Notice2024-13778
Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry; Availability
Primary source
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Published
June 24, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #288 entitled "Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use." This draft guidance describes the FDA Center for Veterinary Medicine's (CVM) recommendations for the information that should be included in Chemistry, Manufacturing, and Controls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.
Full Text
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<title>Federal Register, Volume 89 Issue 121 (Monday, June 24, 2024)</title>
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[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52468-52470]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13778]
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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Protein Products for Veterinary Medicinal Use; Draft Guidance for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.
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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the availability of a draft guidance for industry (GFI) #288 entitled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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#c985a0a3bca8a7e781ac89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="64280d0e11050a4a2c01240200054a0c0c174a030b12">[email protected]</span></a>.
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 <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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