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, 1164-1166 [2024-31523]
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
I. Background
We are announcing the availability of
a guidance for FDA staff and interested
parties entitled ‘‘Evaluating the Public
Health Importance of Food Allergens
Other Than the Major Food Allergens
Listed in the Federal Food, Drug, and
Cosmetic Act.’’ We are issuing this
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The guidance represents the
current thinking of FDA on this topic.
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.
In the Federal Register of April 19,
2022 (87 FR 23181), we announced the
availability of a draft guidance for FDA
staff and stakeholders entitled
‘‘Evaluating the Public Health
Importance of Food Allergens Other
Than the Major Food Allergens Listed in
the Federal Food, Drug, and Cosmetic
Act.’’ We gave interested parties until
August 17, 2022, to submit comments
for us to consider before beginning work
on the final version of the guidance.
This guidance finalizes the approach
we generally intend to take when
evaluating the public health importance
of a non-listed food allergen. The
guidance specifies the scientific factors
and other information relevant to the
labeling and production of food
containing the food allergen that we
generally intend to consider when
evaluating the public health importance
of a non-listed food allergen. It also
describes our recommendations for how
to identify and evaluate the body of
evidence applicable to an evaluation of
the public health importance of a nonlisted food allergen.
Food allergy can be broadly defined
as an adverse health effect arising from
a specific immune response that occurs
reproducibly on exposure to a given
food. A food allergen is the food or
component(s) (often a protein) of a food
that elicits specific immunologic
reactions. While many different types of
food allergies have been identified, food
allergies that are most studied and
understood clinically are those due to
immunoglobulin E antibodies (IgE) that
cause the body to release inflammatory
chemicals. The most severe and
immediately life-threatening food
allergies are those that are mediated by
IgE and are capable of triggering
anaphylaxis, which can be fatal. The
focus of this guidance is primarily IgEmediated food allergy. However, we
recognize that food allergens acting
through other mechanisms may raise
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Jkt 265001
public health concerns. We intend to
evaluate the public health importance of
these allergens on a case-by-case basis.
We will also continue gathering
scientific data and other information on
food allergens acting through other
mechanisms to help inform possible
future action on these allergens, which
may include future guidance or
communications to the public.
In general, the regulatory framework
of the FD&C Act and our regulations
implementing the FD&C Act broadly
apply to the production of food that is
or contains a food allergen through
statutory and regulatory provisions
regarding: (1) food labeling; (2) food
production (e.g., manufacturing,
processing, packing, and holding food);
and (3) the safety of substances added
to food. Under section 403(w) of the
FD&C Act (21 U.S.C. 343(w)), a food is
misbranded if it contains a major food
allergen and fails to declare that major
food allergen as specified on its label
using the major food allergen’s common
or usual name. Section 201(qq)(1) of the
FD&C Act (21 U.S.C. 321(qq)(1)) defines
a ‘‘major food allergen,’’ in part, as any
of the following: milk, eggs, fish (e.g.,
bass, flounder, or cod), Crustacean
shellfish, tree nuts (e.g., almonds,
pecans, or walnuts), wheat, peanuts,
soybeans, and sesame.
We considered all comments received
during the comment period before
developing the final guidance. Some
comments on the draft guidance
requested that we expand the scope of
the guidance to cover non-IgE-mediated
food allergies and to describe the
potential regulatory options available to
FDA. Other comments recommended
that FDA define specific targets for each
evaluation factor laid out in the
framework. We have modified the final
guidance where appropriate. Changes to
the guidance include:
• Clarifying that evidence of non-IgEmediated reactions can be useful as
supplemental data in an evaluation of
the public health importance of a food
allergen;
• Incorporating updated text and a
revised reference to reflect the recent
publication of the Food and Agricultural
Organization of the United Nations and
World Health Organization’s Expert
Committee meeting report; and
• Expanding the discussion regarding
prevalence data when a food is not
regularly consumed in the United
States.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
PO 00000
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Fmt 4703
Sfmt 4703
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 10 have been approved
under OMB control number 0910–0191.
The collections of information in 21
CFR part 101 have been approved under
OMB control number 0910–0381. The
collections of information in section
403(w) of the FD&C Act have been
approved under OMB control number
0910–0792. The collections of
information in 21 CFR part 117 have
been approved under OMB control
number 0910–0751. The collections of
information for Form FDA 3800 have
been approved under OMB control
number 0910–0645. The collections of
information for Form FDA 3500 have
been approved under OMB control
number 0910–0291. The collections of
information in 21 CFR 70.25, 71.1,
170.36, 171.1, 172, 173, 179, and 180
have been approved under OMB control
number 0910–0016.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov. Use the
FDA websites listed in the previous
sentence to find the most current
version of the guidance.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31529 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of three
SUMMARY:
E:\FR\FM\07JAN1.SGM
07JAN1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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 TissueBased 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:
ddrumheller on DSK120RN23PROD with NOTICES1
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
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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 TissueBased 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
PO 00000
Frm 00087
Fmt 4703
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1165
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-201509-18/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 TissueBased Products (HCT/Ps);’’ and
‘‘Recommendations to Reduce the Risk
E:\FR\FM\07JAN1.SGM
07JAN1
1166
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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
Docket
No.
Draft guidance document title
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.
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.
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.
ddrumheller on DSK120RN23PROD with NOTICES1
FDA–
2022–
D–
0466.
FDA–
2022–
D–
0467.
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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 TissueBased 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 TissueBased 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
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
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-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0464]
Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and TissueBased Products; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance document entitled
‘‘Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).’’ This draft guidance
document includes general information
on determining eligibility for donors of
HCT/Ps. In addition, FDA intends to
issue separate guidance documents with
recommendations regarding reducing
the risk of transmission of specific
communicable disease agents and
diseases for donors of HCT/Ps. These
guidance documents are intended to
update an existing guidance.
DATES: Submit either electronic or
written comments on the draft guidance
by February 6, 2025 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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
Docket No. Draft guidance document title
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
