Document ID: FDA-2011-N-0049-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Presubmission Conferences, New Animal Drug Applications and Supporting Regulations, etc.
Posted Date: 2011-02-08T05:00Z

[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6798-6800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2664]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0049]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Presubmission Conferences, New Animal Drug 
Applications and Supporting Regulations, and Food and Drug 
Administration Form 356V

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 6799]]

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 April 11, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.

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 FDA Form 356V--(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 (21 CFR 514.5) 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 an 
NADA seeking approval to legally market a new animal drug. Section 
512(b)(1) sets forth the information required to be submitted in an 
NADA. FDA allows applicants to submit a complete NADA or to submit 
information in support of an NADA for phased review followed by 
submission of an Administrative NADA when FDA finds all the applicable 
technical sections are complete.
    The regulations under 21 CFR 514.1 interpret section 512(b)(1) of 
the FD&C Act and further describe the information that must be 
submitted as part of an 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 entitled ``Evaluating the Safety of 
Antimicrobial New Animal Drugs With Regard to Their Microbiological 
Effects on Bacteria of Human Health Concern'' 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 FDA Form 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    Number of     Annual frequency    Total annual        Hours per
                  21 CFR section/FDA form No.                    respondents \4\   per respondent       responses         response         Total hours
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514.5(b), (d) and (f).........................................               154               .6              92.4                 50             4,620
514.1 and 514.6...............................................               154               .1              15.4                212             3,265
514.4 \2\.....................................................               154              0                 0                    0                 0

[[Page 6800]]

 
514.8(b)......................................................               154              2.84            437.36                35            15,308
514.8(c)(1)...................................................               154               .1              15.4                 71             1,093
514.8(c)(2) and (c)(3)........................................               154               .7             107.8                 20             2,156
514.11........................................................               154               .2              30.8                  1                31
558.5(i)......................................................               154               .01              1.54                 5                 8
514.1(b)(8) and 514.8(c)(1) \3\...............................               154               .21             32.34                90             2,911
FDA Form 356V.................................................               154              5.1             785.4                  5             3,927
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    Total.....................................................  ................  ................  ................  ................            33,319
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Substantial Evidence--Because 21 CFR 514.4 only defines substantial evidence, it should not be viewed as creating additional collection burden.
\3\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the
  overall preapproval safety evaluation.
\4\ Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 154 annual respondents during the 5
  fiscal years, from October 1, 2005, through September 30, 2010, on which these estimates were made. We use this estimate consistently throughout the
  table and calculate the ``annual frequency per respondent'' by dividing the total annual responses by the number of respondents.

    Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2664 Filed 2-7-11; 8:45 am]
BILLING CODE 4160-01-P