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Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs

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 meeting the substantial evidence standards necessary for demonstrating the safety and effectiveness of a new animal drug.

DATES:

Submit written or electronic comments on the collection of information by November 18, 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, 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 Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 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 set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (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.

Substantial Evidence of Effectiveness of New Animal Drugs—21 CFR Part 514 (OMB Control Number 0910-0356)—Extension

Description: Congress enacted the Animal Drug Availability Act of 1996 (ADAA ) (Public Law 104-250) on October 9, 1996. As directed by the ADAA, FDA published a regulation, § 514.4(a) (21 CFR 514.4(a)), to further define substantial evidence in a manner that encourages the submission of NADA's and supplemental NADA's and encourages dose range labeling. Under the ADAA, substantial evidence is the standard that a sponsor must meet to demonstrate the effectiveness of a new animal drug for its intended use under the conditions suggested in its proposed labeling. Section 514.4(a) gives FDA greater flexibility to make case-specific scientific determinations regarding the number and types of adequate and well-controlled studies that will provide, in an efficient manner, substantial evidence that a new animal drug is effective. FDA believes this regulation will address the following issues: (1) Reduce the number of adequate and well-controlled studies necessary to demonstrate the effectiveness of certain combination new animal drugs; (2) eliminate the need for an adequate and well-controlled dose titration study; and may, in limited instances, (3) reduce or eliminate the number of adequate and well-controlled field investigations necessary to demonstrate by substantial evidence the effectiveness of a new animal drug. Table 1 of this document represents the estimated burden of meeting the substantial evidence standard.

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
514.4(a)1904.5860632.6544,036
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: September 15, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-23940 Filed 9-18-03; 8:45 am]

BILLING CODE 4160-01-S