Science in Blood Donation Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 8168 To require the guidance of the Food and Drug Administration on reducing the risk of human immunodeficiency virus (HIV), hepatitis A, and hepa- titis B transmission by blood and blood products (including the donor history questionnaire) to be based on an individual risk assessment of sexual behaviors upon which all donors are evaluated equally, without regard to sexual orientation or gender identity, and for other purposes. IN THE HOUSE OF REPRESENTATIVES SEPTEMBER 4, 2020 Mrs. DEMINGS (for herself and Mr. QUIGLEY) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the guidance of the Food and Drug Administra- tion on reducing the risk of human immunodeficiency virus (HIV), hepatitis A, and hepatitis B transmission by blood and blood products (including the donor history questionnaire) to be based on an individual risk assess- ment of sexual behaviors upon which all donors are eval- uated equally, without regard to sexual orientation or gender identity, 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 VerDate Sep 11 2014 23:48 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8168.IH H8168 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8168 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Science in Blood Dona- 2 tion Act of 2020’’. 3 SEC. 2. REQUIRING GUIDANCE ON REDUCING RISK OF HIV, 4 HEPATITIS A, AND HEPATITIS B TRANS- 5 MISSION BY BLOOD PRODUCTS TO BE BASED 6 ON AN INDIVIDUAL RISK ASSESSMENT. 7 (a) IN GENERAL.—The Secretary of Health and 8 Human Services acting through the Commissioner of Food 9 and Drugs (in this section referred to as the ‘‘Secretary’’) 10 shall— 11 (1) not later than 45 days after the date of en- 12 actment of this Act, revise and publish the guidance 13 of the Food and Drug Administration on reducing 14 the risk of human immunodeficiency virus, hepatitis 15 A, and hepatitis B transmission by blood and blood 16 products so as to eliminate— 17 (A) the recommendation to defer for 3 18 months from the most recent sexual contact, a 19 man who has had sex with another man during 20 the past 3 months; and 21 (B) the recommendation to defer for 3 22 months from the most recent sexual contact, a 23 female who has had sex during the past 3 24 months with a man who has had sex with an- 25 other man in the past 3 months; 26 VerDate Sep 11 2014 23:48 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8168.IH H8168 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8168 IH (2) not later than 45 days after the date of en- 1 actment of this Act, initiate a process— 2 (A) to update such guidance— 3 (i) in conformity with paragraph (1); 4 and 5 (ii) so as to ensure that such guid- 6 ance, including the corresponding donor 7 deferral recommendations, are based on an 8 individual risk assessment of sexual behav- 9 iors upon which all donors are evaluated 10 equally, without regard to sexual orienta- 11 tion or gender identity; and 12 (B) to update the donor history question- 13 naire consistent with the updates under sub- 14 paragraph (A); and 15 (3) not later than 18 months after the date of 16 enactment of this Act— 17 (A) complete the process initiated pursuant 18 to paragraph (2); and 19 (B) publish the updated guidance and 20 donor history questionnaire. 21 (b) SPECIAL RULE.—Throughout the period during 22 which the Secretary is revising guidance pursuant to sub- 23 section (a)(1), the recommendations described in subpara- 24 VerDate Sep 11 2014 23:48 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8168.IH H8168 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8168 IH graphs (A) and (B) of subsections (a)(1) are deemed to 1 be eliminated with respect to any individual who— 2 (1) is a human subject in research; 3 (2) is being routinely tested for human im- 4 munodeficiency virus, hepatitis A, and hepatitis B as 5 part of such research; and 6 (3) is not found, pursuant to such testing, to be 7 positive for human immunodeficiency virus, hepatitis 8 A, or hepatitis B. 9 (c) PROGRESS REPORT.—The Secretary shall— 10 (1) not later than each of 6 and 12 months 11 after the date of enactment of this Act, submit a re- 12 port to the appropriate congressional committees on 13 the progress made pursuant to the process under 14 subsection (a)(2); and 15 (2) not later than 18 months after the date of 16 enactment of this Act, submit a final report to the 17 appropriate congressional committees on the updated 18 guidance and donor history questionnaire. 19 Æ VerDate Sep 11 2014 23:48 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H8168.IH H8168 pbinns on DSKJLVW7X2PROD with BILLS