Notice2024-05686
Manufacture of Batches in Support of Original New Animal Drug Applications, Abbreviated New Animal Drug Applications, and Conditional New Animal Drug Applications; Draft Guidance for Industry; Availability
Primary source
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Published
March 18, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #285 entitled "Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs." This draft guidance is intended to provide recommendations for the primary batches of drug product manufactured to support the approval or conditional approval of new animal drug products. This guidance is applicable to all original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs), and their associated investigational new animal drug files (INADs) and generic investigational new animal drug files, respectively, as well as applications for conditional approval of new animal drugs (CNADAs).
Full Text
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<title>Federal Register, Volume 89 Issue 53 (Monday, March 18, 2024)</title>
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[Federal Register Volume 89, Number 53 (Monday, March 18, 2024)]
[Notices]
[Pages 19326-19327]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1054]
Manufacture of Batches in Support of Original New Animal Drug
Applications, Abbreviated New Animal Drug Applications, and Conditional
New Animal Drug Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry (GFI) #285 entitled
``Manufacture of Batches in Support of Original NADAs, ANADAs, and
CNADAs.'' This draft guidance is intended to provide recommendations
for the primary batches of drug product manufactured to support the
approval or conditional approval of new animal drug products. This
guidance is applicable to all original new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs), and
their associated investigational new animal drug files (INADs) and
generic investigational new animal drug files, respectively, as well as
applications for conditional approval of new animal drugs (CNADAs).
DATES: Submit either electronic or written comments on the draft
guidance by May 17, 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-1054 for ``Manufacture of Batches in Support of Original
NADAs, ANADAs, and CNADAs.'' 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.
[[Page 19327]]
FOR FURTHER INFORMATION CONTACT: Amy Simms, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0648, <a href="/cdn-cgi/l/email-protection#f8b99581d6ab9195958bb89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="06476b7f28556f6b6b7546606267286e6e7528616970">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#285 entitled ``Manufacture of Batches in Support of Original NADAs,
ANADAs, and CNADAs.'' New animal drugs cannot be legally marketed
unless they are the subject of an approved NADA, ANADA, or CNADA. The
Chemistry, Manufacturing, and Controls (CMC) technical section is one
portion of the original ANADA or CNADA and must contain full
information regarding the manufacture of the new animal drug substance
and new animal drug product. Animal drug manufacturing processes must
be robust and able to produce drug product batches of consistent
identity, strength, quality, and purity. Primary batches of drug
product are manufactured as part of the original application. Data from
these batches are used to establish that the manufacturing, sampling,
and control processes described in the CMC portion of the application
will consistently provide a quality, stable drug product that, within a
batch and on a batch-to-batch basis, does not vary beyond the
established specification(s). Additionally, they are used in studies to
establish that the drug product is safe and effective (or in the case
of an ANADA, bioequivalent to the reference listed new animal drug). As
such, the primary batches demonstrate that the applicant can
consistently manufacture batches of same quality as those used in
safety and effectiveness (or bioequivalence) studies. This guidance
provides recommendations for the primary batches of drug product
manufactured to support the approval or conditional approval of new
animal drug products.
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 thinking of FDA on
``Manufacture of Batches in Support of Original NADAs, ANADAs, and
CNADAs.'' 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; the collections of information in 21 CFR 511.1 have been approved
under OMB control number 0910-0117; and the collections of information
in sections 512(b) and 512(n) of the Federal Food, Drug, and Cosmetic
Act have been approved under OMB control number 0910-0669.
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: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05686 Filed 3-15-24; 8:45 am]
BILLING CODE 4164-01-P
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