2010-11808. 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 ...

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 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: [phone], or e-mailed to [e-mail]. 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 Burden¹

21 CFR Section/Form 3538	No. of Respondents	Annual Frequency per Response	Total Annual Responses2	Hours per Respondent	Total Hours
11.2	40	1.3	52	.08	4.2
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.