81 FR 10871 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 41 (March 2, 2016)

The Food and Drug Administration (FDA, we) 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 the collection of information associated with new animal drug applications.

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10871-10873]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2016-N-0628]


Agency Information Collection Activities; Proposed Collection; 
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, we) 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 the collection of information 
associated with new animal drug applications.

DATES:  Submit either electronic or written comments on the collection 
of information by May 2, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0628 for Agency Information Collection Activities; Proposed 
Collection; Comment Request; Reporting Associated with New Animal Drug 
Applications. Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/

[[Page 10872]]

regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: 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.

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.
    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   Average 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);                 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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[[Page 10873]]

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

    Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04575 Filed 3-1-16; 8:45 am]
BILLING CODE 4164-01-P