[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1164-1166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0465, FDA-2022-D-0466, and FDA-2022-D-0467]
Draft Guidances Relating to Recommendations To Reduce the Risk of
Transmission of Relevant Communicable Disease Agents and Diseases by
Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft
Guidances 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 three
[[Page 1165]]
specific draft guidances for industry entitled ``Recommendations to
Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);''
``Recommendations to Reduce the Risk of Transmission of Hepatitis C
Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps);'' and ``Recommendations to Reduce the Risk of
Transmission of Human Immunodeficiency Virus (HIV) by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' These draft
guidances are intended to update existing guidances and to assist
establishments making donor eligibility determinations in understanding
the requirements for determining donor eligibility, including donor
screening and testing, for donors of HCT/Ps. These draft guidances are
also intended to provide establishments making donor eligibility
determinations with recommendations to reduce the risk of transmission
of specific communicable disease agents and diseases, specifically,
hepatitis B virus (HBV), hepatitis C virus (HCV), and human
immunodeficiency virus (HIV), by HCT/Ps.
DATES: Submit either electronic or written comments on the draft
guidances by February 6, 2025 to ensure that the Agency considers your
comment on these draft guidances before it begins work on the final
versions of the guidances.
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 dockets 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 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-2022-D-0465 for ``Recommendations to Reduce the Risk of
Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for
Industry;'' Docket No. FDA-2022-D-0466 for ``Recommendations to Reduce
the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft
Guidance for Industry;'' and Docket No. FDA-2022-D-0467 for
``Recommendations to Reduce the Risk of Transmission of Human
Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' Received
comments will be placed in the dockets 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 dockets to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket numbers, 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 guidances 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 guidances may also be obtained by
phone by calling CBER at 1-800-835-4709 or 240-402-8010. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidances.
FOR FURTHER INFORMATION CONTACT: Victoria Wagman, 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 three draft guidances
entitled: ``Recommendations to Reduce the Risk of Transmission of
Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps);'' ``Recommendations to Reduce the Risk
of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps);'' and ``Recommendations to
Reduce the Risk
[[Page 1166]]
of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' When
finalized, these draft guidances will update existing guidance
documents and assist establishments making donor eligibility
determinations in understanding the requirements for determining donor
eligibility, including donor screening and testing, for donors of HCT/
Ps. When finalized, these specific draft guidances will also provide
establishments making donor eligibility determinations with
recommendations to reduce the risk of transmission of HBV, HCV, and HIV
by HCT/Ps. Updates to existing guidance recommendations include but are
not limited to: revising recommendations for donor screening that
includes reducing certain time-based risk factors and conditions;
assessing HCT/P donor eligibility using the same individual risk-based
questions relevant to risk for every donor regardless of sex or gender,
and for the draft guidance related to HIV, donor testing and screening
for HIV-1 group O risk.
Based on FDA review of the available science, adequacy of available
test methods, studies used to evaluate risk behaviors, and experiences
with updated blood donor screening questions, FDA also recommends
eliminating the HCT/P donor screening questions specific to men who
have sex with men (MSM) and women who have sex with MSM and, instead
recommends assessing HCT/P donor eligibility using the same individual
risk-based questions relevant to HBV, HCV, and HIV risk for every donor
regardless of sex or gender.
Table 1--Three Draft Guidances Issued for Public Comment
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Docket No. Draft guidance document title
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FDA-2022-D-0465........................ Recommendations to Reduce the
Risk of Transmission of
Hepatitis B Virus (HBV) by
Human Cells, Tissues, and
Cellular and Tissue-Based
Products (HCT/Ps); Draft
Guidance for Industry.
FDA-2022-D-0466........................ Recommendations to Reduce the
Risk of Transmission of
Hepatitis C Virus (HCV) by
Human Cells, Tissues, and
Cellular and Tissue-Based
Products (HCT/Ps); Draft
Guidance for Industry.
FDA-2022-D-0467........................ Recommendations to Reduce the
Risk of Transmission of Human
Immunodeficiency Virus (HIV)
by Human Cells, Tissues, and
Cellular and Tissue-Based
Products (HCT/Ps); Draft
Guidance for Industry.
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At a later date, FDA intends to issue additional specific draft
guidances with recommendations regarding specific communicable disease
agents and diseases for donors of HCT/Ps as follows: (1) transmissible
spongiform encephalopathy, (2) Treponema pallidum (syphilis), (3)
Chlamydia trachomatis and Neisseria gonorrhoeae, (4) vaccinia virus,
(5) West Nile virus, (6) human T-lymphotropic virus, (7)
Cytomegalovirus, and (8) communicable disease risks associated with
xenotransplantation.
The draft guidances, when finalized, are intended to supersede
information regarding HBV, HCV, and HIV risk in the document entitled
``Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,''
dated August 2007. Regarding HBV risk, the draft guidance is also
intended to supersede the document entitled ``Use of Nucleic Acid Tests
to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of
Human Cells, Tissues, and Cellular and Tissue-Based Products, Guidance
for Industry'' dated August 2016.
The three draft guidances are being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). These draft
guidances, when finalized, will represent the current thinking of FDA
on ``Recommendations to Reduce the Risk of Transmission of Hepatitis B
Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps);'' ``Recommendations to Reduce the Risk of
Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps);'' and ``Recommendations to
Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV)
by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps).'' They do not establish any rights for any person and are 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 these guidances contains no new collection of information,
they do refer to previously approved FDA collections of information.
The previously approved collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information in 21 CFR part 1271.50 have been approved under OMB control
number 0910-0139.
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: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31523 Filed 1-6-25; 8:45 am]
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