I 

117TH CONGRESS 

1ST SESSION H. R. 3635 

To amend the Public Health Service Act with respect to the Strategic 

National Stockpile, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 28, 2021 

Ms. SLOTKIN (for herself, Mr. HUDSON, Ms. SCHRIER, Mr. MCKINLEY, Ms. 

DEGETTE, Mr. CARTER of Georgia, Mr. BUTTERFIELD, Mrs. WALORSKI, 

Mr. NEGUSE, Mr. UPTON, Mr. MALINOWSKI, Mr. BURGESS, Mrs. DINGELL, Mr. VAN DREW, Mr. SOTO, and Mr. FITZPATRICK) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act with respect to 

the Strategic National Stockpile, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Strengthening America’s Strategic National Stockpile 

6 Act of 2021’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

Sec. 2. Reimbursable transfers. 

Sec. 3. Equipment maintenance. 

Sec. 4. Supply chain flexibility manufacturing pilot. 

Sec. 5. GAO study on the feasibility and benefits of a user fee agreement. 

Sec. 6. Grants for State strategic stockpiles. 

Sec. 7. Action reporting. 

Sec. 8. Improved, transparent processes. 

Sec. 9. Authorization of appropriations. 

1 SEC. 2. REIMBURSABLE TRANSFERS. 

2 Section 319F–2(a) of the Public Health Service Act 

3 (42 U.S.C. 247d–6b(a)) is amended by adding at the end 

4 the following: 

5 ‘‘(6) TRANSFERS AND REIMBURSEMENTS.— 

6 ‘‘(A) IN GENERAL.—Without regard to 

7 chapter 5 of title 40, United States Code, the 

8 Secretary may transfer to any Federal depart9 ment or agency, on a reimbursable basis, any 

10 drugs, vaccines and other biological products, 

11 medical devices, and other supplies in the stock12 pile if— 

13 ‘‘(i) the transferred supplies are less 

14 than one year from expiry; 

15 ‘‘(ii) the stockpile is able to replenish 

16 the supplies, as appropriate; and 

17 ‘‘(iii) the Secretary decides the trans18 fer is in the best interest of the United 

19 States Government. 

20 ‘‘(B) USE OF REIMBURSEMENT.—Reim21 bursement derived from the transfer of supplies 


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1 pursuant to subparagraph (A) may, to the ex2 tent and in the amounts made available in ad3 vance in appropriations Acts, be used by the 

4 Secretary to carry out this section. Funds made 

5 available pursuant to the preceding sentence are 

6 in addition to any other funds that may be 

7 made available for such purpose. 

8 ‘‘(C) RULE OF CONSTRUCTION.—This 

9 paragraph shall not be construed to preclude 

10 transfers of products in the stockpile under 

11 other authorities. 

12 ‘‘(D) REPORT.—Not later than September 

13 30, 2023, the Secretary shall submit to the 

14 Committee on Energy and Commerce of the 

15 House of Representatives and the Committee 

16 on Health, Education, Labor, and Pensions of 

17 the Senate a report on each transfer made 

18 under this paragraph and the amount received 

19 by the Secretary in exchange for that transfer. 

20 ‘‘(E) SUNSET.—The authority to make 

21 transfers under this paragraph shall cease to be 

22 effective on September 30, 2024.’’. 

23 SEC. 3. EQUIPMENT MAINTENANCE. 

24 Section 319F–2 of the Public Health Service Act (42 

25 U.S.C. 247d–6b) is amended— 


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1 (1) in subsection (a)(3)— 

2 (A) in subparagraph (I), by striking ‘‘; 

3 and’’ and inserting a semicolon; 

4 (B) in subparagraph (J), by striking the 

5 period at the end and inserting a semicolon; 

6 and 

7 (C) by inserting the following new subpara8 graph at the end: 

9 ‘‘(K) ensure contents of the stockpile re10 main in good working order and, as appro11 priate, conduct maintenance services on con12 tents of the stockpile; and’’; and 

13 (2) in subsection (c)(7)(B), by adding at the 

14 end the following new clause: 

15 ‘‘(ix) EQUIPMENT MAINTENANCE

16 SERVICE.—In carrying out this section, the 

17 Secretary may enter into contracts for the 

18 procurement of equipment maintenance 

19 services.’’. 

20 SEC. 4. SUPPLY CHAIN FLEXIBILITY MANUFACTURING 

21 PILOT. 

22 (a) IN GENERAL.—Section 319F–2(a)(3) of the Pub23 lic Health Service Act (42 U.S.C. 247d–6b(a)(3)), as 

24 amended by section 3, is further amended by adding at 

25 the end the following new subparagraph: 


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1 ‘‘(L) enhance medical supply chain elas2 ticity and establish and maintain domestic re3 serves of critical medical supplies (including 

4 personal protective equipment, ancillary medical 

5 supplies, and other applicable supplies required 

6 for the administration of drugs, vaccines and 

7 other biological products, and other medical de8 vices (including diagnostic tests)) by— 

9 ‘‘(i) increasing emergency stock of 

10 critical medical supplies; 

11 ‘‘(ii) geographically diversifying do12 mestic production of such medical supplies, 

13 as appropriate; 

14 ‘‘(iii) entering into cooperative agree15 ments or partnerships with respect to man16 ufacturing lines, facilities, and equipment 

17 for the domestic production of such med18 ical supplies; and 

19 ‘‘(iv) managing, either directly or 

20 through cooperative agreements with man21 ufacturers and distributors, domestic re22 serves established under this subparagraph 

23 by refreshing and replenishing stock of 

24 such medical supplies.’’. 


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1 (b) REPORTING; SUNSET.—Section 319F–2(a) of the 

2 Public Health Service Act (42 U.S.C. 247d–6b(a)), as 

3 amended by section 2, is further amended by adding at 

4 the end the following: 

5 ‘‘(7) REPORTING.—Not later than September 

6 30, 2023, the Secretary shall submit to the Com7 mittee on Energy and Commerce of the House of 

8 Representatives and the Committee on Health, Edu9 cation, Labor and Pensions of the Senate a report 

10 on the details of each cooperative agreement or part11 nership entered into under paragraph (3)(L), includ12 ing the amount expended by the Secretary on each 

13 such cooperative agreement or partnership. 

14 ‘‘(8) SUNSET.—The authority to enter into co15 operative agreements or partnerships pursuant to 

16 paragraph (3)(L) shall cease to be effective on Sep17 tember 30, 2024.’’. 

18 (c) FUNDING.—Section 319F–2(f) of the Public 

19 Health Service Act (42 U.S.C. 247d–6b(f)) is amended by 

20 adding at the end the following: 

21 ‘‘(3) SUPPLY CHAIN ELASTICITY.— 

22 ‘‘(A) IN GENERAL.—For the purpose of 

23 carrying out subsection (a)(3)(L), there is au24 thorized to be appropriated $500,000,000 for 


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1 each of fiscal years 2022 through 2024, to re2 main available until expended. 

3 ‘‘(B) RELATION TO OTHER AMOUNTS.— 

4 The amount authorized to be appropriated by 

5 subparagraph (A) for the purpose of carrying 

6 out subsection (a)(3)(L) is in addition to any 

7 other amounts available for such purpose.’’. 

8 SEC. 5. GAO STUDY ON THE FEASIBILITY AND BENEFITS OF 

9 A USER FEE AGREEMENT. 

10 (a) IN GENERAL.—The Comptroller General of the 

11 United States shall conduct a study to investigate the fea12 sibility of establishing user fees to offset certain Federal 

13 costs attributable to the procurement of single-source ma14 terials for the Strategic National Stockpile under section 

15 319F–2 of the Public Health Service Act (42 U.S.C. 

16 247d–6b) and distributions of such materials from the 

17 Stockpile. In conducting this study, the Comptroller Gen18 eral shall consider, to the extent information is available— 

19 (1) whether entities receiving such distributions 

20 generate profits from those distributions; 

21 (2) any Federal costs attributable to such dis22 tributions; 

23 (3) whether such user fees would provide the 

24 Secretary with funding to potentially offset procureVerDate Sep 11 2014 06:36 Jun 24, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.IH H3635

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1 ment costs of such materials for the Strategic Na2 tional Stockpile; and 

3 (4) any other issues the Comptroller General 

4 identifies as relevant. 

5 (b) REPORT.—Not later than February 1, 2024, the 

6 Comptroller General of the United States shall submit to 

7 the Congress a report on the findings and conclusions of 

8 the study under subsection (a). 

9 SEC. 6. GRANTS FOR STATE STRATEGIC STOCKPILES. 

10 Title III of the Public Health Service Act is amended 

11 by inserting after section 319F–4 of such Act (42 U.S.C. 

12 247d–6e) the following new section: 

13 ‘‘SEC. 319F–5. GRANTS FOR STATE STRATEGIC STOCKPILES. 

14 ‘‘(a) IN GENERAL.—The Secretary may establish a 

15 pilot program consisting of awarding grants to States to 

16 expand or maintain a strategic stockpile of commercially 

17 available drugs, devices, personal protective equipment, 

18 and other products deemed by the State to be essential 

19 in the event of a public health emergency. 

20 ‘‘(b) ALLOWABLE USE OF FUNDS.— 

21 ‘‘(1) USES.—A State receiving a grant under 

22 this section may use the grant funds to— 

23 ‘‘(A) acquire commercially available prod24 ucts listed pursuant to paragraph (2) for inclu25 sion in the State’s strategic stockpile; 


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1 ‘‘(B) store, maintain, and distribute prod2 ucts in such stockpile; and 

3 ‘‘(C) conduct planning in connection with 

4 such activities. 

5 ‘‘(2) LIST.—The Secretary shall develop and 

6 publish a list of the products that are eligible, as de7 scribed in subsection (a), for inclusion in a State’s 

8 strategic stockpile using funds received under this 

9 section. 

10 ‘‘(3) CONSULTATION.—In developing the list 

11 under paragraph (2) and otherwise determining the 

12 allowable uses of grant funds under this section, the 

13 Secretary shall consult with States and relevant 

14 stakeholders, including public health organizations. 

15 ‘‘(c) FUNDING REQUIREMENT.—The Secretary may 

16 not obligate or expend any funds to award grants or fund 

17 any previously awarded grants under this section for a fis18 cal year unless the total amount made available to carry 

19 out section 319F–2 for such fiscal year is equal to or 

20 greater than the total amount of funds made available to 

21 carry out section 319F–2 for fiscal year 2022. 

22 ‘‘(d) MATCHING FUNDS.— 

23 ‘‘(1) IN GENERAL.—With respect to the costs of 

24 expanding and maintaining a strategic stockpile 

25 through a grant under this section, as a condition on 


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1 receipt of the grant, a State shall make available (di2 rectly) non-Federal contributions in cash toward 

3 such costs in an amount that is equal to not less 

4 than the amount of Federal funds provided through 

5 the grant. 

6 ‘‘(2) WAIVER.—The Secretary may waive the 

7 requirement of paragraph (1) with respect to a State 

8 for the first two years of the State receiving a grant 

9 under this section if the Secretary determines that 

10 such waiver is needed for the State to establish a 

11 strategic stockpile described in subsection (a). 

12 ‘‘(e) TECHNICAL ASSISTANCE.—The Secretary shall 

13 provide technical assistance to States in establishing, ex14 panding, and maintaining a stockpile described in sub15 section (a). 

16 ‘‘(f) DEFINITION.—In this section, the term ‘drug’ 

17 has the meaning given to that term in section 201 of the 

18 Federal Food, Drug, and Cosmetic Act. 

19 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

20 carry out this section, there is authorized to be appro21 priated $3,500,000,000 for each of fiscal years 2022 

22 through 2024, to remain available until expended. 

23 ‘‘(h) SUNSET.—The authority vested by this section 

24 terminates at the end of fiscal year 2024.’’. 


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1 SEC. 7. ACTION REPORTING. 

2 (a) IN GENERAL.—The Secretary of Health and 

3 Human Services or the Assistant Secretary for Prepared4 ness and Response, in consultation with the Administrator 

5 of the Federal Emergency Management Agency, shall— 

6 (1) not later than 30 days after the date of en7 actment of this Act, issue a report to the Committee 

8 on Energy and Commerce of the House of Rep9 resentatives and the Committee on Health, Edu10 cation, Labor, and Pensions of the Senate regarding 

11 all State, local, Tribal, and territorial requests for 

12 supplies from the Strategic National Stockpile re13 lated to COVID–19; and 

14 (2) not less than every 30 days thereafter 

15 through the end of the emergency period (as such 

16 term is defined in section 1135(g)(1)(B) of the So17 cial Security Act (42 U.S.C. 1320b–5(g)(1)(B))), 

18 submit to such committees an updated version of 

19 such report. 

20 (b) REPORTING PERIOD.— 

21 (1) INITIAL REPORT.—The initial report under 

22 subsection (a) shall address all requests described in 

23 such subsection made during the period— 

24 (A) beginning on January 31, 2022; and 

25 (B) ending on the date that is 30 days be26 fore the date of submission of the report. 


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1 (2) UPDATES.—Each update to the report 

2 under subsection (a) shall address all requests de3 scribed in such subsection made during the period— 

4 (A) beginning at the end of the previous 

5 reporting period under this section; and 

6 (B) ending on the date that is 30 days be7 fore the date of submission of the updated re8 port. 

9 (c) CONTENTS OF REPORT.—The report under sub10 section (a) (and updates thereto) shall include— 

11 (1) the details of each request described in such 

12 subsection, including— 

13 (A) the specific medical countermeasures, 

14 devices, personal protective equipment, and 

15 other materials requested; and 

16 (B) the amount of such materials re17 quested; and 

18 (2) the outcomes of each request described in 

19 subsection (a), including— 

20 (A) whether the request was wholly ful21 filled, partially fulfilled, or denied; 

22 (B) if the request was wholly or partially 

23 fulfilled, the fulfillment amount; and 

24 (C) if the request was partially fulfilled or 

25 denied, a rationale for such outcome. 


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1 SEC. 8. IMPROVED, TRANSPARENT PROCESSES. 

2 (a) IN GENERAL.—Not later than January 1, 2022, 

3 the Secretary of Health and Human Services shall develop 

4 and implement improved, transparent processes for the 

5 use and distribution of drugs, vaccines and other biological 

6 products, medical devices, and other supplies (including 

7 personal protective equipment, ancillary medical supplies, 

8 and other applicable supplies required for the administra9 tion of drugs, vaccines and other biological products, med10 ical devices, and diagnostic tests) in the Strategic National 

11 Stockpile under section 319F–2 of the Public Health Serv12 ice Act (42 U.S.C. 247d–6b) (in this section referred to 

13 as the ‘‘Stockpile’’). 

14 (b) PROCESSES.—The processes developed under 

15 subsection (a) shall include— 

16 (1) the form and manner in which States, local17 ities, Tribes, and territories are required to submit 

18 requests for supplies from the Stockpile; 

19 (2) the criteria used by the Secretary of Health 

20 and Human Services in responding to such requests, 

21 including the reasons for fulfilling or denying such 

22 requests; 

23 (3) what circumstances result in prioritization 

24 of distribution of supplies from the Stockpile to 

25 States, localities, Tribes, or territories; 


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1 (4) clear plans for future, urgent communica2 tion between the Secretary and States, localities, 

3 Tribes, and territories regarding the outcome of 

4 such requests; and 

5 (5) any differences in the processes developed 

6 under subsection (a) for geographically related emer7 gencies, such as weather events, and national emer8 gencies, such as pandemics. 

9 (c) CLASSIFICATION.—The processes developed under 

10 subsection (a) shall be unclassified to the greatest extent 

11 possible consistent with national security. The Secretary 

12 of Health and Human Services may classify portions of 

13 such processes as necessary to protect national security. 

14 (d) REPORT TO CONGRESS.—Not later than January 

15 1, 2022, the Secretary of Health and Human Services 

16 shall— 

17 (1) submit a report to the Committee on En18 ergy and Commerce of the House of Representatives 

19 and the Committee on Health, Education, Labor, 

20 and Pensions of the Senate regarding the improved, 

21 transparent processes developed under this section; 

22 (2) include in such report recommendations for 

23 opportunities for communication (by telebriefing, 

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1 retary and States, localities, Tribes, and territories 

2 regarding such improved, transparent processes; and 

3 (3) submit such report in unclassified form to 

4 the greatest extent possible, except that the Sec5 retary may include a classified appendix if necessary 

6 to protect national security. 

7 SEC. 9. AUTHORIZATION OF APPROPRIATIONS. 

8 Section 319F–2(f)(1) of the Public Health Service 

9 Act (42 U.S.C. 247d–6b(f)(1)) is amended by striking 

10 ‘‘$610,000,000 for each of fiscal years 2019 through 

11 2023’’ and inserting ‘‘$705,000,000 for each of fiscal 

12 years 2022 through 2024’’. 

Æ 


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