S.Amdt. 3280

SA 3280. Mr. PETERS (for himself, Mr. Lankford, and Mr. Braun)
submitted an amendment intended to be proposed by him to the bill S.
4638, to authorize appropriations for fiscal year 2025 for military
activities of the Department of Defense, for military construction, and
for defense activities of the Department of Energy, to prescribe
military personnel strengths for such fiscal year, and for other
purposes; which was ordered to lie on the table; as follows:

At the end of subtitle H of title X, insert the following:

SEC. 10___. U.S. PHARMACEUTICAL SUPPLY CHAINS MAPPING.

(a) Short Title.--This section may be cited as the
``Mapping America's Pharmaceutical Supply Act'' or the ``MAPS
Act''.
(b) Pharmaceutical Supply Chain Mapping.--The Secretary of
Health and Human Services (referred to in this section as the
``Secretary''), in coordination with the heads of other
relevant Federal departments and agencies, shall ensure
coordination of efforts of the Department of Health and Human
Services, including through public-private partnerships, to--
(1) map, or otherwise visualize, the supply chains, from
manufacturing of key starting materials through manufacturing
of finished dosage forms and distribution, of drugs (as
defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)) that are--
(A) directly related to responding to chemical, biological,
radiological, or nuclear threats and incidents covered by the
National Response Framework; or
(B) of greatest priority for providing health care and
identified as being at high risk of shortage; and
(2) use data analytics to identify supply chain
vulnerabilities that pose a threat to national security, as
determined by the Secretary or the heads of other relevant
Federal departments and agencies.
(c) Requirements.--In carrying out subsection (b), the
Secretary shall--
(1) describe the roles and responsibilities of agencies and
offices within the Department of Health and Human Services
related to monitoring such supply chains and assessing any
related vulnerabilities;
(2) facilitate the exchange of information between Federal
departments, agencies, and offices, as appropriate and
necessary to enable such agencies and offices to carry out
roles and responsibilities described in paragraph (1) related
to drugs described in subsection (b)(1), which may include--
(A) the location of establishments registered under
subsection (b), (c), or (i) of section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360) involved in the
production of active pharmaceutical ingredients and finished
dosage forms of drugs described in subsection (b)(1), and the
amount of such ingredients and finished dosage forms produced
at each such establishment;
(B) to the extent available and as appropriate, the
location of establishments so registered involved in the
production of the key starting materials and excipients
needed to produce the active pharmaceutical ingredients and
finished dosage forms, and the amount of such materials and
excipients produced at each such establishment; and
(C) any regulatory actions with respect to such drugs or
the establishments manufacturing such drugs, including with
respect to inspections and related regulatory activities
conducted under section 704 of such Act (21 U.S.C. 374), the
seizure of such a drug pursuant to section 304 of such Act
(21 U.S.C. 334), any recalls of such a drug; inclusion of
such a drug on the drug shortage list under section 506E of
such Act (21 U.S.C. 356e), or prior drug shortages reports of
a discontinuance or interruption in the production of such a
drug under 506C of such Act (21 U.S.C. 355d).
(d) Report.--Not later than 18 months after the date of
enactment of this Act, and annually thereafter, the
Secretary, in consultation with the heads of agencies with
which the Secretary coordinates under subsection (b), shall
submit a report to the relevant committees of Congress on--
(1) the current status of efforts to map and analyze
pharmaceutical supply chains, as described in subsection (b);
(2) activities of the Secretary carried out under this
section to coordinate efforts as described in subsection (b),
including information sharing between relevant Federal
departments, agencies, and offices;
(3) the roles and responsibilities described in subsection
(c)(1), including the identification of any gaps, data
limitations, or areas of unnecessary duplication between such
roles and responsibilities;
(4) the extent to which Federal agencies use data analytics
to conduct predictive modeling of anticipated drug shortages
or risks associated with supply chain vulnerabilities that
pose a threat to national security; and
(5) the extent to which the Secretary has engaged relevant
industry in such mapping.
(e) Confidential Commercial Information.--The exchange of
information among the Secretary and the heads of other
relevant Federal departments and agencies, for purposes of
carrying out this section shall not be a violation of section
1905 of title 18, United States Code. This section shall not
be construed to affect the status, if any, of such
information as trade secret or confidential commercial
information for purposes of section 301(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), section 552
of title 5, United States Code, or section 1905 of title 18,
United States Code.
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