H. R. 2617—1338 
identified pursuant to subsection (a)(2)(B)(iv) for each such 
antibiotic drug; and 
(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 information 
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 Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–41). 
(2) ANTIBIOTIC DRUG.—The term ‘‘antibiotic drug’’ means 
an antibacterial or antifungal drug approved by the Food and 
Drug Administration under section 505(j) of the Federal Food, 
Drug, and Cosmetic 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 mate-
rial’’ means any component of a drug that the Secretary deter-
mines 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 contracts 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. 
Subtitle E—Enhancing Development and 
Combating Shortages of Medical Products 
CHAPTER 1—DEVELOPMENT AND REVIEW 
SEC. 2501. ACCELERATING COUNTERMEASURE DEVELOPMENT 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
DEVELOPMENT
AND 
REVIEW DURING AN EMERGENCY.—
H. R. 2617—1339 
‘‘(1) ACCELERATION
OF
COUNTERMEASURE
DEVELOPMENT 
AND REVIEW.—The Secretary may, at the request of the sponsor 
of a countermeasure, during a domestic, military, or public 
health emergency or material threat described in section 
564A(a)(1)(C), expedite the development and review of counter-
measures that are intended to address such domestic, military, 
or public health emergency or material threat for approval, 
licensure, clearance, or authorization under this title or section 
351 of the Public Health Service Act. 
‘‘(2) ACTIONS.—The actions to expedite the development 
and review of a countermeasure under paragraph (1) may 
include the following: 
‘‘(A) Expedited review of submissions made by sponsors 
of countermeasures to the Food and Drug Administration, 
including rolling submissions of countermeasure applica-
tions and other submissions. 
‘‘(B) Expedited and increased engagement with spon-
sors regarding countermeasure development and manufac-
turing, including— 
‘‘(i) holding meetings with the sponsor and the 
review team and providing timely advice to, and inter-
active communication with, the sponsor regarding the 
development of the countermeasure to ensure that the 
development program to gather the nonclinical and 
clinical data necessary for approval, licensure, clear-
ance, or authorization 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 design of 
the clinical trials is as efficient as practicable, when 
scientifically appropriate, such as by minimizing the 
number of patients exposed to a potentially less effica-
cious treatment; and 
‘‘(v) streamlining the review of approved, licensed, 
cleared, or authorized countermeasures to treat or pre-
vent new or emerging threats, including the review 
of any changes to such countermeasures. 
‘‘(C) Expedited issuance of guidance documents and 
publication of other regulatory information regarding 
countermeasure development and manufacturing. 
‘‘(D) Other steps to expedite the development and 
review of a countermeasure application submitted for 
approval, licensure, clearance, or authorization, as the Sec-
retary determines appropriate. 
‘‘(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, clearance, or authorization under paragraph (1).’’. 
SEC. 2502. THIRD PARTY TEST EVALUATION DURING EMERGENCIES. 
(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:
H. R. 2617—1340 
‘‘(i) THIRD PARTY EVALUATION OF TESTS USED DURING AN EMER-
GENCY.— 
‘‘(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 agree-
ments or contracts with such persons under which such persons 
conduct such evaluations and make such recommendations, 
including, as appropriate, evaluations and recommendations 
regarding the scope of authorization and conditions of 
authorization. 
‘‘(2) REQUIREMENTS
REGARDING
EVALUATIONS
AND
REC-
OMMENDATIONS.— 
‘‘(A) IN
GENERAL.—In evaluating and making rec-
ommendations to the Secretary regarding the validity, 
accuracy, and reliability of in vitro diagnostic products, 
as described in paragraph (1), a person shall consider and 
document whether the relevant criteria under subsection 
(c)(2) of section 564 for issuance of authorization under 
such section are met with respect to the in vitro diagnostic 
product. 
‘‘(B) WRITTEN RECOMMENDATIONS.—Recommendations 
made by a person under this subsection shall be submitted 
to the Secretary in writing, and shall include the reasons 
for such recommendation and other information that may 
be requested by the Secretary. 
‘‘(3) RULE OF CONSTRUCTION.— Nothing in this subsection 
shall be construed to require the 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 authorization authorities under this section or section 564.’’. 
(b) GUIDANCE.—Not later than 1 year after the date of enact-
ment of this Act, the Secretary of Health and Human Services 
(referred to in this subsection as the ‘‘Secretary’’) shall issue draft 
guidance on consultations with persons under subsection (i) of sec-
tion 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–4), as added by subsection (a), including considerations 
concerning 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 guidance. 
SEC. 2503. PLATFORM TECHNOLOGIES. 
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 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).
H. R. 2617—1341 
‘‘(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 this Act or a biological 
product licensed under section 351 of the Public Health Service 
Act; 
‘‘(2) preliminary evidence submitted by the sponsor of the 
approved or licensed drug described in paragraph (1), or a 
sponsor that has been granted a right of reference to data 
submitted in the application for such drug, demonstrates that 
the platform technology has the potential to be incorporated 
in, or utilized by, more than one drug without an adverse 
effect on quality, manufacturing, or safety; and 
‘‘(3) data or information submitted by the applicable person 
under paragraph (2) indicates that incorporation or utilization 
of the platform technology has a reasonable likelihood to bring 
significant efficiencies to the drug development or manufac-
turing process and to the review process. 
‘‘(c) REQUEST FOR DESIGNATION.—A person may request the 
Secretary designate a platform technology as a designated platform 
technology concurrently with, or at any time after, submission 
under section 505(i) of this Act or section 351(a)(3) of the Public 
Health Service Act for the investigation of a drug that incorporates 
or utilizes the platform technology that is the subject of the request. 
‘‘(d) DESIGNATION.— 
‘‘(1) IN GENERAL.—Not later than 90 calendar days after 
the receipt of a request under subsection (c), the Secretary 
shall determine whether the platform 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 described in subsection 
(b), the Secretary shall designate the platform technology as 
a designated platform technology and may expedite the develop-
ment and review of any subsequent application submitted under 
section 505(b) of this Act or section 351(a) of the Public Health 
Service Act for a drug that uses or incorporates the platform 
technology pursuant to subsection (e), as appropriate. 
‘‘(3) DETERMINATION NOT TO DESIGNATE.—If the Secretary 
determines that the platform 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 Secretary may 
revoke a designation made under paragraph (2), if the Secretary 
determines that the designated platform technology no longer 
meets the criteria described in subsection (b). The Secretary 
shall communicate the determination to revoke a designation 
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 tech-
nology from being eligible for expedited approval pathways 
if it is otherwise eligible under this Act or the Public Health 
Service Act.