[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53772-53773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21236]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
 108 on How To Submit Information in Electronic Format to the 
Center for Veterinary Medicine Using the Food and Drug Administration 
Electronic Submission Gateway

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 
September 30, 2013.

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 0910-0454 and 
title ``Guidance for Industry  108 on How to Submit 
Information in Electronic Format to CVM Using the FDA Electronic 
Submission Gateway.'' 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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.

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

    The Center for Veterinary Medicine (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 
Sec.  11.2 (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.
    In the Federal Register of May 16, 2013 (78 FR 28851), 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 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Number of
     21 CFR Part and Form FDA          Number of      responses per     Total annual      Average burden per response              Total hours
                                      respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   11.2; Form FDA 3538........              65              2.4              156   .08 (5 minutes)                   13 (Rounded from 12.5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 53773]]

    Dated: August 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21236 Filed 8-29-13; 8:45 am]
BILLING CODE 4160-01-P