[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69630-69631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1131]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drug Applications and Supporting 
Regulations, and Form FDA 356V

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 paperwork associated with 
applications for new animal drugs.

DATES: Submit either electronic or written comments on the collection 
of information by January 22, 2013.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PIFO, Rm. 
410B, Rockville, MD 20850, 301-796-3794.

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.

Presubmission Conferences, New Animal Drug Applications and Supporting 
Regulations and Guidance 152, and Form FDA 356V--21 CFR 514.5, 
514.1, 514.4, and 514.8 (OMB Control Number 0910-0032)--Extension

    Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360b(b)(3)), any person intending to file a 
new animal drug application (NADA) or supplemental NADA or a request 
for an investigational exemption under section 512(j) of the FD&C Act 
is entitled to one or more conferences with FDA to reach an agreement 
acceptable to FDA establishing a submission or investigational 
requirement. FDA and industry have found that these meetings have 
increased the efficiency of the drug development and drug review 
processes.
    Section 514.5 of Title 21 of the Code of Federal Regulations 
describes the procedures for requesting, conducting, and documenting 
presubmission conferences. Section 514.5(b) describes the information 
that must be included in a letter submitted by a potential applicant 
requesting a presubmission conference, including a proposed agenda and 
a list of expected participants. Section 514.5(d) describes the 
information that must be provided by the potential applicant to FDA at 
least 30 days prior to a presubmission conference. This information 
includes a detailed agenda, a copy of any materials to be presented at 
the conference, a list of proposed indications and, if available, a 
copy of the proposed labeling for the product under consideration, and 
a copy of any background material that provides scientific rationale to 
support the potential applicant's position on issues listed in the 
agenda for the conference. Section 514.5(f) discusses the content of 
the memorandum of conference that will be prepared by FDA and gives the 
potential applicant an opportunity to seek correction to or 
clarification of the memorandum.
    Under section 512(b)(1) of the FD&C Act, any person may file a NADA 
seeking approval to legally market a new animal drug. Section 512(b)(1) 
sets forth the information required to be submitted in a NADA. FDA 
allows applicants to submit a complete NADA or to submit information in 
support of a NADA for phased review followed by submission of an 
administrative NADA when FDA finds all the applicable technical 
sections are complete.
    Section 514.1 of Title 21 of the Code of Federal Regulations 
interprets section 512(b)(1) of the FD&C Act and further describes the 
information that must be submitted as part of a NADA and the manner and 
form in which the NADA must be assembled and submitted. The application 
must include safety and effectiveness data, proposed labeling, product 
manufacturing information, and where necessary, complete information on 
food safety (including microbial food safety) and any methods used to 
determine residues of drug chemicals in edible tissue from food 
producing animals. Guidance 152 outlines a risk assessment 
approach for evaluating the microbial food safety of antimicrobial new 
animal drugs. FDA requests that an applicant accompany NADAs, 
supplemental NADAs, and requests for phased review of data to support 
NADAs, with the Form FDA 356V to ensure efficient and accurate 
processing of information to support new animal drug approval.
    FDA estimates the burden of the collections of information as 
follows:

[[Page 69631]]



                              Table 1--NADAs: Estimated Annual Reporting Burden \1\
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                                                   Number of
  21 CFR Section/FDA Form No.      Number of     responses per   Total  annual   Average burden    Total hours
                                  respondents     respondent       responses      per response
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514.5(b), (d), and (f)                     169            0.41             69                50          3,450
 Requesting presubmission
 conferences..................
514.1 and 514.6 Applications               169            0.07             12               212          2,544
 and amended applications.....
514.8(b) Manufacturing changes             169            2.22            375                35         13,125
 to an approved application...
514.8(c)(1) Labeling and other             169            0.06             10                71            710
 changes to an approved
 application..................
514.8(c)(2) and (3) Labeling               169            0.72            121                20          2,420
 and other changes to an
 approved application.........
514.11 Submission of data,                 169            0.08             14                 1             14
 studies and other information
558.5(i) Requirements for                  169            0.01              1.7               5              8.5
 liquid medicated feed........
514.1(b)(8) and 514.8(c)(1)                169            0.15             25                90          2,250
 \2\ Evidence to establish
 safety and effectiveness.....
FDA Form 356V.................             169            4.37            739                 5          3,695
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    Total.....................  ..............  ..............  ...............  ..............         28,217
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
  antimicrobial concerns as part of the overall preapproval safety evaluation.

    Based on the number of sponsors subject to animal drug user fees, 
FDA estimates that there was an average of 169 annual respondents 
during the 5 fiscal years, from October 1, 2008 through September 30, 
2012, on which these estimates were made. We use this estimate 
consistently throughout the table and calculate the ``total annual 
responses'' by multiplying the number of responses per respondent by 
number of respondents.

    Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28199 Filed 11-19-12; 8:45 am]
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