3361 
† HR 2617 EAS2 
(A) 
MILESTONE-BASED
PAYMENTS.—The 
Secretary may provide payment, including ad-
vance payment or partial payment for signifi-
cant milestones, if the Secretary makes a deter-
mination that such payment is necessary and 
appropriate. 
(B) REPAYMENT.—The contract shall pro-
vide that such payment is required to be repaid 
if there is a failure to perform by the manufac-
turer under the contract; if the specified mile-
stones are reached, an advance or partial pay-
ment shall not be required to be repaid. 
(C) CONTRACT DURATION.— 
(i) IN GENERAL.—Each contract shall 
be for a period not to exceed 5 years. 
(ii) NON-RENEWABILITY.—A contract 
shall not be renewable. 
(iii) NOTIFICATIONS
OF
EXTENSIONS 
AND TERMINATIONS.—If the Secretary de-
cides to terminate a contract prior to its ex-
piration, the Secretary shall notify the 
manufacturer within 90 days of such deter-
mination. 
(D) ADDITIONAL TERMS.—The Secretary, in 
any contract under this subsection—
3362 
† HR 2617 EAS2 
(i) may specify— 
(I) the amount of funding that 
will be dedicated by the Secretary for 
supporting increased manufacturing 
capacity under such contract; and 
(II) the amount of manufacturing 
capacity that such eligible entity must 
meet; and 
(ii) shall provide a clear statement of 
defined Federal Government purpose lim-
ited to uses related to increasing domestic 
manufacturing capacity for antibiotic drugs 
to 
address 
identified 
supply 
chain 
vulnerabilities and challenges to estab-
lishing and maintaining domestic manufac-
turing capacity. 
(E) SUSTAINMENT.—Each contract shall 
provide for the eligible entity to update the stra-
tegic plan required under paragraph (2)(B)(vi) 
throughout the duration of such contract, as re-
quired by the Secretary. 
(b) REPORT.—Not later than 2 years after the date 
of enactment of this Act and every year thereafter until the 
termination or expiration of all such contracts, the Sec-
retary shall submit to the Committee on Health, Education,
3363 
† HR 2617 EAS2 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a 
report on any activities supported under subsection (a), in-
cluding— 
(1) the antibiotic drugs for which the Secretary 
prioritized awards under subsection (a), including a 
description of how the Secretary consulted with stake-
holders to inform such prioritization; 
(2) information regarding each contract awarded 
pursuant to subsection (a), including— 
(A) the recipient of each such contract, in-
cluding any recipients of a subaward; 
(B) the milestone and performance require-
ments pursuant to each such contract; 
(C) the duration of each such contract; 
(D) the amount of funding provided by the 
Secretary pursuant to each such contract, in-
cluding any advanced or partial payments; 
(E) the antibiotic drugs supported through 
each such contract, including a description of the 
medical necessity of each such antibiotic drug 
and any supply chain vulnerabilities, limita-
tions, and related characteristics identified pur-
suant to subsection (a)(2)(B)(iv) for each such 
antibiotic drug; and
3364 
† HR 2617 EAS2 
(F) the amount of increased manufacturing 
capacity for such antibiotic drug that each such 
contract supports; and 
(3) a description of how such contracts address 
supply chain vulnerabilities, including increasing 
manufacturing capacity of antibiotic drugs in the 
United States; and 
(4) a description of the strategic plan submitted 
pursuant to subsection (a)(2)(B)(vi) by each recipient 
of an award under subsection (a). 
(c) RULE OF CONSTRUCTION.—Nothing in this section 
shall be construed— 
(1) to limit, directly or indirectly, or otherwise 
impact the private distribution, purchase, or sale of 
antibiotic drugs or active pharmaceutical ingredients 
or key starting materials; or 
(2) to authorize the Secretary to disclose any in-
formation that is a trade secret, or other privileged or 
confidential information subject to section 552(b)(4) 
of title 5, United States Code, or section 1905 of title 
18, United States Code. 
(d) DEFINITIONS.—For purposes of this section: 
(1) ACTIVE PHARMACEUTICAL INGREDIENT.—The 
term ‘‘active pharmaceutical ingredient’’ has the 
meaning given such term in section 744A of the Fed-
3365 
† HR 2617 EAS2 
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
41). 
(2) ANTIBIOTIC
DRUG.—The term ‘‘antibiotic 
drug’’ means an antibacterial or antifungal drug ap-
proved by the Food and Drug Administration under 
section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) that is of significant 
priority to providing health care and is medically 
necessary to have available at all times in an amount 
adequate to serve patient needs. 
(3) KEY STARTING MATERIAL.—The term ‘‘key 
starting material’’ means any component of a drug 
that the Secretary determines to be necessary to the 
safety and effectiveness of the drug. 
(4) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(e) SUNSET.—The authority to enter into new con-
tracts under this section shall cease to be effective 3 years 
after the date of enactment of this Act, and, beginning on 
the date that is 8 years after the date of enactment of this 
Act, this section shall have no force or effect.
3366 
† HR 2617 EAS2 
Subtitle 
E—Enhancing 
Develop-
ment and Combating Shortages 
of Medical Products 
CHAPTER 1—DEVELOPMENT AND REVIEW 
SEC. 2501. ACCELERATING COUNTERMEASURE DEVELOP-
MENT AND REVIEW. 
Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–4) is amended by adding at the end 
the following: 
‘‘(h) ACCELERATING
COUNTERMEASURE
DEVELOP-
MENT AND REVIEW DURING AN EMERGENCY.— 
‘‘(1) ACCELERATION OF COUNTERMEASURE DE-
VELOPMENT AND REVIEW.—The Secretary may, at the 
request of the sponsor of a countermeasure, during a 
domestic, military, or public health emergency or ma-
terial threat described in section 564A(a)(1)(C), expe-
dite the development and review of countermeasures 
that are intended to address such domestic, military, 
or public health emergency or material threat for ap-
proval, licensure, clearance, or authorization under 
this title or section 351 of the Public Health Service 
Act. 
‘‘(2) ACTIONS.—The actions to expedite the de-
velopment and review of a countermeasure under 
paragraph (1) may include the following:
3367 
† HR 2617 EAS2 
‘‘(A) Expedited review of submissions made 
by sponsors of countermeasures to the Food and 
Drug Administration, including rolling submis-
sions of countermeasure applications and other 
submissions. 
‘‘(B) Expedited and increased engagement 
with sponsors regarding countermeasure develop-
ment and manufacturing, including— 
‘‘(i) holding meetings with the sponsor 
and the review team and providing timely 
advice to, and interactive communication 
with, the sponsor regarding the development 
of the countermeasure to ensure that the de-
velopment program to gather the nonclin-
ical and clinical data necessary for ap-
proval, licensure, clearance, or authoriza-
tion is as efficient as practicable; 
‘‘(ii) involving senior managers and 
experienced review staff, as appropriate, in 
a collaborative, cross-disciplinary review; 
‘‘(iii) assigning a cross-disciplinary 
project lead for the review team to facilitate; 
‘‘(iv) taking steps to ensure that the de-
sign of the clinical trials is as efficient as 
practicable, when scientifically appropriate,
3368 
† HR 2617 EAS2 
such as by minimizing the number of pa-
tients exposed to a potentially less effica-
cious treatment; and 
‘‘(v) streamlining the review of ap-
proved, licensed, cleared, or authorized 
countermeasures to treat or prevent new or 
emerging threats, including the review of 
any changes to such countermeasures. 
‘‘(C) Expedited issuance of guidance docu-
ments and publication of other regulatory infor-
mation regarding countermeasure development 
and manufacturing. 
‘‘(D) Other steps to expedite the develop-
ment and review of a countermeasure applica-
tion submitted for approval, licensure, clearance, 
or authorization, as the Secretary determines ap-
propriate. 
‘‘(3) LIMITATION OF EFFECT.—Nothing in this 
subsection shall be construed to require the Secretary 
to grant, or take any other action related to, a request 
of a sponsor to expedite the development and review 
of a countermeasure for approval, licensure, clear-
ance, or authorization under paragraph (1).’’.
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† HR 2617 EAS2 
SEC. 2502. THIRD PARTY TEST EVALUATION DURING EMER-
GENCIES. 
(a) IN GENERAL.—Section 565 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended 
by section 2501, is further amended by adding at the end 
the following: 
‘‘(i) THIRD PARTY EVALUATION OF TESTS USED DUR-
ING AN EMERGENCY.— 
‘‘(1) IN GENERAL.—For purposes of conducting 
evaluations regarding whether an in vitro diagnostic 
product (as defined in section 809.3 of title 21, Code 
of Federal Regulations (or any successor regulations)) 
for which a request for emergency use authorization 
is submitted under section 564 meets the criteria for 
issuance of such authorization, the Secretary may, as 
appropriate, consult with persons with appropriate 
expertise with respect to such evaluations or enter 
into cooperative agreements or contracts with such 
persons under which such persons conduct such eval-
uations and make such recommendations, including, 
as appropriate, evaluations and recommendations re-
garding the scope of authorization and conditions of 
authorization. 
‘‘(2) REQUIREMENTS REGARDING EVALUATIONS 
AND RECOMMENDATIONS.—
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† HR 2617 EAS2 
‘‘(A) IN
GENERAL.—In evaluating and 
making recommendations to the Secretary re-
garding the validity, accuracy, and reliability of 
in vitro diagnostic products, as described in 
paragraph (1), a person shall consider and docu-
ment whether the relevant criteria under sub-
section (c)(2) of section 564 for issuance of au-
thorization under such section are met with re-
spect to the in vitro diagnostic product. 
‘‘(B) WRITTEN
RECOMMENDATIONS.—Rec-
ommendations made by a person under this sub-
section shall be submitted to the Secretary in 
writing, and shall include the reasons for such 
recommendation and other information that may 
be requested by the Secretary. 
‘‘(3) RULE OF CONSTRUCTION.— Nothing in this 
subsection shall be construed to require the Secretary 
to consult with, or enter into cooperative agreements 
or contracts with, persons as described in paragraph 
(1) for purposes of authorizing an in vitro diagnostic 
product or otherwise affecting the emergency use au-
thorization authorities under this section or section 
564.’’. 
(b) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and
3371 
† HR 2617 EAS2 
Human Services (referred to in this subsection as the ‘‘Sec-
retary’’) shall issue draft guidance on consultations with 
persons under subsection (i) of section 565 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as 
added by subsection (a), including considerations con-
cerning conflicts of interest, compensation arrangements, 
and information sharing. Not later than 1 year after the 
public comment period on such draft guidance ends, the 
Secretary shall issue a revised draft guidance or final guid-
ance. 
SEC. 2503. PLATFORM TECHNOLOGIES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 506J of such Act (21 U.S.C. 356j) the following: 
‘‘SEC. 506K. PLATFORM TECHNOLOGIES. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
program for the designation of platform technologies that 
meet the criteria described in subsection (b). 
‘‘(b) CRITERIA.—A platform technology incorporated 
within or utilized by a drug or biological product is eligible 
for designation as a designated platform technology under 
this section if— 
‘‘(1) the platform technology is incorporated in, 
or utilized by, a drug approved under section 505 of
3372 
† HR 2617 EAS2 
this Act or a biological product licensed under section 
351 of the Public Health Service Act; 
‘‘(2) preliminary evidence submitted by the spon-
sor of the approved or licensed drug described in 
paragraph (1), or a sponsor that has been granted a 
right of reference to data submitted in the application 
for such drug, demonstrates that the platform tech-
nology has the potential to be incorporated in, or uti-
lized by, more than one drug without an adverse effect 
on quality, manufacturing, or safety; and 
‘‘(3) data or information submitted by the appli-
cable person under paragraph (2) indicates that in-
corporation or utilization of the platform technology 
has a reasonable likelihood to bring significant effi-
ciencies to the drug development or manufacturing 
process and to the review process. 
‘‘(c) REQUEST FOR DESIGNATION.—A person may re-
quest the Secretary designate a platform technology as a 
designated platform technology concurrently with, or at any 
time after, submission under section 505(i) of this Act or 
section 351(a)(3) of the Public Health Service Act for the 
investigation of a drug that incorporates or utilizes the 
platform technology that is the subject of the request. 
‘‘(d) DESIGNATION.—
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† HR 2617 EAS2 
‘‘(1) IN GENERAL.—Not later than 90 calendar 
days after the receipt of a request under subsection 
(c), the Secretary shall determine whether the plat-
form technology that is the subject of the request meets 
the criteria described in subsection (b). 
‘‘(2) DESIGNATION.—If the Secretary determines 
that the platform technology meets the criteria de-
scribed in subsection (b), the Secretary shall designate 
the platform technology as a designated platform tech-
nology and may expedite the development and review 
of any subsequent application submitted under section 
505(b) of this Act or section 351(a) of the Public 
Health Service Act for a drug that uses or incor-
porates the platform technology pursuant to sub-
section (e), as appropriate. 
‘‘(3) DETERMINATION
NOT
TO
DESIGNATE.—If 
the Secretary determines that the platform technology 
does not meet the criteria under subsection (b), the 
Secretary shall include with the determination not to 
designate the technology a written description of the 
rationale for such determination. 
‘‘(4) REVOCATION OF DESIGNATION.—The Sec-
retary may revoke a designation made under para-
graph (2), if the Secretary determines that the des-
ignated platform technology no longer meets the cri-
3374 
† HR 2617 EAS2 
teria described in subsection (b). The Secretary shall 
communicate the determination to revoke a designa-
tion to the requesting sponsor in writing, including a 
description of the rationale for such determination. 
‘‘(5) APPLICABILITY.—Nothing in this section 
shall prevent a product that uses or incorporates a 
designated platform technology from being eligible for 
expedited approval pathways if it is otherwise eligible 
under this Act or the Public Health Service Act. 
‘‘(e) ACTIONS.—The Secretary may take actions to ex-
pedite the development and review of an application for a 
drug that incorporates or utilizes a designated platform 
technology, including— 
‘‘(1) engaging in early interactions with the 
sponsor to discuss the use of the designated platform 
technology and what is known about such technology, 
including data previously submitted that is relevant 
to establishing, as applicable, safety or efficacy under 
section 505(b) of this Act or safety, purity, or potency 
under section 351(a) of the Public Health Service Act; 
‘‘(2) providing timely advice to, and interactive 
communication with, the sponsor regarding the devel-
opment of the drug that proposes to use the designated 
platform technology to ensure that the development 
program designed to gather data necessary for ap-
3378 
† HR 2617 EAS2 
evidence and applicable conditions for approval or li-
censure under the applicable Act; or 
‘‘(2) confer any new rights with respect to the 
permissibility of a sponsor of an application for a 
drug product or biological product referencing infor-
mation contained in another application submitted 
by the holder of an approved application under sec-
tion 505(c) of this Act or of a license under section 
351(a) of the Public Health Service Act.’’. 
(b) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall issue draft guidance on the implementation 
of this section. Such guidance shall include examples of 
drugs that can be manufactured using platform tech-
nologies, including drugs that contain or consist of vectors 
and nucleic acids, information about the Secretary’s review 
of platform technologies, information regarding submitting 
for designation, considerations for persons submitting a re-
quest for designation who have been granted a right of ref-
erence, the implementation of the designated platform tech-
nology designation program, efficiencies that may be 
achieved in the development and review of products that 
incorporate or utilize designated platform technologies, and 
recommendations and requirements for making and report-
3379 
† HR 2617 EAS2 
ing manufacturing changes to a designated platform tech-
nology in accordance with section 506K(g) of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection (a)) 
and section 506A of such Act (21 U.S.C. 356a), as applica-
ble. 
(c) REPORT.—Not later than September 30, 2026, and 
annually thereafter until September 30, 2029, the Secretary 
shall issue a report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives that 
shall include— 
(1) the number of requests for designation under 
the program under section 506K of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a); 
(2) the number of designations under such pro-
gram issued, active, and revoked; 
(3) the resources required to carry out such pro-
gram (including the review time used for full-time 
equivalent employees); 
(4) any efficiencies gained in the development, 
manufacturing, and review processes associated with 
such designations; and 
(5) recommendations, if any, to strengthen the 
program to better leverage platform technologies that 
can be used in more than one drug and meet patient
3380 
† HR 2617 EAS2 
needs in a manner as timely as possible, taking into 
consideration the resources available to the Secretary 
of Health and Human Services for carrying out such 
program. 
SEC. 2504. INCREASING EUA DECISION TRANSPARENCY. 
Section 564(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–3(h)) is amended— 
(1) in paragraph (1)— 
(A) by inserting ‘‘on the internet website of 
the Food and Drug Administration and’’ after 
‘‘promptly publish’’; 
(B) by striking ‘‘application under section 
505(i), 512(j), or 520(g), even if such summary 
may indirectly reveal the existence of such appli-
cation’’ and inserting ‘‘application, request, or 
submission under this section or section 505(b), 
505(i), 505(j), 512(b), 512(j), 512(n), 515, 
510(k), 513(f)(2), 520(g), 520(m), 571, or 572 of 
this Act, or section 351(a) or 351(k) of the Public 
Health Service Act, even if such summary may 
reveal the existence of such an application, re-
quest, or submission, or data contained in such 
application, request, or submission’’; and 
(C) by inserting before the period at the end 
of the second sentence the following: ‘‘, which
3381 
† HR 2617 EAS2 
may include a summary of the data and infor-
mation supporting such revisions’’; and 
(2) in paragraph (2), by adding at the end the 
following: ‘‘Information made publicly available by 
the Secretary in accordance with paragraph (1) shall 
be considered a disclosure authorized by law for pur-
poses of section 1905 of title 18, United States Code’’. 
SEC. 2505. IMPROVING FDA GUIDANCE AND COMMUNICA-
TION. 
(a) FDA REPORT AND IMPLEMENTATION OF GOOD 
GUIDANCE PRACTICES.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall develop, and publish on the website of the 
Food and Drug Administration— 
(1) a report identifying best practices for the ef-
ficient prioritization, development, issuance, and use 
of guidance documents, within centers, across the 
Food and Drug Administration, and across other ap-
plicable agencies; and 
(2) a plan for implementation of such best prac-
tices, including across other applicable agencies, 
which shall address— 
(A) streamlining development and review of 
guidance documents within centers and across 
the Food and Drug Administration;
3382 
† HR 2617 EAS2 
(B) streamlining processes for regulatory 
submissions to the Food and Drug Administra-
tion, including through the revision or issuance 
of guidance documents; and 
(C) implementing innovative guidance de-
velopment 
processes 
and 
practices 
and 
transitioning or updating guidance issued dur-
ing the COVID–19 public health emergency, as 
appropriate. 
(b) REPORT AND IMPLEMENTATION OF FDA BEST 
PRACTICES FOR COMMUNICATING WITH EXTERNAL STAKE-
HOLDERS.—The Secretary, acting through the Commis-
sioner of Food and Drugs, shall develop and publish on the 
website of the Food and Drug Administration a report on 
the practices of the Food and Drug Administration to 
broadly communicate with external stakeholders, other than 
through guidance documents, which shall include— 
(1) a review of the types and methods of public 
communication that the Food and Drug Administra-
tion uses to communicate and interact with medical 
product sponsors and other external stakeholders; 
(2) the identification of best practices for the effi-
cient development, issuance, and use of such commu-
nications; and
3383 
† HR 2617 EAS2 
(3) a plan for implementation of best practices 
for communication with external stakeholders, which 
shall address— 
(A) advancing the use of innovative forms 
of communication, including novel document 
types and formats, to provide increased regu-
latory clarity to product sponsors and other 
stakeholders, and advancing methods of commu-
nicating and interacting with medical product 
sponsors and other external stakeholders, includ-
ing the use of tools such as product submission 
templates, webinars, and frequently asked ques-
tions communications; 
(B) streamlining processes for regulatory 
submissions; and 
(C) implementing innovative communica-
tion development processes and transitioning or 
updating communication practices used during 
the COVID–19 public health emergency, as ap-
propriate. 
(c) CONSULTATION.—In developing and publishing the 
report and implementation plan under this section, the Sec-
retary shall consult with stakeholders, including research-
ers, academic organizations, pharmaceutical, biotechnology, 
and medical device developers, clinical research organiza-
3384 
† HR 2617 EAS2 
tions, clinical laboratories, health care providers, patient 
groups, and other appropriate stakeholders. 
(d) MANNER OF ISSUANCE.— For purposes of carrying 
out this section, the Secretary may update an existing re-
port or plan, and may combine the reports and implemen-
tation plans described in subsections (a) and (b) into one 
or more documents. 
(e) TIMING.—The Secretary shall— 
(1) not later than 1 year after the date of enact-
ment of this Act, publish a draft of the reports and 
plans required under this section; and 
(2) not later than 180 days after publication of 
the draft reports and plans under paragraph (1)— 
(A) publish a final report and plan; and 
(B) begin implementation of the best prac-
tices pursuant to such final plan. 
CHAPTER 2—MITIGATING SHORTAGES 
SEC. 2511. ENSURING REGISTRATION OF FOREIGN DRUG 
AND DEVICE MANUFACTURERS. 
(a) REGISTRATION OF CERTAIN FOREIGN ESTABLISH-
MENTS.—Section 510(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(i)) is amended by adding at 
the end the following: 
‘‘(5) The requirements of paragraphs (1) and (2) shall 
apply regardless of whether the drug or device undergoes
3385 
† HR 2617 EAS2 
further 
manufacture, 
preparation, 
propagation, 
compounding, or processing at a separate establishment 
outside the United States prior to being imported or offered 
for import into the United States.’’. 
(b) UPDATING REGULATIONS.—Not later than 2 years 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall update regulations, as 
appropriate, to implement the amendment made by sub-
section (a). 
SEC. 2512. EXTENDING EXPIRATION DATES FOR CERTAIN 
DRUGS. 
(a) IN GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall issue draft guidance, or revise existing guid-
ance, to address recommendations for sponsors of applica-
tions submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) regarding— 
(1) the submission of stability testing data in 
such applications, including considerations for data 
requirements that could be streamlined or reduced to 
facilitate faster review of longer proposed expiration 
dates;
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† HR 2617 EAS2 
(2) establishing in the labeling of drugs the long-
est feasible expiration date scientifically supported by 
such data, taking into consideration how extended ex-
piration dates may— 
(A) help prevent or mitigate drug shortages; 
and 
(B) affect product quality; and 
(3) the use of innovative approaches for drug 
and combination product stability modeling to sup-
port initial product expiration dates and expiration 
date extensions. 
(b) REPORT.—Not later than 2 years after the date 
of enactment of this Act, and again 2 years thereafter, the 
Secretary shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives a report that includes— 
(1) the number of drugs for which the Secretary 
has requested the manufacturer make a labeling 
change regarding the expiration date; and 
(2) for each drug for which the Secretary has re-
quested a labeling change with respect to the expira-
tion date, information regarding the circumstances of 
such request, including— 
(A) the name and dose of such drug;
3387 
† HR 2617 EAS2 
(B) the rationale for the request; 
(C) whether the drug, at the time of the re-
quest, was listed on the drug shortage list under 
section 506E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356e), or was at risk of 
shortage; 
(D) whether the request was made in con-
nection with a public health emergency declared 
under section 319 of the Public Health Service 
Act (42 U.S.C. 247d); and 
(E) whether the manufacturer made the re-
quested change by the requested date, and for in-
stances where the manufacturer does not make 
the requested change, the manufacturer’s jus-
tification for not making the change, if the man-
ufacturer agrees to provide such justification for 
inclusion in the report. 
SEC. 2513. COMBATING COUNTERFEIT DEVICES. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended 
by adding at the end the following: 
‘‘(fff)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification upon any device
3388 
† HR 2617 EAS2 
or container, packaging, or labeling thereof so as to render 
such device a counterfeit device. 
‘‘(2) Making, selling, disposing of, or keeping in posses-
sion, control, or custody, or concealing any punch, die, 
plate, stone, or other thing designed to print, imprint, or 
reproduce the trademark, trade name, or other identifying 
mark or imprint of another or any likeness of any of the 
foregoing upon any device or container, packaging, or label-
ing thereof so as to render such device a counterfeit device. 
‘‘(3) The doing of any act which causes a device to 
be a counterfeit device, or the sale or dispensing, or the hold-
ing for sale or dispensing, of a counterfeit device.’’. 
(b) PENALTIES.—Section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended— 
(1) in subsection (b)(8), by inserting ‘‘, or who 
violates section 301(fff)(3) by knowingly making, sell-
ing or dispensing, or holding for sale or dispensing, 
a counterfeit device,’’ after ‘‘a counterfeit drug’’; and 
(2) in subsection (c), by inserting ‘‘; or (6) for 
having violated section 301(fff)(2) if such person 
acted in good faith and had no reason to believe that 
use of the punch, die, plate, stone, or other thing in-
volved would result in a device being a counterfeit de-
vice, or for having violated section 301(fff)(3) if the 
person doing the act or causing it to be done acted
3389 
† HR 2617 EAS2 
in good faith and had no reason to believe that the 
device was a counterfeit device’’ before the period. 
(c) SEIZURE.—Section 304(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 334(a)(2)) is amend-
ed— 
(1) by striking ‘‘, and (E)’’ and inserting ‘‘, 
(E)’’; and 
(2) by inserting ‘‘, (F) Any device that is a 
counterfeit device, (G) Any container, packaging, or 
labeling of a counterfeit device, and (H) Any punch, 
die, plate, stone, labeling, container, or other thing 
used or designed for use in making a counterfeit de-
vice or devices’’ before the period. 
SEC. 2514. PREVENTING MEDICAL DEVICE SHORTAGES. 
(a) NOTIFICATIONS.—Section 506J of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is amend-
ed— 
(1) in subsection (f), by inserting ‘‘or (h)’’ after 
‘‘subsection (a)’’; 
(2) by redesignating subsections (h) and (i) as 
subsections (i) and (j), respectively; and 
(3) by inserting after subsection (g) the fol-
lowing: 
‘‘(h) ADDITIONAL
NOTIFICATIONS.—The Secretary 
may receive voluntary notifications from a manufacturer