Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Center for Veterinary Medicine's Guidance for Industry #79 “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine” describes the process by which the Center for Veterinary Medicine (CVM) formally resolves disputes relating to scientific controversies. A scientific controversy involves issues concerning a specific product regulated by CVM related to matters of technical expertise and requires specialized education, training, or experience to be understood and resolved. Further, the guidance details information on how the Agency intends to interpret and apply provisions of the existing regulations regarding internal Agency review of decisions. In addition, the guidance outlines the established procedures for persons who are sponsors, applicants, or manufacturers, for animal drugs or other products regulated by CVM, that wish to submit a request for review of a scientific dispute. When a sponsor, applicant, or manufacturer has a scientific disagreement with a written decision by CVM, they may submit a request for a review of that decision by following the established Agency channels of supervision for review.
FDA estimates the burden of this collection of information as follows:
This estimated annual reporting burden is based on CVM's experience over the past 3 years in handling formal appeals for scientific disputes. The number of respondents multiplied by the number of responses per respondent equals the total annual responses. The average burden per response (in hours) is based on discussions with industry and may vary depending on the complexity of the issue(s) involved and the duration of the appeal process.