[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27969-27971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 June 
12, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written

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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 0910-0032. Also include the FDA 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., PI50-400B, 
Rockville, MD 20850, 301-796, 3794, [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.

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.
    In the Federal Register of November 20, 2012, (77 FR 69630), 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--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), (f) Requesting                169            0.41              69              50           3,450
 presubmission conferences......
514.1 and 514.6 Applications and             169            0.07              12             212           2,544
 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 and             169            0.72             121              20           2,420
 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 liquid             169            0.01             1.7               5             8.5
 medicated feed.................
514.1(b)(8) and 514.8(c)(1) \2\              169            0.15              25              90           2,250
 Evidence to establish safety
 and effectiveness..............
Form FDA 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

[[Page 27971]]

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 the number of respondents.

    Dated: May 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11273 Filed 5-10-13; 8:45 am]
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