Notice2024-13796
Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #292 entitled "Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles." This draft guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles. Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed.
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 52470-52471]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Medicated Articles; Draft Guidance for Industry; Availability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.
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SUMMARY: 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the availability of a draft guidance for industry (GFI) #292 entitled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 This draft guidance provides recommendations to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 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DATES: Submit either electronic or written comments on the draft
guidance by August 23, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
<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-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 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
[[Page 52471]]
Medicine (HFV-147), Food and Drug Administration, 7500 Standish Place,
Rockville MD 20855, 240-402-0651, <a href="/cdn-cgi/l/email-protection#f6be9397829e9384d8ba9998918582979090b6909297d89e9e85"><span class="__cf_email__" data-cfemail="6f270a0e1b070a1d41230001081c1b0e09092f090b0e4107071c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA is announcing the availability of a draft GFI #292 entitled
``Chemistry, Manufacturing, and Controls Considerations for Type A
Medicated Articles.'' This draft guidance provides recommendations to
sponsors submitting CMC information for Type A medicated articles. Type
A medicated articles contain new animal drugs and provide for
administration of these drugs in animal feed. Type A medicated articles
are intended solely for use in the manufacture of another Type A
medicated article or in the manufacture of a Type B or Type C medicated
feed. Because Type A medicated articles are not directly administered
to the animal, there are some issues specific to Type A medicated
articles that do not apply to other new animal drug dosage forms. These
unique considerations are highlighted in this guidance under the
relevant Common Technical Document--Quality section headings.
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 Considerations for Type A
Medicated Articles.'' 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 (21 U.S.C. 360b(b) and 360b(n)) 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: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13796 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P
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