[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11713-11716]
[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

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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

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,<PHONE_NUMBER>,
[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

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.

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]
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[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56617-56618]
[FR Doc No: 2023-17841]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2022-0038; FRL-11348-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Stationary Spark Ignition Internal
Combustion Engines (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for Stationary Spark
Ignition Internal Combustion Engines (EPA ICR Number 2227.07, OMB
Control Number 2060-0610), to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through September 30, 2023. Public comments were previously requested
via the Federal Register on July 22, 2022 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments.

DATES: Comments may be submitted on or before September 18, 2023.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2022-0038, to EPA online using https://www.regulations.gov/ (our
preferred method); or by email to [email protected]; or by mail
to: EPA Docket Center, Environmental Protection Agency, Mail Code
28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy
is that all comments received will be included in the public docket
without change, including any personal information provided, unless the
comment includes profanity, threats, information claimed to be
Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this specific information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through September 30, 2023. An agency may
not conduct nor sponsor, and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
    Public comments were previous requested via the Federal Register on
July 22, 2022 during a 60-day comment period (87 FR 43843). This notice
allows

for an additional 30 days for public comments. Supporting documents,
which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov, or in person, at the EPA
Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS) for
Stationary Spark Ignition Internal Combustion Engines (40 CFR part 60,
subpart JJJJ) were promulgated on January 18, 2008; and most-recently
amended on August 10, 2022. These regulations apply to existing and new
manufacturers, owners, and operators of stationary spark ignition (SI)
internal combustion engines (ICE) that commenced construction,
modification, or reconstruction either on or after the dates specified
at 40 CFR 60.4230(a)(1)-(6). New facilities include those that
commenced construction, modification or reconstruction after the date
of proposal. This information is being collected to assure compliance
with 40 CFR part 60, subpart JJJJ.
    In general, all NSPS standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to the NSPS.
    Form Numbers: 5900-596.
    Respondents/affected entities: Manufacturers, owners, and operators
of stationary spark ignition internal combustion engines.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart JJJJ).
    Estimated number of respondents: 20,088 (total).
    Frequency of response: Initially and annually.
    Total estimated burden: 38,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $7,540,000 (per year), which includes
$2,920,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is an increase in the total
estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This increase is not due to any program changes or
changes in regulatory requirements. The change in the burden and cost
estimates is due primarily to an increase in the number of existing
sources subject to rule requirements. This increase is based on the
growth rate from the prior ICR and assumes continued growth in the
manufacture and use of SI ICE. This has led to an increase in O&M
costs, as well as for recordkeeping and reporting costs.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2023-17841 Filed 8-17-23; 8:45 am]
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