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Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 for 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 development of residue detection methodology for human or animal drugs prescribed for extralabel use in animals when the agency has determined there is reasonable probability this use may present a risk to public health due to residues exceeding a safe level.

DATES:

Submit written or electronic comments on the collection of information by March 29, 2002.

ADDRESSES:

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

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FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 16B-26; Rockville, MD 20857, 301-827-1472.

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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 of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information listed below. With respect to the following 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 FDA's 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.

Extralabel Drug Use in Animals—21 CFR Part 530 (OMB Control No. 0910-0325)—Extension

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) (Public Law 103-396) amended the Federal Food, Drug, and Cosmetic Act to permit licensed veterinarians to prescribe extralabel use in animals of approved human and animal drugs. Regulations implementing provisions of AMDUCA are codified under part 530 (21 CFR part 530). A new provision under these regulations in § 530.22(b) permits FDA to establish a safe level for extralabel use in animals of an approved human or animal drug when the agency determines there is reasonable probability that this use may present a risk to the public health. The extralabel use in animals of an approved human or animal drug that results in residues exceeding a safe level is considered an unsafe use of a drug. In conjunction with the establishment of a safe level, the new provision permits FDA to Start Printed Page 3904request development of an acceptable residue detection method for an analysis of residues above any safe level established under part 530. The sponsor may be willing to provide the methodology in some cases, while in others, FDA, the sponsor, and perhaps a third party (e.g., a State agency or a professional association), may negotiate a cooperative arrangement to develop the methodology. If no acceptable analytical method is developed, the agency would be permitted to prohibit extralabel use of the drug. The respondents may be sponsors of new animal drugs, State or Federal government, or individuals.

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

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
530.22 (b)2124,1608,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The Center for Veterinary Medicine (CVM) has not found circumstances to require the establishment of a safe level and subsequent development of an analytical methodology. However, CVM believes there will be instances when an analytical methodology will be required. Thus, we are estimating the reporting burden on one methodology being required annually.

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Dated: January 17, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 02-2051 Filed 1-25-02; 8:45 am]

BILLING CODE 4160-01-S