[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28851-28852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0519]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How To Submit Information in 
Electronic Format to Center for Veterinary Medicine Using the Food and 
Drug Administration's Electronic Submission Gateway

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 the existing reporting 
requests in CVM Guidance 108, ``How to Register with the CVM 
Electronic Submission System to Submit Information in Electronic Format 
using the FDA Electronic Submissions Gateway.''

DATES: Submit either electronic or written comments on the collection 
of information by July 15, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of

[[Page 28852]]

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: 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: 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.

Guidance for Industry 108 on How To Submit Information in 
Electronic Format to CVM Using the FDA Electronic Submission Gateway--
21 CFR 11.2 (OMB Control Number 0910-0454)--Extension

    CVM accepts certain types of submissions electronically with no 
requirement for a paper copy. These types of documents are listed in 
public docket 97S-0251 as required by 21 CFR 11.2. CVM's ability to 
receive and process information submitted electronically is limited by 
its current information technology capabilities and the requirements of 
the Electronic Records; Electronic Signatures final regulation. CVM's 
guidance entitled ``Guidance for Industry 108: How to Submit 
Information in Electronic Format to CVM Using the FDA Electronic 
Submission Gateway'' outlines general standards to be used for the 
submission of any information by email. The likely respondents are 
sponsors for new animal drug applications.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                                  Number of
   21 CFR Part and form FDA       Number of     responses per   Total annual    Average burden     Total hours
                                 respondents     respondent       responses      per response
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Sec.   11.2; Form FDA 3538...              65             2.4             156  0.08 (5 minutes)  13 (Rounded
                                                                                                  from 12.5)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11632 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P