Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications, 15436-15438 [2022-05782]
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15436
Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES1
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:
Bryan Spells, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1117, Silver Spring,
MD 20993–0002, Bryan.Spells@
fda.hhs.gov, 240–402–6511; Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911; Norman Gregory, Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.
(HFV–143), Rockville, MD 20855,
Norman.Gregory@fda.hhs.gov, 240–
402–0684; or Michael Kerrigan, Center
for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.
(HFV–143), Rockville, MD 20855, 240–
402–0644, Michael.Kerrigan@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PQ/CMC is a term used to describe
manufacturing and testing data of
pharmaceutical products. PQ/CMC
encompasses topics such as drug
stability, quality specification, batch
formula, and batch analysis, which are
important aspects of drug development.
PQ/CMC plays an integral part in the
regulatory review process and life cycle
management of pharmaceutical
products. The development of a
structured format for PQ/CMC data will
enable consistency in the content and
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format of PQ/CMC data submitted, thus
providing a harmonized language for
submission content, allowing reviewers
to query the data, and, in general,
contributing to a more efficient and
effective regulatory decision-making
process by creating a standardized data
dictionary.
The impetus for this standardization
effort was the provisions from the 2012
Food and Drug Administration Safety
and Innovation Act (Pub. L. 112–144),
which authorized the Agency to require
certain submissions to be submitted in
a specified electronic format. PQ/CMC
standardization supports FDA’s
regulatory needs in receiving structured
and standardized data in
pharmaceutical quality and includes
two objectives: (1) To standardize the
pharmaceutical quality data that is
currently received by FDA in eCTD
Module 3 from the sponsoring
organizations, and (2) to use these
structured elements and develop a FHIR
data exchange solution.
Through this notice, the Agency is
seeking comment on the mapping of the
PQ/CMC data elements to the various
FHIR Resources. After receiving
comments, the Agency intends to issue
guidance on the standardization of PQ/
CMC data elements and terminologies
for electronic submissions.
II. Electronic Access
Persons with access to the internet
may obtain the draft data elements and
terminologies at either https://
www.fda.gov/industry/fda-resourcesdata-standards or https://
www.regulations.gov.
Dated: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05790 Filed 3–17–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1517]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Abbreviated New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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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 information
collection provisions of abbreviated new
animal drug applications.
DATES: Submit either electronic or
written comments on the collection of
information by May 17, 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 17, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 17, 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
E:\FR\FM\18MRN1.SGM
18MRN1
jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
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–1517 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Abbreviated New Animal Drug
Applications.’’ 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
VerDate Sep<11>2014
18:27 Mar 17, 2022
Jkt 256001
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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.
Abbreviated New Animal Drug
Applications—Section 512(b)(2) and
(n)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))
OMB Control Number 0910–0669—
Extension
Under section 512(b)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), any person may file an abbreviated
new animal drug application (ANADA)
seeking approval of a generic copy of an
approved new animal drug. The
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15437
information required to be submitted as
part of an ANADA is described in
section 512(n)(1) of the FD&C Act.
Among other things, an ANADA is
required to contain information to show
that the proposed generic drug is
bioequivalent to, and has the same
labeling as, the approved new animal
drug. We allow applicants to submit a
complete ANADA or to submit
information in support of an ANADA
for phased review. Applicants may
submit Form FDA 356v with a complete
ANADA or a phased review submission
to ensure efficient and accurate
processing of information. Form FDA
356v is approved under OMB control
number 0910–0032. We use the
information submitted, among other
things, to assess bioequivalence to the
originally approved drug and thus, the
safety and effectiveness of the generic
new animal drug.
The information collection also
includes applicant requests to waive the
requirement to establish bioequivalence
through in vivo studies (biowaiver
requests) for soluble powder oral dosage
form products or certain Type A
medicated articles based upon either of
two methods. We use the information
submitted by applicants in the
biowaiver request as the basis for our
decision whether to grant the request.
Therefore, the information collection
references the guidance document GFI
#171—Demonstrating Bioequivalence
for Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles Containing Active
Pharmaceutical Ingredients Considered
to Be Soluble in Aqueous Media, which
discusses statutory bioequivalence
requirements as well as qualifications
for requesting a waiver from the
requirements. The guidance can be
viewed on our website at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/cvmgfi-171-demonstrating-bioequivalencesoluble-powder-oral-dosage-formproducts-and-type-medicated.
The reporting associated with
ANADAs and related submissions is
necessary to ensure that new animal
drugs are in compliance with section
512(b)(2) of the FD&C Act. We use the
information submitted, among other
things, to assess bioequivalence to the
originally approved drug and thus, the
safety and effectiveness of the generic
new animal drug.
Description of Respondents: The
respondents for this collection of
information are veterinary
pharmaceutical manufacturers.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA Form No.
Total
annual
responses
Average
burden per
response
Total
hours
ANADA ..............................................................................................
Phased review with administrative ANADA ......................................
Biowaiver request for soluble powder oral dosage form product,
using same formulation/manufacturing process approach ...........
Biowaiver request for soluble powder oral dosage form product,
using same API/solubility approach ..............................................
Biowaiver request for Type A medicated article, using same formulation/manufacturing process approach ........................................
Biowaiver request for Type A medicated article, using same API/
solubility approach .........................................................................
356v
356v
20
6
1
5
20
30
159
31.8
3,180
954
N/A
1
1
1
5
5
N/A
5
1
5
10
50
N/A
2
1
2
5
10
N/A
5
1
5
20
100
Total ...........................................................................................
........................
........................
........................
63
........................
4,299
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our records
of generic animal drug applications. We
estimate that we will receive 26 ANADA
submissions per year over the next 3
years and that 6 of those submissions
will request phased review. We estimate
that each applicant that uses the phased
review process will have approximately
five phased reviews per application. We
estimate that an applicant will take
approximately 159 hours to prepare
either an ANADA or the estimated five
ANADA phased review submissions
and the administrative ANADA. Our
estimates of the burden of biowaiver
requests for generic soluble powder oral
dosage form products and Type A
medicated articles differ based on the
type of product and the basis for the
request, as shown in table 1. We
estimate that an applicant will take
between 5 and 20 hours to prepare a
biowaiver request.
Our estimated burden for the
information collection reflects an
overall increase of 695 hours and a
corresponding increase of 12 responses.
Based on a review of the information
collection since our last request for
OMB renewal, the increase in the
burden hours estimate is attributable to
an increase in the number of
respondents submitting generic drug
applications.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05782 Filed 3–17–22; 8:45 am]
BILLING CODE 4164–01–P
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Number of
responses per
respondent
Number of
respondents
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; SHIP COVID–19 Testing and
Mitigation Program Data Collection,
OMB No. 0906–0066—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this Notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than April 18, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call (301)
443–9094.
DATES:
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SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
SHIP COVID–19 Testing and Mitigation
Program Data Collection OMB No.
0906–0066—Extension.
Abstract: The American Rescue Plan
Act of 2021 (Pub. L. 117–2) provided
one-time funding for awards that will be
carried out under section 711 of the
Social Security Act (42 U.S.C.
912(b)(5)). The Small Rural Hospital
Improvement Program (SHIP) is
requesting an extension of an
information collection request. State
grantees will improve health care in
rural areas by using the funding to
provide support to eligible rural
hospitals to increase COVID–19 testing
efforts, expand access to testing in rural
communities, and expand the range of
mitigation activities.
A 60-day Notice published in the
Federal Register, 86 FR 74095
(December 29, 2021). There were no
public comments.
Need and Proposed Use of the
Information: The terms and conditions
for this program specify that, ‘‘hospitals
will be required to report on the number
of tests provided and categories in
which the funding is spent.’’ The data
will allow HRSA to ensure SHIP
COVID–19 recipients are meeting the
terms and conditions of their funding,
while providing HRSA with information
on the effectiveness of funds distributed
through this program.
Likely Respondents: The respondents
will be hospital staff and designated
Representatives, and State Office of
Rural Health Staff.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
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]]>Agencies
[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15436-15438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1517]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Abbreviated New Animal Drug Applications
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 information collection
provisions of abbreviated new animal drug applications.
DATES: Submit either electronic or written comments on the collection
of information by May 17, 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 17, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 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
[[Page 15437]]
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-1517 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Abbreviated New Animal Drug
Applications.'' 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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Abbreviated New Animal Drug Applications--Section 512(b)(2) and (n)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))
OMB Control Number 0910-0669--Extension
Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), any person may file an abbreviated new animal drug
application (ANADA) seeking approval of a generic copy of an approved
new animal drug. The information required to be submitted as part of an
ANADA is described in section 512(n)(1) of the FD&C Act. Among other
things, an ANADA is required to contain information to show that the
proposed generic drug is bioequivalent to, and has the same labeling
as, the approved new animal drug. We allow applicants to submit a
complete ANADA or to submit information in support of an ANADA for
phased review. Applicants may submit Form FDA 356v with a complete
ANADA or a phased review submission to ensure efficient and accurate
processing of information. Form FDA 356v is approved under OMB control
number 0910-0032. We use the information submitted, among other things,
to assess bioequivalence to the originally approved drug and thus, the
safety and effectiveness of the generic new animal drug.
The information collection also includes applicant requests to
waive the requirement to establish bioequivalence through in vivo
studies (biowaiver requests) for soluble powder oral dosage form
products or certain Type A medicated articles based upon either of two
methods. We use the information submitted by applicants in the
biowaiver request as the basis for our decision whether to grant the
request. Therefore, the information collection references the guidance
document GFI #171--Demonstrating Bioequivalence for Soluble Powder Oral
Dosage Form Products and Type A Medicated Articles Containing Active
Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media,
which discusses statutory bioequivalence requirements as well as
qualifications for requesting a waiver from the requirements. The
guidance can be viewed on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated.
The reporting associated with ANADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(2) of the FD&C Act. We use the information submitted,
among other things, to assess bioequivalence to the originally approved
drug and thus, the safety and effectiveness of the generic new animal
drug.
Description of Respondents: The respondents for this collection of
information are veterinary pharmaceutical manufacturers.
FDA estimates the burden of this collection of information as
follows:
[[Page 15438]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity FDA Form No. Number of responses per Total annual burden per Total
respondents respondent responses response hours
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ANADA........................................................ 356v 20 1 20 159 3,180
Phased review with administrative ANADA...................... 356v 6 5 30 31.8 954
Biowaiver request for soluble powder oral dosage form N/A 1 1 1 5 5
product, using same formulation/manufacturing process
approach....................................................
Biowaiver request for soluble powder oral dosage form N/A 5 1 5 10 50
product, using same API/solubility approach.................
Biowaiver request for Type A medicated article, using same N/A 2 1 2 5 10
formulation/manufacturing process approach..................
Biowaiver request for Type A medicated article, using same N/A 5 1 5 20 100
API/solubility approach.....................................
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Total.................................................... .............. .............. .............. 63 .............. 4,299
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our records of generic animal drug
applications. We estimate that we will receive 26 ANADA submissions per
year over the next 3 years and that 6 of those submissions will request
phased review. We estimate that each applicant that uses the phased
review process will have approximately five phased reviews per
application. We estimate that an applicant will take approximately 159
hours to prepare either an ANADA or the estimated five ANADA phased
review submissions and the administrative ANADA. Our estimates of the
burden of biowaiver requests for generic soluble powder oral dosage
form products and Type A medicated articles differ based on the type of
product and the basis for the request, as shown in table 1. We estimate
that an applicant will take between 5 and 20 hours to prepare a
biowaiver request.
Our estimated burden for the information collection reflects an
overall increase of 695 hours and a corresponding increase of 12
responses. Based on a review of the information collection since our
last request for OMB renewal, the increase in the burden hours estimate
is attributable to an increase in the number of respondents submitting
generic drug applications.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05782 Filed 3-17-22; 8:45 am]
BILLING CODE 4164-01-P
