Title: Science in Blood Donation Act of 2020
Policy area: Health

Summary:
Science in Blood Donation Act of 2020
This bill requires the Food and Drug Administration (FDA) to revise its guidance on reducing the risk of transmitting by blood transfusion human immunodeficiency virus, hepatitis A, and hepatitis B.
Specifically, the FDA shall update its guidance to remove recommendations to not receive blood donations from a man who had sex with another man in the past three months. The FDA shall also remove recommendations to not receive blood donations from a woman who in the last three months had sex with such a man.
The FDA's updated guidance shall be based on an individual risk assessment of sexual behaviors that evaluate all donors equally without regard to sexual orientation or gender identity.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8168 Introduced in House (IH)]

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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.

    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 ``Science in Blood Donation Act of 
2020''.

SEC. 2. REQUIRING GUIDANCE ON REDUCING RISK OF HIV, HEPATITIS A, AND 
              HEPATITIS B TRANSMISSION BY BLOOD PRODUCTS TO BE BASED ON 
              AN INDIVIDUAL RISK ASSESSMENT.

    (a) In General.--The Secretary of Health and Human Services acting 
through the Commissioner of Food and Drugs (in this section referred to 
as the ``Secretary'') shall--
            (1) not later than 45 days after the date of enactment of 
        this Act, revise and publish the guidance of the Food and Drug 
        Administration on reducing the risk of human immunodeficiency 
        virus, hepatitis A, and hepatitis B transmission by blood and 
        blood products so as to eliminate--
                    (A) the recommendation to defer for 3 months from 
                the most recent sexual contact, a man who has had sex 
                with another man during the past 3 months; and
                    (B) the recommendation to defer for 3 months from 
                the most recent sexual contact, a female who has had 
                sex during the past 3 months with a man who has had sex 
                with another man in the past 3 months;
            (2) not later than 45 days after the date of enactment of 
        this Act, initiate a process--
                    (A) to update such guidance--
                            (i) in conformity with paragraph (1); and
                            (ii) so as to ensure that such guidance, 
                        including the corresponding donor deferral 
                        recommendations, are 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
                    (B) to update the donor history questionnaire 
                consistent with the updates under subparagraph (A); and
            (3) not later than 18 months after the date of enactment of 
        this Act--
                    (A) complete the process initiated pursuant to 
                paragraph (2); and
                    (B) publish the updated guidance and donor history 
                questionnaire.
    (b) Special Rule.--Throughout the period during which the Secretary 
is revising guidance pursuant to subsection (a)(1), the recommendations 
described in subparagraphs (A) and (B) of subsections (a)(1) are deemed 
to be eliminated with respect to any individual who--
            (1) is a human subject in research;
            (2) is being routinely tested for human immunodeficiency 
        virus, hepatitis A, and hepatitis B as part of such research; 
        and
            (3) is not found, pursuant to such testing, to be positive 
        for human immunodeficiency virus, hepatitis A, or hepatitis B.
    (c) Progress Report.--The Secretary shall--
            (1) not later than each of 6 and 12 months after the date 
        of enactment of this Act, submit a report to the appropriate 
        congressional committees on the progress made pursuant to the 
        process under subsection (a)(2); and
            (2) not later than 18 months after the date of enactment of 
        this Act, submit a final report to the appropriate 
        congressional committees on the updated guidance and donor 
        history questionnaire.
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