Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Guidance for Industry; Availability, 63784-63785 [2022-22816]
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Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices
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 guidance
document.
FOR FURTHER INFORMATION CONTACT:
Lynne Boxer, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
VerDate Sep<11>2014
16:50 Oct 19, 2022
Jkt 259001
Rockville, MD 20855, 240–402–0611,
Lynne.Boxer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2022–22817 Filed 10–19–22; 8:45 am]
I. Background
BILLING CODE 4164–01–P
In the Federal Register of September
23, 2021 (86 FR 52912), FDA published
the notice of availability for a draft
guidance entitled ‘‘Donor Eligibility for
Animal Cells, Tissues, and Cell- and
Tissue-Based Products’’ giving
interested persons until November 22,
2021, to comment on the draft guidance.
FDA received two submissions that
contained multiple comments on the
draft guidance and those comments
were considered as the guidance was
finalized. Editorial changes were made
to improve clarity, for example, by
making clear that the final guidance is
intended to apply to allogeneic and
xenogeneic ACTPs, as opposed to
autologous ACTPs, and by providing
additional, suggested donor screening
and testing information that should be
considered when determining an ACTP
donor’s eligibility. The guidance
announced in this notice finalizes the
draft guidance dated September 2021.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Donor Eligibility
for Animal Cells, Tissues, and Cell- and
Tissue-Based Products.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 been
approved under OMB control number
0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
PO 00000
Frm 00025
Fmt 4703
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0399]
Current Good Manufacturing Practice
for Animal Cells, Tissues, and Celland Tissue-Based Products; 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 final
guidance for industry #253 entitled
‘‘Current Good Manufacturing Practice
for Animal Cells, Tissues, and Cell- and
Tissue-Based Products.’’ FDA’s Center
for Veterinary Medicine (CVM) is
issuing this guidance to provide
establishments that manufacture animal
cells, tissues, and cell- and tissue-based
products (ACTPs) with
recommendations for meeting
requirements for current good
manufacturing practice (CGMP). All
new animal drugs, including ACTPs, are
required to be manufactured in
accordance with CGMP to ensure that
such drugs meet the requirements of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as to safety, and have the
identity, strength, quality, and purity
characteristics, which they purport to or
are represented to possess. This
guidance also provides FDA’s
recommendations for those aspects of
manufacturing specific to ACTPs in
accordance with existing CGMP
regulations, as applicable, and with the
FD&C Act. In this guidance, we
specifically address the methods,
facilities, and controls used for
manufacturing ACTPs.
DATES: The announcement of the
guidance is published in the Federal
Register on October 20, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
E:\FR\FM\20OCN1.SGM
20OCN1
Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
2021–D–0399 for ‘‘Current Good
Manufacturing Practice for Animal
Cells, Tissues, and Cell- and TissueBased Products.’’ 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
VerDate Sep<11>2014
16:50 Oct 19, 2022
Jkt 259001
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 guidance
document.
FOR FURTHER INFORMATION CONTACT:
Lynne Boxer, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0611,
Lynne.Boxer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September
23, 2021 (86 FR 52911), FDA published
the notice of availability for a draft
guidance entitled ‘‘Good Manufacturing
Practices for Animal Cells, Tissues, and
Cell- and Tissue-Based Products’’ giving
interested persons until November 22,
2021, to comment on the draft guidance.
FDA received two submissions that
contained multiple comments on the
draft guidance and those comments
were considered as the guidance was
finalized. Editorial changes were made
PO 00000
Frm 00026
Fmt 4703
Sfmt 9990
63785
to improve clarity, for example, by
making clear that the final guidance is
intended to apply to xenogeneic,
allogeneic, and autologous ACTPs and
that under certain circumstances, we
may not expect an individual
veterinarian or veterinary practice
engaged solely in recovering cells or
tissues for further ACTP processing by
third parties to register with FDA. Other
editorial changes clarify definitions of
terms used in the final guidance, such
as the definition of the term
‘‘establishment.’’ The guidance
announced in this notice finalizes the
draft guidance dated September 2021.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Current Good
Manufacturing Practice for Animal
Cells, Tissues, and Cell- and TissueBased Products.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22816 Filed 10–19–22; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\20OCN1.SGM
20OCN1
Agencies
[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63784-63785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0399]
Current Good Manufacturing Practice for Animal Cells, Tissues,
and Cell- 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, Agency, or we) is
announcing the availability of a final guidance for industry #253
entitled ``Current Good Manufacturing Practice for Animal Cells,
Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for
Veterinary Medicine (CVM) is issuing this guidance to provide
establishments that manufacture animal cells, tissues, and cell- and
tissue-based products (ACTPs) with recommendations for meeting
requirements for current good manufacturing practice (CGMP). All new
animal drugs, including ACTPs, are required to be manufactured in
accordance with CGMP to ensure that such drugs meet the requirements of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and
have the identity, strength, quality, and purity characteristics, which
they purport to or are represented to possess. This guidance also
provides FDA's recommendations for those aspects of manufacturing
specific to ACTPs in accordance with existing CGMP regulations, as
applicable, and with the FD&C Act. In this guidance, we specifically
address the methods, facilities, and controls used for manufacturing
ACTPs.
DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2022.
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 instructions for submitting comments.
[[Page 63785]]
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-2021-D-0399 for ``Current Good Manufacturing Practice for Animal
Cells, Tissues, and Cell- and Tissue-Based Products.'' 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
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lynne Boxer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0611, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 23, 2021 (86 FR 52911), FDA
published the notice of availability for a draft guidance entitled
``Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and
Tissue-Based Products'' giving interested persons until November 22,
2021, to comment on the draft guidance. FDA received two submissions
that contained multiple comments on the draft guidance and those
comments were considered as the guidance was finalized. Editorial
changes were made to improve clarity, for example, by making clear that
the final guidance is intended to apply to xenogeneic, allogeneic, and
autologous ACTPs and that under certain circumstances, we may not
expect an individual veterinarian or veterinary practice engaged solely
in recovering cells or tissues for further ACTP processing by third
parties to register with FDA. Other editorial changes clarify
definitions of terms used in the final guidance, such as the definition
of the term ``establishment.'' The guidance announced in this notice
finalizes the draft guidance dated September 2021.
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Current Good Manufacturing Practice
for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22816 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P