Notice2024-20924
Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability
Primary source
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Published
September 17, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #227 entitled "Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies." This draft guidance provides recommendations to sponsors submitting CMC data submissions to new animal drug applications. This guidance describes the options for soliciting early input from the Center for Veterinary Medicine (CVM) and the process for submission of components of the CMC technical section.
Full Text
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<title>Federal Register, Volume 89 Issue 180 (Tuesday, September 17, 2024)</title>
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[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76117-76119]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1492]
Chemistry, Manufacturing, and Controls Technical Section Filing
Strategies; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry (GFI) #227 entitled
``Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing
Strategies.'' This draft guidance provides recommendations to sponsors
submitting CMC data submissions to new animal drug applications. This
guidance describes the options for soliciting early input from the
Center for Veterinary Medicine (CVM) and the process for submission of
components of the CMC technical section.
DATES: Submit either electronic or written comments on the draft
guidance by November 18, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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,
[[Page 76118]]
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-2014-D-1492 for ``Chemistry, Manufacturing, and Controls (CMC)
Technical Section Filing Strategies.'' 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: Heather Longstaff, Center for
Veterinary Medicine (HFV-147), Food and Drug Administration, 7500
Standish Pl., Rockville MD 20855, 240-402-0651,
<a href="/cdn-cgi/l/email-protection#bef6dbdfcad6dbcc90f2d1d0d9cdcadfd8d8fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="60280501140805124e2c0f0e071314010606200604014e0808134e070f16">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #227 entitled
``Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing
Strategies.'' This guidance provides recommendations to sponsors
submitting CMC data submissions to new animal drug applications. This
draft guidance replaces final GFI #227, issued September 2015, entitled
``Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical
Sections.''
There are several mechanisms to receive input from CVM prior to
submission of the CMC technical section, as well as various approaches
to submitting the CMC technical section itself. For review efficiency,
CVM prefers that full CMC information be provided in a single technical
section submission.
However, there may be instances when submission of the individual
components of the technical section (drug product, drug substance, and
facility sterile process validation information for sterile drug
products) could reduce the overall time to complete a technical
section, and therefore drug approval. This guidance describes the
options for soliciting early input from CVM and the process for
submission of components of the CMC technical section.
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
``Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing
Strategies.'' 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 numbers 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>.
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Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20924 Filed 9-16-24; 8:45 am]
BILLING CODE 4164-01-P
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