H. R. 2617—1342 
‘‘(e) ACTIONS.—The Secretary may take actions to expedite the 
development and review of an application for a drug that incor-
porates 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 sub-
mitted 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 communica-
tion with, the sponsor regarding the development of the drug 
that proposes to use the designated platform technology to 
ensure that the development program designed to gather data 
necessary for approval or licensure is as efficient as practicable, 
which may include holding meetings with the sponsor and 
the review team throughout the development of the drug; and 
‘‘(3) considering inspectional findings, including prior 
findings, related to the manufacture of a drug that incorporates 
or utilizes the designated platform technology. 
‘‘(f) LEVERAGING DATA FROM DESIGNATED PLATFORM TECH-
NOLOGIES.—The Secretary shall, consistent with applicable stand-
ards for approval, authorization, or licensure under this Act and 
section 351(a) of the Public Health Service Act, allow the sponsor 
of an application under section 505(b) of this Act or section 351(a) 
of the Public Health Service Act or a request for emergency use 
authorization under section 564, in order to support approval, licen-
sure, or authorization, to reference or rely upon data and informa-
tion within an application or request for a drug or biological product 
that incorporates or utilizes the same platform technology des-
ignated under subsection (d), provided that— 
‘‘(1) such data and information was submitted by the same 
sponsor, pursuant to the application for the drug with respect 
to which designation of the designated platform technology 
under subsection (d) was granted; or 
‘‘(2) the sponsor relying on such data and information 
received a right of reference to such data and information 
from the sponsor described in paragraph (1). 
‘‘(g) CHANGES TO A DESIGNATED PLATFORM TECHNOLOGY.—A 
sponsor of more than one application approved under section 505(b) 
of this Act or section 351(a) of the Public Health Service Act 
for drugs that incorporate or utilize a designated platform tech-
nology may submit a single supplemental application for proposed 
changes to the designated platform technology that may be 
applicable to more than one such drug that incorporates or utilizes 
the same designated platform technology. Such supplemental 
application may cross-reference data and information submitted 
in other applications and may include one or more comparability 
protocols regarding how such changes to the platform technology 
would be made for each applicable drug or biological product. 
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘platform technology’ means a well-under-
stood and reproducible technology, which may include a nucleic 
acid sequence, molecular structure, mechanism of action, 
delivery method, vector, or a combination of any such tech-
nologies that the Secretary determines to be appropriate, that 
the sponsor demonstrates—
H. R. 2617—1343 
‘‘(A) is incorporated in or utilized by a drug or biological 
product and is essential to the structure or function of 
such drug or biological product; 
‘‘(B) can be adapted for, incorporated into, or utilized 
by, more than one drug or biological product sharing 
common structural elements; and 
‘‘(C) facilitates the manufacture or development of more 
than one drug or biological product through a standardized 
production or manufacturing process or processes. 
‘‘(2) The term ‘designated platform technology’ means a 
platform technology that is designated as a platform technology 
under subsection (d). 
‘‘(i) RULE
OF CONSTRUCTION.—Nothing in this section shall 
be construed to— 
‘‘(1) alter the authority of the Secretary to approve drugs 
pursuant to section 505 of this Act or license biological products 
pursuant to section 351 of the Public Health Service Act, 
including standards of evidence and applicable conditions for 
approval or licensure under the applicable Act; or 
‘‘(2) confer any new rights with respect to the permissibility 
of a sponsor of an application for a drug product or biological 
product referencing information contained in another applica-
tion submitted by the holder of an approved application under 
section 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 enact-
ment of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) shall issue draft 
guidance on the implementation of this section. Such guidance 
shall include examples of drugs that can be manufactured using 
platform technologies, including drugs that contain or consist of 
vectors and nucleic acids, information about the Secretary’s review 
of platform technologies, information regarding submitting for des-
ignation, considerations for persons submitting a request for des-
ignation who have been granted a right of reference, the 
implementation of the designated platform technology designation 
program, efficiencies that may be achieved in the development 
and review of products that incorporate or utilize designated plat-
form technologies, and recommendations and requirements for 
making and reporting manufacturing changes to a designated plat-
form technology 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 applicable. 
(c) REPORT.—Not later than September 30, 2026, and annually 
thereafter until September 30, 2029, the Secretary shall issue a 
report to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of 
the House of Representatives that shall include— 
(1) the number of requests for designation under the pro-
gram under section 506K of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a); 
(2) the number of designations under such program issued, 
active, and revoked; 
(3) the resources required to carry out such program 
(including the review time used for full-time equivalent 
employees);
H. R. 2617—1344 
(4) any efficiencies gained in the development, manufac-
turing, and review processes associated with such designations; 
and 
(5) recommendations, if any, to strengthen the program 
to better leverage platform technologies that can be used in 
more than one drug and meet patient needs in a manner 
as timely as possible, 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 Cosmetic 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 application’’ and inserting ‘‘applica-
tion, 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, request, 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 may include a sum-
mary of the data and information supporting such revi-
sions’’; and 
(2) in paragraph (2), by adding at the end the following: 
‘‘Information made publicly available by the Secretary in accord-
ance with paragraph (1) shall be considered a disclosure author-
ized by law for purposes of section 1905 of title 18, United 
States Code’’. 
SEC. 2505. IMPROVING FDA GUIDANCE AND COMMUNICATION. 
(a) FDA REPORT
AND IMPLEMENTATION
OF GOOD GUIDANCE 
PRACTICES.—The Secretary of Health and Human Services (referred 
to in this section as the ‘‘Secretary’’) shall develop, and publish 
on the website of the Food and Drug Administration— 
(1) a report identifying best practices for the efficient 
prioritization, development, issuance, and use of guidance docu-
ments, within centers, across the Food and Drug Administra-
tion, and across other applicable agencies; and 
(2) a plan for implementation of such best practices, 
including across other applicable agencies, which shall 
address— 
(A) streamlining development and review of guidance 
documents within centers and across the Food and Drug 
Administration; 
(B) streamlining processes for regulatory submissions 
to the Food and Drug Administration, including through 
the revision or issuance of guidance documents; and 
(C) implementing innovative guidance development 
processes and practices and transitioning or updating guid-
ance issued during the COVID–19 public health emergency, 
as appropriate.
H. R. 2617—1345 
(b) REPORT
AND IMPLEMENTATION
OF FDA BEST PRACTICES 
FOR COMMUNICATING WITH EXTERNAL STAKEHOLDERS.—The Sec-
retary, acting through the Commissioner of Food and Drugs, shall 
develop and publish on the website of the Food and Drug Adminis-
tration a report on the practices of the Food and Drug Administra-
tion to broadly communicate with external stakeholders, other than 
through guidance documents, which shall include— 
(1) a review of the types and methods of public communica-
tion that the Food and Drug Administration uses to commu-
nicate and interact with medical product sponsors and other 
external stakeholders; 
(2) the identification of best practices for the efficient 
development, issuance, and use of such communications; and 
(3) a plan for implementation of best practices for commu-
nication with external stakeholders, which shall address— 
(A) advancing the use of innovative forms of commu-
nication, including novel document types and formats, to 
provide increased regulatory clarity to product sponsors 
and other stakeholders, and advancing methods of commu-
nicating and interacting with medical product sponsors 
and other external stakeholders, including the use of tools 
such as product submission templates, webinars, and fre-
quently asked questions communications; 
(B) streamlining processes for regulatory submissions; 
and 
(C) implementing innovative communication develop-
ment processes and transitioning or updating communica-
tion practices used during the COVID–19 public health 
emergency, as appropriate. 
(c) CONSULTATION.—In developing and publishing the report 
and implementation plan under this section, the Secretary shall 
consult 
with 
stakeholders, 
including 
researchers, 
academic 
organizations, pharmaceutical, biotechnology, and medical device 
developers, clinical research organizations, clinical laboratories, 
health care providers, patient groups, and other appropriate stake-
holders. 
(d) MANNER OF ISSUANCE.— For purposes of carrying out this 
section, the Secretary may update an existing report or plan, and 
may combine the reports and implementation 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 enactment 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 practices pursu-
ant to such final plan. 
CHAPTER 2—MITIGATING SHORTAGES 
SEC. 2511. ENSURING REGISTRATION OF FOREIGN DRUG AND DEVICE 
MANUFACTURERS. 
(a) REGISTRATION OF CERTAIN FOREIGN ESTABLISHMENTS.—Sec-
tion 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: