Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability, 1166-1168 [2024-31524]
Download as PDF
<![CDATA[
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and for the draft guidance related to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Draft guidance document title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Draft Guidance for Industry.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Draft Guidance for Industry.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(HCT/Ps); Draft Guidance for Industry.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.
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
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–0464 for ‘‘Recommendations
for Determining Eligibility of Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps).’’
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
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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-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 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:
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
a draft document entitled
‘‘Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
1167
Products (HCT/Ps).’’ This draft guidance
document is intended to update an
existing guidance document 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.
The draft guidance
‘‘Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)’’ includes general
information on determining eligibility
for donors of HCT/Ps. Updates to
existing guidance recommendations
include, but are not limited to, revised
exceptions applicable to certain HCT/
Ps, 21 CFR 1271.90 (81 FR 40517, June
22, 2016); clarifications surrounding the
donor medical history interview; and
additional considerations regarding
specimens for donor testing to avoid
false negative test results.
FDA intends to issue separate,
additional guidance documents with
recommendations regarding reducing
the risk of transmission of specific
communicable disease agents and
diseases for donors of HCT/Ps as
follows: human immunodeficiency
virus, hepatitis B virus, hepatitis C
virus, Mycobacterium tuberculosis
(Mtb), sepsis, human transmissible
spongiform encephalopathies,
cytomegalovirus, Chlamydia
trachomatis and Neisseria gonorrhoeae,
human T-lymphotropic virus,
Treponema pallidum (syphilis),
vaccinia virus, West Nile virus, and
communicable disease risk associated
with xenotransplantation. Please note
that FDA has withdrawn the 2018
guidance for industry ‘‘Donor Screening
Recommendations to Reduce the Risk of
Transmission of Zika Virus by Human
Cells, Tissues, and Cellular and TissueBased Products.’’ FDA has determined
that Zika virus (ZIKV) is no longer a
relevant communicable disease agent or
disease because the available evidence
demonstrates that ZIKV no longer has
sufficient incidence and/or prevalence
to affect the potential HCT/P donor
population.
The draft of the general guidance
document and the associated specific
guidance documents, when finalized,
are intended to supersede the following
guidance documents:
• ‘‘Eligibility Determination for
Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps), Guidance for Industry,’’ dated
August 2007;
• ‘‘Use of Donor Screening Tests To
Test Donors of Human Cells, Tissues
and Cellular and Tissue-Based Products
for Infection with Treponema pallidum
E:\FR\FM\07JAN1.SGM
07JAN1
1168
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
(Syphilis), Guidance for Industry’’ dated
September 2015;
• ‘‘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;
• ‘‘Use of Nucleic Acid Tests To
Reduce the Risk of Transmission of
West Nile Virus from Living Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps),
Guidance for Industry’’ dated September
2016 and corrected May 2017; and
• ‘‘Revised Recommendations for
Determining Eligibility of Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products Who Have
Received Human-Derived Clotting
Factor Concentrates, Guidance for
Industry’’ dated November 2016.
When the general guidance and the
associated specific guidances are
finalized, FDA intends to collate
information from the guidances and
provide comprehensive lists of
recommendations on the FDA website
regarding conditions and behaviors that
increase the donor’s relevant
communicable disease risk, examples of
clinical evidence of relevant
communicable disease, examples of
physical evidence of relevant
communicable disease or high-risk
behavior associated with these diseases,
disease agents for which all donors of
HCT/Ps must be tested, and the types of
tests we currently consider to be
adequate and appropriate to meet the
requirements in 21 CFR 1271.80(c). The
comprehensive lists will cite to the
applicable guidance(s) where the
recommendations are provided.
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 ‘‘Recommendations for Determining
Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).’’ 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. 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 (PRA) (44 U.S.C.
3501–3521). The collections of
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
information in 21 CFR part 1271 have
been approved under OMB control
number 0910–0543.
III. Electronic Access
Persons with access to the internet
may obtain the draft 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. 2024–31524 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–2024–D–2707]
Validation of Certain In Vitro
Diagnostic Devices for Emerging
Pathogens During a Section 564
Declared Emergency; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Validation of Certain
In Vitro Diagnostic Devices for Emerging
Pathogens During a Section 564
Declared Emergency.’’ The draft
guidance describes general
recommendations for the validation of
in vitro diagnostic devices (IVDs) for
emerging pathogens during an
applicable declaration of public health
emergency. This guidance and the
associated template include the
recommendations that apply to test data
and information submitted in a preEmergency Use Authorization (EUA), an
EUA request, or to a test offered as
described in an applicable enforcement
discretion policy. This draft guidance is
not final nor is it for implementation at
this time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 10, 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:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
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
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–
2024–D–2707 for ‘‘Validation of Certain
In Vitro Diagnostic Devices for Emerging
Pathogens During a Section 564
Declared Emergency.’’ 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
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1166-1168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31524]
-----------------------------------------------------------------------
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 Tissue-Based Products; Draft 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 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:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the
[[Page 1167]]
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 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-0464 for ``Recommendations for Determining Eligibility of
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT/Ps).'' 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: 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 a draft document entitled
``Recommendations for Determining Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' This draft
guidance document is intended to update an existing guidance document
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.
The draft guidance ``Recommendations for Determining Eligibility of
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
(HCT/Ps)'' includes general information on determining eligibility for
donors of HCT/Ps. Updates to existing guidance recommendations include,
but are not limited to, revised exceptions applicable to certain HCT/
Ps, 21 CFR 1271.90 (81 FR 40517, June 22, 2016); clarifications
surrounding the donor medical history interview; and additional
considerations regarding specimens for donor testing to avoid false
negative test results.
FDA intends to issue separate, additional guidance documents with
recommendations regarding reducing the risk of transmission of specific
communicable disease agents and diseases for donors of HCT/Ps as
follows: human immunodeficiency virus, hepatitis B virus, hepatitis C
virus, Mycobacterium tuberculosis (Mtb), sepsis, human transmissible
spongiform encephalopathies, cytomegalovirus, Chlamydia trachomatis and
Neisseria gonorrhoeae, human T-lymphotropic virus, Treponema pallidum
(syphilis), vaccinia virus, West Nile virus, and communicable disease
risk associated with xenotransplantation. Please note that FDA has
withdrawn the 2018 guidance for industry ``Donor Screening
Recommendations to Reduce the Risk of Transmission of Zika Virus by
Human Cells, Tissues, and Cellular and Tissue-Based Products.'' FDA has
determined that Zika virus (ZIKV) is no longer a relevant communicable
disease agent or disease because the available evidence demonstrates
that ZIKV no longer has sufficient incidence and/or prevalence to
affect the potential HCT/P donor population.
The draft of the general guidance document and the associated
specific guidance documents, when finalized, are intended to supersede
the following guidance documents:
``Eligibility Determination for Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for
Industry,'' dated August 2007;
``Use of Donor Screening Tests To Test Donors of Human
Cells, Tissues and Cellular and Tissue-Based Products for Infection
with Treponema pallidum
[[Page 1168]]
(Syphilis), Guidance for Industry'' dated September 2015;
``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;
``Use of Nucleic Acid Tests To Reduce the Risk of
Transmission of West Nile Virus from Living Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for
Industry'' dated September 2016 and corrected May 2017; and
``Revised Recommendations for Determining Eligibility of
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
Who Have Received Human-Derived Clotting Factor Concentrates, Guidance
for Industry'' dated November 2016.
When the general guidance and the associated specific guidances are
finalized, FDA intends to collate information from the guidances and
provide comprehensive lists of recommendations on the FDA website
regarding conditions and behaviors that increase the donor's relevant
communicable disease risk, examples of clinical evidence of relevant
communicable disease, examples of physical evidence of relevant
communicable disease or high-risk behavior associated with these
diseases, disease agents for which all donors of HCT/Ps must be tested,
and the types of tests we currently consider to be adequate and
appropriate to meet the requirements in 21 CFR 1271.80(c). The
comprehensive lists will cite to the applicable guidance(s) where the
recommendations are provided.
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
``Recommendations for Determining Eligibility of Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' 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. 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 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 1271 have been approved under OMB control number 0910-
0543.
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: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31524 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
