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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106493-106496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31308]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5603]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drug and Veterinary Master Files

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
associated with new animal drug applications and veterinary master 
files.

DATES: Either electronic or written comments on the collection of 
information must be submitted by February 28, 2025.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 28, 2025. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the

[[Page 106494]]

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-N-5603 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reporting Associated with New 
Animal Drug and Veterinary Master Files.'' Received comments, those 
filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

New Animal Drug Applications and Veterinary Master Files--21 CFR 514 
and 558, and Section 571 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360ccc)

OMB Control Number 0910-0032--Extension

    This information collection supports implementation of section 512 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360b), which governs new animal drugs. Agency regulations in 21 CFR 
part 514 (part 514) and associated regulations 21 CFR part 558, 
establish format and content requirements regarding new animal drug 
application (NADA) submissions, as well as provide for pre-application 
submissions, amended applications, and application supplements. This 
information collection also supports implementation of section 571 of 
the FD&C Act (21 U.S.C. 360ccc) regarding application for conditional 
approval of new animal drug (CNADA) submissions. As set forth in the 
FD&C Act and regulations, requisite elements include safety and 
effectiveness data, proposed labeling, product manufacturing 
information, and where necessary, complete information on food safety 
(including microbial food safety) and any methods used to determine 
residues of drug chemicals in edible tissue from food producing 
animals. Applications must be prepared as appropriate to support the 
submission. Respondents to the information collection are persons 
developing, manufacturing, and/or researching new animal drugs.
    We developed Form FDA 356v (Application for Approval of a New 
Animal Drug (or Submission to Support New Animal Drug Approval)) to 
provide a uniform format for submitting requisite information and to 
ensure efficient processing by the Agency.

[[Page 106495]]

Form FDA 356v is available for download at https://www.fda.gov/about-fda/reports-manuals-forms/forms. We also develop Agency guidance 
documents that may assist respondents with understanding NADA/CNADA 
requirements and related information collection activity. This includes 
FDA Guidance #152 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects), which outlines a 
risk assessment approach for evaluating the microbial food safety of 
antimicrobial new animal drugs and includes Agency recommendations in 
this regard.
    Under section 512(b)(3) of the FD&C Act, any person intending to 
file an NADA or supplemental NADA or a request for an investigational 
exemption under section 512(j) of the FD&C Act may request a conference 
prior to making a submission. Section 514.5 of our regulations (21 CFR 
514.5) sets forth procedures for pre-submission conferences and 
describes documentation associated with making requests, and preparing 
for and conducting meetings. We encourage sponsors to submit data for 
review at the most appropriate and productive times in the drug 
development process. Rather than submitting all data for review as part 
of a complete application, we have found that the submission of data 
supporting discrete technical sections during the investigational phase 
is most appropriate and productive. This ``phased review'' of data 
submissions has created efficiencies for both us and the animal 
pharmaceutical industry.
    We also encourage, as appropriate, the submission of a Veterinary 
Master File (VMF). For more information on VMFs we invite you to visit 
https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-master-files. A VMF provides detailed information used in 
support of application submissions. Questions regarding VMF submissions 
may be directed to the Center for Veterinary Medicine at 
[email protected]. We have found that utilizing VMFs has 
increased the efficiency of the animal drug development and animal drug 
review processes for both FDA and the animal pharmaceutical industry, 
providing for the confidential exchange of information with FDA, and a 
process for reporting information outside of an NADA/CNADA or an 
Investigational New Animal Drug file, as well as an opportunity for 
increased communication with FDA during early stages of product 
development. A holder of a VMF may also authorize other parties to 
reference information included in the VMF without disclosing 
information in the file to those parties. Veterinary master files can 
be used as repositories for information that can be referenced in 
multiple submissions to the Agency.
    Section 558.5(i) of our regulations (21 CFR 558.5(i)) describes the 
procedure for requesting a waiver of the labeling requirements in Sec.  
558.5(h) if there is evidence to indicate that it is unlikely a new 
animal drug would be used in the manufacture of a liquid medicated 
feed.
    Finally, section 571 of the FD&C Act established requirements for 
the conditional approval of certain drugs \1\ and the procedures for 
submitting CNADAs. Although FDA receives fewer than one application 
submission annually under section 571 of the FD&C Act when averaged 
over a 3-year period, we use a place holder of one response and 1 hour 
annually to account for burden associated with these submissions.
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    \1\ Animal drugs intended for use in minor species, minor use in 
major species, or for serious or life-threatening conditions or 
unmet animal or human health needs where a demonstration of 
effectiveness would require a complex or particularly difficult 
study or studies.
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    The reporting associated with NADAs/CNADAs and related submissions 
is necessary to ensure that new animal drugs are in compliance with 
sections 512(b)(1) and 571 of the FD&C Act. We use the information 
collected to review the data, labeling, and manufacturing controls and 
procedures to evaluate the safety and effectiveness of the proposed new 
animal drug.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                   Number of
     21 CFR part, activity         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Sec.   514; applications and               254             2.8             711  42.25...........          30,040
 amendments, pre-submission
 conference requests, evidence
 to establish safety and
 effectiveness, manufacturing,
 labeling, and other changes,
 submission of data studies
 and other changes.
Sec.   558.5(i); requirements              254             .01             2.5  5...............              13
 for liquid medicated feed.
Applications for conditional                 3               1               3  1...............               3
 approval submitted under
 section 571 of the FD&C Act.
Form FDA 356V.................             254            30.8           7,823  0.75 (45                   5,867
                                                                                 minutes).
VMF submissions...............              16               1              16  20..............             320
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    Total.....................  ..............  ..............           8,556  ................          36,243
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

    Although we have characterized the information collection activity 
as a reporting burden, we include in our estimate time required for 
searching data sources and preparing and maintaining necessary and 
applicable records. Based on the number of sponsors subject to animal 
drug user fees, we estimate that there are 254 respondents. We use this 
estimate to calculate the ``number of responses per respondent'' by 
dividing the total annual responses by the number of respondents except 
for CNADA submission and VMFs. For CNADAs we calculate an average of 
three responses and for VMF submissions we calculate and average of 16 
VMFs.
    Our estimated burden for the information collection reflects an 
overall decrease of 2,606 hours and an increase of 928 responses. We 
attribute

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this adjustment to an increase in the number of submissions which 
generate a Form FDA 0356v; however, there is also a decrease to the 
submissions we received reported under part 514.

    Dated: December 16, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31308 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
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