Document ID: FDA-2015-D-1211-0360
Agency: fda
Document Type: Notice
Title: Recommendations for Evaluating Donor Eligibility Using Individual Risk- Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry; Availability
Posted Date: 2023-05-12T04:00Z

[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30765-30767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1211]

Recommendations for Evaluating Donor Eligibility Using Individual 
Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus 
Transmission by Blood and Blood Products; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Recommendations for 
Evaluating Donor Eligibility Using Individual Risk-Based Questions to 
Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood 
and Blood Products; Guidance for Industry.'' The guidance document 
provides blood establishments that collect blood or blood components, 
including Source Plasma, with FDA's revised donor deferral 
recommendations for individuals with increased risk for transmitting 
human immunodeficiency virus (HIV) infection. FDA is also recommending 
that these blood establishments make corresponding revisions to donor 
educational materials, donor history questionnaires and accompanying 
materials, along with revisions to donor requalification and product 
management procedures. The guidance announced in this notice finalizes 
the draft guidance of the same title issued January 2023. This guidance 
also supersedes the guidance entitled ``Revised Recommendations for 
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood 
and Blood Products; Guidance for Industry'' dated April 2020 and 
updated August 2020.

DATES: The announcement of this guidance is published in the Federal 
Register on May 12, 2023.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a

[[Page 30766]]

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-1211 for ``Recommendations for Evaluating Donor Eligibility 
Using Individual Risk-Based Questions to Reduce the Risk of Human 
Immunodeficiency Virus Transmission by Blood and Blood Products; 
Guidance for Industry.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance document 
to the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Andrew Harvan, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance entitled 
``Recommendations for Evaluating Donor Eligibility Using Individual 
Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus 
Transmission by Blood and Blood Products; Guidance for Industry.'' This 
guidance document provides blood establishments that collect blood or 
blood components, including Source Plasma, with FDA's revised donor 
deferral recommendations for individuals with increased risk for 
transmitting HIV infection. FDA is also recommending that these blood 
establishments make corresponding revisions to donor educational 
materials, donor history questionnaires and accompanying materials, 
along with revisions to donor requalification and product management 
procedures.
    In this guidance, based on FDA's review of the available science, 
FDA recommends eliminating the screening questions specific to men who 
have sex with men (MSM) and women who have sex with MSM. Instead, FDA 
recommends assessing donor eligibility using the same individual risk-
based questions relevant to HIV risk for every donor regardless of sex 
or gender. In addition, FDA recommends deferral of any individual 
taking medications to treat or prevent HIV infection. FDA does not 
expect that implementation of these revised recommendations will be 
associated with any adverse effect on the safety or availability of the 
blood supply.
    In the Federal Register of January 30, 2023 (88 FR 5894), FDA 
announced the availability of the draft guidance of the same title. FDA 
considered comments received on this draft guidance as the guidance was 
being finalized and revised the guidance as appropriate in response to 
the comments. For instance, we clarified that all donors, regardless of 
their sex or gender, will be asked the same screening questions with 
respect to HIV risk. We have provided additional information to explain 
why undetectable does not equal untransmissible for blood transfusion 
regarding medication used to treat or prevent HIV infection, and we 
added a recommendation that individuals should not stop taking their 
prescribed medication, including PrEP or PEP, in order to donate blood. 
In response to questions about deferral recommendations for anal sex, 
we clarified that scientific data demonstrate the risk of HIV infection 
is significantly greater for anal sex when compared to other sexual 
exposures. In response to comments requesting clarification on a 
screening question, we included examples of who a ``new partner'' may 
include. Additionally, editorial changes were made to improve clarity. 
The guidance announced in this notice finalizes the draft guidance of 
the same title dated January 2023 and supersedes the guidance entitled 
``Revised Recommendations for Reducing the Risk of Human 
Immunodeficiency Virus Transmission by Blood and Blood Products; 
Guidance for Industry'' dated April 2020 and updated August 2020.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on evaluating donor eligibility using 
individual risk-based questions to reduce the risk of HIV transmission 
by blood and blood products. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

[[Page 30767]]

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR 601.12 have been approved under OMB control 
number 0910-0338; the collections of information in 21 CFR 606.121 and 
parts 610 and 630 have been approved under OMB control number 0910-
0116; and the collections of information for consignee notification 
have been approved under OMB control number 0910-0681.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10252 Filed 5-11-23; 8:45 am]
BILLING CODE 4164-01-P