[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35774-35776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0628]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting Associated 
With 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 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.

[[Page 35775]]


DATES: Fax written comments on the collection of information by July 5, 
2016.

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 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

Reporting Associated With New Animal Drug Applications (NADA)--21 CFR 
514.1, 514.4, 514.5, 514.6, 514.8, 514.11, 558.5--OMB Control Number 
0910-0032--Extension

    Under Section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal 
drug application (NADA) seeking our approval to legally market a new 
animal drug. Section 512(b)(1) sets forth the information required to 
be submitted in a NADA. Sections 514.1, 514.4, 514.6, 514.8, and 514.11 
of our regulations (21 CFR 514.1, 514.4, 514.6, 514.8, and 514.11) 
further specify the information that the NADA must contain. 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. FDA Guidance #152 outlines a risk 
assessment approach for evaluating the microbial food safety of 
antimicrobial new animal drugs. We request that applicants utilize Form 
FDA 356V, as appropriate, to ensure efficient and accurate processing 
of information to support new animal drug approval.
    Under section 512(b)(3) of the FD&C Act, any person intending to 
file a 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 us prior to making a submission. Section 514.5 of 
our regulations (21 CFR 514.5) describes the procedures for requesting, 
conducting, and documenting pre-submission conferences. We have found 
that these meetings have increased the efficiency of the drug 
development and drug review processes. We encourage sponsors to submit 
data for review at the most appropriate and productive times in the 
drug development process. Rather than submitting all data for review as 
part of a complete application, we have found that the submission of 
data supporting discrete technical sections during the investigational 
phase of the new animal drug is the most appropriate and productive. 
This ``phased review'' of data submissions has created efficiencies for 
both us and the animal pharmaceutical industry.
    Finally, Sec.  558.5(i) of our regulations (21 CFR 558.5(i)) 
describes the procedure for requesting a waiver of the labeling 
requirements of Sec.  558.5(h) in the event that there is evidence to 
indicate that it is unlikely a new animal drug would be used in the 
manufacture of a liquid medicated feed.
    The reporting associated with NADAs and related submissions is 
necessary to ensure that new animal drugs are in compliance with 
section 512(b)(1) of the FD&C Act. We use the information collected to 
review the data, labeling, and manufacturing controls and procedures to 
evaluate the safety and effectiveness of the proposed new animal drug.
    In the Federal Register of March 2, 2016 (81 FR 10871), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR Section; Activity         Number of     responses per   Total annual     Avg. burden     Total hours
                                    respondents     respondent       responses     per response
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514.1 & 514.6; applications and              182             .05               9             212           1,908
 amended applications...........
514.1(b)(8) and 514.8(c)(1) \2\;             182             .10              19              90           1,710
 evidence to establish safety
 and effectiveness..............
514.5(b), (d), (f); requesting               182             .49              89              50           4,450
 presubmission conferences......
514.8(b); manufacturing changes              182            1.40             255              35           8,925
 to an approved application.....
514.8(c)(1); labeling and other              182             .05              10              71             710
 changes to an approved
 application....................
514.8(c)(2) & (3); labeling and              182             .43              79              20           1,580
 other changes to an approved
 application....................
514.11; submission of data,                  182             .09              16               1              16
 studies and other information..
558.5(i); requirements for                   182             .01               1               5               5
 liquid medicated feed..........
Form FDA 356V...................             182            2.92             531               5           2,655
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    TOTAL.......................  ..............  ..............            1009  ..............          21,959
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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 pre-approval safety evaluation.

    Based on the number of sponsors subject to animal drug user fees, 
we estimate an average of 182 annual respondents during the 5 fiscal 
years, from October 1, 2010, through September 30, 2014, 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 total number of respondents. We base 
our

[[Page 35776]]

estimates of the average burden per response on our experience with 
NADAs and related submissions.

    Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13078 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P