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 hepatitis 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 Administration 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 assessment of sexual behaviors upon which all donors are evaluated equally, without regard to sexual orientation or 

gender identity, 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, 


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•HR 8168 IH

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Science in Blood Dona3 tion Act of 2020’’. 

4 SEC. 2. REQUIRING GUIDANCE ON REDUCING RISK OF HIV, 

5 HEPATITIS A, AND HEPATITIS B TRANS6 MISSION BY BLOOD PRODUCTS TO BE BASED 

7 ON AN INDIVIDUAL RISK ASSESSMENT. 

8 (a) IN GENERAL.—The Secretary of Health and 

9 Human Services acting through the Commissioner of Food 

10 and Drugs (in this section referred to as the ‘‘Secretary’’) 

11 shall— 

12 (1) not later than 45 days after the date of en13 actment of this Act, revise and publish the guidance 

14 of the Food and Drug Administration on reducing 

15 the risk of human immunodeficiency virus, hepatitis 

16 A, and hepatitis B transmission by blood and blood 

17 products so as to eliminate— 

18 (A) the recommendation to defer for 3 

19 months from the most recent sexual contact, a 

20 man who has had sex with another man during 

21 the past 3 months; and 

22 (B) the recommendation to defer for 3 

23 months from the most recent sexual contact, a 

24 female who has had sex during the past 3 

25 months with a man who has had sex with an26 other man in the past 3 months; 


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•HR 8168 IH

1 (2) not later than 45 days after the date of en2 actment of this Act, initiate a process— 

3 (A) to update such guidance— 

4 (i) in conformity with paragraph (1); 

5 and 

6 (ii) so as to ensure that such guid7 ance, including the corresponding donor 

8 deferral recommendations, are based on an 

9 individual risk assessment of sexual behav10 iors upon which all donors are evaluated 

11 equally, without regard to sexual orienta12 tion or gender identity; and 

13 (B) to update the donor history question14 naire consistent with the updates under sub15 paragraph (A); and 

16 (3) not later than 18 months after the date of 

17 enactment of this Act— 

18 (A) complete the process initiated pursuant 

19 to paragraph (2); and 

20 (B) publish the updated guidance and 

21 donor history questionnaire. 

22 (b) SPECIAL RULE.—Throughout the period during 

23 which the Secretary is revising guidance pursuant to sub24 section (a)(1), the recommendations described in subparaVerDate Sep 11 2014 23:48 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8168.IH H8168

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•HR 8168 IH

1 graphs (A) and (B) of subsections (a)(1) are deemed to 

2 be eliminated with respect to any individual who— 

3 (1) is a human subject in research; 

4 (2) is being routinely tested for human im5 munodeficiency virus, hepatitis A, and hepatitis B as 

6 part of such research; and 

7 (3) is not found, pursuant to such testing, to be 

8 positive for human immunodeficiency virus, hepatitis 

9 A, or hepatitis B. 

10 (c) PROGRESS REPORT.—The Secretary shall— 

11 (1) not later than each of 6 and 12 months 

12 after the date of enactment of this Act, submit a re13 port to the appropriate congressional committees on 

14 the progress made pursuant to the process under 

15 subsection (a)(2); and 

16 (2) not later than 18 months after the date of 

17 enactment of this Act, submit a final report to the 

18 appropriate congressional committees on the updated 

19 guidance and donor history questionnaire. 

Æ 


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