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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7971 Introduced in House (IH)]

<DOC>

116th CONGRESS
  2d Session
                                H. R. 7971

To direct the Food and Drug Administration to solicit and consider the 
    recommendations of the Vaccines and Related Biological Products 
Advisory Committee before taking certain actions with respect to COVID-
                  19 vaccines, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             August 7, 2020

Mr. Krishnamoorthi (for himself, Mr. Connolly, Ms. Tlaib, Ms. Pressley, 
 Ms. Porter, Mr. Khanna, and Mr. DeSaulnier) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
To direct the Food and Drug Administration to solicit and consider the 
    recommendations of the Vaccines and Related Biological Products 
Advisory Committee before taking certain actions with respect to COVID-
                  19 vaccines, and for other purposes.

    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 ``Expeditious Vaccine Advice with 
Legitimate, Unbiased, Apolitical, and Technical Expertise Act'' or the 
``EVALUATE Act''.

SEC. 2. REQUIRED CONSIDERATION OF ADVISORY COMMITTEE RECOMMENDATIONS.

    (a) Vaccine Licensure or Authorization.--Before licensing or 
authorizing any vaccine for COVID-19 or SARS-CoV-2 infection (in this 
section referred to as a ``COVID-19 vaccine''), the Commissioner of 
Food and Drugs shall--
            (1) solicit recommendations from the Vaccines and Related 
        Biological Products Advisory Committee on whether the available 
        data are adequate to support the safety and effectiveness of 
        the COVID-19 vaccine and whether additional studies to further 
        evaluate safety and effectiveness should be required before or 
        after licensing or authorization;
            (2) receive such recommendations at an open meeting;
            (3) give public notice of such meeting at least 3 business 
        days in advance of the meeting; and
            (4) publicly document how such recommendations were 
        considered when licensing or authorizing the COVID-19 vaccine.
    (b) Minor or Technical Changes.--Subsection (a) does not apply--
            (1) to minor or technical changes to a license or 
        authorization that is in effect; or
            (2) in cases involving a change to a license or 
        authorization if the Commissioner of Food and Drugs publishes a 
        determination that the change is not substantial and a meeting 
        under subsection (a) would not be appropriate.
    (c) Provision of Information.--
            (1) In general.--In connection with a meeting of the 
        Vaccines and Related Biological Products Advisory Committee 
        convened for purposes of subsection (a), the Commissioner of 
        Food and Drugs shall--
                    (A) provide to the Advisory Committee, at least 3 
                business days prior to the meeting, any data, summaries 
                of data, briefing documents, and other information to 
                be presented at the meeting by the Commissioner and the 
                sponsor of the COVID-19 vaccine, and make reasonable 
                efforts to provide any additional data, summaries of 
                data, or information requested by the Advisory 
                Committee before the meeting; and
                    (B) promptly make available on the Food and Drug 
                Administration's website minutes, audiovisual 
                recordings, transcripts, data, summaries of data, 
                briefing documents, and other information or documents 
                made available to or prepared for or by the Advisory 
                Committee.
            (2) Exception.--The Commissioner need not make available 
        minutes, audiovisual recordings, transcripts, data, summaries 
        of data, briefing documents, and other information or documents 
        pursuant to paragraph (1)(B) if the Commissioner--
                    (A) determines that the minutes, audiovisual 
                recordings, transcripts, data, summaries of data, 
                briefing documents, or other information or documents 
                should be withheld from disclosure in accordance with 
                section 552b(c) of title 5, United States Code; and
                    (B) promptly makes available on the public website 
                of the Food and Drug Administration a written 
                explanation of the reasons for not disclosing the 
                minutes, audiovisual recordings, transcripts, data, 
                summaries of data, briefing documents, or other 
                information or documents.
                                 <all>
```