IB 

Union Calendar No. 418 

116TH CONGRESS 

2D SESSION H. R. 7574 

[Report No. 116–518] 

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

National Stockpile, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 13, 2020 

Ms. SLOTKIN (for herself, Mrs. BROOKS of Indiana, Ms. ESHOO, Mr. CARTER

of Georgia, Mrs. DINGELL, Mrs. WALORSKI, Ms. DEGETTE, Mr. MCKINLEY, Mr. BUTTERFIELD, Mr. VAN DREW, Mr. SOTO, Mr. UPTON, Mr. 

MALINOWSKI, Mr. HUDSON, Ms. SCHRIER, Mr. GIANFORTE, Mr. 

CISNEROS, Mr. NEGUSE, and Mr. BURGESS) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

SEPTEMBER 18, 2020 

Additional sponsors: Mr. LUJA ́N and Mr. FITZPATRICK

SEPTEMBER 18, 2020 

Reported with an amendment; committed to the Committee of the Whole 

House on the State of the Union and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on July 13, 2020] 


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A BILL 

To amend the Public Health Service Act with respect to 

the Strategic National Stockpile, and for other purposes. 


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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 Act 

6 of 2020’’. 

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

8 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. 

9 SEC. 2. REIMBURSABLE TRANSFERS. 

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

11 (42 U.S.C. 247d–6b(a)) is amended by adding at the end 

12 the following: 

13 ‘‘(6) TRANSFERS AND REIMBURSEMENTS.— 

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

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

16 Secretary may transfer to any Federal depart17 ment or agency, on a reimbursable basis, any 

18 drugs, vaccines and other biological products, 

19 medical devices, and other supplies in the stock20 pile if— 


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1 ‘‘(i) the transferred supplies are less 

2 than one year from expiry; 

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

4 the supplies, as appropriate; and 

5 ‘‘(iii) the Secretary decides the transfer 

6 is in the best interest of the United States 

7 Government. 

8 ‘‘(B) USE OF REIMBURSEMENT.—Reim9 bursement derived from the transfer of supplies 

10 pursuant to subparagraph (A) may be used by 

11 the Secretary, without further appropriation and 

12 without fiscal year limitation, to carry out this 

13 section. 

14 ‘‘(C) RULE OF CONSTRUCTION.—This para15 graph shall not be construed to preclude transfers 

16 of products in the stockpile under other authori17 ties. 

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

19 30, 2022, the Secretary shall submit to the Com20 mittee on Energy and Commerce of the House of 

21 Representatives and the Committee on Health, 

22 Education, Labor, and Pensions of the Senate a 

23 report on each transfer made under this para24 graph and the amount received by the Secretary 

25 in exchange for that transfer. 


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

2 transfers under this paragraph shall cease to be 

3 effective on September 30, 2023.’’. 

4 SEC. 3. EQUIPMENT MAINTENANCE. 

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

6 U.S.C. 247d–6b) is amended— 

7 (1) in subsection (a)(3)— 

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

9 and’’ and inserting a semicolon; 

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

11 period at the end and inserting a semicolon; and 

12 (C) by inserting the following new subpara13 graph at the end: 

14 ‘‘(K) ensure contents of the stockpile remain 

15 in good working order and, as appropriate, con16 duct maintenance services on contents of the 

17 stockpile; and’’; and 

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

19 the following new clause: 

20 ‘‘(ix) EQUIPMENT MAINTENANCE SERV21 ICE.—In carrying out this section, the Sec22 retary may enter into contracts for the pro23 curement of equipment maintenance serv24 ices.’’. 


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1 SEC. 4. SUPPLY CHAIN FLEXIBILITY MANUFACTURING 

2 PILOT. 

3 (a) IN GENERAL.—Section 319F–2(a)(3) of the Public 

4 Health Service Act (42 U.S.C. 247d–6b(a)(3)), as amended 

5 by section 3, is further amended by adding at the end the 

6 following new subparagraph: 

7 ‘‘(L) enhance medical supply chain elas8 ticity and establish and maintain domestic re9 serves of critical medical supplies (including per10 sonal protective equipment, ancillary medical 

11 supplies, and other applicable supplies required 

12 for the administration of drugs, vaccines and 

13 other biological products, and other medical de14 vices (including diagnostic tests)) by— 

15 ‘‘(i) increasing emergency stock of crit16 ical medical supplies; 

17 ‘‘(ii) geographically diversifying do18 mestic production of such medical supplies, 

19 as appropriate; 

20 ‘‘(iii) entering into cooperative agree21 ments or partnerships with respect to man22 ufacturing lines, facilities, and equipment 

23 for the domestic production of such medical 

24 supplies; and 

25 ‘‘(iv) managing, either directly or 

26 through cooperative agreements with manuVerDate Sep 11 2014 01:05 Sep 19, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\H7574.RH H7574

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1 facturers and distributors, domestic reserves 

2 established under this subparagraph by re3 freshing and replenishing stock of such med4 ical supplies.’’. 

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

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

7 amended by section 2, is further amended by adding at the 

8 end the following: 

9 ‘‘(7) REPORTING.—Not later than September 30, 

10 2022, the Secretary shall submit to the Committee on 

11 Energy and Commerce of the House of Representa12 tives and the Committee on Health, Education, Labor 

13 and Pensions of the Senate a report on the details of 

14 each cooperative agreement or partnership entered 

15 into under paragraph (3)(L), including the amount 

16 expended by the Secretary on each such cooperative 

17 agreement or partnership. 

18 ‘‘(8) SUNSET.—The authority to enter into coop19 erative agreements or partnerships pursuant to para20 graph (3)(L) shall cease to be effective on September 

21 30, 2023.’’. 

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

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

24 at the end the following: 

25 ‘‘(3) SUPPLY CHAIN ELASTICITY.— 


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1 ‘‘(A) IN GENERAL.—For the purpose of car2 rying out subsection (a)(3)(L), there is author3 ized to be appropriated $500,000,000 for each of 

4 fiscal years 2020 through 2023, to remain avail5 able until expended. 

6 ‘‘(B) RELATION TO OTHER AMOUNTS.—The 

7 amount authorized to be appropriated by sub8 paragraph (A) for the purpose of carrying out 

9 subsection (a)(3)(L) is in addition to any other 

10 amounts available for such purpose.’’. 

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

12 A USER FEE AGREEMENT. 

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

14 United States shall conduct a study to investigate the feasi15 bility of establishing user fees to offset certain Federal costs 

16 attributable to the procurement of single-source materials 

17 for the Strategic National Stockpile under section 319F– 

18 2 of the Public Health Service Act (42 U.S.C. 247d–6b) and 

19 distributions of such materials from the Stockpile. In con20 ducting this study, the Comptroller General shall consider, 

21 to the extent information is available— 

22 (1) whether entities receiving such distributions 

23 generate profits from those distributions; 

24 (2) any Federal costs attributable to such dis25 tributions; 


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1 (3) whether such user fees would provide the Sec2 retary with funding to potentially offset procurement 

3 costs of such materials for the Strategic National 

4 Stockpile; and 

5 (4) any other issues the Comptroller General 

6 identifies as relevant. 

7 (b) REPORT.—Not later than February 1, 2023, the 

8 Comptroller General of the United States shall submit to 

9 the Congress a report on the findings and conclusions of 

10 the study under subsection (a). 

11 SEC. 6. GRANTS FOR STATE STRATEGIC STOCKPILES. 

12 Title III of the Public Health Service Act is amended 

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

14 247d–6e) the following new section: 

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

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

17 pilot program consisting of awarding grants to States to 

18 expand or maintain a strategic stockpile of commercially 

19 available drugs, medical equipment, personal protective 

20 equipment, and other products deemed by the State to be 

21 essential in the event of a public health emergency. 

22 ‘‘(b) ALLOWABLE USE OF FUNDS.— 

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

24 this section may use the grant funds to— 


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1 ‘‘(A) acquire commercially available prod2 ucts listed pursuant to paragraph (2) for inclu3 sion in the State’s strategic stockpile; 

4 ‘‘(B) store, maintain, and distribute prod5 ucts in such stockpile; and 

6 ‘‘(C) conduct planning in connection with 

7 such activities. 

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

9 publish a list of the products that are eligible, as de10 scribed in subsection (a), for inclusion in a State’s 

11 strategic stockpile using funds received under this sec12 tion. 

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

14 under paragraph (2) and otherwise determining the 

15 allowable uses of grant funds under this section, the 

16 Secretary shall consult with States and relevant 

17 stakeholders, including public health organizations. 

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

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

20 any previously awarded grants under this section for a fis21 cal year unless the total amount made available to carry 

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

23 than the total amount of funds made available to carry out 

24 section 319F–2 for fiscal year 2020. 

25 ‘‘(d) MATCHING FUNDS.— 


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

2 expanding and maintaining a strategic stockpile 

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

4 receipt of the grant, a State shall make available (di5 rectly) non-Federal contributions in cash toward such 

6 costs in an amount that is equal to not less than the 

7 amount of Federal funds provided through the grant. 

8 ‘‘(2) WAIVER.—The Secretary may waive the re9 quirement of paragraph (1) with respect to a State 

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

11 under this section if the Secretary determines that 

12 such waiver is needed for the State to establish a stra13 tegic stockpile described in subsection (a). 

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

15 provide technical assistance to States in establishing, ex16 panding, and maintaining a stockpile described in sub17 section (a). 

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

19 the meaning given to that term in section 201 of the Federal 

20 Food, Drug, and Cosmetic Act. 

21 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

22 out this section, there is authorized to be appropriated 

23 $3,500,000,000 for each of fiscal years 2020 through 2023, 

24 to remain available until expended. 


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

2 terminates at the end of fiscal year 2023.’’. 

3 SEC. 7. ACTION REPORTING. 

4 (a) IN GENERAL.—The Assistant Secretary for Pre5 paredness and Response (in this section referred to as the 

6 ‘‘Assistant Secretary’’), in coordination with the Adminis7 trator of the Federal Emergency Management Agency, 

8 shall— 

9 (1) not later than 30 days after the date of en10 actment of this Act, issue a report to the Committee 

11 on Energy and Commerce of the House of Representa12 tives and the Committee on Health, Education, 

13 Labor, and Pensions of the Senate regarding all 

14 State, local, Tribal, and territorial requests for sup15 plies from the Strategic National Stockpile related to 

16 COVID–19; and 

17 (2) not less than every 30 days thereafter through 

18 the end of the emergency period (as such term is de19 fined in section 1135(g)(1)(B) of the Social Security 

20 Act (42 U.S.C. 1320b–5(g)(1)(B))), submit to such 

21 committees an updated version of such report. 

22 (b) REPORTING PERIOD.— 

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

24 subsection (a) shall address all requests described in 

25 such subsection made during the period— 


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1 (A) beginning on January 31, 2020; and 

2 (B) ending on the date that is 30 days be3 fore the date of submission of the report. 

4 (2) UPDATES.—Each update to the report under 

5 subsection (a) shall address all requests described in 

6 such subsection made during the period— 

7 (A) beginning at the end of the previous re8 porting period under this section; and 

9 (B) ending on the date that is 30 days be10 fore the date of submission of the updated report. 

11 (c) CONTENTS OF REPORT.—The report under sub12 section (a) (and updates thereto) shall include— 

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

14 subsection, including— 

15 (A) the specific medical countermeasures, 

16 devices, personal protective equipment, and other 

17 materials requested; and 

18 (B) the amount of such materials requested; 

19 and 

20 (2) the outcomes of each request described in sub21 section (a), including— 

22 (A) whether the request was wholly fulfilled, 

23 partially fulfilled, or denied; 

24 (B) if the request was wholly or partially 

25 fulfilled, the fulfillment amount; and 


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1 (C) if the request was partially fulfilled or 

2 denied, a rationale for such outcome. 

3 SEC. 8. IMPROVED, TRANSPARENT PROCESSES. 

4 (a) IN GENERAL.—Not later than January 1, 2021, 

5 the Secretary of Health and Human Services, in collabora6 tion with the Assistant Secretary for Preparedness and Re7 sponse and the Director of the Centers for Disease Control 

8 and Prevention, shall develop and implement improved, 

9 transparent processes for the use and distribution of drugs, 

10 vaccines and other biological products, medical devices, and 

11 other supplies (including personal protective equipment, 

12 ancillary medical supplies, and other applicable supplies 

13 required for the administration of drugs, vaccines and other 

14 biological products, medical devices, and diagnostic tests) 

15 in the Strategic National Stockpile under section 319F–2 

16 of the Public Health Service Act (42 U.S.C. 247d–6b) (in 

17 this section referred to as the ‘‘Stockpile’’). 

18 (b) PROCESSES.—The processes developed under sub19 section (a) shall include— 

20 (1) the form and manner in which States, local21 ities, Tribes, and territories are required to submit re22 quests for supplies from the Stockpile; 

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

24 and Human Services in responding to such requests, 


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1 including the reasons for fulfilling or denying such 

2 requests; 

3 (3) what circumstances result in prioritization of 

4 distribution of supplies from the Stockpile to States, 

5 localities, Tribes, or territories; 

6 (4) clear plans for future, urgent communication 

7 between the Secretary and States, localities, Tribes, 

8 and territories regarding the outcome of such requests; 

9 and 

10 (5) any differences in the processes developed 

11 under subsection (a) for geographically related emer12 gencies, such as weather events, and national emer13 gencies, such as pandemics. 

14 (c) CLASSIFICATION.—The processes developed under 

15 subsection (a) shall be unclassified to the greatest extent pos16 sible consistent with national security. The Secretary of 

17 Health and Human Services may classify portions of such 

18 processes as necessary to protect national security. 

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

20 1, 2021, the Secretary of Health and Human Services 

21 shall— 

22 (1) submit a report to the Committee on Energy 

23 and Commerce of the House of Representatives and 

24 the Committee on Health, Education, Labor, and 


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1 Pensions of the Senate regarding the improved, trans2 parent processes developed under this section; 

3 (2) include in such report recommendations for 

4 opportunities for communication (by telebriefing, 

5 phone calls, or in-person meetings) between the Sec6 retary and States, localities, Tribes, and territories 

7 regarding such improved, transparent processes; and 

8 (3) submit such report in unclassified form to 

9 the greatest extent possible, except that the Secretary 

10 may include a classified appendix if necessary to pro11 tect national security. 

12 SEC. 9. AUTHORIZATION OF APPROPRIATIONS. 

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

14 (42 U.S.C. 247d-6b(f)(1)) is amended by striking 

15 ‘‘$610,000,000 for each of fiscal years 2019 through 2023’’ 

16 and inserting ‘‘$705,000,000 for each of fiscal years 2020 

17 through 2023’’. 


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Union Calendar No. 418 

116TH CONGRESS 

2D SESSION H. R. 7574 

[Report No. 116–518] 

A BILL 

To amend the Public Health Service Act with reother purposes. spect to the Strategic National Stockpile, and for 

SEPTEMBER 18, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


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