EVALUATE Act

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 Advi- sory 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) intro- duced 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 Re- lated Biological Products Advisory Committee before tak- ing certain actions with respect to COVID–19 vaccines, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Expeditious Vaccine 4 Advice with Legitimate, Unbiased, Apolitical, and Tech- 5 nical Expertise Act’’ or the ‘‘EVALUATE Act’’. 6 VerDate Sep 11 2014 19:51 Aug 28, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7971.IH H7971 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 7971 IH SEC. 2. REQUIRED CONSIDERATION OF ADVISORY COM- 1 MITTEE RECOMMENDATIONS. 2 (a) VACCINE LICENSURE OR AUTHORIZATION.—Be- 3 fore licensing or authorizing any vaccine for COVID–19 4 or SARS–CoV–2 infection (in this section referred to as 5 a ‘‘COVID–19 vaccine’’), the Commissioner of Food and 6 Drugs shall— 7 (1) solicit recommendations from the Vaccines 8 and Related Biological Products Advisory Committee 9 on whether the available data are adequate to sup- 10 port the safety and effectiveness of the COVID–19 11 vaccine and whether additional studies to further 12 evaluate safety and effectiveness should be required 13 before or after licensing or authorization; 14 (2) receive such recommendations at an open 15 meeting; 16 (3) give public notice of such meeting at least 17 3 business days in advance of the meeting; and 18 (4) publicly document how such recommenda- 19 tions were considered when licensing or authorizing 20 the COVID–19 vaccine. 21 (b) MINOR OR TECHNICAL CHANGES.—Subsection 22 (a) does not apply— 23 (1) to minor or technical changes to a license 24 or authorization that is in effect; or 25 VerDate Sep 11 2014 19:51 Aug 28, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7971.IH H7971 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 7971 IH (2) in cases involving a change to a license or 1 authorization if the Commissioner of Food and 2 Drugs publishes a determination that the change is 3 not substantial and a meeting under subsection (a) 4 would not be appropriate. 5 (c) PROVISION OF INFORMATION.— 6 (1) IN GENERAL.—In connection with a meet- 7 ing of the Vaccines and Related Biological Products 8 Advisory Committee convened for purposes of sub- 9 section (a), the Commissioner of Food and Drugs 10 shall— 11 (A) provide to the Advisory Committee, at 12 least 3 business days prior to the meeting, any 13 data, summaries of data, briefing documents, 14 and other information to be presented at the 15 meeting by the Commissioner and the sponsor 16 of the COVID–19 vaccine, and make reasonable 17 efforts to provide any additional data, sum- 18 maries of data, or information requested by the 19 Advisory Committee before the meeting; and 20 (B) promptly make available on the Food 21 and Drug Administration’s website minutes, 22 audiovisual recordings, transcripts, data, sum- 23 maries of data, briefing documents, and other 24 VerDate Sep 11 2014 19:51 Aug 28, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7971.IH H7971 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 7971 IH information or documents made available to or 1 prepared for or by the Advisory Committee. 2 (2) EXCEPTION.—The Commissioner need not 3 make available minutes, audiovisual recordings, 4 transcripts, data, summaries of data, briefing docu- 5 ments, and other information or documents pursu- 6 ant to paragraph (1)(B) if the Commissioner— 7 (A) determines that the minutes, audio- 8 visual recordings, transcripts, data, summaries 9 of data, briefing documents, or other informa- 10 tion or documents should be withheld from dis- 11 closure in accordance with section 552b(c) of 12 title 5, United States Code; and 13 (B) promptly makes available on the public 14 website of the Food and Drug Administration a 15 written explanation of the reasons for not dis- 16 closing the minutes, audiovisual recordings, 17 transcripts, data, summaries of data, briefing 18 documents, or other information or documents. 19 Æ VerDate Sep 11 2014 19:51 Aug 28, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H7971.IH H7971 pamtmann on DSKBC07HB2PROD with BILLS