Notice2022-05782
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 53 (Friday, March 18, 2022)</title>
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[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15436-15438]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05782]
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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.
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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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#b2e2e0f3e1c6d3d4d4f2d4d6d39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="36666477654257505076505257185e5e4518515940">[email protected]</span></a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-171-demonstrating-bioequivalence-soluble-powder-oral-dosage-form-products-and-type-medicated</a>.
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
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