[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5894-5895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01796]
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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Transmission by Blood and Blood Products; Draft Guidance for Industry;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the availability of a draft guidance entitled ``Recommendations for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and Blood Products; Draft Guidance for Industry.'' The draft guidance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. This draft guidance, when finalized, will
supersede 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DATES: Submit either electronic or written comments on the draft
guidance by March 31, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
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 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
[[Page 5895]]
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; Draft
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 draft guidance 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 draft 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 draft
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 draft 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; Draft Guidance for
Industry.'' This draft 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 draft guidance, based on FDA's review of the available
science, FDA recommends eliminating the time-based deferrals for men
who have sex with men (MSM) and women who have sex with MSM. Instead,
FDA recommends assessing donor eligibility using gender-inclusive,
individual risk-based questions relevant to HIV risk. In addition, FDA
recommends deferral of any individual taking medications to treat or
prevent HIV infection. FDA does not expect that implementation of these
recommendations will be associated with any adverse effect on the
safety of the blood supply.
This draft guidance, when finalized, will supersede 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 draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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.
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 draft 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: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01796 Filed 1-27-23; 8:45 am]
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