otherwise met the requirements to receive free or reduced price meals, as determined through an ap- plication process using the eligibility cri- teria for free or reduced price meals under this Act; or ‘‘(C) has been determined to be eligible for the program under this section in accordance with subsection (c)(1)(B).
‘‘(3) ELIGIBLE HOUSEHOLD.—The term ‘eligi- ble household’ means a household that includes at least 1 eligible child.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3973 ‘‘(4) SUPPLEMENTAL FOODS.—The term ‘sup- plemental foods’— ‘‘(A) means foods— ‘‘(i) containing nutrients determined by nutritional research to be lacking in the diets of children; and ‘‘(ii) that promote the health of the population served by the program under this section, as indicated by relevant nutri- tion science, public health concerns, and cultural eating patterns, as determined by the Secretary; and ‘‘(B) includes foods not described in sub- paragraph (A) substituted by State agencies, with the approval of the Secretary, that— ‘‘(i) provide the nutritional equivalent of foods described in such subparagraph; and ‘‘(ii) allow for different cultural eating patterns than foods described in such sub- paragraph.’’.
(d) AMENDMENTS TO P-EBT FOR SUMMER 2023.— Section 1101(i) of the Families First Coronavirus Re- sponse Act (7 U.S.C.

2011 note; Public Law 116–127) is amended— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3974 (1) by striking ‘‘The Secretary’’ and inserting the following: ‘‘(1) IN GENERAL.—The Secretary’’; (2) in paragraph (1) (as so designated), by in- serting ‘‘approve or’’ after ‘‘may’’; and (3) by adding at the end the following: ‘‘(2) LIMITATION.—A State shall not provide benefits during a covered summer period pursuant to paragraph (1) to children who, at the end of the school year immediately preceding the covered sum- mer period, attended a school that did not partici- pate in the school lunch program or school breakfast program described in that paragraph.
‘‘(3) OTHER ASSISTANCE NOT REQUIRED.—A State shall not be required to provide assistance under subsection (a) or (h) in order to provide as- sistance under this subsection.’’.

(e) NO DUPLICATION OF SUMMER BENEFITS.—A State may not provide to a household summer EBT bene- fits (as described in section 13A(a) of the Richard B. Rus- sell National School Lunch Act) under that section and benefits under section 1101(i) of the Families First Coronavirus Response Act (7 U.S.C.
2011 note; Public Law 116–127) for the same period.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

SEC.

503.

OFFSETS.

3975 (a) SUMMER 2023.—Section 1101(i) of the Families First Coronavirus Response Act (7 U.S.C.
2011 note; Public Law 116–127) (as amended by section 502(d)) is amended by adding at the end the following: ‘‘(4) SUMMER 2023.—Any benefits issued to households during a covered summer period pursu- ant to paragraph (1) in summer 2023 shall not ex- ceed $120 per child for the covered summer period, except that benefits may be proportionately higher consistent with any adjustments established under section 12(f) of the Richard B. Russell National School Lunch Act (42 U.S.C.

1760(f)).’’.
1760(f)).’’.

(b) ALLOTMENTS.—Section 2302 of the Families First Coronavirus Response Act (7 U.S.C.

2011 note; Public Law 116–127) is amended by adding at the end the following: ‘‘(d) SUNSET.—The authority under subsection (a)(1) shall expire after the issuance of February 2023 benefits under that subsection.’’.

TITLE V—OTHER MATTERS SEC.

601.

SUPPORT FOR COTTON MERCHANDISERS.


(a) COTTON MERCHANDISER PANDEMIC ASSIST- 24 ANCE.— 25 26 (1) PANDEMIC ASSISTANCE PAYMENTS TO COT- TON MERCHANDISERS.—The Secretary shall make December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3976 pandemic assistance payments, under terms and conditions as determined by the Secretary, to cotton merchandisers that purchased cotton from a United States cotton producer or marketed cotton on behalf of a United States cotton producer during the period that begins on March 1, 2020, and ends on the date of enactment of this Act.
(2) PAYMENT DETERMINATIONS.—The Sec- retary shall take into consideration economic im- pacts of COVID–19 and other supply chain disrup- tions in determining payment rates under this sub- section, such that the amounts made available under paragraph (4)(A) are fully expended no later than 1 year after the date of enactment of this section.

(3) COTTON MERCHANDISER DEFINED.—In this subsection, the term ‘‘cotton merchandiser’’ means an entity that markets, sells, or trades cotton to end users.
(4) FUNDING LIMITATIONS.— (A) IN GENERAL.—Of the funds made available under subsection (b), the Secretary shall make available $100,000,000 to carry out this subsection.

(B) ADMINISTRATIVE EXPENSES.—The Secretary may use not more than 1 percent of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3977 the funds under subparagraph (A) for adminis- trative costs necessary to carry out this sub- section.
(b) FUNDING.—The Secretary shall make available $100,000,000 to be derived from the unobligated balances of amounts made available under section 751 of division N of the Consolidated Appropriations Act, 2021 (Public Law 116–260) to carry out subsection (a).

SEC.

602.

ASSISTANCE FOR RICE PRODUCERS.

(a) IN GENERAL.—The Secretary shall make a 1- time payment to each producer of rice on a farm in the United States with respect to the 2022 crop year.
(b) PAYMENT AMOUNT.—In accordance with the amount made available under subsection (e), the amount of a payment to a rice producer on a farm under sub- section (a) shall be equal to the product obtained by multi- plying— (1) the payment rate per pound, as determined by the Secretary, but which shall be— (A) the same for all varieties of rice; (B) not less than 2 cents per pound; and (C) notwithstanding subparagraph (B), ad- justed by the Secretary such that the amount made available under subsection (e) is fully ex- pended; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3978 (2)(A) in the case of a producer with an aver- age actual production history per planted acre of rice determined in accordance with subparagraphs (A), (B), and (E) of section 508(g)(2) of the Fed- eral Crop Insurance Act (7 U.S.C.
1508(g)(2)), that average actual production history; or (B) in the case of a producer without an aver- age actual production history described in subpara- graph (A)— (i) if an area yield for the 2022 crop year determined in accordance with subparagraphs (C) and (E) of that section is available, that area yield; or (ii) if an area yield described in clause (i) is not available, the yield determined by the Secretary; and (3) the sum obtained by adding, as applicable— (A) the number of certified planted acres of rice on the farm for the 2022 crop year, as reported to the Secretary; and (B) the number of certified acres of rice prevented from being planted on the farm for the 2022 crop year, as reported to the Sec- retary, multiplied by the prevented planting coverage factor applicable to those acres.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3979 (c) LIMITATIONS.— (1) IN GENERAL.—In carrying out this section, the Secretary shall impose payment limitations con- sistent with section 760.1507(b) of title 7, Code of Federal Regulations (as in effect on September 30, 2021).
(2) SEPARATE LIMITATIONS.—The payment limitations imposed under paragraph (1) shall be separate from annual payment limitations under any other program.

(d) DEADLINE.—The Secretary shall make payments under this section not later than 120 days after the date of enactment of this Act.
(e) FUNDING.— (1) RESCISSION.—Of the unobligated balance of the amounts made available by section 751 of divi- sion N of the Consolidated Appropriations Act, 2021 (Public Law 116–260; 134 Stat.

2105), $250,000,000 is rescinded.

(2) APPROPRIATION.—There is appropriated to the Secretary, out of any amounts in the Treasury not otherwise appropriated, $250,000,000 to carry out this section.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3980 SEC.

603.

ENACTMENT OF CHRONIC WASTING DISEASE RE- SEARCH AND MANAGEMENT ACT.

The provisions of H.R.

5608 of the 117th Congress, as engrossed in the House of Representatives on Decem- ber 8, 2021, are hereby enacted into law.

TITLE VI—PESTICIDES Subtitle A—Pesticide Registration Improvement Act of 2022 SEC.

701.

SHORT TITLE.

10 This title may be cited as the ‘‘Pesticide Registration 11 Improvement Act of 2022’’.

12 SEC.

702.
702.

BILINGUAL LABELING.

Section 3(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a(f)) is amended by adding at the end the following: ‘‘(5) BILINGUAL LABELING.— ‘‘(A) REQUIREMENT.— ‘‘(i) IN GENERAL.—Subject to clause (ii), not later than the applicable deadline described in subparagraph (B), each reg- istered pesticide product released for ship- ment shall include— ‘‘(I) the translation of the parts of the labeling contained in the Span- ish Translation Guide described in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3981 subparagraph (G) on the product con- tainer; or ‘‘(II) a link to such translation via scannable technology or other elec- tronic methods readily accessible on the product label.
‘‘(ii) EXCEPTIONS.—Notwithstanding clause (i)— ‘‘(I) an antimicrobial pesticide product may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable tech- nology or other electronic methods readily accessible on the product label; or ‘‘(II) a non-agricultural pesticide product that is not classified by the Administrator as restricted use under subsection (d)(1)(A) may, in lieu of including a translation or a link under clause (i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product label.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3982 ‘‘(B) DEADLINES FOR BILINGUAL LABEL- ING.— ‘‘(i) PESTICIDE PRODUCTS CLASSI- FIED AS RESTRICTED USE.—In the case of pesticide products classified by the Admin- istrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph is the date that is 3 years following the date of enactment of this paragraph.
‘‘(ii) PESTICIDE PRODUCTS NOT CLAS- SIFIED AS RESTRICTED USE.—In the case of pesticide products not classified by the Administrator as restricted use under sub- section (d)(1)(A), the deadline specified in this subparagraph shall be as follows: ‘‘(I) AGRICULTURAL.— ‘‘(aa) ACUTE TOXICITY CAT- EGORY I.—For agricultural pes- ticides classified as Acute Tox- icity Category I, the date that is 3 years after the date of enact- ment of this paragraph.
‘‘(bb) ACUTE TOXICITY CAT- EGORY II.—For agricultural pes- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3983 ticides classified as Acute Tox- icity Category II, the date that is 5 years after the date of enact- ment of this paragraph.
‘‘(II) ANTIMICROBIAL AND NON- AGRICULTURAL.— ‘‘(aa) ACUTE TOXICITY CAT- EGORY I.—For antimicrobial and non-agricultural pesticide prod- ucts classified as Acute Toxicity Category I, the date that is 4 years after the date of enactment of this paragraph.

‘‘(bb) ACUTE TOXICITY CAT- EGORY II.—For antimicrobial and non-agricultural pesticide products classified as Acute Tox- icity Category II, the date that is 6 years after the date of enact- ment of this paragraph.
‘‘(III) OTHER PESTICIDE PROD- UCTS.—With respect to pesticide products not described in subclause (I) or (II), the date that is 8 years December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3984 after the date of enactment of this paragraph.
‘‘(C) IMPLEMENTATION.— ‘‘(i) NON-NOTIFICATION.— ‘‘(I) IN GENERAL.—In carrying out this paragraph, the Administrator shall allow translations of the parts of the label of a pesticide contained in the Spanish Translation Guide de- scribed in subparagraph (G) and scannable technology or other elec- tronic methods to be added using non- notification procedures.
‘‘(II) NON-NOTIFICATION PROCE- DURE DEFINED.—In this clause, the term ‘non-notification procedure’ re- fers to a procedure under which a change may be made to a pesticide label without notifying the Adminis- trator.

‘‘(ii) COOPERATION AND CONSULTA- TION.—In carrying out this paragraph, the Administrator shall cooperate and consult with State lead agencies for pesticide regu- lation for the purpose of implementing bi- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3985 lingual labeling as provided in this para- graph as expeditiously as possible.

‘‘(iii) END USE LABELING.—The la- beling requirements of this paragraph shall apply to end use product labels.
‘‘(iv) INCORPORATION TIMEFRAME.— After initial translation deadlines provided in subparagraph (B), updates to the Span- ish Translation Guide described in sub- paragraph (G) shall be incorporated into labeling on the earlier of— ‘‘(I) in the case of agricultural use pesticide labels, as determined by the Administrator— ‘‘(aa) 1 year after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or ‘‘(bb) the released for ship- ment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the up- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3986 dated Spanish Label Translation Guide described in subparagraph (G); and ‘‘(II) in the case of antimicrobial and non-agricultural use pesticide la- bels, as determined by the Adminis- trator— ‘‘(aa) 2 years after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or ‘‘(bb) the released for ship- ment date specified on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the up- dated Spanish Label Translation Guide described in subparagraph (G).
‘‘(v) NOTIFICATION OF UPDATES TO THE SPANISH TRANSLATION GUIDE FOR PESTICIDE LABELING.—Not later than 10 days after updating the Spanish Trans- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3987 lation Guide described in subparagraph (G), the Administrator shall notify reg- istrants of the update to such guide.
‘‘(D) ACCESSIBILITY OF BILINGUAL LA- BELING FOR FARM WORKERS.—Not later than 180 days after the date of enactment of this paragraph, to the maximum extent practicable, the Administrator shall seek stakeholder input on ways to make bilingual labeling required under this paragraph accessible to farm work- ers.
‘‘(E) PLAN.—Not later than 3 years after the date of enactment of this paragraph, the Administrator shall implement a plan to ensure that farm workers have access to the bilingual labeling required under this paragraph.

‘‘(F) REPORTING.—Not later than 2 years after the date of enactment of this paragraph, the Administrator shall develop and implement, and make publicly available, a plan for tracking the adoption of the bilingual labeling required under this paragraph.
‘‘(G) SPANISH TRANSLATION GUIDE DE- SCRIBED.—The Spanish Translation Guide de- scribed in this subparagraph is the Spanish December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3988 Translation Guide for Pesticide Labeling issued in October 2019, as in effect on the date of en- actment of the Pesticide Registration Improve- ment Act of 2022, and any successor guides or amendments to such guide.’’.

SEC.

703.

EXTENSION AND MODIFICATION OF MAINTE- NANCE FEE AUTHORITY.
(a) EXTENSION AND MODIFICATION OF MAINTE- NANCE FEE AUTHORITY.—Section 4(i) of the Federal In- secticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a– 11 1(i)) is amended— (1) in paragraph (1)— (A) in subparagraph (C), by striking ‘‘2023’’ and inserting ‘‘2022, and $42,000,000 for each of fiscal years 2023 through 2027’’; (B) in subparagraph (D)— (i) in clause (i), by striking ‘‘2023’’ and inserting ‘‘2022, and $172,000 for each of fiscal years 2023 through 2027’’; and (ii) in clause (ii), by striking ‘‘2023’’ and inserting ‘‘2022, and $277,200 for each of fiscal years 2023 through 2027’’; (C) in subparagraph (E)(i)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3989 (i) in subclause (I), by striking ‘‘2023’’ and inserting ‘‘2022, and $105,000 for each of fiscal years 2023 through 2027’’; and (ii) in subclause (II), by striking ‘‘2023’’ and inserting ‘‘2022, and $184,800 for each of fiscal years 2023 through 2027’’; (D) by redesignating subparagraphs (G), (H), and (I) as subparagraphs (L), (M), and (N); (E) by inserting after subparagraph (F) the following: ‘‘(G) FARM WORKER TRAINING AND EDU- CATION GRANTS.— ‘‘(i) SET-ASIDE.—In addition to amounts otherwise available, for fiscal years 2023 through 2027, the Adminis- trator shall use not more than $7,500,000 of the amounts collected under this para- graph to provide grants to organizations described in clause (ii) for purposes of fa- cilitating— ‘‘(I) training of farm workers; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3990 ‘‘(II) education of farm workers with respect to— ‘‘(aa) rights of farm workers relating to pesticide safety; and ‘‘(bb) the worker protection standard under part 170 of title 40, Code of Federal Regulations (or successor regulations); ‘‘(III) the development of new in- formational materials; ‘‘(IV) the development of training modules; and ‘‘(V) the development of innova- tive methods of delivery of such infor- mational materials and training mod- ules.
‘‘(ii) ELIGIBILITY.—To be eligible to receive a grant under this subparagraph, an organization shall have demonstrated experience in— ‘‘(I) providing training and edu- cation services for farm workers or handlers of pesticides; or December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3991 ‘‘(II) developing informational materials for farm workers or han- dlers of pesticides.
‘‘(iii) COMMUNITY-BASED ORGANIZA- TIONS.— ‘‘(I) COMMUNITY-BASED NON- PROFIT FARM WORKER ORGANIZATION GRANTS.—The Administrator shall use funds available under clause (i) to provide grants to community-based non-profit farm worker organizations.

‘‘(II) APPLICATION OF FUNDS.— The Administrator shall apply the unspent balance of funds available (up to $1,800,000) under clause (i) in fis- cal years 2025 through 2027 to carry out subclause (I).
‘‘(iv) INTERIM FUNDING.—In addition to amounts otherwise available, the Admin- istrator may use not more than $1,200,000 in fiscal years 2023 and 2024 to fund ex- isting cooperative agreements that were authorized under section 33(c)(3)(B), as such section was in effect as of March 8, 2019.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3992 ‘‘(v) PARTNERSHIPS.—Organizations described in clause (ii) may apply for a grant under this subparagraph as a part- nership with another organization, pro- vided such organizations, at the time of application, have entered into an agree- ment designating— ‘‘(I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expendi- ture of Federal funds; ‘‘(II) performance of the assist- ance agreement; ‘‘(III) liability for claims for re- covery of unallowable costs incurred under the agreement; and ‘‘(IV) specifying roles in per- forming the proposed scope of work for the assistance agreement.
‘‘(H) HEALTH CARE PROVIDER TRAIN- ING.— ‘‘(i) SET-ASIDE.—In addition to other amounts available, for the period of fiscal December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3993 years 2023 through 2027, the Adminis- trator shall use not more than $2,500,000 of the amounts collected under this para- graph to provide grants to nonprofit orga- nizations described in clause (ii) for pur- poses of facilitating— ‘‘(I) technical assistance and training of health care providers relat- ing to the recognition, treatment, and management of pesticide-related inju- ries and illnesses; ‘‘(II) the development of informa- tional materials for technical assist- ance and training described in sub- clause (I); and ‘‘(III) the development of out- reach and delivery methods relating to the recognition, treatment, and man- agement of pesticide-related illnesses.
‘‘(ii) ELIGIBILITY.—To be eligible to receive a grant under this subparagraph, a nonprofit organization shall have dem- onstrated experience in providing technical assistance and training to health care pro- viders who serve farm worker populations.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3994 ‘‘(iii) PARTNERSHIPS.—Organizations described in clause (ii) may apply for a grant under this subparagraph as a part- nership with another organization, pro- vided such organizations, at the time of application, have entered into an agree- ment designating— ‘‘(I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expendi- ture of Federal funds; ‘‘(II) performance of the assist- ance agreement; ‘‘(III) liability for claims for re- covery of unallowable costs incurred under the agreement; and ‘‘(IV) roles in performing the proposed scope of work for the assist- ance agreement.
‘‘(I) PARTNERSHIP GRANTS.—In addition to funds otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 3995 amounts collected under this paragraph for partnership grants.
‘‘(J) PESTICIDE SAFETY EDUCATION PRO- GRAM.—In addition to amounts otherwise avail- able, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this paragraph to carry out the pesticide safety education program.
‘‘(K) TECHNICAL ASSISTANCE TO GRANT- EES.— ‘‘(i) SET-ASIDE.—In addition to other amounts available, for fiscal years 2023 through 2027, the Administrator shall use not more than $1,750,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations, subject to such conditions as the Administrator es- tablishes to prevent conflicts of interest, to provide easily accessible technical assist- ance to grantees receiving, and potential grantees applying for, grants under sub- paragraphs (G) and (H).
‘‘(ii) CONSIDERATIONS.—In evalu- ating requests for grants under this sub- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3996 paragraph, the Administrator shall con- sider, at a minimum, the extent to which— ‘‘(I) the organization applying for the grant has experience providing technical assistance to farm worker or clinician-training organizations; and ‘‘(II) the proposed project would make specific technical assistance available to organizations seeking in- formation and assistance con- cerning— ‘‘(aa) the grant application process; ‘‘(bb) the drafting of grant applications; and ‘‘(cc) compliance with grant management and reporting re- quirements.
‘‘(iii) NO SUITABLE ORGANIZATION.— If no suitable organization requests a grant under this subparagraph, the Admin- istrator shall provide technical assistance described in clause (i) using the amounts made available by that clause.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3997 ‘‘(iv) STAKEHOLDER INPUT.—In for- mulating requests for proposals for grants under subparagraphs (G) and (H) for a fiscal year, the Administrator shall solicit and consider, in an open and transparent manner that does not provide a competitive advantage to any person or persons, input from persons who conduct farm worker education and training, or technical assist- ance and training of clinicians, regarding the request for proposals.’’; and (F) in subparagraph (N) (as so redesig- nated), by striking ‘‘2023’’ and inserting ‘‘2027’’; and (2) in paragraph (2)— (A) by striking ‘‘section 33(b)(3)’’ and in- serting ‘‘section 33(b)(3)(B)’’; and (B) by striking ‘‘the Pesticide Registration Improvement Extension Act of 2018 and ending on September 30, 2025’’ and inserting ‘‘the Pesticide Registration Improvement Act of 2022 and ending on September 30, 2029’’.
(b) EXTENSION OF PROHIBITION ON TOLERANCE FEES.—Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

346a(m)(3)) is amended by December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

3998 striking ‘‘the Pesticide Registration Improvement Renewal Act and ending on September 30, 2023’’ and inserting ‘‘the Pesticide Registration Improvement Act of 2022 and ending on September 30, 2027’’.

SEC.

704.
SEC.

704.

REREGISTRATION AND EXPEDITED PROCESSING FUND.

Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a–1(k)) is amended— (1) in paragraph (2)(A), in the first sentence, by inserting ‘‘including, to the maximum extent practicable, during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appro- priations,’’ after ‘‘limitation,’’; (2) by striking paragraphs (3) and (4) and in- serting the following: ‘‘(3) REVIEW OF REGISTRANT SUBMISSIONS NOT COVERED BY SECTION 33(B)(3)(B).— ‘‘(A) DEFINITION OF SUBMISSION NOT COVERED BY SECTION 33(B)(3)(B).—In this paragraph, the term ‘submission not covered by section 33(b)(3)(B)’ means any submission filed by a registrant with the Administrator relating to a registration that is not covered by a fee table under section 33(b)(3)(B).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
3999 ‘‘(B) SET-ASIDE.— ‘‘(i) IN GENERAL.—In addition to amounts otherwise available for each of fis- cal years 2023 through 2027, the Adminis- trator shall use approximately 1⁄8 of the amounts made available to the Adminis- trator in the Reregistration and Expedited Processing Fund for the activities de- scribed in clause (ii).
‘‘(ii) ACTIVITIES.—In addition to amounts otherwise available, the Adminis- trator shall use amounts made available under clause (i) to obtain sufficient per- sonnel and resources to process submis- sions not covered by section 33(b)(3)(B) to meet the applicable deadlines described in— ‘‘(I) the notice of the Adminis- trator entitled ‘Pesticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formu- lation Amendments’ and dated Octo- ber 22, 1998 (and any successor amendments to such notice); and December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4000 ‘‘(II) subsections (c)(3)(B) and (h) of section 3.

‘‘(4) DEVELOPMENT OF PUBLIC HEALTH PER- FORMANCE STANDARDS FOR ANTIMICROBIAL PES- TICIDE DEVICES.— ‘‘(A) SET-ASIDE.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Rereg- istration and Expedited Processing Fund for the activities described in subparagraph (B).
‘‘(B) ANTIMICROBIAL PESTICIDE DE- VICES.—The Administrator shall use amounts made available under subparagraph (A) to de- velop efficacy test methods for antimicrobial pesticide devices making public health claims.’’; (3) in paragraph (5)(A), by striking ‘‘2018 through 2023’’ and inserting ‘‘2023 through 2027’’; (4) by redesignating paragraphs (6) and (7) as paragraphs (9) and (10), respectively; (5) by inserting after paragraph (5) the fol- lowing: ‘‘(6) AGENCY TRAINING AND STAFF.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4001 ‘‘(A) SET-ASIDE.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Rereg- istration and Expedited Processing Fund for the activities described in subparagraph (B).
‘‘(B) ACTIVITIES.—The Administrator shall use amounts made available under sub- paragraph (A) to carry out the following activi- ties: ‘‘(i) TRAINING FOR AGENCY EMPLOY- EES.—The Administrator shall administer training and education programs for em- ployees of the Environmental Protection Agency, relating to the regulatory respon- sibilities and policies established by this Act, including programs— ‘‘(I) for improving the scientific, technical, and administrative skills of officers and employees authorized to administer programs under this Act; ‘‘(II) to align competencies iden- tified by the Administrator for mis- sion accomplishment; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4002 ‘‘(III) for addressing best prac- tices for operational performance and improvement; ‘‘(IV) for improving administra- tive processes and procedures and ad- dressing efficiency issues; ‘‘(V) to promote consistent regu- latory decision-making; and ‘‘(VI) for educating registrants and regulated stakeholders on regu- latory procedures.
‘‘(ii) AGREEMENTS WITH INSTITU- TIONS OF HIGHER EDUCATION.—Not later than 1 year, to the maximum extent prac- ticable, after the date of enactment of the Pesticide Registration Improvement Act of 2022, the Administrator shall establish a competitive grant program to develop training curricula and programs in accord- ance with clause (i) through financial as- sistance agreements with 1 or more of the following institutions of higher education: ‘‘(I) Non-land-grant colleges of agriculture (as defined in section 1404 of the National Agricultural Re- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4003 search, Extension, and Teaching Pol- icy Act of 1977 (7 U.S.C.

3103)).

‘‘(II) Land-grant colleges and universities (as defined in section 1404 of the National Agricultural Re- search, Extension, and Teaching Pol- icy Act of 1977 (7 U.S.C.

3103)).

‘‘(III) 1994 Institutions (as de- fined in section 532 of the Equity in Educational Land-Grant Status Act of 1994 (7 U.S.C.

301 note; Public Law 103–382)).


‘‘(7) VECTOR EXPEDITED REVIEW VOUCH- ERS.— ‘‘(A) SET-ASIDE.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Rereg- istration and Expedited Processing Fund to es- tablish and carry out the Vector Expedited Re- view Voucher program in accordance with sub- paragraph (B).
‘‘(B) VECTOR EXPEDITED REVIEW VOUCH- ER PROGRAM.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 4004 ‘‘(i) DEFINITIONS.—In this subpara- graph: ‘‘(I) PROGRAM.—The term ‘pro- gram’ means the Vector Expedited Review Voucher program established under clause (ii).
‘‘(II) VOUCHER.—The term ‘voucher’ means a voucher— ‘‘(aa) issued under the pro- gram by the Administrator to a pesticide registration applicant that entitles the holder to an ex- pedited review described under clause (vi) of a single different pesticide registration action; and ‘‘(bb) the entitlement to which may be transferred (in- cluding by sale) by the holder of the voucher, without limitation on the number of times the voucher may be transferred, be- fore the voucher is redeemed.
‘‘(ii) ESTABLISHMENT.—Not later than one year after the date of enactment of the Pesticide Registration Improvement December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

1 4005 Act of 2022, the Administrator, acting though the Office of Pesticide Programs, shall establish a program to be known as the Vector Expedited Review Voucher pro- gram.
‘‘(iii) PURPOSE.—The purpose of the program is to incentivize the development of new insecticides to control and prevent the spread of vector borne disease by expe- diting reviews by decreasing decision re- view times provided in section 33(b)(3)(B).
‘‘(iv) ISSUANCE OF VOUCHERS.— ‘‘(I) IN GENERAL.—For each of fiscal years 2023 through 2027, the Administrator shall issue a voucher to a pesticide registration applicant for a new active ingredient if the applicant submits and has successfully reg- istered a mosquito-control product that— ‘‘(aa) demonstrates a proven efficacy against pyrethroid or other insecticide-resistant mos- quitoes; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4006 ‘‘(bb) prevents, mitigates, destroys, or repels pyrethroid or other insecticide-resistant mos- quitoes, with a novel or unique mechanism or mode of action, different from other insecticides already registered by the Admin- istrator for mosquito control; ‘‘(cc) targets mosquitoes ca- pable of spreading such diseases as Malaria, Dengue, Zika, Chikungunya, St. Louis encepha- litis, Eastern encephalitis, West- ern encephalitis, West Nile en- cephalitis, Cache Valley encepha- litis, LaCrosse encephalitis, and Yellow Fever; ‘‘(dd) the registrant has submitted a global access plan that will be made publicly avail- able for the active ingredient and that includes— ‘‘(AA) manufacturing locations, including any li- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4007 censed third-party manufac- turers; ‘‘(BB) distribution and procurement processes for malaria vector control pro- grams in selected countries; and ‘‘(CC) the prices for common quantities of the product; ‘‘(ee) meets the appropriate guidelines as being effective in the primary vector control inter- vention areas, including insecti- cide-treated nets and indoor re- sidual spray; ‘‘(ff) is made accessible for use in— ‘‘(AA) the United States, including territories or possessions of the United States; and ‘‘(BB) countries where mosquito-borne diseases, December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4008 such as malaria, are preva- lent; ‘‘(gg) meets registration re- quirements for human health and environmental effects, labeling, and presents no unreasonable ad- verse effects to the environment; ‘‘(hh) broadens the adoption of integrated pest management strategies, such as insecticide re- sistance management, or makes those strategies more effective; ‘‘(ii) is not contained in any pesticide product registered by the Administrator as of the date of the enactment of the Pesticide Registration Improvement Act of 2022; or ‘‘(jj) does not contain as at- tested to by the registrant, an ac- tive ingredient approved in the 2- year period preceding the date of registration by any global strin- gent regulatory authority for the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4009 same uses, vectors, and applica- tions.

‘‘(II) MOSQUITO VECTOR PRI- ORITY.—For each of fiscal years 2023 through 2027, the focus of the pro- gram shall be to incentivize the devel- opment of insecticides to control and prevent the spread of mosquitoes bearing diseases described in sub- clause (I)(cc).
‘‘(III) EXCEPTION.—If the Ad- ministrator determines that there is a significant public health benefit, an active ingredient that is registered for agricultural use that is repurposed and submitted for control of mosqui- toes and that otherwise meets the re- quirements of subclause (I) (excluding items (bb) and (jj)) as determined necessary by the Administrator, shall be considered a mosquito control product meeting the criteria specified in such subclause.
‘‘(IV) ELIGIBILITY CRITERIA MODIFICATIONS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4010 ‘‘(aa) IN GENERAL.—Begin- ning in fiscal year 2028, the Ad- ministrator shall review the pro- gram and recommend— ‘‘(AA) modifications to the requirements described in subclause (I); and ‘‘(BB) additional vec- tors to be included in the program, prioritizing vectors that pose the most signifi- cant population health risks.
‘‘(bb) PUBLIC INVOLVE- MENT.—In carrying out item (aa), the Administrator shall so- licit the involvement of reg- istrants, nongovernmental organi- zations, and governmental agen- cies engaged in vector-borne dis- ease mitigation and treatment.

‘‘(v) REDEMPTION OF VOUCHERS.— To redeem a voucher, the holder shall— ‘‘(I) notify the Administrator of the intent of the holder to submit a pesticide application with a voucher December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4011 for expedited review not less than 90 days before the submission of the ap- plication; and ‘‘(II) pay the applicable registra- tion service fee under section 33(b).
‘‘(vi) EXPEDITED REVIEW.—On re- demption of a voucher, in furtherance of the purpose described in clause (iii), the Administrator shall expedite decision re- view times as follows: ‘‘(I) 6 months less than the deci- sion review time for Category R010, New Active Ingredient, Food use.

‘‘(II) 6 months less than the de- cision review time for Category R020, New Active Ingredient, Food use; re- duced risk.
‘‘(III) 6 months less than the de- cision review time for Category R060, New Active Ingredient, Non-food use; outdoor.

‘‘(IV) 6 months less than the de- cision review time for Category R110, New Active Ingredient, Non-food use; indoor.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4012 ‘‘(V) 4 months less than the deci- sion review time for Category R070, New Active Ingredient, Non-food use; outdoor; reduced risk.

‘‘(VI) 2 months less than the de- cision review time for Category R120, New Active Ingredient, Non-food use; indoor; reduced risk.
‘‘(vii) REPORTS.—Not later than Sep- tember 30, 2025, and not later than Sep- tember 30 of each year thereafter, the Ad- ministrator shall issue a report on the pro- gram, including— ‘‘(I) the number of submissions seeking a voucher; ‘‘(II) the total time in review for each such submission; ‘‘(III) the number of such vouch- ers awarded; ‘‘(IV) the number of such vouch- ers redeemed; and ‘‘(V) with respect to each such redeemed voucher— ‘‘(aa) the decision review time for the pesticide application December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4013 for which the voucher was re- deemed; and ‘‘(bb) the average standard decision review time for the ap- plicable pesticide category.

‘‘(C) UNUSED AMOUNTS.—Any unused amounts made available under this paragraph at the end of each fiscal year shall be made available to the Administrator to carry out other activities for which amounts in the Rereg- istration and Expedited Processing Fund are authorized to be used.
‘‘(8) PESTICIDE SURVEILLANCE PROGRAM.—In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Rereg- istration and Expedited Processing Fund to support the interagency agreement with the National Insti- tute for Occupational Safety and Health to support the Sentinel Event Notification System for Occupa- tional Risk pesticides program— ‘‘(A) with a goal of increasing the number of participating States, prioritizing expansion in December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4014 States with the highest numbers of agricultural workers; and ‘‘(B) to improve reporting by participating States.’’; and (6) in paragraph (10) (as so redesignated), in the first sentence, by striking ‘‘(2), (3), (4), and (5)’’ and inserting ‘‘(2) through (8)’’.

SEC.

705.

PESTICIDE REGISTRATION SERVICE FEES.


(a) EXTENSION AND MODIFICATION OF FEE AU- THORITY.— (1) IN GENERAL.—Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w–8(b)) is amended— (A) in paragraph (2)(E)(iii), by striking ‘‘after review’’ and inserting ‘‘on completion of, where appropriate, the initial screening of the contents of the application or the preliminary technical screening’’; (B) by striking ‘‘paragraph (3)’’ each place it appears and inserting ‘‘paragraph (3)(B)’’; (C) in paragraph (3), by striking ‘‘Subject to paragraph (6),’’ and inserting the following: ‘‘(A) DATA EVALUATION RECORDS.—At the decision review time under a fee table speci- fied in subparagraph (B) or as agreed upon December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4015 under subsection (f)(5), for each covered appli- cation under a fee table specified in such sub- paragraph (B), the Administrator shall— ‘‘(i) complete data evaluation records for studies submitted by the applicant in support of the application; and ‘‘(ii) release those data evaluation records to the applicant, using appropriate protections for confidential business infor- mation.
‘‘(B) SCHEDULE, ACTIONS, AND FEES.— Subject to paragraph (6),’’; (D) in paragraph (6)— (i) by amending subparagraph (A) to read as follows: ‘‘Subject to the following sentence, effective for a covered application received during the period beginning on October 1, 2024, and ending on September 30, 2026, the Administrator may increase by 5 percent the registration service fee payable for the application under para- graph (3).
No adjustment may be made under the preceding sentence until the date on which the Administrator begins to im- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4016 plement clauses (i) and (ii) of subsection (k)(2)(A).’’; and (ii) by amending subparagraph (B) to read as follows: ‘‘Subject to the following sentence, effective for a covered application received on or after October 1, 2026, the Administrator may increase by an addi- tional 5 percent the registration service fee in effect as of September 30, 2026.
No ad- justment may be made under the preceding sentence until the date on which the Ad- ministrator begins to implement any rec- ommendations for process improvements contained in the report under subsection (c)(4), as appropriate.’’; and (E) in paragraph (7)(A), by striking ‘‘(commonly referred to as a Gold Seal letter)’’ and inserting ‘‘(including a Gold Seal letter and a Certificate of Establishment)’’.
(2) CONFORMING AMENDMENT.—Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136w–8) is amended by striking ‘‘sub- section (b)(3)’’ each place it appears and inserting ‘‘subsection (b)(3)(B)’’.

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4017 (b) PESTICIDE REGISTRATION FUND.—Section 33(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w–8(c)) is amended— (1) in paragraph (3), by striking subparagraph (B) and inserting the following: ‘‘(B) ENDANGERED SPECIES REVIEW OF OUTDOOR USE OF PESTICIDE PRODUCTS.— ‘‘(i) IN GENERAL.—The Administrator shall use the amounts made available in the Fund to develop, receive comments with respect to, and finalize, guidance to registrants regarding analysis necessary to support the review of outdoor uses of pes- ticide products under the Endangered Spe- cies Act of 1973 (16 U.S.C.

1531 et seq.).
1531 et seq.).

‘‘(ii) DEADLINES FOR GUIDANCE.— The Administrator shall issue final guid- ance required by clause (i) in accordance with the following: ‘‘(I) With respect to new active ingredients or any registration review decision proposed for 1 or more out- door uses, not later than 9 months after the date of enactment of the December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4018 Pesticide Registration Improvement Act of 2022.

‘‘(II) With respect to new out- door uses of a registered pesticide, not later than 1 year after the date of en- actment of the Pesticide Registration Improvement Act of 2022.

‘‘(III) With respect to anti- microbial pesticide products, not later than 3 years after the date of enact- ment of the Pesticide Registration Im- provement Act of 2022.
‘‘(C) INDEPENDENT THIRD PARTY ASSESS- MENTS.— ‘‘(i) IN GENERAL.—The Administrator shall use the amounts made available in the Fund to carry out the activities de- scribed in clauses (ii) and (iii).
‘‘(ii) WORKFORCE ASSESSMENT.— ‘‘(I) IN GENERAL.—The Admin- istrator shall procure a competitive contract with a qualified, independent contractor with expertise in assessing public sector workforce data analysis and reporting to conduct an assess- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4019 ment of current methodologies and data or metrics available to represent the workforce implementing the Pes- ticide Registration Improvement Act of 2022 and the amendments made by that Act, including an assessment of filled and vacant positions and full- time equivalent employees relating to that implementation.
‘‘(II) REPORT.—Not later than 2 years after the date of enactment of the Pesticide Registration Improve- ment Act of 2022— ‘‘(aa) the contractor selected under subclause (I) shall submit to the Administrator a report de- scribing— ‘‘(AA) the findings from the assessment under that subclause; and ‘‘(BB) recommenda- tions for improved meth- odologies to represent full- time equivalent resources de- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4020 scribed in that subclause; and ‘‘(bb) the Administrator shall publish the report sub- mitted under item (aa) on the website of the Environmental Protection Agency.
‘‘(iii) PROCESS ASSESSMENT.— ‘‘(I) IN GENERAL.— ‘‘(aa) CONTRACTS.—Within 1 year of the date of enactment of the Pesticide Registration Im- provement Act of 2022, to the extent practicable, the Adminis- trator shall issue a competitive contract to a private, inde- pendent consulting firm— ‘‘(AA) to conduct the assessment described in sub- clause (II); and ‘‘(BB) to submit to the Administrator a report de- scribing the findings of the assessment and the proc- esses and performance of December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4021 the Environmental Protec- tion Agency relating to the implementation of the Pes- ticide Registration Improve- ment Act of 2022 and the amendments made by that Act.

‘‘(bb) ELIGIBILITY.—The firm described in item (aa) shall be capable of performing the technical analysis, management assessment, and program evalua- tion tasks required to address the scope of the assessment under subclause (II).
‘‘(II) ASSESSMENT.— ‘‘(aa) IN GENERAL.—The Administrator, applicants, and registrants shall participate in a targeted assessment of the proc- ess for the review of applications submitted under this Act.

‘‘(bb) CONSULTATION.—The firm selected under subclause (I) shall consult with the Adminis- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4022 trator and applicants at the start of the assessment under item (aa) and prior to submission of the report under subclause (I)(aa)(BB).
‘‘(cc) REQUIREMENTS.—The assessment under item (aa) shall evaluate and make recommenda- tions regarding— ‘‘(AA) the initial con- tent screen; ‘‘(BB) the preliminary technical screen; ‘‘(CC) performance, processes, and progress to- ward reducing renegotiation rates and the average length of renegotiations; ‘‘(DD) performance, processes, and progress to- ward eliminating the backlog of registrant submissions not covered by subsection (b)(3); December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4023 December 19, 2022 (11:48 p.m.) ‘‘(EE) performance, processes, and progress to- ward ensuring that all reg- istrant submissions not cov- ered by subsection (b)(3) are completed by the applicable deadlines described in the notice of the Administrator entitled ‘Pesticide Registra- tion Notice (PR) 98–10: No- tifications, Non-Notifications and Minor Formulation Amendments’ and dated Oc- tober 22, 1998 (and any successor amendments to that notice) and described in subsections (c)(3)(B) and (h) of section 3; ‘‘(FF) compliance with the provisions of this Act re- lating to renegotiations and registrant submissions not covered by subsection (b)(3); ‘‘(GG) information technology systems; U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4024 December 19, 2022 (11:48 p.m.) ‘‘(HH) recommended improvements to employee training; ‘‘(II) performance, progress, and processes in completing registration re- view; and ‘‘(JJ) other appropriate issues, such as submissions by inert suppliers and fast- track amendments under subsections (c)(3)(B) and (h) of section 3.
‘‘(III) REPORT TO CONGRESS.— Not later than 1 year after the receipt of an assessment required under this section, the Administrator shall sub- mit to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives— ‘‘(aa) a copy of each such assessment; and ‘‘(bb) the Administrator’s evaluation of the findings and U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4025 recommendations contained in each such assessment.
‘‘(IV) RECOMMENDATIONS.—The Administrator shall include with the report submitted under subclause (III) a classification of each rec- ommendation described in the report as— ‘‘(aa) can be implemented through administrative action of the Administrator; or ‘‘(bb) requires a statutory change.’’; and (2) in paragraph (4)— (A) in subparagraph (A), by striking ‘‘and’’ at the end; (B) by redesignating subparagraph (B) as subparagraph (C); and (C) by inserting after subparagraph (A) the following: ‘‘(B) shall be available during periods in which Environmental Protection Agency em- ployees are on shutdown or emergency furlough as a result of a lapse in appropriations; and’’.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4026 (c) ASSESSMENT OF FEES.—Section 33(d)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136w–8(d)(2)) is amended— (1) by striking ‘‘(as in existence in fiscal year 2012)’’; and (2) by striking ‘‘the amount of appropriations for covered functions for fiscal year 2012 (excluding the amount of any fees appropriated for the fiscal year).’’ and inserting ‘‘$166,000,000.’’.
(d) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS AND PREVENT DOUBLE PAYMENT OF REG- ISTRATION FEES.—Section 33(e) of the Federal Insecti- cide, Fungicide, and Rodenticide Act (7 U.S.C.
136w– 8(e)) is amended— (1) by striking the subsection designation and heading and all that follows through ‘‘To the max- imum’’ and inserting the following: ‘‘(e) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS AND PREVENT DOUBLE PAYMENT OF REG- 20 ISTRATION FEES.— ‘‘(1) REDUCTION OF DECISION TIME REVIEW PERIODS.—To the maximum’’; and (2) by adding at the end the following: ‘‘(2) PREVENTION OF DOUBLE PAYMENT OF REGISTRATION SERVICE FEES.—The Administrator December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4027 shall develop and implement a process to determine the appropriate fee category or categories for an ap- plication that qualifies for more than one fee cat- egory in order to assist applicants and prevent un- necessary payment of fees for multiple categories for a single application.’’.

(e) DECISION TIME REVIEW PERIODS.—Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w–8(f)) is amended— (1) in paragraph (1), by striking ‘‘Pesticide Registration Improvement Extension Act of 2018’’ and inserting ‘‘Pesticide Registration Improvement Act of 2022’’; (2) in paragraph (4)— (A) in subparagraph (B)— (i) in clause (i), by adding at the end the following: ‘‘(III) FINAL FEE CATEGORY.— The fee category of a covered applica- tion or other actions may not be changed, without providing the infor- mation to the applicant, after comple- tion of the preliminary technical screening described in clause (iv).’’; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4028 (ii) in clause (iii), in the matter pre- ceding subclause (I), by inserting ‘‘auto- mate the process, to the maximum extent practicable, and’’ before ‘‘determine’’; and (iii) in clause (iv)— (I) in the matter preceding sub- clause (I), by striking ‘‘shall deter- mine if—’’ and inserting ‘‘shall—’’; (II) in subclause (I)— (aa) by inserting ‘‘determine if’’ before ‘‘the application and’’; and (bb) by striking ‘‘and’’ at the end; (III) in subclause (II)— (aa) by inserting ‘‘determine if’’ before ‘‘the application, data,’’; and (bb) by striking the period at the end and inserting a semi- colon; and (IV) by adding at the end the fol- lowing: ‘‘(III) determine, if applicable, whether an application qualifies for a December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4029 reduced risk determination under sub- section (c)(10) or (h) of section 3; ‘‘(IV) grant or deny any data waiver requests submitted by the ap- plicant with the application; ‘‘(V) verify and validate the accu- racy of the fee category selected by the applicant; and ‘‘(VI) notify the applicant, in writing, if a new or different fee cat- egory is required and calculate the new decision review time based on the original submission date.’’; and (B) by striking subparagraph (E) and in- serting the following: ‘‘(E) APPLICATIONS FOR REDUCED RISK.— ‘‘(i) FEE.—If an application for a re- duced risk new active ingredient or a re- duced risk new use is determined not to qualify as reduced risk, the applicant shall pay the difference in fee for the cor- responding non-reduced risk application.
‘‘(ii) DECISION REVIEW TIME PE- RIOD.—After receipt by the Administrator December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4030 of the original covered reduced risk appli- cation and fee, the decision time review pe- riod for the corresponding non-reduced risk application shall begin within the time periods described in subparagraph (A), based on the submission date of the origi- nal covered reduced risk application.’’; and (3) by striking paragraph (5) and inserting the following: ‘‘(5) EXTENSION OF DECISION TIME REVIEW PERIOD.— ‘‘(A) NOTIFICATION.—If the Administrator cannot meet a decision time review period under this subsection, the Administrator shall notify the applicant, in writing, of— ‘‘(i) the reasons why additional time is needed; and ‘‘(ii) the number of days needed that would allow the Administrator to make a regulatory decision.
‘‘(B) EXTENSION BY NEGOTIATION OR MU- TUAL AGREEMENT.—The Administrator, acting solely through the Director of the Office of Pes- ticide Programs, and the applicant may mutu- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4031 ally agree, in writing, to extend a decision time review period under this subsection if— ‘‘(i) there is new or additional data or information from the applicant that is nec- essary for the Administrator to make a de- cision on the application that cannot be made available within the original decision time review period; or ‘‘(ii) a public comment period associ- ated with the application generates signifi- cant comments that cannot be addressed within the original decision time review pe- riod.
‘‘(C) PRIORITY.—Once a decision time re- view period for a covered action described in subsection (b)(3)(B) is missed or extended, the Administrator shall make any action on the ap- plication a priority.’’.

(f) REPORTS AND INFORMATION TECHNOLOGY.— Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w–8) is amended by strik- ing subsection (k) and inserting the following: ‘‘(k) REPORTS AND INFORMATION TECHNOLOGY.— ‘‘(1) REPORTS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4032 ‘‘(A) IN GENERAL.—Not later than 120 days after the last day of each of fiscal years 2023 through 2027, the Administrator shall publish an annual report describing— ‘‘(i) actions taken under this section; ‘‘(ii) registrant submissions not cov- ered by subsection (b)(3)(B); ‘‘(iii) the initial content and prelimi- nary technical screenings required in sub- section (f)(4)(B); and ‘‘(iv) staffing relating to implementing the Pesticide Registration Improvement Act of 2022 and the amendments made by that Act.
‘‘(B) CONTENTS.—Each report published under subparagraph (A) shall include a sum- mary of the following information: ‘‘(i) ACTIONS UNDER THIS SEC- TION.—To the extent practicable, data for each action taken under this section that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, including— ‘‘(I) the Action Code; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4033 ‘‘(II) the application receipt date; ‘‘(III) the electronic portal track- ing number assigned to the applica- tion at the time of submission to the electronic submission portal or the Environmental Protection Agency tracking number; ‘‘(IV) the original decision due date based on the Action Code; ‘‘(V) the dates of any renegoti- ations and the renegotiated due dates, if applicable; ‘‘(VI) the reasons for each re- negotiation, if applicable; ‘‘(VII) if the submission had to be recoded, reassigned codes, if appli- cable; ‘‘(VIII) the date that the submis- sion was recoded, if applicable; ‘‘(IX) the decision completion date, if the action has been completed; ‘‘(X) the status of the action, which may be— ‘‘(aa) failed initial content screen; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4034 ‘‘(bb) failed preliminary technical screen; ‘‘(cc) approved; ‘‘(dd) withdrawn; ‘‘(ee) denied; ‘‘(ff) do not grant; or ‘‘(gg) pending; ‘‘(XI) the reason for any denial or do not grant decision, if applicable; ‘‘(XII) a review of the progress made in carrying out each require- ment of subsections (e) and (f), in- cluding, to the extent determined ap- propriate by the Administrator and consistent with the authorities of the Administrator and limitations on dele- gation of functions by the Adminis- trator, recommendations for the allow- ance and use of summaries of acute toxicity studies; ‘‘(XIII) a review of the progress in carrying out section 3(g), includ- ing— ‘‘(aa) the number of pes- ticides or pesticide cases reviewed December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4035 and the number of registration review decisions completed, in- cluding— ‘‘(AA) the number of cases cancelled; ‘‘(BB) the number of cases requiring risk mitiga- tion measures; ‘‘(CC) the number of cases removing risk mitiga- tion measures; ‘‘(DD) the number of cases with no risk mitigation needed; and ‘‘(EE) the number of cases in which risk mitiga- tion has been fully imple- mented; ‘‘(XIV) a review of the progress made toward implementing enhance- ments to— ‘‘(aa) the electronic tracking of conditional registrations; and ‘‘(bb) the endangered species database; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4036 ‘‘(XV) a review of the progress made in updating the Pesticide Inci- dent Data System, including progress toward making the information con- tained in the System available to the public (as the Administrator deter- mines is appropriate); ‘‘(XVI) an assessment of the public availability of summary pes- ticide usage data; ‘‘(XVII) the number of the active ingredients approved, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any suc- cessor program) of the Environmental Protection Agency; ‘‘(XVIII) with respect to funds in the Reregistration and Expedited Processing Fund described under sec- tion 4(k), a review that includes— ‘‘(aa) a description of the amount and use of such funds— ‘‘(AA) to carry out ac- tivities relating to worker December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4037 December 19, 2022 (11:48 p.m.) protection under subpara- graphs (G) and (H) of sec- tion 4(i)(1); ‘‘(BB) to award part- nership grants under sub- paragraph (I) of such sec- tion; and ‘‘(CC) to carry out the pesticide safety education program under subpara- graph (J) of such section; ‘‘(bb) an evaluation of the appropriateness and effectiveness of the activities, grants, and pro- gram under subparagraphs (G), (H), (I), and (J) of such section; ‘‘(cc) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program in accord- ance with the stakeholder input provided under such subpara- graphs; and ‘‘(dd) with respect to activi- ties relating to worker protection U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4038 carried out under subparagraphs (G) and (H) of section 4(i)(1), a summary of the analyses from stakeholders, including from worker community-based organi- zations, on the appropriateness and effectiveness of such activi- ties.
‘‘(XIX) beginning two years after enactment, report on the progress of meeting the deadlines listed in para- graph (5) of section 3(f); and ‘‘(XX) a review of progress made in implementing the pesticide surveil- lance program referred to in para- graph (8) of section 4(k).
‘‘(ii) REGISTRANT SUBMISSIONS NOT COVERED BY SECTION 33(B)(3)(B).—Each registrant submission not covered by sub- section (b)(3)(B), that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, in- cluding— ‘‘(I) the submission date; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4039 ‘‘(II) the electronic portal track- ing number assigned to the applica- tion at the time of the submission of the application to the electronic sub- mission portal; ‘‘(III) the type of regulatory ac- tion, as defined by statute or guidance document, and the specific label ac- tion; ‘‘(IV) the status of the action; ‘‘(V) the due date; ‘‘(VI) the reason for the outcome; and ‘‘(VII) the completion date, if ap- plicable.
‘‘(iii) SCREENING PROCESS.—Data for the initial content screens and preliminary technical screens that are completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, organized by registering division, in- cluding— ‘‘(I) the number of applications successfully passing each type of screen; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4040 ‘‘(II) the number of applications that failed the screening process for each type of screen; ‘‘(III) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(II); ‘‘(IV) the number of notifications issued by the Administrator under subsection (f)(4)(B)(ii)(I) and the number of applications resulting in a rejection; and ‘‘(V) the number of notifications issued under section 152.105 of title 40, Code of Federal Regulations (or successor regulations), and to the ex- tent practicable, the reasons for that issuance.
‘‘(iv) STAFFING.—Data on the staff- ing relating to work covered under the Pes- ticide Registration Improvement Act of 2022 and the amendments made by that Act, organized by registering division, in- cluding— ‘‘(I) the number of new hires and personnel departures; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4041 ‘‘(II) the number of full-time equivalents at the end of each fiscal year; ‘‘(III) the number of full-time equivalents working on registration review activities; and ‘‘(IV) the number of full-time equivalents working on registrant sub- missions not covered by subsection (b)(3)(B).
‘‘(C) PUBLICATION.—The Administrator shall publish each report under subparagraph (A)— ‘‘(i) on the website of the Environ- mental Protection Agency; and ‘‘(ii) by such other methods as the Administrator determines to be the most effective for efficiently disseminating the report.
‘‘(2) INFORMATION TECHNOLOGY.— ‘‘(A) SYSTEM.—Not later than 1 year after the date of enactment of the Pesticide Registra- tion Improvement Act of 2022, the Adminis- trator shall establish an information technology system that— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4042 ‘‘(i) includes all registering divisions in the Office of Pesticide Programs; ‘‘(ii) provides a real-time, accurate, tracking system for all regulatory submis- sions to the Office of Pesticide Programs; ‘‘(iii) provides a real-time, accessible information that provides each applicant confidential, online access to the status and progress of the regulatory submissions of the applicant; and ‘‘(iv) updates the electronic submis- sion portal— ‘‘(I) to ensure that label reviews are limited to current label changes, to the maximum extent practicable; ‘‘(II) to automate, to the extent practicable, minor, low risk regulatory actions; and ‘‘(III) to allow self-certification of certain regulatory actions, as deter- mined by the Administrator.
‘‘(B) ACCESS TO REGISTRATION DATA AND DECISIONS.—The Administrator shall imple- ment efforts to expand existing, and develop new, information technology tools and data- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4043 bases to improve access by Environmental Pro- tection Agency employees to data used to fulfill registrations, and public access to information about regulatory decisionmaking tools, includ- ing opportunities for— ‘‘(i) analysis of the impact of sub- mitted studies on Environmental Protec- tion Agency assessments and decisions; ‘‘(ii) facilitation of read-across or computational model development to help fill information gaps; ‘‘(iii) tracking and reporting submis- sion and decision metrics relating to the use and acceptance of test methods; and ‘‘(iv) drafting and publication of poli- cies communicating Environmental Protec- tion Agency acceptance of novel tech- nologies or approaches.’’.
(g) TERMINATION OF EFFECTIVENESS.—Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136w–8(m)) is amended— (1) by striking ‘‘2023’’ each place it appears and inserting ‘‘2027’’; and (2) in paragraph (2)— (A) in subparagraph (A)— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4044 (i) in the subparagraph heading, by striking ‘‘2024’’ and inserting ‘‘2028’’ ; and (ii) by striking ‘‘2024’’ and inserting ‘‘2028’’; and (B) in each of subparagraphs (B) and (C)— (i) in the subparagraph heading, by striking ‘‘2025’’ each place it appears and inserting ‘‘2029’’; and (ii) by striking ‘‘2025’’ each place it appears and inserting ‘‘2029’’.

SEC.

706.
SEC.

706.

REVISION OF TABLES REGARDING COVERED PES- TICIDE REGISTRATION APPLICATIONS AND OTHER COVERED ACTIONS AND THEIR COR- RESPONDING REGISTRATION SERVICE FEES.

Section 33(b)(3) of the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C.
136w–8(b)(3)) (as amended by section 705(a)(1)(C)) is amended by striking subparagraph (B) and inserting the following: ‘‘(B) SCHEDULE, ACTIONS, AND FEES.— Subject to paragraph (6), the schedule of reg- istration applications and other covered actions and their corresponding registration service fees shall be as follows: December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4045 ‘‘TABLE 1.
4045 ‘‘TABLE 1.

— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R010 1 New Active In- 36 1,079,356 gredient, Food use.

(2) (3) R020 2 New Active In- 27 899,464 gredient, Food use; reduced risk.
(2) (3) R040 3 New Active In- 18 662,883 gredient, Food use; Experi- mental Use Permit appli- cation; estab- lish temporary tolerance; sub- mitted before application for registration; credit 45% of fee toward new active in- gredient appli- cation that fol- lows.

(3) (4) R060 4 New Active In- 30 749,886 gredient, Non- food use; out- door.

(2) (3) R070 5 New Active In- 24 624,905 gredient, Non- food use; out- door; reduced risk.
(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4046 ‘‘TABLE 1.

— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS—Continued EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R090 6 New Active In- 16 463,930 gredient, Non- food use; out- door; Experi- mental Use Permit appli- cation; sub- mitted before application for registration; credit 45% of fee toward new active in- gredient appli- cation that fol- lows.
(3) (4) R110 7 New Active In- 20 417,069 gredient, Non- food use; in- door.

(2) (3) (4) R120 8 New Active In- 14 347,556 gredient, Non- food use; in- door; reduced risk.

(2) (3) (4) R121 9 New Active In- 18 261,322 gredient, Non- food use; in- door; Experi- mental Use Permit appli- cation; sub- mitted before application for registration; credit 45% of fee toward new active in- gredient appli- cation that fol- lows.

(3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4047 ‘‘TABLE 1.

— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS—Continued EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R122 10 Enriched iso- 27 454,526 mer(s) of reg- istered mixed- isomer active ingredient.

(2) (3) R123 11 New Active In- 27 676,296 gredient, Seed treatment only; includes agricultural and non-agri- cultural seeds; non-food use, not requiring a tolerance.
(2) (3) R126 12 (new) New Active In- 31 743,925 gredient, Seed treatment only; limited uptake into raw agricul- tural commod- ities; use re- quiring a tol- erance.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4048 ‘‘TABLE 1.

— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R125 13 New Active In- 16 463,930 gredient, Seed treatment; Ex- perimental Use Permit application; submitted be- fore applica- tion for reg- istration; cred- it 45% of fee toward new active ingre- dient applica- tion that fol- lows.

(3) (4) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4049 (3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 2.
‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES Decision Review Time (Months)(1) Registra- tion Service Fee ($) 23 274,388 17 64,028 23 454,490 21 378,742 EPA No.

New CR No.

Action R130 14 R140 15 R150 R155 16 17 First food use; indoor; food/ food handling.

(2) (3) (5) Additional food use; Indoor; food/food han- dling.

(3) (4) (5) First food use.

(2) (3) (5) First food use, Experimental Use Permit application; active ingre- dient reg- istered for non-food use.
(3) (4) (5) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4050 ‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 18 378,742 17 113,728 14 94,774 12 94,774 17 682,357 12 568,632 EPA No.

New CR No.

Action R160 R170 R175 18 19 20 R180 21 R190 22 R200 23 First food use; reduced risk.

(2) (3) (5) Additional food use.


(3) (4) (5) Additional food uses covered within a crop group result- ing from the conversion of existing ap- proved crop group(s) to one or more revised crop groups.

(3) (4) (5) Additional food use; reduced risk.

(3) (4) (5) Additional food uses; 6 or more sub- mitted in one application.

(3) (4) (5) Additional Food Use; 6 or more sub- mitted in one application; Reduced Risk.

(3) (4) (5) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4051 ‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 70,210 6 28,434 16 45,453 10 37,878 6 28,434 EPA No.

New CR No.

Action R210 24 R220 25 R230 26 R240 27 R250 28 Additional food use; Experi- mental Use Permit appli- cation; estab- lish temporary tolerance; no credit toward new use reg- istration.
(3) (4) (5) Additional food use; Experi- mental Use Permit appli- cation; crop destruct basis; no credit to- ward new use registration.

(3) (4) (5) Additional use; non-food; out- door.

(3) (4) (5) Additional use; non-food; out- door; reduced risk.

(3) (4) (5) Additional use; non-food; out- door; Experi- mental Use Permit appli- cation; no credit toward new use reg- istration.

(3) (4) (5) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4052 ‘‘TABLE 2.
4052 ‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 8 28,434 12 21,954 9 18,296 6 13,940 EPA No.

New CR No.

Action R251 29 R260 R270 30 31 R271 32 Experimental Use Permit application which requires no changes to the toler- ance(s); non- crop destruct basis.

(3) (5) New use; non- food; indoor.

(3) (4) (5) New use; non- food; indoor; reduced risk.
(3) (4) (5) New use; non- food; indoor; Experimental Use Permit application; no credit toward new use reg- istration.

(3) (4) (5) R273 33 Additional use; 12 72,302 seed treatment only; use not requiring a new tolerance; includes crops with estab- lished toler- ances (e.g., for soil or foliar application).

(3) (4) (5) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4053 ‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R274 34 Additional use; 12 433,793 seed treatment only; 6 or more sub- mitted in one application; uses not re- quiring new tolerances; in- cludes crops with estab- lished toler- ances (e.g., for soil or foliar application).

(3) (4) (5) R276 35 (new) R277 36 (new) Additional use, 14 79,560 seed treatment only; limited uptake into raw agricul- tural commod- ities; use re- quiring a tol- erance.
(3) (4) (5) Additional use, 14 477,360 seed treatment only; 6 or more sub- mitted in one application; limited uptake into raw agri- cultural com- modities; use requiring a tolerance.

(3) (4) (5) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4054 (2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s).

All items in the covered applica- tion must be submitted together in one package.

Each application for an addi- tional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval.
However, if a new use application only proposes to register the new use for a new product and there are no amend- ments in the application, then review of one new product application is covered by the new use fee.

All such associated applications that are submitted together will be subject to the new use decision review time.
Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new deci- sion review time for a new use.
If the new-use application includes non-food (in- door and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the appli- cant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4055 (5) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R280 37 Establish toler- 22 457,311 ances for resi- dues in im- ported com- modities; new active ingre- dient or first food use.

(2) R290 38 Establish toler- 16 91,465 ances for resi- dues in im- ported com- modities; Ad- ditional new food use.
R291 39 Establish toler- 16 548,773 ances for resi- dues in im- ported com- modities; addi- tional food uses; 6 or more crops submitted in one petition.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4056 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 64,987 EPA No.

New CR No.
New CR No.

Action R292 40 Amend an estab- lished toler- ance (e.g., de- crease or in- crease) and/or harmonize es- tablished toler- ances with Codex Max- imum Residue Limits; domes- tic or import; applicant-initi- ated.

R293 41 Establish toler- 13 76,656 ance(s) for in- advertent resi- dues in one crop; appli- cant-initiated.

R294 42 Establish toler- 13 459,922 ances for inad- vertent resi- dues; 6 or more crops submitted in one applica- tion; appli- cant-initiated.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4057 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 16 94,774 EPA No.

New CR No.
New CR No.

Action R295 43 Establish toler- ance(s) for residues in one rotational crop in response to a specific rota- tional crop ap- plication; sub- mission of cor- responding label amend- ments which specify the necessary plant-back re- strictions; ap- plicant-initi- ated.
(3) (4) R296 44 Establish toler- 16 568,632 ances for resi- dues in rota- tional crops in response to a specific rota- tional crop pe- tition; 6 or more crops submitted in one applica- tion; submis- sion of cor- responding label amend- ments which specify the necessary plant-back re- strictions; ap- plicant-initi- ated.

(3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4058 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES—Continued EPA No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R297 45 Amend 6 or 12 389,897 R298 46 more estab- lished toler- ances (e.g., de- crease or in- crease) in one petition; do- mestic or im- port; appli- cant-initiated.

Amend an estab- lished toler- ance (e.g., de- crease or in- crease); do- mestic or im- port; submis- sion of cor- responding amended la- bels (requiring science re- view).
(3) (4) 14 83,940 R299 47 Amend 6 or 14 408,853 more estab- lished toler- ances (e.g., de- crease or in- crease); do- mestic or im- port; submis- sion of cor- responding amended la- bels (requiring science re- view).

(3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4059 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES—Continued EPA No.

R281 New CR No.
R281 New CR No.

48 (new) R282 49 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) Establish toler- 12 68,599 ances for resi- dues in im- ported com- modities; addi- tional new food use; sub- mission of res- idue chemistry data review conducted by Codex or other competent na- tional regu- latory author- ity.
Establish toler- 12 411,580 ances for resi- dues in im- ported com- modities; addi- tional new food uses; 6 or more crops submitted in one petition; submission of residue chem- istry data re- view conducted by Codex or other com- petent na- tional regu- latory author- ity.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4060 (2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the base fee for the category.

All items in the cov- ered application must be submitted together in one package.

Each application for an additional new product registration and new inert approval(s) that is sub- mitted in the amendment application package is subject to the registration serv- ice fee for a new product or a new inert approval.
However, if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application, then review of one new product ap- plication is covered by the base fee.

All such associated applications that are submitted together will be subject to the category decision review time.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4061 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R300 50 New product; or 4 2,270 similar combina- tion product (al- ready registered) to an identical or substantially similar in com- position and use to a registered product; reg- istered source of active ingredient; no data review on acute toxicity, efficacy or child- resistant pack- aging — only product chem- istry data; cite- all data citation, or selective data citation where applicant owns all required data, or applicant sub- mits specific au- thorization letter from data owner.
Category also in- cludes 100% re- package of reg- istered end-use or manufac- turing-use prod- uct that requires no data submis- sion nor data matrix.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4062 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R301 51 New product; or 4 2,720 similar combina- tion product (al- ready registered) to an identical or substantially similar in com- position and use to a registered product; reg- istered source of active ingredient; selective data ci- tation only for data on product chemistry and/or acute toxicity and/or public health pest effi- cacy (identical data citation and claims to cited product(s)), where applicant does not own all required data and does not have a specific authorization let- ter from data owner.
(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4063 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R310 52 New end-use or 7 10,466 manufacturing- use product with registered source(s) of ac- tive ingre- dient(s); includes products con- taining two or more registered active ingredi- ents previously combined in other registered products; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 4.
Child-resistant packaging and/or 4. pest(s) requiring efficacy – for up to 3 target pests.

(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4064 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 8 12,364 EPA No.

New CR No.
Action R314 53 New end-use prod- uct containing up to three reg- istered active in- gredients never before registered as this combina- tion in a formu- lated product; new product label is identical or substantially similar to the la- bels of currently registered prod- ucts which sepa- rately contain the respective component active ingredients; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. child resistant packaging and/or 4. pest(s) requiring efficacy (4) for up to 3 target pests.
(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4065 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 10 18,097 EPA No.

New CR No.
Action R319 54 New end-use prod- uct containing up to three reg- istered active in- gredients never before registered as this combina- tion in a formu- lated product; new product label is identical or substantially similar to the la- bels of currently registered prod- ucts which sepa- rately contain the respective component active ingredients; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. child resistant packaging and/or 4. pest(s) requiring efficacy (4) - for 4 to 7 target pests.
(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4066 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 9 18,994 EPA No.

New CR No.
Action R318 55 New end-use prod- uct containing four or more reg- istered active in- gredients never before registered as this combina- tion in a formu- lated product; new product label is identical or substantially similar to the la- bels of currently registered prod- ucts which sepa- rately contain the respective component active ingredients; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. child resistant packaging and/or 4. pest(s) requiring efficacy – for up to 3 target pests.
(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4067 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 11 24,727 EPA No.

New CR No.
Action R321 56 New end-use prod- uct containing four or more reg- istered active in- gredients never before registered as this combina- tion in a formu- lated product; new product label is identical or substantially similar to the la- bels of currently registered prod- ucts which sepa- rately contain the respective component active ingredients; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. child resistant packaging and/or 4. pest(s) requiring efficacy (4) - for 4 to 7 target pests.
(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4068 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R315 57 New end-use on- 9 14,075 animal product, registered source of active ingre- dient(s) with submission of data and/or waivers for only: 1. animal safety and 2. pest(s) requiring efficacy and/or 3. product chem- istry and/or 4. acute toxicity and/or 5. child resistant packaging.

(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4069 ‘‘TABLE 4.
4069 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R316 58 New end-use or 9 16,199 manufacturing- use product with registered source(s) of ac- tive ingredient(s) including prod- ucts containing two or more reg- istered active in- gredients pre- viously combined in other reg- istered products; excludes prod- ucts requiring or citing an animal safety study; and requires review of data and/or waivers for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. child resistant packaging and/or 4. pest(s) requiring efficacy - for 4 to 7 target pests.
(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4070 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R317 59 New end-use or 10 21,932 manufacturing- use product with registered source(s) of ac- tive ingredient(s) including prod- ucts containing two or more reg- istered active in- gredients pre- viously combined in other reg- istered products; excludes prod- ucts requiring or citing an animal safety study; and requires review of data and/or waivers for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. child resistant packaging and/or 4.
Pest(s) requiring efficacy - for greater than 7 target pests, (2) (3) (4) New product; new physical form; requires data re- view in science divisions.

(2) (3) (5) 12 18,958 R320 60 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4071 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R331 61 New product; re- 3 3,627 pack of identical registered end- use product as a manufacturing- use product; same registered uses only.

(2) (3) R332 62 New manufac- 24 405,919 R333 63 turing-use prod- uct; registered active ingredient; unregistered source of active ingredient; sub- mission of com- pletely new ge- neric data pack- age; registered uses only; re- quires review in RD and science divisions.
(2) (3) New product; man- ufacturing-use product or end- use product with unregistered source of active ingredient; re- quires science data review; new physical form; etc.

Cite-all or selective data ci- tation where ap- plicant owns all required data.

(2) (3) 11 28,434 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4072 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 33,108 EPA No.
New CR No.

Action R334 64 New product; man- ufacturing-use product or end- use product with unregistered source of the ac- tive ingredient; requires science data review; new physical form; etc.

Selective data citation.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4073 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 23,400 EPA No.

R361 New CR No.
65 (new) Action New end-use prod- uct containing up to three reg- istered active in- gredients never before registered as this combina- tion in a formu- lated product; new product label is identical or substantially similar to the la- bels of currently registered prod- ucts which sepa- rately contain the respective component active ingredients; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3.
Child resistant packaging and/or 4. pest(s) requiring efficacy – for more than 7 tar- get pests.

(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4074 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 13 25,350 EPA No.

R362 New CR No.
66 (new) Action New end-use prod- uct containing four or more reg- istered active in- gredients never before registered as this combina- tion in a formu- lated product; new product label is identical or substantially similar to the la- bels of currently registered prod- ucts which sepa- rately contain the respective component active ingredients; ex- cludes products requiring or cit- ing an animal safety study; re- quires review of data package within RD only; includes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3.
Child resistant packaging and/or 4. pest(s) requiring efficacy – for more than 7 tar- get pests.

(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4075 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

R363 New CR No.
R363 New CR No.

67 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) New product; re- 6 7,800 pack of identical registered manu- facturing-use product as an end-use product; same registered uses only, with no additional data.

(2) (3) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingre- dient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ‘‘pest(s) requiring efficacy’’ are both invertebrate and vertebrate pests.

Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.
), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emer- ald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations.

This list may be updated/refined as invasive pest needs arise.

All other pests (e.g., vertebrates) are listed in the Pes- ticide Registration Notice 2002-1.
To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows.

If seeking a label claim against a general pest group (e.g., cockroaches, mosqui- toes, termites, etc.

), each group will count as 1.

If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.)

or specific pests (e.g., smokybrown cockroach, house fly, etc.)
without a general claim, then each sub- group or specific pest will count as 1.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4076 (5) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
‘‘TABLE 5.

— REGISTRATION DIVISION (RD) — AMENDMENTS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 4 7,150 6 8,584 EPA No.

New CR No.

Action R340 68 R341 69 Amendment re- quiring data review within RD (e.g., changes to precautionary label state- ments); in- cludes adding/ modifying pest(s) claims for up to 2 target pests; excludes prod- ucts requiring or citing an animal safety study.
(2) (3) Amendment re- quiring data review within RD (e.g., changes to precautionary label state- ments), in- cludes adding/ modifying pest(s) claims for greater than 2 target pests; excludes products re- quiring or cit- ing an animal safety study.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4077 ‘‘TABLE 5.

— REGISTRATION DIVISION (RD) — AMENDMENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 7 12,643 9 18,958 EPA No.

New CR No.
New CR No.

Action R345 70 R350 71 Amending on- animal prod- ucts previously registered, with the sub- mission of data and/or waivers for only: 1. animal safety and 2. pest(s) requir- ing efficacy and/or 3. product chem- istry and/or 4. acute toxicity and/or 5. child resistant packaging.
(2) (3) (4) Amendment re- quiring data review in science divi- sions (e.g., changes to Re- stricted Entry Interval, or Personal Pro- tective Equip- ment, or Preharvest In- terval, or use rate, or num- ber of applica- tions; or add aerial applica- tion; or modify Ground Water/Surface Water advi- sory state- ment).

(2) (3) (5) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4078 ‘‘TABLE 5.
4078 ‘‘TABLE 5.

— REGISTRATION DIVISION (RD) — AMENDMENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 8 18,958 8 18,958 6 14,463 EPA No.

New CR No.

Action R351 72 R352 73 R371 74 Amendment add- ing a new un- registered source of ac- tive ingre- dient.

(2) (3) Amendment add- ing already approved uses; selective meth- od of support; does not apply if the appli- cant owns all cited data.
(2) (3) Amendment to Experimental Use Permit; (does not in- clude extend- ing a permit’s time period).

(3) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

(2) (a) EPA-initiated amendments shall not be charged registration service fees.

(b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees.
(c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in sec- tion 3(h) and are not subject to registration service fees.

(d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees.

(e) Submissions with data and requiring data review are subject to registration service fees.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4079 (3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, ‘‘pest(s) requiring efficacy’’ are both invertebrate and vertebrate pests.

Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.
), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emer- ald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations.

This list may be updated/refined as invasive pest needs arise.

All other pests (e.g., vertebrates) are listed in the Pes- ticide Registration Notice 2002-1.
To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows.

If seeking a label claim against a general pest group (e.g., cockroaches, mosqui- toes, termites, etc.

), each group will count as 1.

If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.)

or specific pests (e.g., smokybrown cockroach, house fly, etc.)
without a general claim, then each sub- group or specific pest will count as 1.

(5) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.
To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 6.

— REGISTRATION DIVISION (RD) — OTHER ACTIONS EPA No.

New CR No.

Action R124 75 Conditional Rul- ing on Pre-ap- plication Study Waiv- ers; applicant- initiated.

Decision Review Time (Months)(1) Registra- tion Service Fee ($) 6 3,627 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4080 ‘‘TABLE 6.

— REGISTRATION DIVISION (RD) — OTHER ACTIONS—Continued EPA No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R272 76 Review of Study 3 3,627 Protocol applicant- ini- tiated; ex- cludes Data Analysis Re- porting Tool, pre- registra- tion con- ference, Rapid Response re- view, develop- mental neurotoxicity protocol re- view, protocol needing Human Stud- ies Review Board review, companion animal safety protocol.

Rebuttal of Agency re- viewed pro- tocol, appli- cant initiated.
3 3,627 R275 77 R278 78 (new) Review of Pro- 5 4,927 tocol for com- panion animal safety study.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4081 ‘‘TABLE 6.

— REGISTRATION DIVISION (RD) — OTHER ACTIONS—Continued EPA No.

R279 New CR No.
R279 New CR No.

79 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) Comparative 3 5,200 product deter- mination for reduced risk submission, applicant initi- ated; sub- mitted before application for reduced risk new active in- gredient or re- duced risk new use.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

‘‘TABLE 7.
‘‘TABLE 7.

— ANTIMICROBIAL DIVISION (AD) — NEW ACTIVE INGREDIENTS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) A380 80 New Active In- 26 227,957 A390 81 gredient; Indi- rect Food use; establish toler- ance or toler- ance exemp- tion if re- quired.

(2) (3) (4) New Active In- gredient; Di- rect Food use; establish toler- ance or toler- ance exemp- tion if re- quired.
(2) (3) (4) 26 329,265 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4082 ‘‘TABLE 7.

— ANTIMICROBIAL DIVISION (AD) — NEW ACTIVE INGREDIENTS—Continued EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) A410 82 New Active In- 23 278,659 gredient Non- food use.

(2) (3) (4) A431 83 New Active In- 14 114,984 gredient, Non- food use; low- risk.
(2) (3) (4) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

(2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.
The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.

Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.
All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4083 (4) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.
To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 8.

— ANTIMICROBIAL DIVISION (AD) — NEW USES EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) A440 84 New Use, Indi- 23 45,737 rect Food Use, establish toler- ance or toler- ance exemp- tion.
(2) (3) (4) (6) A441 85 Additional Indi- 23 164,639 A450 86 A451 87 rect food uses; establish toler- ances or toler- ance exemp- tions if re- quired; 6 or more sub- mitted in one application.

(3) (4) (5) (6) New use, Direct food use, es- tablish toler- ance or toler- ance exemp- tion.

(2) (3) (4) (6) Additional Direct food uses; es- tablish toler- ances or toler- ance exemp- tions if re- quired; 6 or more sub- mitted in one application.
(3) (4) (5) (6) 23 137,198 22 261,333 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4084 ‘‘TABLE 8.

— ANTIMICROBIAL DIVISION (AD) — NEW USES—Continued EPA No.

New CR No.

Action A500 A501 88 89 New use, non- food.

(4) (5) (6) New use, non- food; 6 or more sub- mitted in one application.
(4) (5) (6) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 15 45,737 17 109,764 (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

346a) for an in- gredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4085 (4) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s).

All items in the covered applica- tion must be submitted together in one package.

Each application for an addi- tional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval.
However, if a new use application only proposes to register the new use for a new product and there are no amend- ments in the application, then review of one new product application is covered by the new use fee.

All such associated applications that are submitted together will be subject to the new use decision review time.
Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new deci- sion review time for a new use.
If the new-use application includes non-food (in- door and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the appli- cant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
(6) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4086 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 4 1,833 EPA No.

New CR No.
New CR No.

Action A530 90 New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation where appli- cant owns all required data; or applicant submits spe- cific authoriza- tion letter from data owner.

Cat- egory also in- cludes 100% re-package of registered end- use or manu- facturing-use product that requires no data submis- sion nor data matrix.
(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4087 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 4 2,616 EPA No.

New CR No.
New CR No.

Action A531 91 New product; identical or substantially similar in composition and use to a registered product; reg- istered source of active in- gredient: selec- tive data cita- tion only for data on prod- uct chemistry and/or acute toxicity and/or public health pest efficacy, where appli- cant does not own all re- quired data and does not have a specific authorization letter from data owner.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4088 ‘‘TABLE 9.
4088 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 5 7,322 EPA No.

New CR No.

Action A532 92 New product; identical or substantially similar in composition and use to a registered product; reg- istered active ingredient; un- registered source of ac- tive ingre- dient; cite-all data citation except for product chem- istry; product chemistry data submitted.
(2) (3) A550 93 New end-use 9 18,958 A560 94 product; uses other than FIFRA §2(mm); non- FQPA prod- uct.

(2) (3) (5) New manufac- turing-use product; reg- istered active ingredient; se- lective data ci- tation.

(2) (3) 6 18,054 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4089 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 18 26,135 9 18,958 5 7,322 EPA No.

New CR No.
New CR No.

Action A565 95 A572 96 A460 97 (new) New manufac- turing-use product; reg- istered active ingredient; un- registered source of ac- tive ingre- dient; submis- sion of new generic data package; reg- istered uses only; requires science review.

(2) (3) New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to Re- stricted Entry Interval, or Personal Pro- tective Equip- ment, or use rate).
(2) (3) (4) (7) New end-use product; FIFRA §2(mm) uses only; 0 to 10 public health organisms.

(2) (3) (5) (6) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4090 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 6 10,158 7 12,995 9 15,831 10 18,668 11 21,505 EPA No.

A461 New CR No.
A461 New CR No.

98 (new) A462 99 (new) A463 100 (new) A464 101 (new) A465 102 (new) Action New end-use product; FIFRA §2(mm) uses only; 11 to 20 public health organisms.

(2) (3) (5) (6) New end-use product; FIFRA §2(mm) uses only; 21 to 30 public health organisms.

(2) (3) (5) (6) New end-use product; FIFRA §2(mm) uses only; 31 to 40 public health organisms.

(2) (3) (5) (6) New end-use product; FIFRA §2(mm) uses only; 41 to 50 public health organisms.
(2) (3) (5) (6) New end-use product; FIFRA §2(mm) uses only; 51 or more public health orga- nisms.

(2) (3) (5) (6) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4091 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued EPA No.

A470 New CR No.
A470 New CR No.

103 (new) A471 104 (new) A472 105 (new) A473 106 (new) A474 107 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) Label amend- 4 5,493 ment requiring data review; 0 to 10 public health orga- nisms.

(3) (4) (5) (6) Label amend- 5 8,506 ment requiring data review; 11 to 20 pub- lic health or- ganisms.

(3) (4) (5) (6) Label amend- 6 10,219 ment requiring data review; 21 to 30 pub- lic health or- ganisms.
(3) (4) (5) (6) Label amend- 7 11,933 ment requiring data review; 31 to 40 pub- lic health or- ganisms.

(3) (4) (5) (6) Label amend- 8 13,646 ment requiring data review; 41 to 50 pub- lic health or- ganisms.

(3) (4) (5) (6) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4092 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued EPA No.

A475 New CR No.
A475 New CR No.

108 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) Label amend- 9 15,766 ment requiring data review; 51 or more public health organisms.

(3) (4) (5) (6) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingre- dient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) (a) EPA-initiated amendments shall not be charged registration service fees.

(b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees.

(c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in sec- tion 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) No- tices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees.

(e) Submissions with data and requiring data review are subject to registration service fees.

(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective method to support acute toxicity data requirements.
(6) Once an application for an amendment or a new product with public health organisms has been submitted and classified into any of categories A460 through A465 or A470 through A475, additional organisms submitted for the same product before the first application is granted will result in combination and reclassification of both the original and subsequent submissions into the ap- propriate new category based on the sum of the number of organisms in both submissions.
Submission of additional organisms would result in a new PRIA start date and may require additional fees to meet the fee of a new category.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4093 (7) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 9 9,151 6 6,776 12 17,424 EPA No.

New CR No.

Action A520 109 A521 110 A522 111 Experimental Use Permit application, non-food use.
(2) (3) Review of public health efficacy study protocol within AD, per AD Inter- nal Guidance for the Effi- cacy Protocol Review Proc- ess; Code will also include review of pub- lic health effi- cacy study protocol; appli- cant-initiated; Tier 1. Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Re- view Expert Panel; Code will also in- clude review of public health efficacy study protocol; appli- cant-initiated; Tier 2.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4094 ‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EX- PERIMENTAL USE PERMITS AND OTHER ACTIONS— Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 18 219,512 18 137,198 EPA No.

New CR No.

Action A537 112 A538 113 New Active In- gredient/New Use, Experi- mental Use Permit appli- cation; Direct food use; Es- tablish toler- ance or toler- ance exemp- tion if re- quired.
Credit 45% of fee to- ward new ac- tive ingre- dient/new use application that follows.

(3) New Active In- gredient/New Use, Experi- mental Use Permit appli- cation; Indi- rect food use; Establish tol- erance or tol- erance exemp- tion if re- quired Credit 45% of fee to- ward new ac- tive ingre- dient/new use application that follows.

(3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4095 ‘‘TABLE 10.
4095 ‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EX- PERIMENTAL USE PERMITS AND OTHER ACTIONS— Continued EPA No.

New CR No.

Action A539 114 A529 115 A523 116 A571 117 A533 118 New Active In- gredient/New Use, Experi- mental Use Permit appli- cation; Nonfood use.

Credit 45% of fee toward new active in- gredient/new use application that follows.

(3) Amendment to Experimental Use Permit; requires data review or risk assessment.
(2) (3) Review of pro- tocol other than a public health efficacy study (i.e., Toxicology or Exposure Pro- tocols).

Science reassess- ment: refined ecological risk, and/or endan- gered species; applicant-initi- ated.

(3) Exemption from the require- ment of an Experimental Use Permit.

(2) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 15 132,094 9 16,383 9 17,424 18 137,198 4 3,559 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4096 ‘‘TABLE 10.
4096 ‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EX- PERIMENTAL USE PERMITS AND OTHER ACTIONS— Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 4 6,776 6 3,454 4 3,559 4 3,389 EPA No.

New CR No.

Action A534 119 A535 120 A536 121 A575 122 (new) Rebuttal of Agency re- viewed pro- tocol, appli- cant initiated.

Conditional rul- ing on pre-ap- plication study waiver or data bridging argu- ment; appli- cant-initiated.
Conditional rul- ing on pre-ap- plication direct food, indirect food, nonfood use determina- tion; appli- cant-initiated.

Efficacy simi- larity deter- mination; if two products can be bridged or if confirm- atory efficacy data are need- ed.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4097 (2) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
3) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 11.
‘‘TABLE 11.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — NEW ACTIVE INGREDI- ENTS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B580 123 New active in- 22 73,173 gredient; peti- tion to estab- lish a toler- ance.

(2) (3) (4) B590 124 New active in- 20 45,737 gredient; peti- tion to estab- lish a toler- ance exemp- tion.

(2) (3) (4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4098 ‘‘TABLE 11.
4098 ‘‘TABLE 11.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — NEW ACTIVE INGREDI- ENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 15 27,443 12 18,296 9 9,151 EPA No.

New CR No.

Action B600 125 B610 126 B620 127 New active in- gredient; no change to a permanent tol- erance or tol- erance exemp- tion (includes non-food uses).
(2) (3) (4) New active in- gredient; Ex- perimental Use Permit application; petition to es- tablish a per- manent or temporary tol- erance or tem- porary toler- ance exemp- tion.

(3) (4) New active in- gredient; Ex- perimental Use Permit application; non-food use (includes crop destruct).

(3) (4) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4099 (2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.
The base fee for the category covers a maximum of five new products.

Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(4) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4100 ‘‘TABLE 12.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW USES EPA No.

New CR No.

Action B630 128 B640 129 First food use; petition to es- tablish/amend a tolerance ex- emption.

(2) (4) (5) First food use; petition to es- tablish/amend a tolerance.
(2) (4) (5) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 13 18,296 19 27,443 B644 130 New use, no 8 18,296 change to an established tol- erance or tol- erance exemp- tion (includes non-food uses).

(3) (4) (5) New use; Experi- mental Use Permit; peti- tion to estab- lish a perma- nent or tem- porary toler- ance or toler- ance exemp- tion.

(4) (5) New use; Experi- mental Use Permit; non- food use (in- cludes crop de- struct).
(4) (5) B645 131 B646 132 12 18,296 7 9,151 (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4101 (2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s).

All items in the covered applica- tion must be submitted together in one package.

Each application for an addi- tional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval.
However, if a new use application only proposes to register the new use for a new product and there are no amend- ments in the application, then review of one new product application is covered by the new use fee.

All such associated applications that are submitted together will be subject to the new use decision review time.
Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new deci- sion review time for a new use.
If the new-use application includes non-food (in- door and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the appli- cant at the applicant’s initiative to support the application after completion of the preliminary technical screen, and (c) is not itself a covered registration ap- plication, must be assessed 25% of the full registration service fee for the new use application.
(4) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4102 (5) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.
To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 13.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW PRODUCTS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 6 1,833 9 7,322 EPA No.

New CR No.
New CR No.

Action B660 133 B670 134 New product; registered source of ac- tive ingre- dient(s); iden- tical or sub- stantially simi- lar in composi- tion and use to a registered product; no change in an established tol- erance or tol- erance exemp- tion; no data submission or data matrix (or submission of product chemistry data only).
(2) (3) New product; registered source of ac- tive ingre- dient(s); no change in an established tol- erance or tol- erance exemp- tion; (includ- ing non-food); Must address Product-Spe- cific Data Re- quirements.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4103 ‘‘TABLE 13.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — NEW PRODUCTS—Con- tinued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B672 135 New product; 15 13,069 unregistered source of at least one ac- tive ingredient (or registered source with new generic data package); no change in an established tolerance or tolerance ex- emption (in- cluding non- food); must address Prod- uct-Specific and Generic Data Require- ments.
(2) (3) B673 136 New product; 12 7,322 unregistered source of ac- tive ingre- dient(s); cita- tion of Tech- nical Grade Active Ingre- dient (TGAI) data pre- viously re- viewed and ac- cepted by the Agency; re- quires an Agency deter- mination that the cited data support the new product.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4104 ‘‘TABLE 13.
4104 ‘‘TABLE 13.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — NEW PRODUCTS—Con- tinued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 4 1,833 EPA No.

New CR No.

Action B674 137 New product; re- pack of iden- tical registered end-use prod- uct or repack of an end-use product as a manufac- turing-use product; same registered uses only.
(2) (3) B677 138 New end-use 12 12,643 non-food ani- mal product with submis- sion of two or more target animal safety studies; in- cludes data and/or waivers of data for only: 1. product chem- istry and/or 2. acute toxicity and/or 3. public health pest efficacy and/or 4. animal safety studies and/or 5. child resistant packaging.

(2) (3) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingre- dient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4105 (3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.

‘‘TABLE 14.
‘‘TABLE 14.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — AMENDMENTS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 7 7,322 11 18,296 EPA No.

New CR No.

Action B621 139 B622 140 Amendment; Ex- perimental Use Permit; no change to an established temporary or permanent tol- erance or tol- erance exemp- tion.

(3) (4) Amendment; Ex- perimental Use Permit; petition to amend a per- manent or temporary tol- erance or tol- erance exemp- tion.
(3) (4) B641 141 Amendment; 13 18,296 changes to an established tol- erance or tol- erance exemp- tion.

(4) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4106 ‘‘TABLE 14.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — AMENDMENTS—Contin- ued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 5 7,322 7 8,714 EPA No.

New CR No.
New CR No.

Action B680 142 B681 143 Amendment; reg- istered sources of active in- gredient(s); no new use(s); no changes to an established tol- erance or tol- erance exemp- tion; requires data submis- sion.

(2) (3) Amendment; un- registered source of ac- tive ingre- dient(s); no change to an established tol- erance or tol- erance exemp- tion; requires data submis- sion.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4107 ‘‘TABLE 14.
4107 ‘‘TABLE 14.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — AMENDMENTS—Contin- ued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 6 7,322 8 12,643 EPA No.

New CR No.

Action B683 144 B684 145 Amendment; no change to an established tol- erance or tol- erance exemp- tion; requires review/update of previous risk assess- ment(s) with- out data sub- mission (e.g., labeling changes to Re- stricted Entry Interval, Per- sonal Protec- tive Equip- ment, Preharvest In- terval).
(2) (3) Amending non- food animal product that includes sub- mission of tar- get animal safety data; previously reg- istered.

(2) (3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4108 ‘‘TABLE 14.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — AMENDMENTS—Contin- ued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B685 146 Amendment; add 5 7,322 a new bio- chemical un- registered source of ac- tive ingredient or a new mi- crobial produc- tion site; re- quires submis- sion of anal- ysis of samples data and source/produc- tion site-spe- cific manufac- turing process description.

(3) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees.

(b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees.

(c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in sec- tion 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) No- tices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.

(e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4109 (4) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.
To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 15.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION LEPIDOPTERAN PHEROMONES (SCLP) (BPPD) — STRAIGHT-CHAIN EPA No.

New CR No.

Action B690 147 B700 148 B701 149 SCLP; new ac- tive ingre- dient; food or non-food use.

(2) (6) (7) SCLP; Experi- mental Use Permit appli- cation; new ac- tive ingredient or new use.

(6) (7) SCLP; Extend or amend Ex- perimental Use Permit.
(6) (7) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 7 3,662 7 1,833 4 1,833 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4110 ‘‘TABLE 15.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION LEPIDOPTERAN PHEROMONES (SCLP)—Continued (BPPD) — STRAIGHT-CHAIN EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B710 150 SCLP; new 4 1,833 product; reg- istered source of active in- gredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tol- erance or tol- erance exemp- tion; no data submission or data matrix (or only prod- uct chemistry data); (In- cludes 100% re-pack; re- pack of reg- istered end-use product as a manufac- turing-use product).
(3) (6) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4111 ‘‘TABLE 15.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION LEPIDOPTERAN PHEROMONES (SCLP)—Continued (BPPD) — STRAIGHT-CHAIN EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B720 151 SCLP; new 5 1,833 product; reg- istered source of active in- gredient(s); no change in an established tol- erance or tol- erance exemp- tion (including non-food); Must address Product-Spe- cific Data Re- quirements.
(3) (6) B721 152 SCLP: new 7 3,836 product; un- registered source of ac- tive ingre- dient; no change in an established tol- erance or tol- erance exemp- tion (including non-food); must address Product-Spe- cific and Ge- neric Data Re- quirements.

(3) (6) SCLP; new use and/or amend- ment; petition to establish a tolerance or tolerance ex- emption.

(4) (5) (6) (7) 7 3,552 B722 153 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4112 ‘‘TABLE 15.
4112 ‘‘TABLE 15.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION LEPIDOPTERAN PHEROMONES (SCLP)—Continued (BPPD) — STRAIGHT-CHAIN EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B730 154 SCLP; amend- 5 1,833 ment requiring data submis- sion.

(4) (6) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any applica- tion for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use applica- tion.

The application must be received by the Agency in one package.

The base fee for the category covers a maximum of five new products.
Each application for an additional new product registration and new inert approval that is sub- mitted in the new active ingredient application package or first food use applica- tion package is subject to the registration service fee for a new product or a new inert approval.

All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time.
In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
Any information that (a) was nei- ther requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration appli- cation, must be assessed 25% of the full registration service fee for the new ac- tive ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingre- dient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

(4) (a) EPA-initiated amendments shall not be charged registration service fees.
(b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees.

(c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in sec- tion 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) No- tices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.

(e) Submissions with data and requiring data review are subject to registration service fees.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4113 (5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s).

All items in the covered applica- tion must be submitted together in one package.

Each application for an addi- tional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval.
However, if a new use application only proposes to register the new use for a new product and there are no amend- ments in the application, then review of one new product application is covered by the new use fee.

All such associated applications that are submitted together will be subject to the new use decision review time.
Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new deci- sion review time for a new use.
If the new-use application includes non-food (in- door and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the appli- cant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
(6) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(7) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4114 ‘‘TABLE 16.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — OTHER ACTIONS EPA No.

New CR No.

Action B614 155 B682 156 B616 157 (new) B617 158 (new) Pre-application; Conditional Ruling on ra- tionales for addressing a data require- ment in lieu of data; appli- cant-initiated; applies to one (1) rationale at a time.
Protocol review; applicant initi- ated; excludes time for Human Stud- ies Review Board review (Includes re- buttal of pro- tocol review).

Pre-application; Conditional Ruling on a non-food use determination.

Pre-application; biochemical classification determination.

Decision Review Time (Months)(1) Registra- tion Service Fee ($) 3 3,627 3 3,487 5 4,715 5 4,715 (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4115 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 9 137,198 EPA No.

New CR No.
New CR No.

Action B740 159 Experimental Use Permit application; no petition for tolerance/toler- ance exemp- tion; includes: 1. non-food/feed use(s) for a new (2) or registered (3) PIP (12); 2. food/feed use(s) for a new or reg- istered PIP with crop de- struct; 3. food/feed use(s) for a new or reg- istered PIP in which an es- tablished toler- ance/tolerance exemption ex- ists for the in- tended use(s).

(4) (5) (12) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4116 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 182,927 13 182,927 EPA No.

New CR No.

Action B750 160 B771 161 Experimental Use Permit application; with a petition to establish a temporary or permanent tol- erance/toler- ance exemp- tion for the active ingre- dient.

Includes new food/feed use for a reg- istered (3) PIP.
(4) (12) Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tol- erance/toler- ance exemp- tion for the active ingre- dient; credit 75% of B771 fee toward registration application for a new active ingredient that follows.

(5) (12) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4117 ‘‘TABLE 17.
4117 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 3 18,296 9 45,737 16 228,657 EPA No.

New CR No.

Action B772 162 B773 163 B780 164 Application to amend or ex- tend a PIP Experimental Use Permit; no petition since the es- tablished toler- ance/tolerance exemption for the active in- gredient is un- affected.
(12) Application to amend or ex- tend a PIP Experimental Use Permit; with petition to extend a temporary tol- erance/toler- ance exemp- tion for the active ingre- dient.

(12) Registration ap- plication; new (2) PIP; non- food/feed or food/feed with- out tolerance petition based on an existing permanent tol- erance exemp- tion.

(5) (12) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4118 ‘‘TABLE 17.
4118 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 17 246,949 19 292,682 EPA No.

New CR No.

Action B800 165 B820 166 Registration ap- plication; new (2) PIP; with petition to es- tablish perma- nent tolerance/ tolerance ex- emption for the active in- gredient based on an existing temporary tol- erance/toler- ance exemp- tion.
(5) (12) (14) Registration ap- plication; new (2) PIP; with petition to es- tablish or amend a per- manent toler- ance/tolerance exemption of an active in- gredient.

(5) (12) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4119 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 9 182,927 9 54,881 EPA No.

New CR No.
New CR No.

Action B851 167 B870 168 Registration ap- plication; new event of a pre- viously reg- istered PIP active ingre- dient(s); no petition since permanent tol- erance/toler- ance exemp- tion is already established for the active in- gredient(s).

(12) Registration ap- plication; reg- istered (3) PIP; new product; new use; no peti- tion since a permanent tol- erance/toler- ance exemp- tion is already established for the active in- gredient(s).
(4) (12) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4120 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 9 45,737 13 182,927 EPA No.

New CR No.
New CR No.

Action B880 169 B883 170 Registration ap- plication; reg- istered (3) PIP; new product or new terms of registration; additional data sub- mitted; no pe- tition since a permanent tol- erance/toler- ance exemp- tion is already established for the active in- gredient(s).
(5) (6) (7) (12) (14) Registration ap- plication; new (2) PIP, seed increase with negotiated acreage cap and time-lim- ited registra- tion; with peti- tion to estab- lish a perma- nent tolerance/ tolerance ex- emption for the active in- gredient based on an existing temporary tol- erance/toler- ance exemp- tion.

(5) (8) (12) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4121 ‘‘TABLE 17.
4121 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 19 228,657 6 45,737 EPA No.

New CR No.

Action B884 171 B885 172 Registration ap- plication; new (2) PIP, seed increase with negotiated acreage cap and time-lim- ited registra- tion; with peti- tion to estab- lish a perma- nent tolerance/ tolerance ex- emption for the active in- gredient.
(5) (8) (12) (14) Registration ap- plication; reg- istered (2) PIP, seed in- crease; breed- ing stack of previously ap- proved PIPs, same crop; no petition since a permanent tolerance/toler- ance exemp- tion is already established for the active in- gredient(s).

(9) (12) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4122 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) B890 173 Application to 9 91,465 amend a seed increase reg- istration; con- verts registra- tion to com- mercial reg- istration; no petition since permanent tol- erance/toler- ance exemp- tion is already established for the active in- gredient(s).

(5) (12) (14) Application to amend a reg- istration, in- cluding actions such as modi- fying an IRM plan, or add- ing an insect to be con- trolled.
(5) (10) (11) (12) 6 18,296 B900 174 B902 175 PIP Protocol re- 3 9,151 B903 176 12 91,465 view.

Inert ingredient permanent tol- erance exemp- tion; e.g., a marker such as NPT II; re- viewed in BPPD.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4123 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 182,927 EPA No.

New CR No.
New CR No.

Action B904 177 Import tolerance or tolerance exemption; processed com- modities/food only (inert or active ingre- dient).

B905 178 FIFRA Sci- 6 91,465 9 45,733 9 18,296 B906 179 B907 180 entific Advi- sory Panel Re- view.

Petition to estab- lish a tem- porary toler- ance/tolerance exemption for one or more active ingredi- ents.
Petition to estab- lish a perma- nent tolerance/ tolerance ex- emption for one or more active ingredi- ents based on an existing temporary tol- erance/toler- ance exemp- tion.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4124 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued EPA No.

B909 New CR No.
B909 New CR No.

181 (new) B910 182 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) PIP tolerance 6 18,296 exemption de- termination; applicant-initi- ated; request to determine if an existing tolerance ex- emption ap- plies to a PIP.

Biotechnology Notification for small-scale field testing of genetically en- gineered mi- crobes.

3 9,151 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4125 ‘‘TABLE 17.
4125 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 182,927 EPA No.

B921 New CR No.

183 (new) Action Experimental Use Permit application; genetic modi- fications in animals in- tended for use as a pesticide (e.g., for pest population control); non- food/feed.
This category would cover sub- stances pro- duced and used in ani- mals that are intended for use as a pes- ticide, such as for pest popu- lation control, including the genetic mate- rial in such animals.

Cred- it 75% of B921 fee to- ward registra- tion applica- tion for the new active in- gredient that follows (B922).

(5) (12) (13) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4126 ‘‘TABLE 17.
4126 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 16 228,657 EPA No.

B922 New CR No.

184 (new) Action Registration ap- plication; new active ingre- dient; genetic modifications in animals in- tended for use as a pesticide (e.g., for pest population control); non- food/feed.
This category would cover sub- stances pro- duced and used in ani- mals that are intended for use as a pes- ticide, such as for pest popu- lation control, including the genetic mate- rial in such animals.

(5) (12) (13) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4127 ‘‘TABLE 17.
4127 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 15 228,658 EPA No.

B923 New CR No.

185 (new) Action Experimental Use Permit application; genetic modi- fications in animals in- tended for use as a pesticide (e.g., for pest population control); with petition to es- tablish a tem- porary or per- manent toler- ance/tolerance exemption of an active in- gredient.
This category would cover sub- stances pro- duced and used in ani- mals that are intended for use as a pes- ticide, such as for pest popu- lation control, including the genetic mate- rial in such animals.

Cred- it 75% of B923 fee to- ward registra- tion applica- tion for the new active in- gredient that follows (B924).

(5) (12) (13) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4128 ‘‘TABLE 17.
4128 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 19 292,682 EPA No.

B924 New CR No.

186 (new) Action Registration ap- plication; new active ingre- dient; genetic modifications in animals in- tended for use as a pesticide (e.g., for pest population control); with petition to es- tablish a per- manent toler- ance/tolerance exemption of an active in- gredient.
This category would cover sub- stances pro- duced and used in ani- mals that are intended for use as a pes- ticide, such as for pest popu- lation control, including the genetic mate- rial in such animals.

(5) (12) (13) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4129 ‘‘TABLE 17.
4129 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 11 27,452 17 82,329 EPA No.

B925 New CR No.
B925 New CR No.

187 (new) B926 188 (new) Action Experimental Use Permit application; exogenous ap- plications of RNA to elicit the RNA in- terference pathway in pests; non- food/feed; credit 75% of B925 fee to- ward registra- tion applica- tion for the new active in- gredient that follows (B926).

(5) (12) Registration ap- plication; new active ingre- dient; exoge- nous applica- tions of RNA to elicit the RNA inter- ference path- way in pests; non-food/feed.
(5) (12) (14) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4130 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 14 54,889 EPA No.

B927 New CR No.
B927 New CR No.

189 (new) Action Experimental Use Permit application; exogenous ap- plications of RNA to elicit the RNA in- terference pathway in pests; with pe- tition to estab- lish a tem- porary or per- manent toler- ance/tolerance exemption of an active in- gredient; cred- it 75% of B927 fee to- ward registra- tion applica- tion for the new active in- gredient that follows (B928).

(5) (12) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4131 ‘‘TABLE 17.
4131 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 22 137,210 10 7,322 EPA No.

B928 New CR No.

190 (new) B929 191 (new) Action Registration ap- plication; new active ingre- dient; exoge- nous applica- tions of RNA to elicit the RNA inter- ference path- way in pests; with petition to establish a permanent tol- erance/toler- ance exemp- tion of an ac- tive ingre- dient.
(5) (12) (14) Registration ap- plication; new product, reg- istered active ingredient; ex- ogenous appli- cations of RNA to elicit the RNA in- terference pathway in pests; no peti- tion since a permanent tol- erance/toler- ance exemp- tion is already established for the active in- gredient(s).

(5) (12) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4132 ‘‘TABLE 17.
4132 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PRE- VENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 3 18,296 9 45,737 6 18,296 EPA No.

B930 New CR No.

192 (new) B931 193 (new) B932 194 (new) Action Application to amend or ex- tend a non- PIP Emerging Technologies Experimental Use Permit; no petition since the es- tablished toler- ance/tolerance exemption for the active in- gredient is un- affected.
(12) Application to amend or ex- tend a non- PIP Emerging Technologies Experimental Use Permit; with petition to extend a temporary tol- erance/toler- ance exemp- tion for the active ingre- dient.

(12) Amendment; ap- plication to amend a non- PIP Emerging Technologies registration.

(4) (5) (12) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.
(2) ‘New PIP’ means a PIP with an active ingredient that has not been reg- istered.

(3) ‘Registered PIP’ means a PIP with an active ingredient that is currently registered.

(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4133 (5) If, during review of the application, it is determined that review by the FIFRA Scientific Advisory Panel (SAP) is needed, the applicant will submit an application for category B905, which will be processed concurrently, and the de- cision review time for both applications will be the longer of the two associated applications.

The scientific data involved in this category are complex.
EPA often seeks technical advice from the SAP on risks that pesticides pose to wild- life, farm workers, pesticide applicators, non-target species, insect resistance, and novel scientific issues surrounding new technologies.

The scientists of the SAP neither make nor recommend policy decisions.

They provide advice on the science used to make these decisions.

Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides.
Due to the time it takes to schedule and prepare for meetings with the SAP, ad- ditional time and costs are needed.

(6) Registered PIPs stacked through conventional breeding.

(7) Deployment of a registered PIP with a different Insecticide Resistance Management (IRM) plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA’s determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance.

The uncer- tainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations.
Registrants are encouraged to consult with EPA prior to submission of a reg- istration application in this category.

(9) Application can be submitted prior to or concurrently with an application for commercial registration.

(10) For example, IRM plan modifications that are applicant-initiated.

(11) (a) EPA-initiated amendments shall not be charged registration service fees.
(b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in section 3(c)(3)(B) and are not subject to registration service fees.

(c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in sec- tion 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) No- tices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.

(e) Submissions with data and requiring data review are subject to registration service fees.
(12) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(13) This category does not include genetic modifications in animals not in- tended for use as a pesticide, e.g., genetic modifications in animals intended for food use or animals intended for use as companion animals.
(14) If the Administrator determines that endangered species analysis is re- quired for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for en- dangered species assessment one time only for up to 50%, upon written notifica- tion to the applicant, prior to completion of the technical screening.

To the ex- tent practicable, any reason for renegotiation should be resolved during the same extension.
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4134 ‘‘TABLE 18.

— INERT INGREDIENTS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 15 38,698 13 10,750 11 4,742 6 15,803 6 7,903 4 4,742 EPA No.

New CR No.

Action I001 195 I002 196 I003 197 I004 198 I005 199 I006 200 Approval of new food use inert ingredient.

(2) (3) Amend currently approved inert ingredient tol- erance or ex- emption from tolerance; new data.
(2) Amend currently approved inert ingredient tol- erance or ex- emption from tolerance; no new data.

(2) Approval of new non-food use inert ingre- dient.

(2) Amend currently approved non- food use inert ingredient with new use pattern; new data.

(2) Amend currently approved non- food use inert ingredient with new use pattern; no new data.

(2) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4135 ‘‘TABLE 18.

— INERT INGREDIENTS—Continued EPA No.

New CR No.


Action I007 201 I008 202 I009 203 Approval of sub- stantially simi- lar non-food use inert in- gredients when original inert is compositionall- y similar with similar use pattern.

(2) Approval of new or amended polymer inert ingredient, food use.

(2) Approval of new or amended polymer inert ingredient, non-food use.
(2) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 5 2,371 7 5,374 4 4,427 I010 204 Petition to 7 2,371 amend a single tolerance ex- emption descriptor, or single non- food use descriptor, to add ≤ 10 CASRNs; no new data.

(2) I011 205 Approval of new 26 856,631 food use safener with tolerance or exemption from toler- ance.

(2) Approval of new non-food use safener.

(2) I012 206 21 595,147 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4136 ‘‘TABLE 18.
4136 ‘‘TABLE 18.

— INERT INGREDIENTS—Continued EPA No.

New CR No.

Action I013 207 I014 208 I015 209 Approval of addi- tional food use for previously approved safener with tolerance or exemption from toler- ance.

(2) Approval of addi- tional non- food use for previously ap- proved safener.

(2) Approval of new generic data for previously approved food use safener.
(2) Decision Review Time (Months)(1) Registra- tion Service Fee ($) 17 90,260 15 36,074 26 386,589 I016 210 Approval of 15 79,942 amendment(s) to tolerance and label for previously ap- proved safener.

(2) I017 211 (new) Add new source of previously approved safener.

8 18,958 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4137 ‘‘TABLE 18.

— INERT INGREDIENTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 3 2,371 EPA No.

New CR No.
New CR No.

Action I018 212 (new) Petition to add one approved inert ingre- dient (CASRN) to the Com- modity Inert Ingredient List; no data.

(4) (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

(2) If another covered application is submitted that depends upon an applica- tion to approve an inert ingredient, each application will be subject to its respec- tive registration service fee.
The decision review time for both submissions will be the longest of the associated applications.

If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.

(3) If EPA data rules are amended to newly require clearance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
346a) for an in- gredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.

(4) Due to low fee and short time frame this category is not eligible for small business waivers.

‘‘TABLE 19.
‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 14 11,378 EPA No.

New CR No.

Action M001 213 Study protocol requiring Human Stud- ies Review Board review as defined in 40 CFR Part 26 in support of a currently registered ac- tive ingre- dient.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4138 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) M002 214 Completed study 14 11,378 requiring Human Stud- ies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient.

(2) M003 215 External tech- 12 91,651 nical peer re- view of new active ingre- dient, product, or amendment (e.g., consulta- tion with FIFRA Sci- entific Advi- sory Panel) for an action with a decision timeframe of less than 12 months.
Appli- cant initiated request based on a require- ment of the Administrator, as defined by FIFRA § 25(d), in sup- port of a novel active ingre- dient, or unique use pattern or ap- plication tech- nology.

Ex- cludes PIP ac- tive .ingredients.

(3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4139 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) M004 216 External tech- 18 91,651 nical peer re- view of new active ingre- dient, product, or amendment (e.g., consulta- tion with FIFRA Sci- entific Advi- sory Panel) for an action with a decision timeframe of greater than 12 months.
Applicant ini- tiated request based on a re- quirement of the Adminis- trator, as de- fined by FIFRA § 25(d), in sup- port of a novel active ingre- dient, or unique use pattern or ap- plication tech- nology.

Ex- cludes PIP ac- tive ingredi- ents.

(3) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4140 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) M005 217 New Product: 9 31,604 Combination, Contains a combination of active ingredi- ents from a registered and/ or unregis- tered source; conventional, antimicrobial and/or biopes- ticide.

Re- quires coordi- nation with other regu- latory divi- sions to con- duct review of data, label and/or verify the validity of existing data as cited.

Only existing uses for each active ingredient in the combina- tion product.
(4) (5) (6) M006 218 Request for up 1 398 to 5 letters of certification (Gold Seal) for one ac- tively reg- istered prod- uct (excludes distributor products).

(7) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4141 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) M007 219 Request to ex- 12 7,903 M008 220 15 2,371 tend Exclusive Use of data as provided by FIFRA Sec- tion 3(c)(1)(F)(ii).

Request to grant Exclusive Use of data as pro- vided by FIFRA Sec- tion 3(c)(1)(F)(vi) for a minor use, when a FIFRA Sec- tion 2(ll)(2) determination is required.

M009 221 Non-FIFRA 6 3,389 M010 222 Regulated De- termination; applicant-initi- ated, per prod- uct.
Conditional rul- ing on pre-ap- plication, product sub- stantial simi- larity.

4 3,389 M011 223 Label amend- 4 5,230 ment to add the DfE logo; requires data review; no other label changes.

(8) December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4142 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) M012 224 (new) Request for up 1 398 to 5 letters of certification (Certificate of Establish- ment) for one actively reg- istered prod- uct or one product pro- duced for ex- port (excludes distributor products).

(7) M013 225 (new) Cancer reassess- 18 284,144 ment; appli- cant-initiated.

M014 227 (new) Pre-application nano-particle determination.
8 17,424 (1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

(2) Any other covered application that is associated with and dependent on the review by the Human Studies Review Board will be subject to its separate registration service fee.

The decision review times for the associated actions run concurrently, but will end at the date of the latest review time.
(3) Any other covered application that is associated with and dependent on the FIFRA Scientific Advisory Panel review will be subject to its separate reg- istration service fee.

The decision review time for the associated action will be extended by the decision review time for the SAP review.

(4) If another covered application is submitted that depends upon an applica- tion to approve an inert ingredient, each application will be subject to its respec- tive registration service fee.
The decision review time for both submissions will be the longest of the associated applications.

If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.
(5) An application for a new end-use product using a source of active ingre- dient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4143 (6) Where the action involves approval of a new or amended label, on or be- fore the end date of the decision review time, the Agency shall provide to the ap- plicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent re- submission, but forfeits the associated registration service fee.
For cases de- scribed in (b), the applicant shall have up to 30 calendar days to reach agree- ment with the Agency on the final terms of the Agency-accepted label.

If the ap- plicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agen- cy-stamped label to the registrant within 2 business days following the reg- istrant’s written or electronic confirmation of agreement to the Agency.
(7) Due to low fee and short time frame this category is not eligible for small business waivers.

(8) This category includes amendments the sole purpose of which is to add ‘Design for the Environment’ (DfE) (or equivalent terms that do not use ‘safe’ or derivatives of ‘safe’) logos to a label.

DfE is a voluntary program.


A label bearing a DfE logo is not considered an Agency endorsement because the ingre- dients in the qualifying product must meet objective, scientific criteria estab- lished and widely publicized by EPA.’’.

SEC.

707.

INFORMATION.


Not later than 180 days after the date of enactment of this title, the Administrator of the Environmental Pro- tection Agency shall post on a single webpage of the website of the Environmental Protection Agency aggre- gated information on pesticide regulation under the Fed- eral Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136 et seq.
136 et seq.

), including— (1) all guidance relating to risk assessment, risk mitigation, benefits assessments, and cost-ben- efit balancing; (2) hyperlinks to resources, including the De- partment of Agriculture’s ‘‘national list of allowed and prohibited substances’’ for organic crop and livestock production; December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4144 (3) biopesticides and pesticides exempt pursu- ant to section 25(b) of the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C.

136w(b)); and (4) integrated pest management principles de- veloped under section 28(c) of such Act (7 U.S.C.

136w–3(c)), including technical assistance for imple- mentation of those principles.

SEC.

708.

IMPLEMENTATION DATES WITH RESPECT TO FEES.


(a) FEE INCREASES.— (1) REGISTRATION SERVICE FEES.—With re- spect to amendments made by this title to increase registration service fees specified in section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w–8), such increases shall not be effec- tive until the date that is 60 days after the date of the enactment of this title, regardless of whether such section 33 specifies (as so amended) that such increases are effective for fiscal year 2023.

(2) MAINTENANCE FEES.—With respect to amendments made by this title to increase the amount of maintenance fees to be collected under section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a–1(i)), such in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4145 creases shall be effective beginning on October 1, 2022.

(b) SET-ASIDES.—With respect to any set-asides specified in subsection (i) or (k) of section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136a–1), such set-asides shall be effective beginning on October 1, 2022.
Subtitle B—Other Matters Relating to Pesticides SEC.

711.

REGISTRATION REVIEW DEADLINE EXTENSION.

(a) IN GENERAL.—Notwithstanding section 3(g)(1)(A)(iii)(I) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a(g)(1)(A)(iii)(I)), the Administrator of the Environmental Protection Agency (referred to in this section as the ‘‘Administrator’’) shall complete the initial registration review of each pesticide or pesticide case covered by that section not later than October 1, 2026.
19 (b) INTERIM REGISTRATION REVIEW DECISION RE- 20 QUIREMENTS.— (1) DEFINITION OF COVERED INTERIM REG- ISTRATION REVIEW DECISION.—In this subsection, the term ‘‘covered interim registration review deci- sion’’ means an interim registration review deci- sion— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4146 (A) that is associated with an initial reg- istration review described in subsection (a); (B) that is noticed in the Federal Register during the period beginning on the date of en- actment of this Act and ending on October 1, 2026; and (C) for which the Administrator has not, as of the date on which the decision is noticed in the Federal Register, made effects deter- minations or completed any necessary consulta- tion under section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C.

1536(a)(2)).
1536(a)(2)).

(2) REQUIREMENTS.—Any covered interim reg- istration review decision shall include, where applica- ble, measures to reduce the effects of the applicable pesticide on— (A) species listed under the Endangered Species Act of 1973 (16 U.S.C.

1531 et seq.

); or (B) any designated critical habitat.


(3) CONSULTATION.—In developing measures described in paragraph (2), the Administrator shall take into account the input received from the Sec- retary of Agriculture and other members of the interagency working group established under section December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4147 3(c)(11) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136a(c)(11)).

TITLE DIVISION JJ—NORTH ATLANTIC RIGHT WHALES I—NORTH ATLANTIC RIGHT WHALES AND REGULA- TIONS SEC.

101.

NORTH ATLANTIC RIGHT WHALES AND REGULA- TIONS.


(a) IN GENERAL.—Notwithstanding any other provi- sion of law except as provided in subsection (b), for the period beginning on the date of enactment of this Act and ending on December 31, 2028, the Final Rule amending the regulations implementing the Atlantic Large Whale Take Reduction Plan (86 Fed.

Reg.
Reg.

51970) shall be deemed sufficient to ensure that the continued Federal and State authorizations of the American lobster and Jonah crab fisheries are in full compliance with the Ma- rine Mammal Protection Act of 1972 (16 U.S.C.

1361 et seq.)

and the Endangered Species Act of 1973 (16 U.S.C.

1531 et seq.).
1531 et seq.).

The National Marine Fisheries Service shall— 23 24 25 (1) throughout the period described in the pre- ceding sentence, in consultation with affected States and fishing industry participants, promote the inno- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4148 vation and adoption of gear technologies in the fish- eries described in the preceding sentence, in order to implement additional whale protection measures by December 31, 2028; (2) promulgate new regulations for the Amer- ican lobster and Jonah crab fisheries consistent with the Marine Mammal Protection Act of 1972 (16 U.S.C.

1361 et seq.)

and the Endangered Species Act of 1973 (16 U.S.C.

1531 et seq.)
that take ef- fect by December 31, 2028, utilizing existing and in- novative gear technologies, as appropriate; and (3) in consultation with affected States, submit an annual report to Congress on the status of North Atlantic Right Whales, the actions taken and plans to implement measures expected to not exceed Po- tential Biological Removal by December 31, 2028, the amount of serious injury and mortality by fish- ery and country, and the proportion of the American lobster and Jonah crab fisheries that have transitioned to innovative gear technologies that re- duce harm to the North Atlantic Right Whale.
(b) EXCEPTION.—The provisions of subsection (a) shall not apply to an existing emergency rule, or any ac- tion taken to extend or make final an emergency rule that December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4149 is in place on the date of enactment of this Act, affecting lobster and Jonah crab.

TITLE II—GRANT AUTHORITY SEC.

201.

CONSERVATION AND MITIGATION ASSISTANCE.
(a) ASSISTANCE.— (1) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, the Sec- retary of Commerce, acting through the Under Sec- retary of Commerce for Oceans and Atmosphere (in this title referred to as the ‘‘Under Secretary’’) shall establish a program to provide competitive financial assistance, on an annual basis, and cooperative agreements including multiyear grants and direct payment, to eligible entities for eligible uses, such as projects designed to reduce the lethal and sub-lethal effects of human activities on North Atlantic right whales.
(2) USE OF EXISTING AUTHORITIES.—Assist- ance provided under this section shall be carried out in a manner consistent with authorities available to the Secretary under the Endangered Species Act of 1973 (16 U.S.C.

1531 et seq.)

and the Marine Mammal Protection Act of 1972 (16 U.S.C.

1361 et seq.).

1 December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4150 (3) COOPERATIVE AGREEMENTS.—The Under Secretary may enter into cooperative agreements with the National Fish and Wildlife Foundation es- tablished by the National Fish and Wildlife Founda- tion Establishment Act (16 U.S.C.

3701 et seq.)

to carry out this title.
(b) ELIGIBLE ENTITIES.—An entity is an eligible en- tity for purposes of assistance awarded under subsection (a) if the entity is— (1) a relevant port authority for a port; (2) a relevant State, regional, local, or Tribal government; (3) any other individual or entity, as deter- mined appropriate by the Under Secretary, includ- ing— (A) an owner or operator of a vessel, as defined under section 3 of title 1, United States Code; and (B) participants within sectors of the mari- time industry, such as boating, shipping, fish- ing, fishing gear and rope manufacturing, and other maritime activities; (4) a nonprofit organization or research institu- tion with expertise in commercial fisheries, gear in- December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4151 novation, and North Atlantic right whale conserva- tion; or (5) a consortium of entities described in para- graphs (1) through (4).
(c) ELIGIBLE USES.—Assistance awarded under sub- section (a) may be used to develop, assess, and carry out activities that reduce human induced threats to North At- lantic right whales, including— (1) funding research to identify, deploy, or test innovative gear technologies; (2) subsidizing acquisition of innovative gear technologies to improve adoption of those tech- nologies by fisheries participants, which may include direct payment to fisheries participants; (3) training for fisheries participants to im- prove deployment, safety, and adoption of innovative gear technologies; (4) funding for monitoring necessary to support dynamic management of fisheries, vessel traffic, or other needs; and (5) other uses as determined by the Under Sec- retary in consultation with relevant eligible entities.
(d) PRIORITY.—In determining whether to fund project proposals under this section, the Under Secretary shall prioritize projects— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4152 (1) with a substantial likelihood of reducing le- thal and sub-lethal effects on North Atlantic right whales from fishing gear entanglements or vessel collisions; (2) that include cooperation with fishing indus- try participants or other private sector stakeholders; and (3) that demonstrate, or have the potential to provide, economic benefits to small businesses based in the United States.
(e) PROHIBITED USES.— (1) IN GENERAL.—Except as provided in para- graph (2), funds awarded under this section may not be used to distribute resources to an entity or indi- vidual that is not a United States person (as defined in section 7701(a)(3) of the Internal Revenue Code of 1986).
(2) EXCEPTION.—Funds awarded under this section may be used to distribute resources to a partnership that includes an entity or individual that is not a United States person (as defined in section 7701(a)(30) of the Internal Revenue Code of 1986) if the resources are distributed directly to a partner in the partnership that is a United States person (as so defined).
December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4153 (f) PROJECT REPORTING.— (1) IN GENERAL.—Each individual or entity that receives assistance under this section for a project shall submit to the Under Secretary periodic reports (at such intervals as the Under Secretary may require) that include all information that the Under Secretary, after consultation with other gov- ernment officials, determines is necessary to evaluate the progress and success of the project for the pur- poses of ensuring positive results, assessing prob- lems, and fostering improvements.
(2) AVAILABILITY TO THE PUBLIC.—Reports under paragraph (1) shall be made available to the public in a timely manner.

SEC.

202.

REPORT TO CONGRESS.


Not later than 2 years after the date of enactment of this Act, and every 5 years thereafter, the Under Sec- retary shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Com- mittee on Natural Resources of the House of Representa- tives a report on the results and effectiveness of projects receiving assistance provided under this title.

SEC.

203.

FUNDING.


(a) AUTHORIZATION OF APPROPRIATIONS.— December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.

4154 (1) AUTHORIZATION.—There is authorized to be appropriated to the Under Secretary to carry out this title $50,000,000 (of which not less than $40,000,000 shall be for innovative gear deployment and technology) for each of fiscal years 2023 through 2032.
(2) ADMINISTRATIVE EXPENSES.—Of the amounts authorized to be appropriated under this subsection for a fiscal year, the Under Secretary may expend not more than 5 percent, or up to $80,000, whichever is greater, to pay the adminis- trative expenses necessary to carry out this title.
(b) ACCEPTANCE AND USE OF DONATIONS.—The Under Secretary may accept, receive, solicit, hold, admin- ister, and use any gift, devise, or bequest, consistent with policy of the Department of Commerce in effect on the date of enactment of this Act, to provide assistance under section 201.

19 TITLE III—CONTINUOUS PLANKTON RECORDER SEC.

301.

SURVEY.
301.

SURVEY.

(a) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, and on an ongoing basis thereafter, the Secretary of Commerce shall conduct a Continuous Plankton Recorder survey.

December 19, 2022 (11:48 p.m.) U:\2023OMNI\FinalFY23\JRQ121922.xml SEN. APPRO.
4155 (b) REQUIRED ELEMENTS.—For the purpose of con- ducting the survey required under subsection (a), the Northeast Fisheries Science Center shall— (1) to the extent possible, utilize the resources of and partner with, on a volunteer basis, research institutions, nonprofit organizations, commercial ves- sels, and other Federal agencies; (2) in as short a time as possible, ensure rel- evant survey samples and results are analyzed, stored, archived, and made publicly available; (3) prioritize the collection of plankton samples and data that inform the conservation of North At- lantic right whales; and (4) to the extent practicable, coordinate with the Government of Canada to develop a transbound- ary understanding of plankton abundance and dis- tribution.
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section there is authorized to be appropriated to the Secretary of Commerce $300,000 for each of fiscal years 2023 through 2032, which shall be derived from ex- isting funds otherwise appropriated to the Secretary.

1 December 19, 2022 (11:48 p.m.)