[Federal Register Volume 89, Number 53 (Monday, March 18, 2024)]
[Notices]
[Pages 19326-19327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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New Animal Drug Applications; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry (GFI) #285 entitled 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 This draft guidance is intended to provide recommendations 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DATES: Submit either electronic or written comments on the draft 
guidance by May 17, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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.

[[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, [email protected].

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 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: 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