Union Calendar No. 418
116th CONGRESS 2d Session |
[Report No. 116–518]
To amend the Public Health Service Act with respect to the Strategic National Stockpile, and for other purposes.
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. Luján 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]
To amend the Public Health Service Act with respect to the Strategic National Stockpile, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
(a) Short title.—This Act may be cited as the “Strengthening America’s Strategic National Stockpile Act of 2020”.
(b) Table of contents.—The table of contents for 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.
Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)) is amended by adding at the end the following:
“(6) TRANSFERS AND REIMBURSEMENTS.—
“(A) IN GENERAL.—Without regard to chapter 5 of title 40, United States Code, the Secretary may transfer to any Federal department or agency, on a reimbursable basis, any drugs, vaccines and other biological products, medical devices, and other supplies in the stockpile if—
“(B) USE OF REIMBURSEMENT.—Reimbursement derived from the transfer of supplies pursuant to subparagraph (A) may be used by the Secretary, without further appropriation and without fiscal year limitation, to carry out this section.
“(C) RULE OF CONSTRUCTION.—This paragraph shall not be construed to preclude transfers of products in the stockpile under other authorities.
“(D) REPORT.—Not later than September 30, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on each transfer made under this paragraph and the amount received by the Secretary in exchange for that transfer.
Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended—
(a) In general.—Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)), as amended by section 3, is further amended by adding at the end the following new subparagraph:
“(L) enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, and other medical devices (including diagnostic tests)) by—
(b) Reporting; sunset.—Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as amended by section 2, is further amended by adding at the end the following:
“(7) REPORTING.—Not later than September 30, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the details of each cooperative agreement or partnership entered into under paragraph (3)(L), including the amount expended by the Secretary on each such cooperative agreement or partnership.
(c) Funding.—Section 319F–2(f) of the Public Health Service Act (42 U.S.C. 247d–6b(f)) is amended by adding at the end the following:
(a) In general.—The Comptroller General of the United States shall conduct a study to investigate the feasibility of establishing user fees to offset certain Federal costs attributable to the procurement of single-source materials for the Strategic National Stockpile under section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) and distributions of such materials from the Stockpile. In conducting this study, the Comptroller General shall consider, to the extent information is available—
Title III of the Public Health Service Act is amended by inserting after section 319F–4 of such Act (42 U.S.C. 247d–6e) the following new section:
“SEC. 319F–5. Grants for State strategic stockpiles.
“(a) In general.—The Secretary may establish a pilot program consisting of awarding grants to States to expand or maintain a strategic stockpile of commercially available drugs, medical equipment, personal protective equipment, and other products deemed by the State to be essential in the event of a public health emergency.
“(b) Allowable use of funds.—
“(1) USES.—A State receiving a grant under this section may use the grant funds to—
“(c) Funding requirement.—The Secretary may not obligate or expend any funds to award grants or fund any previously awarded grants under this section for a fiscal year unless the total amount made available to carry out section 319F–2 for such fiscal year is equal to or greater than the total amount of funds made available to carry out section 319F–2 for fiscal year 2020.
“(d) Matching funds.—
“(1) IN GENERAL.—With respect to the costs of expanding and maintaining a strategic stockpile through a grant under this section, as a condition on receipt of the grant, a State shall make available (directly) non-Federal contributions in cash toward such costs in an amount that is equal to not less than the amount of Federal funds provided through the grant.
“(2) WAIVER.—The Secretary may waive the requirement of paragraph (1) with respect to a State for the first two years of the State receiving a grant under this section if the Secretary determines that such waiver is needed for the State to establish a strategic stockpile described in subsection (a).
“(e) Technical assistance.—The Secretary shall provide technical assistance to States in establishing, expanding, and maintaining a stockpile described in subsection (a).
“(f) Definition.—In this section, the term ‘drug’ has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act.
(a) In general.—The Assistant Secretary for Preparedness and Response (in this section referred to as the “Assistant Secretary”), in coordination with the Administrator of the Federal Emergency Management Agency, shall—
(1) not later than 30 days after the date of enactment of this Act, issue a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate regarding all State, local, Tribal, and territorial requests for supplies from the Strategic National Stockpile related to COVID–19; and
(2) not less than every 30 days thereafter through the end of the emergency period (as such term is defined in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B))), submit to such committees an updated version of such report.
(b) Reporting period.—
(1) INITIAL REPORT.—The initial report under subsection (a) shall address all requests described in such subsection made during the period—
(c) Contents of report.—The report under subsection (a) (and updates thereto) shall include—
(1) the details of each request described in such subsection, including—
(a) In general.—Not later than January 1, 2021, the Secretary of Health and Human Services, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, shall develop and implement improved, transparent processes for the use and distribution of drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests) in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) (in this section referred to as the “Stockpile”).
(b) Processes.—The processes developed under subsection (a) shall include—
(1) the form and manner in which States, localities, Tribes, and territories are required to submit requests for supplies from the Stockpile;
(2) the criteria used by the Secretary of Health and Human Services in responding to such requests, including the reasons for fulfilling or denying such requests;
(3) what circumstances result in prioritization of distribution of supplies from the Stockpile to States, localities, Tribes, or territories;
(c) Classification.—The processes developed under subsection (a) shall be unclassified to the greatest extent possible consistent with national security. The Secretary of Health and Human Services may classify portions of such processes as necessary to protect national security.
(d) Report to Congress.—Not later than January 1, 2021, the Secretary of Health and Human Services shall—
(1) submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate regarding the improved, transparent processes developed under this section;
Section 319F–2(f)(1) of the Public Health Service Act (42 U.S.C. 247d-6b(f)(1)) is amended by striking “$610,000,000 for each of fiscal years 2019 through 2023” and inserting “$705,000,000 for each of fiscal years 2020 through 2023”.
Union Calendar No. 418 | |||||
| |||||
[Report No. 116–518] | |||||
A BILL | |||||
To amend the Public Health Service Act with respect to the Strategic National Stockpile, and for other purposes. | |||||
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 |