IIB 

117TH CONGRESS 

1ST SESSION H. R. 3635 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 21, 2021 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

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, 


kjohnson on DSK79L0C42PROD with BILLS
2 

HR 3635 RFS

1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Strengthening America’s Strategic National Stockpile 

4 Act of 2021’’. 

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

6 this Act is as follows: 

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. 

7 SEC. 2. REIMBURSABLE TRANSFERS. 

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

9 (42 U.S.C. 247d–6b(a)) is amended by adding at the end 

10 the following: 

11 ‘‘(6) TRANSFERS AND REIMBURSEMENTS.— 

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

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

14 Secretary may transfer to any Federal depart15 ment or agency, on a reimbursable basis, any 

16 drugs, vaccines and other biological products, 

17 medical devices, and other supplies in the stock18 pile if— 

19 ‘‘(i) the transferred supplies are less 

20 than one year from expiry; 


kjohnson on DSK79L0C42PROD with BILLS
3 

HR 3635 RFS

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

2 the supplies, as appropriate; and 

3 ‘‘(iii) the Secretary decides the trans4 fer is in the best interest of the United 

5 States Government. 

6 ‘‘(B) USE OF REIMBURSEMENT.—Reim7 bursement derived from the transfer of supplies 

8 pursuant to subparagraph (A) may, to the ex9 tent and in the amounts made available in ad10 vance in appropriations Acts, be used by the 

11 Secretary to carry out this section. Funds made 

12 available pursuant to the preceding sentence are 

13 in addition to any other funds that may be 

14 made available for such purpose. 

15 ‘‘(C) RULE OF CONSTRUCTION.—This 

16 paragraph shall not be construed to preclude 

17 transfers of products in the stockpile under 

18 other authorities. 

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

20 30, 2023, the Secretary shall submit to the 

21 Committee on Energy and Commerce of the 

22 House of Representatives and the Committee 

23 on Health, Education, Labor, and Pensions of 

24 the Senate a report on each transfer made 


kjohnson on DSK79L0C42PROD with BILLS
4 

HR 3635 RFS

1 under this paragraph and the amount received 

2 by the Secretary in exchange for that transfer. 

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

4 transfers under this paragraph shall cease to be 

5 effective on September 30, 2024.’’. 

6 SEC. 3. EQUIPMENT MAINTENANCE. 

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

8 U.S.C. 247d–6b) is amended— 

9 (1) in subsection (a)(3)— 

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

11 and’’ and inserting a semicolon; 

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

13 period at the end and inserting a semicolon; 

14 and 

15 (C) by inserting the following new subpara16 graph at the end: 

17 ‘‘(K) ensure contents of the stockpile re18 main in good working order and, as appro19 priate, conduct maintenance services on con20 tents of the stockpile; and’’; and 

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

22 end the following new clause: 

23 ‘‘(ix) EQUIPMENT MAINTENANCE

24 SERVICE.—In carrying out this section, the 

25 Secretary may enter into contracts for the 


kjohnson on DSK79L0C42PROD with BILLS
5 

HR 3635 RFS

1 procurement of equipment maintenance 

2 services.’’. 

3 SEC. 4. SUPPLY CHAIN FLEXIBILITY MANUFACTURING 

4 PILOT. 

5 (a) IN GENERAL.—Section 319F–2(a)(3) of the Pub6 lic Health Service Act (42 U.S.C. 247d–6b(a)(3)), as 

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

8 the end the following new subparagraph: 

9 ‘‘(L) enhance medical supply chain elas10 ticity and establish and maintain domestic re11 serves of critical medical supplies (including 

12 personal protective equipment, ancillary medical 

13 supplies, and other applicable supplies required 

14 for the administration of drugs, vaccines and 

15 other biological products, and other medical de16 vices (including diagnostic tests)) by— 

17 ‘‘(i) increasing emergency stock of 

18 critical medical supplies; 

19 ‘‘(ii) geographically diversifying do20 mestic production of such medical supplies, 

21 as appropriate; 

22 ‘‘(iii) entering into cooperative agree23 ments or partnerships with respect to man24 ufacturing lines, facilities, and equipment 


kjohnson on DSK79L0C42PROD with BILLS
6 

HR 3635 RFS

1 for the domestic production of such med2 ical supplies; and 

3 ‘‘(iv) managing, either directly or 

4 through cooperative agreements with man5 ufacturers and distributors, domestic re6 serves established under this subparagraph 

7 by refreshing and replenishing stock of 

8 such medical supplies.’’. 

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

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

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

12 the end the following: 

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

14 30, 2023, the Secretary shall submit to the Com15 mittee on Energy and Commerce of the House of 

16 Representatives and the Committee on Health, Edu17 cation, Labor and Pensions of the Senate a report 

18 on the details of each cooperative agreement or part19 nership entered into under paragraph (3)(L), includ20 ing the amount expended by the Secretary on each 

21 such cooperative agreement or partnership. 

22 ‘‘(8) SUNSET.—The authority to enter into co23 operative agreements or partnerships pursuant to 

24 paragraph (3)(L) shall cease to be effective on Sep25 tember 30, 2024.’’. 


kjohnson on DSK79L0C42PROD with BILLS
7 

HR 3635 RFS

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

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

3 adding at the end the following: 

4 ‘‘(3) SUPPLY CHAIN ELASTICITY.— 

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

6 carrying out subsection (a)(3)(L), there is au7 thorized to be appropriated $500,000,000 for 

8 each of fiscal years 2022 through 2024, to re9 main available until expended. 

10 ‘‘(B) RELATION TO OTHER AMOUNTS.— 

11 The amount authorized to be appropriated by 

12 subparagraph (A) for the purpose of carrying 

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

14 other amounts available for such purpose.’’. 

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

16 A USER FEE AGREEMENT. 

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

18 United States shall conduct a study to investigate the fea19 sibility of establishing user fees to offset certain Federal 

20 costs attributable to the procurement of single-source ma21 terials for the Strategic National Stockpile under section 

22 319F–2 of the Public Health Service Act (42 U.S.C. 

23 247d–6b) and distributions of such materials from the 

24 Stockpile. In conducting this study, the Comptroller Gen25 eral shall consider, to the extent information is available— 


kjohnson on DSK79L0C42PROD with BILLS
8 

HR 3635 RFS

1 (1) whether entities receiving such distributions 

2 generate profits from those distributions; 

3 (2) any Federal costs attributable to such dis4 tributions; 

5 (3) whether such user fees would provide the 

6 Secretary with funding to potentially offset procure7 ment costs of such materials for the Strategic Na8 tional Stockpile; and 

9 (4) any other issues the Comptroller General 

10 identifies as relevant. 

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

12 Comptroller General of the United States shall submit to 

13 the Congress a report on the findings and conclusions of 

14 the study under subsection (a). 

15 SEC. 6. GRANTS FOR STATE STRATEGIC STOCKPILES. 

16 Title III of the Public Health Service Act is amended 

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

18 247d–6e) the following new section: 

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

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

21 pilot program consisting of awarding grants to States to 

22 expand or maintain a strategic stockpile of commercially 

23 available drugs, devices, personal protective equipment, 

24 and other products deemed by the State to be essential 

25 in the event of a public health emergency. 


kjohnson on DSK79L0C42PROD with BILLS
9 

HR 3635 RFS

1 ‘‘(b) ALLOWABLE USE OF FUNDS.— 

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

3 this section may use the grant funds to— 

4 ‘‘(A) acquire commercially available prod5 ucts listed pursuant to paragraph (2) for inclu6 sion in the State’s strategic stockpile; 

7 ‘‘(B) store, maintain, and distribute prod8 ucts in such stockpile; and 

9 ‘‘(C) conduct planning in connection with 

10 such activities. 

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

12 publish a list of the products that are eligible, as de13 scribed in subsection (a), for inclusion in a State’s 

14 strategic stockpile using funds received under this 

15 section. 

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

17 under paragraph (2) and otherwise determining the 

18 allowable uses of grant funds under this section, the 

19 Secretary shall consult with States and relevant 

20 stakeholders, including public health organizations. 

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

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

23 any previously awarded grants under this section for a fis24 cal year unless the total amount made available to carry 

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


kjohnson on DSK79L0C42PROD with BILLS
10 

HR 3635 RFS

1 greater than the total amount of funds made available to 

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

3 ‘‘(d) MATCHING FUNDS.— 

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

5 expanding and maintaining a strategic stockpile 

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

7 receipt of the grant, a State shall make available (di8 rectly) non-Federal contributions in cash toward 

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

10 than the amount of Federal funds provided through 

11 the grant. 

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

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

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

15 under this section if the Secretary determines that 

16 such waiver is needed for the State to establish a 

17 strategic stockpile described in subsection (a). 

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

19 provide technical assistance to States in establishing, ex20 panding, and maintaining a stockpile described in sub21 section (a). 

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

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

24 Federal Food, Drug, and Cosmetic Act. 


kjohnson on DSK79L0C42PROD with BILLS
11 

HR 3635 RFS

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

2 carry out this section, there is authorized to be appro3 priated $3,500,000,000 for each of fiscal years 2022 

4 through 2024, to remain available until expended. 

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

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

7 SEC. 7. ACTION REPORTING. 

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

9 Human Services or the Assistant Secretary for Prepared10 ness and Response, in consultation with the Administrator 

11 of the Federal Emergency Management Agency, shall— 

12 (1) not later than 30 days after the date of en13 actment of this Act, issue a report to the Committee 

14 on Energy and Commerce of the House of Rep15 resentatives and the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate regarding 

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

18 supplies from the Strategic National Stockpile re19 lated to COVID–19; and 

20 (2) not less than every 30 days thereafter 

21 through the end of the emergency period (as such 

22 term is defined in section 1135(g)(1)(B) of the So23 cial Security Act (42 U.S.C. 1320b–5(g)(1)(B))), 

24 submit to such committees an updated version of 

25 such report. 


kjohnson on DSK79L0C42PROD with BILLS
12 

HR 3635 RFS

1 (b) REPORTING PERIOD.— 

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

3 subsection (a) shall address all requests described in 

4 such subsection made during the period— 

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

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

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

9 under subsection (a) shall address all requests de10 scribed in such subsection made during the period— 

11 (A) beginning at the end of the previous 

12 reporting period under this section; and 

13 (B) ending on the date that is 30 days be14 fore the date of submission of the updated re15 port. 

16 (c) CONTENTS OF REPORT.—The report under sub17 section (a) (and updates thereto) shall include— 

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

19 subsection, including— 

20 (A) the specific medical countermeasures, 

21 devices, personal protective equipment, and 

22 other materials requested; and 

23 (B) the amount of such materials re24 quested; and 


kjohnson on DSK79L0C42PROD with BILLS
13 

HR 3635 RFS

1 (2) the outcomes of each request described in 

2 subsection (a), including— 

3 (A) whether the request was wholly ful4 filled, partially fulfilled, or denied; 

5 (B) if the request was wholly or partially 

6 fulfilled, the fulfillment amount; and 

7 (C) if the request was partially fulfilled or 

8 denied, a rationale for such outcome. 

9 SEC. 8. IMPROVED, TRANSPARENT PROCESSES. 

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

11 the Secretary of Health and Human Services shall develop 

12 and implement improved, transparent processes for the 

13 use and distribution of drugs, vaccines and other biological 

14 products, medical devices, and other supplies (including 

15 personal protective equipment, ancillary medical supplies, 

16 and other applicable supplies required for the administra17 tion of drugs, vaccines and other biological products, med18 ical devices, and diagnostic tests) in the Strategic National 

19 Stockpile under section 319F–2 of the Public Health Serv20 ice Act (42 U.S.C. 247d–6b) (in this section referred to 

21 as the ‘‘Stockpile’’). 

22 (b) PROCESSES.—The processes developed under 

23 subsection (a) shall include— 


kjohnson on DSK79L0C42PROD with BILLS
14 

HR 3635 RFS

1 (1) the form and manner in which States, local2 ities, Tribes, and territories are required to submit 

3 requests for supplies from the Stockpile; 

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

5 and Human Services in responding to such requests, 

6 including the reasons for fulfilling or denying such 

7 requests; 

8 (3) what circumstances result in prioritization 

9 of distribution of supplies from the Stockpile to 

10 States, localities, Tribes, or territories; 

11 (4) clear plans for future, urgent communica12 tion between the Secretary and States, localities, 

13 Tribes, and territories regarding the outcome of 

14 such requests; and 

15 (5) any differences in the processes developed 

16 under subsection (a) for geographically related emer17 gencies, such as weather events, and national emer18 gencies, such as pandemics. 

19 (c) CLASSIFICATION.—The processes developed under 

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

21 possible consistent with national security. The Secretary 

22 of Health and Human Services may classify portions of 

23 such processes as necessary to protect national security. 


kjohnson on DSK79L0C42PROD with BILLS
15 

HR 3635 RFS

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

2 1, 2022, the Secretary of Health and Human Services 

3 shall— 

4 (1) submit a report to the Committee on En5 ergy and Commerce of the House of Representatives 

6 and the Committee on Health, Education, Labor, 

7 and Pensions of the Senate regarding the improved, 

8 transparent processes developed under this section; 

9 (2) include in such report recommendations for 

10 opportunities for communication (by telebriefing, 

11 phone calls, or in-person meetings) between the Sec12 retary and States, localities, Tribes, and territories 

13 regarding such improved, transparent processes; and 

14 (3) submit such report in unclassified form to 

15 the greatest extent possible, except that the Sec16 retary may include a classified appendix if necessary 

17 to protect national security. 

18 SEC. 9. AUTHORIZATION OF APPROPRIATIONS. 

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

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

21 ‘‘$610,000,000 for each of fiscal years 2019 through 


kjohnson on DSK79L0C42PROD with BILLS
16 

HR 3635 RFS

1 2023’’ and inserting ‘‘$705,000,000 for each of fiscal 

2 years 2022 through 2024’’. 

Passed the House of Representatives October 20, 

2021. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


kjohnson on DSK79L0C42PROD with BILLS