Notice2025-10884
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug and Veterinary Master Files
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25335-25336]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10884]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5603]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 16, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0032. Also include the FDA docket
number found in brackets in the heading of this document.
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,
<a href="/cdn-cgi/l/email-protection#8cdcdecddff8edeaeacceae8eda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="08585a495b7c696e6e486e6c692660607b266f677e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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. Form FDA 356v is available
for download at <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>. 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--
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to
Their Microbiological Effects on Bacteria of Human Health Concern
(January 2023) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects</a>), 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 presubmission 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
<a href="https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-master-files">https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-master-files</a>. 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
<a href="/cdn-cgi/l/email-protection#294a5f444c5a5c4b44405d5d4c5b694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="caa9bca7afb9bfa8a7a3bebeafb88aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a>. 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. VMFs 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 the
[[Page 25336]]
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 comply 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.
In the Federal Register of December 20, 2024 (89 FR 106493), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 Total
21 CFR Part, activity Number of responses per annual Average burden per Total
respondents respondent responses response hours
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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 minutes)......... 5,867
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 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: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10884 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P
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