E7-2485. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter

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 March 16, 2007.

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].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter—21 CFR 514.117(b)(2) and 21 CFR 511.1(b)(5); (OMB Control Number 0910-0453)—Extension

The Center for Veterinary Medicine (CVM) monitors the final disposition of investigational animals where such animals do not enter the human food chain immediately at the completion of the investigational study. CVM's monitoring of the final disposition of investigational food animals is intended to ensure that unsafe residues of new animal drugs do not get into the food supply. CVM issues a slaughter authorization letter to investigational new animal drug (INAD) sponsors that sets the terms under which investigational animals may be slaughtered (21 CFR 511.1(b)(5)). Also in this letter, CVM requests that sponsors submit a notice of final disposition of investigational animals not intended for immediate slaughter (NFDA). NFDAs have historically been submitted to CVM on paper. CVM's guidance on “How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter” provides sponsors with the option to submit an NFDA as an e-mail attachment to CVM via the Internet.

In the Federal Register of November 9, 2006 (71 FR 65827), FDA published a 60-day notice soliciting public comment on the proposed collection of information requirements. In response to that notice, no comments were received.

The likely respondents for this collection are are INAD sponsors.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section / Form No.	No. of Respondents	Annual Frequency per Response	Total Annual Responses2	Hours per Response	Total Hours
511.1(b)(5)/ Form FDA 3487	25	1.44	36	.08	2.88
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Electronic submissions received between July 1, 2005, and June 30, 2006.

The number of respondents in Table 1 are the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. (36 x hours per response (.08) = 2.88 total hours).

Dated: February 7, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.