Document ID: FDA-2010-N-0057-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: How to Submit Information in Electronic Format to Center for Veterinary Medicine Using FDA Electronic Submission Gateway
Posted Date: 2010-05-18T04:00Z

[Federal Register: May 18, 2010 (Volume 75, Number 95)]
[Notices]               
[Page 27790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18my10-80]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0057]

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

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.

DATES: Fax written comments on the collection of information by June 
17, 2010.

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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0454. 
Also include the FDA docket number found in brackets in the heading of 
this document

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, Rockville, MD 20850, 301-796-3793.

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 on How to Submit Information in Electronic Format 
to the Center for Veterinary Medicine Using the FDA Electronic 
Submission Gateway (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 
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: 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 e-mail. The likely 
respondents are sponsors for new animal drug applications.
    In the Federal Register of February 5, 2010 (75 FR 6038), 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\
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 21 CFR Section/         No. of        Annual Frequency     Total Annual        Hours per
    Form 3538         Respondents        per Response       Responses\2\        Respondent        Total Hours
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11.2                              40                1.3                 52                .08                4.2
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.

    The number of respondents in table 1 of this document is the number 
of sponsors registered to make electronic submissions (40). The number 
of total annual responses is based on a review of the actual number of 
such submissions made between January 1, 2008, and December 31, 2008 
(52 x hours per response (.08) = 4.2 total hours).

    Dated: May 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.

[FR Doc. 2010-11808 Filed 5-17-10; 8:45 am]
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