[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11713-11716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the 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-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 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

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 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,\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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects.
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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 
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 our 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 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.

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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