[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]


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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 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.....................................
                                                              ------------------------------------------------------------------------------------------
    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