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, 30765-30767 [2023-10252]
Download as PDF
<![CDATA[
30765
Federal Register / Vol. 88, No. 92 / Friday, May 12, 2023 / Notices
could serve as educators and resources
to assist Medicare beneficiaries and
others to detect and report error, fraud,
and abuse.
This tool provides ACL an
opportunity to assess the success and
impact of the training provided to the
SHIP and SMP grantees by ACL along
with determining the future training
needs of the program grantees. Section
301 of the Public Health Service Act (42
U.S.C. 241) is the authorizing law for
data collections within the Department
of Health and Human Services (HHS).
Specifically, agencies within HHS
should ‘‘collect and make available
through publications and other
appropriate means . . . research and
other activities.’’
The March 3, 1998, White House
Memorandum, ‘‘Conducting
Conversations with America to Further
Improve Customer Service,’’ directs
agencies ‘‘to track customer service
measurements, then take necessary
actions to change or improve how the
agency operates, as appropriate.
Integrate what your agency learns from
its customers with your agency’s
strategic plans, operating plans, and
performance measures required by the
Government Performance and Results
Act of 1993, reporting on financial and
program performance under the Chief
Financial Officers Act of 1990, and the
Government Management Reform Act of
1994.’’ The information collected in this
survey is necessary to ensure that ACL
is meeting the technical assistance
needs of the attendees and to capture
valuable feedback to be used for future
training meetings. By gathering feedback
on the quality of the training and
content provided, we can ensure
attendee satisfaction and gather
information for future planning. ACL
administers a contract to develop and
provide the training conference
evaluation tool for ACL’s approval. The
proposed data collection tools may be
found on the ACL website for review at:
https://www.acl.gov/about-acl/publicinput.
Estimated Program Burden: ACL
estimates the burden of this collection
of information as follows:
ACL will collect data once following
the Annual SMP/SHIP/MIPPA National
Training Conference. This evaluation
will be sent to all event attendees,
which is estimated to include maximum
486 participants, each survey is
estimated at .25 hours to complete. This
time estimate is based on research
performed by ACL with the existing
survey instrument and in consideration
of previous survey content and length.
The target number 486 is a result of 54
states/territories, each sending up to 9
conference participants who may be
eligible to complete a survey (54 * 9 =
486). Factoring in an additional 40 nongrantee, non-federal partner event
participants (486 + 40 = 526). 526
respondents taking 15 minutes to
complete for a total of 131.5 annual
burden hours.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Responses
per
respondent
Average
burden
hours per
response
(minutes)
Total
burden
hours
526
1
15
131.5
Dated: May 8, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2023–10120 Filed 5–11–23; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1211]
Recommendations for Evaluating
Donor Eligibility Using Individual RiskBased Questions To Reduce the Risk
of Human Immunodeficiency Virus
Transmission by Blood and Blood
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
lotter on DSK11XQN23PROD with NOTICES1
HHS.
ACTION:
Notice of availability.
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
SUMMARY:
VerDate Sep<11>2014
19:11 May 11, 2023
Jkt 259001
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.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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
E:\FR\FM\12MYN1.SGM
12MYN1
30766
Federal Register / Vol. 88, No. 92 / Friday, May 12, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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://
VerDate Sep<11>2014
19:11 May 11, 2023
Jkt 259001
www.govinfo.gov/content/pkg/FR-201509-18/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 RiskBased 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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\12MYN1.SGM
12MYN1
Federal Register / Vol. 88, No. 92 / Friday, May 12, 2023 / Notices
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-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Enhancing HIV Care of
Women, Infants, Children and Youth
Building Capacity Through
Communities of Practice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:11 May 11, 2023
Jkt 259001
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
Comments on this ICR should be
received no later than June 12, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, Samantha
Miller, the HRSA Information Collection
Clearance Officer, at paperwork@
hrsa.gov or call (301) 594–4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enhancing HIV Care of Women, Infants,
Children and Youth Building Capacity
through Communities of Practice, OMB
No. 0915–xxxx—New.
Abstract: HRSA aims to increase
delivery of evidence-based interventions
that enhance client outcomes, increase
the skill level of the HIV workforce
providing care and treatment to Women,
Infants, Children and Youth, and
involve partnerships for dissemination
of best practices to Ryan White HIV/
AIDS Program (RWHAP) Part D
participants. To that end, HRSA seeks to
implement a Communities of Practice
(CoP) platform for RWHAP Part D
recipients. A CoP engages recipient
teams in improvement learning sessions
using subject matter experts along with
application experts who help recipient
teams select, test, and implement
changes on the front line of care.
Through organizational selfassessments, didactic learning on
specific care topics, goals setting, and
work plan development, each team can
strategically benefit their organization.
CoPs afford participants the opportunity
to work in a group to solve a recognized
challenge related to a CoP domain and
support dialogue among participants
and the consultant/subject matter
experts. Recipient teams commit to
working over a period of 12 months,
alternating between Learning Sessions
in which teams come together to learn
about the chosen topic and to plan
changes, and Action Periods in which
the teams return to their respective
organizations and test those changes in
their clinic settings. The domains for the
proposed CoPs are trauma informed
care, pre-conception counseling, and
DATES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
30767
youth transitioning into adult HIV care
services.
A 60-day notice published in the
Federal Register on February 27, 2023,
vol. 88, No. 38; pp. 12386–12387. The
one comment received was outside the
scope of the ICR, and therefore no
changes to the information collection
were made as a result of this comment.
Need and Proposed Use of the
Information: Process and outcome
evaluations are a critical part of
ensuring that CoP initiatives were
implemented as planned and met their
intended outcome. Evaluation of
technical assistance (TA) depends on
establishing clear goals and plans from
the beginning of the process. This
includes specifying the intended impact
of the TA with concrete, measurable
objectives. To judge performance against
goals, HRSA will administer TA
evaluation surveys following TA and
training, webinars, teleconferences, and
meetings. Findings will drive quality
improvement activities and reports.
The evaluation plan focuses on
process and impact evaluation of all
CoP Teams (Pre-Conception Counseling
and Sexual Health, Trauma-Informed
Care, and Transitioning Adolescents to
Adult Care) over the duration of the 4year period of performance. The
evaluation plan components will be
operationalized to include TA
satisfaction measures (reaction), change
in knowledge after the TA (learning),
and change in behavior or practice after
the introduction of evidence-based
interventions (behavior). More
specifically, the evaluation plan
includes (1) post TA satisfaction
measures, (2) pre-post measures of CoP
staff knowledge about effective
practices, (3) retrospective measures to
gather measures of CoP staff knowledge
for the first community of practice only,
and (4) measures of TA usefulness and
impact on CoP performance.
Likely Respondents: Up to 90 RWHAP
Part D Women, Infants, Children and
Youth recipients will participate in the
CoPs. Each recipient may have up to six
staff members who may complete the
survey.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
