Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Veterinary Master Files, 11713-11716 [2022-04373]
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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
Decisions, Suspension/Revocation of
Certificates, or Patient and Physician
Notification Orders’’ to the Office of the
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Abiy Desta, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4282, Silver Spring,
MD 20993–0002, 301–796–5699.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Mammography Quality
Standards Act (42 U.S.C. 263b), all
mammography facilities, except
facilities of the Department of Veteran
Affairs, must be accredited by an
approved accreditation body and
certified by FDA (or an approved State
certification agency) to provide
mammography services (42 U.S.C.
263b(b)(1) and (d)(1)(iv)). For a facility
to be certified it must meet certain
requirements including: (1) Be
accredited by an FDA-approved
accreditation body; (2) undergo periodic
review of its clinical images by its
accreditation body; (3) have an annual
survey by a medical physicist; (4) meet
federally developed quality standards
for personnel qualifications, equipment,
radiation dose, quality assurance
programs, recordkeeping, and reporting;
and (5) undergo periodic inspection to
assure it meets the federally developed
quality standards.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Appeal Options
Available to Mammography Facilities
Concerning Adverse Accreditation
Decisions, Suspension/Revocation of
Certificates, or Patient and Physician
Notification Orders’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 19004 and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulation and guidance have been
approved by OMB as listed in the
following table:
OMB control
No.
21 CFR part or guidance
Topic
‘‘Guidance for Industry and Food and Drug Administration Staff; Center for Devices
and Radiological Health Appeals Processes’’.
900 ................................................................................................................................
Appeals Process .......................................
0910–0738
Mammography Facilities ...........................
0910–0309
Dated: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04405 Filed 3–1–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0482]
BILLING CODE 4164–01–P
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This guidance document describes the
processes available to mammography
facilities to request additional review of
an adverse appeals decision on a
facility’s accreditation and/or a
suspension or revocation of certificate,
and/or a patient and physician
notification order. It provides general
information about each process, as well
as guidance on how to submit related
requests to the Division of
Mammography Quality Standards and
FDA. This guidance supersedes section
4.5 of the CDRH Appeals Processes
guidance document dated July 2, 2019
(https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/center-devices-andradiological-health-cdrh-appealsprocesses).
A notice of availability of the draft
guidance appeared in the Federal
Register of July 21, 2020 (85 FR 44097).
FDA received no comments and no
substantive changes have been made in
the final guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Appeal Options
Available to Mammography Facilities
Concerning Adverse Accreditation
Decisions, Suspension/Revocation of
Certificates, or Patient and Physician
Notification Orders.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
11713
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drug
Applications and Veterinary Master
Files
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
Frm 00028
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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
SUMMARY:
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11714
Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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.’’
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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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.
SUPPLEMENTARY INFORMATION:
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
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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
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/reportsmanuals-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.
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 cvmesubmitter@
fda.hhs.gov. 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
11715
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 § 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.
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
Number of
respondents
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21 CFR section; activity
§§ 514.1 and 514.6; applications and amended applications.
§§ 514.1(b)(8) and 514.8(c)(1); 2 evidence to establish safety and effectiveness.
§ 514.5(b), (d), and (f); requesting presubmission
conferences.
§ 514.8(b); manufacturing changes to an approved
application.
§ 514.8(c)(1); labeling and other changes to an approved application.
§ 514.8(c)(2) and (3); labeling and other changes to
an approved application.
§ 514.11; submission of data studies and other information.
§ 558.5(i); requirements for liquid medicated feed ......
Applications for conditional approval submitted under
section 571 of the FD&C Act.
1 Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/cvmgfi-152-evaluating-safety-antimicrobial-new-animaldrugs-regard-their-microbiological-effects.
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Number of
responses per
respondent
Total annual
responses
Frm 00030
Total hours
187
0.07
13
212 .........................
2,756
187
0.44
82
90 ...........................
7,380
187
0.67
125
50 ...........................
6,250
187
2
374
35 ...........................
13,090
187
0.06
11
71 ...........................
781
187
0.84
157
20 ...........................
3,140
187
0.13
24
1 .............................
24
187
1
0.01
1
2
1
5 .............................
1 .............................
10
1
2 Animal drugs intended for use in minor species,
minor use in major species, or for serious or lifethreatening conditions or unmet animal or human
health needs where a demonstration of effectiveness
PO 00000
Average burden
per response
Fmt 4703
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would require a complex or particularly difficult
study or studies.
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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Form FDA 356V ..........................................................
VMF submissions ........................................................
187
15
36.5
1
6,825
15
0.75 (45 minutes) ...
20 ...........................
5,118
300
Total ......................................................................
........................
........................
7,628
................................
38,849
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall preapproval safety evaluation.
2
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0836]
Pre-Launch Activities Importation
Requests; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘PreLaunch Activities Importation Requests
(PLAIR).’’ This guidance finalizes and
updates the draft guidance of the same
title issued on July 24, 2013. This
guidance finalizes FDA’s approach for
overseeing requests regarding the
importation of unapproved finished
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SUMMARY:
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dosage form drug products by
applicants preparing products for
market launch based on anticipated
approval of a pending new drug
application (NDA) or an abbreviated
new drug application (ANDA). This
guidance also applies to biologics
licensing applications (BLAs) regulated
by the Center for Drug Evaluation and
Research. This guidance further
describes the procedures for making
these requests and FDA’s actions on
such requests. Finalizing this policy
will help increase efficiencies in
ensuring timely access to drug products
upon approval.
DATES: The announcement of the
guidance is published in the Federal
Register on March 2, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows.
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’’).
PO 00000
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Fmt 4703
Sfmt 4703
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–
2013–D–0836 for ‘‘Pre-Launch Activities
Importation Requests (PLAIR).’’
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
E:\FR\FM\02MRN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
