[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29273-29275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0450]


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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 July 11, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 29274]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-N-0450] for ``Abbreviated New Animal Drug Applications.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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--Sections 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 
(the 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 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. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
         FD&C Act sections 512 (b)(2) and (n)(1)             FDA Form        Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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ANADA...................................................            356v              18               1              18             159           2,862

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Phased Review with Administrative ANADA.................            356v               3               5              15            31.8             477
                                                                                                                                         ---------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           3,339
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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 experience with ANADA submissions and 
requests for phased review. We estimate that we will receive 21 ANADA 
submissions per year over the next three years and that three 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 5 
ANADA phased review submissions and the administrative ANADA.

    Dated: May 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11114 Filed 5-10-16; 8:45 am]
 BILLING CODE 4164-01-P