Agency information collection activities; proposals, submissions, and approvals,

[Federal Register: January 8, 2004 (Volume 69, Number 5)]

[Notices]

[Page 1299-1300]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr08ja04-27]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0328]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on 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 the proposed collection of information listed below 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 February 9, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: (202) 395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (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--(OMB Control Number 0910-0453)--Extension

The Center for Veterinary Medicine (CVM) monitors the final disposition of food animals treated with investigational new animal drugs in situations where the treated animals do not enter the human food chain immediately at the completion of the investigational study. CVM believes that monitoring of the final disposition of such food animals is consistent with its responsibility to protect the public health under the Federal Food, Drug, and Cosmetic Act. In addition, CVM believes that acceptable standards of study conduct such as those set out in 21 CFR 514.117 would include sponsors accounting for the disposition of all animals treated with investigational new animal drugs.

This guidance document describes the procedures that should be followed by sponsors who wish to file a notice of disposition electronically on FDA Form 3487. The information sponsors should include on the form includes the sponsor's name and address, and information about the investigational animals. The form has been revised at the request of the sponsors to add a box that can be checked if the submission amends a notice of disposition previously submitted to CVM and to allow for consistency across forms. The likely respondents to this collection of information are new animal drug sponsors who have conducted clinical studies under 21 CFR 511.1(b).

In the Federal Register of August 7, 2003 (68 FR 47078), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

[[Page 1300]]

Table 1.--Estimated Annual Reporting Burden\1\

Annual FDA Form No. of Frequency Total Hours per Total

No. Respondents per

Annual Response Hours Respondent Responses

3487

12

27

324

0.81 262

\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 31, 2003. Jeffrey Shuren, Assistant Commissioner for Policy.

[FR Doc. 04-347 Filed 1-7-04; 8:45 am]

BILLING CODE 4160-01-S