I 

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. 

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. 

4 This Act may be cited as the ‘‘Expeditious Vaccine 

5 Advice with Legitimate, Unbiased, Apolitical, and Tech6 nical Expertise Act’’ or the ‘‘EVALUATE Act’’. 


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1 SEC. 2. REQUIRED CONSIDERATION OF ADVISORY COM2 MITTEE RECOMMENDATIONS. 

3 (a) VACCINE LICENSURE OR AUTHORIZATION.—Be4 fore licensing or authorizing any vaccine for COVID–19 

5 or SARS–CoV–2 infection (in this section referred to as 

6 a ‘‘COVID–19 vaccine’’), the Commissioner of Food and 

7 Drugs shall— 

8 (1) solicit recommendations from the Vaccines 

9 and Related Biological Products Advisory Committee 

10 on whether the available data are adequate to sup11 port the safety and effectiveness of the COVID–19 

12 vaccine and whether additional studies to further 

13 evaluate safety and effectiveness should be required 

14 before or after licensing or authorization; 

15 (2) receive such recommendations at an open 

16 meeting; 

17 (3) give public notice of such meeting at least 

18 3 business days in advance of the meeting; and 

19 (4) publicly document how such recommenda20 tions were considered when licensing or authorizing 

21 the COVID–19 vaccine. 

22 (b) MINOR OR TECHNICAL CHANGES.—Subsection 

23 (a) does not apply— 

24 (1) to minor or technical changes to a license 

25 or authorization that is in effect; or 


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1 (2) in cases involving a change to a license or 

2 authorization if the Commissioner of Food and 

3 Drugs publishes a determination that the change is 

4 not substantial and a meeting under subsection (a) 

5 would not be appropriate. 

6 (c) PROVISION OF INFORMATION.— 

7 (1) IN GENERAL.—In connection with a meet8 ing of the Vaccines and Related Biological Products 

9 Advisory Committee convened for purposes of sub10 section (a), the Commissioner of Food and Drugs 

11 shall— 

12 (A) provide to the Advisory Committee, at 

13 least 3 business days prior to the meeting, any 

14 data, summaries of data, briefing documents, 

15 and other information to be presented at the 

16 meeting by the Commissioner and the sponsor 

17 of the COVID–19 vaccine, and make reasonable 

18 efforts to provide any additional data, sum19 maries of data, or information requested by the 

20 Advisory Committee before the meeting; and 

21 (B) promptly make available on the Food 

22 and Drug Administration’s website minutes, 

23 audiovisual recordings, transcripts, data, sum24 maries of data, briefing documents, and other 


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1 information or documents made available to or 

2 prepared for or by the Advisory Committee. 

3 (2) EXCEPTION.—The Commissioner need not 

4 make available minutes, audiovisual recordings, 

5 transcripts, data, summaries of data, briefing docu6 ments, and other information or documents pursu7 ant to paragraph (1)(B) if the Commissioner— 

8 (A) determines that the minutes, audio9 visual recordings, transcripts, data, summaries 

10 of data, briefing documents, or other informa11 tion or documents should be withheld from dis12 closure in accordance with section 552b(c) of 

13 title 5, United States Code; and 

14 (B) promptly makes available on the public 

15 website of the Food and Drug Administration a 

16 written explanation of the reasons for not dis17 closing the minutes, audiovisual recordings, 

18 transcripts, data, summaries of data, briefing 

19 documents, or other information or documents. 

Æ 


pamtmann on DSKBC07HB2PROD with BILLS