[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.
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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]
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