[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34880-34882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 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 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 
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.
    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:

[[Page 34882]]



                                                     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