Notice2022-12355
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug Applications and Veterinary Master Files
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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 8, 2022
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 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34880-34882]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12355]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0482]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drug
Applications and Veterinary Master Files
AGENCY: Food and Drug Administration, Health and Human Services (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 8, 2022.
ADDRESSES: To ensure that comments on the information collection are
received,
[[Page 34881]]
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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#da8a889b89aebbbcbc9abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="96c6c4d7c5e2f7f0f0d6f0f2f7b8fefee5b8f1f9e0">[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
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 and associated regulations in 21 CFR part 558, establish
format and content requirements regarding new animal drug application
(NADA) submissions, as well as provide for preapplication 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
Agency 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 particular 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 from our website 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,\1\ which outlines a risk assessment approach for evaluating the
microbial food safety of antimicrobial new animal drugs and includes
Agency recommendations in this regard.
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\1\ Available at: <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>.
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Under section 512(b)(3) of the FD&C Act, any person intending to
file a 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 recommend submission of data supporting
discrete technical sections during the investigational phase, rather
than submitting all data for review as part of a complete application.
This ``phased review'' of data submissions creates efficiencies in the
review process for both FDA 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 our Center for Veterinary Medicine at
<a href="/cdn-cgi/l/email-protection#1d7e6b70786e687f70746969786f5d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="0b687d666e787e6966627f7f6e794b6d6f6a25636378256c647d">[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 FDA and the animal pharmaceutical industry,
providing for the confidential exchange of information with FDA and a
process for reporting information outside of a NADA/CNADA or an
investigational new animal drug file, as well as an opportunity for
increased communication with FDA during the 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 FDA regulations (21 CFR 558.5(i)) describes the
procedure for requesting a waiver of the labeling requirements in Sec.
558.5(h) in the event that 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 establishes requirements for
the conditional approval of certain drugs \2\ and the procedures for
submitting applications for conditional approval. Although FDA receives
fewer than one application submission under section 571 of the FD&C Act
annually when averaged over a 3-year period, we use a placeholder of
one response and 1 hour annually to account for the burden associated
with these submissions.
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\2\ 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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Information collection 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 review
the information, including data, labeling, and manufacturing controls
and procedures, to evaluate the safety and effectiveness of the
proposed new animal drug.
In the Federal Register of March 2, 2022 (87 FR 11713), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but did not pertain
to the information collection requirements.
FDA estimates the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Sec. Sec. 514.1 and 514.6; applications 187 0.07 13 212...................................... 2,756
and amended applications.
Sec. Sec. 514.1(b)(8) and 514.8(c)(1); \2\ 187 0.44 82 90....................................... 7,380
evidence to establish safety and
effectiveness.
Sec. 514.5(b), (d), and (f); requesting 187 0.67 125 50....................................... 6,250
presubmission conferences.
Sec. 514.8(b); manufacturing changes to an 187 2 374 35....................................... 13,090
approved application.
Sec. 514.8(c)(1); labeling and other 187 0.06 11 71....................................... 781
changes to an approved application.
Sec. 514.8(c)(2) and (3); labeling and 187 0.84 157 20....................................... 3,140
other changes to an approved application.
Sec. 514.11; submission of data studies and 187 0.13 24 1........................................ 24
other information.
Sec. 558.5(i); requirements for liquid 187 0.01 2 5........................................ 10
medicated feed.
Applications for conditional approval 1 1 1 1........................................ 1
submitted under section 571 of the FD&C Act.
Form FDA 356V................................ 187 36.5 6,825 0.75 (45 minutes)........................ 5,118
VMF submissions.............................. 15 1 15 20....................................... 300
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Total.................................... .............. .............. 7,628 ......................................... 38,849
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the
overall preapproval safety evaluation.
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. As stated above, although we receive fewer than one
submission annually when averaged over a 3-year period, we attribute
one response and 1 hour annually to account for CNADA submissions.
We have adjusted our estimate of the information collection to
reflect a decrease in burden associated with application submissions in
acknowledgement of respondents' preference in using FDA's
``eSubmitter'' system, which automatically generates Form FDA 356v and
allows respondents to complete the form and submit applications and
associated information electronically.
Dated: June 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12355 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P
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