81 FR 60705 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 171 (September 2, 2016)

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60705-60706]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
3, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0669. 
Also

[[Page 60706]]

include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Abbreviated New Animal Drug Applications--Sections (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.
    In the Federal Register of May 11, 2016 (81 FR 29273), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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                   Number of    responses      Total       Average       Total
             (n)(1)                 FDA Form     respondents      per         annual    burden  per     hours
                                                               respondent   responses     response
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ANADA..........................  356v..........           18            1           18          159        2,862
Phased Review with               356v..........            3            5           15         31.8          477
 Administrative ANADA.
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    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: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21128 Filed 9-1-16; 8:45 am]
 BILLING CODE 4164-01-P