Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry; Availability, 52468-52470 [2024-13778]
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52468
Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
approved this document, authorizes
Vanessa Garcia, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–13696 Filed 6–21–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–2272]
Determination That INVEGA
(Paliperidone) Extended-Release
Tablet, 1.5 Milligrams, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that INVEGA
(paliperidone) extended-release tablet,
1.5 milligrams (mg), was not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
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SUMMARY:
VerDate Sep<11>2014
18:55 Jun 21, 2024
Jkt 262001
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
INVEGA (paliperidone) extendedrelease tablet, 1.5 mg, is the subject of
NDA 021999, held by Janssen
Pharmaceuticals, Inc. NDA 021999 was
initially approved on December 19,
2006, for the INVEGA paliperidone
extended-release 3 mg, 6 mg, 9 mg, and
12 mg dose tablets, and the supplement
for the INVEGA paliperidone extendedrelease 1.5 mg dose tablet was approved
on August 26, 2008. INVEGA is
indicated for the treatment of
schizophrenia and schizoaffective
disorder.
In a letter dated February 9, 2023,
Janssen Pharmaceuticals, Inc., notified
FDA that INVEGA (paliperidone)
extended-release tablet, 1.5 mg, was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Aurobindo Pharma USA, Inc.,
submitted a citizen petition dated May
7, 2024 (Docket No. FDA–2024–P–
2272), under 21 CFR 10.30, requesting
that the Agency determine whether
INVEGA (paliperidone) extendedrelease tablet, 1.5 mg, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that INVEGA (paliperidone)
extended-release tablet, 1.5 mg, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
suggesting that INVEGA (paliperidone)
extended-release tablet, 1.5 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of INVEGA
(paliperidone) extended-release tablet,
1.5 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list INVEGA (paliperidone)
extended-release tablet, 1.5 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13803 Filed 6–21–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–1668]
Chemistry, Manufacturing, and
Controls in Support of Recombinant
Protein Products for Veterinary
Medicinal Use; 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 for industry (GFI) #288
entitled ‘‘Chemistry, Manufacturing,
and Controls in Support of Recombinant
Protein Products for Veterinary
Medicinal Use.’’ This draft guidance
SUMMARY:
E:\FR\FM\24JNN1.SGM
24JNN1
Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
describes the FDA Center for Veterinary
Medicine’s (CVM) recommendations for
the information that should be included
in Chemistry, Manufacturing, and
Controls (CMC) submissions to New
Animal Drug Applications (NADAs),
Conditional New Animal Drug
Applications (CNADAs), Investigational
New Animal Drug (INAD) files, and
Veterinary Master Files (VMFs) specific
to recombinant protein-based
intermediates, drug substances, and
drug products. Recombinant proteins
are produced with recombinant
deoxyribonucleic acid (DNA)
technology. The production of
recombinant proteins has unique
characteristics; therefore, the
recommended information related to
manufacture, characterization, and
stability may differ from other FDA
guidances specific to synthetic chemical
substances.
DATES: Submit either electronic or
written comments on the draft guidance
by August 23, 2024 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
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
VerDate Sep<11>2014
18:55 Jun 21, 2024
Jkt 262001
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–1668 for ‘‘Chemistry,
Manufacturing, and Controls in Support
of Recombinant Protein Products for
Veterinary Medicinal Use.’’ 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-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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
52469
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:
Lijuan He, Center for Veterinary
Medicine (HFV–144), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–796–5122,
Lijuan.He@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #288
entitled ‘‘Chemistry, Manufacturing,
and Controls in Support of Recombinant
Protein Products for Veterinary
Medicinal Use.’’ Recombinant proteins
are produced with recombinant DNA
technology. Recombinant protein-based
animal drug products regulated by FDA
are subject to the same statutory and
regulatory requirements as other new
animal drugs, including current good
manufacturing practices and labeling
requirements.
The production of recombinant
proteins has unique characteristics.
Therefore, the recommended
information related to their
manufacture, characterization, and
stability may differ from other FDA
guidances that address animal drugs
that are synthetic chemical substances.
This guidance focuses on recombinant
proteins, including monoclonal
antibodies (mAbs), bispecific
antibodies, and fusion proteins,
produced in mammalian cells. Other
FDA guidances address, in part,
recombinant protein drug substances for
human drug products; however, they do
not address recommended information
specific to animal drug products. This
draft guidance recommends the
information that should be submitted
for recombinant protein-based
intermediates, drug substances, and
drug products for NADAs, CNADAs,
INAD files, and VMFs.
This level 1 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
E:\FR\FM\24JNN1.SGM
24JNN1
52470
Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
thinking of FDA on ‘‘Chemistry,
Manufacturing, and Controls in Support
of Recombinant Protein Products for
Veterinary Medicinal Use.’’ 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 514 have
been approved under OMB control
number 0910–0032 and the collections
of information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117.
III. Electronic Access
Persons with access to the internet
may obtain the draft 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.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13778 Filed 6–21–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
articles. Type A medicated articles
contain new animal drugs and provide
for administration of these drugs in
animal feed.
DATES: Submit either electronic or
written comments on the draft guidance
by August 23, 2024 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
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
Food and Drug Administration
[Docket No. FDA–2024–D–1202]
Chemistry, Manufacturing, and
Controls Considerations for Type A
Medicated Articles; 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 for industry (GFI) #292
entitled ‘‘Chemistry, Manufacturing,
and Controls Considerations for Type A
Medicated Articles.’’ This draft
guidance provides recommendations to
sponsors submitting chemistry,
manufacturing, and controls (CMC)
information for Type A medicated
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:55 Jun 21, 2024
Jkt 262001
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–1202 for ‘‘Chemistry,
Manufacturing, and Controls
Considerations for Type A Medicated
Articles.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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-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:
Heather Longstaff, Center for Veterinary
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52468-52470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13778]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1668]
Chemistry, Manufacturing, and Controls in Support of Recombinant
Protein Products for Veterinary Medicinal Use; 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 for industry (GFI) #288 entitled
``Chemistry, Manufacturing, and Controls in Support of Recombinant
Protein Products for Veterinary Medicinal Use.'' This draft guidance
[[Page 52469]]
describes the FDA Center for Veterinary Medicine's (CVM)
recommendations for the information that should be included in
Chemistry, Manufacturing, and Controls (CMC) submissions to New Animal
Drug Applications (NADAs), Conditional New Animal Drug Applications
(CNADAs), Investigational New Animal Drug (INAD) files, and Veterinary
Master Files (VMFs) specific to recombinant protein-based
intermediates, drug substances, and drug products. Recombinant proteins
are produced with recombinant deoxyribonucleic acid (DNA) technology.
The production of recombinant proteins has unique characteristics;
therefore, the recommended information related to manufacture,
characterization, and stability may differ from other FDA guidances
specific to synthetic chemical substances.
DATES: Submit either electronic or written comments on the draft
guidance by August 23, 2024 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 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-1668 for ``Chemistry, Manufacturing, and Controls in Support
of Recombinant Protein Products for Veterinary Medicinal Use.''
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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lijuan He, Center for Veterinary
Medicine (HFV-144), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-796-5122, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#288 entitled ``Chemistry, Manufacturing, and Controls in Support of
Recombinant Protein Products for Veterinary Medicinal Use.''
Recombinant proteins are produced with recombinant DNA technology.
Recombinant protein-based animal drug products regulated by FDA are
subject to the same statutory and regulatory requirements as other new
animal drugs, including current good manufacturing practices and
labeling requirements.
The production of recombinant proteins has unique characteristics.
Therefore, the recommended information related to their manufacture,
characterization, and stability may differ from other FDA guidances
that address animal drugs that are synthetic chemical substances. This
guidance focuses on recombinant proteins, including monoclonal
antibodies (mAbs), bispecific antibodies, and fusion proteins, produced
in mammalian cells. Other FDA guidances address, in part, recombinant
protein drug substances for human drug products; however, they do not
address recommended information specific to animal drug products. This
draft guidance recommends the information that should be submitted for
recombinant protein-based intermediates, drug substances, and drug
products for NADAs, CNADAs, INAD files, and VMFs.
This level 1 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
[[Page 52470]]
thinking of FDA on ``Chemistry, Manufacturing, and Controls in Support
of Recombinant Protein Products for Veterinary Medicinal Use.'' 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 514 have been approved under OMB control number 0910-
0032 and the collections of information in 21 CFR part 511 have been
approved under OMB control number 0910-0117.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13778 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P
