Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1696589061567.pdf (United States)
(a) IN GENERAL.—The Secretary shall establish a pilot program under which the Secretary establishes procedures to provide increased interaction with sponsors of rare disease drug develop- ment programs for purposes of advancing the development of effi- cacy 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 conduct up to 3 public workshops, which shall be completed not later than Sep- tember 30, 2026, to discuss topics relevant 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 evidence and real world data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare dis- eases.
(c) REPORTS.— (1) INTERIM REPORT.—Not later than September 30, 2026, the Secretary shall 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 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 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 describing the outcomes of the pilot program estab- lished under this section.
(d) GUIDANCE.—Not later than September 30, 2027, the Sec- retary shall issue guidance describing best practices and strategies for development of efficacy endpoints, including surrogate and inter- mediate endpoints, for rare diseases.

(e) SUNSET.—The Secretary may not accept any new application or request to participate in the program established by this section on or after October 1, 2027.

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 ‘‘preclinical tests (including tests on animals)’’ and inserting ‘‘nonclinical tests’’; and (B) in paragraph (2)(B), by striking ‘‘animal’’ and inserting ‘‘nonclinical tests’’; and (2) by inserting after subsection (y) the following: H. R. 2617—1364 ‘‘(z) NONCLINICAL TEST DEFINED.—For purposes of this section, the term ‘nonclinical test’ means a test conducted 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 systems.

‘‘(3) Computer modeling.

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

‘‘(5) Animal tests.’’.

(b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATIONS.—Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C.
262(k)(2)(A)(i)(I)) is amended to read as follows: ‘‘(bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described 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 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 product’’; (C) in clause (i) of such subparagraph (A), as so redesig- nated, by striking ‘‘appropriate postapproval studies’’ and inserting ‘‘an appropriate postapproval study or studies’’; and (D) by adding at the end the following: ‘‘(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 paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary.
‘‘(C) POSTAPPROVAL STUDY CONDITIONS.—Not later than the date of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion.
‘‘(D) STUDIES BEGUN BEFORE APPROVAL.—The Secretary may require, as appropriate, a study or studies to be under- way prior to approval, or within a specified time period after the date of approval, of the applicable product.’’; and (2) in paragraph (3)— (A) in the matter preceding subparagraph (A), by striking ‘‘(as prescribed by the Secretary in regulations which shall informal hearing)’’ and inserting ‘‘described in subparagraph (B)’’; include an opportunity for an H. R. 2617—1365 (B) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively 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 redesig- nated, by striking ‘‘drug with due diligence’’ and inserting ‘‘product with due diligence, including with respect to condi- tions specified 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 DESCRIBED.—Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval— ‘‘(i) providing the sponsor with— ‘‘(I) due notice; ‘‘(II) an explanation for the proposed with- drawal; ‘‘(III) an opportunity for a meeting 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 participated in the proposed with- drawal of approval (other than a meeting pursuant to subclause (III)) and is not subordi- nate of an individual (other than the Commis- sioner) who participated in such proposed withdrawal; ‘‘(ii) providing an opportunity for public comment on the proposal to withdraw approval; ‘‘(iii) the publication of a summary of the public comments received, and the Secretary’s response to such comments, on
 the website of the Food and Drug Administration; and ‘‘(iv) convening and consulting an advisory com- mittee 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 request.’’.
(b) REPORTS OF POSTMARKETING STUDIES.—Section 506B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356b(a)) is amended— (1) by redesignating paragraph (2) as paragraph (3); and (2) by inserting after paragraph (1) the following: ‘‘(2) ACCELERATED APPROVAL.—Notwithstanding paragraph (1), a sponsor of a drug approved 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 and not less frequently than every 180 days thereafter, until the study is completed or terminated.
H. R. 2617—1366 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 postapproval 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-stage development meetings with the Food and Drug Administration; (B) the use of novel clinical trial designs that may be used to conduct appropriate postapproval studies as may be required under section 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 accel- erated 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 enactment of this Act; and (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 approval 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 Council 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 Biologics Evaluation and Research.

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

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

H. R. 2617—1367 (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 director within the Office of Neuro- science.
(3) DUTIES OF THE COUNCIL.— (A) MEETINGS.—The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-dis- ciplinary approaches 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 include— (i) developing guidance for Food and Drug Administration staff and best practices 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 review 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 Administration a report on the activities of the Council.

(f) RULE OF CONSTRUCTION.—Nothing in this section (including the amendments made by this section) shall be construed to affect ongoing withdrawal proceedings 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 enact- ment of this Act.

Such proceedings may continue 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 Commis- sioner 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 licensure under section 351 of the Public Health Service Act (42 U.S.C.
262) of antifungal therapies designed to treat coccidioi- domycosis (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 H. R. 2617—1368 to subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance.
(c) WORKSHOP.—To assist entities developing preventive vac- cines for fungal infections and coccidioidomycosis, 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 amended— (1) in subsection (c)— (A) in paragraph (2), by striking ‘‘; or’’ and inserting ‘‘;’’; (B) in paragraph (3), by striking the period 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 follows: ‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.—The term ‘qualified infectious disease product’ means a drug (including a biological product), including an antibacterial 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-threatening infec- tion, including such an infection caused by— ‘‘(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or ‘‘(B) qualifying pathogens listed by the Secretary under subsection (f).’’.
(b) PRIORITY REVIEW.—Section 524A(a) of the Federal 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 DESIGNA- TION PROGRAM.

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

351 et seq.
351 et seq.

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

506L.

ADVANCED MANUFACTURING TECHNOLOGIES DESIGNA- TION PROGRAM.

‘‘(a) IN GENERAL.—Not later than 1 year after the date of enactment of this section, the Secretary shall initiate a program under which persons may request designation of an advanced manu- facturing technology as described in subsection (b).
H. R. 2617—1369 ‘‘(b) DESIGNATION PROCESS.—The Secretary shall establish a process for the designation under this section of methods of manu- facturing drugs, including biological products, and active pharma- ceutical ingredients of such drugs, as advanced manufacturing tech- nologies.
A method of manufacturing, or a combination of manufac- turing methods, is eligible for designation as an advanced manufac- turing technology if such method or combination of methods incor- porates a novel technology, or uses an established 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 des- ignated manufacturing method; or ‘‘(2) increasing or maintaining the supply of— ‘‘(A) a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or ‘‘(B) a drug that is on the drug shortage list under section 506E.
‘‘(c) EVALUATION AND DESIGNATION OF AN ADVANCED MANUFAC- TURING TECHNOLOGY.— ‘‘(1) SUBMISSION.—A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufac- turing meets the criteria described in subsection (b) in a par- ticular context of use.
The Secretary may facilitate the develop- ment and review of such data or information by— ‘‘(A) providing timely advice to, and interactive commu- nication with, such person regarding the development of the method of manufacturing; and ‘‘(B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable.
‘‘(2) EVALUATION AND DESIGNATION.—Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing tech- nology, 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— ‘‘(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, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and ‘‘(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing tech- nology designation holder, to reference 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 designated advanced manufacturing technology for use in manufacturing H. R. 2617—1370 drugs in the same context of use for which the designation was granted.
‘‘(e) IMPLEMENTATION AND EVALUATION OF ADVANCED MANU- FACTURING 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 obtain input and recommendations from relevant stakeholders regarding— ‘‘(A) the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and ‘‘(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing tech- nologies and other innovative 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 implementation of the program under this section; and ‘‘(ii) not later than 2 years after the date of enact- ment of this section, issue final guidance regarding the implementation of such program.
‘‘(B) CONTENT.—The guidance described in subpara- graph (A) shall address— ‘‘(i) the process by which a person may request a designation under subsection (b); ‘‘(ii) the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions; ‘‘(iii) the process to expedite the development and review of applications under subsection (d); and ‘‘(iv) the criteria described in subsection (b) for eligibility for such a designation.
‘‘(3) REPORT.—Not later than 3 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administra- tion 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 a report con- taining a description and evaluation of the program being con- ducted under this section, including the types of innovative manufacturing approaches supported under the program.
Such report shall include the following: ‘‘(A) The number of persons that have requested des- ignations and that have been granted designations.

‘‘(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.

‘‘(C) The average number of calendar days for comple- tion of evaluations under subsection (c)(2).
‘‘(D) An analysis of the factors in data submissions that result in determinations to designate and not to des- ignate after evaluation under subsection (c)(2).

H. R. 2617—1371 including supplemental applications, ‘‘(E) The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.
‘‘(f) SUNSET.—The Secretary— ‘‘(1) may not consider any requests for designation sub- mitted under subsection (c) after October 1, 2032; and ‘‘(2) may continue all activities under this section with respect to advanced manufacturing technologies that were des- ignated 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 IMPROVEMENTS SEC.

3221.
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 nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regula- tion))’’.

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 pursuant 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 inactive ingredients not permitted under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of Federal Regulations (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 prescription drug product section of the list under this paragraph as follows: ‘‘(aa) With respect to such an application submitted 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 sub- section (b)(2) that is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug in the application pursu- ant to subsection (b)(2) at the time of approval of such applica- tion 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 resubmission 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 equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Sec- retary.
H. R. 2617—1372 ‘‘(bb) With respect to such an application approved 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 equivalence 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 application if a request for such evaluation is submitted as an amendment to the application, provided that— ‘‘(AA) such request for a therapeutic equivalence evaluation is being sought with respect to a listed drug relied upon in the application, and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equiva- lent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor 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 relevant application, includes all necessary data and information for the thera- peutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner pre- scribed 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.’’.

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 gen- erally should be considered by the Secretary when reviewing requests from sponsors of drugs subject to risk evaluation and mitigation strategies to change third-party vendors engaged by sponsors to aid in implementation and management of the strategies.
(2) FACTORS.—Such factors include the potential 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 Com- mittee on Energy and Commerce of the House of Representatives H. R. 2617—1373 and the Committee on Health, Education, Labor, and Pensions of the Senate a report on— (1) the number of changes in third-party vendors (engaged by sponsors to aid implementation and management of risk evaluation and mitigation strategies) for an approved risk evaluation and mitigation strategy the Secretary has approved under 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 applicable.

SEC.

3224.

ENHANCING ACCESS TO AFFORDABLE MEDICINES.

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 following: ‘‘(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the applica- tion is otherwise eligible for approval under this subsection; ‘‘(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; ‘‘(iii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ 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 procedure 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 classification under section 513(f)(2), submit a single submission containing— ‘‘(1) the information needed for such a request; and ‘‘(2) sufficient information to enable the Secretary to deter- mine whether such laboratory examination or procedure satis- fies the criteria to be categorized under section 353(d)(3) of the Public Health Service Act.’’.
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 under sub- section (a) shall include at least 1 population health-specific rep- resentative.

H. R. 2617—1374 (c) SUNSET.—This section shall cease to be effective on October 1, 2027.

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 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 the third-party review program under section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360m).
360m).

Such report shall include— (1) a description of the financial and staffing resources used to carry out such program; (2) a description of actions taken by the Secretary pursuant section 523(b)(2)(C) of the Federal 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.

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 certification under this subparagraph of a device manufactured by a device establish- ment 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 premarket report pursuant to subsection (l) or (m) of section 510, and the device is imported or offered for import into the United States.
‘‘(ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable require- ments of this Act.

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

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

SEC.

3305.

ENSURING CYBERSECURITY OF MEDICAL DEVICES.


(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 application 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 information as the Secretary may require to ensure that such cyber device meets the cybersecurity require- ments under subsection (b).
H. R. 2617—1375 ‘‘(b) CYBERSECURITY REQUIREMENTS.—The sponsor 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 disclosure 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, critical 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.
‘‘(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 characteristics vali- dated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.
‘‘(d) EXEMPTION.—The Secretary may identify devices, or cat- egories or types of devices, that are exempt from meeting the cybersecurity requirements established by this section and regula- tions 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 Secretary.’’.

(b) PROHIBITED ACT.—Section 301(q) of the Federal 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 cybersecurity).’’.
(c) RULE OF CONSTRUCTION.—Nothing in this section, including the amendments made by this section, shall be construed to affect the Secretary’s authority related to ensuring that there is a reason- able 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 submission submitted before such effective date shall not be subject to the requirements under sub- section (a) or (b) of section 524B of the Federal Food, Drug, and Cosmetic Act, as added by this section.
(e) GUIDANCE FOR INDUSTRY AND FDA STAFF ON DEVICE CYBER- SECURITY.—Not later than 2 years after the date of enactment of this Act, and periodically thereafter as appropriate, the Secretary, H. R. 2617—1376 in consultation with the Director of the Cybersecurity and Infra- structure Security Agency, shall review and, as appropriate and after soliciting and receiving feedback from device manufacturers, health care providers, third-party-device servicers, patient advo- cates, and other appropriate stakeholders, update the guidance entitled ‘‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices’’ (or a successor document).
(f) RESOURCES REGARDING CYBERSECURITY OF DEVICES.—Not later than 180 days after the date of enactment 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 information 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 soft- ware security updates.
Through such report, the Comptroller Gen- eral shall examine— (1) challenges for device manufacturers, health care pro- viders, health systems, and patients in accessing Federal sup- port to address vulnerabilities across Federal agencies; (2) how Federal agencies can strengthen coordination 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 legally marketed device under section 1006 when intended for such use or uses’’ after ‘‘banned device’’.
(b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with section 516 of the Federal Food, Drug, and Cos- metic 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 H. R. 2617—1377 under contract with, the Food and Drug Administration, in regu- latory decision-making with respect to devices, the Secretary shall— (1) request access to the datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising 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 other- wise appropriate, to the extent practicable, provide the manu- facturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or person- ally identifiable information.
(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 communications 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 section shall be construed to require the delay of any regulatory decision-making or other action of the Food and Drug Administration.

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 amended by inserting after section 515B (21 U.S.C.

360e–3) the following: ‘‘SEC.

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 section 515, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2).
‘‘(2) PREDETERMINED CHANGE CONTROL PLAN.—The Sec- retary may approve a predetermined change control plan sub- mitted in an application, including a supplemental application, under section 515 that describes planned changes that may be made to the device (and that would otherwise require 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 requirements 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 pre- market notification shall not be required for a change to a device cleared under section 510(k), if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2).
H. R. 2617—1378 ‘‘(2) PREDETERMINED CHANGE CONTROL PLAN.—The Sec- retary may clear a predetermined change control plan sub- mitted in a notification submitted 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 requirements 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 determination of substantial equivalence pursuant to section 513(i), the Secretary shall not compare a device to changed versions of a device imple- mented in accordance with an established predetermined change control plan as a predicate device.

Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate 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 Fed- eral Food, Drug, and Cosmetic 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 SIGNIFICANT 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 sub- stantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radio- logical Health regarding 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 application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the reso- lution of such controversies or differences of opinion.’’.
SEC.

3309.

SMALL BUSINESS FEE WAIVER.

(a) IN GENERAL.—Section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j) is amended— (1) by striking ‘‘No fee’’ and inserting the following: ‘‘(i) IN GENERAL.—No fee’’; and (2) by adding at the end the following: ‘‘(ii) SMALL BUSINESSES FEE WAIVER.— ‘‘(I) DEFINITION OF SMALL BUSINESS.—For pur- poses of this clause, the term ‘small business’ H. R. 2617—1379 means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
‘‘(II) WAIVER.—The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the ini- tial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as deter- mined by the Secretary.
‘‘(III) FIRMS SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.—The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established (I).
The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they sub- mitted to the Internal Revenue Service.

If no tax forms are submitted for any affiliate, the establish- ment shall certify that the establishment has no affiliates.
in subclause ‘‘(IV) FIRMS NOT SUBMITTING TAX RETURNS TO THE UNITED STATES INTERNAL REVENUE SERVICE.— In the case of an establishment that has not pre- viously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certifi- cation, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the cri- teria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered.
The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment’s or affiliate’s gross receipts 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 con- verting such local currency to dollars, and the dates during which these receipts or sales were collected.
The establishment 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 submitted certifications for all of its affiliates, or that the establishment has no affiliates.

H. R. 2617—1380 ‘‘(V) REQUEST FOR WAIVER.—An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Sec- retary at least 60 days before the fee is required pursuant to subparagraph (C).
The decision of the Secretary 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 FORMULA SUPPLY.


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

321(z)).

(2) CRITICAL FOOD.—Section 201 of the Federal 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.’’.

(b) OFFICE OF CRITICAL FOODS.— (1) IN GENERAL.—The Secretary shall establish within the Center for Food Safety and Applied Nutrition 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 respon- sible for oversight, coordination, and facilitation of activities related to critical foods, as defined 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 SHORTAGES.— ‘‘(1) IN GENERAL.—The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any per- son who intends to introduce or deliver for introduction into interstate commerce any new infant formula.
‘‘(2) EFFECTIVE PERIOD.—The waiver authority under this subsection shall remain in effect— ‘‘(A) for 90 days beginning on the date that the Sec- retary distributes information under section 424(a)(2) with respect to a shortage 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 enact- ment of this Act, the Secretary shall submit a report to the Com- mittee on Health, Education, Labor, and Pensions of the Senate H. R. 2617—1381 and the Committee on Energy and Commerce of the House of Representatives that includes— (1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a(d)) each year since 2012; (2) how many of such submissions received requests from the Secretary for additional information; (3) how long after receiving such submissions the Secretary sent such requests for additional information; (4) what additional information the Secretary requested of the persons submitting such submissions; and (5) the date each new infant formula described in subpara- graph (A) was first marketed, if available.
(e) INFANT FORMULA FLEXIBILITIES.—The Secretary shall pub- lish a list on the website of the Department of Health and Human Services providing information on how to identify appropriate sub- stitutes for infant formula products in shortage that are relied upon by infants and other individuals with inborn errors of metabo- lism or other serious health conditions.
(f) INTERNATIONAL HARMONIZATION OF INFANT FORMULA REQUIREMENTS.— (1) IN GENERAL.—The Secretary— (A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutri- tional requirements; and (B) may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that 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 Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph 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 report 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 com- petition with respect to such infant formula; and (III) any differences between infant formula marketed in the United States and infant formula marketed in the European Union, including with respect to nutritional content and applicable labeling and other regulatory requirements; and (ii) include recommendations, including for infant formula manufacturers, on measures to address supply and market competition in the United States.
H. R. 2617—1382 (C) FINAL REPORT.—The agreement under subpara- graph (A) shall specify that the National Academies shall, not later than 1 year after the date of enactment of this Act, complete such study and submit a report on the results 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 SUPPORT INFANT FORMULA INNOVATION.— (1) CONGRESSIONAL NOTIFICATION OF RECALL.—Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a), as amended by subsection (c), is further amended by adding at the end the following: ‘‘(k) CONGRESSIONAL NOTIFICATION OF RECALL.— ‘‘(1) IN GENERAL.—Not later than 24 hours after the initi- ation of a recall of infant formula as described in subsection (e), 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 Representa- tives a notification of such recall.
‘‘(2) CONTENTS.—A notification under paragraph (1) shall include the following: ‘‘(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health.
‘‘(B) If the recall is voluntarily initiated by the manu- facturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded.

‘‘(C) Specification of when the Food and Drug Adminis- tration was first made aware of the instance or cir- cumstances surrounding the recall.
‘‘(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 Fed- eral 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 Sec- retary under subsection (d).
‘‘(B) The number of such submissions that included any new ingredients that were not included 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 subsection (b).
‘‘(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to H. R. 2617—1383 evaluate compliance with the requirements for infant for- mulas under subsection (b).

‘‘(E) A breakdown of the information described in sub- paragraphs (A) through (D) between 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 Cosmetic Act (21 U.S.C.
350a(d)) is amended by adding at the end the following: ‘‘(4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.’’.

(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 revised by the Secretary under paragraph (2), as so revised’’ and inserting the following: ‘‘, which shall be reviewed by the Secretary every 4 years as appropriate.
In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutri- ents, including international infant formula standards.

The Sec- retary 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 consider- ations 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 Cosmetic 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 initiation of a recall of infant formula, the manufacturer of the recalled infant formula shall submit information to the Secretary regarding such recall.
(B) CONTENTS.—A submission under subparagraph (A) shall include the following: (i) A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including— (I) to identify and address any cause of, and contributing in, known or suspected adulteration or known or suspected misbranding; and factor (II) if appropriate, to restore operation of the impacted facilities.
(ii) In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to H. R. 2617—1384 respond to such recall, impacts over 10 percent of the production 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 cur- rent domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula.
(2) REPORT TO CONGRESS.— (A) IN GENERAL.—Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in 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 Rep- resentatives.
(B) CONTENTS.—A report under subparagraph (A) shall include the following: (i) Information concerning the current domestic supply of infant formula, including— (I) a breakdown of the specific types of formula involved; and (II) an estimate of how long current supplies will last.
(ii) If a submission or submissions under para- graph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States— (I) actions to work with the impacted manufac- turer or other manufacturers to increase produc- tion; and (II) specification of— (aa) any additional authorities needed regarding production or importation to fill a supply gap; and (bb) any supplemental funding necessary (3) SUNSET.—This subsection shall cease to have force or to address the shortage.
effect on September 30, 2026.
(i) COORDINATION WITH MANUFACTURER.— (1) IN GENERAL.— (A) COMMUNICATION FOLLOWING INSPECTION.—Upon completing an inspection of an infant formula manufac- turing 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— (i) address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and (ii) safely restart production at the facility.
(B) RESPONSE TO MANUFACTURER.—Not later than 7 days after receiving a written communication from a manu- facturer of infant formula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an infant formula impacted by a recall, the Secretary, H. R. 2617—1385 acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication con- cerning the sufficiency of the proposed corrective 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 consumption in the United States.

If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner.
The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant 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 inspec- tions, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic 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 foreign 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.— (1) IN GENERAL.—The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant depart- ments 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 infant formula supply chain, protect against future contamina- tion and other potential causes of supply disruptions and short- ages, and ensure parents and caregivers have access to infant formula and information they need.
(2) IMMEDIATE NATIONAL STRATEGY.—The national strategy under paragraph (1) shall include efforts— (A) to increase the resiliency of the infant formula supply chain in the short-term by— (i) assessing causes of any supply disruption 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 immediate infant for- mula needs associated with the shortage; and (iii) developing a plan to increase infant formula supply, including through increased competition; and (B) to ensure the development and updating of edu- cation and communication materials for parents and care- givers that cover— (i) where and how to find infant formula; (ii) comparable infant formulas on the market; H. R. 2617—1386 (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 national strategy under paragraph (1) to include efforts to improve preparedness against infant formula shortages in the long-term by— (A) outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages; (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 supply and mitigate future shortages; and (D) recommending other necessary authorities 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 amended 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 critical food (as defined in section 201(ss)) shall notify the Secretary of a perma- nent 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 than 5 business days after such discontinuance or such interruption.
‘‘(2) DISTRIBUTION OF INFORMATION.—Not later than 5 cal- endar days after receiving a notification under paragraph (1), if the Secretary has determined 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 Sec- retary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.
‘‘(3) CONFIDENTIALITY.—Nothing in this subsection author- izes the Secretary to disclose 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.
‘‘(4) MEANINGFUL DISRUPTION.—In this subsection, the term ‘meaningful disruption’— ‘‘(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability H. R. 2617—1387 of the manufacturer 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 flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.
‘‘(b) RISK MANAGEMENT PLANS.—Each manufacturer of a critical food shall develop, maintain, and implement, 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 supply 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, alternative suppliers, stockpiling of inventory, or other means; and ‘‘(3) shall be subject to inspection and copying by the Sec- retary 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 failure; 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 subparagraph (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 had a reasonable basis for not submit- ting a notification as required under subsection (a), the require- ments of paragraph (1)(B) shall not apply.’’.

(l) SPECIALTY INFANT FORMULA FOR IMPORTATION.—Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a), as amended by subsection (f)(2), is further amended by adding at the end the following: ‘‘(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 specialty infant formula.
Such a waiver may be applicable to— ‘‘(A) the importation of specialty infant formula from any country that is determined by the Secretary to be H. R. 2617—1388 implementing and enforcing requirements for infant for- mula that provide a similar assurance of safety and nutri- tional adequacy as the requirements of this Act; or ‘‘(B) the distribution and sale of such imported specialty infant formula.
‘‘(2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and require- ments under this Act with respect to, specialty infant formula that is subject to a waiver under paragraph (1).

‘‘(3) DEFINITION OF SPECIALTY INFANT FORMULA.—In this subsection, the term ‘specialty infant formula’ means infant formula described in subsection (h)(1).’’.
(m) IMPORTATION FOR PERSONAL USE.— (1) IN GENERAL.—Notwithstanding any provision 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 supply 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 Sec- retary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).

(2) LIMITATIONS.—Infant formula may be imported pursu- ant 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 pro- vider becomes aware of any adverse event which the health care provider reasonably suspects 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 Administration 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; (B) the labeling of such infant formula may not meet the standards and other requirements 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 formula 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 importation of infant formula should consult with their pediatrician about such importation.

H. R. 2617—1389 Subtitle E—Cosmetics SEC.

3501.

SHORT TITLE.
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.)

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

604.

DEFINITIONS.

‘‘In this chapter: ‘‘(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 ingredients with a qualitatively and quantitatively set composition for use in a finished product.

‘‘(3) FACILITY.— ‘‘(A) IN GENERAL.—The term ‘facility’ includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distrib- uted in the United States.
‘‘(B) Such term does not include any of the following: ‘‘(i) Beauty shops and salons, unless such establish- ment manufactures or processes cosmetic products at that location.
‘‘(ii) Cosmetic product retailers, including indi- vidual sales representatives, direct 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 products 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 airlines) that pro- vide complimentary cosmetic products to customers incidental to other services.

‘‘(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
‘‘(vii) An establishment that manufactures or proc- esses cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.

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

‘‘(II) Relabeling.

‘‘(III) Packaging.

‘‘(IV) Repackaging.

‘‘(V) Holding.

‘‘(VI) Distributing.


H. R. 2617—1390 ‘‘(C) CLARIFICATION.—For the purposes of subpara- graph (B)(viii), the terms ‘packaging’ and ‘repackaging’ do not include filling a product container with a cosmetic product.
‘‘(4) RESPONSIBLE PERSON.—The term ‘responsible person’ means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act.
‘‘(5) SERIOUS ADVERSE EVENT.—The term ‘serious 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 disability or inca- pacity; ‘‘(v) a congenital anomaly or birth defect; ‘‘(vi) an infection; or ‘‘(vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alter- ation of appearance), other than as intended, 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 REQUIREMENTS.—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 person.
‘‘(b) SUBMISSION OF REPORTS.— ‘‘(1) SERIOUS ADVERSE EVENT REPORT.—The responsible per- son 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 after the report is received by the responsible person.
‘‘(2) NEW MEDICAL INFORMATION.—The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.
‘‘(3) CONSOLIDATION OF REPORTS.—The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related 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 person shall receive reports of adverse events through the domestic address, H. R. 2617—1391 domestic telephone number, or electronic contact information included on the label in accordance with section 609(a).
‘‘(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 manu- factured or distributed 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 manufacturing or processing of the cosmetic products described in subsection 612(b), shall maintain such records for a period of 3 years.
‘‘(2) INSPECTION.— ‘‘(A) IN GENERAL.— The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 704.
‘‘(B) AUTHORIZED PERSON.—For purposes of this para- graph, the term ‘authorized person’ means an officer or employee of the Department of Health and Human Services who has— ‘‘(i) appropriate credentials, as determined by the Secretary; and ‘‘(ii) been duly designated by the Secretary to have access to the records required 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 categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person.
The respon- sible person shall ensure that the requested information is sub- mitted 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— ‘‘(1) a safety report under section 756 and may be accom- panied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute 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 referred to as the ‘Privacy Act of 1974’) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the ‘Freedom of Information Act’), and shall not be publicly disclosed unless all personally identifi- able information is redacted.
‘‘(h) EFFECT OF SECTION.— H. R. 2617—1392 ‘‘(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, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.
‘‘(2) PERSONALLY IDENTIFIABLE INFORMATION.—Notwith- standing any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, 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 information to the Secretary.
‘‘(3) USE OF REPORTS.—Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with this section.

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

‘‘SEC.

606.

GOOD MANUFACTURING PRACTICE.


‘‘(a) IN GENERAL.—The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and inter- national standards, in accordance with section 601.

Any such regula- tions shall be intended to protect the public health and ensure that cosmetic products are not adulterated.
Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices 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 regula- tions will apply.
Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, 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 cos- metics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.
‘‘(c) TIMEFRAME.—The Secretary shall publish a notice of pro- posed 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.

H. R. 2617—1393 ‘‘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 Modernization of Cosmetics Regu- lation 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 oper- ates a facility that first engages, after the date of enactment of the Modernization 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 or 60 days after the deadline for registra- tion under subparagraph (A), whichever is later.
‘‘(2) BIENNIAL RENEWAL OF REGISTRATION.—A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.

‘‘(3) CONTRACT MANUFACTURERS.—If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person.
Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or proc- essed at such facility.

‘‘(4) UPDATES TO CONTENT.—A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under sub- section (b)(2).
‘‘(5) ABBREVIATED RENEWAL REGISTRATIONS.—The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registra- tion of such facility under paragraph (1) or (2).
‘‘(b) FORMAT; CONTENTS OF REGISTRATION.— ‘‘(1) IN GENERAL.—Registration information under this sec- tion may be submitted at such time and in such manner as the Secretary may prescribe.
‘‘(2) CONTENTS.—The registration under subsection (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 cosmetic products manufactured or processed in the facility are sold; and H. R. 2617—1394 ‘‘(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
‘‘(c) COSMETIC PRODUCT LISTING.— ‘‘(1) IN GENERAL.—For each cosmetic product, the respon- sible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.
‘‘(2) COSMETIC PRODUCT LISTING.—The responsible person of a cosmetic product that is marketed 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 Modernization 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 renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person sub- mitted the previous listing.
‘‘(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 proc- essed; ‘‘(ii) the name and contact number of the respon- sible person and the name for the cosmetic product, as such name appears on the label; ‘‘(iii) the applicable cosmetic category or categories for the cosmetic product; ‘‘(iv) a list of ingredients in the cosmetic 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 ingredient; and ‘‘(v) the product listing number, if any previously assigned by the Secretary under subsection (d).
‘‘(B) FLEXIBLE LISTINGS.—A single listing submission for a cosmetic product may include multiple cosmetic prod- ucts 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 facility registration or separately.

‘‘(d) FACILITY REGISTRATION AND PRODUCT LISTING 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 H. R. 2617—1395 and a product listing number to each cosmetic product.
The Sec- retary shall not make such product listing number publicly avail- able.

‘‘(e) CONFIDENTIALITY.—In response to a request under section 552 of title 5, United States Code, information described in sub- section (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 States Code.
‘‘(f) SUSPENSIONS.— ‘‘(1) SUSPENSION OF REGISTRATION OF A FACILITY.—The Sec- retary may suspend the registration 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 serious 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 suffi- ciently pervasive to raise concerns about other products manu- factured in the facility.
‘‘(2) NOTICE OF SUSPENSION.—Before suspending 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 (A), for the responsible person to provide a plan for addressing the reasons for possible suspension 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 pro- viding opportunity for an informal hearing under paragraph (3), the Secretary determines 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 Sec- retary.
The Secretary shall review such plan not later than 14 business days after the 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 deter- mination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility.
H. R. 2617—1396 ‘‘(6) EFFECT OF SUSPENSION.—If the registration of the facility is suspended under this section, no person shall intro- duce or deliver for introduction into commerce in the United States cosmetic products from such facility.

‘‘(7) NO DELEGATION.—The authority conferred by this sec- tion 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.

‘‘(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 SAFETY.—The term ‘ade- quate substantiation of safety’ means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredi- ents, 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 conditions of use as are customary or usual.

The Secretary 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 determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as 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 product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.

‘‘(b) FRAGRANCE ALLERGENS.—The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product.
Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation.

The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after the date of enact- ment 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 rulemaking closes, shall issue a final rulemaking.
In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance H. R. 2617—1397 and format of requirements in the European Union, and may estab- lish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
‘‘(c) COSMETIC PRODUCTS FOR PROFESSIONAL USE.— ‘‘(1) DEFINITION OF PROFESSIONAL.—For purposes of this subsection, the term ‘professional’ means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.
‘‘(2) PROFESSIONAL USE LABELING.—A cosmetic 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 statement that the product shall be administered or used only by licensed professionals; and ‘‘(B) is in conformity with the requirements 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 that the Secretary reason- ably believes is likely to be affected 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 humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate creden- tials 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 believes 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 humans.
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 functions subject to this Act), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to limit the authority of the Secretary 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 adulterated 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 Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article.
If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary H. R. 2617—1398 may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.
‘‘(b) HEARING.—The Secretary shall provide the responsible per- son who is subject to an order under subsection (a) with an oppor- tunity 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 the order.
‘‘(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 determines 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 appropriate 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 notification as required by such order.
‘‘(e) NOTICE TO PERSONS AFFECTED.—If the Secretary deter- mines 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, 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 regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification— ‘‘(A) of the recall to consumers and retailers 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 associated with such article; and ‘‘(iii) to the extent practicable, information for con- sumers about similar cosmetics 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.
‘‘(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 distribution or to recall under any other provision of this chapter.

H. R. 2617—1399 ‘‘SEC.

612.

SMALL BUSINESSES.


‘‘(a) IN GENERAL.—Responsible persons, and owners and opera- tors 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 subsection (b), shall be considered small businesses and not subject to the requirements of section 606 or 607.
‘‘(b) REQUIREMENTS APPLICABLE TO ALL MANUFACTURERS AND PROCESSORS OF COSMETICS.—The exemptions under subsection (a) shall not apply to any responsible 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 conditions of use that are customary or usual.

‘‘(2) Cosmetic products that are injected.

‘‘(3) Cosmetic products that are intended for internal use.
‘‘(4) Cosmetic products that are intended to alter appear- ance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

‘‘SEC.

613.

EXEMPTION FOR CERTAIN PRODUCTS AND FACILITIES.


‘‘(a) IN GENERAL.—Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements 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 sub- ject 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 cosmetic products.

‘‘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 is different from or in addition to, or otherwise not identical with, any requirement applicable under this chapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.
‘‘(b) LIMITATION.—Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, ref- erendum, regulation, or other State action, except as expressly provided in subsection (a).
Notwithstanding subsection (a), nothing in this section 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 requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient 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, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for H. R. 2617—1400 damages or the liability of any person under the law of any State, whether statutory or based in common law.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to amend, expand, or limit the provisions under section 752.’’.

SEC.

3503.

ENFORCEMENT AND CONFORMING AMENDMENTS.

(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 information 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 practice requirements of section 606.
‘‘(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 defined 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 required 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 inserting ‘‘564, 605, 703’’; and (ii) by striking ‘‘564, 760’’ and inserting ‘‘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 (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 section 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 ‘‘described in such section 605, 760, or 761’’; and (D) in section 801(b) (21 U.S.C.
381(b))— H. R. 2617—1401 (i) by striking ‘‘requirements of sections 760 or 761,’’ and inserting ‘‘requirements 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 (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 enact- ment of this Act.
(c) CONFIDENTIALITY.— (1) IN GENERAL.—The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential commercial information that is obtained by the Secretary of Health and Human Services pursuant to this sub- title, including the amendments made by this subtitle.
(2) CLARIFICATION.—Nothing in this subtitle, including the amendments made by this subtitle, shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

331(j)) 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.

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 inserting 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 inspection 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 enactment of this Act, shall promulgate proposed regulations 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.

SEC.

3506.

PFAS IN COSMETICS.


(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use.

In conducting such assessment, the Secretary may, as appro- priate, consult with the National Center for Toxicological Research.
H. R. 2617—1402 (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 assess- ment conducted under subsection (a).

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 exception of appropriate allow- ances.

SEC.

3508.
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 subtitle (including the amendments made by this subtitle) and hiring personnel required to carry out this subtitle (including the amendments made by this subtitle).

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

3601.
3601.

DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.

(a) DRUGS.—Section 505 of the Federal Food, Drug, and Cos- metic Act (21 U.S.C.
355) is amended by adding 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 successor regulations), or, as appropriate, another pivotal study of a new drug (other than bio- availability or bioequivalence 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.
‘‘(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 modifications to the diversity action plan.

Any such modifications 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 requirement in para- graph (1), (2), or (3) if the Secretary determines that a waiver is necessary based on what is known or what can be determined about the prevalence or incidence 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 H. R. 2617—1403 would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.
‘‘(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.

‘‘(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 submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary.
‘‘(ii) The sponsor of a device for which submission of an applica- tion for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), shall develop a diversity 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 section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515 for such device.
‘‘(B) A diversity action plan under clause (i) or (ii) of subpara- graph (A) shall include— ‘‘(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 requirement in subpara- graph (A) or (B) if the Secretary determines 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 inves- tigation in accordance with a diversity action plan would otherwise 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— (1) the format and content of the diversity action 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 include characteristics H. R. 2617—1404 such as geographic location and socioeconomic status, including with respect to— (A) the rationale for the sponsor’s enrollment goals, which may include— (i) the estimated prevalence or incidence 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 incidence 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; or pharmacokinetic relevant any (iii) pharmacogenomic data; (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, socioeconomic status, and ethnicity; (II) non-demographic factors, including co- morbidities affecting the patient population; and (III) potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and (v) any other data or information relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women; and (B) an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel; (2) submission of any modifications to the diversity 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 sponsor’s reasons for why the sponsor does not expect to meet such goals.
(b) ISSUANCE.—The Secretary shall— H. R. 2617—1405 (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 subsection (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 enroll- ment commences after the date that is 180 days after the publica- tion of final guidance required under this section.

SEC.

3603.

PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY DIVER- SITY.
(a) IN GENERAL.—Not later than one year after the date of enactment of this Act, the Secretary, in consultation 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 enrollment of historically underrepresented popu- lations in clinical studies and encouraging clinical study participa- tion that reflects the prevalence of the disease or condition 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 condition by demographic subgroup, including possible sources for such data and meth- odologies for assessing such data; (2) considerations for the dissemination, as appropriate, after approval, of information to the public on clinical study enrollment demographic data; (3) the establishment of goals for enrollment in clinical trials, including the relevance of the estimated 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 underrepresented populations and to encourage clinical study participation that reflects the population expected to use the drug or device under study, including with respect to— (A) the establishment of inclusion and exclusion cri- teria for certain subgroups, such as pregnant and lactating women and individuals with disabilities, including intellec- tual or developmental disabilities or mental illness; (B) considerations regarding informed consent 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 related 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.
H. R. 2617—1406 (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 Administration a report on the topics discussed at such workshop.

The report shall include a sum- mary of topics and responses to any recommendations raised in such workshop.

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 Sec- retary shall submit to the Congress, and publish on the public website of the Food and Drug Administration, a report that— (1) summarizes, in aggregate, the diversity action 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 devices 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 action plans were not met.
(b) CONFIDENTIALITY.—Nothing in this section shall be con- strued as authorizing the Secretary to disclose 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.

SEC.

3605.

PUBLIC MEETING ON CLINICAL STUDY FLEXIBILITIES INITI- ATED 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 Administration during the COVID–19 emer- gency period to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled ‘‘Conduct of Clin- ical 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 subse- quent 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 convened, 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 include discussion of— (1) the actions sponsors took to utilize such recommenda- tions and the frequency at which such recommendations were employed; H. R. 2617—1407 (2) the characteristics of the sponsors, studies, and patient populations impacted by such recommendations; (3) a consideration of how recommendations intended to mitigate disruption of clinical studies during 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, especially unrepresented or underrepresented racial and ethnic minorities; and (4) recommendations for incorporating certain clinical study disruption mitigation recommendations into current or addi- tional guidance to improve clinical study access and enrollment of diverse patient populations.
(c) COVID–19 EMERGENCY PERIOD DEFINED.—In this section, the term ‘‘COVID–19 emergency period’’ has 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 enactment of this Act, issue or revise draft guidance that includes rec- ommendations to clarify and advance the use of decentralized clinical studies to support 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 comment 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 telehealth, local labora- tories, local health care providers, or other options for remote data collection, could support decentralized clinical studies, including guidance 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 mini- mize or reduce burdens for clinical study participants through the use of digital health technology, telehealth, local health care providers 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 evaluation of data collected within a decentralized clinical study setting.

(4) Recommendations for methods of remote data collection, including clinical trial participant experience data, through the use of digital health technologies, telemedicine, local labora- tories, local health care providers, or other options for data collection.
H. R. 2617—1408 (5) Considerations for sponsors to minimize or reduce bur- dens for clinical trial participants associated with participating in a clinical trial, such as the use of digital technologies, tele- medicine, local laboratories, local health care providers, or other data collection or assessment options, health care provider home visits, direct-to-participant shipping of investigational drugs and devices, and electronic informed consent, as appropriate.
(6) Recommendations regarding conducting decentralized clinical trials to facilitate and encourage meaningful diversity among clinical trial participants, including with respect to race, ethnicity, age, sex, and geographic location, as appropriate.
(7) Recommendations for strategies and methods for recruiting, retaining, and engaging with clinical trial partici- pants, including communication regarding the role of clinical trial participants and community partners to facilitate clinical trial recruitment and engagement, including with respect to diverse and underrepresented populations, as appropriate.

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

(10) Recommendations related to digital health technology and other remote assessment tools that may support decentral- ized clinical trials, including guidance on appropriate techno- logical platforms and tools, data collection and use, data integ- rity, 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 within a decentralized clinical trial to support the development of the drug or device, if the manner is different from that used for a nondecentralized trial.

(12) Considerations for sponsors to validate digital tech- nologies and establish appropriate clinical endpoints for use in decentralized trials.

(13) Considerations for privacy and security of personally identifiable information of trial participants.
(14) Considerations for conducting clinical trials using cen- conjunction with decentralized tralized approaches approaches.

(c) DEFINITION.—In this section, the term ‘‘decentralized clinical study’’ means a clinical study in which some or all of the study- related activities occur at a location separate from the investigator’s location.

in SEC.

3607.

MODERNIZING CLINICAL TRIALS.
(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 appropriate 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 utilizing such technology for purposes of supporting the development of, and H. R. 2617—1409 review of applications for, drugs and devices.
Not later than 18 months after the public comment period on such draft guid- ance 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 incorporate 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— (i) recommendations for the protection of trial participant data that are collected or used in research using digital health technologies; (ii) compliance with the regulations promulgated under section 264(c) of the Health Insurance Port- ability and Accountability 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 Regulations, the Federal policy for the protection of human subjects under subpart A of part 46 of title 45, Code of Federal Regulations (commonly known as the ‘‘Common Rule’’), and part 2 of title 42, Code of Federal Regulations (or any successor regulations); and (iii) recommendations for the protection of clinical trial participant data against cybersecurity threats, as applicable; (C) considerations on data collection methods to help increase recruitment of clinical trial participants and the level of participation of such participants, reduce burden on clinical trial participants, and optimize data quality; (D) recommendations for the use of electronic methods to obtain informed consent from clinical trial participants, taking into consideration applicable Federal law, including subpart B of part 50 of title 21, Code of Federal Regulations (or successor regulations), and, as appropriate, State law; (E) best practices for communication between sponsors and the Secretary on the development 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 collected through digital health technologies to support the development of the drug or device; (H) recommendations regarding the data and informa- tion needed to demonstrate that a digital health technology is fit-for-purpose for a clinical trial, and a description of how the Secretary will evaluate such data and information; and (I) recommendations for increasing access to, and the use of, digital health technologies in clinical trials to facili- tate the inclusion of diverse and underrepresented popu- lations, as appropriate, including considerations for access H. R. 2617—1410 to, and the use of, digital health technologies in clinical trials by people with disabilities and pediatric 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 appro- priate.

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 on the use of expansion cohorts and other seamless clinical trial designs to assess different aspects of product candidates 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 conduct 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 logis- tics and facilitate the efficient collection and analysis of clinical trial data, including any planned interim analyses and how such analyses could be used to streamline the product development and review processes; (D) considerations to assist sponsors in ensuring the rights, safety, and welfare of clinical trial participants, maintaining compliance with good clinical practice regula- tions, minimizing risks to clinical trial data integrity, and ensuring the reliability of clinical trial results; (E) recommendations for communication between spon- sors and the Food and Drug Administration on the develop- ment of seamless, concurrent, or other adaptive clinical trial designs, 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 collected through seamless, concurrent, or other adaptive clinical trial designs to sup- port the development of drugs.
(c) INTERNATIONAL HARMONIZATION.—The Secretary shall, as appropriate, work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regu- lation and use of decentralized clinical trials, digital technology in clinical trials, and seamless, concurrent, and other adaptive or innovative clinical trial designs.

H. R. 2617—1411 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 appears and inserting ‘‘devices’’.

(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, propagation, compounding, or processing of a drug’’ and inserting ‘‘an establishment that is engaged in the manufacture, preparation, propaga- tion, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under para- graph (5)(C),’’; and (B) by striking ‘‘records requested.’’ and inserting the following: ‘‘records or other information 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 Secretary 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 Cosmetic Act, as amended by paragraph (1); (ii) processes for responding to such requests elec- tronically 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 reasonable in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.
(B) TIMING.—The Secretary shall— limits, and (i) not later than 1 year 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 comment period for such draft guidance, issue final guidance under subparagraph (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: ‘‘(5)(A) The Secretary may, to ensure the accuracy and reli- ability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable require- ments 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.
H. R. 2617—1412 ‘‘(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submis- sions described in subparagraph (E), including records and informa- tion related to the conduct, results, and analyses of, and the protec- tion of human and animal trial participants participating in, such studies.
‘‘(C)(i) The sites and facilities subject to inspection by the Sec- retary 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 submission to the Secretary under this Act or the Public Health Service Act related to marketing authorization 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).
‘‘(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 individual or entity, engaged by contract, grant, or other business arrange- ment 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 subpara- graph (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— ‘‘(I) permitting the Secretary to record or copy such informa- tion for purposes of this paragraph; ‘‘(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 information described in subparagraph (B) is or was generated, held, processed, ana- lyzed, 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 limits and in a reason- able manner.
H. R. 2617—1413 ‘‘(E) The studies and submissions described in this subpara- graph are each of the following: ‘‘(i) Clinical and nonclinical studies submitted to the Sec- retary in support of, or otherwise related to, applications and other submissions to the Secretary under this Act or the Public Health Service Act for marketing authorization of a product described 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 paragraph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.’’.
(b) REVIEW OF PROCESSES AND PRACTICES; GUIDANCE FOR INDUSTRY.— (1) IN GENERAL.—The Secretary shall— (A) review processes and practices in effect as of the date of enactment of this Act applicable 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 facili- tate the consistency of such processes and practices.
(2) GUIDANCE.— (A) IN GENERAL.—The Secretary shall issue guidance describing the processes and practices applicable to inspec- tions 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 advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspec- tions.
(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).

H. R. 2617—1414 SEC.

3613.

IMPROVING FOOD AND DRUG ADMINISTRATION INSPEC- TIONS.

(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 subparagraph (G); and (2) by inserting after subparagraph (E) the following: ‘‘(F) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this Act, including the history of violations related to products exported from 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 subparagraph (D); and (2) by inserting after subparagraph (B) the following: ‘‘(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy require- ments that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspec- tions, if applicable and appropriate.’’.
(c) RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.—Sec- tion 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 and Drug Omnibus Reform Act of 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a for- eign government or an agency of a foreign government, as allowed 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 Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1).’’.

SEC.

3614.
SEC.

3614.

GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISH- MENTS 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 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 inspec- tions conducted by— (1) the Secretary of foreign establishments pursuant to subsections (h) and (i) of section 510 and section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360; 374); or H. R. 2617—1415 (2) a foreign government or an agency of a foreign govern- ment pursuant to section 809 of such Act (21 U.S.C.

384e).
(b) CONTENTS.—The report conducted under subsection (a) shall include— (1) what alternative tools, including remote inspections or remote evaluations, other countries are utilizing to facilitate inspections of foreign establishments; (2) how frequently trusted foreign regulators conduct inspections of foreign facilities that could be useful to the Food and Drug Administration to review in lieu of its own inspections; (3) how frequently and under what circumstances, including for what types of inspections, the Secretary utilizes existing agreements or arrangements 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 appropriately expanded; (4) whether the Secretary has accepted reports of inspec- tions of facilities in China and India conducted 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 agreement with and, if applicable, reasons why the Secretary declined to enter into a mutual recognition agreement with such foreign governments or agencies; (6) what tools, if any, the Secretary used to facilitate inspec- tions of domestic facilities that could also be effectively utilized to appropriately inspect foreign facilities; (7) what steps the Secretary has taken to identify and evaluate tools and strategies the Secretary may use to continue oversight with respect to inspections when in-person inspections are disrupted; (8) how the Secretary is considering incorporating alter- native tools into the inspection activities 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 identify and evaluate how the Secretary may use alternative tools to address workforce shortages to carry out such inspection activities.

SEC.

3615.

UNANNOUNCED FOREIGN FACILITY INSPECTIONS 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 violations 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 unan- nounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection; H. R. 2617—1416 (2) costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establish- ments; (3) barriers to conducting unannounced inspections of for- eign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and (4) approaches for mitigating any negative effects of con- ducting announced inspections of foreign human drug establish- ments.
(b) PILOT PROGRAM SCOPE.—The inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections 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.).

(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 fol- lowing 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 recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establish- ments; (2) findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and (3) the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act.
SEC.

3616.

ENHANCING COORDINATION AND TRANSPARENCY 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 inves- tigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program regarding— ‘‘(1) the reviews of reports shared pursuant to section 704(b)(2); and ‘‘(2) any feedback or corrective or preventive actions in response to such reports.’’; and (2) by amending subsection (f) to read as follows: ‘‘(f) TEMPORARY SUNSET.—Subsection (a) shall cease to be effec- tive on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act.
Sub- sections (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 Administration Safety and Innovation Act and ending on H. R. 2617—1417 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), respectively; (B) by inserting after paragraph (2) the following: ‘‘(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 Administration with expertise regarding drug shortages, and the number of such reports that were sent;’’; and (C) in paragraph (5)(A), as so redesignated, by striking ‘‘paragraph (7)’’ and inserting ‘‘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 AGREEMENTS 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: ‘‘(A)(i) the number of domestic and foreign establish- ments registered pursuant to this section in the previous fiscal year; ‘‘(ii) the number of such registered establishments in each region of interest; ‘‘(iii) the number of such domestic establishments and the number of such foreign establishments, including the number of establishments in each region of interest, that the Secretary 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 number of inspections to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary con- ducted in the previous fiscal year; ‘‘(v) the number of routine surveillance inspections the Secretary conducted in the previous fiscal year, including in each region of interest; ‘‘(vi) the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspec- tions described in clause (iv), including in each region of interest; and ‘‘(vii) the number of inspections the Secretary has rec- ognized pursuant to an agreement entered into pursuant to section 809, or otherwise recognized, for each of the types of inspections described
 in clauses (v) and (vi), H. R. 2617—1418 including for inspections of establishments in each region of interest.’’; (C) in subparagraph (B), by striking ‘‘; and’’ and inserting a semicolon; inserting ‘‘; and’’; and (D) in subparagraph (C), by striking the period and (E) by adding at the end the following: ‘‘(D) the status of the efforts of the Food and Drug Administration to expand its recognition of inspections con- ducted 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, including the People’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate.’’.
SEC.

3617.

ENHANCING TRANSPARENCY OF DRUG FACILITY INSPEC- TION 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 section 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 fol- lowing: ‘‘(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including— ‘‘(A) the median in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(11)(A)(i)); for drugs described time ‘‘(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 pursu- ant 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 regu- latory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).
‘‘(3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting H. R. 2617—1419 related to conditions observed by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken.
‘‘(4) The number of facilities that failed to implement ade- quate corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold rec- ommendation for an application under review, including the number of such facilities manufacturing each category of drugs listed in subparagraphs (A) through (C) of paragraph (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 section 201(g) and not a device under section 201(h).
‘‘(2) For purposes of this subsection: ‘‘(A) The term ‘contrast agent’ means an article 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 Regu- lations (or any successor regulations); or ‘‘(ii) is a diagnostic agent that improves the visualiza- tion of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.
‘‘(B) The term ‘radioactive drug’ has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regula- tions (or any successor regulations), except that such term does not include— ‘‘(i) an implant or article similar to an implant; ‘‘(ii) an article that applies radiation from outside of the body; or ‘‘(iii) the radiation source of an article described 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 section 201(h), unless another provision of this Act otherwise indicates a different classification.
‘‘(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 Prescription Drug User Fee Amendments of 2022, legally marketed as devices; and ‘‘(B) deemed drugs pursuant to paragraph (1)’’.

H. R. 2617—1420 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 Administra- tion, 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 December 2015; and (2) brief the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the review and, as appropriate, any resulting update.

SEC.

3623.

STRATEGIC WORKFORCE PLAN AND REPORT.

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

371 et seq.)
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 Administra- tion, a coordinated strategy and report to provide direction for the activities 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 Administration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and scientific advancements, and support the develop- ment, review, and regulation of medical products.
Each such report shall be known as the ‘Food and Drug Administration Strategic Workforce Plan’.

‘‘(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).
‘‘(c) CONTENTS OF THE FOOD AND DRUG ADMINISTRATION STRA- TEGIC WORKFORCE PLAN.—Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall— ‘‘(1) include agency-wide human capital strategic goals and priorities for recruiting, hiring, training, developing, and retaining a qualified workforce for the Food and Drug Adminis- tration; ‘‘(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 miti- gate those risks; ‘‘(4) establish performance measures, benchmarks, 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 H. R. 2617—1421 ‘‘(5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce.
‘‘(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) eligible for retirement, the expertise of such employees, and the employing center of such employees; ‘‘(2) the vacancy and turnover rates for employees with different types of expertise and from different centers, including any changes or trends related to such rates; ‘‘(3) the results of the Federal Employee Viewpoint Survey for employees of the Food and Drug Administration, including any changes or trends related to such results; ‘‘(4) rates of pay for different types of positions, including rates for different types of expertise within the same field (such as differences in pay between different medical special- ists), 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 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 Adminis- tration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administra- tion 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 recruitment, 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, including protecting such workforce during public health emergencies.’’.

SEC.

3624.

ENHANCING FOOD AND DRUG ADMINISTRATION HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFES- SIONAL PERSONNEL.
Section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379d–3a) is amended— (1) in subsection (a)— (A) by inserting ‘‘, including cross-cutting operational positions,’’ after ‘‘professional positions’’; and (B) by inserting ‘‘and the regulation of food and cos- metics’’ after ‘‘medical products’’; and (2) in subsection (d)(1)— (A) in the matter preceding subparagraph (A)— H. R. 2617—1422 (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 extent’’ and all that follows through ‘‘, including’’ and inserting ‘‘that includes’’; (B) in subparagraph (A)— (i) by inserting ‘‘updated’’ before ‘‘analysis’’; and (ii) by striking ‘‘; and’’ and inserting a semicolon; (C) by redesignating subparagraph (B) as subpara- graph (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 applicable 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 striking ‘‘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.
379h(g)(2)) is amended— (1) in subparagraph (A)(ii)— (A) by striking ‘‘shall be available to defray’’ and inserting the following: ‘‘shall be available— ‘‘(I) for fiscal year 2023, to defray’’; (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 addi- tional number of full-time equivalent positions in the Department 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 mainte- nance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and sup- plies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this sec- tion, 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)— H. R. 2617—1423 (A) by striking ‘‘available for a fiscal year beginning after fiscal year 2012’’ and inserting the following: ‘‘avail- able— ‘‘(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 applica- tions (including such costs for an additional number of full-time equivalent positions in the Department 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, ren- ovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connec- tion with the process for the review of biosimilar biological 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 ‘‘subparagraph (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 described in subclause (I) or (II) of such subparagraph, as applicable,’’.
(c) GDUFA AUTHORITY.—Section 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–42) is amended— (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 involved.’’ and inserting ‘‘such fiscal year; and’’; and (iii) by adding at the end the following: ‘‘(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an addi- tional number of full-time equivalent positions in the Department of Health and Human Services to be engaged 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 mainte- nance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and sup- plies in connection with human generic drug activi- ties, is no less than $97,000,000 multiplied by H. R. 2617—1424 the adjustment factor defined in section 744A(3) applicable to the fiscal year involved.’’; and (B) in subparagraph (B), by striking ‘‘for human generic activities’’ and inserting ‘‘as described in subclause (I) or (II) of such subparagraph, as applicable,’’.
(d) MDUFA AUTHORITY.—Section 738 of the Federal 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— ‘‘(I) for fiscal year 2023, to defray’’; (ii) by striking the period and inserting ‘‘; and’’; and (iii) 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 device applications (including such costs for an additional number of full-time equivalent positions in the Department 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, ren- ovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connec- tion with the process for the review of device applications, is no less than the amount allocated 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 sub- clause (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 Reauthoriza- tion 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 Cosmetic 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 included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52).

H. R. 2617—1425 SEC.

3626.

USER FEE PROGRAM TRANSPARENCY AND ACCOUNT- ABILITY.

(a) PDUFA.— (1) REAUTHORIZATION; REPORTING REQUIREMENTS.—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 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.’’; (B) by adding at the end of paragraph (3)(B) the fol- lowing: ‘‘(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 spon- sors to be conducted in person (in such manner as the Secretary shall prescribe 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 center.’’; and (C) in paragraph (4)— (i) by amending subparagraph (A) to read as fol- lows: ‘‘(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 1001(b) of the Prescription
 Drug User Fee Amendments of 2022 and the number of remaining 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 Research, 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 fol- lows:
 ‘‘(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 identi- fying— ‘‘(i) drivers of such changes; and H. R. 2617—1426 ‘‘(ii) changes in the average total cost per full- time equivalent in the prescription drug review pro- gram;’’; (iii) in subparagraph (C), by striking the period and inserting ‘‘; and’’; and (iv) 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 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), respectively; (B) by inserting after paragraph (3) the following: ‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on nego- tiations on the reauthorization of this part 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 (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking ‘‘Before presenting the rec- ommendations developed under paragraphs (1) through (5) to the Congress, the’’ and inserting ‘‘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 summarize’’.
(b) MDUFA.— (1) REAUTHORIZATION; REPORTING REQUIREMENTS.—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 following: ‘‘(IV) the number of investigational device exemption applications submitted under section 520(g) per fiscal year, including for each review division; and ‘‘(V) the number of expedited development and priority review requests and designations under section 515B per fiscal year, including for each review 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)— H. R. 2617—1427 (i) by amending subclause (I) to read as follows: ‘‘(I) data, analysis, and discussion 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 Amend- ments of 2022 and the number of remaining vacan- cies, the number of full-time equivalents funded by fees collected pursuant to section 738, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation 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 discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying— ‘‘(aa) drivers of such changes; and ‘‘(bb) changes in the average total cost per full-time equivalent in the medical device review program;’’; (iii) in subclause (III), by striking the period and inserting ‘‘; and’’; and (iv) by adding at the end the following: ‘‘(IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types.’’.
(2) REAUTHORIZATION.—Section 738A(b) of the Federal is Food, Drug, and Cosmetic Act (21 U.S.C.
379j–1(b)) amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively; (B) by inserting after paragraph (3) the following: ‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on nego- tiations on the reauthorization of this part 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 (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking ‘‘Before presenting the rec- ommendations developed under paragraphs (1) through (5) to the Congress, the’’ and inserting ‘‘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 summarize’’.
(c) GDUFA.— (1) REAUTHORIZATION; REPORTING REQUIREMENTS.—Section 744C(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–43(a)(3)) is amended— H. R. 2617—1428 (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 Amendments of 2022 and the number of remaining vacancies, 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, for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;’’; the Center (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 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), respectively; (B) by inserting after paragraph (3) the following: ‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on nego- tiations on the reauthorization of this part 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 (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking ‘‘Before presenting the rec- ommendations developed under paragraphs (1) through (5) to the Congress, the’’ and inserting ‘‘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 summarize’’.
(d) BSUFA.— (1) REAUTHORIZATION; REPORTING REQUIREMENTS.—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 Amendments of 2022 and the number of remaining H. R. 2617—1429 vacancies, 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, the Center for Biologics Evaluation and Research, the Office of Regu- latory 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 biological product applications, including identifying— ‘‘(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 applica- tion.’’.
(2) REAUTHORIZATION.—Section 744I(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j–53(f)) is amended— (A) by redesignating paragraphs (2) and (3) as para- graphs (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 reauthorization of this part, the Secretary shall— ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization; ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization; ‘‘(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 frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representa- tives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under para- graph (2).
‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on nego- tiations on the reauthorization of this part 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 (C) by adding at the end the following: ‘‘(7) MINUTES OF NEGOTIATION MEETINGS.— ‘‘(A) PUBLIC AVAILABILITY.—The Secretary shall make publicly available, on the public website of the Food and H. R. 2617—1430 Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize, in sufficient detail, any sub- stantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.’’.

SEC.

3627.

IMPROVING INFORMATION TECHNOLOGY SYSTEMS OF THE FOOD AND DRUG ADMINISTRATION.
(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 appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated information technology strategic plan to mod- ernize the information technology systems of the Food and Drug Administration.
Each such report shall be known as the ‘‘Food and Drug Administration Strategic Information Tech- nology Plan’’.

The first such report may include the Data and Technology Modernization Strategy, as set forth in the letters described in section 1001(b) of the FDA User Fee Reauthoriza- tion Act of 2022 (division F of Public Law 117–180).
(2) CONTENT OF STRATEGIC PLAN.—The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall include— (A) agency-wide strategic goals and priorities for mod- ernizing the information technology 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 mission; (B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against such strategic goals and prior- ities; (C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of poten- tial public health concerns; (D) challenges and risks the Food and Drug Adminis- tration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks; (E) the ways in which the Food and Drug Administra- tion will use the Plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and (F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital plan- ning.
H. R. 2617—1431 (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 Tech- nology 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 Adminis- tration to achieve the strategic goals and priorities set forth in such previous Plans.
(b) GAO REPORT.— (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 implementation of the Food and Drug Administration Strategic Information Technology Plan adopted pursuant to subsection (a).
(2) CONTENT OF REPORT.—The report required under para- graph (1) shall include an assessment of— (A) the development and implementation of the Food and Drug Administration Strategic Information Technology Plan, including the sufficiency of the plan, progress of the Food and Drug Administration in meeting the results- oriented goals, milestones, and performance measures identified in such plan and any gaps in such implementa- tion; (B) the efficiency and effectiveness of the Food and Drug Administration’s expenditures on information tech- nology systems over the preceding 10 fiscal years, including the implementation by the Food and Drug Administration of the Technology Modernization Action Plan and Data Modernization Action Plan; (C) challenges posed by the information technology systems of the Food and Drug Administration for carrying out the Food and Drug Administration’s public health mis- sion, including on meeting user fee agreement performance goals, conducting inspections, responding to identified safety concerns, and keeping pace with new scientific and medical advances; and (D) recommendations for the Food and Drug Adminis- tration to address the identified challenges, improve its implementation of the Food and Drug Administration Stra- tegic Information Technology Plan, and to otherwise improve the Food and Drug Administration’s information technology systems.
SEC.

3628.

REPORTING ON MAILROOM AND OFFICE OF THE EXECUTIVE SECRETARIAT OF THE FOOD AND DRUG ADMINISTRA- TION.
(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 the Senate and the Committee on Energy and Commerce of the House of Representatives on— H. R. 2617—1432 (1) information related to policies, procedures, and activities of the mailroom and the Office of the Executive Secretariat of the Food and Drug Administration, including— (A) taking receipt, tracking, managing, and prioritizing confidential informant complaints; (B) taking receipt of common carrier packages to the Food and Drug Administration; (C) the organizational structure and management of the mailroom; (D) the organizational structure and management of the Office of the Executive Secretariat; (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 Secretariat; (G) the number of vacant positions in the mailroom; (H) the number of vacant positions in the Office of the Executive Secretariat; (I) the average number of days for response to cor- respondence 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 correspond- ence in the Office of the Executive Secretariat that has not been appropriately responded to by the Food and Drug Administration and the number of correspondence or common carrier packages in any backlog; (L) a rationale for the failure of the Office of the Executive Secretariat to respond to correspondence in any backlog and the position of the decision-making official who determined not to respond to such correspondence; (M) the number of whistleblower correspondence received, including within each agency center; (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 correspondence-related activities, including a breakdown of budget authority and user fee dollars; and (P) the performance of third-party contractors respon- sible for correspondence-related activities with respect to the receipt and tracking 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, managing, 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, Labor, and Pensions of the Senate H. R. 2617—1433 and the Committee on Energy and Commerce of the House of Representatives on the implementation of the new or revised poli- cies of the Food and Drug Administration reported under subsection (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 Office of the Executive Secre- tariat; (5) the length of time required to resolve each such backlog; (6) any known issues of unreasonable delays in correspond- ence being provided to the intended recipient, or in correspond- ence being lost, and the measures taken to remedy such delays or lost items; (7) the average number of days it takes to respond to correspondence received by the Office of the Executive Secre- tariat; (8) the resources expended by the mailroom, including a breakdown of budget authority and user fee dollars; and (9) the resources expended by the Office of the Executive Secretariat on correspondence-related activities, 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, managing, and prioritization of correspondence.
SEC.

3629.

FACILITATING THE USE OF REAL WORLD EVIDENCE.


(a) GUIDANCE.—Not later than 1 year after the date of enact- ment of this Act, the Secretary shall issue or revise existing guid- ance on considerations for the use of real world data and real world evidence to support regulatory decision-making, as follows: (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)).
262(a)(3)).

Such guidance 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 drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360bbb–3), and considerations for standards and methodologies for collection and analysis H. R. 2617—1434 of real world evidence included in such applications and submis- sions, as appropriate.
(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 under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

360(k), 360c(f)(2), 360e), to support an investigational use exemption submission under section 520(g) of such Act (21 U.S.C.
360j(g)), and to support 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 guidance 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 considerations 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 standards and meth- odologies 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 Service Act (42 U.S.C.
247d) on January 31, 2020, with respect to COVID–19, the Secretary 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 on— (1) the number of applications, submissions, or requests submitted for clearance, approval, or authorization under sec- tion 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 pre- viously granted; (2) of the number of applications so submitted, the number of such applications— (A) for which real world evidence was submitted and used to support a regulatory decision; and (B) for which real world evidence was submitted and determined to be insufficient to support a regulatory deci- sion; and (3) a summary explanation of why, in the case of applica- tions described in paragraph (2)(B), real world evidence could not be used to support regulatory decisions.
(c) INFORMATION DISCLOSURE.—Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 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’’).

H. R. 2617—1435 SEC.

3630.

FACILITATING EXCHANGE OF PRODUCT INFORMATION 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 appears and inserting ‘‘drug or device’’, respectively; (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 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’’; 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 para- graph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product information 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 selec-
 tion of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investiga- tional use of a drug or device that is 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), provided— ‘‘(A) the product information includes— ‘‘(i) a clear statement that the investigational drug or device or investigational use of a drug
 or device has not been approved, cleared, granted marketing authoriza- tion, 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 development 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, premarket notifica- tion, or request for classification for the investigational H. R. 2617—1436 drug or device or investigational use has been sub- mitted to the Secretary and when such a submission is planned; ‘‘(iii) in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of— ‘‘(I) all material aspects of study design, method- ology, and results; and ‘‘(II) all material limitations related to the study design, methodology, and results; ‘‘(iv) where applicable, a prominent statement dis- closing the indication or indications for which the Secretary has approved, granted marketing 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 product or its review status; and ‘‘(B) the product information does not include— ‘‘(i) information that represents that an unapproved product— ‘‘(I) has 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); 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 authorization, cleared, or licensed— ‘‘(I) is so approved, granted marketing authoriza- tion, cleared, or licensed; or ‘‘(II) that the product is safe or effective for the use or uses for which the drug or device is being studied.
‘‘(2) For purposes of this paragraph, the term ‘product informa- tion’ includes— ‘‘(A) information describing the drug or device (such as drug class, device description, and features); ‘‘(B) information about the indication or indications being investigated; ‘‘(C) the anticipated timeline for a possible approval, clear- ance, marketing authorization, or licensure pursuant to section 505, 510(k), 513, or 515 of this Act or section 351 of the Public Health Service Act; ‘‘(D) drug or device pricing information; ‘‘(E) patient utilization projections; ‘‘(F) product-related programs or services; and ‘‘(G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or effi- cacy.’’.
(b) GAO STUDY AND REPORT.—Beginning on the date that is 5 years and 6 months after the date of enactment of this Act, H. R. 2617—1437 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 subsection (a), between manufacturers of drugs and devices (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 between such manufacturers and payors.

(2) The manner of communication between such manufac- turers and payors.
(3)(A) Whether such manufacturers file an application 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 manufactur- ers 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 Administration approves, grants marketing authorization, clears, or licenses the new drug or device or new use.
(C) The timeframe between the initial communications per- mitted under section 502(gg) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), regarding an inves- tigational drug or device or investigational use, and the initial marketing of such drug or device.

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 Commis- sioner of Food and Drugs, concerning blood donation.

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

4101.
4101.

EXTENSION OF INCREASED INPATIENT HOSPITAL 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 preceding 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 (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, H. R. 2617—1438 2022, and ending on December 23, 2022’ ’’ and inserting ‘‘through 2024’’; and (C) in subclause (IV), by striking ‘‘the portion 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 inserting ‘‘through 2024’’; and (B) in clause (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) 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 PRO- GRAM.

(a) IN GENERAL.—Section 1886(d)(5)(G) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(G)) is amended— (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 beginning on October 1, 2022, and ending on December 23, 2022,’’ and inserting ‘‘fiscal year 2024’’.

(2) PERMITTING HOSPITALS TO DECLINE RECLASSIFICATION.— Section 13501(e)(2) of the Omnibus 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 fiscal 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 AMBULANCE SERV- ICES.

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 ‘‘January 1, 2025’’ in each such place.

H. R. 2617—1439 Subtitle B—Other Expiring Medicare Provisions SEC.

4111.

EXTENDING INCENTIVE PAYMENTS FOR PARTICIPATION IN ELIGIBLE ALTERNATIVE PAYMENT MODELS.

(a) IN GENERAL.—Section 1833(z) of the Social Security 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 (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.

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.
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)— (i) in the matter preceding subparagraph (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 semicolon; and (iv) by adding at the end the following new sub- paragraphs: ‘‘(C) such services furnished on or after January 1, 2023, and before January 1, 2024, by 2.5 percent; and H. R. 2617—1440 ‘‘(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 services furnished in 2021, 2022, 2023, or 2024’’; and (iii) by striking ‘‘or 2022, respectively’’ 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 begin- ning 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 (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 begin- ning on the first day after the end of such emergency period and ending on December 31, 2024’’.
(b) EXPANDING PRACTITIONERS ELIGIBLE TO FURNISH TELE- HEALTH 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 beginning 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 period beginning on the first day after the end of such emergency period and ending on December 31, 2024’’.
(c) EXTENDING TELEHEALTH SERVICES FOR FEDERALLY QUALI- FIED 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 December 31, 2024, during the period beginning on the first 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 TELECOMMUNICATIONS TECHNOLOGY.— (1) DELAY IN REQUIREMENTS FOR MENTAL HEALTH SERVICES FURNISHED THROUGH TELEHEALTH.—Section 1834(m)(7)(B)(i) of H. R. 2617—1441 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 emergency 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 amended— (A) in the heading, by striking ‘‘TO HOSPICE PATIENTS’’; and (B) in paragraph (2), 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))’’.
(3) MENTAL HEALTH VISITS FURNISHED BY FEDERALLY QUALI- FIED 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 HOSPICE 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 provide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of the date of the enact- ment of this paragraph that are furnished via an audio-only tele- communications 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 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 an audio-only communications system during the period beginning on the first day after the end of such emer- gency period and ending on December 31, 2024’’.
(f) USE OF TELEHEALTH TO CONDUCT FACE-TO-FACE ENCOUNTER PRIOR TO RECERTIFICATION OF ELIGIBILITY FOR HOSPICE CARE DURING EMERGENCY PERIOD.—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 inserting ‘‘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 December 31, 2024’’.
(g) STUDY ON TELEHEALTH AND MEDICARE PROGRAM INTEG- RITY.— H. R. 2617—1442 (1) IN GENERAL.— (A) STUDY.—The Secretary shall conduct a study using medical record review, as described in subparagraph (C), on program integrity 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 extent that such information is avail- able) 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 Secretary may also review and analyze information on— (i) any geographic differences in utilization of tele- health services; (ii) documentation of the care and methods of delivery associated with telehealth services; and (iii) other areas, as determined appropriate by the Secretary.
(C) MEDICAL RECORD REVIEW.—In conducting the study under subparagraph (A), the Secretary shall conduct med- ical 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 section 1135(g)(1)(B) of the Social Secu- rity 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 program integrity review (as defined in paragraph (2)(B)), as determined appropriate by the Secretary.
(D) REPORTS.— (i) INTERIM REPORT.—Not later than October 1, 2024, the Secretary shall submit to the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives an interim report on the study conducted 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 Commerce 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 Sec- retary of Health and Human Services.
(B) STANDARD PROGRAM INTEGRITY REVIEW.—The term ‘‘standard program integrity review’’ refers to the review of any claim that requires a review of the associated med- ical record by the Secretary to determine the medical neces- sity of the services furnished or to identify potential fraud.

H. R. 2617—1443 term (C) TELEHEALTH SERVICE.—The ‘‘telehealth service’’ has the meaning given that term in section 1834(m)(4)(F) of the Social Security Act (42 U.S.C.

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

(3) FUNDING.—In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management 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.—Notwithstanding 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 LABORATORY TEST PAYMENT CHANGES.

(a) REVISED PHASE-IN OF REDUCTIONS FROM PRIVATE 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 (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 ESTABLISHMENT OF MEDICARE PAY- MENT 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 inserting ‘‘January 1, 2024’’; and (B) by striking ‘‘March 31, 2023’’ and inserting ‘‘March 31, 2024’’.

Subtitle C—Medicare Mental Health Provisions SEC.

4121.

COVERAGE OF MARRIAGE AND FAMILY THERAPIST SERV- ICES AND MENTAL HEALTH COUNSELOR 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— (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 subpara- graph: H. R. 2617—1444 ‘‘(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 adding 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 SERVICES.—The term ‘marriage and family therapist services’ means services fur- nished by a marriage and family therapist (as defined in para- graph (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 law) of the State in which such services are furnished, as would otherwise be covered if furnished by a physician or as an incident to a physician’s professional service.
‘‘(2) MARRIAGE AND FAMILY THERAPIST.—The term ‘marriage and family therapist’ means an individual who— ‘‘(A) possesses a master’s or doctor’s degree which quali- fies 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 para- graph (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 performed at least 2 years of clinical supervised experience in marriage and family therapy; and ‘‘(D) meets such other requirements as specified by the Secretary.
‘‘(3) MENTAL HEALTH COUNSELOR SERVICES.—The term ‘mental health counselor services’ means services furnished by a mental health counselor (as defined in paragraph (4)) for the diagnosis and treatment of mental illnesses (other than services 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 otherwise be covered if furnished by a physician or as incident 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 degree which quali- fies for licensure or certification as a mental health coun- selor, clinical professional counselor, or professional coun- selor under the State law of the State in which such indi- vidual furnishes the services described in paragraph (3); ‘‘(B) is licensed or certified as a mental health coun- selor, clinical professional counselor, or professional coun- selor by the State in which the services are furnished; H. R. 2617—1445 ‘‘(C) after obtaining such a degree has performed at least 2 years of clinical supervised experience in mental health counseling; and ‘‘(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 determined for payment of a psychologist under subparagraph (L)’’.
(4) EXCLUSION OF MARRIAGE AND FAMILY THERAPIST SERV- ICES AND MENTAL HEALTH COUNSELOR SERVICES FROM SKILLED NURSING FACILITY PROSPECTIVE PAYMENT SYSTEM.—Section 1888(e)(2)(A)(ii) of (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 services (as defined in section 1861(lll)(3)),’’ after ‘‘qualified psychologist services,’’.
the Social Security Act (5) INCLUSION OF MARRIAGE AND FAMILY THERAPISTS AND MENTAL HEALTH COUNSELORS AS PRACTITIONERS FOR ASSIGN- MENT OF CLAIMS.—Section 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 defined in section 1861(lll)(2)).

‘‘(viii) A mental health counselor (as defined in section 1861(lll)(4)).’’.
(b) COVERAGE OF CERTAIN MENTAL HEALTH SERVICES 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 sub- section (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))’’.

(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 inserting ‘‘, 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 Security Act (42 U.S.C.
1395ww(h)) is amended— (1) in paragraph (4)(F)(i), by striking ‘‘and (9)’’ and inserting ‘‘(9), and (10)’’; H. R. 2617—1446 (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 RESIDENCY POSITIONS IN PSYCHIATRY AND PSYCHIATRY SUBSPECIALTIES.— ‘‘(A) ADDITIONAL RESIDENCY POSITIONS.— ‘‘(i) IN GENERAL.—For fiscal year 2026, the Sec- retary shall, subject to the succeeding provisions of this paragraph, increase the otherwise applicable resi- dent limit for each qualifying hospital (as defined in subparagraph (F)) that submits a timely application under this subparagraph by such number as the Sec- retary may approve effective beginning July 1 of the fiscal year of the increase.
‘‘(ii) NUMBER AVAILABLE FOR DISTRIBUTION.—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 psychiatry 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 paragraph as a result of an increase in the otherwise applicable resident limit by January 31 of the fiscal year of the increase.

Such increase shall be effective beginning July 1 of such fiscal year.
‘‘(B) DISTRIBUTION.—For purposes of providing an increase in the otherwise applicable resident limit under subparagraph (A), the following shall apply: ‘‘(i) CONSIDERATIONS IN DISTRIBUTION.—In deter- mining 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 positions 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 CAT- EGORIES 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: ‘‘(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 reference resident level of the hospital (as specified in subparagraph (F)(iii)) is greater than the otherwise applicable resident limit.
‘‘(III) Hospitals in States with— ‘‘(aa) new medical schools that received ‘Candidate School’ status from the Liaison Committee on Medical Education or that H. R. 2617—1447 received ‘Pre-Accreditation’ status from the American Osteopathic Association Commission on Osteopathic College Accreditation on or after January 1, 2000, and that have achieved or continue to progress toward ‘Full Accredita- tion’ status (as such term is defined by the Liaison Committee on Medical Education) or toward ‘Accreditation’ status (as such term is defined by the American Osteopathic Associa- tion Commission on Osteopathic College Accreditation); or ‘‘(bb) additional locations and branch cam- puses established on or after January 1, 2000, by medical schools with ‘Full Accreditation’ status (as such term is defined by the Liaison Committee on Medical Education) or ‘Accredi- tation’ status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation).
‘‘(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 Secretary.

‘‘(iii) PRO RATA APPLICATION.—The Secretary shall ensure that each qualifying hospital that submits a timely application under subparagraph (A) receives at least 1 (or a fraction of 1) of the positions made avail- able under this paragraph before any qualifying hos- pital receives more than 1 of such positions.
‘‘(C) REQUIREMENTS.— ‘‘(i) LIMITATION.—A hospital may not receive more than 10 additional full-time equivalent residency posi- tions under this paragraph.
‘‘(ii) PROHIBITION ON DISTRIBUTION TO HOSPITALS WITHOUT AN INCREASE AGREEMENT.—No increase in the otherwise applicable resident limit of a hospital may be made under this paragraph unless such hos- pital agrees to increase the total number of full-time equivalent residency positions under the approved medical residency training program of such hospital by the number of such positions made available by such increase under this paragraph.
‘‘(iii) REQUIREMENT FOR HOSPITALS TO EXPAND PRO- GRAMS.—If a hospital that receives an increase in the otherwise applicable resident limit under this para- graph would be eligible for an adjustment to the other- wise applicable resident limit for participation in a new medical residency training 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 available under this paragraph are used to expand an existing program of the hospital, and not for participation in a new medical residency training program.
‘‘(D) APPLICATION OF PER RESIDENT AMOUNTS FOR NON- PRIMARY CARE.—With respect to additional residency posi- tions in a hospital attributable to the increase provided H. R. 2617—1448 under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for nonprimary care computed 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 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 aggregated pursuant to paragraph (4)(H) among members of the same affiliated group.
‘‘(F) DEFINITIONS.—In this paragraph: ‘‘(i) OTHERWISE APPLICABLE RESIDENT LIMIT.—The term ‘otherwise applicable 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 with- out regard to this paragraph but taking into account paragraphs (7)(A), (7)(B), (8)(A), (8)(B), and (9)(A).
‘‘(ii) PSYCHIATRY OR PSYCHIATRY SUBSPECIALTY RESIDENCY.—The term ‘psychiatry or psychiatry sub- specialty residency’ means a residency in psychiatry as accredited by the Accreditation Council for Graduate Medical Education for the purpose of preventing, diag- nosing, and treating mental health disorders.

‘‘(iii) QUALIFYING HOSPITAL.—The term ‘qualifying hospital’ means a hospital described in any of sub- clauses (I) through (IV) of subparagraph (B)(ii).
‘‘(iv) REFERENCE RESIDENT LEVEL.—The term ‘ref- erence resident level’ means, with respect to a hospital, the resident level for the most recent cost reporting period of the hospital ending on or before the date of enactment of this paragraph, 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 Security Act (42 U.S.C.
1395ww(d)(5)(B)) is amended— (1) in clause (v), in the third sentence, by striking ‘‘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: ‘‘(xiii) For discharges occurring on or after July 1, 2026, insofar as an additional payment amount under this subpara- graph is attributable to resident positions distributed to a hos- pital under subsection (h)(10), the indirect teaching adjustment factor shall be computed in the same manner as provided 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 ‘‘paragraph (10),’’ after ‘‘paragraph (8),’’.

H. R. 2617—1449 SEC.

4123.

IMPROVING MOBILE CRISIS CARE IN MEDICARE.

(a) PAYMENT FOR PSYCHOTHERAPY FOR CRISIS SERVICES FUR- NISHED IN AN APPLICABLE SITE OF SERVICE.— (1) IN GENERAL.—Section 1848(b) of the Social Security Act (42 U.S.C.
1395w–4(b)) is amended by adding at the end the following new paragraph: ‘‘(12) PAYMENT FOR PSYCHOTHERAPY FOR CRISIS SERVICES FURNISHED IN AN APPLICABLE SITE OF SERVICE.— ‘‘(A) IN GENERAL.—The Secretary shall establish new HCPCS codes under the fee 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 psychotherapy 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 furnished 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 determined 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 this subsection applies and other than an office setting.
‘‘(ii) PSYCHOTHERAPY FOR CRISIS SERVICES.—The code descriptions for services described in subpara- graph (B) shall be the same as the code descriptions for services 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.’’.

NEUTRALITY.—Section 1848(c)(2)(B)(iv) of such Act (42 U.S.C.
1395w–4(c)(2)(B)(iv)) is amended— (2) WAIVER BUDGET OF (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 communications mechanisms to provide education and outreach to stakeholders with respect to the ability of health professionals 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.
H. R. 2617—1450 (c) OPEN DOOR FORUM.—Not later than January 1, 2024, the Secretary shall convene stakeholders and experts for an open door forum or other appropriate mechanism to discuss current Medicare program coverage and payment policies for services that can be furnished to provide care to a Medicare beneficiary who is experi- encing 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 INTEGRATION SERVICES.—Not later than January 1, 2024, the Sec- retary 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 participate, consistent with applicable requirements for auxiliary personnel, in the furnishing of— (1) psychotherapy for crisis services billed under the Medi- care 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 furnished to a Medicare beneficiary experiencing a mental 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 sub- section (a).
(2) BEHAVIORAL HEALTH INTEGRATION SERVICES.—The term ‘‘behavioral health integration services’’ means services identi- fied, 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).
(4) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Health and Human Services.

SEC.

4124.

ENSURING ADEQUATE COVERAGE OF OUTPATIENT MENTAL HEALTH SERVICES UNDER THE MEDICARE PROGRAM.

(a) MODIFICATION OF DEFINITION OF PARTIAL HOSPITALIZATION SERVICES.—Section 1861(ff)(1) of the Social Security Act (42 U.S.C.
1395x(ff)(1)) is amended by inserting ‘‘for an individual determined (not less frequently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week’’ after ‘‘pre- scribed by a physician’’.

(b) COVERAGE OF INTENSIVE OUTPATIENT SERVICES.— (1) SCOPE OF BENEFITS.— (A) COMMUNITY MENTAL HEALTH CENTERS.—Section 1832(a)(2)(J) of the Social Security Act (42 U.S.C.
1395k(a)(2)(J)) is amended by inserting ‘‘and intensive out- patient services’’ after ‘‘partial hospitalization services’’.

(B) INCIDENT-TO SERVICES.—Section 1861(s)(2)(B) is amended by inserting ‘‘or intensive outpatient services’’ after ‘‘partial hospitalization services’’.

H. R. 2617—1451 (2) DEFINITION.—Section 1861(ff) of the Social Security Act (42 U.S.C.
1395x(ff)) is amended— (A) in the header, by inserting ‘‘; Intensive Outpatient Services’’ after ‘‘Partial Hospitalization 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 individual ‘deter- mined (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 ‘determined (not less frequently than once every other month) by a physician to have a need for such services 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 subparagraph (B)), a Federally qualified health center, or a rural health clinic’.’’.
(3) EXCLUSION FROM CALCULATION OF CERTAIN 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 services’’ 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 adding ‘‘and’’ at the end; and (III) by inserting after subparagraph (C) the following new subparagraph: ‘‘(D) intensive outpatient services (as defined in section 1861(ff)(4)),’’; and (ii) in paragraph (3), by striking ‘‘through (C)’’ and inserting ‘‘through (D)’’.

(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 hospitalization 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 intensive 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 serv- ices furnished by a hospital.
H. R. 2617—1452 ‘‘(B) EXCLUSION.—Costs associated with intensive out- patient services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective payment system under this sub- section.’’; and (2) in subsection (y)— (A) in the header, by striking ‘‘TO HOSPICE 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 intensive 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 out- patient services shall not be used to determine the amount of payment for rural health clinic services under the meth- odology 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.

SEC.

4125.
SEC.

4125.

IMPROVEMENTS TO MEDICARE PROSPECTIVE PAYMENT SYSTEM FOR PSYCHIATRIC HOSPITALS AND PSYCHIATRIC UNITS.

(a) IMPROVEMENTS THROUGH ADDITIONAL CLAIMS DATA.—Sec- tion 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 pursuant to subparagraph (D) and for other purposes as determined appropriate by the Secretary.

The Secretary shall begin to collect such data by not later than October 1, 2023.
‘‘(B) DATA AND INFORMATION.—The data and informa- tion to be collected under subparagraph (A) may include— ‘‘(i) charges, including those related to ancillary services; ‘‘(ii) the required intensity of behavioral moni- toring, such as cognitive deficit, suicide ideations, vio- lent behavior, and need for physical restraint; and ‘‘(iii) interventions, such as detoxification services for substance abuse, dependence on respirator, total parenteral nutritional support, dependence on renal dialysis, and burn care.
‘‘(C) METHOD OF COLLECTION.—The Secretary may col- lect the additional data and information under subpara- graph (A) on cost reports, on claims, or otherwise.
‘‘(D) REVISIONS TO PAYMENT RATES.— ‘‘(i) IN GENERAL.—Notwithstanding the preceding paragraphs of this subsection or section 124 of the H. R. 2617—1453 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, implement revisions to the methodology for deter- mining the payment rates under the system described in paragraph (1) for psychiatric hospitals and psy- chiatric units, as the Secretary determines to be appro- priate.
Such revisions may be based on a review of data and information collected under subparagraph (A).
‘‘(ii) REVIEW.—The Secretary may make revisions to the diagnosis-related group classifications, in accord- ance with subsection (d)(4)(C), to reflect nursing and staff resource use and costs involved in furnishing services at such hospitals and units, including consider- ations for patient complexity and prior admission to an inpatient 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.—Revisions in payment implemented pursuant to clause (i) for a rate year shall result in the same estimated amount of aggregate expenditures 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.’’.

(b) IMPROVEMENTS THROUGH STANDARDIZED PATIENT ASSESS- MENT DATA.—Section 1886(s) of the Social Security Act (42 U.S.C.
1395ww(s)), as amended by subsection (a), is further amended— (1) in paragraph (4)— (A) in subparagraph (A)(i), by striking ‘‘subparagraph (C)’’ and inserting ‘‘subparagraphs (C) and (E)’’; (B) by redesignating subparagraph (E) as subpara- graph (F); (C) by inserting after subparagraph (D) the following new subparagraph: ‘‘(E) STANDARDIZED PATIENT ASSESSMENT DATA.— ‘‘(i) IN GENERAL.—For rate year 2028 and each subsequent rate year, in addition to such data on the quality measures described in subparagraph (C), each psychiatric hospital and psychiatric unit shall submit to the Secretary, through the use of a standardized assessment instrument implemented under clause (iii), the standardized patient assessment data described in clause (ii).
Such data shall be submitted with respect to admission and discharge of an individual (and may be submitted more frequently as the Secretary deter- mines appropriate).
‘‘(ii) STANDARDIZED PATIENT ASSESSMENT DATA DESCRIBED.—For purposes of clause (i), the standard- ized patient assessment data described in this clause, with respect to a psychiatric hospital or psychiatric unit, is data with respect to the following categories: ‘‘(I) Functional status, such as mobility and self-care at admission to a psychiatric hospital or H. R. 2617—1454 unit and before discharge from a psychiatric hos- pital or unit.
‘‘(II) Cognitive function, such as ability to express ideas and to understand, and mental status, such as depression and dementia.

‘‘(III) Special services, treatments, and inter- ventions for psychiatric conditions.

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

‘‘(V) Impairments, such as incontinence and an impaired ability to hear, see, or swallow.

‘‘(VI) Other categories as determined appro- priate by the Secretary.
‘‘(iii) STANDARDIZED ASSESSMENT INSTRUMENT.— ‘‘(I) IN GENERAL.—For purposes of clause (i), the Secretary shall implement a standardized assessment instrument that provides for the submission of standardized patient assessment data under this title with respect to psychiatric hospitals and psychiatric units which enables comparison 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 Insur- ance Trust Fund under section 1817 to the Centers for Medicare & Medicaid Services Program Management Account, of $10,000,000 for purposes of carrying out subclause (I).’’; and (D) in subparagraph (F), as redesignated by subpara- graph (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 DIAGNOSIS-RELATED GROUP CLASSIFICATIONS.— ‘‘(A) IN GENERAL.—Notwithstanding the preceding paragraphs of this subsection (other than paragraph (5)) or section 124 of the Medicare, Medicaid, and SCHIP Bal- anced Budget Refinement Act of 1999, beginning not later than rate year 2031, in addition to any revisions pursuant to paragraph (5), the Secretary shall, by regulation, imple- ment 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 in paragraph the patient assessment data described (4)(E)(ii).
‘‘(B) BUDGET NEUTRALITY.—Revisions in payment implemented pursuant to subparagraph (A) for a rate year shall result in the same estimated amount of aggregate expenditures 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.’’.
H. R. 2617—1455 (c) IMPROVEMENTS THROUGH INCLUSION OF PATIENTS’ PERSPEC- TIVE 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 measure of patients’ perspective on care.’’; and (2) in subparagraph (E), by inserting ‘‘, including the quality measure of patients’ perspective on care described in subparagraph (D)(iv),’’ after ‘‘shall report quality measures’’.

SEC.

4126.
SEC.

4126.

EXCEPTION FOR PHYSICIAN WELLNESS PROGRAMS.

(a) IN GENERAL.—Section 1877(e) of the Social Security 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 improvement or maintenance pro- gram offered to a physician by an entity, if— ‘‘(A) such program— ‘‘(i) consists of counseling, mental health services, a suicide prevention program, or a substance use dis- order prevention and treatment program; ‘‘(ii) is made available to a physician for the pri- mary purpose of preventing suicide, improving mental health and resiliency, or providing training in appro- priate strategies to promote the mental health and resiliency of such physician; ‘‘(iii) is set out in a written policy, approved in advance of the operation of the program by the gov- erning body of the entity providing such program (and which shall be updated accordingly in advance to 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 evidence-based sup- port for the design of the program; ‘‘(III) the estimated cost of the program; ‘‘(IV) the personnel (including the qualifica- tions of such personnel) conducting the program; and ‘‘(V) the method by which such entity will evaluate the use and success of the program; ‘‘(iv) is offered by an entity described in subpara- graph (B) with a formal medical staff to all physicians who practice in the geographic area served by such fide entity, appointments to the medical staff of such entity or otherwise have clinical privileges at such entity; including physicians who hold bona ‘‘(v) is offered to all such physicians on the same terms and conditions and 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 H. R. 2617—1456 ‘‘(vii) meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient 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 Sec- retary; and ‘‘(C) neither the provision of such program, nor the value of such program, are contingent 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.’’.
(b) EXCEPTION UNDER THE ANTI-KICKBACK STATUTE.—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 program, or a substance use dis- order prevention 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 physician or other clinician; ‘‘(III) is set out in a written policy, approved in advance of the operation of the program by the gov- erning body of the 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 evidence-based sup- port for the design of the program; ‘‘(cc) the estimated cost of the program; ‘‘(dd) the personnel (including the qualifica- tions of such personnel) implementing the pro- gram; and ‘‘(ee) the method by which such entity will evaluate the use and success 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 H. R. 2617—1457 entity or otherwise have clinical privileges at such entity; ‘‘(V) is offered to all such physicians and clinicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a physician or clinician for such entity; ‘‘(VI) is evidence-based and conducted by a quali- fied health professional; and
 ‘‘(VII) meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient 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 determined by the Sec- retary; and ‘‘(iii) neither the provision of such program, nor the value of such program, are contingent upon the number or value of referrals made by a physician or other clinician to such 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-KICK- BACK STATUTE FOR CERTAIN CONTINGENCY MANAGE- MENT 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 CONTIN- GENCY MANAGEMENT INTERVENTIONS.— ‘‘(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 param- eters for such a safe harbor.
In conducting the review under the previous sentence, the Inspector General shall consider the extent to which providing such a safe harbor for evidence-based contingency management incentives may result in any of the factors described in paragraph (2).
‘‘(B) REPORT.—Not later than two years after the date of the enactment of this paragraph, the Secretary and the Inspector General shall submit to Congress rec- ommendations, including based on the review conducted under subparagraph (A), for improving access to evidence- based interventions while ensuring quality of care, ensuring fidelity to evidence-based practices, and including strong program integrity safe- guards that prevent increased waste, fraud, and abuse and prevent medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care program.’’.
contingency management H. R. 2617—1458 SEC.

4128.

PROVIDER OUTREACH AND REPORTING ON CERTAIN BEHAVIORAL HEALTH INTEGRATION SERVICES.

(a) 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 practitioners partici- pating 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 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 education initiative described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Com- merce 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 education initiative described in subsection (a), and 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 Representa- tives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries (including those bene- ficiaries accessing services 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 FURNISHED BY OPIOID TREAT- MENT 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-physi- cian 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 opioid use disorder 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 Medi- care program, including describing the requirements for billing and 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 furnished 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- H. R. 2617—1459 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 initiatives described in sub- section (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 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 education initiatives described in subsection (a), and 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 Representa- tives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who, during the pre- ceding year, were furnished opioid use disorder treatment serv- ices 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 COVERAGE OF MENTAL HEALTH AND SUBSTANCE USE DISORDER BENE- FITS 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 disorder benefits offered by Medicare Advantage plans (including specialized MA plans for special needs individ- uals, as defined in section 1859(b)(6) of the Social 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 bene- fits 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 include 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 bene- fits offered; and (D) other items determined appropriate by the Comp- troller General.
(3) PLAN AND SERVICE SPECIFIC.—To the extent practicable, the study under paragraph (1) shall examine differences by type of Medicare Advantage plan and type of item or service.
(4) BOTH REQUIRED AND SUPPLEMENTAL BENEFITS.—For purposes of the study under paragraph (1), benefits offered H. R. 2617—1460 by Medicare Advantage plans (including specialized MA plans for special needs individuals) under part C of title XVIII of the Social Security Act shall include both and differentiate between— (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).

Subtitle D—Other Medicare Provisions SEC.

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— (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 following new subparagraph: ‘‘(C) for the period beginning on the date of the enact- ment of this subparagraph and ending on December 31, 2024, an oral antiviral drug that may be dispensed only upon a prescription 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 PAY- MENT 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 (3) by adding at the end the following new subparagraph: ‘‘(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.
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 section 4121(a), is amended— (A) in subsection (s)(2)— (i) in subparagraph (HH), by striking ‘‘and’’ after the semicolon at the end; H. R. 2617—1461 (ii) in subparagraph (II), by striking the period at the end and inserting ‘‘; and’’; and (iii) by adding at the end the following new subparagraph: ‘‘(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 compression garments and other items determined by the Secretary 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 specialist (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 Secu- rity Act (42 U.S.C.
1395l(a)(1)) , as amended by section 4121(a), is amended— (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 treatment items (as defined in section 1861(mmm)), the amount paid shall be equal to 80 percent of the lesser of the actual 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 determine an appro- priate 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 Administration, and group health plans and health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act), and such other information as the Secretary deter- mines appropriate.
‘‘(2) FREQUENCY LIMITATION.—No payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the Secretary may establish.
‘‘(3) APPLICATION OF COMPETITIVE ACQUISITION.—In the case of lymphedema compression treatment items that are included in a competitive acquisition program in a competitive acquisi- tion area under section 1847(a)— H. R. 2617—1462 ‘‘(A) the payment basis under this subsection 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 subsection for an area that is not a competitive acquisi- tion area under section 1847, and in the case of such adjustment, paragraphs (8) and (9) of section 1842(b) shall not be applied.’’.
(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 TREATMENT ITEMS.— Lymphedema compression treatment 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 amended— (1) in subsection (a)(20)(D), by adding at the end the fol- lowing new clause: ‘‘(iv) Lymphedema compression treatment items (as defined in section 1861(mmm)).’’.

(2) in subsection (j)(5)— (A) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and (B) by inserting after subparagraph (D) the following new subparagraph: ‘‘(E) lymphedema compression treatment items (as defined in section 1861(mmm));’’.

SEC.

4134.
SEC.

4134.

PERMANENT IN-HOME BENEFIT FOR IVIG SERVICES.

(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 ‘‘glob- ulin’’; 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 Security 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 globulin described in section 1861(s)(2)(Z) that are furnished 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 adminis- tration of such intravenous immune globulin to such individual in the patient’s home during a calendar day in an amount that the Secretary determines to be appropriate, which may be based on the payment established pursuant to subsection (d) of section 101 of the Medicare IVIG Access and Strength- ening Medicare and Repaying Taxpayers Act of 2012.
For pur- poses of the preceding sentence, such separate bundled payment H. R. 2617—1463 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 subpara- graphs (F) and (G), respectively; and (2) by inserting after subparagraph (D) the following new subparagraph: ‘‘(E) items and services related to the administration of intravenous immune globulin furnished on or after January 1, 2024, as described 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 section 4121(a) and section 4133(a), is amended— (1) by striking ‘‘and’’ before ‘‘(GG)’’; and (2) by inserting before the semicolon at the end the fol- lowing: ‘‘, 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 actual 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 appropriated, and there is hereby appropriated, out of any monies in the Treasury not otherwise appropriated, $4,300,000 for purposes of paying for items and services furnished under the demonstration project established by the Medicare IVIG Access and Strength- ening Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C.

1395l note).
1395l note).

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

SEC.

4135.

ACCESS TO NON-OPIOID TREATMENTS FOR PAIN RELIEF.

(a) IN GENERAL.—Section 1833(t) of the Social Security Act (42 U.S.C.
1395l(t)) is amended— (1) in paragraph (2)(E), by inserting ‘‘and temporary addi- tional payments for non-opioid treatments 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 RELIEF.— ‘‘(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 pay- ment 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 H. R. 2617—1464 specified in clause (ii) for such non-opioid treatment for pain relief.
‘‘(ii) AMOUNT OF PAYMENT.—Subject to the limita- tion 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 determines is associ- ated with the drug or biological; or ‘‘(II) a medical device, the amount of the hos- pital’s charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device.
‘‘(iii) LIMITATION.—The 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 services) with which the non-opioid treatment for pain relief is furnished, as determined by the Secretary.
‘‘(iv) DEFINITION OF NON-OPIOID TREATMENT FOR PAIN RELIEF.—In this subparagraph, the term ‘non- opioid treatment for pain relief’ means a drug, biological product, or medical device that— additional ‘‘(I) in the case of a drug or biological product, has a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, with- out 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 postsurgical 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 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 ability to replace, reduce, or avoid intraoperative or post- operative 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 transitional pass- through payment under paragraph (6); and ‘‘(IV) has payment that is packaged into a payment for a covered OPD service (or group of services).’’.
(b) AMBULATORY SURGICAL CENTER PAYMENT SYSTEM.—Section 1833(i) of the Social Security Act (42 U.S.C.
1395l(i)) is amended by adding at the end the following new paragraph: H. R. 2617—1465 ‘‘(10) TEMPORARY ADDITIONAL PAYMENTS FOR NON-OPIOID TREATMENTS FOR PAIN RELIEF.— ‘‘(A) IN GENERAL.—In the case of surgical services fur- nished on or after January 1, 2025, and before January 1, 2028, the payment system described in paragraph (2)(D)(i) shall provide, in a budget-neutral manner, for an additional payment for a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (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 treatment 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 sub- section.’’.
(c) EVALUATION OF COVERAGE AND PAYMENT FOR NON-OPIOID THERAPIES AND THERAPEUTIC SERVICES FOR PAIN MANAGEMENT.— (1) REPORT TO CONGRESS.—Not later than January 1, 2028, the Secretary of Health and Human Services (in this subsection referred to as the ‘‘Secretary’’) shall submit to Congress a report— (A) identifying limitations, gaps, barriers to access, or deficits in Medicare coverage or reimbursement for restorative therapies, behavioral approaches, and com- plementary and integrative health services that are identi- fied in the Pain Management Best Practices Inter-Agency Task Force Report and that have demonstrated the ability to replace or reduce opioid consumption; (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 serv- ices; and (C) comparing, for the 12-month period following the first 6 months in which additional payment for non-opioid treatments for pain relief (as defined in clause (iv) of section 1833(t)(16)(G) of the Social Security Act, as added by sub- section (a)) is made under such section 1833(t)(16)(G)— (i) with respect to Medicare beneficiaries who received a non-opioid treatment for pain relief (as so defined) as part of a covered OPD service, the quantity of opioids administered, dispensed, and prescribed for the same covered OPD service, including postoperative management; and (ii) with respect to Medicare beneficiaries 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 administered, dispensed, and prescribed for the same covered OPD service, including postoperative management.
(2) REPORTING STANDARD AND PUBLIC CONSULTATION.—In developing the report described in paragraph (1), the Secretary shall compare results from nationally represented samples of H. R. 2617—1466 beneficiaries and consult with relevant stakeholders as deter- mined appropriate by the Secretary.
(3) EXCLUSIVE TREATMENT.—Any drug, biological 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 added by subsection (a)) shall not be considered a therapeutic service for purposes of the report under paragraph (1).

SEC.

4136.

TECHNICAL AMENDMENTS TO MEDICARE SEPARATE PAY- MENT FOR DISPOSABLE NEGATIVE PRESSURE WOUND THERAPY DEVICES.

(a) IN GENERAL.—Section 1834(s) of the Social Security Act (42 U.S.C.
1395m(s)) is amended— (1) by amending paragraph (3) to read as follows: ‘‘(3) PAYMENT.— ‘‘(A) IN GENERAL.—The separate payment amount established under this paragraph for an applicable dispos- able 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 device; ‘‘(ii) for 2024, the supply price used to determine the relative value for the service under the fee schedule under section 1848 (as of January 1, 2022) for the applicable disposable device, updated by the specified adjustment described in subparagraph (B) for such year; and ‘‘(iii) for 2025 and each subsequent year, the pay- ment amount established under this paragraph for such device for the previous year, updated by the speci- fied 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 subpara- graph for a year is equal to— ‘‘(I) the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending in June of the previous year; minus ‘‘(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 THERAPY SERVICES FROM SEPARATE PAYMENT.—With respect to applicable devices furnished on or after January 1, 2024, the separate H. R. 2617—1467 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 established under section 1895 and shall not be separately billable.’’; and (2) by adding at the end the following new paragraph: ‘‘(4) IMPLEMENTATION.—As part of submitting claims for the separate payment established under this subsection, begin- ning 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 Deficit 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 Reauthorization 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: ‘‘(v) in the case of episodes and visits ending during 2023, by 1 percent; and’’.

SEC.

4138.

REMEDYING ELECTION REVOCATIONS RELATING TO ADMINISTRATION OF COVID–19 VACCINES.
(a) IN GENERAL.—Section 1821(b)(5)(A) of the Social Security Act (42 U.S.C.

1395i–5(b)(5)(A)) is amended— (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 enact- ment 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 RELATING TO REV- OCATION OF ELECTION.—Notwithstanding 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 administration described (42 U.S.C.
1395x(s)(10)(A)), the following rules shall apply: in section 1861(s)(10)(A) of such Act (1) Beginning on such date of enactment, such individual may make an election under such section, which shall take effect immediately upon its execution, 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 effective date for an election described in subparagraph (A) or (B) of such paragraph (4).

H. R. 2617—1468 SEC.

4139.

PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PROGRAM.
(a) AREAS OTHER THAN RURAL AND NONCONTIGUOUS 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 applicable 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.
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 Regulations (or any successor regulation) until the date immediately following the last day of the emergency period described 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 provisions 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 INITIA- TIVE.
‘‘(a) IN GENERAL.— ‘‘(1) EXTENSION.—With respect to inpatient hospital admis- sions occurring during the period beginning on the first day after the end of the emergency period described in section 1135(g)(1)(B) and ending on December, 31, 2024, the Secretary of Health and Human Services shall grant waivers and flexibili- ties (as described in paragraph (2)) to an individual hospital that submits a request for such waivers and flexibilities and meets specified criteria (as described in paragraph (3)) in order to participate in the Acute Hospital Care at Home initiative of the Secretary.
‘‘(2) ACUTE HOSPITAL CARE AT HOME WAIVERS AND FLEXIBILI- TIES.—For the purposes of paragraph (1), the waivers and flexi- bilities described in this paragraph are the following waivers and flexibilities that were made available to individual hospitals under the Acute Hospital Care at Home initiative of the Sec- retary during the emergency period described in section 1135(g)(1)(B): ‘‘(A) Subject to paragraph (3)(D), waiver of the require- ments 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 require- ments under section 482.41 of title 42, Code of Federal Regulations (or any successor regulation).
H. R. 2617—1469 ‘‘(B) Flexibility to allow a hospital to furnish inpatient services, including routine services, outside the hospital under arrangements, as described in Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital 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 Extenders, Improving Access to Medi- care, Medicaid, 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 in place for such initiative during such emergency 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 Secretary the criteria it would use to ensure that hospital services be furnished only to an individual 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 serv- ices 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 individual is only eligible for services under paragraph (1) if the indi- vidual is a hospital inpatient or is a patient of the hospital’s emergency department for whom the hospital determines that an inpatient level of care is required (as described in subparagraph (A)).
‘‘(D) The hospital shall meet all patient safety stand- ards 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 Secretary, at a time, form and manner determined by the Secretary, any data and information the Secretary determines nec- essary to do the following: ‘‘(i) Monitor the quality of care furnished, and to the extent practicable, ensure the safety of individuals and analyze costs of such care.

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

‘‘(F) The hospital meets such other requirements and conditions as the Secretary determines appropriate.
H. R. 2617—1470 ‘‘(4) TERMINATION.—The Secretary may terminate a hos- pital from participation in such initiative (and the waivers and flexibilities applicable to such hospital) if the Secretary determines that the hospital no longer meets the criteria described in paragraph (3).
‘‘(b) STUDY AND REPORT.— ‘‘(1) IN GENERAL.—The Secretary shall conduct a study to— ‘‘(A) analyze, to the extent practicable, the criteria established by hospitals under the Acute Hospital Care at Home initiative of the Secretary 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 individuals with similar conditions and characteristics in the inpatient setting and through the Acute Hospital Care at Home initiative, including health outcomes, hospital readmis- sion rates, hospital mortality rates, length of stay, infection rates, and patient experience of care; ‘‘(ii) clinical conditions treated and diagnosis- related groups of discharges from the inpatient setting and under the Acute Hospital Care at Home initiative; ‘‘(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 serv- ices (such as in-person visits and virtual contacts with patients) furnished in the Acute Hospital Care at Home initiative and furnished in the inpatient 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 Sec- retary 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 otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $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 instruc- tion 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 MEDI- CARE PROGRAM FOR CERTAIN DEVICES 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— H. R. 2617—1471 (1) in subparagraph (B)(iii), in the matter preceding sub- clause (I), by striking ‘‘A category’’ and inserting ‘‘Subject to subparagraph (K), a category’’; and (2) by adding at the end the following new subparagraph: ‘‘(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 December 31, 2022, such pass-through status shall be extended for a 1–year period beginning 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 device (as determined by the Secretary) from the payment amount under this subsection for a cov- ered OPD service (or group of services) with which it is packaged.
‘‘(iii) NO APPLICATION OF AGGREGATE 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 annual aggregate adjustments under subparagraph (E) for 2023; or ‘‘(II) in making any budget neutrality adjust- ments under this subsection for 2023.’’.
(b) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary of Health and Human Service may implement the amendments made by subsection (a) by program instruction or otherwise.

SEC.

4142.

INCREASING TRANSPARENCY FOR HOME HEALTH PAY- MENTS UNDER THE MEDICARE PROGRAM.

(a) TRANSPARENCY.—In notice and comment rulemaking used to implement section 1895(b)(3)(D) of the Social Security Act (42 U.S.C.
1395fff(b)(3)(D), the Secretary 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 internet website of the Centers for Medicare & Medicaid Services the following: (1) Electronic data files showing the Centers for Medicare & Medicaid Services simulation of 60-day episodes under the home health prospective payment 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 deter- mining 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 1895(b)(2)(B) and 1895(b)(4)(B) of the Social Security 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 H. R. 2617—1472 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 respect to the home health prospective payment system 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 respect to the home health prospective payment system rate for calendar year 2023 as finalized in the final rule entitled ‘‘Medicare Program; Calendar Year 2023 Home Health Prospec- tive Payment System 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 Reg- ister 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 establishing the methodology to implement such sec- tion, or to suggest that the Secretary’s promulgation of the method- ology implementing such Calendar Year 2023 home health final rule was inadequate under Chapter 5 of title 5, United States Code (commonly known as the ‘‘Administrative 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 Social Security Act (42 U.S.C.
1395ww(l)(2)(B)) is amended— (1) by striking ‘‘PAYMENTS.—Such ratio’’ and inserting ‘‘PAY- MENTS.— ‘‘(i) IN GENERAL.—Subject to clause (ii), such ratio’’; and (2) by adding at the end the following new clause: ‘‘(ii) EXCEPTION TO ANNUAL LIMITATION FOR EACH OF 2010 THROUGH 2019.—For each of 2010 through 2019, the limitation under clause (i) on the total amount of additional payments for nursing and allied health education to be distributed to hospitals under this sub- section 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 nursing and allied health.’’.
(b) NO AFFECT ON PAYMENTS FOR DIRECT GRADUATE MEDICAL EDUCATION.—Section 1886(h)(3)(D)(iii) of the Social Security Act (42 U.S.C.
1395ww(h)(3)(D)(iii)) is amended by adding at the end the following sentence: ‘‘In applying the preceding sentence for each of 2010 through 2019, the Secretary shall not take into account any increase in the total amount of such additional payment amounts for such nursing and allied health education for portions H. R. 2617—1473 of cost reporting periods 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 Medicare & Medicaid Serv- ices Program Management Account for fiscal year 2023, out of in the Treasury not otherwise appropriated, any amounts $3,000,000, to remain available 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 DEDUCT- IBLE FOR TELEHEALTH.
(a) IN GENERAL.—Section 223(c)(2)(E) of the Internal 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 ‘‘(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 December 31, 2022.

Subtitle F—Offsets SEC.


4161.

REDUCTION OF MEDICARE IMPROVEMENT FUND.

Section 1898(b)(1) of the Social Security Act (42 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 MEDICARE.

Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C.
1395f(i)(2)(B)) is amended— (1) in clause (ii), by striking ‘‘2031’’ and inserting ‘‘2032’’; and (2) in clause (iii), by striking ‘‘2031’’ and inserting ‘‘2032’’.

SEC.

4163.

MEDICARE DIRECT SPENDING REDUCTIONS.

Section 251A(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C.
901a(6)) is amended— (1) in subparagraph (B), in the matter preceding clause (i)— H. R. 2617—1474 (A) by striking ‘‘On the dates OMB issues its sequestra- tion 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 submits the budget under section 1105 of title 31, United States Code, for fiscal year 2032, the President shall order a sequestration of pay- ments for the Medicare programs specified in section 256(d), effective upon issuance, such that, notwithstanding the 2 per- cent 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 percent; 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 percent.’’.
TITLE V—MEDICAID AND CHIP PROVISIONS Subtitle A—Territories SEC.

5101.

MEDICAID ADJUSTMENTS FOR THE TERRITORIES.

(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) or (iii)’’; and ‘‘clause (ii)’’ and inserting (II) by striking ‘‘and’’ at the end; (ii) in clause (ii), by striking the semicolon and inserting ‘‘; and’’; and (iii) by adding at the end the following new clause: ‘‘(iii) for fiscal year 2023 and each subsequent fiscal year, the amount specified 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 Puerto 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), subject to paragraphs (12) and (13), the amounts specified in this paragraph are the following: ‘‘(A) For fiscal year 2023, $3,275,000,000.
‘‘(B) For fiscal year 2024, $3,325,000,000.

‘‘(C) For fiscal year 2025, $3,475,000,000.

H. R. 2617—1475 ‘‘(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 following: ‘‘(i) For fiscal year 2020, the sum of the amount provided under this subsection for Puerto Rico for fiscal year 2019, increased 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 Statistics) for the 12-month period ending in March preceding the beginning of the fiscal year, rounded to the nearest $100,000.
‘‘(ii) For each of fiscal years 2021 through 2027, the sum of the amount provided under this subpara- graph for the preceding fiscal year, increased in accord- ance with the percentage increase described in clause (i), rounded to the nearest $100,000.
‘‘(G) For fiscal year 2029 and each subsequent fiscal year, the sum of the amount specified 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 published 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 subparagraph (F) for fiscal year 2028 or under subparagraph (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’ interpretation of the flush language following paragraph (2)(E) (as described in the letters sent by the Centers for Medicare & Medicaid Services to the Director 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 subse- quent 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) estab- lishes a reimbursement floor, implemented through a directed 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.
H. R. 2617—1476 ‘‘(B) APPLICATION TO MANAGED CARE.—In certifying whether Puerto Rico has established a reimbursement floor under a directed payment arrangement plan that satisfies the requirements of subparagraph (A)— ‘‘(i) for fiscal year 2023, the Secretary shall apply such requirements to payments for physician services under a managed care contract entered into or renewed 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 serv- ices such as primary 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 entered into or renewed, such reimbursement floor shall be deemed to satisfy such requirements for the subsequent fiscal year.
‘‘(C) NONAPPLICATION OF INCREASE IN DETERMINING ALLOTMENTS FOR SUBSEQUENT FISCAL YEARS.—An increase under this paragraph 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 applicable, 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 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 Secretary 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 paragraph 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— (1) in the header, by striking ‘‘TEMPORARY’’; (2) in paragraph (2)— (A) by striking ‘‘subject to section 1108(g)(7)(C),’’; and H. R. 2617—1477 (B) by striking ‘‘December 23, 2022’’ and inserting ‘‘Sep- tember 30, 2027,’’; and (3) in paragraph (3), by striking ‘‘for the period beginning December 21, 2019, and ending December 23, 2022’’ and inserting ‘‘beginning December 21, 2019’’.
(c) APPLICATION OF ASSET VERIFICATION PROGRAM REQUIRE- MENTS 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 Sec- retary 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 striking ‘‘EXEMP- TION OF TERRITORIES’’ and inserting ‘‘EXEMPTION OF CERTAIN TERRITORIES’’; and (ii) by striking ‘‘and the District of Columbia’’ and inserting ‘‘, the District of Columbia, and Puerto Rico’’; and (2) in subsection (k)— (A) in paragraph (1)— (i) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively, and adjusting the margins accordingly; (ii) in the matter preceding clause (i), as so redesig- nated— (I) by striking ‘‘beginning on or after January 1, 2021’’; and (II) by striking ‘‘for a non-compliant 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 inserting ‘‘; and’’; and (iv) by adding at the end the following new subparagraph: ‘‘(B) a non-compliant State that is Puerto Rico shall be reduced— ‘‘(i) for calendar quarters in fiscal year 2026 begin- ning 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 REQUIREMENT.—Section REPORTING 1108(g)(9) of the Social Security Act (42 U.S.C.
1308(g)(9)) is amended— OF H. R. 2617—1478 (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 Medicare, Medicaid, and CHIP, and Strengthening Public 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 PROCUREMENT 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 officer (other than the director of such agency) to serve as the Contracting and Procurement Oversight Lead to carry out the duties specified in subclause (II).
‘‘(II) DUTIES.—Not later than 60 days after the end of each fiscal quarter (beginning with the first fiscal quarter beginning on or after the date that is 1 year after the date of the enactment of this clause), the officer designated pursuant to subclause (I) shall, with respect to each contract described in clause (iii) with an annual value exceeding $150,000 entered into during such quarter, certify to the Secretary either— that extenuating ‘‘(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 Regulations (or successor regulations); or ‘‘(bb) circumstances (including a lack of multiple entities competing for such contract) prevented the compliance of such contract with such standards.
‘‘(III) PUBLICATION.—The officer designated pursuant to subclause (I) shall make public each certification containing extenuating circumstances described in subclause (II)(bb) not later than 30 days after such certification is made, including a description of, and justification of, such extenu- ating circumstances.
‘‘(IV) REVIEW OF COMPLIANCE.—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.’’.

H. R. 2617—1479 (f) MEDICAID DATA SYSTEMS IMPROVEMENT PAYMENTS.—Section 1108 of the Social Security Act (42 U.S.C.
1308) is amended by adding at the end the following new subsection: ‘‘(i) DATA SYSTEMS IMPROVEMENT PAYMENTS.— ‘‘(1) IN GENERAL.—Subject to paragraphs (2) and (3), the Secretary shall pay to each eligible territory an amount equal to 100 percent of the qualifying data system improvement expenditures incurred by such territory on or after October 1, 2023.
‘‘(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 specify an allotment for each eligible territory for payments 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 equitable allot- ment of such payments.
‘‘(4) NO EFFECT ON TERRITORIAL CAPS.—A payment to an eligible territory under this subsection shall not be taken into account for purposes of applying the payment limits under subsections (f) and (g).

‘‘(5) DEFINITIONS.—In this subsection: ‘‘(A) ELIGIBLE TERRITORY.—The term ‘eligible territory’ means American Samoa, Guam, the Northern Mariana Islands, and the Virgin Islands.
‘‘(B) QUALIFYING DATA SYSTEM IMPROVEMENT EXPENDI- TURE.—The term ‘qualifying data system improvement expenditure’ means an expenditure by an eligible territory to improve, update, or enhance a data system that is used by the territory to carry out an administrative activity for which Federal financial participation 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 development, financing, systems implementation and oper- ation, 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 (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 toward achieving, the goals described in such stra- tegic plan, and any policy changes relating to such goals H. R. 2617—1480 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 Mar- iana Islands, and the Virgin Islands.

Subtitle B—Medicaid and CHIP Coverage SEC.

5111.

FUNDING EXTENSION OF THE CHILDREN’S HEALTH INSUR- ANCE PROGRAM AND RELATED PROVISIONS.

(a) IN GENERAL.—Section 2104(a) of the Social Security 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 inserting ‘‘for fiscal year 2029’’; (B) in subparagraph (A), by striking ‘‘beginning 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 ‘‘beginning on April 1, 2027, and ending on September 30, 2027’’ and inserting ‘‘beginning on April 1, 2029, and ending on Sep- tember 30, 2029’’.
(b) CHIP ALLOTMENTS.— (1) IN GENERAL.—Section 2104(m) of the Social Security Act (42 U.S.C.
1397dd(m)) is amended— (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 inserting ‘‘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 striking ‘‘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 H. R. 2617—1481 (C) by striking ‘‘beginning on October 1, 2026, and ending on March 31, 2027’’ and inserting ‘‘beginning on October 1, 2028, and ending on March 31, 2029’’.
(c) OTHER RELATED CHIP POLICIES.— (1) PEDIATRIC QUALITY MEASURES PROGRAM.—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 subpara- graph: ‘‘(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 (B) in subparagraph (A) by striking ‘‘September 30, 2027’’ each place it appears and inserting ‘‘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,’’; (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) OPTION.—Section EXPRESS 1902(e)(13)(I) of (42 U.S.C.

1396a(e)(13)(I)) is amended by striking ‘‘2027’’ and inserting ‘‘2029’’.
the Social Security Act ELIGIBILITY LANE H. R. 2617—1482 (2) CONFORMING AMENDMENTS FOR ASSURANCE OF AFFORD- ABILITY STANDARD FOR CHILDREN AND FAMILIES.—Section 1902(gg)(2) of the Social Security Act (42 U.S.C.

1396a(gg)(2)) is amended— (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 appears and inserting ‘‘2029,’’.

SEC.

5112.

CONTINUOUS ELIGIBILITY FOR CHILDREN UNDER MED- ICAID 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 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 eligible for benefits under a State plan (or waiver of such plan) approved under this title under subsection (a)(10)(A) shall remain eligible for such benefits until the earlier of— ‘‘(A) the end of the 12-month period beginning 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 resi- dent of such State.’’.
(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 sub- paragraphs (L) through (U), respectively; and (2) by inserting after subparagraph (J) the following new subparagraph: ‘‘(K) Section 1902(e)(12) (relating to 1 year of contin- uous eligibility for children), except 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 MED- ICAID AND CHIP.

Effective as if included in the enactment of sections 9812 and 9822 of the American Rescue Plan Act of 2021 (Public Law 117– 2), subsection (b) of each such section is amended by striking ‘‘during the 5-year period’’.

SEC.
SEC.

5114.

EXTENSION OF MONEY FOLLOWS THE PERSON REBAL- ANCING DEMONSTRATION.

(a) IN GENERAL.—Subsection (h) of section 6071 of the Deficit Reduction Act of 2005 (42 U.S.C.
1396a note) is amended— H. R. 2617—1483 (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 subsequent fiscal year’’; and (3) by adding at the end the following new paragraph: ‘‘(3) TECHNICAL ASSISTANCE.—In addition to amounts other- wise 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, $5,000,000, to remain available until expended, for carrying out subsections (f) and (g).’’.
(b) REDISTRIBUTION OF UNEXPENDED GRANT AWARDS.—Sub- section (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 fol- lowing 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 Secretary and added to the appropriation for the fifth suc- ceeding fiscal year.’’.

SEC.

5115.
SEC.

5115.

EXTENSION OF MEDICAID PROTECTIONS AGAINST SPOUSAL IMPOVERISHMENT FOR RECIPIENTS OF HOME AND COMMUNITY-BASED SERVICES.

Section 2404 of the Patient Protection and Affordable Care Act (42 U.S.C.

1396r–5 note) is amended by striking ‘‘September 30, 2023’’ and inserting ‘‘September 30, 2027’’.

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 INSTITU- TIONS.
(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 subpara- graph: ‘‘(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 H. R. 2617—1484 to be released from a public institution following adjudica- tion, the State shall have in place a plan, and in accordance with such plan, provide for— ‘‘(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 diagnostic 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 release of such eligible juvenile from such public institution, and for at least 30 days following the release of such eligible juvenile from such institution, targeted case manage- ment services, including referrals for such eligible juve- nile to the appropriate care and services available in the geographic region of the home or residence of such eligible juvenile (where feasible) under the State plan (or waiver of such plan);’’; and (2) in subsection (nn)(3), by striking ‘‘(30)’’ and inserting ‘‘(31)’’.
(b) AUTHORIZATION OF FEDERAL FINANCIAL PARTICIPATION.— 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 serv- ices required under such section’’ after ‘‘(except as a patient in a medical institution’’.
(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 OF A PUBLIC INSTITUTION.— that— ‘‘(1) IN GENERAL.—The State child health plan shall provide ‘‘(A) the State shall not terminate eligibility 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; ‘‘(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) imme- diately before becoming an inmate of a public institution, the State shall, prior to the child’s release from such public institution, conduct a redetermination 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 redetermination that the child continues to meet the eligibility requirements for such child health assistance, the State shall restore H. R. 2617—1485 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 institution (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 assistance sub- mitted by, or on behalf of, the child such that the State makes a determination of eligibility for the child with respect to child health assistance upon release of the child from the public institution.
‘‘(2) REQUIRED COVERAGE OF SCREENINGS, DIAGNOSTIC SERV- ICES, REFERRALS, AND CASE MANAGEMENT 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 adjudication, the State shall have in place a plan for providing, and shall provide in accord- ance 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 ‘‘except as pro- vided 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: ‘‘(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 institution, 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 covered 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 FINANCIAL PARTICIPATION FOR INMATES WHO ARE ELIGIBLE JUVE- NILES PENDING DISPOSITION OF CHARGES.

(a) MEDICAID.— (1) IN GENERAL.—The subdivision (A) of section 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)) following para- graph (31) of such section, as amended by section 5121(b), is further amended by inserting ‘‘, or, at the option of the State, for an individual who is an eligible juvenile (as defined in section 1902(nn)(2)), while such individual is an inmate 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 H. R. 2617—1486 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 described in the subdivision (A) following paragraph (31) of section 1905(a), during such period beginning after the disposi- tion of charges with respect to such individual)’’ after ‘‘is such an inmate’’.

(b) CHIP.—Section 2110(b)(7) of the Social Security Act (42 is U.S.C.
13977jj(b)(7)), as added by section 5121(c)(2)(B), amended— (1) in the heading, by striking ‘‘EXCEPTION’’ and inserting ‘‘EXCEPTIONS’’; and (2) by adding at the end the following new sentence: ‘‘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 period 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 fur- nished for periods beginning on or after such date.

SEC.

5123.

REQUIRING ACCURATE, UPDATED, AND SEARCHABLE PRO- VIDER DIRECTORIES.

(a) APPLICATION TO MANAGED CARE.—Section 1932(a)(5) of the Social Security Act (42 U.S.C.
1396u–2(a)(5)) is amended— (1) in subparagraph (B)(i), by inserting ‘‘, including as required by subparagraph (E)’’ before the period at the end; and (2) by adding at the end the following new subparagraph: ‘‘(E) PROVIDER DIRECTORIES.— ‘‘(i) IN GENERAL.—Each managed care organiza- tion, 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 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 required by the Secretary) on a public website, a searchable directory of network providers, which shall include physicians, hospitals, pharmacies, providers of mental health services, pro- viders 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 provider; ‘‘(III) the address at which the provider pro- vides services; ‘‘(IV) the telephone number of the provider; and H. R. 2617—1487 ‘‘(V) information regarding— ‘‘(aa) the provider’s cultural and linguistic capabilities, including languages (including American Sign Language) offered by the pro- vider or by a skilled medical
 interpreter who provides interpretation services at the pro- vider’s office; ‘‘(bb) whether the provider is accepting as new patients, individuals who receive med- ical assistance under this title; ‘‘(cc) whether the provider’s office or facility has accommodations for individuals with physical disabilities, including offices, exam rooms, and equipment; ‘‘(dd) the Internet website of such pro- vider, if applicable; and ‘‘(ee) whether the provider offers covered services via telehealth; and ‘‘(VI) other relevant information, as required by the Secretary.
‘‘(ii) NETWORK DEFINED.—In this PROVIDER subparagraph, the term ‘network provider’ includes any provider, group of providers, or entity that has a net- work provider agreement with a managed care organization, a prepaid inpatient health plan (as defined by the Secretary), a prepaid ambulatory health plan (as defined 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 REQUIRE- MENTS.—Section 1902(a) of the Social Security Act (42 U.S.C.
1396a) is amended— (1) by striking paragraph (83) and inserting the following: ‘‘(83) provide that in the case of a State plan (or waiver of the plan) that provides medical assistance 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 required by the Secretary) on the public website of the State agency administering the State plan, a searchable direc- tory of the providers described in subsection (mm) that, in addition to such other requirements 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 serv- ices; ‘‘(D) the telephone number of the provider; ‘‘(E) information regarding— H. R. 2617—1488 ‘‘(i) the provider’s cultural and linguistic capabili- ties, including languages (including American Sign Language) offered by the provider or by a skilled med- ical interpreter who provides interpretation services at the provider’s office; ‘‘(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 disabil- ities, including offices, exam rooms, and equipment; ‘‘(iv) the Internet website of such provider, if applicable; and ‘‘(v) whether the provider offers covered services via telehealth; and ‘‘(F) other relevant information as required by the Sec- retary;’’; 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, hospitals, pharmacies, pro- viders 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— ‘‘(A) in the case of a provider or a provider type for which the State agency, as a condition of receiving payment for items and services furnished by the provider to individ- uals eligible to receive medical assistance under the State plan (or a waiver of the plan), requires the enrollment of the provider with the State agency, includes a provider that— ‘‘(i) is enrolled with the agency as of the date on which the directory is published 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 require such enrollment, includes a provider that received payment under the State plan (or a waiver of the plan) in the 12-month period preceding the date on which the directory is published or updated (as applicable) under subsection (a)(83).
‘‘(2) STATE OPTION TO INCLUDE OTHER PARTICIPATING PRO- VIDERS.—At State option, a provider described in this subsection may include any provider who furnishes services and is partici- pating 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 section)’’ 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 CRISIS H. R. 2617—1489 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 Assistant Secretary for Mental Health and Substance Use, shall issue guidance to States regarding Med- icaid and CHIP 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 continuum of crisis response services that— (A) includes crisis call centers, including 988 crisis services hotlines, mobile crisis teams, crisis response serv- ices delivered in home, community, residential facility, and hospital settings, and coordination with follow-on mental health and substance use disorder services, such as inten- sive outpatient and partial hospitalization 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, trauma-informed care, and crisis de-escalation.
(2) Outlines the Federal authorities through which States may finance and enhance under Medicaid and CHIP the avail- ability of crisis response services across each stage of the con- tinuum 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 hotlines, and how Medicaid administrative funding, including enhanced matching, and the Medicaid Information Technology Architecture 3.0 framework, may be used to establish or enhance regional or statewide crisis call centers, including 988 crisis services hotlines, 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 services initiatives, behavioral disorder-specific crisis response, trained peer support services, and establishing 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 differing patient popu- lations, including urban, rural, and frontier communities, dif- fering age groups, cultural 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 assessments.
(7) Identifies strategies to facilitate timely provision of crisis response services, including how States can enable access to crisis response services without requiring a diagnosis, the use of presumptive eligibility at different stages of the con- tinuum of crisis response services, the use of telehealth to deliver crisis response services, strategies to make crisis response services available 24/7 in medically underserved H. R. 2617—1490 regions, and best practices used by States and health providers for maximizing capacity to deliver 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 individ- uals regardless of payor.

(9) Describes best practices for establishing effective connections with follow-on mental health and substance use disorder services, as well as with social services and supports.
(10) Describes best practices for coordinating and financing a continuum of crisis response services through Medicaid man- aged care organizations, prepaid inpatient health plans, prepaid ambulatory health plans, and fee-for-service delivery systems, including when States carve-out from delivery through Med- icaid managed care organizations, prepaid inpatient health plans, prepaid ambulatory health plans, or fee-for-service sys- tems, mental health or substance use disorder benefits or a subset of such services.
(11) Identifies strategies and best practices for measuring and monitoring utilization of, and outcomes related to, crisis response services.
(b) TECHNICAL ASSISTANCE CENTER.— (1) IN GENERAL.—Not later than July 1, 2025, the Secretary, in coordination with the Administrator of the Centers for Medi- care & Medicaid Services and the Assistant Secretary for Mental Health and Substance Use, shall establish a technical assistance 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 assist- ance shall, at least in part, provide support to States in— (A) leveraging the Federal authorities through which Medicaid and CHIP may finance mental health and sub- stance 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 subsection (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 successful 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 information when appro- priate.
(c) FUNDING.—There is appropriated to the Secretary, out of any funds in the Treasury not otherwise appropriated, to remain available until expended for purposes 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.
H. R. 2617—1491 (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 Requirements SEC.

5131.

TRANSITIONING FROM MEDICAID FMAP INCREASE REQUIREMENTS.

(a) the Families First Coronavirus Response Act (42 U.S.C.
1396d note) is amended— IN GENERAL.—Section 6008 of (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 calendar quarter in which the last day of such emergency period occurs’’ and inserting ‘‘December 31, 2023’’; (C) by striking ‘‘6.2 percentage points’’ and inserting ‘‘the applicable number of percentage 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 pur- poses of paragraph (1), the applicable 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 ‘‘subsection (a)(1)’’; (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 enactment of this section’’ and inserting ‘‘as of March 18, 2020,’’; (ii) by striking ‘‘such date of enactment’’ and inserting ‘‘March 18, 2020,’’; (iii) by striking ‘‘the last day of the month in which the emergency period described in subsection (a) ends’’ and inserting ‘‘March 31, 2023,’’; and (iv) by striking ‘‘the end of the month in which such emergency period ends’’ and inserting ‘‘March 31, 2023,’’; H. R. 2617—1492 (3) by redesignating the subsection (d) added by section 11 of division X of the Consolidated Appropriations Act, 2021 (Public Law 116–260) as subsection (e); and (4) by adding at the end the following new subsections: ‘‘(f) ELIGIBILITY REDETERMINATIONS DURING TRANSITION PERIOD.— ‘‘(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 ‘transi- tion period’), if a State described in such subsection satisfies the conditions of subsection (b) and paragraph (2) of this sub- section, the State shall
 receive the increase 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 described in paragraph (3) of subsection (b), from initiating renewals, post-enrollment verifications, and redeterminations over a 12-month period for all individuals 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 paragraph with respect to a State and the transition period are the following: ‘‘(A) COMPLIANCE WITH FEDERAL REQUIREMENTS.—The State conducts eligibility redeterminations under title XIX of the Social Security Act in accordance with all Federal requirements redeterminations, to 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 alternative processes and proce- dures approved by the Secretary of Health and Human Services.
applicable such ‘‘(B) MAINTENANCE OF UP-TO-DATE CONTACT INFORMA- TION.—The State, using the National Change of Address Database Maintained by the United States Postal Service, State health and human services agencies, or other reliable sources of contact information, attempts to ensure that it has up-to-date contact information (including a mailing address, phone number, and email address) for each indi- vidual for whom the State conducts an eligibility redeter- mination.
‘‘(C) REQUIREMENT TO ATTEMPT TO CONTACT BENE- FICIARIES PRIOR TO DISENROLLMENT.—The State does not disenroll from the State plan or waiver any individual who is determined ineligible for medical assistance under the State plan or waiver pursuant to such a redetermina- tion on the basis of returned mail unless the State first undertakes a 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 applicable) shall not qualify for the increase described in subsection (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 CORRECTIVE ACTION.— Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended by adding at the end the following new subsection: H. R. 2617—1493 ‘‘(tt) REQUIREMENTS RELATING TO TRANSITION FROM FAMILIES FIRST CORONAVIRUS RESPONSE ACT FMAP INCREASE REQUIRE- MENTS; ENFORCEMENT AND 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 publicly available, on the activities of the State relating to eligibility redeterminations conducted during such period, and which include, with respect to the month for which the report is submitted, the following information: ‘‘(A) The number of eligibility renewals initiated, bene- ficiaries renewed on a total and ex parte basis, and individ- uals whose coverage for medical assistance, child health assistance, or pregnancy-related assistance was terminated.
‘‘(B) The number of individuals whose coverage for medical assistance, child health assistance, or pregnancy- related assistance was so terminated for procedural rea- sons.

‘‘(C) Where applicable, the number of individuals 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 Centers for Medi- care & 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 eligibility for assistance under this title or title XXI are not 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 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 secure electronic transfer by the Federal or State American Health Benefit Exchange, or a basic health program established 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 applicable) the basic health pro- gram established under section 1331 of such Act; and ‘‘(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 Affordable Care Act in which the systems used to determine eligibility for assistance H. R. 2617—1494 under this title or title XXI are integrated with the systems used to determine eligibility for coverage under a qualified health plan with advance payment under section 1412(a) of the Patient 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 who were deter- mined eligible for a qualified health plan, as defined in section 1301(a)(1) of the Patient Protec- tion and Affordable Care Act, or (if applicable) the basic health program 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 pro- gram plan (if applicable).
‘‘(E) The total call center volume, average wait times, and average abandonment rate (as determined by the Sec- retary) for each call center of the State agency responsible for administering the State plan under this title (or a waiver of such plan) during such month.

‘‘(F) Such other information related to eligibility redeterminations and renewals during the period described in paragraph (1), as identified by the Secretary.
‘‘(2) ENFORCEMENT AND CORRECTIVE ACTION.— ‘‘(A) IN GENERAL.—For each fiscal quarter that occurs during the period that begins on July 1, 2023, and ends on June 30, 2024, if a State does not satisfy the require- ments of paragraph (1), the Federal medical assistance percentage determined for the State for the quarter under section 1905(b) shall be reduced by the number of percent- age 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) AUTHORITY.— CORRECTIVE ACTION PLAN; ADDITIONAL ‘‘(i) IN GENERAL.—The Secretary may assess a State’s compliance with all Federal requirements applicable to eligibility redeterminations and the reporting requirements described in paragraph (1), and, if the Secretary determines that a State did not comply with any such requirements 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 action plan in accordance with clause (ii).
‘‘(ii) CORRECTIVE ACTION PLAN.—A State that receives a written notice from the Secretary that the Secretary has determined that the State is not in compliance with a requirement described in clause (i) shall— ‘‘(I) not later than 14 days after receiving such notice, submit a corrective action plan to the Sec- retary; H. R. 2617—1495 ‘‘(II) not later than 21 days after the date on which such corrective action plan is submitted to the Secretary, 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 implement an approved corrective action plan in accordance with clause (ii), the Secretary may, in addi- tion to any reduction applied under subparagraph (A) to the Federal medical assistance percentage deter- mined for the State and any other remedy available to the Secretary for the purpose of carrying out this title, require the State to suspend making all or some terminations of eligibility for medical assistance from the State plan under this title (including any waiver of such plan) that are for procedural reasons until the State takes appropriate corrective action, as deter- mined by the Secretary, and may impose a civil money penalty of not more than $100,000 for each day a State is not in compliance.’’.
(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 fiscal 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 Reauthorization Act of 2022’’.

(b) OUTCOMES DASHBOARD.—Section 511(d)(1) of the Social Security Act (42 U.S.C.
711(d)(1)) is amended— (1) in the paragraph heading, by striking ‘‘BENCHMARK AREAS’’ and inserting ‘‘BENCHMARK AREAS RELATED TO INDI- VIDUAL FAMILY OUTCOMES’’; (2) in subparagraph (D)(i), by striking ‘‘(B)’’ and inserting ‘‘(C)’’; and (3) by redesignating subparagraphs (B) through (D) as sub- paragraphs (C) through (E), respectively, and inserting after subparagraph (A) the following: ‘‘(B) OUTCOMES DASHBOARDS.—The Secretary shall, directly or by grant or contract, establish and operate a website accessible to the public that includes an annually updated dashboard that— H. R. 2617—1496 ‘‘(i) provides easy-to-understand information 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 before the date of the enactment of this section unless administering agencies and the Secretary agree pursuant to subsection (h)(6) that addi- tional 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 entity showing outcome indicators and how the outcomes compare to benchmarks described in subclause (II); ‘‘(II) information on the outcome indicators and levels established for each requisite outcome eligible entity; ‘‘(III) information on each model employed in the program operated by each eligible
 entity, and regarding each benchmark area described in sub- section (d)(1)(A) in which the model used by the eligible entity is expected to affect participant out- comes; ‘‘(IV) the most recently available information from the report required by subparagraph (E) of this paragraph; ‘‘(V) an electronic link to the State needs assessment under subsection (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
 requisite outcome level or any other requirement 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 paragraph, and if so, a link to the plan, an explanation of the reason for the implementa- tion 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 sovereignty, data privacy, and participant con- fidentiality; and ‘‘(iv) protects data privacy and confidentiality of participant families.’’.
(c) FUNDING.— (1) GRANT AMOUNTS.— (A) IN GENERAL.—Section 511(c)(4) of the Social Secu- rity 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 respect to each of fiscal years 2023 through 2027 for which an eligible entity not referred to in subsection (k)(2)(A) H. R. 2617—1497 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, except as provided in subclause (II) of this clause.
‘‘(II) SUBSTITUTION OF SUCCESSOR ELIGIBLE ENTITY FOR PREDECESSOR.—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 eligible under this subparagraph for fiscal 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 entity is— ‘‘(aa) the amount made available under subsection (k) for base grants for fiscal year 2023 that remains after making the reserva- tions required by subsection (k)(2) or any other reductions required by Federal law for fiscal year 2023; multiplied by ‘‘(bb) the percentage of children in all States who have not attained 5 years of age (as determined by the Secretary on the basis of the data most recently available before fiscal year 2023) that is represented by the number of such children in the State in which the eligible entity is operating a program pursuant to this section (as so determined).
‘‘(II) ADJUSTMENTS STABLE FUNDING.—If the amount otherwise payable to an eligible entity under subclause (I) for fiscal year 2023 is less than 90 percent, or greater than 110 percent, of the amount payable under this section to the eligible entity for the program for fiscal year 2021, the Secretary shall increase the amount otherwise so payable to 90 percent, or decrease the amount otherwise so payable to 110 percent, as the case may be, of the amount otherwise so payable.
ENSURE TO ‘‘(III) ADJUSTMENT TO ENSURE ALL BASE GRANT FUNDS ARE ALLOCATED.—If the amount described by subclause (I)(aa) is different than the total of the amounts otherwise described by subclause (I) after applying subclause (II), the Secretary shall increase or decrease the amounts otherwise so described after applying subclause (II) by such equal percentage as is necessary to reduce that difference to zero.
‘‘(IV) MINIMUM BASE GRANT AMOUNT.—Not- withstanding the preceding provisions of this H. R. 2617—1498 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 respect to each of fiscal years 2024 through 2027 for which an eligible entity not referred to in subsection (k)(2)(A) is awarded a grant under this section, the Sec- retary shall increase 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 sub- clause (II) of this clause with respect to the eligible entity for the fiscal year and the additional matching amount (if any) determined under clause (iii) of this subparagraph with respect to the eligible entity for the fiscal year.
‘‘(II) MATCHING AMOUNT.— ‘‘(aa) IN GENERAL.—Subject to item (bb) of this subclause, 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 entity for home visiting serv- ices in the State for the fiscal year, from Federal funds made available for the fiscal year under this subparagraph; 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 sub- clause (IV) for the State in which the eligible entity is operating a program under this sec- tion for the fiscal year.
‘‘(III) DETERMINATION OF OBLIGATIONS FROM NON-FEDERAL FUNDS.—For purposes of this clause, the total amount obligated by an eligible entity from non-Federal funds is the total of the amounts that are obligated by the eligible entity from non- Federal sources, to the extent that— ‘‘(aa) the services are delivered in compli- ance with subsections (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 requirement in subsection (f).
‘‘(IV) STATE amount allotted under this subclause for a State in which an eligible entity is operating a program under this section for a fiscal year is— ALLOTMENTS.—The ‘‘(aa) the minimum matching grant alloca- tion amount for the fiscal year; plus H. R. 2617—1499 ‘‘(bb)(AA) the amount (if any) by which the amount made available under subsection (k) for matching grants for the fiscal year that reservations remains after making required by subsection (k)(2) or any other reduction required by Federal law for the fiscal year exceeds the sum of the minimum matching grant allocation amounts for all eligible entities for the fiscal year; multiplied by the ‘‘(BB) the percentage of children in all States who have not attained 5 years of age and are members of families with income not exceeding the poverty line (as determined by the Secretary 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 subclause (IV), the minimum matching grant allocation amount for a fiscal year is— ‘‘(aa) in the case of fiscal year 2024, $776,000; ‘‘(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 required 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 minimum matching grant allocation amount to each eligible entity operating a program under this section for the fiscal year, the Secretary may make a propor- tionate adjustment to the minimum matching grant allocation amount for the fiscal year to accommodate the reductions.
‘‘(ii) SUBMISSION OF STATEMENT EXPRESSING INTEREST IN ADDITIONAL MATCHING FUNDS IF AVAIL- ABLE.—Before the beginning of a fiscal year for which an eligible entity desires a matching grant under this subparagraph for a program operated under this sec- tion, the eligible entity shall submit to the Secretary a statement as to whether the eligible entity desires additional matching grant funds that may be made available under clause (iii) for the fiscal year.
‘‘(iii) CARRYOVER AND REALLOCATION OF UNOBLI- GATED FUNDS.— ‘‘(I) IN GENERAL.—If the Secretary determines that an amount allotted under clause (i)(IV) of this subparagraph 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 H. R. 2617—1500 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 subparagraph 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.
‘‘(II) STATE ALLOTMENTS.—The Secretary shall allot to each eligible entity that has made such a submission for a fiscal year— ‘‘(aa) the total amount (if any) made avail- able under subclause (I) for the fiscal year; multiplied by ‘‘(bb) the percentage of children who have not attained 5 years of age and are members of families with income not exceeding the pov- erty line (as determined by the Secretary on the basis of the most recently available data) in all of the States in which any eligible entity that has made such a submission is so oper- ating a program, that is represented by the number of such children in the State (as so determined) in which the eligible entity is operating such a program.
‘‘(III) ADDITIONAL MATCHING AMOUNT.— ‘‘(aa) IN GENERAL.—Subject to item (bb) of this subclause, the additional 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 entity for home visiting serv- ices in the State for the fiscal year, from Federal funds made available for the fiscal year under this subparagraph; 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 eligible entity under clause (i).
‘‘(bb) additional LIMITATION.—The matching amount with 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 pro- gram 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 H. R. 2617—1501 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 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.—Sec- tion 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 inserting the following: ‘‘(B) 2 percent of such amount for purposes of providing technical assistance, directly or through grants or con- tracts— ‘‘(i) for purposes as otherwise described in sub- sections (c)(5), (d)(1)(C)(iii), (d)(1)(E)(iii), and (d)(4)(E); and ‘‘(ii) to entities referred to in subparagraph (A) of this paragraph; ‘‘(C) 2 percent of such amount for purposes of the provision of workforce support, retention, and case manage- ment, including workforce-related technical assistance, to eligible entities, research and evaluation, and program administration, directly or through grants or contracts, 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 purposes of research and evaluation (directly or through grants or contracts), and for administering this section (directly, through con- tracts, or otherwise).’’.
(3) APPROPRIATIONS.— (A) IN GENERAL.—Section 511(j)(1) of the Social Secu- rity Act (42 U.S.C.
711(j)(1)) is amended by striking sub- paragraphs (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; H. R. 2617—1502 ‘‘(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 expenditures made pursuant to section 201 of division D of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (Public Law 117–180) and section 201 of division C of the Further Continuing Appropriations and Extensions Act, 2023 shall be charged to the appropriation made by section 511(j)(1)(A) of the Social Security Act for fiscal year 2023 (as added by subparagraph (A) of this para- graph).
(C) REPEAL.—Section 201 of title II of division 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 ADMINISTRATION.—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 RESERVED FOR RESEARCH, EVALUATION, AND ADMINISTRATION.—To the extent that the amounts reserved 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 section or to offset any reduction with respect to this section that is required by Federal law.’’.
(d) REQUIREMENT THAT HOME VISITING PROGRAMS BE TAR- GETED 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 SUPPORT TARGETED, INTENSIVE HOME VISITING SERVICES.—The program uses the grant to provide or support targeted, intensive home vis- iting services for the populations described in paragraph (5).’’.
(e) LIMITATION ON USE OF FUNDS FOR ADMINISTRATION.— (1) IN GENERAL.—Section 511(d) of the Social Security Act (42 U.S.C.

711(d)) is amended by adding at the end the fol- lowing: ‘‘(5) LIMITATION ON USE OF FUNDS FOR ADMINISTRATIVE COSTS.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B) of this paragraph, an eligible entity to which funds are provided under subsection (c) or (h)(2)(B) shall not use more than 10 percent of the funds to cover the costs of administration.
‘‘(B) AUTHORITY TO GRANT EXCEPTIONS.— ‘‘(i) IN GENERAL.—The Secretary may authorize an eligible entity that meets a condition of clause (ii) of this subparagraph to exceed the percentage limita- tion in subparagraph (A) with respect to a program conducted under this subsection by not more than 5 H. R. 2617—1503 percentage points, subject to such terms and conditions as the Secretary deems appropriate.
‘‘(ii) CONDITIONS.—An eligible entity meets a condi- tion of this clause if the eligible entity— ‘‘(I) conducts the program by directly 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, pro- poses to expand services in 1 or more communities identified in the statewide needs assessment under subsection (b) and in which home visiting services are not provided; or ‘‘(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 redesignating subparagraphs (D) through (G) as sub- paragraphs (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 redesignating 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 submit 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 summary of the outcomes measured by the entity with respect to each bench- mark described in subsection (e)(5) that apply to the entity; ‘‘(2) information regarding any technical assistance funded under subparagraph (B) or (C) of subsection (k)(2), including the type of any such assistance provided; ‘‘(3) information on the demographic makeup of families served by each such entity to the extent possible while respecting participant confidentiality, including race, ethnicity, educational attainment at enrollment, 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 population 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 expended 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 sub- section (k)(2)(C); ‘‘(9) information relating to those eligible entities for which funding is reserved under subsection (k)(2)(A), with modifica- tions as necessary to reflect tribal data sovereignty, data pri- vacy, and participant confidentiality; and ‘‘(10) a list of data elements collected from eligible entities, and the purpose of each data element in measuring performance or enforcing requirements under this section.’’.
(2) CONFORMING AMENDMENTS.— H. R. 2617—1504 (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 inserting ‘‘(k)’’; and inserting (II) by striking ‘‘(k)(1)(B)’’ and ‘‘(l)(1)(B)’’.

(B) Section 511A(c) of such Act (42 U.S.C.

711a(c)) is amended in each of paragraphs (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: ‘‘(6) REDUCTION OF ADMINISTRATIVE BURDEN.— ‘‘(A) IN GENERAL.—The Secretary shall reduce the bur- den, on States and public and private implementing agen- cies at the local level, of administering this section, by— ‘‘(i) reviewing and revising administrative data collection instruments and forms to eliminate duplica- tion and streamline reporting requirements for States, eligible entities referred to in subsection (k)(2)(A), and nonprofit organizations referred to in subsection (l)(1)(B), including timelines for submitting reports; ‘‘(ii) conducting an analysis of the total number of hours reported by administering agencies on com- plying with paperwork requirements, and exploring, in consultation with administering agencies, ways to reduce the number of hours spent by at least 15 per- cent; ‘‘(iii) conducting a review of paperwork and data tribal grantees, and collection requirements exploring, in consultation with tribes and tribal organizations, ways to reduce administrative burden, respect sovereignty, and acknowledge the different focus points for tribal grantees; for ‘‘(iv) collecting input from relevant State fiscal offi- cials to align fiscal requirements and oversight for States and eligible entities to ensure consistency with standards and guidelines for other Federal formula grant programs; and ‘‘(v) consulting with administering agencies and service delivery model representatives on needed and unneeded data elements regarding the dashboards pro- vided for in subsection (d)(1)(B), consistent with the data requirements of such subsection.
‘‘(B) FINDINGS ON PAPERWORK REDUCTION.— ‘‘(i) INCLUSION IN REPORT.—In the 1st report sub- mitted pursuant to subsection (j) more than 18 months after the date of the enactment of this Act, the Sec- retary shall include the findings of the Secretary with respect to the matters described in subparagraph (A).

‘‘(ii) IMPLEMENTATION.—Within 2 years after com- plying with clause (i), the Secretary shall implement the findings referred to in clause (i).’’.
(h) VIRTUAL HOME VISITING AUTHORIZATION AND RESTRIC- TIONS.— H. R. 2617—1505 (1) VIRTUAL HOME VISITS.— (A) APPLICATION REQUIREMENTS.—Section 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 eligible entity to encourage in-person home visits; and ‘‘(ii) a description of the considerations to be used in determining when a virtual home visit is appro- priate, including client consent, client preference, geographic limitations, model fidelity, and hazardous conditions including public health emergencies, weather events, health concerns for home visitors and client families, and other local issues; ‘‘(B) an assurance that— ‘‘(i) the virtual home visit is implemented 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 the criteria established under subsection using (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 during 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 program is conducted, is in effect shall be extended by the length of time in which the declaration is in effect.’’.
(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 inserting after paragraph (3) the following: ‘‘(4) VIRTUAL HOME VISITS.— ‘‘(A) IN GENERAL.—A virtual home visit conducted under the program shall be considered a home visit for purposes of this section if the application for funding of the program submitted pursuant to this section most recently after the effective date of this paragraph includes the material described in subsection (e)(10).
‘‘(B) STANDARDS FOR TRAINING APPLICABLE TO VIRTUAL SERVICE DELIVERY.—The standards for training require- ments 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 grant is made submits the report described in subsection (e)(8)(A) for the year.

H. R. 2617—1506 ‘‘(D) VIRTUAL HOME VISIT DEFINED.—In this section, the term ‘virtual home visit’ means a visit conducted solely by use of electronic information and telecommunications technologies.
‘‘(E) TECHNICAL ASSISTANCE.—If the Secretary finds that an eligible entity has not complied with the assurance described in subsection (e)(10)(C), the Secretary shall, directly or through grants, contracts, or cooperative agree- ments, provide the eligible entity with such technical assist- ance 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 respect to the program, the program provides in-person service consistent with the assur- ances.’’.

(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 sub- section 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 telecommuni- cations technologies.
(i) EFFECTIVE DATE.— (1) IN GENERAL.—Except as provided in paragraph (2), this section and the amendments made by this section shall take effect on October 1, 2022.

(2) VIRTUAL HOME VISITING PROVISIONS.—The amendments made by subsection (h) shall take effect on October 1, 2023.

SEC.

6102.

EXTENSION OF TEMPORARY ASSISTANCE FOR NEEDY FAMI- LIES 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.

1-YEAR EXTENSION OF CHILD AND FAMILY SERVICES PRO- GRAMS.
(a) The following provisions of the Social Security Act are each amended by striking ‘‘2022’’ and inserting ‘‘2023’’: (1) Section 436(a) (42 U.S.C.

629f(a)).

H. R. 2617—1507 (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 ‘‘2023’’: (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)).

TITLE VII—SUPPLEMENTAL FUNDING FOR THE WORLD TRADE CENTER HEALTH PROGRAM SEC.

7701.

SUPPLEMENTAL FUNDING FOR THE WORLD TRADE CENTER HEALTH PROGRAM.

(a) IN GENERAL.—Title XXXIII of the Public Health Service Act (42 U.S.C.

300mm et seq.)

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

3352.

SUPPLEMENTAL FUND.


‘‘(a) IN GENERAL.—There is established a fund to be known as the World Trade Center Health Program Supplemental Fund (referred to in this section as the ‘Supplemental Fund’), consisting of amounts deposited into the Fund under subsection (b).
‘‘(b) AMOUNT.—Out of any money in the Treasury not otherwise fiscal year 2023 appropriated, $1,000,000,000, for deposit into the Supplemental Fund, which amounts shall remain available through fiscal year 2032. is appropriated there for ‘‘(c) USES OF FUNDS.—Amounts deposited into the Supplemental Fund under subsection (b) shall be available, without further appro- priation and without regard to any spending limitation under sec- tion 3351(c), to the WTC Program Administrator as needed at the discretion of such Administrator, for carrying out any provision in this title, including sections 3303 and 3341(c).
‘‘(d) RETURN OF FUNDS.—Any amounts that remain in the Supplemental Fund on September 30, 2032, shall be deposited into the Treasury as miscellaneous receipts.’’.

(b) CONFORMING AMENDMENTS.—Title XXXIII of the Public Health Service Act (42 U.S.C.

300mm et seq.)

is amended— (1) in section 3311(a)(4)(B)(i)(II) (42 U.S.C.

300mm– 21(a)(4)(B)(i)(II)), by striking ‘‘section 3351’’ and inserting ‘‘sec- tions 3351 and 3352’’; (2) in section 3321(a)(3)(B)(i)(II) (42 U.S.C.
300mm– 31(a)(3)(B)(i)(II)), by striking ‘‘section 3351’’ and inserting ‘‘sec- tions 3351 and 3352’’; (3) in section 3331 (42 U.S.C.
300mm–41)— (A) in subsection (a), by inserting ‘‘and the World Trade Center Health Program Supplemental Fund’’ before the period at the end; and (B) in subsection (d)— (i) in paragraph (1)(B), by inserting ‘‘(excluding any expenditures from amounts in the World Trade Center Health Program Supplemental Fund under sec- tion 3352)’’ before the period at the end; and H. R. 2617—1508 (ii) in paragraph (2), in the flush text following subparagraph ‘‘(excluding any expenditures from amounts in the World Trade Center Health Program Supplemental Fund under section 3352)’’ before the period at the end; and (4) in section 3351(b) (42 U.S.C.
300mm–61(b))— inserting (C), by (A) in paragraph (2), by inserting ‘‘or as available from the World Trade Center Health Program Supplemental Fund under section 3352’’ before the period at the end; and (B) in paragraph (3), by inserting ‘‘or as available from the World Trade Center Health Program Supplemental Fund under section 3352’’ before the period at the end.

(c) PREVENTION AND PUBLIC HEALTH FUND.—Section 4002(b) of the Patient Protection and Affordable Care Act (42 U.S.C.
300u- 11(b)) is amended— (1) in paragraph (8), by striking ‘‘$1,800,000,000; and’’ and inserting ‘‘$1,525,000,000;’’; (2) by striking paragraph (9) and inserting the following: ‘‘(9) for each of fiscal years 2028 and 2029, $1,725,000,000; and’’; and (3) by adding at the end the following: ‘‘(10) for fiscal year 2030 and each fiscal year thereafter, $2,000,000,000.’’.

SEC.

7702.

RESEARCH COHORT FOR EMERGING HEALTH IMPACTS ON YOUTH.

(a) IN GENERAL.—Section 3341 of the Public Health Service Act (42 U.S.C.
300mm–51) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1), by striking ‘‘With respect’’ through ‘‘subtitle B, the’’ and inserting ‘‘The’’; and (B) by striking ‘‘of such individuals’’ each place it appears; (2) in subsection (b)(1), by inserting ‘‘and individuals who were exposed within a geographic area related to the September 11, 2001, terrorist attacks in a manner similar to the exposure within such geographic area experienced by individuals meeting the eligibility criteria under section 3311(a)(2) or 3321(a)(1)(B)’’ after ‘‘treatment’’; (3) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and (4) by inserting after subsection (b) the following: ‘‘(c) RESEARCH COHORT FOR EMERGING HEALTH IMPACTS ON YOUTH.— ‘‘(1) IN GENERAL.—The WTC Program Administrator, in consultation with the Secretary of Education, shall establish a research cohort of sufficient size to conduct future research studies on the health and educational impacts of exposure to airborne toxins, or any other hazard or adverse condition, resulting from the September 11, 2001, terrorist attacks, including on the population of individuals who were 21 years of age or younger at the time of exposure, including such individuals who are screening-eligible WTC survivors or cer- tified-eligible WTC survivors.
H. R. 2617—1509 ‘‘(2) POPULATIONS STUDIED.—The research cohort under paragraph (1) may include— ‘‘(A) individuals who, on September 11, 2001, were 21 years of age or younger and were— ‘‘(i) outside the New York City disaster area; and ‘‘(ii) in— ‘‘(I) the area of Manhattan not further north than 14th Street; or ‘‘(II) Brooklyn; and ‘‘(B) control populations, including populations of individuals who, on September 11, 2001, were 21 years of age or younger.’’.
(b) FUNDING.—Section 3351(b) of such Act (42 U.S.C.

300mm– 61(b)) is amended by inserting after paragraph (3) the following: ‘‘(4) LIMITATION FOR RESEARCH COHORT FOR EMERGING HEALTH IMPACTS ON YOUTH.—Notwithstanding paragraph (1), the amounts made available under such paragraph may not be used for fiscal years 2023 through 2032 to carry out sub- section (c) of section 3341.’’.

(c) CONFORMING AMENDMENT.—Section 3301(f)(2)(E) of such Act (42 U.S.C.
300mm(f)(2)(E)) is amended by striking ‘‘section 3341(a)’’ and inserting ‘‘subsection (a) or (c) of section 3341’’.

DIVISION GG—MERGER FILING FEE MODERNIZATION SEC.

101.

SHORT TITLE.

This division may be cited as the ‘‘Merger Filing Fee Moderniza- tion Act of 2022’’.

TITLE I—MODERNIZING MERGER FIL- ING FEE COLLECTIONS; ACCOUNT- ABILITY REQUIREMENTS; LIMITATION ON FUNDING SEC.

101.

MODIFICATION OF PREMERGER NOTIFICATION FILING FEES.

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 inserting ‘‘$30,000’’; inserting (ii) by striking ‘‘$100,000,000’’ and ‘‘$161,500,000’’; (iii) by striking ‘‘2004’’ and inserting ‘‘2023’’; and (iv) by striking ‘‘2003’’ and inserting ‘‘2022’’; (B) in paragraph (2)— (i) by striking ‘‘$125,000’’ and inserting ‘‘$100,000’’; inserting (ii) by striking ‘‘$100,000,000’’ and ‘‘$161,500,000’’; (iii) by striking ‘‘but less’’ and inserting ‘‘but is less’’; and (iv) by striking ‘‘and’’ at the end; (C) in paragraph (3)— H. R. 2617—1510 (i) by striking ‘‘$280,000’’ and inserting ‘‘$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 published);’’; and (D) by adding at the end the following: ‘‘(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 September 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.
‘‘(2) As soon as practicable, but not later than January 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 increase 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.’’.

SEC.

102.

REPORTING REQUIREMENTS FOR MERGER FEE COLLEC- TIONS.
(a) FTC AND DOJ JOINT REPORT.—For each of fiscal years 2023 through 2027, the Federal Trade Commission 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 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 this section, as adjusted by the Merger Filing Fee Modernization Act of 2022, as compared to the funds made available to the Federal Trade Commission and the Department of Justice, respectively, from premerger notification filing fees as the fees were deter- mined in fiscal year 2022.
(2) The total revenue derived from premerger notification filing fees, by tier, by the Federal Trade Commission and the Department of Justice, respectively.

(3) The gross cost of operations of the Federal Trade Commission, by Budget Activity, and the Antitrust Division of the Department of Justice, respectively.
H. R. 2617—1511 (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 Commis- sion took or declined 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 actions that were decided on a 3 to 2 vote.
(c) SUMMARY.—The Federal Trade Commission and the Depart- ment of Justice shall make the report required under subsection (a) available to the Committees on the Judiciary of the House of Representatives and of the Senate, and shall, for fiscal years 2023 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 subsections (a) and (b) of this section, to the Committees on the Judiciary of the House of Representatives and of the Senate.
TITLE II—DISCLOSURE OF SUBSIDIES BY FOREIGN ADVERSARIES 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 procure- ment 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 market, or other- wise change the incentives of the firm in ways that undermine competition following an acquisition.
(2) Foreign subsidies are particularly problematic when granted by countries or entities that constitute a strategic or economic threat to United States interests.

(3) The Made in China 2025 plan, states that the Chinese Communist Party will ‘‘support enterprises to carry out mergers and acquisitions (M&A), equity investment, and venture capital overseas’’.
(4) The 2020 report to Congress from the bipartisan 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 champions in surpassing and supplanting global market leaders’’.
The report warns that the risk is particularly acute when it comes to emerging technologies, where China seeks to ‘‘surpass and displace the United States altogether [and that] [f]ailure to appreciate 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 Phillips stated, ‘‘[O]ne area where antitrust needs to reckon with the strategic interests H. R. 2617—1512 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 industrial policies or to protect national security’’.
(b) PURPOSE.—The purpose of this section 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 receive from countries or entities that are strategic or economic 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 section 40207 of the Infrastructure Investment and Jobs Act (42 U.S.C.

18741(a)).

(b) ACCOUNTING FOR FOREIGN GOVERNMENT SUBSIDIES.—A per- son required to file a notification under section 7A of the Clayton Act (15 U.S.C.

18a) that received a subsidy from a foreign entity of concern shall include in such notification content regarding such subsidy.
(c) AUTHORITY OF ANTITRUST REGULATORS.—The Federal Trade Commission, with the concurrence of the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice, and in consultation with the Chairperson of the Committee on Foreign Investment in the United States, the Secretary of Com- merce, the Chair of the United States International Trade Commis- sion, the United States Trade Representative, and the heads of other appropriate agencies, and by rule in accordance 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, violate the antitrust laws.
(d) EFFECTIVE DATE.—Subsection (b) shall take effect on the date on which the rule described in subsection (c) takes effect.

TITLE III—VENUE FOR STATE ANTITRUST ENFORCEMENT SEC.

301.

VENUE FOR STATE ANTITRUST ENFORCEMENT.

Section 1407 of title 28, United States Code, is amended— (1) in subsection (g) by inserting ‘‘or a State’’ after ‘‘United States’’ and striking ‘‘; but shall not include section 4A of the Act of October 15, 1914, as added July 7, 1955 (69 Stat.

282; 15 U.S.C.
282; 15 U.S.C.

15a)’’; and (2) by striking subsection (h).

DIVISION HH—AGRICULTURE SEC.

101.

DEFINITION.

In this division, the term ‘‘Secretary’’ means the Secretary of Agriculture.

H. R. 2617—1513 TITLE I—CONSERVATION SEC.

201.

GREENHOUSE GAS TECHNICAL ASSISTANCE PROVIDER AND THIRD-PARTY VERIFIER PROGRAM.
(a) DEFINITIONS.—In this section: (1) ADVISORY COUNCIL.—The term ‘‘Advisory Council’’ means the Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program Advisory Council established under subsection (f)(1).
(2) AGRICULTURE OR FORESTRY CREDIT.—The term ‘‘agri- culture 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 agricultural or forestry activity.
SOCIALLY (3) BEGINNING, LIMITED RESOURCE, OR VETERAN FARMER, RANCHER, OR PRIVATE FOREST LANDOWNER.—The term ‘‘beginning, socially disadvantaged, limited resource, or veteran farmer, rancher, or private forest landowner’’ means a farmer, rancher, or private forest land- owner who is— DISADVANTAGED, (A) a beginning farmer or rancher (as defined in section 2501(a) of the Food, Agriculture, 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 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 entity’’ 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 management 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 described in protocols for vol- untary environmental credit markets.
(5) GREENHOUSE GAS.—The term ‘‘greenhouse gas’’ means— (A) carbon dioxide; (B) methane; (C) nitrous oxide; and (D) any other gas that the Secretary, in consultation with the Advisory Council, determines 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 H. R. 2617—1514 follows a transparent and thorough science-based methodology (including 1 or more baseline scenarios)— (A) for the development of projects to prevent, reduce, or mitigate greenhouse gas emissions (including projects to sequester carbon); and (B) for demonstrating how to quantify, monitor, report, and verify the prevention, reduction, or mitigation of green- house gas emissions by projects described in subparagraph (A).
(8) SOCIALLY DISADVANTAGED GROUP.—The term ‘‘socially disadvantaged group’’ has the meaning given that term in section 355(e) of the Consolidated Farm and Rural Development Act (7 U.S.C.

2003(e)).
2003(e)).

(9) TECHNICAL ASSISTANCE.—The term ‘‘technical assist- ance’’ means technical expertise, information, and tools to assist a farmer, rancher, or private forest landowner, who is engaged in or wants to engage in a project to prevent, reduce, or mitigate greenhouse gas emissions (including a project to sequester carbon), as necessary to meet a protocol.
(10) VOLUNTARY ENVIRONMENTAL CREDIT MARKET.—The term ‘‘voluntary environmental credit market’’ means a vol- untary 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 pro- gram to register covered entities that carry out activities described in subsection (c)(2) will further each of the fol- lowing purposes: (i) Facilitating the participation of farmers, ranchers, and private forest landowners in voluntary environmental credit markets.
(ii) Facilitating the provision of technical assist- ance, through covered entities, to farmers, ranchers, and private forest landowners to help overcome bar- riers to entry into voluntary environmental credit mar- kets.

(iii) Ensuring that participating farmers, ranchers, and private forest landowners 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 environmental credit markets, including information relating to the basic market structure and the various roles and qualifications of different parties.

(B) CONSIDERATIONS.—In making the determination under this paragraph, the Secretary shall consider the results of the assessment conducted under subsection (g)(2)(A) and any other relevant information.
(2) ESTABLISHMENT.—If the Secretary determines under paragraph (1) that establishing such a program will further H. R. 2617—1515 such purposes, the Secretary shall establish a voluntary pro- gram, to be known as the ‘‘Greenhouse Gas Technical Assist- ance Provider and Third-Party Verifier Program’’, to register covered 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 reasons for such determination, including how establishing a program under this subsection would or would not further each of the purposes described in paragraph (1)(A).
(c) PROTOCOLS, QUALIFICATIONS, AND ACTIVITIES.— (1) WIDELY ACCEPTED PROTOCOLS AND QUALIFICATIONS.— After providing public notice and at least a 60-day period for public comment, but not later than 90 days after the date on which the Program is established, the Secretary shall pub- lish— (A) a list of, and documents relating to, widely accepted protocols that are designed to ensure consistency, reli- ability, effectiveness, efficiency, and transparency of vol- untary environmental credit markets, including protocol documents and details relating to— (i) calculations; (ii) sampling methodologies; (iii) voluntary environmental credit accounting principles; (iv) systems for verification, monitoring, measure- ment, and reporting; and (v) methods to account for additionality, perma- nence, leakage, and, where appropriate, avoidance of double counting; and (B) descriptions of widely accepted qualifications pos- sessed by covered entities that provide technical assistance to farmers, ranchers, and private forest landowners.
(2) ACTIVITIES.—A covered entity may register under the Program with respect to technical assistance or process verification the covered entity carries 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, including 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 reductions; (G) reforestation; (H) forest management, including improving har- vesting practices and thinning diseased trees; (I) prevention of the conversion of forests, grasslands, and wetlands; (J) restoration of wetlands or grasslands; H. R. 2617—1516 (K) grassland management, including prescribed grazing; (L) current practices associated with private land con- servation 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 appropriate.
(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 relating 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 pub- lished under paragraph (1) to include any additional protocols or qualifications described in paragraph (3).
(d) REGISTRATION, WEBSITE, AND PUBLICATION OF LISTS.— (1) REGISTRATION LIST.— (A) IN GENERAL.—Not later than 1 year after estab- lishing 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 information to the Secretary, which list the Secretary shall regularly update.
(B) REGISTRATION.—A covered entity may register under the Program to be included on the registration list by submitting to the Secretary, through a website main- tained by the Secretary, information that— (i) shall include— (I) the region in which the covered entity pro- vides 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 (ii) may include additional information that— (I) has been identified by the Advisory Council in its initial assessment under subsection (g)(1) to ensure certainty for producers in the market- place for agriculture or forestry credits; 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 main- tained by the Secretary— (A) information describing how covered entities may register under the Program in accordance with paragraph (1); H. R. 2617—1517 (B) a list of the widely accepted protocols and qualifica- tions published by the Secretary under subsection (c)(1); and (C) instructions and suggestions to assist farmers, ranchers, and private forest landowners in facilitating the development of agriculture or forestry credits and accessing voluntary environmental credit markets, including— (i) through working with covered entities reg- istered under the Program; and (ii) by providing information relating to programs, registries, and protocols of programs and registries that provide market-based participation opportunities for working and conservation agricultural and forestry lands.
(3) PROGRAMMATIC INTEGRITY.—The Secretary shall ensure, to the maximum extent practicable, that covered entities reg- istered under the Program— (A) act in good faith to provide realistic estimates of costs and revenues relating to activities 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 management practices for agricul- tural and forestry activities that prevent, reduce, or miti- gate greenhouse gas emissions (including through the sequestration of carbon).
(4) REMOVAL FROM REGISTRATION LIST.— (A) IN GENERAL.— (i) REMOVAL.—The Secretary shall remove a cov- ered entity from the registration list under the Pro- gram if the Secretary 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 miti- gate 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 representa- tive sample of covered entities, which shall occur not less frequently than once each year; or (II) as necessary.

(B) APPEAL OF REMOVAL.— (i) IN GENERAL.—A covered entity that has been removed from the registration list pursuant to subpara- graph (A) may appeal the determination to the Sec- retary.
(ii) RE-REGISTRATION.—A covered entity that appeals a determination under clause (i) may re-reg- ister under the Program if the covered entity success- fully proves, as determined by the Secretary, that the covered entity has acted in accordance with, as applicable— (I) the information provided by the entity under paragraph (1)(B); and H. R. 2617—1518 (II) best management practices for agricultural and forestry activities that prevent, reduce, or miti- gate greenhouse gas emissions (including through the sequestration of carbon).
(C) NOTIFICATION.—If the Secretary removes 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, ranchers, and private forest landowners to which the covered entity provided tech- nical assistance or the verification of the processes described in protocols of voluntary environmental credit markets; and (ii) notify those farmers, ranchers, and private forest landowners of the removal.
(5) SAVINGS CLAUSE.—Nothing in this section authorizes the Secretary to compel a farmer, rancher, 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, regardless of whether the person or entity is registered under the Program, shall not make a fraudulent submission under subsection (d) or make a fraudulent claim regarding the presence of that person or entity on the registration list published under such subsection.
(2) PENALTY.—Any person or entity that violates paragraph (1) shall be— (A) subject to a civil penalty equal to such amount as the Secretary determines to be appropriate, not to exceed $1,000 per violation; and (B) ineligible to register under the Program for the 5-year period beginning on the date of the violation.
(f) GREENHOUSE GAS TECHNICAL ASSISTANCE PROVIDER AND THIRD-PARTY VERIFIER PROGRAM ADVISORY COUNCIL.— (1) IN GENERAL.—During the 90-day period beginning on the date on which the Program is established, the Secretary shall establish an advisory council, to be known as the ‘‘Green- house Gas Technical Assistance Provider and Third-Party Verifier Program Advisory Council’’.
(2) MEMBERSHIP.— (A) IN GENERAL.—The Advisory Council shall be com- posed of members appointed by the Secretary in accordance with this paragraph.

(B) GENERAL REPRESENTATION.—The Advisory Council shall— (i) be broadly representative of the agriculture and private forest sectors; (ii) include beginning, socially disadvantaged, lim- ited resource, and veteran farmers, ranchers, and pri- vate forest landowners; and (iii) be composed of not less than 51 percent farmers, ranchers, or private forest landowners.
(C) MEMBERS.—Members appointed under subpara- graph (A) shall include— (i) not more than 2 representatives of the Depart- ment of Agriculture, as determined by the Secretary; H. R. 2617—1519 (ii) not more than 1 representative of the Environ- mental 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 agri- culture 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 a manner that is broadly rep- resentative of the private forest sector; (vi) not more than 4 representatives of the relevant scientific research community, including not fewer than 2 representatives from land-grant colleges and univer- sities (as defined in section 1404 of the National Agri- cultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C.
3103)), of which 1 shall be a rep- resentative of a college or university eligible to receive 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 professionals familiar with voluntary environmental credit markets and the verification requirements in those markets; (viii) not more than 3 members of nongovern- mental or civil society organizations with relevant expertise, of which not fewer than 1 shall represent the interests of socially disadvantaged groups; (ix) not more than 3 members of private sector entities or organizations that participate in voluntary environmental credit markets; and (x) any other individual whom the Secretary deter- mines to be necessary to ensure that the Advisory Council is composed of a diverse group of representa- tives of industry, academia, independent researchers, 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 appointed— (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.
(ii) ADDITIONAL TERMS.—After the initial term of a member of the Advisory Council, including the mem- bers first appointed, the member may serve not more than 4 additional 2-year terms.

(3) MEETINGS.— H. R. 2617—1520 (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 begin- ning on the date on which the members are appointed under paragraph (2)(A), the Advisory Council shall hold an initial 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 qualifica- tions published by the Secretary under subsection (c)(1); and (ii) the activities described in subsection (c)(1)(B); (B) make recommendations to the Secretary regarding the best practices that should be included in the protocols, description of qualifications, and activities described in subparagraph (A); and (C) advise the Secretary regarding— (i) the current methods used by voluntary environ- mental credit markets to quantify and verify the prevention, reduction, or mitigation of greenhouse gas emissions (including the sequestration of carbon); (ii) means to reduce barriers to entry in the busi- the ness of providing verification of the processes described in protocols of voluntary environmental credit markets for covered entities, including by improving technical assistance provided by the Secretary; technical assistance or (iii) means to reduce compliance and verification costs for farmers, ranchers, and private forest land- owners in entering voluntary environmental credit markets, including through mechanisms and processes to aggregate the value of activities across land owner- ship; (iv) issues relating to land and asset ownership in light of evolving voluntary environmental credit markets; and (v) additional means to reduce barriers 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 land- owners.
(5) COMPENSATION.—The members of the Advisory 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 activities 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 Secretary; or (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 H. R. 2617—1521 (B) providing advice or recommendations regarding, or otherwise participating in, matters 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 integrity of the Advisory Council, the Program, or the technical assist- ance or verification activities described under sub- section (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 Agri- culture, Nutrition, and Forestry of the Senate an initial assess- ment that examines ways to ensure certainty for farmers, ranchers, or private forest landowners in the marketplace for agriculture or forestry credits, including identification of any information 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 incorporates information from existing publications and reports of the Department of Agriculture and other entities with relevant expertise, regarding— (i) the number and categories of non-Federal actors in the nonprofit and for-profit sectors involved in development, generation, or sale of agriculture or for- estry credits in voluntary environmental credit mar- kets; (ii) the estimated overall domestic market demand for agriculture or forestry credits at the end of the preceding 4-calendar year period, and historically, in voluntary environmental credit markets; (iii) the total number of agriculture or forestry credits (measured in metric tons of carbon dioxide equivalent) that were estimated to be in development, generated, or sold in market transactions during the preceding 4-calendar year period, and historically, 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 compliance and verification costs described in subsection (f)(4)(C)(iii); (vi) the state of monitoring and measurement tech- nologies needed to quantify long-term carbon seques- tration in soils and from other activities to prevent, reduce, or mitigate greenhouse gas emissions in the agriculture and forestry sectors; H. R. 2617—1522 (vii) means to reduce barriers to entry into vol- untary environmental credit markets 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 landowners; (viii) the extent to which the existing regimes for generating
 and selling agriculture or forestry credits (as the regimes exist at the end of the preceding 4- calendar year period, and historically), and existing voluntary environmental credit markets, may be impeded or constricted, or achieve greater scale and reach, if the Department of Agriculture were involved, including involvement in education described in clause (ix); (ix) the extent to which Department of Agriculture education of stakeholders about voluntary environ- mental credit markets would benefit those stake- holders, including whether that education would reduce barriers to entry identified under clause (v); credit markets, (x) the extent to which existing protocols of vol- including untary environmental verification, additionality, permanence, and reporting, adequately take into consideration and account for fac- tors encountered by the agriculture and private forest sectors in preventing, reducing, or mitigating green- house gas emissions (including by sequestering carbon) through agriculture and forestry practices, considering variances across regions, topography, soil types, crop or species varieties, and business models; (xi) the extent to which existing protocols of vol- untary environmental credit markets consider options to ensure the continued valuation, through discounting or other means, of agriculture and forestry credits in the case of the practices underlying those credits being disrupted due to unavoidable events, including produc- tion challenges and natural disasters; and (xii) opportunities for other voluntary markets out- side of voluntary environmental credit markets to foster the trading, buying, or selling of credits that are derived from activities that provide other ecosystem 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 Committee on Agri-
 culture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives.
(3) QUADRIENNIAL ASSESSMENT.—The Secretary, in con- sultation with the Administrator of the Environmental Protec- tion Agency and the Advisory Council, shall conduct the assess- ment described in paragraph (2)(A) and publish and submit such assessment in accordance with subparagraphs (B) and (C) of paragraph (2) every 4 years after the publication and H. R. 2617—1523 submission of the first assessment under subparagraphs (B) and (C) of paragraph (2).
(h) CONFIDENTIALITY.— (1) PROHIBITION.— (A) IN GENERAL.—Except as provided in paragraph (2), the Secretary, any other officer or employee of the Depart- ment of Agriculture or any agency of the Department of Agriculture, 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 information, including in a contract or service agreement, of a farmer, rancher, or private forest landowner, obtained by the Secretary under subsection (d)(4)(C)(i); and (II) confidential business information in a con- tract or service agreement of a farmer, rancher, or private forest landowner obtained by the Sec- retary under subsection (d)(4)(C)(i).
(ii) AGGREGATED RELEASE.—Information described in clause (i) may be released to the public if the information has been transformed into a statistical or aggregate form that does not allow the identification of the person who supplied or is the subject of the particular information.
(2) EXCEPTION.—Paragraph (1) shall not prohibit the disclo- sure by an officer or employee of the Federal Government of information described in paragraph (1)(B) as otherwise directed by the Secretary or the Attorney General for enforce- ment purposes.

(i) FUNDING.— (1) AUTHORIZATION OF APPROPRIATIONS.—In addition to the amount made available under paragraph (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).
(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 appropriated 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 section shall be construed to provide authority to the Secretary for the establish- ment or operation of a Federal market through which agriculture or forestry credits may be bought or sold.

H. R. 2617—1524 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 follows: ‘‘(1) ESTABLISHMENT OF PUBLIC-PRIVATE PARTNERSHIP CON- TRIBUTIONS ACCOUNTS.—The Secretary shall establish the nec- essary accounts and process to accept contributions of private funds for the purposes of addressing the changing climate, sequestering carbon, improving wildlife habitat, protecting sources of drinking water, and addressing other natural resource priorities identified by the Secretary.’’; (3) in paragraph (2), by striking ‘‘a conservation program administered by the Secretary under subtitle D shall be depos- ited 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 appropriate, taking into consideration— ‘‘(i) the source of the funds to be contributed; ‘‘(ii) the natural resource concerns to be addressed through the use of the funds; ‘‘(iii) the amount of funds to be contributed; ‘‘(iv) whether the activities proposed to be carried out using the funds are consistent 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 subparagraph (B), the Secretary may provide matching Federal funds, and deter- mine 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 FUNDING FOR STATES.— The Secretary may not provide any matching Federal funds pursuant to subparagraph (A) in a manner that would result in a substantial reduction in the historical distribu- tion of Federal funding to any State for any covered pro- gram.

‘‘(C) LIMITATION.—No funds made available pursuant to Public Law 117–169 may be used to provide matching Federal funds pursuant to subparagraph (A).
‘‘(5) ROLE OF CONTRIBUTING ENTITY.—An entity 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 contrib- uted funds are intended to be used; H. R. 2617—1525 ‘‘(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, subject 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 ‘‘(E) work with the Secretary to promote the activities funded pursuant to this subsection.
‘‘(6) PRODUCER PARTICIPATION.— ‘‘(A) NOTIFICATION.—The Secretary shall establish a process to provide notice to producers— ‘‘(i) of activities that may be carried out, through a covered program, pursuant to this section; and ‘‘(ii) any terms prescribed by the contributing entity under paragraph (5)(D) with respect to such activities.
‘‘(B) RETENTION OF ENVIRONMENTAL SERVICES BENE- FITS.—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 REQUIREMENTS.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), the Secretary shall ensure that the terms and condi- tions of activities carried out using funds contributed under this subsection are consistent with the requirements of the applicable covered program.
‘‘(B) ADJUSTMENTS.— ‘‘(i) IN GENERAL.—The Secretary may, if the Sec- retary determines necessary, adjust a regulatory requirement of a covered program, or related guidance, as it applies to an activity carried out using funds contributed under this subsection— ‘‘(I) to provide a simplified process; or ‘‘(II) local cir- to better reflect unique cumstances and to address a specific priority of the contributing entity.
‘‘(ii) LIMITATION.—The Secretary shall not adjust the application of statutory requirements for a covered program, including requirements governing appeals, payment limits, and conservation compliance.
‘‘(8) REPORT.—Not later than December 31, 2024, and each year thereafter through December 31, 2031, the Secretary shall submit to the Committee on Agriculture of the House of Rep- resentatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that contains— ‘‘(A) the name and a description of each entity contrib- uting 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 contrib- uting private funds under this subsection for which the Secretary has provided matching Federal funds, and the H. R. 2617—1526 level of that match, including the amount of such matching Federal funds; and ‘‘(C) the total amounts of— ‘‘(i) private funds contributed under this sub- section; and ‘‘(ii) matching Federal funds provided by the Sec- retary under paragraph (4).
‘‘(9) COVERED PROGRAM DEFINED.—In this subsection, the term ‘covered program’ means a program carried out by the Secretary under— ‘‘(A) subtitle D (except for subchapter B of such sub- title), subtitle H, or subtitle I; ‘‘(B) section 403 of the Agricultural Credit Act of 1978 (16 U.S.C.

2203); ‘‘(C) title V of the Healthy Forests Restoration 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.
1001 et seq.

), except for any program estab- lished by the Secretary to carry out section 14 of such Act (16 U.S.C.

1012).

‘‘(10) DURATION OF AUTHORITY.—The authority of the Sec- retary under this subsection shall expire, with respect to each covered program, on the date on which the authority of the covered program expires.’’.

TITLE II—COMMODITY FUTURES TRAD- ING COMMISSION WHISTLEBLOWER PROGRAM SEC.

301.

IN GENERAL.

Section 1(b) of Public Law 117–25 (135 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 following: ‘‘(2) ADDITIONAL TRANSFERS.—In addition to amounts trans- ferred under paragraph (1), the Commission 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 inserting ‘‘para- graphs (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: H. R. 2617—1527 ‘‘(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 ‘‘(B) the Secretary determines that the modification or termination— ‘‘(i) will address a compelling public need for which there is no practicable alternative; 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 sub- section, the Secretary shall enter into a compensatory arrangement, as the Secretary determines to be appro- priate.
‘‘(B) MODIFICATION.—In the case of a modification of an easement or other interest in land under this sub- section— ‘‘(i) as a condition of the modification, the owner of the land shall enter into a compensatory arrange- ment, as the Secretary determines to be appropriate, to incur the costs of modification; and ‘‘(ii) the Secretary shall ensure that— ‘‘(I) the modification will not adversely affect the forest ecosystem functions and values for which the easement or other interest in land was acquired; ‘‘(II) any adverse impacts will be mitigated by enrollment and restoration of other land that provides greater forest ecosystem functions and values at no additional cost to the Federal Govern- ment; 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 ongoing basis, as informed by the process outlined in paragraph (4), that describes security measures that— (A) are effective, as determined by the Secretary, in including detecting and preventing theft of benefits, through card skimming, card cloning, and other similar fraudulent methods; (B) are consistent with for detecting, identifying, and preventing debit and credit card skimming, card cloning, and other similar fraudulent methods; and industry standards (C) consider the feasibility of cost, availability, and implementation for States; H. R. 2617—1528 (2) promulgate regulations through notice-and-comment rulemaking to require State agencies to take the security meas- ures described in the guidance issued under paragraph (1); (3) not later than December 1, 2023, promulgate regulations (including an interim final rule) to require State agencies to implement procedures for the replacement of benefits consistent with subsection (b); (4) coordinate with the Administrator of the Administration for Children and Families of the Department of Health and Human Services, the Attorney General of the United States, State agencies, retail food stores, and EBT contractors— (A) to determine— (i) how benefits are being stolen through card skimming, card cloning, and other similar fraudulent methods; (ii) how those stolen benefits are used; and (iii) to the maximum extent practicable, the loca- tions where card skimming, card cloning, and other similar fraudulent methods are taking place; (B) including equipment enhancements for retail food stores, to prevent benefits from being stolen through card skimming, card cloning, and other similar fraudulent methods; and to establish measures, (C) to establish standard reporting methods 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 Forestry of the Senate and the Committee on Agriculture of the House of Representatives a report that includes— (A) to the maximum extent practicable, information on the frequency of theft of benefits and the location of those thefts, including benefits stolen through card skim- ming, card cloning, and other similar fraudulent methods; (B) a description of the determinations made under paragraph (4)(A), the measures established under para- graph (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 consistently detect, track, report, and prevent theft of benefits, including bene- fits 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 conditions that— (1) the State agency shall submit to the Secretary 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— (A) includes appropriate procedures, as determined by the Secretary, for the timely submission of claims to, timely H. R. 2617—1529 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 options 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 submitted claim is valid; (iii) procedures for the documentation of replace- ment 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 estab- lished by section 11(e) of the Food and Nutrition Act of 2008 (7 U.S.C.
2020(e)) and corresponding regula- tions concerning replacement issuances; and (vi) the State agency’s use and planned use of benefit theft prevention measures, including any addi- tional guidance that may be issued under subsection (a)(1); (B) includes appropriate procedures, as determined 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 subsection (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 house- hold; or (ii) the amount equal to 2 months of the monthly allotment of the household immediately 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 during the period beginning on October 1, 2022, and ending on September 30, 2024; (3) plans approved under paragraph (1) will remain in effect until the effective date of the rule promulgated 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 ‘‘allotment’’, ‘‘ben- efit’’, ‘‘household’’, ‘‘retail food store’’, and ‘‘State agency’’ have the meaning given those terms in section 3 of the Food and Nutrition Act of 2008 (7 U.S.C.

2012).
2012).

H. R. 2617—1530 (d) RESCISSION.—Of the unobligated balances made available for the Supplemental Nutrition Assistance Program as authorized by section 1101(b)(1) of the American 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 organizations’’ after ‘‘State agencies’’ each place it appears; and (2) in paragraph (2)(B), in the matter preceding clause ‘‘and Indian Tribal organization’’ before (i), by inserting ‘‘budget’’.

(b) NONCONGREGATE MEALS.—Section 13 of the Richard B. Rus- sell 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 program meals under this section for noncon- gregate consumption in a rural area with no congregate meal service, as determined by the Secretary.
‘‘(B) SUMMER 2023.—Notwithstanding any other provi- sion in this paragraph, for summer 2023, the Secretary may allow States to use implementation models developed by the Secretary for demonstration projects carried out 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), to carry out subparagraph (A).
‘‘(C) ELIGIBILITY DETERMINATION.—In administering this paragraph, the Secretary shall ensure that noncon- gregate meals are only available for a child— ‘‘(i) in an area in which poor economic 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 section 4 of the Child Nutrition Act of 1966 (42 U.S.C.

1773).
1773).

‘‘(D) PRIORITIES.— ‘‘(i) IN GENERAL.—States shall— ‘‘(I) identify areas with no congregate meal service that could benefit the most from the provi- sion of noncongregate meals; and ‘‘(II) encourage participating service institu- tions in those areas to provide noncongregate meals as appropriate.
‘‘(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 reduced price breakfast under section 4 of the Child Nutrition Act of 1966 (42 U.S.C.

1773).
H. R. 2617—1531 ‘‘(E) ADMINISTRATION.—In administering this para- graph, the Secretary shall ensure that— ‘‘(i) any meal served for noncongregate consump- tion— ‘‘(I) meets all applicable State and local health, safety, and sanitation 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 subsection (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 paragraph, the Secretary shall promulgate regulations (which shall include interim final regulations) to carry out this section, including provisions— ‘‘(i) to ensure the integrity of the alternative option for program delivery described in subparagraph (A); and ‘‘(ii) to incorporate best practices and lessons learned from noncongregate demonstration projects under section 749(g) of the Agriculture, Rural Develop- ment, 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 program 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 described in subsection (a)(13), if applicable, including 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 Secretary by January 1 of each year of its intent to admin- ister the applicable program and shall submit for approval by February 15 a management and administration plan for H. R. 2617—1532 the applicable program for the fiscal year, which shall include, as
 applicable— ‘‘(A) the requirements listed in subparagraphs (A) through (G) of paragraph (1); ‘‘(B) the administrative budget of the State for admin- istering the summer EBT program under section 13A; ‘‘(C) the State’s plan to comply with the State require- ments 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 con- gregate 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 summer EBT bene- fits (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 summer.’’.
(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 Indian Tribal organiza- tions electing to participate in such program shall, beginning with summer 2024 and annually for each summer thereafter, issue to each eligible household 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 assistance through electronic benefit transfer or methods described in clauses (ii) and (iii) of subsection (b)(2)(B) during the summer months for each eligible 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 bene- fits issued pursuant to subsection (a) by a State may only be used by the eligible household that receives such summer EBT benefits to purchase food (as defined in sec- tion 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 established 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 Puerto Rico, and the Commonwealth of the Northern Mariana Islands.
‘‘(B) BENEFITS ISSUED BY COVERED INDIAN 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 supplemental foods from vendors that have been approved for participation in the special supplemental nutrition program for women, H. R. 2617—1533 infants, and children under section 17 of the Child Nutri- tion 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 proportionately higher consistent with the adjustments established under section 12(f) for each eligible child in the eligible household per month during the summer operational period; and ‘‘(ii) for calendar year 2025 and each year there- after, in an amount equal to the 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 dollar increment; and ‘‘(B) may be issued— ‘‘(i) in the form of an EBT card; ‘‘(ii) through other electronic methods, as deter- mined by the Secretary; or ‘‘(iii) in the case of a State that does not issue nutrition assistance program benefits 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 pursu- ant 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 Act of 1966 (42 U.S.C.

1786), as applicable; and ‘‘(B) to the maximum extent practicable, incorporate technology tools consistent with industry standards that track or prevent theft of benefits, cloning, or other fraudu- lent 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 during the summer months, with appropriate issuance and expungement timelines as determined 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 continuous school calendar, the Secretary shall establish alternative plans for the period during which summer EBT benefits may be issued pursu- ant to subsection (a) and used.
‘‘(c) ENROLLMENT IN PROGRAM.— ‘‘(1) STATE REQUIREMENTS.—States that elect to participate in the program under this section shall— ‘‘(A) with respect to summer, automatically enroll each eligible child who is directly certified, is an identified stu- dent (as defined in section 11(a)(1)(F)(i)), or is otherwise determined by a school food authority to be eligible to H. R. 2617—1534 receive free or reduced price meals in the instructional year immediately preceding the summer or during the summer operational period in the program under this sec- tion, 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 determinations 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.
‘‘(2) COVERED INDIAN TRIBAL ORGANIZATION REQUIRE- MENTS.—Covered Indian Tribal organizations 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 administrative expenses incurred by the State agency or covered Indian Tribal organization in oper- ating 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 summer 2024, the Secretary shall not allow States to use the authority in 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), to provide access to food through electronic benefit transfer benefits to children during the summer 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 shall include interim final regu- lations) 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 Develop- ment, Food and Drug Administration, 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 H. R. 2617—1535 ‘‘(4) allow States and covered Indian Tribal organizations to streamline program administration, including by— ‘‘(A) automatically enrolling each eligible child who is able to be directly certified; and ‘‘(B) establishing a single summer operational period.
‘‘(g) ADMINISTRATIVE AND MANAGEMENT PLAN.—Beginning in 2024, each State desiring to participate in the program under this section shall comply with the requirements under section 13(n).
‘‘(h) DEFINITIONS.—In this section: ‘‘(1) COVERED INDIAN TRIBAL ORGANIZATION.—The term ‘cov- ered Indian Tribal organization’ means an Indian Tribal organization that participates in the special supplemental nutri- tion program 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 imme- diately preceding such summer or during the summer oper- ational period— ‘‘(i) certified to receive free or reduced price lunch under the school lunch program under this Act; ‘‘(ii) certified to receive free or reduced price break- fast 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 imme- diately 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 defined 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 application process using the eligibility criteria 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 ‘eligible household’ means a household that includes at least 1 eligible child.
‘‘(4) SUPPLEMENTAL FOODS.—The term ‘supplemental 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 nutrition science, public health concerns, and cultural eating patterns, as determined by the Secretary; and ‘‘(B) includes foods not described in subparagraph (A) substituted by State agencies, with the approval of the Secretary, that— ‘‘(i) provide the nutritional equivalent of foods described in such subparagraph; and H. R. 2617—1536 ‘‘(ii) allow for different cultural eating patterns than foods described in such subparagraph.’’.
(d) AMENDMENTS TO P-EBT FOR SUMMER 2023.—Section 1101(i) of the Families First Coronavirus Response Act (7 U.S.C.
2011 note; Public Law 116–127) is amended— (1) by striking ‘‘The Secretary’’ and inserting the following: ‘‘(1) IN GENERAL.—The Secretary’’; (2) in paragraph (1) (as so designated), by inserting ‘‘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 summer 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 assistance under this subsection.’’.

(e) NO DUPLICATION OF SUMMER BENEFITS.—A State may not provide to a household summer EBT benefits (as described in section 13A(a) of the Richard B. Russell 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.

SEC.

503.

OFFSETS.

(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 pursuant to paragraph (1) in summer 2023 shall not exceed $120 per child for the covered summer period, except that benefits may be proportionately higher consistent with any adjustments established under sec- tion 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 ASSISTANCE.— (1) PANDEMIC ASSISTANCE PAYMENTS TO COTTON MERCHAN- DISERS.—The Secretary shall make pandemic assistance pay- ments, under terms and conditions as determined by the Sec- retary, 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.
H. R. 2617—1537 (2) PAYMENT DETERMINATIONS.—The Secretary shall take into consideration economic impacts of COVID–19 and other supply chain disruptions in determining payment rates under this subsection, 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 the Secretary shall make available subsection $100,000,000 to carry out this subsection.

(b), (B) ADMINISTRATIVE EXPENSES.—The Secretary may use not more than 1 percent of the funds under subpara- graph (A) for administrative costs necessary to carry out this subsection.
(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 Appro- priations 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 subsection (a) shall be equal to the product obtained by multiplying— (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), adjusted by the Secretary such that the amount made available under sub- section (e) is fully expended; (2)(A) in the case of a producer with an average actual production history per planted acre of rice determined in accord- ance with subparagraphs (A), (B), and (E) of section 508(g)(2) of the Federal 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 average actual production history described in subparagraph (A)— (i) if an area yield for the 2022 crop year determined in accordance with subparagraphs (C) and (E) of that sec- tion is available, that area yield; or (ii) if an area yield described in clause (i) is not avail- able, 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 Sec- retary; and (B) the number of certified acres of rice prevented from being planted on the farm for the 2022 crop year, H. R. 2617—1538 as reported to the Secretary, multiplied by the prevented planting coverage factor applicable to those acres.
(c) LIMITATIONS.— (1) IN GENERAL.—In carrying out this section, the Secretary shall impose payment limitations consistent 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 division 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 Sec- retary, out of any amounts in the Treasury not otherwise appro- priated, $250,000,000 to carry out this section.

SEC.

603.

ENACTMENT OF CHRONIC WASTING DISEASE RESEARCH AND MANAGEMENT ACT.

The provisions of H.R.


5608 of the 117th Congress, as engrossed in the House of Representatives on December 8, 2021, are hereby enacted into law.

TITLE VI—PESTICIDES Subtitle A—Pesticide Registration Improvement Act of 2022 SEC.

701.

SHORT TITLE.

This title may be cited as the ‘‘Pesticide Registration Improve- ment Act of 2022’’.

SEC.

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 registered pesticide product released for ship- ment shall include— ‘‘(I) the translation of the parts of the labeling contained in the Spanish Translation Guide described in subparagraph (G) on the product con- tainer; or ‘‘(II) a link to such translation via scannable technology or other electronic methods readily accessible on the product label.
‘‘(ii) EXCEPTIONS.—Notwithstanding clause (i)— H. R. 2617—1539 ‘‘(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 technology or other elec- tronic 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.
‘‘(B) DEADLINES FOR BILINGUAL LABELING.— ‘‘(i) PESTICIDE PRODUCTS CLASSIFIED AS RESTRICTED USE.—In the case of pesticide products classified by the Administrator 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 enact- ment of this paragraph.
‘‘(ii) PESTICIDE PRODUCTS NOT CLASSIFIED AS RESTRICTED USE.—In the case of pesticide products not classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph shall be as follows: ‘‘(I) AGRICULTURAL.— ‘‘(aa) ACUTE TOXICITY CATEGORY I.—For agricultural pesticides classified as Acute Tox- icity Category I, the date that is 3 years after the date of enactment of this paragraph.
‘‘(bb) ACUTE TOXICITY CATEGORY II.—For agricultural pesticides classified as Acute Tox- icity Category II, the date that is 5 years after the date of enactment of this paragraph.

NON-AGRICUL- ‘‘(II) ANTIMICROBIAL AND TURAL.— ‘‘(aa) ACUTE TOXICITY CATEGORY I.—For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category I, the date that is 4 years after the date of enactment of this paragraph.
‘‘(bb) ACUTE TOXICITY CATEGORY II.—For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category II, the date that is 6 years after the date of enactment of this paragraph.

‘‘(III) OTHER PRODUCTS.—With PESTICIDE respect to pesticide products not described in sub- clause (I) or (II), the date that is 8 years after the date of enactment of this paragraph.
‘‘(C) IMPLEMENTATION.— ‘‘(i) NON-NOTIFICATION.— ‘‘(I) IN GENERAL.—In carrying out this para- graph, the Administrator shall allow translations of the parts of the label of a pesticide contained in the Spanish Translation Guide described in subparagraph (G) and scannable technology or H. R. 2617—1540 other electronic methods to be added using non- notification procedures.
‘‘(II) NON-NOTIFICATION PROCEDURE DEFINED.—In this clause, the term ‘non-notification procedure’ refers to a procedure under which a change may be made to a pesticide label without notifying the Administrator.

‘‘(ii) COOPERATION AND CONSULTATION.—In car- rying out this paragraph, the Administrator shall cooperate and consult with State lead agencies for pesticide regulation for the purpose of implementing bilingual labeling as provided in this paragraph as expeditiously as possible.
‘‘(iii) END USE LABELING.—The labeling require- ments of this paragraph shall apply to end use product labels.
‘‘(iv) INCORPORATION TIMEFRAME.—After initial translation deadlines provided in subparagraph (B), updates to the Spanish Translation Guide described in subparagraph (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 shipment date speci- fied on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); and ‘‘(II) in the case of antimicrobial and non-agri- cultural use pesticide labels, as determined by the Administrator— ‘‘(aa) 2 years after the date of publication of the updated Spanish Label Translation Guide described in subparagraph (G); or ‘‘(bb) the released for shipment date speci- fied on the EPA Stamped Approved Label after the pesticide label is next changed or amended following the date of publication of the updated 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- lation Guide described in subparagraph (G), the Administrator shall notify registrants of the update to such guide.
‘‘(D) ACCESSIBILITY OF BILINGUAL LABELING FOR FARM WORKERS.—Not later than 180 days after the date of enact- ment 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 workers.
H. R. 2617—1541 ‘‘(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 DESCRIBED.—The Spanish Translation Guide described in this subparagraph is the Spanish Translation Guide for Pesticide Labeling issued in October 2019, as in effect on the date of enactment of the Pesticide Registration Improvement Act of 2022, and any successor guides or amendments to such guide.’’.

SEC.

703.

EXTENSION AND MODIFICATION OF MAINTENANCE FEE AUTHORITY.
(a) EXTENSION AND MODIFICATION OF MAINTENANCE FEE AUTHORITY.—Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a–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)— (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 EDUCATION TRAINING AND GRANTS.— ‘‘(i) SET-ASIDE.—In addition to amounts otherwise available, for fiscal years 2023 through 2027, the Administrator shall use not more than $7,500,000 of the amounts collected under this paragraph to provide grants to organizations described in clause (ii) for pur- poses of facilitating— ‘‘(I) training of farm workers; ‘‘(II) education of farm workers with respect to— ‘‘(aa) rights of farm workers relating to pesticide safety; and H. R. 2617—1542 ‘‘(bb) the worker protection standard under part 170 of title 40, Code of Federal Regulations (or successor regulations); ‘‘(III) the development of new
 informational materials; ‘‘(IV) the development of training modules; and ‘‘(V) the development of innovative methods of delivery of such informational materials and training modules.
‘‘(ii) ELIGIBILITY.—To be eligible to receive a grant under this subparagraph, an organization shall have demonstrated experience in— ‘‘(I) providing training and education services for farm workers or handlers of pesticides; or ‘‘(II) developing informational materials for farm workers or handlers of pesticides.
‘‘(iii) COMMUNITY-BASED ORGANIZATIONS.— ‘‘(I) COMMUNITY-BASED NON-PROFIT FARM WORKER ORGANIZATION GRANTS.—The Adminis- trator shall use funds available under clause (i) to provide grants to community-based non-profit farm worker organizations.

‘‘(II) APPLICATION OF FUNDS.—The Adminis- trator shall apply the unspent balance of funds available (up to $1,800,000) under clause (i) in fiscal years 2025 through 2027 to carry out sub- clause (I).
‘‘(iv) INTERIM FUNDING.—In addition to amounts otherwise available, the Administrator may use not more than $1,200,000 in fiscal years 2023 and 2024 to fund existing cooperative agreements that were authorized under section 33(c)(3)(B), as such section was in effect as of March 8, 2019.
‘‘(v) PARTNERSHIPS.—Organizations described in clause (ii) may apply for a grant under this subpara- graph as a partnership with another organization, pro- vided such organizations, at the time of application, have entered into an agreement 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 expenditure of Fed- eral funds; ‘‘(II) performance of the assistance agreement; liability for claims for recovery of ‘‘(III) unallowable costs incurred under the agreement; and ‘‘(IV) specifying roles in performing the pro- posed scope of work for the assistance agreement.
‘‘(H) HEALTH CARE PROVIDER TRAINING.— ‘‘(i) SET-ASIDE.—In addition to other amounts available, for the period of fiscal years 2023 through 2027, the Administrator shall use not more than $2,500,000 of the amounts collected under this para- graph to provide grants to nonprofit organizations described in clause (ii) for purposes of facilitating— H. R. 2617—1543 ‘‘(I) technical assistance and training of health care providers relating to the recognition, treat- ment, and management of pesticide-related injuries and illnesses; ‘‘(II) the development of informational mate- training technical assistance and for rials described in subclause (I); and ‘‘(III) the development of outreach and delivery methods relating to the recognition, treatment, and management of pesticide-related illnesses.
‘‘(ii) ELIGIBILITY.—To be eligible to receive a grant under this subparagraph, a nonprofit organization shall have demonstrated experience in providing tech- nical assistance and training to health care providers who serve farm worker populations.
‘‘(iii) PARTNERSHIPS.—Organizations described in clause (ii) may apply for a grant under this subpara- graph as a partnership with another organization, pro- vided such organizations, at the time of application, have entered into an agreement 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 expenditure of Fed- eral funds; ‘‘(II) performance of the assistance agreement; liability for claims for recovery of ‘‘(III) unallowable costs incurred under the agreement; and ‘‘(IV) roles in performing the proposed scope of work for the assistance agreement.
‘‘(I) PARTNERSHIP GRANTS.—In addition to funds other- wise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this paragraph for partnership grants.
‘‘(J) PESTICIDE SAFETY EDUCATION PROGRAM.—In addi- tion to amounts otherwise available, for each of fiscal years 2023 through 2027, the Administrator shall use not more than $500,000 of the amounts collected under this para- graph to carry out the pesticide safety education program.
‘‘(K) TECHNICAL ASSISTANCE TO GRANTEES.— ‘‘(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 condi- tions as the Administrator establishes to prevent con- flicts of interest, to provide easily accessible technical assistance to grantees receiving, and potential grantees applying for, grants under subparagraphs (G) and (H).
‘‘(ii) CONSIDERATIONS.—In evaluating requests for grants under this subparagraph, the Administrator shall consider, at a minimum, the extent to which— ‘‘(I) the organization applying for the grant has experience providing technical assistance to H. R. 2617—1544 farm worker or clinician-training organizations; and ‘‘(II) the proposed project would make specific technical assistance available to organizations seeking information and assistance concerning— ‘‘(aa) the grant application process; ‘‘(bb) the drafting of grant applications; and ‘‘(cc) compliance with grant management and reporting requirements.
‘‘(iii) NO SUITABLE ORGANIZATION.—If no suitable organization requests a grant under this subparagraph, the Administrator shall provide technical assistance described in clause (i) using the amounts made avail- able by that clause.
‘‘(iv) INPUT.—In STAKEHOLDER formulating 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 tech- nical assistance and training of clinicians, regarding the request for proposals.’’; and (F) in subparagraph (N) (as so redesignated), by striking ‘‘2023’’ and inserting ‘‘2027’’; and (2) in paragraph (2)— (A) by striking ‘‘section 33(b)(3)’’ and inserting ‘‘section 33(b)(3)(B)’’; and (B) by striking ‘‘the Pesticide Registration Improve- ment Extension Act of 2018 and ending on September 30, 2025’’ and ‘‘the Pesticide Registration Improvement Act of 2022 and ending on September 30, 2029’’.
inserting (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 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.

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 appropriations,’’ after ‘‘limitation,’’; (2) by striking paragraphs (3) and (4) and inserting the following: ‘‘(3) REVIEW OF REGISTRANT SUBMISSIONS NOT COVERED BY SECTION 33(B)(3)(B).— ‘‘(A) DEFINITION OF SUBMISSION NOT COVERED BY SEC- TION 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 H. R. 2617—1545 a registration that is not covered by a fee table under section 33(b)(3)(B).
‘‘(B) SET-ASIDE.— ‘‘(i) IN GENERAL.—In addition to amounts otherwise available for each of fiscal years 2023 through 2027, the Administrator shall use approximately 1⁄8 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in clause (ii).
‘‘(ii) ACTIVITIES.—In addition to amounts otherwise available, the Administrator shall use amounts made available under clause (i) to obtain sufficient personnel and resources to process submissions not covered by section 33(b)(3)(B) to meet the applicable deadlines described in— ‘‘(I) the notice of the Administrator entitled ‘Pesticide Registration Notice (PR) 98–10: Notifica- tions, Non-Notifications and Minor Formulation Amendments’ and dated October 22, 1998 (and any successor amendments to such notice); and ‘‘(II) subsections (c)(3)(B) and (h) of section 3.
‘‘(4) DEVELOPMENT OF PUBLIC HEALTH PERFORMANCE STAND- ARDS FOR ANTIMICROBIAL PESTICIDE 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 DEVICES.—The Adminis- trator shall use amounts made available under subpara- graph (A) to develop 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 following: ‘‘(6) AGENCY TRAINING AND STAFF.— ‘‘(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 subparagraph (A) to carry out the following activities: ‘‘(i) TRAINING FOR AGENCY EMPLOYEES.—The Administrator shall administer training and education programs for employees of the Environmental Protec- tion Agency, relating to the regulatory responsibilities and policies established by this Act, including pro- grams— H. R. 2617—1546 ‘‘(I) for improving the scientific, technical, and administrative skills of officers and employees authorized to administer programs under this Act; ‘‘(II) to align competencies identified by the Administrator for mission accomplishment; ‘‘(III) for addressing best practices for oper- ational performance and improvement; ‘‘(IV) for improving administrative processes and procedures and addressing efficiency issues; ‘‘(V) to promote consistent regulatory decision- making; and ‘‘(VI) for educating registrants and regulated stakeholders on regulatory procedures.
‘‘(ii) AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION.—Not later than 1 year, to the maximum extent practicable, after the date of enactment of the Pesticide Registration Improvement Act of 2022, the Administrator shall establish a competitive grant pro- gram to develop training curricula and programs in accordance with clause (i) through financial assistance 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 Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C.
3103)).

‘‘(II) Land-grant colleges and universities (as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C.

3103)).

‘‘(III) 1994 Institutions (as defined 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 VOUCHERS.— ‘‘(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 establish and carry out the Vector Expedited Review Voucher program in accordance with subparagraph (B).
‘‘(B) VECTOR EXPEDITED REVIEW VOUCHER PROGRAM.— ‘‘(i) DEFINITIONS.—In this subparagraph: ‘‘(I) PROGRAM.—The term ‘program’ means the Vector Expedited Review Voucher program estab- lished under clause (ii).
‘‘(II) VOUCHER.—The term ‘voucher’ means a voucher— ‘‘(aa) issued under the program by the Administrator to a pesticide registration applicant that entitles the holder to an expe- dited review described under clause (vi) of a single different pesticide registration action; and ‘‘(bb) the entitlement to which may be transferred (including by sale) by the holder H. R. 2617—1547 of the voucher, without limitation on the number of times the voucher may be trans- ferred, before the voucher is redeemed.
‘‘(ii) ESTABLISHMENT.—Not later than one year after the date of enactment of the Pesticide Registra- tion Improvement Act of 2022, the Administrator, acting though the Office of Pesticide Programs, shall establish a program to be known as the Vector Expe- dited Review Voucher program.
‘‘(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 expediting reviews by decreasing decision review 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 registered a mosquito-control product that— ‘‘(aa) demonstrates a proven efficacy against pyrethroid or other insecticide-resist- ant mosquitoes; ‘‘(bb) prevents, mitigates, destroys, or repels pyrethroid or other insecticide-resistant mosquitoes, with a novel or unique mechanism or mode of action, different from other insecti- cides already registered by the Administrator for mosquito control; ‘‘(cc) targets mosquitoes capable of spreading such diseases as Malaria, Dengue, Zika, Chikungunya, St. Louis encephalitis, Eastern encephalitis, Western encephalitis, West Nile encephalitis, 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 ingredient and that includes— for the active ‘‘(AA) manufacturing locations, including any licensed third-party manu- facturers; ‘‘(BB) distribution and procurement processes for malaria vector control pro- grams in selected countries; and ‘‘(CC) the prices for common quan- tities of the product; ‘‘(ee) meets the appropriate guidelines as being effective in the primary vector control intervention areas, insecticide- treated nets and indoor residual spray; ‘‘(ff) is made accessible for use in— including ‘‘(AA) the United States,
 including territories or possessions of the United States; and H. R. 2617—1548 ‘‘(BB) countries where mosquito-borne diseases, such as malaria, are prevalent; ‘‘(gg) meets registration requirements for human health and environmental effects, labeling, and presents no unreasonable adverse effects to the environment; ‘‘(hh) broadens the adoption of integrated pest management strategies, such as insecti- cide resistance 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 attested to by the registrant, an active ingredient approved in the 2-year period preceding the date of reg- istration by any global stringent regulatory authority for the same uses, vectors, and applications.
‘‘(II) MOSQUITO VECTOR PRIORITY.—For each of fiscal years 2023 through 2027, the focus of the program shall be to incentivize the develop- ment of insecticides to control and prevent the spread of mosquitoes bearing diseases described in subclause (I)(cc).
‘‘(III) EXCEPTION.—If the Administrator deter- mines 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 mosquitoes and that otherwise meets the requirements of subclause (I) (excluding items (bb) and (jj)) as determined necessary by the Administrator, shall be considered a mosquito con- trol product meeting the criteria specified in such subclause.
‘‘(IV) ELIGIBILITY CRITERIA MODIFICATIONS.— ‘‘(aa) IN GENERAL.—Beginning in fiscal year 2028, the Administrator shall review the program and recommend— ‘‘(AA) modifications to the require- ments described in subclause (I); and ‘‘(BB) additional vectors to be included in the program, prioritizing vectors that pose the most significant population health risks.
‘‘(bb) PUBLIC INVOLVEMENT.—In carrying out item (aa), the Administrator shall solicit the involvement of registrants, nongovern- mental organizations, and governmental agen- cies engaged in vector-borne disease 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 H. R. 2617—1549 a voucher for expedited review not less than 90 days before the submission of the application; and ‘‘(II) pay the applicable registration service fee under section 33(b).
‘‘(vi) EXPEDITED REVIEW.—On redemption of a voucher, in furtherance of the purpose described in clause (iii), the Administrator shall expedite decision review times as follows: ‘‘(I) 6 months less than the decision review time for Category R010, New Active Ingredient, Food use.

‘‘(II) 6 months less than the decision review time for Category R020, New Active Ingredient, Food use; reduced risk.
‘‘(III) 6 months less than the decision review time for Category R060, New Active Ingredient, Non-food use; outdoor.

‘‘(IV) 6 months less than the decision review time for Category R110, New Active Ingredient, Non-food use; indoor.

‘‘(V) 4 months less than the decision review time for Category R070, New Active Ingredient, Non-food use; outdoor; reduced risk.

‘‘(VI) 2 months less than the decision review time for Category R120, New Active Ingredient, Non-food use; indoor; reduced risk.
‘‘(vii) REPORTS.—Not later than September 30, 2025, and not later than September 30 of each year thereafter, the Administrator shall issue a report on the program, including— ‘‘(I) the number of submissions seeking a voucher; ‘‘(II) the total time in review for each such submission; ‘‘(III) the number of such vouchers awarded; ‘‘(IV) the number of such vouchers redeemed; and ‘‘(V) with respect to each such redeemed voucher— ‘‘(aa) the decision review time for the pes- ticide application for which the voucher was redeemed; and ‘‘(bb) the average standard decision review time for the applicable 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 Reregistration 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 Reregistration and Expedited Processing Fund to support the interagency agreement with the National Institute for Occupational Safety and Health to support the Sentinel Event Notification System for Occupational Risk pesticides program— H. R. 2617—1550 ‘‘(A) with a goal of increasing the number of partici- pating States, prioritizing expansion in 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 AUTHORITY.— (1) IN GENERAL.—Section 33(b) of the Federal Insecticide, is Fungicide, and Rodenticide Act (7 U.S.C.
136w–8(b)) 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 specified in subparagraph (B) or as agreed upon under subsection (f)(5), for each covered application under a fee table specified in such subparagraph (B), the Administrator shall— ‘‘(i) complete data evaluation records for studies submitted by the applicant in support of the applica- tion; and ‘‘(ii) release those data evaluation records to the applicant, using appropriate protections for confiden- tial business information.
‘‘(B) SCHEDULE, ACTIONS, AND FEES.—Subject to para- graph (6),’’; (D) in paragraph (6)— (i) by amending subparagraph (A) to read as fol- lows: ‘‘Subject to the following sentence, effective for a covered application received during the period begin- ning 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 paragraph (3).
No adjustment may be made under the preceding sentence until the date on which the Administrator begins to implement clauses (i) and (ii) of subsection (k)(2)(A).’’; and (ii) by amending subparagraph (B) to read as fol- lows: ‘‘Subject to the following sentence, effective for a covered application received on or after October 1, 2026, the Administrator may increase by an additional 5 percent the registration service fee in effect as of September 30, 2026.
No adjustment may be made under the preceding sentence until the date on which the Administrator begins to implement any rec- ommendations for process improvements contained in the report under subsection (c)(4), as appropriate.’’; and H. R. 2617—1551 (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 ‘‘subsection (b)(3)’’ each place it appears and inserting ‘‘subsection (b)(3)(B)’’.

(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 pesticide products under the Endangered Species Act of 1973 (16 U.S.C.

1531 et seq.).
1531 et seq.).

‘‘(ii) DEADLINES FOR GUIDANCE.—The Adminis- trator shall issue final guidance 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 outdoor uses, not later than 9 months after the date of enactment of the Pesticide Reg- istration Improvement Act of 2022.
‘‘(II) With respect to new outdoor uses of a registered pesticide, not later than 1 year after the date of enactment of the Pesticide Registration Improvement Act of 2022.

‘‘(III) With respect to antimicrobial pesticide products, not later than 3 years after the date of enactment of the Pesticide Registration Improve- ment Act of 2022.
‘‘(C) INDEPENDENT THIRD PARTY ASSESSMENTS.— ‘‘(i) IN GENERAL.—The Administrator shall use the amounts made available in the Fund to carry out the activities described in clauses (ii) and (iii).
‘‘(ii) WORKFORCE ASSESSMENT.— ‘‘(I) IN GENERAL.—The Administrator shall procure a competitive contract with a qualified, independent contractor with expertise in assessing public sector workforce data analysis and reporting to conduct an assessment of current methodologies and data or metrics available to represent the workforce implementing the Pesticide 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 Improvement Act of 2022— H. R. 2617—1552 ‘‘(aa) the contractor selected under sub- clause (I) shall submit to the Administrator a report describing— ‘‘(AA) the findings from the assess- ment under that subclause; and to represent ‘‘(BB) recommendations for improved methodologies full-time equivalent resources described in that subclause; and ‘‘(bb) the Administrator shall publish the report submitted 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 Improvement Act of 2022, to the extent prac- issue a ticable, the Administrator shall competitive contract to a private, independent consulting firm— ‘‘(AA) to conduct the assessment described in subclause (II); and ‘‘(BB) to submit to the Administrator a report describing the findings of the assessment and the processes and performance of the Environmental Protec- tion Agency relating to the implementa- tion of the Pesticide 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 evaluation 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 process for the review of applications submitted under this Act.
‘‘(bb) CONSULTATION.—The firm selected under subclause (I) shall consult with the Administrator 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 rec- ommendations regarding— ‘‘(AA) the initial content screen; ‘‘(BB) the preliminary technical screen; ‘‘(CC) performance, processes, and progress toward reducing renegotiation H. R. 2617—1553 rates and the average length of renegoti- ations; ‘‘(DD) performance, processes, and progress toward eliminating the backlog of registrant submissions not covered by subsection (b)(3); (b)(3) are completed by ‘‘(EE) performance, processes, and progress toward ensuring that all reg- istrant submissions not covered by sub- the section applicable deadlines described in the notice of the Administrator entitled ‘Pes- ticide Registration Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments’ and dated October 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 relating to renegotiations and registrant submissions not covered by sub- section (b)(3); ‘‘(GG) information technology sys- tems; ‘‘(HH) recommended improvements to employee training; ‘‘(II) performance, progress, and proc- esses in completing registration review; 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 submit to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agri- culture of the House of Representatives— ‘‘(aa) a copy of each such assessment; and ‘‘(bb) the Administrator’s evaluation of the findings and recommendations contained in each such assessment.
‘‘(IV) RECOMMENDATIONS.—The Administrator shall include with the report submitted under sub- clause (III) a classification of each recommendation described in the report as— ‘‘(aa) can be through administrative action of the Administrator; or ‘‘(bb) requires a statutory change.’’; and implemented (2) in paragraph (4)— (A) in subparagraph (A), by striking ‘‘and’’ at the end; (B) by redesignating subparagraph (B) as subpara- graph (C); and (C) by inserting after subparagraph (A) the following: H. R. 2617—1554 ‘‘(B) shall be available during periods in which Environ- mental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations; and’’.
(c) ASSESSMENT OF FEES.—Section 33(d)(2) of the Federal Insec- ticide, 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 inserting ‘‘$166,000,000.’’.
(d) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS AND PREVENT DOUBLE PAYMENT OF REGISTRATION FEES.—Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w–8(e)) is amended— fiscal year).’’ and the for (1) by striking the subsection designation and heading and all that follows through ‘‘To the maximum’’ and inserting the following: ‘‘(e) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS AND PREVENT DOUBLE PAYMENT OF REGISTRATION 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 shall develop and implement a process to determine the appropriate fee category or categories for an application that qualifies for more than one fee category in order to assist applicants and prevent unnecessary payment of fees for multiple categories for a single application.’’.
(e) DECISION TIME REVIEW PERIODS.—Section 33(f) of the Fed- eral 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 application or other actions may not be changed, without providing the information to the applicant, after completion of the preliminary technical screening described in clause (iv).’’; (ii) in clause (iii), in the matter preceding subclause (I), by inserting ‘‘automate the process, to the max- imum extent practicable, and’’ before ‘‘determine’’; and (iii) in clause (iv)— (I) in the matter preceding subclause (I), by inserting ‘‘shall determine if—’’ and striking ‘‘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)— H. R. 2617—1555 (aa) by inserting ‘‘determine if’’ before ‘‘the application, data,’’; and (bb) by striking the period at the end and inserting a semicolon; and (IV) by adding at the end the following: ‘‘(III) determine, if applicable, whether an application qualifies for a reduced risk determina- tion under subsection (c)(10) or (h) of section 3; ‘‘(IV) grant or deny any data waiver requests submitted by the applicant with the application; ‘‘(V) verify and validate the accuracy of the fee category selected by the applicant; and ‘‘(VI) notify the
 applicant, in writing, if a new or different fee category is required and calculate the new decision review time based on the original submission date.’’; and (B) by striking subparagraph (E) and inserting the following: ‘‘(E) APPLICATIONS FOR REDUCED RISK.— ‘‘(i) FEE.—If an application for a reduced risk new active ingredient or a reduced risk new use is deter- mined not to qualify as reduced risk, the applicant shall pay the difference in fee for the corresponding non-reduced risk application.
‘‘(ii) DECISION REVIEW TIME PERIOD.—After receipt by the Administrator of the original covered reduced risk application and fee, the decision time review period for the corresponding non-reduced risk application shall begin within the time periods described in subparagraph (A), based on the submission date of the original 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 MUTUAL AGREE- MENT.—The Administrator, acting solely through the Director of the Office of Pesticide Programs, and the applicant may mutually agree, in writing, to extend a deci- sion time review period under this subsection if— ‘‘(i) there is new or additional data or information from the applicant that is necessary for the Adminis- trator to make a decision on the application that cannot be made available within the original decision time review period; or ‘‘(ii) a public comment period associated with the application generates significant comments that cannot be addressed within the original decision time review period.
‘‘(C) PRIORITY.—Once a decision time review period for a covered action described in subsection (b)(3)(B) is H. R. 2617—1556 missed or extended, the Administrator shall make any action on the application 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 striking subsection (k) and inserting the following: ‘‘(k) REPORTS AND INFORMATION TECHNOLOGY.— ‘‘(1) REPORTS.— ‘‘(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 covered by sub- section (b)(3)(B); ‘‘(iii) the initial content and preliminary technical screenings required in subsection (f)(4)(B); and ‘‘(iv) staffing relating to implementing the Pesticide Registration Improvement Act of 2022 and the amend- ments made by that Act.
‘‘(B) CONTENTS.—Each report published under subpara- graph (A) shall include a summary of the following informa- tion: ‘‘(i) ACTIONS UNDER THIS SECTION.—To the extent practicable, data for each action taken under this sec- tion that is completed during the fiscal year covered by the report or pending at the conclusion of that fiscal year, registering division, including— organized by ‘‘(I) the Action Code; ‘‘(II) the application receipt date; ‘‘(III) the electronic portal tracking number assigned to the application at the time of submis- sion to the electronic submission portal or the tracking Environmental Protection Agency number; ‘‘(IV) the original decision due date based on the Action Code; ‘‘(V) the dates of any renegotiations and the renegotiated due dates, if applicable; ‘‘(VI) the reasons for each renegotiation, if applicable; ‘‘(VII) if the submission had to be recoded, reassigned codes, if applicable; ‘‘(VIII) the date that the submission 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; ‘‘(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; H. R. 2617—1557 ‘‘(XII) a review of the progress made in car- rying out each requirement of subsections (e) and (f), including, to the extent determined appropriate by the
 Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for the allowance and use of summaries of acute toxicity studies; ‘‘(XIII) a review of the progress in carrying out section 3(g), including— ‘‘(aa) the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including— ‘‘(AA) the number of cases cancelled; ‘‘(BB) the number of cases requiring risk mitigation
 measures; ‘‘(CC) the number of cases removing risk mitigation measures; ‘‘(DD) the number of cases with no risk mitigation needed; and ‘‘(EE) the number of cases in which risk mitigation has been fully imple- mented; ‘‘(XIV) a review of the progress made toward implementing enhancements to— ‘‘(aa) the electronic tracking of conditional registrations; and ‘‘(bb) the endangered species database; ‘‘(XV) a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate); ‘‘(XVI) an assessment of the public availability of summary pesticide 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 successor program) of the Environmental Protection Agency; ‘‘(XVIII) with respect to funds in the Rereg- istration and Expedited Processing Fund described under section 4(k), a review that includes— ‘‘(aa) a description of the amount and use of such funds— ‘‘(AA) to carry out activities relating to worker protection under subparagraphs (G) and (H) of section 4(i)(1); ‘‘(BB) to award partnership grants under subparagraph (I) of such section; and ‘‘(CC) to carry out the pesticide safety education program under subparagraph (J) of such section; ‘‘(bb) an evaluation of the appropriateness and
 effectiveness of the activities, grants, and H. R. 2617—1558 program 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 accordance with the stakeholder input provided under such sub- paragraphs; and ‘‘(dd) with respect to activities relating to worker protection carried out under subpara- graphs (G) and (H) of section 4(i)(1), a sum- mary of the analyses from stakeholders, including
 community-based organizations, on the appropriateness and effectiveness of such activities.
‘‘(XIX) beginning two years after enactment, report on the progress of meeting the deadlines listed in paragraph (5) of section 3(f); and from worker the pesticide ‘‘(XX) a review of progress made in imple- surveillance program menting referred to in paragraph (8) of section 4(k).
‘‘(ii) REGISTRANT SUBMISSIONS NOT COVERED BY SECTION 33(B)(3)(B).—Each registrant submission not covered by subsection (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 reg- istering division, including— ‘‘(I) the submission date; ‘‘(II) the electronic portal tracking number assigned to the application at the time of the submission of the application to the electronic submission portal; ‘‘(III) the type of regulatory action, as defined by statute or guidance document, and the specific label action; ‘‘(IV) the status of the action; ‘‘(V) the due date; ‘‘(VI) the reason for the outcome; and ‘‘(VII) the completion date, if applicable.
‘‘(iii) SCREENING PROCESS.—Data for the initial con- tent 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, including— ‘‘(I) the number of applications successfully passing each type of screen; ‘‘(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 rejec- tion; and ‘‘(V) the number of notifications issued under section 152.105 of title 40, Code of Federal Regula- tions (or successor regulations), and to the extent practicable, the reasons for that issuance.
H. R. 2617—1559 ‘‘(iv) STAFFING.—Data on the staffing relating to work covered under the Pesticide Registration Improve- ment Act of 2022 and the amendments made by that Act, organized by registering division, including— ‘‘(I) the number of new hires and personnel departures; ‘‘(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 submissions not covered by subsection (b)(3)(B).
‘‘(C) PUBLICATION.—The Administrator shall publish each report under subparagraph (A)— ‘‘(i) on the website of the Environmental 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 Registration Improvement Act of 2022, the Administrator shall establish an informa- tion technology system that— ‘‘(i) includes all registering divisions in the Office of Pesticide Programs; ‘‘(ii) provides a real-time, accurate, tracking system for all regulatory submissions 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 submis- sions of the applicant; and ‘‘(iv) updates the electronic submission 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 regu- latory actions, as determined by the Administrator.
‘‘(B) ACCESS TO REGISTRATION DATA AND DECISIONS.— The Administrator shall implement efforts to expand existing, and develop new, information technology tools and databases to improve access by Environmental Protec- tion Agency employees to data used to fulfill registrations, and public access to information about regulatory decision- making tools, including opportunities for— ‘‘(i) analysis of the impact of submitted studies on Environmental Protection Agency assessments and decisions; ‘‘(ii) facilitation of read-across or computational model development to help fill information gaps; ‘‘(iii) tracking and reporting submission and deci- sion metrics relating to the use and acceptance of test methods; and H. R. 2617—1560 ‘‘(iv) drafting and publication of policies commu- nicating Environmental Protection Agency acceptance of novel technologies or approaches.’’.
(g) TERMINATION OF EFFECTIVENESS.—Section 33(m) of the Fed- eral 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)— (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 PESTICIDE REG- ISTRATION APPLICATIONS AND OTHER COVERED ACTIONS AND THEIR CORRESPONDING REGISTRATION SERVICE FEES.

Section 33(b)(3) of the Federal Insecticide, Fungicide, 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 para- graph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows: ‘‘TABLE 1.

— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) R010 1 New Active Ingre- 36 1,079,356 dient, Food use.

(2) (3) R020 2 New Active Ingre- 27 899,464 dient, Food use; re- duced risk.

(2) (3) R040 3 New Active Ingre- 18 662,883 dient, Food use; Ex- perimental Use Per- mit application; es- tablish temporary tolerance; submitted before application for registration; credit 45% of fee to- ward new active in- gredient application that follows.

(3) (4) H. R. 2617—1561 ‘‘TABLE 1.


— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS—Continued EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) R060 4 New Active Ingre- 30 749,886 dient, Non-food use; outdoor.

(2) (3) R070 5 New Active Ingre- 24 624,905 dient, Non-food use; outdoor; reduced risk.
(2) (3) R090 6 New Active Ingre- 16 463,930 dient, Non-food use; outdoor; Experi- mental Use Permit application; sub- mitted before appli- cation for registra- tion; credit 45% of fee toward new ac- tive ingredient ap- plication that fol- lows.

(3) (4) R110 7 New Active Ingre- 20 417,069 dient, Non-food use; indoor.

(2) (3) (4) R120 8 New Active Ingre- 14 347,556 dient, Non-food use; indoor; reduced risk.
(2) (3) (4) R121 9 New Active Ingre- 18 261,322 dient, Non-food use; indoor; Experi- mental Use Permit application; sub- mitted before appli- cation for registra- tion; credit 45% of fee toward new ac- tive ingredient ap- plication that fol- lows.

(3) (4) Enriched isomer(s) of registered mixed- isomer active ingre- dient.

(2) (3) R122 10 27 454,526 H. R. 2617—1562 ‘‘TABLE 1.

— REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) R123 11 New Active Ingre- 27 676,296 dient, Seed treat- ment only; includes agricultural and non-agricultural seeds; non-food use, not requiring a tol- erance.

(2) (3) R126 12 (new) New Active Ingre- 31 743,925 dient, Seed treat- ment only; limited uptake into raw ag- ricultural commod- ities; use requiring a tolerance.
(2) (3) R125 13 New Active Ingre- 16 463,930 dient, Seed treat- ment; Experimental Use Permit applica- tion; submitted be- fore application for registration; credit 45% of fee toward new active ingre- dient application that follows.

(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 application 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 re- view period as the new active ingredient or first food use application.

The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.

All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
H. R. 2617—1563 (3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 2.
‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES Action Decision Review Time (Months)(1) Registration Service Fee ($) EPA No.

R130 New CR No.

14 R140 15 First food use; indoor; food/food handling.

(2) (3) (5) Additional food use; Indoor; food/food handling.

(3) (4) (5) R150 16 First food use.

(2) (3) R155 17 (5) First food use, Experi- mental Use Permit application; active ingredient reg- istered for non-food use.
(3) (4) (5) 23 274,388 17 64,028 23 21 454,490 378,742 R160 18 First food use; re- 18 378,742 duced risk.

(2) (3) (5) R170 19 Additional food use.

(3) (4) (5) R175 20 Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups.

(3) (4) (5) 17 14 113,728 94,774 H. R. 2617—1564 ‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES— Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) R180 21 Additional food use; 12 94,774 reduced risk.

(3) (4) (5) R190 22 Additional food uses; 17 682,357 6 or more submitted in one application.

(3) (4) (5) R200 23 Additional Food Use; 12 568,632 R210 24 R220 25 6 or more submitted in one application; Reduced Risk.

(3) (4) (5) Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use reg- istration.
(3) (4) (5) Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registra- tion.

(3) (4) (5) 12 70,210 6 28,434 R230 26 Additional use; non- 16 45,453 R240 27 R250 28 food; outdoor.

(3) (4) (5) Additional use; non- food; outdoor; re- duced risk.

(3) (4) (5) Additional use; non- food; outdoor; Ex- perimental Use Per- mit application; no credit toward new use registration.
(3) (4) (5) 10 37,878 6 28,434 R251 29 Experimental Use 8 28,434 Permit application which requires no changes to the tol- erance(s); non-crop destruct basis.

(3) (5) H. R. 2617—1565 ‘‘TABLE 2.

— REGISTRATION DIVISION (RD) — NEW USES— Continued EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) R260 30 New use; non-food; in- 12 21,954 R270 R271 31 32 door.

(3) (4) (5) New use; non-food; in- door; reduced risk.
(3) (4) (5) New use; non-food; in- door; Experimental Use Permit applica- tion; no credit to- ward new use reg- istration.

(3) (4) (5) 9 6 18,296 13,940 R273 33 Additional use; seed 12 72,302 treatment only; use not requiring a new tolerance; includes crops with estab- lished tolerances (e.g., for soil or foliar application).
(3) (4) (5) R274 34 Additional use; seed 12 433,793 treatment only; 6 or more submitted in one application; uses not requiring new tolerances; in- cludes crops with established toler- ances (e.g., for soil or foliar applica- tion).

(3) (4) (5) R276 35 (new) R277 36 (new) Additional use, seed 14 79,560 treatment only; lim- ited uptake into raw agricultural commodities; use requiring a toler- ance.
(3) (4) (5) Additional use, seed 14 477,360 treatment only; 6 or more submitted in one application; lim- ited uptake into raw agricultural commodities; use requiring a toler- ance.

(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.
H. R. 2617—1566 (2) All requests for new uses (food and/or nonfood) contained in any application 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 re- view period as the new active ingredient or first food use application.

The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.

All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’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 application must be submitted together in one package.

Each application for an additional new prod- uct registration and new inert approval(s) that is submitted in the new use applica- tion 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 amendments in the application, then review of one new product application is covered by the new use fee.

All such associated ap- plications 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 decision review time for a new use.
If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appro- priate fee is due for each type of new use and the longest decision review time ap- plies 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 ap- plicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use appli- cation.
(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.
H. R. 2617—1567 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES EPA No.

R280 New CR No.

37 R290 38 R291 39 R292 40 R293 41 Action Decision Review Time (Months)(1) Registration Service Fee ($) Establish tolerances for residues in im- ported commodities; new active ingre- dient or first food use.

(2) Establish tolerances for residues in im- ported commodities; Additional new food use.
Establish tolerances for residues in im- ported commodities; additional food uses; 6 or more crops submitted in one petition.

Amend an established tolerance (e.g., de- crease or increase) and/or harmonize established toler- ances with Codex Maximum Residue Limits; domestic or import; applicant- initiated.

Establish tolerance(s) for inadvertent resi- dues in one crop; applicant-initiated.
22 457,311 16 91,465 16 548,773 12 64,987 13 76,656 R294 42 Establish tolerances 13 459,922 for inadvertent resi- dues; 6 or more crops submitted in one application; ap- plicant-initiated.

H. R. 2617—1568 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES—Continued EPA No.

R295 New CR No.
R295 New CR No.

43 Action Decision Review Time (Months)(1) Registration Service Fee ($) 16 94,774 Establish tolerance(s) for residues in one rotational crop in response to a spe- cific rotational crop application; submis- sion of cor- responding label amendments which specify the nec- essary plant-back restrictions; appli- cant-initiated.
(3) (4) R296 44 Establish tolerances 16 568,632 for residues in rota- tional crops in re- sponse to a specific rotational crop peti- tion; 6 or more crops submitted in one application; submission of cor- responding label amendments which specify the nec- essary plant-back restrictions; appli- cant-initiated.

(3) (4) R297 45 Amend 6 or more es- 12 389,897 R298 46 tablished tolerances (e.g., decrease or in- crease) in one peti- tion; domestic or import; applicant- initiated.
Amend an established tolerance (e.g., de- crease or increase); domestic or import; submission of cor- responding amend- ed labels (requiring science review).

(3) (4) 14 83,940 H. R. 2617—1569 ‘‘TABLE 3.

— REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) R299 47 Amend 6 or more es- 14 408,853 R281 48 (new) R282 49 (new) tablished tolerances (e.g., decrease or in- crease); domestic or import; submission of corresponding amended labels (re- quiring science re- view).

(3) (4) Establish tolerances for residues in im- ported commodities; additional new food use; submission of residue chemistry data review con- ducted by Codex or other competent na- tional regulatory authority.
Establish tolerances for residues in im- ported commodities; additional new food uses; 6 or more crops submitted in one petition; sub- mission of residue chemistry data re- view conducted by Codex or other com- petent national reg- ulatory authority.

12 68,599 12 411,580 (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.
H. R. 2617—1570 (2) All requests for new uses (food and/or nonfood) contained in any application 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 re- view period as the new active ingredient or first food use application.

The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.

All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered prod- uct labels are covered by the base fee for the category.

All items in the covered ap- plication 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 amendment application package is subject to the registration service fee for a new product or a new inert approval.
However, if an amendment application only pro- poses to register the amendment for a new product and there are no amendments in the application, then review of one new product application is covered by the base fee.

All such associated applications that are submitted together will be subject to the category decision review time.

H. R. 2617—1571 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS Decision Review Time (Months)(1) Registra- tion Service Fee ($) 4 2,270 4 2,720 EPA No.

New CR No.
New CR No.

Action R300 50 R301 51 New product; or similar combination product (already registered) to an identical or sub- stantially similar in composition and use to a registered product; registered source of ac- tive ingredient; no data review on acute toxicity, efficacy or child-resistant pack- aging — only product chemistry data; cite-all data citation, or selec- tive data citation where applicant owns all required data, or applicant submits spe- cific authorization let- ter from data owner.
Category also includes 100% re- package of registered end-use or manufacturing-use product that requires no data submission nor data matrix.
(2) (3) New product; or similar combination product (already registered) to an identical or sub- stantially similar in composition and use to a registered product; registered source of ac- tive ingredient; selec- tive data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy (identical data citation and claims to cited product(s)), where ap- plicant does not own all required data and does not have a spe- cific authorization let- ter from data owner.
(2) (3) H. R. 2617—1572 ‘‘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 manu- 7 10,466 facturing-use product with registered source(s) of active in- gredient(s); includes products containing two or more registered active ingredients pre- viously combined in other registered prod- ucts; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 4.
Child-resistant pack- aging and/or 4. pest(s) requiring effi- cacy – for up to 3 tar- get pests.

(2) (3) (4) H. R. 2617—1573 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R314 53 New end-use product 8 12,364 containing up to three registered active ingre- dients never before registered as this com- bination in a formu- lated product; new product label is iden- tical or substantially similar to the labels of currently registered products which sepa- rately contain the re- spective component ac- tive ingredients; ex- cludes products requir- ing or citing an animal safety study; requires review of data package within RD only; in- cludes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 3. child resistant pack- aging and/or 4. pest(s) requiring effi- cacy (4) for up to 3 tar- get pests.
(2) (3) H. R. 2617—1574 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

New CR No.
Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) R319 54 New end-use product 10 18,097 containing up to three registered active ingre- dients never before registered as this com- bination in a formu- lated product; new product label is iden- tical or substantially similar to the labels of currently registered products which sepa- rately contain the re- spective component ac- tive ingredients; ex- cludes products requir- ing or citing an animal safety study; requires review of data package within RD only; in- cludes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 3. child resistant pack- aging and/or 4. pest(s) requiring effi- cacy (4) - for 4 to 7 tar- get pests.
(2) (3) H. R. 2617—1575 ‘‘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 product containing four or more registered active ingredients never be- fore registered as this combination in a for- mulated product; new product label is iden- tical or substantially similar to the labels of currently registered products which sepa- rately contain the re- spective component ac- tive ingredients; ex- cludes products requir- ing or citing an animal safety study; requires review of data package within RD only; in- cludes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 3. child resistant pack- aging and/or 4. pest(s) requiring effi- cacy – for up to 3 tar- get pests.
(2) (3) (4) H. R. 2617—1576 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 11 24,727 9 14,075 EPA No.

New CR No.
Action R321 56 R315 57 New end-use product containing four or more registered active ingredients never be- fore registered as this combination in a for- mulated product; new product label is iden- tical or substantially similar to the labels of currently registered products which sepa- rately contain the re- spective component ac- tive ingredients; ex- cludes products requir- ing or citing an animal safety study; requires review of data package within RD only; in- cludes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 3. child resistant pack- aging and/or 4. pest(s) requiring effi- cacy (4) - for 4 to 7 tar- get pests.
(2) (3) New end-use on-animal product, registered source of active ingre- dient(s) with submis- sion of data and/or waivers for only: 1. animal safety and 2. pest(s) requiring effi- cacy and/or 3. product chemistry and/or 4. acute toxicity and/or 5. child resistant pack- aging.

(2) (3) (4) H. R. 2617—1577 ‘‘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 manu- 9 16,199 facturing-use product with registered source(s) of active in- gredient(s) including products containing two or more registered active ingredients pre- viously combined in other registered prod- ucts; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: 1. product chemistry and/or 2. acute toxicity and/or 3. child resistant pack- aging and/or 4. pest(s) requiring effi- cacy - for 4 to 7 target pests.
(2) (3) (4) R317 59 New end-use or manu- 10 21,932 facturing-use product with registered source(s) of active in- gredient(s) including products containing two or more registered active ingredients pre- viously combined in other registered prod- ucts; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only: 1. product chemistry and/or 2. acute toxicity and/or 3. child resistant pack- aging and/or 4.
Pest(s) requiring effi- cacy - for greater than 7 target pests, (2) (3) (4) H. R. 2617—1578 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 12 18,958 3 3,627 24 405,919 11 28,434 12 33,108 EPA No.

New CR No.

Action R320 60 R331 61 R332 62 R333 63 R334 64 New product; new phys- ical form; requires data review in science divisions.
(2) (3) (5) New product; repack of identical registered end-use product as a manufacturing-use product; same reg- istered uses only.

(2) (3) New manufacturing-use product; registered ac- tive ingredient; unreg- istered source of active ingredient; submission of completely new ge- neric data package; registered uses only; requires review in RD and science divisions.
(2) (3) New product; manufac- turing-use product or end-use product with unregistered source of active ingredient; re- quires science data re- view; new physical form; etc.

Cite-all or selective data citation where applicant owns all required data.

(2) (3) New product; manufac- turing-use product or end-use product with unregistered source of the active ingredient; requires science data review; new physical form; etc.

Selective data citation.

(2) (3) H. R. 2617—1579 ‘‘TABLE 4.


— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued EPA No.

R361 New CR No.
65 (new) Action Decision Review Time (Months)(1) Registra- tion Service Fee ($) New end-use product 12 23,400 containing up to three registered active ingre- dients never before registered as this com- bination in a formu- lated product; new product label is iden- tical or substantially similar to the labels of currently registered products which sepa- rately contain the re- spective component ac- tive ingredients; ex- cludes products requir- ing or citing an animal safety study; requires review of data package within RD only; in- cludes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 3.
Child resistant pack- aging and/or 4. pest(s) requiring effi- cacy – for more than 7 target pests.

(2) (3) (4) H. R. 2617—1580 ‘‘TABLE 4.

— REGISTRATION DIVISION (RD) — NEW PRODUCTS—Continued Decision Review Time (Months)(1) Registra- tion Service Fee ($) 13 25,350 6 7,800 EPA No.

R362 New CR No.
66 (new) R363 67 (new) Action New end-use product containing four or more registered active ingredients never be- fore registered as this combination in a for- mulated product; new product label is iden- tical or substantially similar to the labels of currently registered products which sepa- rately contain the re- spective component ac- tive ingredients; ex- cludes products requir- ing or citing an animal safety study; requires review of data package within RD only; in- cludes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/or 3.
Child resistant pack- aging and/or 4. pest(s) requiring effi- cacy – for more than 7 target pests.

(2) (3) (4) New product; repack of identical registered manufacturing-use product as an end-use product; same reg- istered 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 ingredient 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.
H. R. 2617—1581 (3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA cat- egories, ‘‘pest(s) requiring efficacy’’ are both invertebrate and vertebrate pests.

In- vertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.
), struc- tural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald 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 Pesticide Registration Notice 2002-1.
To determine the number of pests for the PRIA categories, pest groups, sub- groups, 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, mosquitoes, 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 subgroup or specific pest will count as 1.

(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.
To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 5.

— REGISTRATION DIVISION (RD) — AMENDMENTS EPA No.

R340 New CR No.

68 Action Decision Review Time (Months)(1) Registration Service Fee ($) 4 7,150 Amendment requiring data review within RD (e.g., changes to precautionary label statements); in- cludes adding/modi- fying pest(s) claims for up to 2 target pests; excludes products requiring or citing an animal safety study.
(2) (3) H. R. 2617—1582 ‘‘TABLE 5.

— REGISTRATION DIVISION (RD) — AMENDMENTS—Continued EPA No.

R341 New CR No.

69 R345 70 Action Decision Review Time (Months)(1) Registration Service Fee ($) 6 8,584 7 12,643 Amendment requiring data review within RD (e.g., changes to precautionary label statements), in- cludes adding/modi- fying pest(s) claims for greater than 2 target pests; ex- cludes products re- quiring or citing an animal safety study.
(2) (3) Amending on-animal products previously registered, with the submission of data and/or waivers for only: 1. animal safety and 2. pest(s) requiring ef- ficacy and/or 3. product chemistry and/or 4. acute toxicity and/ or 5. child resistant packaging.
(2) (3) (4) R350 71 Amendment requiring 9 18,958 data review in science divisions (e.g., changes to Re- stricted Entry In- terval, or Personal Protective Equip- ment, or Preharvest Interval, or use rate, or number of applications; or add aerial application; or modify Ground Water/Surface Water advisory statement).

(2) (3) (5) Amendment adding a new unregistered source of active in- gredient.

(2) (3) R351 72 8 18,958 H. R. 2617—1583 ‘‘TABLE 5.

— REGISTRATION DIVISION (RD) — AMENDMENTS—Continued EPA No.
R352 New CR No.

73 R371 74 Action Decision Review Time (Months)(1) Registration Service Fee ($) 8 18,958 6 14,463 Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data.

(2) (3) Amendment to Exper- imental Use Permit; (does not include extending a per- mit’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 section 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments sub- mitted 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.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA cat- egories, ‘‘pest(s) requiring efficacy’’ are both invertebrate and vertebrate pests.

In- vertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.
), struc- tural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald 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 Pesticide Registration Notice 2002-1.
To determine the number of pests for the PRIA categories, pest groups, sub- groups, 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, mosquitoes, 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 subgroup or specific pest will count as 1.

H. R. 2617—1584 (5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.
To the extent 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 Decision Review Time (Months)(1) Registration Service Fee ($) 6 3 3 5 3 3,627 3,627 3,627 4,927 5,200 R124 75 Conditional Ruling on R272 76 R275 77 R278 R279 78 (new) 79 (new) Pre-application Study Waivers; ap- plicant-initiated.
Review of Study Pro- tocol applicant- ini- tiated; excludes Data Analysis Re- porting Tool, pre- registration con- ference, Rapid Re- sponse review, de- velopmental neurotoxicity pro- tocol review, pro- tocol needing Human Studies Re- view Board review, companion animal safety protocol.

Rebuttal of Agency re- viewed protocol, ap- plicant initiated.

Review of Protocol for companion animal safety study.
Comparative product determination for reduced risk sub- mission, applicant initiated; submitted before application for reduced risk new active ingre- dient or reduced 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.

H. R. 2617—1585 ‘‘TABLE 7.

— ANTIMICROBIAL DIVISION (AD) — NEW ACTIVE INGREDIENTS EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) A380 80 New Active Ingre- 26 227,957 dient; Indirect Food use; establish toler- ance or tolerance exemption if re- quired.

(2) (3) (4) A390 81 New Active Ingre- 26 329,265 dient; Direct Food use; establish toler- ance or tolerance exemption if re- quired.

(2) (3) (4) New Active Ingredient Non-food use.

(2) (3) (4) A410 82 23 278,659 A431 83 New Active Ingre- 14 114,984 dient, 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 application 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 re- view period as the new active ingredient or first food use application.
The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.
All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
H. R. 2617—1586 (3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 8.
‘‘TABLE 8.

— ANTIMICROBIAL DIVISION (AD) — NEW USES EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) A440 84 New Use, Indirect 23 45,737 Food Use, establish tolerance or toler- ance exemption.

(2) (3) (4) (6) A441 85 Additional Indirect 23 164,639 A450 86 A451 87 food uses; establish tolerances or toler- ance exemptions if required; 6 or more submitted in one application.

(3) (4) (5) (6) New use, Direct food use, establish toler- ance or tolerance exemption.
(2) (3) (4) (6) Additional Direct food uses; establish tol- erances or tolerance exemptions if re- quired; 6 or more submitted in one application.

(3) (4) (5) (6) 23 137,198 22 261,333 A500 88 New use, non-food.

(4) 15 45,737 (5) (6) H. R. 2617—1587 ‘‘TABLE 8.

— ANTIMICROBIAL DIVISION (AD) — NEW USES— Continued EPA No.

A501 New CR No.

89 Action Decision Review Time (Months)(1) Registration Service Fee ($) New use, non-food; 6 or more submitted in one application.
(4) (5) (6) 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 application 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 re- view period as the new active ingredient or first food use application.
The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.
All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active 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 ingredient 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) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
H. R. 2617—1588 (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 application must be submitted together in one package.

Each application for an additional new prod- uct registration and new inert approval(s) that is submitted in the new use applica- tion 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 amendments in the application, then review of one new product application is covered by the new use fee.

All such associated ap- plications 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 decision review time for a new use.
If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appro- priate fee is due for each type of new use and the longest decision review time ap- plies 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 ap- plicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use appli- cation.
(6) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 9.
‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS EPA No.

A530 New CR No.

90 Action Decision Review Time (Months)(1) Registration Service Fee ($) 4 1,833 New product, iden- tical or substan- tially similar in composition and use to a registered prod- uct; no data review or only product chemistry data; cite all data citation or selective data cita- tion where appli- cant owns all re- quired data; or ap- plicant submits spe- cific authorization letter from data owner.
Category also includes 100% re-package of reg- istered end-use or manufacturing-use product that re- quires no data sub- mission nor data matrix.

(2) (3) H. R. 2617—1589 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued EPA No.

A531 New CR No.
A531 New CR No.

91 A532 92 A550 93 A560 94 Action Decision Review Time (Months)(1) Registration Service Fee ($) New product; iden- tical or substan- tially similar in composition and use to a registered prod- uct; registered source of active in- gredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where ap- plicant does not own all required data and does not have a specific au- thorization letter from data owner.
(2) (3) New product; iden- tical or substan- tially similar in composition and use to a registered prod- uct; registered ac- tive ingredient; un- registered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data sub- mitted.

(2) (3) New end-use product; uses other than FIFRA §2(mm); non-FQPA product.

(2) (3) (5) New manufacturing- use product; reg- istered active ingre- dient; selective data citation.
(2) (3) 4 2,616 5 7,322 9 18,958 6 18,054 H. R. 2617—1590 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued EPA No.

A565 New CR No.

95 Action Decision Review Time (Months)(1) Registration Service Fee ($) 18 26,135 New manufacturing- use product; reg- istered active ingre- dient; unregistered source of active in- gredient; submis- sion of new generic data package; reg- istered uses only; requires science re- view.
(2) (3) A572 96 New Product or 9 18,958 amendment requir- ing data review for risk assessment by Science Branch (e.g., changes to Re- stricted Entry In- terval, or Personal Protective 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) 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) A460 97 (new) A461 98 (new) A462 99 (new) A463 100 (new) A464 101 (new) 5 7,322 6 10,158 7 12,995 9 15,831 10 18,668 H. R. 2617—1591 ‘‘TABLE 9.

— ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS—Continued EPA No.

A465 New CR No.
A465 New CR No.

102 (new) A470 103 (new) A471 104 (new) A472 105 (new) A473 106 (new) A474 107 (new) A475 108 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) New end-use product; FIFRA §2(mm) uses only; 51 or more public health orga- nisms.

(2) (3) (5) (6) 11 21,505 Label amendment re- 4 5,493 quiring data review; 0 to 10 public health organisms.

(3) (4) (5) (6) Label amendment re- 5 8,506 quiring data review; 11 to 20 public health organisms.
(3) (4) (5) (6) Label amendment re- 6 10,219 quiring data review; 21 to 30 public health organisms.

(3) (4) (5) (6) Label amendment re- 7 11,933 quiring data review; 31 to 40 public health organisms.

(3) (4) (5) (6) Label amendment re- 8 13,646 quiring data review; 41 to 50 public health organisms.

(3) (4) (5) (6) Label amendment re- 9 15,766 quiring 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 ingredient 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.
H. R. 2617—1592 (3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’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 section 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments sub- mitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration serv- ice fees.

(e) Submissions with data and requiring data review are subject to registra- tion 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 or- ganisms 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 appropriate 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 addi- tional fees to meet the fee of a new category.
(7) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 10.
‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) A520 109 Experimental Use 9 9,151 Permit application, non-food use.

(2) (3) H. R. 2617—1593 ‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EXPERI- MENTAL USE PERMITS AND OTHER ACTIONS—Continued EPA No.

A521 New CR No.
110 A522 111 Action Decision Review Time (Months)(1) Registration Service Fee ($) 6 6,776 12 17,424 Review of public health efficacy study protocol with- in AD, per AD In- ternal Guidance for the Efficacy Pro- tocol Review Proc- ess; Code will also include review of public health effi- cacy study protocol; applicant-initiated; Tier 1. Review of public health efficacy study protocol out- side AD by mem- bers of AD Efficacy Protocol Review Ex- pert Panel; Code will also include re- view of public health efficacy study protocol; ap- plicant-initiated; Tier 2.
A537 112 New Active Ingre- 18 219,512 dient/New Use, Ex- perimental Use Per- mit application; Di- rect food use; Estab- lish tolerance or tol- erance exemption if required.

Credit 45% of fee toward new active ingre- dient/new use appli- cation that follows.
(3) A538 113 New Active Ingre- 18 137,198 dient/New Use, Ex- perimental Use Per- mit application; In- direct food use; Es- tablish tolerance or tolerance exemption if required Credit 45% of fee toward new active ingre- dient/new use appli- cation that follows.

(3) H. R. 2617—1594 ‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EXPERI- MENTAL USE PERMITS AND OTHER ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) A539 114 New Active Ingre- 15 132,094 dient/New Use, Ex- perimental Use Per- mit application; Nonfood use.

Credit 45% of fee toward new active ingre- dient/new use appli- cation that follows.

(3) Amendment to Exper- imental Use Permit; requires data re- view or risk assess- ment.
(2) (3) A529 115 9 16,383 A523 116 Review of protocol 9 17,424 other than a public health efficacy study (i.e., Toxi- cology or Exposure Protocols).

Science reassessment: refined ecological risk, and/or endan- gered species; appli- cant-initiated.

(3) Exemption from the requirement of an Experimental Use Permit.

(2) Rebuttal of Agency re- viewed protocol, ap- plicant initiated.
A571 117 A533 118 A534 119 A535 120 Conditional ruling on A536 121 pre-application study waiver or data bridging argu- ment; applicant-ini- tiated.

Conditional ruling on pre-application di- rect food, indirect food, nonfood use determination; ap- plicant-initiated.

18 137,198 4 4 6 3,559 6,776 3,454 4 3,559 H. R. 2617—1595 ‘‘TABLE 10.

— ANTIMICROBIAL DIVISION (AD) — EXPERI- MENTAL USE PERMITS AND OTHER ACTIONS—Continued EPA No.

A575 New CR No.
A575 New CR No.

122 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) 4 3,389 Efficacy similarity de- termination; if two products can be bridged or if con- firmatory efficacy data are needed.

(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) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
3) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 11.
‘‘TABLE 11.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION (BPPD) — NEW ACTIVE INGREDIENTS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B580 123 New active ingre- 22 73,173 dient; petition to es- tablish a tolerance.

(2) (3) (4) B590 124 New active ingre- 20 45,737 dient; petition to es- tablish a tolerance exemption.

(2) (3) (4) H. R. 2617—1596 ‘‘TABLE 11.


— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION (BPPD) — NEW ACTIVE INGREDIENTS— Continued EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B600 125 New active ingre- 15 27,443 dient; no change to a permanent toler- ance or tolerance exemption (includes non-food uses).
(2) (3) (4) B610 126 New active ingre- 12 18,296 dient; Experimental Use Permit applica- tion; petition to es- tablish a permanent or temporary toler- ance or temporary tolerance exemp- tion.

(3) (4) B620 127 New active ingre- 9 9,151 dient; Experimental Use Permit applica- tion; non-food use (includes crop de- struct).

(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 application 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 re- view period as the new active ingredient or first food use application.

The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.

All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
H. R. 2617—1597 (3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 12.
‘‘TABLE 12.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW USES EPA No.

B630 New CR No.

128 B640 129 B644 130 Action Decision Review Time (Months)(1) Registration Service Fee ($) 13 18,296 19 27,443 8 18,296 First food use; peti- tion to establish/ amend a tolerance exemption.

(2) (4) (5) First food use; peti- tion to establish/ amend a tolerance.

(2) (4) (5) New use, no change to an established toler- ance or tolerance exemption (includes non-food uses).
(3) (4) (5) B645 131 New use; Experi- 12 18,296 mental Use Permit; petition to establish a permanent or temporary tolerance or tolerance exemp- tion.

(4) (5) B646 132 New use; Experi- 7 9,151 mental Use Permit; non-food use (in- cludes crop de- struct).

(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.
H. R. 2617—1598 (2) All requests for new uses (food and/or nonfood) contained in any application 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 re- view period as the new active ingredient or first food use application.

The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.

All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active 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 application must be submitted together in one package.

Each application for an additional new prod- uct registration and new inert approval(s) that is submitted in the new use applica- tion 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 amendments in the application, then review of one new product application is covered by the new use fee.

All such associated ap- plications 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 decision review time for a new use.
If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appro- priate fee is due for each type of new use and the longest decision review time ap- plies 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 ap- plicant at the applicant’s initiative to support the application after completion of the preliminary technical screen, and (c) is not itself a covered registration application, 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 before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.
H. R. 2617—1599 ‘‘TABLE 13.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW PRODUCTS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B660 133 New product; reg- 6 1,833 istered source of ac- tive ingredient(s); identical or sub- stantially similar in composition and use to a registered prod- uct; no change in an established toler- ance or tolerance exemption; no data submission or data matrix (or submis- sion of product chemistry data only).
(2) (3) B670 134 New product; reg- 9 7,322 B672 135 istered source of ac- tive ingredient(s); no change in an es- tablished tolerance or tolerance exemp- tion; (including non- food); Must address Product-Specific Data Requirements.
(2) (3) New product; unregis- tered source of at least one active in- gredient (or reg- istered source with new generic data package); no change in an established tolerance or toler- ance exemption (in- cluding non-food); must address Prod- uct-Specific and Ge- neric Data Require- ments.

(2) (3) 15 13,069 H. R. 2617—1600 ‘‘TABLE 13.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION (BPPD) — NEW PRODUCTS—Continued EPA No.

B673 New CR No.
B673 New CR No.

136 B674 137 B677 138 Action Decision Review Time (Months)(1) Registration Service Fee ($) 12 7,322 4 1,833 12 12,643 New product; unregis- tered source of ac- tive ingredient(s); citation of Technical Grade Active Ingre- dient (TGAI) data previously reviewed and accepted by the Agency; requires an Agency determina- tion that the cited data support the new product.
(2) (3) New product; repack of identical reg- istered end-use product or repack of an end-use product as a manufacturing- use product; same registered uses only.

(2) (3) New end-use non-food animal product with submission of two or more target ani- mal safety studies; includes data and/or waivers of data for only: 1. product chemistry and/or 2. acute toxicity and/ or 3. public health pest efficacy and/or 4. animal safety stud- ies 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 ingredient 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.
H. R. 2617—1601 (3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

‘‘TABLE 14.
‘‘TABLE 14.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — AMENDMENTS EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B621 139 Amendment; Experi- 7 7,322 mental Use Permit; no change to an es- tablished temporary or permanent toler- ance or tolerance exemption.

(3) (4) B622 140 Amendment; Experi- 11 18,296 mental Use Permit; petition to amend a permanent or tem- porary tolerance or tolerance exemp- tion.
(3) (4) Amendment; changes to an established tolerance or toler- ance exemption.

(4) B641 141 13 18,296 B680 142 Amendment; reg- 5 7,322 istered sources of active ingredient(s); no new use(s); no changes to an es- tablished tolerance or tolerance exemp- tion; requires data submission.

(2) (3) H. R. 2617—1602 ‘‘TABLE 14.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — AMENDMENTS—Continued EPA No.

B681 New CR No.
B681 New CR No.

143 Action Decision Review Time (Months)(1) Registration Service Fee ($) 7 8,714 Amendment; unregis- tered source of ac- tive ingredient(s); no change to an es- tablished tolerance or tolerance exemp- tion; requires data submission.
(2) (3) B683 144 Amendment; no 6 7,322 change to an estab- lished tolerance or tolerance exemp- tion; requires re- view/update of pre- vious risk assess- ment(s) without data submission (e.g., labeling changes to Re- stricted Entry In- terval, Personal Protective Equip- ment, Preharvest Interval).

(2) (3) B684 145 Amending non-food 8 12,643 animal product that includes submission of target animal safety data; pre- viously registered.
(2) (3) B685 146 Amendment; add a 5 7,322 new biochemical un- registered source of active ingredient or a new microbial production site; re- quires submission of analysis of sam- ples data and source/production site-specific manu- facturing 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.

H. R. 2617—1603 (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 section 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments sub- mitted by notification under Pesticide Registration (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.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 15.
‘‘TABLE 15.

— BIOPESTICIDES AND POLLUTION PREVEN- TION (BPPD) LEPIDOPTERAN PHEROMONES (SCLP) DIVISION STRAIGHT-CHAIN — EPA No.

B690 New CR No.

147 B700 148 B701 149 Action Decision Review Time (Months)(1) Registration Service Fee ($) SCLP; new active in- gredient; food or non-food use.

(2) (6) (7) SCLP; Experimental Use Permit applica- tion; new active in- gredient or new use.

(6) (7) SCLP; Extend or amend Experi- mental Use Permit.

(6) (7) 7 7 3,662 1,833 4 1,833 H. R. 2617—1604 ‘‘TABLE 15.
— BIOPESTICIDES AND POLLUTION PREVEN- TION (BPPD) LEPIDOPTERAN PHEROMONES (SCLP)—Continued DIVISION STRAIGHT-CHAIN — EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B710 150 SCLP; new product; 4 1,833 registered source of active ingredient(s); identical or sub- stantially similar in composition and use to a registered prod- uct; no change in an established toler- ance or tolerance exemption; no data submission or data matrix (or only product chemistry data); (Includes 100% re-pack; re- pack of registered end-use product as a manufacturing- use product).
(3) (6) B720 151 SCLP; new product; 5 1,833 registered source of active ingredient(s); no change in an es- tablished tolerance or tolerance exemp- tion (including non- food); Must address Product-Specific Data Requirements.

(3) (6) B721 152 SCLP: new product; 7 3,836 unregistered source of active ingredient; no change in an es- tablished tolerance or tolerance exemp- tion (including non- food); must address Product-Specific and Generic Data Requirements.
(3) (6) SCLP; new use and/or amendment; peti- tion to establish a tolerance or toler- ance exemption.

(4) (5) (6) (7) B722 153 7 3,552 H. R. 2617—1605 ‘‘TABLE 15.

— BIOPESTICIDES AND POLLUTION PREVEN- TION (BPPD) LEPIDOPTERAN PHEROMONES (SCLP)—Continued DIVISION STRAIGHT-CHAIN — EPA No.

B730 New CR No.

154 Action Decision Review Time (Months)(1) Registration Service Fee ($) SCLP; amendment re- quiring data sub- mission.
(4) (6) 5 1,833 (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 application 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 re- view period as the new active ingredient or first food use application.
The applica- tion 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 submitted in the new active in- gredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval.
All such associ- ated applications that are submitted together will be subject to the new active ingre- dient 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 applica- tion for another new product containing the same active ingredient or an amend- ment 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 in- gredient.
In the case of a first food use application, until that first food use is ap- proved, 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 neither 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 cov- ered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient 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 section 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments sub- mitted by notification under Pesticide Registration (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.

H. R. 2617—1606 (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 application must be submitted together in one package.

Each application for an additional new prod- uct registration and new inert approval(s) that is submitted in the new use applica- tion 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 amendments in the application, then review of one new product application is covered by the new use fee.

All such associated ap- plications 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 decision review time for a new use.
If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appro- priate fee is due for each type of new use and the longest decision review time ap- plies 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 ap- plicant at the applicant’s initiative to support the application after completion of the preliminary technical screening, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use appli- cation.
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(7) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 16.
‘‘TABLE 16.

— BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — OTHER ACTIONS EPA No.

B614 New CR No.

155 Action Decision Review Time (Months)(1) Registration Service Fee ($) 3 3,627 Pre-application; Con- ditional Ruling on rationales for ad- dressing a data re- quirement in lieu of data; applicant-ini- tiated; applies to one (1) rationale at a time.

H. R. 2617—1607 ‘‘TABLE 16.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION (BPPD) — OTHER ACTIONS—Continued EPA No.

B682 New CR No.
B682 New CR No.

156 Action Decision Review Time (Months)(1) Registration Service Fee ($) 3 3,487 Protocol review; appli- cant initiated; ex- cludes time for Human Studies Re- view Board review (Includes rebuttal of protocol review).

B616 B617 157 (new) Pre-application; Con- ditional Ruling on a non-food use deter- mination.

158 (new) Pre-application; bio- chemical classifica- tion determination.
5 5 4,715 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.

‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP) (BPPD) — PLANT-INCORPORATED EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B740 159 Experimental Use 9 137,198 Permit application; no petition for toler- ance/tolerance ex- emption; includes: 1. non-food/feed use(s) for a new (2) or reg- istered (3) PIP (12); 2. food/feed use(s) for a new or registered PIP with crop de- struct; 3. food/feed use(s) for a new or registered PIP in which an es- tablished tolerance/ tolerance exemption exists for the in- tended use(s).
(4) (5) (12) H. R. 2617—1608 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) B750 160 Experimental Use 12 182,927 Permit application; with a petition to establish a tem- porary or perma- nent tolerance/toler- ance exemption for the active ingre- dient.

Includes new food/feed use for a registered (3) PIP.
(4) (12) B771 161 Experimental Use 13 182,927 Permit application; new (2) PIP; with petition to establish a temporary toler- ance/tolerance ex- emption for the ac- tive ingredient; credit 75% of B771 fee toward registra- tion application for a new active ingre- dient that follows.

(5) (12) Application to amend or extend a PIP Ex- perimental Use Per- mit; no petition since the estab- lished tolerance/tol- erance exemption for the active ingre- dient is unaffected.
(12) Application to amend or extend a PIP Ex- perimental Use Per- mit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient.

(12) B772 162 B773 163 3 18,296 9 45,737 H. R. 2617—1609 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B780 New CR No.
B780 New CR No.

164 B800 165 B820 166 Action Decision Review Time (Months)(1) Registration Service Fee ($) 16 228,657 17 246,949 19 292,682 Registration applica- tion; new (2) PIP; non-food/feed or food/feed without tolerance petition based on an exist- ing permanent tol- erance exemption.

(5) (12) (14) Registration applica- tion; new (2) PIP; with petition to es- tablish permanent tolerance/tolerance exemption for the active ingredient based on an exist- ing temporary toler- ance/tolerance ex- emption.
(5) (12) (14) Registration applica- tion; new (2) PIP; with petition to es- tablish or amend a permanent toler- ance/tolerance ex- emption of an active ingredient.

(5) (12) (14) B851 167 Registration applica- 9 182,927 tion; new event of a previously reg- istered PIP active ingredient(s); no pe- tition since perma- nent tolerance/toler- ance exemption is already established for the active ingre- dient(s).

(12) H. R. 2617—1610 ‘‘TABLE 17.


— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B870 New CR No.

168 B880 169 B883 170 Action Decision Review Time (Months)(1) Registration Service Fee ($) 9 54,881 9 45,737 13 182,927 Registration applica- tion; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is al- ready established for the active ingre- dient(s).
(4) (12) (14) Registration applica- tion; registered (3) PIP; new product or new terms of reg- istration; additional data submitted; no petition since a per- manent tolerance/ tolerance exemption is already estab- lished for the active ingredient(s).
(5) (6) (7) (12) (14) Registration applica- tion; new (2) PIP, seed increase with negotiated acreage cap and time-lim- ited registration; with petition to es- tablish a permanent tolerance/tolerance exemption for the active ingredient based on an exist- ing temporary toler- ance/tolerance ex- emption.

(5) (8) (12) (14) H. R. 2617—1611 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B884 New CR No.
B884 New CR No.

171 B885 172 B890 173 B900 174 Action Decision Review Time (Months)(1) Registration Service Fee ($) 19 228,657 6 45,737 9 91,465 6 18,296 Registration applica- tion; new (2) PIP, seed increase with negotiated acreage cap and time-lim- ited registration; with petition to es- tablish a permanent tolerance/tolerance exemption for the active ingredient.
(5) (8) (12) (14) Registration applica- tion; registered (2) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a per- manent tolerance/ tolerance exemption is already estab- lished for the active ingredient(s).

(9) (12) Application to amend a seed increase reg- istration; converts registration to com- mercial registration; no petition since permanent toler- ance/tolerance ex- emption is already established for the active ingredient(s).
(5) (12) (14) Application to amend a registration, in- cluding actions such as modifying an IRM plan, or adding an insect to be con- trolled.

(5) (10) (11) (12) B902 175 PIP Protocol review.

3 9,151 H. R. 2617—1612 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B903 New CR No.
B903 New CR No.

176 B904 177 B905 178 B906 179 B907 180 B909 181 (new) B910 182 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) Inert ingredient per- manent tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.

Import tolerance or tolerance exemp- tion; processed com- modities/food only (inert or active in- gredient).

FIFRA Scientific Ad- visory Panel Re- view.


Petition to establish a temporary toler- ance/tolerance ex- emption for one or more active ingredi- ents.

Petition to establish a permanent toler- ance/tolerance ex- emption for one or more active ingredi- ents based on an existing temporary tolerance/tolerance exemption.

PIP tolerance exemp- tion determination; applicant-initiated; request to deter- mine if an existing tolerance exemption applies to a PIP.
Biotechnology Notifi- cation for small- scale field testing of genetically engi- neered microbes.

12 91,465 12 182,927 6 9 91,465 45,733 9 18,296 6 18,296 3 9,151 H. R. 2617—1613 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B921 New CR No.
B921 New CR No.

183 (new) B922 184 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) Experimental Use 12 182,927 Permit application; genetic modifica- tions in animals in- tended for use as a pesticide (e.g., for pest population con- trol); non-food/feed.

This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals.
Credit 75% of B921 fee toward registra- tion application for the new active in- gredient that fol- lows (B922).

(5) (12) (13) Registration applica- tion; new active in- gredient; genetic modifications in animals intended for use as a pes- ticide (e.g., for pest population control); non-food/feed.

This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals.
(5) (12) (13) (14) 16 228,657 H. R. 2617—1614 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B923 New CR No.
B923 New CR No.

185 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) Experimental Use 15 228,658 Permit application; genetic modifica- tions in animals in- tended for use as a pesticide (e.g., for pest population con- trol); with petition to establish a tem- porary or perma- nent tolerance/toler- ance exemption of an active ingre- dient.
This category would cover sub- stances produced and used in animals that are intended for use as a pes- ticide, such as for pest population con- trol, including the genetic material in such animals.

Cred- it 75% of B923 fee toward registration application for the new active ingre- dient that follows (B924).

(5) (12) (13) (14) H. R. 2617—1615 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B924 New CR No.
B924 New CR No.

186 (new) B925 187 (new) B926 188 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) 19 292,682 Registration applica- tion; new active in- gredient; genetic modifications in animals intended for use as a pes- ticide (e.g., for pest population control); with petition to es- tablish a permanent tolerance/tolerance exemption of an ac- tive ingredient.
This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals.

(5) (12) (13) (14) Experimental Use 11 27,452 Permit application; exogenous applica- tions of RNA to elic- it the RNA inter- ference pathway in pests; non-food/feed; credit 75% of B925 fee toward registra- tion application for the new active in- gredient that fol- lows (B926).
(5) (12) Registration applica- tion; new active in- gredient; exogenous applications of RNA to elicit the RNA in- terference pathway in pests; non-food/ feed.

(5) (12) (14) 17 82,329 H. R. 2617—1616 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B927 New CR No.
B927 New CR No.

189 (new) B928 190 (new) B929 191 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) Experimental Use 14 54,889 Permit application; exogenous applica- tions of RNA to elic- it the RNA inter- ference pathway in pests; with petition to establish a tem- porary or perma- nent tolerance/toler- ance exemption of an active ingre- dient; credit 75% of B927 fee toward registration applica- tion for the new ac- tive ingredient that follows (B928).
(5) (12) Registration applica- tion; new active in- gredient; exogenous applications of RNA to elicit the RNA in- terference pathway in pests; with peti- tion to establish a permanent toler- ance/tolerance ex- emption of an active ingredient.
(5) (12) (14) Registration applica- tion; new product, registered active in- gredient; exogenous applications of RNA to elicit the RNA in- terference pathway in pests; no petition since a permanent tolerance/tolerance exemption is al- ready established for the active ingre- dient(s).

(5) (12) 22 137,210 10 7,322 H. R. 2617—1617 ‘‘TABLE 17.

— BIOPESTICIDES AND POLLUTION PREVEN- TION DIVISION PROTECTANTS (PIP)—Continued (BPPD) — PLANT-INCORPORATED EPA No.

B930 New CR No.
B930 New CR No.

192 (new) B931 193 (new) B932 194 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) Application to amend or extend a non-PIP Emerging Tech- nologies Experi- mental Use Permit; no petition since the established toler- ance/tolerance ex- emption for the ac- tive ingredient is unaffected.
(12) Application to amend or extend a non-PIP Emerging Tech- nologies Experi- mental Use Permit; with petition to ex- tend a temporary tolerance/tolerance exemption for the active ingredient.

(12) Amendment; applica- tion to amend a non-PIP Emerging Technologies reg- istration.

(4) (5) (12) 3 18,296 9 45,737 6 18,296 (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 registered.

(3) ‘Registered PIP’ means a PIP with an active ingredient that is currently reg- istered.

(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn.
(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 decision 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 ad- vice from the SAP on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, insect resistance, and novel scientific issues sur- rounding 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 envi- ronment from risks posed by pesticides.
Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed.

(6) Registered PIPs stacked through conventional breeding.

(7) Deployment of a registered PIP with a different Insecticide Resistance Man- agement (IRM) plan (e.g., seed blend).
H. R. 2617—1618 (8) The negotiated acreage cap will depend upon EPA’s determination of the po- tential environmental exposure, risk(s) to non-target organisms, and the risk of tar- geted pest developing resistance to the pesticidal substance.

The uncertainty 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 registration 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 section 3(h) and are not subject to registration service fees.
(d) Registrant initiated amendments sub- mitted by notification under Pesticide Registration (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.
(12) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(13) This category does not include genetic modifications in animals not intended 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 required for this action, using guidance finalized according to section 33(c)(3)(B) for this spe- cific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening.

To the extent practicable, any reason for renegotiation should be resolved during the same extension.

‘‘TABLE 18.
‘‘TABLE 18.

— INERT INGREDIENTS EPA No.

I001 New CR No.

195 I002 196 Action Decision Review Time (Months)(1) Registration Service Fee ($) 15 38,698 13 10,750 Approval of new food use inert ingre- dient.

(2) (3) Amend currently ap- proved inert ingre- dient tolerance or exemption from tol- erance; new data.

(2) H. R. 2617—1619 ‘‘TABLE 18.

— INERT INGREDIENTS—Continued EPA No.

I003 New CR No.
I003 New CR No.

197 I004 198 Action Decision Review Time (Months)(1) Registration Service Fee ($) Amend currently ap- proved inert ingre- dient tolerance or exemption from tol- erance; no new data.

(2) Approval of new non- food use inert ingre- dient.

(2) 11 4,742 6 6 15,803 7,903 I005 199 Amend currently ap- proved non-food use inert ingredient with new use pat- tern; new data.
(2) I006 200 Amend currently ap- 4 4,742 I007 201 I008 202 I009 203 I010 204 I011 205 proved non-food use inert ingredient with new use pat- tern; no new data.

(2) Approval of substan- tially similar non- food use inert ingre- dients when origi- nal inert is compositionally 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) Petition to amend a single tolerance ex- emption descriptor, or single non-food use descriptor, to add ≤ 10 CASRNs; no new data.

(2) Approval of new food use safener with tolerance or exemp- tion from tolerance.

(2) 5 2,371 7 4 7 5,374 4,427 2,371 26 856,631 H. R. 2617—1620 ‘‘TABLE 18.

— INERT INGREDIENTS—Continued Action Decision Review Time (Months)(1) Registration Service Fee ($) EPA No.

I012 New CR No.

206 Approval of new non- food use safener.


(2) I013 207 Approval of additional I014 208 I015 209 food use for pre- viously approved safener with toler- ance or exemption from tolerance.

(2) Approval of additional non-food use for previously approved safener.

(2) Approval of new ge- neric data for pre- viously approved food use safener.
(2) 21 17 595,147 90,260 15 36,074 26 386,589 I016 210 Approval of amend- 15 79,942 I017 I018 211 (new) 212 (new) ment(s) to tolerance and label for pre- viously approved safener.

(2) Add new source of previously approved safener.

Petition to add one approved inert in- gredient (CASRN) to the Commodity Inert Ingredient List; no data.

(4) 8 3 18,958 2,371 (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 application to approve an inert ingredient, each application will be subject to its respective reg- istration service fee.

The decision review time for both submissions will be the long- est of the associated applications.

If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be as- sessed 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 ingredient 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 busi- ness waivers.

H. R. 2617—1621 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS EPA No.

M001 New CR No.

213 M002 214 Action Decision Review Time (Months)(1) Registration Service Fee ($) 14 11,378 14 11,378 Study protocol requir- ing Human Studies Review Board re- view as defined in 40 CFR Part 26 in support of a cur- rently registered ac- tive ingredient.
Completed study re- quiring Human Studies Review Board review as de- fined in 40 CFR Part 26 in support of an active ingre- dient.

(2) M003 215 External technical 12 91,651 peer review of new active ingredient, product, or amend- ment (e.g., consulta- tion with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months.
Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingre- dient, or unique use pattern or applica- tion technology.

Ex- cludes PIP active .ingredients.

(3) H. R. 2617—1622 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

New CR No.
New CR No.

Action Decision Review Time (Months)(1) Registration Service Fee ($) M004 216 External technical 18 91,651 peer review of new active ingredient, product, or amend- ment (e.g., consulta- tion with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of great- er than 12 months.

Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingre- dient, or unique use pattern or applica- tion technology.
Ex- cludes PIP active ingredients.

(3) M005 217 New Product: Com- 9 31,604 bination, Contains a combination of ac- tive ingredients from a registered and/or unregistered source; conven- tional, antimicrobial and/or biopesticide.

Requires coordina- tion with other reg- ulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited.

Only existing uses for each active ingredient in the combination prod- uct.
(4) (5) (6) Request for up to 5 letters of certifi- cation (Gold Seal) for one actively reg- istered product (ex- cludes distributor products).

(7) 1 398 M006 218 H. R. 2617—1623 ‘‘TABLE 19.

— EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No.

M007 New CR No.
M007 New CR No.

219 M008 220 M009 221 M010 222 M011 223 M012 224 (new) Action Decision Review Time (Months)(1) Registration Service Fee ($) 12 7,903 15 2,371 6 4 4 3,389 3,389 5,230 1 398 Request to extend Ex- clusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii).

Request to grant Ex- clusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determina- tion is required.

Non-FIFRA Regulated Determination; ap- plicant-initiated, per product.
Conditional ruling on pre-application, product substantial similarity.

Label amendment to add the DfE logo; requires data re- view; no other label changes.

(8) Request for up to 5 letters of certifi- cation (Certificate of Establishment) for one actively reg- istered product or one product pro- duced for export (excludes dis- tributor products).

(7) M013 M014 225 (new) 227 (new) Cancer reassessment; applicant-initiated.

Pre-application nano- particle determina- tion.


18 8 284,144 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 re- view 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.

H. R. 2617—1624 (3) Any other covered application that is associated with and dependent on the FIFRA Scientific Advisory Panel review will be subject to its separate registration 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 application to approve an inert ingredient, each application will be subject to its respective reg- istration service fee.

The decision review time for both submissions will be the long- est of the associated applications.

If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be as- sessed for approval of those ingredients.
(5) An application for a new end-use product using a source of active ingredient 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.
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant 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 re- quests 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 difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the asso- ciated registration service fee.
For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label.

If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall pro- vide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’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 busi- ness 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 ingredients in the qualifying product must meet objective, scientific criteria established 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 Protection Agency shall post on a single webpage of the website of the Environmental Protection Agency aggregated information on pesticide regulation under the Federal 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-benefit balancing; (2) hyperlinks to resources, including the Department of Agriculture’s ‘‘national list of allowed and prohibited sub- stances’’ for organic crop and livestock production; (3) biopesticides and pesticides exempt pursuant to section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136w(b)); and (4) integrated pest management principles developed under section 28(c) of such Act (7 U.S.C.

136w–3(c)), including tech- nical assistance for implementation of those principles.

SEC.

708.

IMPLEMENTATION DATES WITH RESPECT TO FEES.

(a) FEE INCREASES.— (1) REGISTRATION SERVICE FEES.—With respect to amend- ments 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 H. R. 2617—1625 not be effective 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 increases 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 Protec- tion 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.
(b) INTERIM REGISTRATION REVIEW DECISION REQUIREMENTS.— (1) DEFINITION OF COVERED INTERIM REGISTRATION REVIEW DECISION.—In this subsection, the term ‘‘covered interim reg- istration review decision’’ means an interim registration review decision— (A) that is associated with an initial registration review described in subsection (a); (B) that is noticed in the Federal Register during the period beginning on the date of enactment 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 Reg- ister, made effects determinations or completed any nec- essary consultation under section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C.
1536(a)(2)).

(2) REQUIREMENTS.—Any covered interim registration review decision shall include, where applicable, 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 Secretary of Agriculture and other members of the interagency working group established under section 3(c)(11) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136a(c)(11)).

H. R. 2617—1626 DIVISION II—PREGNANT WORKERS SEC.

101.

SHORT TITLE.
101.

SHORT TITLE.

This division may be cited as the ‘‘Pregnant Workers Fairness Act’’.

SEC.

102.

DEFINITIONS.

As used in this division— (1) the term ‘‘Commission’’ means the Equal Employment Opportunity Commission; (2) the term ‘‘covered entity’’— (A) has the meaning given the term ‘‘respondent’’ in section 701(n) of the Civil Rights Act of 1964 (42 U.S.C.
2000e(n)); and (B) includes— (i) an employer, which means a person engaged in industry affecting commerce who has 15 or more employees as defined in section 701(b) of title VII of the Civil Rights Act of 1964 (42 U.S.C.

2000e(b)); (ii) an employing office, as defined in section 101 of the Congressional Accountability Act of 1995 (2 U.S.C.
1301) and section 411(c) of title 3, United States Code; (iii) an entity employing a State employee described in section 304(a) of the Government Employee Rights Act of 1991 (42 U.S.C.

2000e–16c(a)); and (iv) an entity to which section 717(a) of the Civil Rights Act of 1964 (42 U.S.C.

2000e–16(a)) applies; (3) the term ‘‘employee’’ means— (A) an employee (including an applicant), as defined in section 701(f) of the Civil Rights Act of 1964 (42 U.S.C.
2000e(f)); (B) a covered employee (including an applicant), as defined in section 101 of the Congressional Accountability Act of 1995 (2 U.S.C.

1301), and an individual described in section 201(d) of that Act (2 U.S.C.

1311(d)); (C) a covered employee (including an applicant), as defined in section 411(c) of title 3, United States Code; (D) a State employee (including an applicant) described in section 304(a) of the Government Employee Rights Act of 1991 (42 U.S.C.
2000e–16c(a)); or (E) an employee (including an applicant) to which sec- tion 717(a) of the Civil Rights Act of 1964 (42 U.S.C.
2000e–16(a)) applies; (4) the term ‘‘known limitation’’ means physical or mental condition related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions that the employee or employee’s representative has communicated to the employer whether or not such condition meets the definition of disability specified in section 3 of the Americans with Disabilities Act of 1990 (42 U.S.C.
12102); (5) the term ‘‘person’’ has the meaning given such term in section 701(a) of the Civil Rights Act of 1964 (42 U.S.C.
2000e(a)); H. R. 2617—1627 (6) the term ‘‘qualified employee’’ means an employee or applicant who, with or without reasonable accommodation, can perform the essential functions of the employment position, except that an employee or applicant shall be considered quali- fied if— (A) any inability to perform an essential function is for a temporary period; near future; and (B) the essential function could be performed in the (C) the inability to perform the essential function can be reasonably accommodated; and (7) the terms ‘‘reasonable accommodation’’ and ‘‘undue hardship’’ have the meanings given such terms in section 101 of the Americans with Disabilities Act of 1990 (42 U.S.C.
12111) and shall be construed as such terms are construed under such Act and as set forth in the regulations required by this division, including with regard to the interactive process that will typically be used to determine an appropriate reasonable accommodation.

SEC.

103.

NONDISCRIMINATION WITH REGARD TO REASONABLE ACCOMMODATIONS RELATED TO PREGNANCY.
It shall be an unlawful employment practice for a covered entity to— (1) not make reasonable accommodations to the known limitations related to the pregnancy, childbirth, or related med- ical conditions of a qualified employee, unless such covered entity can demonstrate that the accommodation would impose an undue hardship on the operation of the business of such covered entity; (2) require a qualified employee affected by pregnancy, childbirth, or related medical conditions to accept an accommo- dation other than any reasonable accommodation arrived at through the interactive process referred to in section 102(7); (3) deny employment opportunities to a qualified employee if such denial is based on the need of the covered entity to make reasonable accommodations to the known limitations related to the pregnancy, childbirth, or related medical condi- tions of the qualified employee; (4) require a qualified employee to take leave, whether paid or unpaid, if another reasonable accommodation can be provided to the known limitations related to the pregnancy, childbirth, or related medical conditions of the qualified employee; or (5) take adverse action in terms, conditions, or privileges of employment against a qualified employee on account of the employee requesting or using a reasonable accommodation to the known limitations related to the pregnancy, childbirth, or related medical conditions of the employee.
SEC.

104.

REMEDIES AND ENFORCEMENT.

(a) EMPLOYEES COVERED BY TITLE VII OF THE CIVIL RIGHTS ACT OF 1964.— (1) IN GENERAL.—The powers, remedies, and procedures provided in sections 705, 706, 707, 709, 710, and 711 of the Civil Rights Act of 1964 (42 U.S.C.

2000e–4 et seq.)

to the Commission, the Attorney General, or any person alleging a violation of title VII of such Act (42 U.S.C.

2000e et seq.)
2000e et seq.)

H. R. 2617—1628 shall be the powers, remedies, and procedures this division provides to the Commission, the Attorney General, or any per- son, respectively, alleging an unlawful employment practice in violation of this division against an employee described in section 102(3)(A) except as provided in paragraphs (2) and (3) of this subsection.

(2) COSTS AND FEES.—The powers, remedies, and proce- dures provided in subsections (b) and (c) of section 722 of the Revised Statutes (42 U.S.C.
1988) shall be the powers, remedies, and procedures this division provides to the Commis- sion, the Attorney General, or any person alleging such practice.

(3) DAMAGES.—The powers, remedies, and procedures pro- vided in section 1977A of the Revised Statutes (42 U.S.C.
1981a), including the limitations contained in subsection (b)(3) of such section 1977A, shall be the powers, remedies, and procedures this division provides to the Commission, the Attorney General, or any person alleging such practice (not an employment practice specifically excluded from coverage under section 1977A(a)(1) of the Revised Statutes (42 U.S.C.

1981a(a)(1))).
1981a(a)(1))).

(b) EMPLOYEES COVERED BY CONGRESSIONAL ACCOUNTABILITY ACT OF 1995.— (1) IN GENERAL.—The powers, remedies, and procedures provided in the Congressional Accountability Act of 1995 (2 U.S.C.

1301 et seq.)

for the purposes of addressing allegations of violations of section 201(a)(1) of such Act (2 U.S.C.
1311(a)(1)) shall be the powers, remedies, and procedures this division provides to address an allegation of an unlawful employment practice in violation of this division against an employee described in section 102(3)(B), except as provided in paragraphs (2) and (3) of this subsection.

(2) COSTS AND FEES.—The powers, remedies, and proce- dures provided in subsections (b) and (c) of section 722 of the Revised Statutes (42 U.S.C.
1988) for the purposes of addressing allegations of such a violation shall be the powers, remedies, and procedures this division provides to address allegations of such practice.

(3) DAMAGES.—The powers, remedies, and procedures pro- vided in section 1977A of the Revised Statutes (42 U.S.C.
1981a), including the limitations contained in subsection (b)(3) of such section 1977A, for purposes of addressing allegations of such a violation, shall be the powers, remedies, and proce- dures this division provides to address any allegation of such practice (not an employment practice specifically excluded from coverage under section 1977A(a)(1) of the Revised Statutes (42 U.S.C.

1981a(a)(1))).
(c) EMPLOYEES COVERED BY CHAPTER 5 OF TITLE 3, UNITED STATES CODE.— (1) IN GENERAL.—The powers, remedies, and procedures provided in chapter 5 of title 3, United States Code, to the President, the Commission, the Merit Systems Protection Board, or any person alleging a violation of section 411(a)(1) of such title shall be the powers, remedies, and procedures this division provides to the President, the Commission, the Board, or any person, respectively, alleging an unlawful employ- ment practice in violation of this division against an employee H. R. 2617—1629 described in section 102(3)(C), except as provided in paragraphs (2) and (3) of this subsection.
(2) COSTS AND FEES.—The powers, remedies, and proce- dures provided in subsections (b) and (c) of section 722 of the Revised Statutes (42 U.S.C.

1988) shall be the powers, remedies, and procedures this division provides to the Presi- dent, the Commission, the Board, or any person alleging such practice.

(3) DAMAGES.—The powers, remedies, and procedures pro- vided in section 1977A of the Revised Statutes (42 U.S.C.
1981a), including the limitations contained in subsection (b)(3) of such section 1977A, shall be the powers, remedies, and procedures this division provides to the President, the Commis- sion, the Board, or any person alleging such practice (not an employment practice specifically excluded from coverage under section 1977A(a)(1) of the Revised Statutes (42 U.S.C.

1981a(a)(1))).
1981a(a)(1))).

(d) EMPLOYEES COVERED BY GOVERNMENT EMPLOYEE RIGHTS ACT OF 1991.— (1) IN GENERAL.—The powers, remedies, and procedures provided in sections 302 and 304 of the Government Employee Rights Act of 1991 (42 U.S.C.

2000e–16b; 2000e–16c) to the Commission or any person alleging a violation of section 302(a)(1) of such Act (42 U.S.C.
2000e–16b(a)(1)) shall be the powers, remedies, and procedures this division provides to the Commission or any person, respectively, alleging an unlawful employment practice in violation of this division against an employee described in section 102(3)(D), except as provided in paragraphs (2) and (3) of this subsection.

(2) COSTS AND FEES.—The powers, remedies, and proce- dures provided in subsections (b) and (c) of section 722 of the Revised Statutes (42 U.S.C.
1988) shall be the powers, remedies, and procedures this division provides to the Commis- sion or any person alleging such practice.

(3) DAMAGES.—The powers, remedies, and procedures pro- vided in section 1977A of the Revised Statutes (42 U.S.C.
1981a), including the limitations contained in subsection (b)(3) of such section 1977A, shall be the powers, remedies, and procedures this division provides to the Commission or any person alleging such practice (not an employment practice specifically excluded from coverage under section 1977A(a)(1) of the Revised Statutes (42 U.S.C.

1981a(a)(1))).
1981a(a)(1))).

(e) EMPLOYEES COVERED BY SECTION 717 OF THE CIVIL RIGHTS ACT OF 1964.— (1) IN GENERAL.—The powers, remedies, and procedures provided in section 717 of the Civil Rights Act of 1964 (42 U.S.C.
2000e–16) to the Commission, the Attorney General, the Librarian of Congress, or any person alleging a violation of that section shall be the powers, remedies, and procedures this division provides to the Commission, the Attorney General, the Librarian of Congress, or any person, respectively, alleging an unlawful employment practice in violation of this division against an employee described in section 102(3)(E), except as provided in paragraphs (2) and (3) of this subsection.
(2) COSTS AND FEES.—The powers, remedies, and proce- dures provided in subsections (b) and (c) of section 722 of the Revised Statutes (42 U.S.C.

1988) shall be the powers, H. R. 2617—1630 remedies, and procedures this division provides to the Commis- sion, the Attorney General, the Librarian of Congress, or any person alleging such practice.

(3) DAMAGES.—The powers, remedies, and procedures pro- vided in section 1977A of the Revised Statutes (42 U.S.C.
1981a), including the limitations contained in subsection (b)(3) of such section 1977A, shall be the powers, remedies, and procedures this division provides to the Commission, the Attorney General, the Librarian of Congress, or any person alleging such practice (not an employment practice specifically excluded from coverage under section 1977A(a)(1) of the Revised Statutes (42 U.S.C.

1981a(a)(1))).
1981a(a)(1))).

(f) PROHIBITION AGAINST RETALIATION.— (1) IN GENERAL.—No person shall discriminate against any employee because such employee has opposed any act or prac- tice made unlawful by this division or because such employee made a charge, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under this division.
(2) PROHIBITION AGAINST COERCION.—It shall be unlawful to coerce, intimidate, threaten, or interfere with any individual in the exercise or enjoyment of, or on account of such individual having exercised or enjoyed, or on account of such individual having aided or encouraged any other individual in the exercise or enjoyment of, any right granted or protected by this division.
(3) REMEDY.—The remedies and procedures otherwise pro- vided for under this section shall be available to aggrieved individuals with respect to violations of this subsection.

(g) LIMITATION.—Notwithstanding subsections (a)(3), (b)(3), (c)(3), (d)(3), and (e)(3), if an unlawful employment practice involves the provision of a reasonable accommodation pursuant to this divi- sion or regulations implementing this division, damages may not be awarded under section 1977A of the Revised Statutes (42 U.S.C.
1981a) if the covered entity demonstrates good faith efforts, in consultation with the employee with known limitations related to pregnancy, childbirth, or related medical conditions who has informed the covered entity that accommodation is needed, to iden- tify and make a reasonable accommodation that would provide such employee with an equally effective opportunity and would not cause an undue hardship on the operation of the covered entity.

SEC.

105.

RULEMAKING.


(a) EEOC RULEMAKING.—Not later than 1 year after the date of enactment of this Act, the Commission shall issue regulations in an accessible format in accordance with subchapter II of chapter 5 of title 5, United States Code, to carry out this division.

Such regulations shall provide examples of reasonable accommodations addressing known limitations related to pregnancy, childbirth, or related medical conditions.
(b) OCWR RULEMAKING.— (1) IN GENERAL.—Not later than 6 months after the Commission issues regulations under subsection (a), the Board (as defined in section 101 of the Congressional Accountability Act of 1995 (2 U.S.C.

1301)) shall (in accordance with section 304 of the Congressional Accountability Act of 1995 (2 U.S.C.

1384)), issue regulations to implement the provisions of this division made applicable to employees described in section 102(3)(B), under section 104(b).
H. R. 2617—1631 (2) PARALLEL WITH AGENCY REGULATIONS.—The regulations issued under paragraph (1) shall be the same as substantive regulations issued by the Commission under subsection (a) except to the extent that the Board may determine, for good cause shown and stated together with the regulations issued under paragraph (1) that a modification of such substantive regulations would be more effective for the implementation of the rights and protection under this division.

SEC.

106.
SEC.

106.

WAIVER OF STATE IMMUNITY.

A State shall not be immune under the 11th Amendment to the Constitution from an action in a Federal or State court of competent jurisdiction for a violation of this division.

In any action against a State for a violation of this division, remedies (including remedies both at law and in equity) are available for such a violation to the same extent as such remedies are available for such a violation in an action against any public or private entity other than a State.
SEC.

107.

RELATIONSHIP TO OTHER LAWS.
(a) IN GENERAL.—Nothing in this division shall be construed— (1) to invalidate or limit the powers, remedies, and proce- dures under any Federal law or law of any State or political subdivision of any State or jurisdiction that provides greater or equal protection for individuals affected by pregnancy, child- birth, or related medical conditions; or (2) by regulation or otherwise, to require an employer- sponsored health plan to pay for or cover any particular item, procedure, or treatment or to affect any right or remedy avail- able under any other Federal, State, or local law with respect to any such payment or coverage requirement.
(b) RULE OF CONSTRUCTION.—This division is subject to the applicability to religious employment set forth in section 702(a) of the Civil Rights Act of 1964 (42 U.S.C.

2000e–1(a)).

SEC.

108.

SEVERABILITY.

If any provision of this division or the application of that provision to particular persons or circumstances is held invalid or found to be unconstitutional, the remainder of this division and the application of that provision to other persons or cir- cumstances shall not be affected.

SEC.

109.
SEC.

109.

EFFECTIVE DATE.

This division shall take effect on the date that is 180 days after the date of enactment of this Act.

DIVISION JJ—NORTH ATLANTIC RIGHT WHALES TITLE I—NORTH ATLANTIC RIGHT WHALES AND REGULATIONS SEC.

101.

NORTH ATLANTIC RIGHT WHALES AND REGULATIONS.


(a) IN GENERAL.—Notwithstanding any other provision 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, H. R. 2617—1632 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 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.).
The National Marine Fisheries Service shall— (1) throughout the period described in the preceding sen- tence, in consultation with affected States and fishing industry participants, promote the innovation and adoption of gear tech- nologies in the fisheries described in the preceding sentence, in order to implement additional whale protection measures by December 31, 2028; (2) promulgate new regulations for the American lobster and Jonah crab fisheries consistent with the Marine Mammal Protection Act of 1972 (16 U.S.C.
1361 et seq.)

and the Endan- gered Species Act of 1973 (16 U.S.C.

1531 et seq.)
that take effect by December 31, 2028, utilizing existing and innovative 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 Potential Biological Removal by December 31, 2028, the amount of serious injury and mortality by fishery and country, and the proportion of the American lobster and Jonah crab fisheries that have transitioned to innovative gear technologies that reduce harm to the North Atlantic Right Whale.
(b) EXCEPTION.—The provisions of subsection (a) shall not apply to an existing emergency rule, or any action taken to extend or make final an emergency rule that 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 Secretary of Commerce, acting through the Under Secretary 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 enti- ties 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.—Assistance provided under this section shall be carried out in a manner consistent with authorities available to the Secretary under the Endan- gered 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.).
1361 et seq.).

(3) COOPERATIVE AGREEMENTS.—The Under Secretary may enter into cooperative agreements with the National Fish and H. R. 2617—1633 Wildlife Foundation established by the National Fish and Wild- life Foundation Establishment Act (16 U.S.C.

3701 et seq.)

to carry out this title.
(b) ELIGIBLE ENTITIES.—An entity is an eligible entity for pur- poses 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 determined appro- priate by the Under Secretary, including— (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 maritime industry, such as boating, shipping, fishing, fishing gear and rope manufacturing, and other maritime activities; (4) a nonprofit organization or research institution with expertise in commercial fisheries, gear innovation, and North Atlantic right whale conservation; or (5) a consortium of entities described in paragraphs (1) through (4).
(c) ELIGIBLE USES.—Assistance awarded under subsection (a) may be used to develop, assess, and carry out activities that reduce human induced threats to North Atlantic 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 technologies by fisheries partici- pants, which may include direct payment to fisheries partici- pants; (3) training for fisheries participants to improve deploy- ment, 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 Secretary in consultation with relevant eligible entities.
(d) PRIORITY.—In determining whether to fund project proposals under this section, the Under Secretary shall prioritize projects— (1) with a substantial likelihood of reducing lethal and sub-lethal effects on North Atlantic right whales from fishing gear entanglements or vessel collisions; (2) that include cooperation with fishing industry partici- pants 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 paragraph (2), funds awarded under this section may not be used to distribute resources to an entity or individual 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).
(f) PROJECT REPORTING.— H. R. 2617—1634 (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 government officials, determines is necessary to evaluate the progress and success of the project for the purposes of ensuring positive results, assessing problems, 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 Secretary shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Natural Resources of the House of Representatives a report on the results and effectiveness of projects receiving assistance provided under this title.

SEC.

203.

FUNDING.


(a) AUTHORIZATION OF APPROPRIATIONS.— (1) AUTHORIZATION.—There is authorized to be appro- priated 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 administrative expenses necessary to carry out this title.
(b) ACCEPTANCE AND USE OF DONATIONS.—The Under Secretary may accept, receive, solicit, hold, administer, 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.

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.
(b) REQUIRED ELEMENTS.—For the purpose of conducting 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, non- profit organizations, commercial vessels, and other Federal agencies; (2) in as short a time as possible, ensure relevant survey samples and results are analyzed, stored, archived, and made publicly available; H. R. 2617—1635 (3) prioritize the collection of plankton samples and data that inform the conservation of North Atlantic right whales; and (4) to the extent practicable, coordinate with the Govern- ment of Canada to develop a transboundary understanding of plankton abundance and distribution.
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion 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 existing funds otherwise appropriated to the Secretary.

DIVISION KK—PUMP FOR NURSING MOTHERS ACT SEC.

101.

SHORT TITLE.

This division may be cited as the ‘‘Providing Urgent Maternal Protections for Nursing Mothers Act’’ or the ‘‘PUMP for Nursing Mothers Act’’.

SEC.

102.
SEC.

102.

BREASTFEEDING ACCOMMODATIONS IN THE WORKPLACE.

(a) EXPANDING EMPLOYEE ACCESS TO BREAK TIME AND SPACE.— The Fair Labor Standards Act of 1938 (29 U.S.C.

201 et seq.)

is amended— (1) in section 7 (29 U.S.C.

207), by striking subsection (r); and (2) by inserting after section 18C (29 U.S.C.

218c) the following: ‘‘SEC.

18D.

BREASTFEEDING ACCOMMODATIONS IN THE WORKPLACE.


‘‘(a) IN GENERAL.—An employer shall provide— ‘‘(1) a reasonable break time for an employee to express breast milk for such employee’s nursing child for 1 year after the child’s birth each time such employee has need to express the milk; and ‘‘(2) a place, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public, which may be used by an employee to express breast milk.
‘‘(b) COMPENSATION.— ‘‘(1) IN GENERAL.—Subject to paragraph (2), an employer shall not be required to compensate an employee receiving reasonable break time under subsection (a)(1) for any time spent during the workday for such purpose unless otherwise required by Federal or State law or municipal ordinance.

‘‘(2) RELIEF FROM DUTIES.—Break time provided under sub- section (a)(1) shall be considered hours worked if the employee is not completely relieved from duty during the entirety of such break.
‘‘(c) EXEMPTION FOR SMALL EMPLOYERS.—An employer that employs less than 50 employees shall not be subject to the require- ments of this section, if such requirements would impose an undue hardship by causing the employer significant difficulty or expense when considered in relation to the size, financial resources, nature, or structure of the employer’s business.
‘‘(d) EXEMPTION FOR CREWMEMBERS OF AIR CARRIERS.— H. R. 2617—1636 ‘‘(1) IN GENERAL.—An employer that is an air carrier shall not be subject to the requirements of this section with respect to an employee of such air carrier who is a crewmember ‘‘(2) DEFINITIONS.—In this subsection: ‘‘(A) AIR CARRIER.—The term ‘air carrier’ has the meaning given such term in section 40102 of title 49, United States Code.
‘‘(B) CREWMEMBER.—The term ‘crewmember’ has the meaning given such term in section 1.1 of title 14, Code of Federal Regulations (or successor regulations).

‘‘(e) APPLICABILITY TO RAIL CARRIERS.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), an employer that is a rail carrier shall be subject to the require- ments of this section.
‘‘(2) CERTAIN EMPLOYEES.—An employer that is a rail car- rier shall be subject to the requirements of this section with respect to an employee of such rail carrier who is a member of a train crew involved in the movement of a locomotive or rolling stock or who is an employee who maintains the right of way, provided that compliance with the requirements of this section does not— ‘‘(A) require the employer to incur significant expense, such as through the addition of such a member of a train crew in response to providing a break described in sub- section (a)(1) to another such member of a train crew, removal or retrofitting of seats, or the modification or retro- fitting of a locomotive or rolling stock; or ‘‘(B) result in unsafe conditions for an individual who is an employee who maintains the right of way.
‘‘(3) SIGNIFICANT EXPENSE.—For purposes of paragraph (2)(A), it shall not be considered a significant expense to modify or retrofit a locomotive or rolling stock by installing a curtain or other screening protection.

‘‘(4) DEFINITIONS.—In this subsection: ‘‘(A) EMPLOYEE WHO MAINTAINS THE RIGHT OF WAY.— The term ‘employee who maintains the right of way’ means an employee who is a safety-related railroad employee described in section 20102(4)(C) of title 49, United States Code.
‘‘(B) RAIL CARRIER.—The term ‘rail carrier’ means an employer described in section 13(b)(2).

‘‘(C) TRAIN CREW.—The term ‘train crew’ has the meaning given such term as used in chapter II of subtitle B of title 49, Code of Federal Regulations (or successor regulations).

‘‘(f) APPLICABILITY TO MOTORCOACH SERVICES OPERATORS.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), an employer that is a motorcoach services operator shall be subject to the requirements of this section.
‘‘(2) EMPLOYEES WHO ARE INVOLVED IN THE MOVEMENT OF A MOTORCOACH.—An employer that is a motorcoach services operator shall be subject to the requirements of this section with respect to an employee of such motorcoach services oper- ator who is involved in the movement of a motorcoach provided that compliance with the requirements of this section does not— H. R. 2617—1637 ‘‘(A) require the employer to incur significant expense, such as through the removal or retrofitting of seats, the modification or retrofitting of a motorcoach, or unscheduled stops; or ‘‘(B) result in unsafe conditions for an employee of a motorcoach services operator or a passenger of a motor- coach.
‘‘(3) SIGNIFICANT EXPENSE.—For purposes of paragraph (2)(A), it shall not be considered a significant expense— ‘‘(A) to modify or retrofit a motorcoach by installing a curtain or other screening protection if an employee requests such a curtain or other screening protection; or ‘‘(B) for an employee to use scheduled stop time to express breast milk.
‘‘(4) DEFINITIONS.—In this subsection: ‘‘(A) MOTORCOACH; MOTORCOACH SERVICES.—The terms ‘motorcoach’ and ‘motorcoach services’ have the meanings given the terms in section 32702 of the Motorcoach Enhanced Safety Act of 2012 (49 U.S.C.

31136 note).

‘‘(B) MOTORCOACH SERVICES OPERATOR.—The term ‘motorcoach services operator’ means an entity that offers motorcoach services.
‘‘(g) NOTIFICATION PRIOR TO COMMENCEMENT OF ACTION.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), before commencing an action under section 16(b) for a violation of subsection (a)(2), an employee shall— ‘‘(A) notify the employer of such employee of the failure to provide the place described in such subsection; and ‘‘(B) provide the employer with 10 days after such notification to come into compliance with such subsection with respect to the employee.
‘‘(2) EXCEPTIONS.—Paragraph (1) shall not apply in a case in which— ‘‘(A) the employee has been discharged because the employee— ‘‘(i) has made a request for the break time or place described in subsection (a); or ‘‘(ii) has opposed any employer conduct related to this section; or ‘‘(B) the employer has indicated that the employer has no intention of providing the place described in subsection (a)(2).
‘‘(h) INTERACTION WITH STATE AND FEDERAL LAW.— ‘‘(1) LAWS PROVIDING GREATER PROTECTION.—Nothing in this section shall preempt a State law or municipal ordinance that provides greater protections to employees than the protec- tions provided for under this section.

‘‘(2) NO EFFECT ON TITLE 49 PREEMPTION.—This section shall have no effect on the preemption of a State law or munic- ipal ordinance that is preempted under subtitle IV, V, or VII of title 49, United States Code.’’.
(b) CLARIFYING REMEDIES.—The Fair Labor Standards Act of 1938 (29 U.S.C.

201 et seq.)

is amended— (1) in section 15(a) (29 U.S.C.

215(a))— (A) by striking the period at the end of paragraph (5) and inserting ‘‘; and’’; and (B) by adding at the end the following: H. R. 2617—1638 ‘‘(6) to violate any of the provisions of section 18D.’’; and (2) in section 16(b) (29 U.S.C.

216(b)), by striking ‘‘15(a)(3)’’ each place the term appears and inserting ‘‘15(a)(3) or 18D’’.
(c) AUTHORIZING EMPLOYEES TO TEMPORARILY OBSCURE THE FIELD OF VIEW OF AN IMAGE RECORDING DEVICE ON A LOCOMOTIVE OR ROLLING STOCK WHILE EXPRESSING BREAST MILK.—Section 20168(f) of title 49, United States Code, is amended— (1) by striking ‘‘A railroad carrier’’ and inserting the fol- lowing: ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), a railroad carrier’’; and (2) by adding at the end the following: ‘‘(2) TEMPORARILY OBSCURING FIELD OF VIEW OF AN IMAGE RECORDING DEVICE WHILE EXPRESSING BREAST MILK.— ‘‘(A) IN GENERAL.—For purposes of expressing breast milk, an employee may temporarily obscure the field of view of an image recording device required under this section if the passenger train on which such device is installed is not in motion.
‘‘(B) RESUMING OPERATION.—The crew of a passenger train on which an image recording device has been obscured pursuant to subparagraph (A) shall ensure that such image recording device is no longer obscured immediately after the employee has finished expressing breast milk and before resuming operation of the passenger train.’’.

SEC.

103.

EFFECTIVE DATE.

(a) EXPANDING ACCESS.—The amendments made by section 102(a) shall take effect on the date of enactment of this Act.
(b) REMEDIES AND CLARIFICATION.—The amendments made by section 102(b) shall take effect on the date that is 120 days after the date of enactment of this Act.

(c) AUTHORIZING EMPLOYEES TO TEMPORARILY OBSCURE THE FIELD OF VIEW OF AN IMAGE RECORDING DEVICE ON A LOCOMOTIVE OR ROLLING STOCK WHILE EXPRESSING BREAST MILK.—The amend- ments made by section 102(c) shall take effect on the date of enactment of this Act.
(d) APPLICATION OF LAW TO EMPLOYEES OF RAIL CARRIERS.— (1) IN GENERAL.—Section 18D of the Fair Labor Standards Act of 1938 (as added by section 102(a)) shall not apply to employees who are members of a train crew involved in the movement of a locomotive or rolling stock or who are employees who maintain the right of way of an employer that is a rail carrier until the date that is 3 years after the date of enactment of this Act.
(2) DEFINITIONS.—In this subsection: (A) EMPLOYEE; EMPLOYER.—The terms ‘‘employee’’ and ‘‘employer’’ have the meanings given such terms in section 3 of the Fair Labor Standards Act of 1938 (29 U.S.C.

203).

(B) EMPLOYEES WHO MAINTAINS THE RIGHT OF WAY; RAIL CARRIER; TRAIN CREW.—The terms ‘‘employee who maintains the right of way’’, ‘‘rail carrier’’, and ‘‘train crew’’ have the meanings given such terms in section 18D(e)(4) of the Fair Labor Standards Act of 1938, as added by section 102(a).
H. R. 2617—1639 (e) APPLICATION OF LAW TO EMPLOYEES OF MOTORCOACH SERV- ICES OPERATORS.— (1) IN GENERAL.—Section 18D of the Fair Labor Standards Act of 1938 (as added by section 102(a)) shall not apply to employees who are involved in the movement of a motorcoach of an employer that is a motorcoach services operator until the date that is 3 years after the date of enactment of this Act.
(2) DEFINITIONS.—In this subsection: (A) EMPLOYEE; EMPLOYER.—The terms ‘‘employee’’ and ‘‘employer’’ have the meanings given such terms in section 3 of the Fair Labor Standards Act of 1938 (29 U.S.C.

203).

(B) MOTORCOACH; MOTORCOACH SERVICES OPERATOR.— The terms ‘‘motorcoach’’ and ‘‘motorcoach services operator’’ have the meanings given such terms in section 18D(f)(4) of the Fair Labor Standards Act of 1938, as added by section 102(a).
DIVISION LL—STATE, LOCAL, TRIBAL, AND TERRITORIAL FISCAL RECOV- INFRASTRUCTURE, AND DIS- ERY, ASTER RELIEF FLEXIBILITY SEC.

101.

SHORT TITLE.

This division may be cited as the ‘‘State, Local, Tribal, and Territorial Fiscal Recovery, Infrastructure, and Disaster Relief Flexibility Act’’.

SEC.

102.

AUTHORITY TO USE CORONAVIRUS RELIEF FUNDS FOR INFRASTRUCTURE PROJECTS.

(a) IN GENERAL.—Title VI of the Social Security Act (42 U.S.C.

801 et seq.
), as amended by section 40909 of the Infrastructure Investment and Jobs Act, is amended— (1) in section 602— (A) in subsection (a)(1), by inserting ‘‘(except as pro- vided in subsection (c)(5))’’ after ‘‘December 31, 2024’’; and (B) in subsection (c)— (i) in paragraph (1)— (I) in the matter preceding subparagraph (A), by striking ‘‘paragraph (3)’’ and inserting ‘‘para- graphs (3), (4), and (5)’’; (II) by amending subparagraph (C) to read as follows: ‘‘(C) for the provision of government services up to an amount equal to the greater of— ‘‘(i) the amount of the reduction in revenue of such State, territory, or Tribal government due to the COVID–19 public health emergency relative to reve- nues collected in the most recent full fiscal year of the State, territory, or Tribal government prior to the emergency; or ‘‘(ii) $10,000,000;’’; (III) in subparagraph (D), by striking the period at the end and inserting ‘‘; or’’; and H. R. 2617—1640 (IV) by adding at the end the following new subparagraph: ‘‘(E) to provide emergency relief from natural disasters or the negative economic impacts of natural disasters, including temporary emergency housing, food assistance, financial assistance for lost wages, or other immediate needs.’’; and (ii) by adding at the end the following new para- graph: ‘‘(5) AUTHORITY TO USE FUNDS FOR CERTAIN INFRASTRUC- TURE PROJECTS.— ‘‘(A) IN GENERAL.—Subject to subparagraph (C), not- withstanding any other provision of law, a State, territory, or Tribal government receiving a payment under this
 sec- tion may use funds provided under such payment for projects described in subparagraph (B), including, to the extent consistent with guidance or rules issued by the Secretary or the head of a Federal agency to which the Secretary has delegated authority pursuant to subpara- graph (C)(iv)— ‘‘(i) in the case of a project eligible under section 117 of title 23, United States Code, or section 5309 or 6701 of title 49, United States Code, to satisfy a non-Federal share requirement applicable to such a
 project; and ‘‘(ii) in the case of a project eligible for credit assistance under the TIFIA program under chapter 6 of title 23, United States Code— ‘‘(I) to satisfy a non-Federal share requirement applicable to such a project; and ‘‘(II) to repay a loan provided under such pro- gram.
‘‘(B) PROJECTS DESCRIBED.—A project referred to in subparagraph (A) is any of the following: ‘‘(i) A project eligible under section 117 of title 23, United States Code.

‘‘(ii) A project eligible under section 119 of title 23, United States Code.

‘‘(iii) A project eligible under section 124 of title 23, United States Code, as added by the Infrastructure Investment and Jobs Act.

‘‘(iv) A project eligible under section 133 of title 23, United States Code.
‘‘(v) An activity to carry out section 134 of title 23, United States Code.

‘‘(vi) A project eligible under section 148 of title 23, United States Code.

‘‘(vii) A project eligible under section 149 of title 23, United States Code.

‘‘(viii) A project eligible under section 151(f) of title 23, United States Code, as added by the Infra- structure Investment and Jobs Act.

‘‘(ix) A project eligible under section 165 of title 23, United States Code.
‘‘(x) A project eligible under section 167 of title 23, United States Code.

H. R. 2617—1641 ‘‘(xi) A project eligible under section 173 of title 23, United States Code, as added by the Infrastructure Investment and Jobs Act.

‘‘(xii) A project eligible under section 175 of title 23, United States Code, as added by the Infrastructure Investment and Jobs Act.

‘‘(xiii) A project eligible under section 176 of title 23, United States Code, as added by the Infrastructure Investment and Jobs Act.
‘‘(xiv) A project eligible under section 202 of title 23, United States Code.

‘‘(xv) A project eligible under section 203 of title 23, United States Code.

‘‘(xvi) A project eligible under section 204 of title 23, United States Code.

‘‘(xvii) A project eligible under the program for national infrastructure investments (commonly known as the ‘Rebuilding American Infrastructure with Sustainability and Equity (RAISE) grant program’).
‘‘(xviii) A project eligible for credit assistance under the TIFIA program under chapter 6 of title 23, United States Code.

‘‘(xix) A project that furthers the completion of a designated route of the Appalachian Development Highway System under section 14501 of title 40, United States Code.

‘‘(xx) A project eligible under section 5307 of title 49, United States Code.

‘‘(xxi) A project eligible under section 5309 of title 49, United States Code.
‘‘(xxii) A project eligible under section 5311 of title 49, United States Code.

‘‘(xxiii) A project eligible under section 5337 of title 49, United States Code.

‘‘(xxiv) A project eligible under section 5339 of title 49, United States Code.

‘‘(xxv) A project eligible under section 6703 of title 49, United States Code, as added by the Infrastructure Investment and Jobs Act.

‘‘(xxvi) A project eligible under title I of the Housing and Community Development Act of 1974 (42 U.S.C.

5301 et seq.).
5301 et seq.).

‘‘(xxvii) A project eligible under the bridge replace- ment, rehabilitation, preservation, protection, and construction program under paragraph (1) under the heading ‘HIGHWAY INFRASTRUCTURE PROGRAM’ under the heading ‘FEDERAL HIGHWAY ADMINISTRATION’ under the heading ‘DEPARTMENT OF TRANSPOR- TATION’ under title VIII of division J of the Infrastruc- ture Investment and Jobs Act.
‘‘(C) LIMITATIONS; APPLICATION OF REQUIREMENTS.— ‘‘(i) LIMITATION ON AMOUNTS TO BE USED FOR INFRASTRUCTURE PROJECTS.— ‘‘(I) IN GENERAL.—The total amount that a State, territory, or Tribal government may use from a payment made under this section for uses H. R. 2617—1642 described in subparagraph (A) shall not exceed the greater of— ‘‘(aa) $10,000,000; and ‘‘(bb) 30 percent of such payment.
‘‘(II) RULE OF APPLICATION.—The spending limitation under subclause (I) shall not apply to any use of funds permitted under paragraph (1), and any such use of funds shall be disregarded for purposes of applying such spending limitation.

‘‘(ii) LIMITATION ON OPERATING EXPENSES.—Funds provided under a payment made under this section shall not be used for operating expenses of a project described in clauses (xx) through (xxiv) of subpara- graph (B).
‘‘(iii) APPLICATION OF REQUIREMENTS.—Except as otherwise determined by the Secretary or the head of a Federal agency to which the Secretary has dele- gated authority pursuant to clause (iv) or provided in this section— ‘‘(I) the requirements of section 60102 of the Infrastructure Investment and Jobs Act shall apply to funds provided under a payment made under this section that are used pursuant to subpara- graph (A) for a project described in clause (xxvi) of subparagraph (B) that relates to broadband infrastructure; ‘‘(II) the requirements of titles 23, 40, and 49 of the United States Code, title I of the Housing and Community Development Act of 1974 (42 U.S.C.
5301 et seq.

), and the National Environ- mental Policy Act of 1969 (42 U.S.C.

4321 et.
seq) shall apply to funds provided under a payment made under this section that are used for projects described in subparagraph (B); and ‘‘(III) a State government receiving a payment under this section may use funds provided under such payment for projects described in clauses (i) through (xxvii) of subparagraph (B), as applicable, that— ‘‘(aa) demonstrate progress in achieving a state of good repair as required by the State’s asset management plan under section 119(e) of title 23, United States Code; and ‘‘(bb) support the achievement of 1 or more performance targets of the State established under section 150 of title 23, United States Code.
‘‘(iv) OVERSIGHT.—The Secretary may delegate oversight and administration of the requirements described in clause (iii) to the appropriate Federal agency.

‘‘(v) SUPPLEMENT, NOT SUPPLANT.—Amounts from a payment made under this section that are used by a State, territory, or Tribal government for uses described in subparagraph (A) shall supplement, and not supplant, other Federal, State, territorial, Tribal, H. R. 2617—1643 and local government funds (as applicable) otherwise available for such uses.
‘‘(D) REPORTS.—The Secretary, in consultation with the Secretary of Transportation, shall provide periodic reports on the use of funds by States, territories, and Tribal govern- ments under subparagraph (A).
‘‘(E) AVAILABILITY.—Funds provided under a payment made under this section to a State, territory, or Tribal government shall remain available for obligation for a use described in subparagraph (A) through December 31, 2024, except that no amount of such funds may be expended after September 30, 2026.’’; and (2) in subsection 603— (A) in subsection (a), by inserting ‘‘(except as provided in subsection (c)(6))’’ after ‘‘December 31, 2024’’; and (B) in subsection (c)— (i) in paragraph (1)— (I) in the matter preceding subparagraph (A), by striking ‘‘paragraphs (3) and (4)’’ and inserting ‘‘paragraphs (3), (4), (5), and (6)’’; (II) by amending subparagraph (C) to read as follows: ‘‘(C) for the provision of government services up to an amount equal to the greater of— ‘‘(i) the amount of the reduction in revenue of such metropolitan city, nonentitlement unit of local government, or county due to the COVID–19 public health emergency relative to revenues collected in the most recent full fiscal year of the metropolitan city, nonentitlement unit of local government, or county to the emergency; or ‘‘(ii) $10,000,000;’’; (III) in subparagraph (D), by striking the period at the end and inserting ‘‘; or’’; and (IV) by adding at the end the following new subparagraph: ‘‘(E) to provide emergency relief from natural disasters or the negative economic impacts of natural disasters, including temporary emergency housing, food assistance, financial assistance for lost wages, or other immediate needs.’’; and (ii) by adding at the
 end the following new para- graph: ‘‘(6) AUTHORITY TO USE FUNDS FOR CERTAIN INFRASTRUC- TURE PROJECTS.— ‘‘(A) IN GENERAL.—Subject to subparagraph (B), not- withstanding any other provision of law, a metropolitan city, nonentitlement unit of local government, or county receiving a payment under this section may use funds provided under such payment for projects described in subparagraph (B) of section 602(c)(5), including, to the extent consistent with guidance or rules issued by the Secretary or the head of a
 Federal agency to which the Secretary has delegated authority pursuant to subpara- graph (B)(iv)— ‘‘(i) in the case of a project eligible under section 117 of title 23, United States Code, or section 5309 H. R. 2617—1644 or 6701 of title 49, United States Code, to satisfy a non-Federal share requirement applicable to such a project; and ‘‘(ii) in the case of a project eligible for credit assistance under the TIFIA program under chapter 6 of title 23, United States Code— ‘‘(I) to satisfy a non-Federal share requirement applicable to such a project; and ‘‘(II) to repay a loan provided under such pro- gram.
‘‘(B) LIMITATIONS; APPLICATION OF REQUIREMENTS.— ‘‘(i) LIMITATION ON AMOUNTS TO BE USED FOR INFRASTRUCTURE PROJECTS.— ‘‘(I) IN GENERAL.—The total amount that a metropolitan city, nonentitlement unit of local government, or county may use from a payment made under this section for uses described in subparagraph (A) shall not exceed the greater of— ‘‘(aa) $10,000,000; and ‘‘(bb) 30 percent of such payment.
‘‘(II) RULE OF APPLICATION.—The spending limitation under subclause (I) shall not apply to any use of funds permitted under paragraph (1), and any such use of funds shall be disregarded for purposes of applying such spending limitation.

‘‘(ii) LIMITATION ON OPERATING EXPENSES.—Funds provided under a payment made under this section shall not be used for operating expenses of a project described in clauses (xx) through (xxiv) of section 602(c)(5)(B).
‘‘(iii) APPLICATION OF REQUIREMENTS.—Except as otherwise determined by the Secretary or the head of a Federal agency to which the Secretary has dele- gated authority pursuant to clause (iv) or provided in this section— ‘‘(I) the requirements of section 60102 of the Infrastructure Investment and Jobs Act shall apply to funds provided under a payment made under this section that are used pursuant to subpara- graph (A) for a project described in clause (xxvi) of section 602(c)(5)(B) that relates to broadband infrastructure; and ‘‘(II) the requirements of titles 23, 40, and 49 of the United States Code, title I of the Housing and Community Development Act of 1974 (42 U.S.C.
5301 et seq.

), and the National Environ- mental Policy Act of 1969 (42 U.S.C.

4321 et.

seq) shall apply to funds provided under a payment made under this section that are used for projects described in section 602(c)(5)(B).

‘‘(iv) OVERSIGHT.—The Secretary may delegate oversight and administration of the requirements described in clause (iii) to the appropriate Federal agency.
‘‘(v) SUPPLEMENT, NOT SUPPLANT.—Amounts from a payment made under this section that are used by a metropolitan city, nonentitlement unit of local H. R. 2617—1645 government, or county for uses described in subpara- graph (A) shall supplement, and not supplant, other Federal, State, territorial, Tribal, and local government funds (as applicable) otherwise available for such uses.
‘‘(C) REPORTS.—The Secretary, in consultation with the Secretary of Transportation, shall provide periodic reports on the use of funds by metropolitan cities, nonentitlement units of local government, or counties under subparagraph (A).
‘‘(D) AVAILABILITY.—Funds provided under a payment made under this section to a metropolitan city, nonentitle- ment unit of local government, or county shall remain available for obligation for a use described in subparagraph (A) through December 31, 2024, except that no amount of such funds may be expended after September 30, 2026.’’.

(b) TECHNICAL AMENDMENTS.—Sections 602(c)(3) and 603(c)(3) of title VI of the Social Security Act (42 U.S.C.
802(c)(3), 803(c)(3)) are each amended by striking ‘‘paragraph (17) of’’.

(c) GUIDANCE AND EFFECTIVE DATE.— (1) GUIDANCE OR RULE.—Within 60 days of the date of enactment of this Act, the Secretary of the Treasury, in con- sultation with the Secretary of Transportation, shall issue guid- ance or promulgate a rule to carry out the amendments made by this section, including updating reporting requirements on the use of funds under this section.
(2) EFFECTIVE DATE.—The amendments made by this sec- tion shall take effect upon the issuance of guidance or the promulgation of a rule described in paragraph (1).
(d) DEPARTMENT TREASURY ADMINISTRATIVE THE OF EXPENSES.— (1) REDUCTION OF FUNDS AVAILABLE FOR ADMINISTRATIVE EXPENSES.—Title IV of division A of the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116–136) is amended— (A) in section 4003(f), by striking ‘‘$100,000,000’’ and inserting ‘‘61,000,000’’; and (B) in section 4112(b), by striking ‘‘$100,000,000’’ and inserting ‘‘$67,000,000’’.
(2) AUTHORITY.—Notwithstanding any other provision of law, the unobligated balances from amounts made available to the Secretary of the Treasury (referred to in this subsection as the ‘‘Secretary’’) for administrative expenses pursuant to the provisions specified in paragraph (3) shall be available to the Secretary (in addition to any other appropriations pro- vided for such purpose) for the purpose described in paragraph (4) (subject to the limitation in such paragraph) and for administrative expenses of the Department of the Treasury, except for the Internal Revenue Service, determined by the Secretary to be necessary to respond to the coronavirus emer- gency, including any expenses necessary to implement any provision of— (A) the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116–136); (B) division N of the Consolidated Appropriations Act, 2021 (Public Law 116–260); (C) the American Rescue Plan Act (Public Law 117– 2); or H. R. 2617—1646 (D) title VI of the Social Security Act (42 U.S.C.
801 et seq.).

(3) PROVISIONS SPECIFIED.—The provisions specified in this paragraph are the following: (A) Amounts made available under section 4027(a) of the Coronavirus Aid, Relief, and Economic Security Act (15 U.S.C.

9061(a)) to pay costs and administrative expenses under section 4003(f) of such Act (15 U.S.C.

9042(f))) and amounts made available by section 4120(a) of the Coronavirus Aid, Relief, and Economic Security Act (15 U.S.C.
9080) to pay costs and administrative expenses under section 4112(b) of such Act (15 U.S.C.

9072(b)) (after application of the amendments made by paragraph (1) of this subsection).

(B) Section 421(f)(2) of division N of the Consolidated Appropriations Act, 2021 (Public Law 116–260).

(C) Sections 3201(a)(2)(B), 3206(d)(1)(A), and 7301(b)(5) of the American Rescue Plan Act of 2021 (Public Law 117–2).

(D) Section 602(a)(2) of the Social Security Act (42 U.S.C.

802(a)(2)).
802(a)(2)).

(4) PAYMENTS TO ELIGIBLE REVENUE SHARING CONSOLI- DATED GOVERNMENTS.—Of amounts made available under para- graph (2), up to $10,600,000 shall be available to the Secretary (in addition to any other appropriations provided for such pur- pose) for making payments to eligible revenue sharing consoli- dated governments under subsection (g) of section 605 of the Social Security Act (42 U.S.C.

805), as added by section 103 of this Act.

SEC.

103.
SEC.

103.

ALLOWING PAYMENTS TO ELIGIBLE REVENUE SHARING CONSOLIDATED GOVERNMENTS FROM LOCAL ASSISTANCE AND TRIBAL CONSISTENCY FUND.

(a) IN GENERAL.—Section 605 of the Social Security Act (42 U.S.C.
805) is amended by adding at the end the following new subsection: ‘‘(g) PAYMENTS TO ELIGIBLE REVENUE SHARING CONSOLIDATED GOVERNMENTS.— ‘‘(1) PAYMENTS TO ELIGIBLE REVENUE SHARING CONSOLI- DATED GOVERNMENTS FOR FISCAL YEARS 2023 AND 2024.—The Secretary shall allocate and pay to each eligible revenue sharing consolidated government for each of fiscal years 2023 and 2024 an amount equal to the amount that the Secretary would have allocated to such eligible revenue sharing consolidated government for fiscal year 2022 if all eligible revenue sharing consolidated governments had been treated as eligible revenue sharing counties for purposes of being eligible for payments under subsection (b)(1) for such fiscal year using the allocation methodology adopted by the Department of the Treasury for such eligible revenue sharing counties as of the date of enact- ment of this subsection.
‘‘(2) FUNDING FOR PAYMENTS.— ‘‘(A) IN GENERAL.—The Secretary shall make the alloca- tions and payments described in paragraph (1) from the amounts described in subparagraph (B), which shall be available to the Secretary for such purpose notwithstanding any other provision of law.
H. R. 2617—1647 ‘‘(B) AMOUNTS DESCRIBED.—The amounts described in this subparagraph are the following: ‘‘(i) Any amount allocated to an eligible revenue sharing county under subsection (b)(1) for fiscal year 2022 or 2023 that, as of January 31, 2023, has not been requested by such county.

‘‘(ii) Amounts made available to the Secretary under section 102(d)(4) of the State, Local, Tribal, and Territorial Fiscal Recovery, Infrastructure, and Dis- aster Relief Flexibility Act.’’.
(b) CONFORMING AMENDMENTS.—Section 605 of the Social Secu- rity Act (42 U.S.C.
805), as amended by subsection (a), is further amended— (1) in subsection (a), by inserting ‘‘, subject to subsection (g),’’ after ‘‘obligated’’; (2) in subsection (c), by striking ‘‘or an eligible Tribal government’’ and inserting ‘‘, an eligible Tribal government, or an eligible revenue sharing consolidated government’’; (3) in subsections (d) and (e), by inserting ‘‘or eligible revenue sharing consolidated government’’ after ‘‘eligible rev- enue sharing county’’ each place it appears; and (4) in subsection (f)— (A) by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively; and (B) by inserting before paragraph (2) (as so redesig- nated) the following new paragraph: ‘‘(1) ELIGIBLE REVENUE SHARING CONSOLIDATED GOVERN- MENT.—The term ‘eligible revenue sharing consolidated govern- ment’ means a county, parish, or borough— ‘‘(A) that has been classified by the Bureau of the Census as an active government consolidated with another government; and ‘‘(B) for which, as determined by the Secretary, there is a negative revenue impact due to implementation of a Federal program or changes to such program.’’.
SEC.

104.

EXTENSION OF AVAILABILITY OF CORONAVIRUS RELIEF FUND PAYMENTS TO TRIBAL GOVERNMENTS.

Section 601(d)(3) of the Social Security Act (42 U.S.C.

801(d)(3)) is amended by inserting ‘‘(or, in the case of costs incurred by a Tribal government, during the period that begins on March 1, 2020, and ends on December 31, 2022)’’ before the period.

SEC.

105.

RESCISSION OF CORONAVIRUS RELIEF AND RECOVERY FUNDS DECLINED BY STATES, TERRITORIES, OR OTHER GOVERNMENTAL ENTITIES.
Title VI of the Social Security Act (42 U.S.C.

801 et seq.)

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

606.

RESCISSION OF FUNDS DECLINED BY STATES, TERRITORIES, OR OTHER GOVERNMENTAL ENTITIES.
‘‘(a) RESCISSION.— ‘‘(1) IN GENERAL.—Subject to paragraphs (2) and (3), if a State, territory, or other governmental entity provides notice to the Secretary of the Treasury in the manner provided by the Secretary of the Treasury that the State, territory, or other governmental entity intends to decline all or a portion of the amounts that are to be awarded to the State, territory, H. R. 2617—1648 or other governmental entity from funds appropriated under this title, an amount equal to the unaccepted amounts or por- tion of such amounts allocated by the Secretary of the Treasury as of the date of such notice that would have been awarded to the State, territory, or other governmental entity shall be rescinded from the applicable appropriation account.
‘‘(2) EXCLUSION.—Paragraph (1) shall not apply with respect to funds that are to be paid to a State under section 603 for distribution to nonentitlement units of local government.
‘‘(3) RULES OF CONSTRUCTION.—Paragraph (1) shall not be construed as— ‘‘(A) preventing a sub-State governmental entity, including a nonentitlement unit of local government, from notifying the Secretary of the Treasury that the sub-State governmental entity intends to decline all or a portion of the amounts that a State may distribute to the entity from funds appropriated under this title; or ‘‘(B) allowing a State to prohibit or otherwise prevent a sub-State governmental entity from providing such a notice.
‘‘(b) USE FOR DEFICIT REDUCTION.—Amounts rescinded under subsection (a) shall be deposited in the general fund of the Treasury for the sole purpose of deficit reduction.
‘‘(c) STATE OR OTHER GOVERNMENTAL ENTITY DEFINED.—In this section, the term ‘State, territory, or other governmental entity’ means any entity to which a payment may be made directly to the entity under this title other than a Tribal government, as defined in sections 601(g), 602(g), and 604(d), and an eligible Tribal government, as defined in section 605(f).’’.

DIVISION MM—FAIRNESS FOR 9/11 FAMILIES ACT SEC.

101.

IMPROVEMENTS TO THE JUSTICE FOR UNITED STATES VIC- TIMS OF STATE SPONSORED TERRORISM ACT.
(a) SHORT TITLE.—This section may be cited as the ‘‘Fairness for 9/11 Families Act’’.

(b) IN GENERAL.—Section 404 of the Justice for United States Victims of State Sponsored Terrorism Act (34 U.S.C.
20144) is amended— (1) in subsection (b)— (A) in paragraph (1)(B), in the first sentence, by inserting ‘‘and during the 1-year period beginning on the date of enactment of the Fairness for 9/11 Families Act, the Special Master may utilize an additional 5 full-time equivalent Department of Justice personnel’’ before the period at the end; and (B) in paragraph (2)(A), by inserting ‘‘Not later than 30 days after the date of enactment of the Fairness for 9/11 Families Act, the Special Master shall update, as necessary as a result of the enactment of such Act, such procedures and other guidance previously issued by the Special Master.’’ after the period at the end of the second sentence; (2) in subsection (c)(3)(A), by striking clause (ii) and inserting the following: H. R. 2617—1649 ‘‘(ii) Not later than 90 days after the date of obtaining a final judgment, with regard to a final judg- ment obtained on or after the date of that publication, unless— ‘‘(I) the final judgment was awarded to a 9/ 11 victim, 9/11 spouse, or 9/11 dependent before the date of enactment of the United States Victims of State Sponsored Terrorism Fund Clarification Act, in which case such United States person shall have 90 days from the date of enactment of such Act to submit an application for payment; or ‘‘(II) the final judgment was awarded to a 1983 Beirut barracks bombing victim or a 1996 Khobar Towers bombing victim before the date of enact- ment of the Fairness for 9/11 Families Act, in which case such United States person shall have
 180 days from the date of enactment of such Act to submit an application for payment.’’; (3) in subsection (d)— (A) in paragraph (3)(B), by adding at the end the following: ‘‘(iii) For the purposes of clause (i), the calculation of the total compensatory damages received or entitled or scheduled to be received by an applicant who is a 1983 Beirut barracks bombing victim or a 1996 Khobar Towers bombing victim from any source other than the Fund shall include the total amount received by the applicant as a result of or in connection with the proceedings captioned Peterson v. Islamic Republic of Iran, No.
10 Vic.

4518 (S.D.N.Y.

), or the proceedings captioned In Re 650 Fifth Avenue & Related Properties, No.

08 Civ.

10934 (S.D.N.Y.
filed Dec. 17, 2008), such that any such applicant who has received or is entitled or scheduled to receive 30 percent or more of such applicant’s compensatory damages judgment as a result of or in connection with such proceedings shall not receive any payment from the Fund, except in accordance with the requirements of clause (i), or as part of a lump-sum catch-up payment in accordance with paragraph (4)(D).’’; and (B) in paragraph (4)— (i) in subparagraph (A), by striking ‘‘(B) and (C)’’ and inserting ‘‘(B), (C), and (D)’’; (ii) in subparagraph (C), by adding at the end the following: ‘‘(iv) AUTHORIZATION.— ‘‘(I) IN GENERAL.—The Special Master shall in authorize amounts equal to the amounts described in sub- clauses (I), (II), and (III) of clause (iii).
lump sum catch-up payments ‘‘(II) APPROPRIATIONS.— ‘‘(aa) IN GENERAL.—There are authorized to be appropriated and there are appropriated to the Fund such sums as are necessary to carry out this clause, to remain available until expended.
H. R. 2617—1650 ‘‘(bb) LIMITATION.—Amounts appropriated pursuant to item (aa) may not be used for a purpose other than to make lump sum catch- up payments under this clause.’’; and (iii) by adding at the end the following: ‘‘(D) LUMP SUM CATCH-UP PAYMENTS FOR 1983 BEIRUT BARRACKS BOMBING VICTIMS AND 1996 KHOBAR TOWERS BOMBING VICTIMS.— ‘‘(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Fairness for 9/11 Families Act, and in accordance with clauses (i) and (ii) of paragraph (3)(A), the Comptroller General of the United States shall conduct an audit and publish in the Federal Register a notice of proposed lump sum catch-up payments to the 1983 Beirut barracks bombing victims and the 1996 Khobar Towers bombing victims who have submitted applications in accordance with subsection (c)(3)(A)(ii)(II) on or after such date of enactment, in amounts that, after receiving the lump sum catch-up payments, would result in the percentage of the claims of such victims received from the Fund being equal to the percentage of the claims of non- 9/11 victims of state sponsored terrorism received from the Fund, as of such date of enactment.
‘‘(ii) PUBLIC COMMENT.—The Comptroller General shall provide an opportunity for public comment for a 30-day period beginning on the date on which the notice is published under clause (i).
‘‘(iii) REPORT.—Not later than 30 days after the expiration of the comment period in clause (ii), the Comptroller General of the United States shall submit to the Committee on the Judiciary and the Committee on Appropriations of the Senate, the Committee on the Judiciary and the Committee on Appropriations of the House of Representatives, and the Special Master a report that includes the determination of the Comptroller General on— ‘‘(I) the amount of the proposed lump sum catch-up payment for each 1983 Beirut barracks bombing victim; ‘‘(II) the amount of the proposed lump sum catch-up payment for each 1996 Khobar Towers bombing victim; and ‘‘(III) amount of lump sum catch-up payments described in subclauses (I) and (II).
‘‘(iv) LUMP SUM CATCH-UP PAYMENT RESERVE FUND.— ‘‘(I) IN GENERAL.—There is established within the Fund a lump sum catch-up payment reserve fund, to remain in reserve except in accordance with this subsection.
‘‘(II) AUTHORIZATION.—Not earlier than 90 days after the date on which the Comptroller Gen- eral submits the report required under clause (iii), and not later than 1 year after such date, the Special Master shall authorize lump sum catch- up payments from the reserve fund established H. R. 2617—1651 under subclause (I) in amounts equal to the amounts described in subclauses (I) and (II) of clause (iii).
‘‘(III) APPROPRIATIONS.— ‘‘(aa) IN GENERAL.—There are authorized to be appropriated and there are appropriated to the lump sum catch-up payment reserve fund $3,000,000,000 to carry out this clause, to remain available until expended.

‘‘(bb) LIMITATION.—Except as provided in subclause (IV), amounts appropriated pursu- ant to item (aa) may not be used for a purpose other than to make lump sum catch-up pay- ments under this clause.
‘‘(IV) EXPIRATION.— ‘‘(aa) IN GENERAL.—The lump sum catch- up payment reserve fund established by this clause shall be terminated not later than 1 year after the Special Master disperses all lump sum catch-up payments pursuant to sub- clause (II).
‘‘(bb) REMAINING AMOUNTS.—All amounts remaining in the lump sum catch-up payment in excess of the amounts reserve described in subclauses (I) and (II) of clause (iii) shall be deposited into the Fund under this section.’’; fund (4) in subsection (e)(2)(B), by adding at the end the fol- lowing: ‘‘(v) EXCEPTION FOR 1983 BEIRUT BARRACKS BOMBING VICTIMS AND 1996 KHOBAR TOWERS BOMBING VICTIMS.—Nothing in this subparagraph shall apply with respect to— ‘‘(I) a 1983 Beirut barracks bombing victim or a 1996 Khobar Towers bombing victim who submits subsection (c)(3)(A)(ii)(II) on or after the date of enactment of the Fairness for 9/11 Families Act; or application under an ‘‘(II) the assets, or the net proceeds of the sale of properties or related assets, attributable to a person described in subclause (I).’’; and (5) in subsection (j), by adding at the end the following: ‘‘(15) 1983 BEIRUT BARRACKS BOMBING VICTIM.—The term ‘1983 Beirut barracks bombing victim’— ‘‘(A) means a plaintiff, or estate or successor in interest thereof, who has an eligible claim under subsection (c) that arises out of the October 23, 1983, bombing of the United States Marine Corps barracks in Beirut, Lebanon; and ‘‘(B) includes a plaintiff, estate, or successor in interest described in subparagraph (A) who is a judgment creditor in the proceedings captioned Peterson v. Islamic Republic of Iran, No.
10 Vic.

4518 (S.D.N.Y.

), or a Settling Judgment Creditor as identified in the order dated May 27, 2014, in the proceedings captioned In Re 650 Fifth Avenue & Related Properties, No.

08 Vic.10934 (S.D.N.Y.

filed Dec. 17, 2008).
H. R. 2617—1652 ‘‘(16) 1996 KHOBAR TOWERS BOMBING VICTIM.—The term ‘1996 Khobar Towers bombing victim’— ‘‘(A) means a plaintiff, or estate or successor in interest thereof, who has an eligible claim under subsection (c) that arises out of the June 25, 1996 bombing of the Khobar Tower housing complex in Saudi Arabia; and ‘‘(B) includes a plaintiff, estate, or successor in interest described in subparagraph (A) who is a judgment creditor in the proceedings captioned Peterson v. Islamic Republic of Iran, No.
10 Vic.

4518 (S.D.N.Y.

), or a Settling Judgment Creditor as identified in the order dated May 27, 2014, in the proceedings captioned In Re 650 Fifth Avenue & Related Properties, No.

08 Vic.10934 (S.D.N.Y.

filed Dec. 17, 2008).’’.


(c) GAO REPORT ON FUNDING FOR THE UNITED STATES VICTIMS OF STATE SPONSORED TERRORISM FUND.—Not later than 180 days after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report evaluating ways to increase deposits into the United States Victims of State Sponsored Terrorism Fund established under paragraph (1) of sec- tion 404(e) of the Justice for United States Victims of State Spon- sored Terrorism Act (34 U.S.C.
20144(e)) (in this subsection referred to as the ‘‘Fund’’), including assessing the advisability and effect of— (1) expanding the scope of the criminal offenses for which funds, and the net proceeds from the sale of property, forfeited or paid to the United States are deposited in the Fund under paragraph (2)(A)(i) of such section; (2) expanding the scope of the civil penalties or fines for which funds, and the net proceeds from the sale of property, forfeited or paid to the United States are deposited in the Fund under paragraph (2)(A)(ii) of such section to include civil penalties or fines imposed, including as part of a settlement agreement, on an entity for providing material support to an organization designated as a foreign terrorist organization under section 219 of the Immigration and Nationality Act (8 U.S.C.
1189); and (3) increasing to 100 percent the percentage of funds, and the net proceeds from the sale of property, forfeited or paid to the United States as a civil penalty or fine that are deposited in the Fund under paragraph (2)(A)(ii) of such section.
(d) RESCISSIONS.— (1) BUSINESS LOANS PROGRAM ACCOUNT.—Of the unobli- gated balances of amounts made available under the heading ‘‘Small Business Administration—Business Loans Program Account, CARES Act’’, for carrying out paragraphs (36) and (37) of section 7(a) of the Small Business Act (15 U.S.C.

636(a)), $4,954,772,000 are hereby rescinded.


(2) SHUTTERED VENUE OPERATORS GRANT.—Of the unobli- gated balances of amounts made available under the heading ‘‘Small Business Administration—Shuttered Venue Operators’’, for carrying out section 324 of division N of the Consolidated Appropriations Act, 2021 (15 U.S.C.

9009a), $459,000,000 are hereby rescinded.


H. R. 2617—1653 (3) AVIATION MANUFACTURING PAYROLL SUPPORT PRO- GRAM.—Of the unobligated balances of amounts made available under section 7202 of the American Rescue Plan Act of 2021 (15 U.S.C.

9132), $568,228,000 are hereby rescinded.

Speaker of the House of Representatives.

Vice President of the United States and President of the Senate.