Title: Operation Warp Speed Act of 2021
Policy area: Health

Summary:
Operation Warp Speed Act of 2021
This bill modifies procedures for Emergency Use Authorization (EUA) and provides additional authority to the Department of Health and Human Services (HHS) for vaccine production in response to a public health emergency. It also makes changes to the administration of the Strategic National Stockpile. (An EUA temporarily authorizes use of an otherwise unapproved medical product or device in certain emergency situations.)
Among other modifications, the bill places additional requirements on EUA approvals. Specifically, HHS may only approve an EUA if, after consulting four specified agencies, at least three of them vote to grant approval. Currently, HHS's authority to approve an EUA, which it has delegated to the Food and Drug Administration, is not limited by the votes of consulting agencies.
Additionally, the bill authorizes the use of HHS funds to produce a vaccine before it is licensed or authorized in response to a public health emergency. The bill also establishes the Office of Operation Warp Speed within the HHS Office of the Assistant Secretary for Preparedness and Response to expedite the production of vaccines and medical countermeasures to respond to public health emergencies.
With respect to the Strategic National Stockpile, HHS must assess, as part of its annual threat-based review, the levels of and supply chains for materials in the stockpile. HHS must also give priority to domestic manufacturers when procuring materials for the stockpile. If materials cannot be sourced domestically, HHS must give priority to manufacturers that are not located in China.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1604 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 1604

 To codify the successes of rapid development of safe vaccines through 
Operation Warp Speed, for the next administration to use as a guide in 
                     the event of another pandemic.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 13, 2021

  Mr. Cotton introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To codify the successes of rapid development of safe vaccines through 
Operation Warp Speed, for the next administration to use as a guide in 
                     the event of another pandemic.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Operation Warp Speed Act of 2021''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) COVID-19 has infected more than 32,000,000 people in 
        the United States and taken the lives of more than 550,000.
            (2) The Trump Administration's creation of Operation Warp 
        Speed, on May 15, 2020, and the development of 3 COVID-19 
        vaccines, in less than a year, was the greatest success in 
        getting the COVID-19 pandemic under control, and one of the 
        greatest public health programs in history.
            (3) As a result of the Trump Administration's partnership 
        with the private sector, more than 150,000,000 doses of 
        authorized vaccines have been administered in the United 
        States.
            (4) The unprecedented rapid deployment of COVID-19 vaccines 
        and therapeutics, thanks to the public-private partnership of 
        Operation Warp Speed, has helped the United States combat the 
        spread of COVID-19, protect at-risk populations, save millions 
        of lives, and return to normal life.

SEC. 3. CODIFYING SUCCESSES.

    (a) Addressing the Strategic National Stockpile.--
            (1) Annual threat-based review.--In conducting the annual 
        threat-based review with respect to the Strategic National 
        Stockpile under section 319F-2(a)(2)(A) of the Public Health 
        Service Act (42 U.S.C. 247d-6b(a)(2)(A)), the Secretary of 
        Health and Human Services (referred to in this section as the 
        ``Secretary'') shall ensure that such review considers, and the 
        report to Congress includes, information about the supply 
        levels in such stockpile and any materials that may be missing. 
        The review described in the previous sentence shall include a 
        supply chain assessment of materials in the Strategic National 
        Stockpile that considers whether the United States could 
        procure such materials in the event of a pandemic that limits 
        trade and access to international supply chains.
            (2) Procuring supplies for the sns.--In procuring supplies 
        for the Strategic National Stockpile under section 319F-2(a) of 
        the Public Health Service Act (42 U.S.C. 247d-6b(a)), the 
        Secretary shall--
                    (A) give priority to manufacturers of such 
                supplies, including vaccines, that are manufactured by 
                companies located in the United States;
                    (B) in the case that no domestic manufacturer is 
                available for certain supplies, including vaccines, 
                assess ways to ramp up domestic manufacturing of such 
                supplies, including vaccines; and
                    (C) in the case that no domestic manufacturer is 
                available for certain supplies, including vaccines, and 
                it is determined that domestic manufacturing cannot be 
                ramped up in an appropriate amount of time, give 
                priority to companies that are located in countries 
                other than the People's Republic of China.
    (b) Increasing Speed for Safe EUA.--Section 564 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
            (1) in subsection (c)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by inserting ``the Commissioner of Food 
                        and Drugs,'' before ``the Assistant Secretary 
                        for''; and
                            (ii) by striking ``the Secretary 
                        concludes'' and inserting ``not fewer than 3 of 
                        such Commissioner, such Assistant Secretary, 
                        and such Directors, vote in favor of such 
                        authorization after concluding'';
                    (B) in paragraph (4), by striking ``; and'' and 
                inserting a semicolon;
                    (C) by redesignating paragraph (5) as paragraph 
                (6); and
                    (D) by inserting after paragraph (4) the following:
            ``(5) that the product complies with standards for clinical 
        trials established by the Secretary, in consultation with such 
        Commissioner, such Assistant Secretary, and such Directors; 
        and''; and
            (2) by adding at the end the following:
    ``(n) Consideration of Data.--The Secretary, and the heads of 
agencies described in subsection (c), shall consider the data submitted 
with respect to a product for which authorization is being sought under 
this section, on a rolling basis, as such data becomes available to 
such Secretary and heads of agencies.''.
    (c) Gaps in Clinical Trials.--The Director of the National 
Institutes of Health shall assess any geographical gaps in clinical 
trial sites for drugs or biological products and shall develop a plan 
for increasing the number of such sites across broad geographic areas.
    (d) Requiring ASPR To Improve Manufacturing Capabilities Under 
Conditions of Pressure.--
            (1) Vaccine production.--The Secretary is authorized to use 
        amounts made available to the Department of Health and Human 
        Services for purposes of producing vaccines in response to a 
        public health emergency prior to emergency use authorization of 
        such vaccine under section 564 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb-3) or licensure of such vaccine 
        under section 351 of the Public Health Service Act (42 U.S.C. 
        262).
            (2) Operation warp speed director.--Section 2811 of the 
        Public Health Service Act (42 U.S.C. 300hh-10) is amended by 
        adding at the end the following:
    ``(g) Operation Warp Speed Director.--There is established within 
the Office of the Assistant Secretary for Preparedness and Response an 
Office of Operation Warp Speed, for purposes of responding to public 
health emergencies by ensuring timely and sufficient development of 
vaccines and other medical countermeasures (including vaccines, 
therapeutics, and diagnostics), as well as domestic manufacturing, 
through preparation in advance of any such public health emergency. 
Such Office shall be headed by a Director who has substantial relevant 
private sector experience and is appointed by the President, by and 
with the advice and consent of the Senate.''.
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