Notice2022-04373
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Veterinary Master Files
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Published
March 2, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 41 (Wednesday, March 2, 2022)</title>
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[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11713-11716]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04373]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0482]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drug Applications 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
[[Page 11714]]
information associated with new animal drug applications and veterinary
master files.
DATES: Submit either electronic or written comments on the collection
of information by May 2, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 2, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 2, 2022. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-N-0482 for ``New Animal Drug Applications 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#e7b7b5a6b493868181a7818386c98f8f94c9808891"><span class="__cf_email__" data-cfemail="eebebcafbd9a8f8888ae888a8fc086869dc0898198">[email protected]</span></a>.
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
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 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
[[Page 11715]]
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 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 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 our Center for Veterinary Medicine at
<a href="/cdn-cgi/l/email-protection#ed8e9b80889e988f80849999889fad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="ddbeabb0b8aea8bfb0b4a9a9b8af9dbbb9bcf3b5b5aef3bab2ab">[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.
We estimate the burden of this collection of information as
follows:
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.
[[Page 11716]]
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: February 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04373 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P
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