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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Final Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine

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Information about this document as published in the Federal Register.

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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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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by April 14, 2005.


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.

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Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 4B-41, Rockville, MD 20857, 301-827-1472.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Title: Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine

Description: FDA is issuing a final guidance on the Center for Veterinary Medicine (CVM) process for formally resolving disputes relating to scientific controversies. The final guidance describes procedures for formally appealing such disputes. The final guidance provides information on how the agency intends to interpret and apply provisions of the existing regulations regarding internal agency review of decisions (§ 10.75 (21 CFR 10.75)). In a final rule issued in the Federal Register of November 18, 1998 (63 FR 63978), FDA amended § 10.75 to reflect the provisions of FDAMA. This final guidance document outlines the recommended procedures for persons who are applicants for approval of animal drugs or other products regulated by CVM who wish to submit a request for review of a scientific dispute.

The final guidance recommends a procedure whereby applicants first seek review through the supervisory chain of command. If the issue is not resolved at the supervisor's level, the interested person may request in writing that the matter be reviewed at the next higher supervisory level. This process may continue throughout the agency's entire supervisory chain of command through CVM and up to the level of the Commissioner of Food and Drugs (Commissioner). At each level of review (Division, Office Director, Deputy Center Director, and Center Director levels) CVM recommends that the applicant identify the information in the administrative file upon which the request is based. If the appeal contains new information not previously contained in the administrative file, the matter will, in accordance with 21 CFR 10.75(d), be returned to the appropriate lower level in CVM for reevaluation based on that new information. After the applicant has appealed the decision through the supervisory chain of command, they may request review through an ad hoc appeals committee or review by the Veterinary Medicine Advisory Committee (VMAC) in writing to the CVM Ombudsman. If the applicant seeks review by the Ad Hoc Committee, the Chair should provide them the opportunity to submit written arguments to the Committee. The applicant may submit a letter appealing the Ad Hoc Committee's decision to the CVM Director and then to the Commissioner. CVM recommends that persons filing a request for review by VMAC provide the CVM Ombudsman with a concise summary of the scientific issue in dispute, including a summary of the particular FDA action or decision to which the requesting party objects, the results of all efforts that have been made to resolve the dispute to date, and a clear articulated summary of the arguments and relevant data and information.

The information collected will form the basis for resolving the dispute between the requester and FDA. The likely respondents to this collection of information are applicants for approval of animal drugs or other products regulated by CVM who have a scientific dispute with FDA and who request a review of the matter.

Based on FDA's experience with dispute resolution, the agency expects that most persons seeking formal dispute resolution will have gathered the materials during any previous efforts to resolve the dispute with the agency. CVM considered the number and substance of similar appeals made to FDA in recent years under Guide 1240.3130 to arrive at numbers reflected in table 1 of this document. Guidance #79 will supercede Guide 1240.3130 and CVM will eliminate the guide from the P & P Manual.

In the Federal Register of May 19, 2003 (68 FR 27094), 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:

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Table 1.—Estimated Annual Reporting Burden1

No. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per RespondentTotal Hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The use of VMAC for resolving scientific disputes represents a new process for CVM. Although the procedures for requesting dispute resolution by a scientific advisory committee as set forth in the final guidance document are new, CVM estimates that the number of respondents who would submit requests would not increase. The number of hours per respondent (30) encompasses a wide range depending on the dispute involved. The estimate was based on discussions with industry and is an average of hours per respondent.

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Dated: March 9, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-5040 Filed 3-14-05; 8:45 am]