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

[Federal Register: August 7, 2003 (Volume 68, Number 152)]

[Notices]

[Page 47078-47079]

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

[DOCID:fr07au03-51]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0328]

Agency Information Collection Activities; Proposed Collection; 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 an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for sponsors electronically submitting notices of final disposition of investigational animals not intended for immediate slaughter.

DATES: Submit written or electronic comments on the collection of information by October 6, 2003.

ADDRESSES: Submit electronic comments on the collection of information to: http://www.fda.gov/dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. Collection of information is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the proposed collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA s functions, including whether the information will have practical utility; (2) the accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

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 Part 511 (OMB Control Number 0910-0453)--Extension

CVM monitors the final disposition of food animals treated with

[[Page 47079]]

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).

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

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

21 CFR Section/

No. of

Annual Frequency Total Annual

Hours per

Total Hours FDA Form Respondents per Respondents

Responses

Response

3487

12

27

324

0.81

262

\1\ There are no capital costs associated with this collection of information.

The estimates in table 1 of this document resulted from discussions with new animal drug sponsors. The estimated burden includes notices of disposition submitted on paper and by e-mail.

Dated: July 30, 2003. Jeffrey Shuren, Assistant Commissioner for Policy.

[FR Doc. 03-20061 Filed 8-6-03; 8:45 am]

BILLING CODE 4160-01-S