[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the draft guidance of the same title issued January 2023.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.
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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