Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability, 1141-1143 [2024-31538]
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1141
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Labeling of Plant-Based Alternatives to
Animal-Derived Foods: Draft Guidance
for Industry
OMB Control Number 0910–0381—
Revision
The draft guidance, once finalized,
will provide recommendations on best
practices for naming and labeling of
certain plant-based alternative foods.
Industry’s use of these
recommendations for naming and
labeling plant-based alternative foods
will help ensure consumers understand
the nature of individual plant-based
alternative foods, including differences
among these products, and have the
information they need to make informed
purchasing decisions.
Standards of identity have not been
established for plant-based alternative
foods. As such, plant-based alternative
foods are non-standardized foods and
must be labeled with their common or
usual name, or in the absence thereof,
a statement of identity that accurately
describes the food. See 21 CFR 101.3(b).
Many plant-based alternative foods are
novel foods and do not have common or
usual names established by common
usage. Currently, products appear to be
identified in multiple ways, sometimes
inconsistently across the category. Thus,
the purpose of this guidance is to
provide our recommendations on best
practices for naming and labeling of
certain plant-based foods that are
marketed and sold as alternatives for
animal-derived foods.
Description of respondents:
Respondents to this information
collection are manufacturers, packers,
and distributors of plant-based
alternative foods that are marketed and
sold in the United States. Respondents
are from the private sector (for-profit
businesses).
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN
Activity
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Total capital
costs 1 2
Labeling recommendations in ‘‘Labeling of
Plant-Based Alternatives to Animal-Derived
Foods’’ ..........................................................
160
5
800
1
800
$1,231,200
1 One-time
2 There
relabeling costs.
are no operating and maintenance costs associated with this collection of information.
The estimates in table 1 are based on
our experience with similar labeling
programs. We estimate that each year
160 manufacturers will relabel their
products following recommendations
found in the draft guidance. We
estimate that each manufacturer will
relabel 5 products for 800 total annual
disclosures (160 manufacturers × 5
labels). Each disclosure will take an
estimated 1 hour to complete for an
annual third-party disclosure burden of
800 hours (800 disclosures × 1 hour).
We estimate that there will be an annual
capital cost of $1,231,200 associated
with relabeling. This is the cost of
designing a revised label and
incorporating it into the manufacturing
process. We believe that this will be a
one-time burden per respondent.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, https://www.fda.gov/
FoodGuidances, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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. 2024–31535 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–3067]
Recommendations To Reduce the Risk
of Transmission of Disease Agents
Associated With Sepsis by Human
Cells, Tissues, and Cellular and
Tissue-Based Products; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
final guidance for immediate
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
implementation entitled
‘‘Recommendations To Reduce the Risk
of Transmission of Disease Agents
Associated with Sepsis by Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).’’ FDA is issuing this
guidance to provide establishments
making donor eligibility determinations
with recommendations to reduce the
risk of transmission of infections due to
sepsis by HCT/Ps. This notice is being
issued to respond to a public health
safety concern and to address the urgent
need for updated recommendations in
making a donor eligibility determination
when screening a donor for clinical
evidence of sepsis and clinical signs to
consider.
DATES: The announcement of the
guidance is published in the Federal
Register on January 7, 2025.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\07JAN1.SGM
07JAN1
1142
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–
2024–D–3067 for ‘‘Recommendations To
Reduce the Risk of Transmission of
Disease Agents Associated with Sepsis
by 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
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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-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 to the
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 labels to
assist that 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:
Jessica Gillum, 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 for immediate
implementation entitled
‘‘Recommendations To Reduce the Risk
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
of Transmission of Disease Agents
Associated with Sepsis by Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).’’
FDA is issuing the guidance to
provide establishments making donor
eligibility determinations with
recommendations to reduce the risk of
transmission of disease agents
associated with sepsis for donors of
human cells, tissues, and cellular and
tissue-based products. This guidance
supersedes the information regarding
sepsis in the August 2007 guidance
entitled ‘‘Eligibility Determination for
Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps).’’ The August 2007 guidance
identified sepsis as a relevant
communicable disease agent or disease
under 21 CFR 1271.3(r)(2).
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of another guidance for
immediate implementation entitled
‘‘Recommendations To Reduce the Risk
of Transmission of Mycobacterium
Tuberculosis (Mtb) by Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).’’ This guidance is
being issued to assist establishments
that make donor eligibility
determinations for donors of human
cells, tissues, and cellular and tissuebased products, with recommendations
for screening donors for evidence of,
and risk factors for, infection with Mtb,
the organism that causes tuberculosis,
which can be a cause of sepsis.
We are issuing this guidance
consistent with our good guidance
practices (GGP) regulation (§ 10.115 (21
CFR 10.115)). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
appropriate (§ 10.115(g)(2)). We made
this determination because of the urgent
need to update recommendations to
industry for screening a donor for risk
factors and conditions, and clinical and
physical evidence, associated with the
disease agents that cause sepsis.
Although this guidance document is
immediately in effect, it remains subject
to comment in accordance with FDA’s
GGP regulation.
The guidance represents the current
thinking of FDA on ‘‘Recommendations
To Reduce the Risk of Transmission of
Disease Agents Associated with Sepsis
by 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.
E:\FR\FM\07JAN1.SGM
07JAN1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / 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. 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 1271 relating to
HCT/Ps, including establishing and
maintaining records, investigation and
reporting of adverse actions and
documentation of methods used in
facilities related to HCT/Ps, which,
includes but not limited to donor
screening, donor testing, and labeling
have been approved under OMB control
number 0910–0543.
Electronic Submissions
Food and Drug Administration
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’’).
[Docket No. FDA–2024–D–5376]
Written/Paper Submissions
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 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31538 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Type VII Veterinary Master File for
Research and Development and Risk
Reviews; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
guidance for industry (GFI) #260
entitled ‘‘Type VII Veterinary Master
File for Research and Development and
Risk Reviews.’’ This draft guidance,
when finalized, will describe FDA’s
current thinking regarding the use of
Type VII Veterinary Master Files (Type
VII VMFs). Type VII VMFs are
appropriate for research and
development of animal cells, tissues,
and cell- and tissue-based products
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
(ACTPs), gene therapies, and heritable
intentional genomic alterations (IGAs)
in animals.
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:
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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–5376 for ‘‘Type VII Veterinary
Master File for Research and
Development and Risk Reviews.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
1143
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-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 to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Lynne Boxer, Center for Veterinary
Medicine, Food and Drug
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1141-1143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-3067]
Recommendations To Reduce the Risk of Transmission of Disease
Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and
Tissue-Based Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for immediate
implementation entitled ``Recommendations To Reduce the Risk of
Transmission of Disease Agents Associated with Sepsis by Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' FDA is
issuing this guidance to provide establishments making donor
eligibility determinations with recommendations to reduce the risk of
transmission of infections due to sepsis by HCT/Ps. This notice is
being issued to respond to a public health safety concern and to
address the urgent need for updated recommendations in making a donor
eligibility determination when screening a donor for clinical evidence
of sepsis and clinical signs to consider.
DATES: The announcement of the guidance is published in the Federal
Register on January 7, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the
[[Page 1142]]
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-3067 for ``Recommendations To Reduce the Risk of
Transmission of Disease Agents Associated with Sepsis by 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 guidance to the
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 labels to assist that 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: Jessica Gillum, 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 for
immediate implementation entitled ``Recommendations To Reduce the Risk
of Transmission of Disease Agents Associated with Sepsis by Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).''
FDA is issuing the guidance to provide establishments making donor
eligibility determinations with recommendations to reduce the risk of
transmission of disease agents associated with sepsis for donors of
human cells, tissues, and cellular and tissue-based products. This
guidance supersedes the information regarding sepsis in the August 2007
guidance entitled ``Eligibility Determination for Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' The
August 2007 guidance identified sepsis as a relevant communicable
disease agent or disease under 21 CFR 1271.3(r)(2).
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of another guidance for immediate implementation
entitled ``Recommendations To Reduce the Risk of Transmission of
Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps).'' This guidance is being issued to
assist establishments that make donor eligibility determinations for
donors of human cells, tissues, and cellular and tissue-based products,
with recommendations for screening donors for evidence of, and risk
factors for, infection with Mtb, the organism that causes tuberculosis,
which can be a cause of sepsis.
We are issuing this guidance consistent with our good guidance
practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are
implementing this guidance without prior public comment because we have
determined that prior public participation is not feasible or
appropriate (Sec. 10.115(g)(2)). We made this determination because of
the urgent need to update recommendations to industry for screening a
donor for risk factors and conditions, and clinical and physical
evidence, associated with the disease agents that cause sepsis.
Although this guidance document is immediately in effect, it remains
subject to comment in accordance with FDA's GGP regulation.
The guidance represents the current thinking of FDA on
``Recommendations To Reduce the Risk of Transmission of Disease Agents
Associated with Sepsis by 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.
[[Page 1143]]
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 1271 relating to HCT/Ps, including establishing and
maintaining records, investigation and reporting of adverse actions and
documentation of methods used in facilities related to HCT/Ps, which,
includes but not limited to donor screening, donor testing, and
labeling have been approved under OMB control number 0910-0543.
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 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31538 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
