Document ID: FDA-2009-N-0497-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
Posted Date: 2009-11-02T05:00Z

[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]               
[Page 56643-56644]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no09-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0497]

 
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, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the paperwork associated with abbreviated 
new animal drug applications submitted to the Center for Veterinary 
Medicine, FDA.

DATES: Submit written or electronic comments on the collection of 
information by January 4, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3793.

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, 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--FD&C Act/Section 512(n)(1) 
(OMB Control Number 0910-NEW)

    On November 16, 1988, the President signed into law the Generic 
Animal Drug and Patent Restoration Act (GADPTRA) (Public Law 100-670). 
Under Section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act), as amended by GADPTRA, 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 abbreviated application is described in section 
512(n)(1) of the act. Among other things, an abbreviated application is 
required to contain information to show that the proposed generic drug 
is bioequivalent to, and has the same labeling as, the approved drug 
referenced in the abbreviated application. FDA allows applicants to

[[Page 56644]]

submit a complete ANADA or to submit information in support of an ANADA 
for phased review followed by the submission of an Administrative ANADA 
when FDA finds that all the applicable technical sections for an ANADA 
are complete. FDA requests that an applicant accompany ANADAs and 
requests for phased review of data to support ANADAs with the Form FDA 
356v to ensure efficient and accurate processing of information to 
support approval of the generic new animal drug.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
      FD&C Act  Section 512(n)(1)            FDA Form         Respondents        per Response        Responses           Response         Total Hours
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ANADA                                               356 V                 17                  1                 17                159              2,703
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Phased Review with                                  356 V                  5                  5                 25               31.8                795
Administrative ANADA
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Total                                   .................  .................  .................  .................  .................              3,498
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    ANADA paperwork burden (Section 512(n)(1) of the act) (21 U.S.C. 
360b(b)(2)): Over the past 5 fiscal years, from October 2003 through 
September 2008, FDA has received an average of 22 ANADAs per year. FDA 
estimates that preparing the paperwork required under Section 512 
(n)(1) of the act to be contained in an ANADA, whether all of the 
information is submitted with the ANADA or the applicant submits 
information for phased review followed by an Administrative ANADA that 
references that information, will take approximately 159 hours. FDA is 
estimating that each ANADA that uses the phased review process will 
have approximately 5 phased reviews per application. Therefore, 
assuming that 5 respondents will take advantage of the phased review 
option per year and an average of 5 phased reviews are submitted per 
application, times 31.8 hours per phased review, equals 795 total hours 
per year or 159 hours per application.
    FDA believes that with time, more sponsors will take advantage of 
the phased review option, as it provides greater flexibility. 
Eventually, phased review will increase to the point of being the 
majority of ANADAs submitted during the course of the year. FDA also 
estimates that it takes sponsors of ANADAs approximately 25 percent 
less time to put together the information to support an ANADA than an 
NADA because they only need to provide evidence of bioequivalence and 
not the data required in an NADA to support a full demonstration of 
safety and effectiveness.
    Form FDA 356v: FDA requests that an applicant fill out and send in 
with an ANADA and requests for phased review of data to support an 
ANADAs, a Form FDA 356v to ensure efficient and accurate processing of 
information to support the approval of a generic new animal drug.
    This notice also refers to previously approved collections of 
information found in FDA regulations. The collections of information 
under 21 CFR 514.80, which describes records and reports that are 
required post approval, have been approved under OMB Control No. 0910-
0284.

    Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26290 Filed 10-30-09; 8:45 am]

BILLING CODE 4160-01-S