[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Pages 20684-20685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8906]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.


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 May 13, 

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 e-mailed 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[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 FDA Form 356V--(OMB Control Number 0910-0032)--

    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) 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) of the FD&C Act 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.
    In the Federal Register of February 8, 2011 (76 FR 6798), 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 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                     Number of       Number of     Total annual     burden per
   21 CFR Section/FDA Form No.      respondents    responses per     responses     response  (in    Total hours
                                        \4\         respondent                        Hours)
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
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

[[Page 20685]]

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
    Total.......................  ..............  ..............  ..............  ..............         33,319
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
\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: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8906 Filed 4-12-11; 8:45 am]