2011-26132. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

Fax written comments on the collection of information by November 10, 2011.

ADDRESSES:

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: FDA Desk Officer, Fax: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0566. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, [e-mail].

SUPPLEMENTARY INFORMATION:

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

Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine—21 CFR Part 10.75 (OMB Control Number 0910-0566)—Extension

Respondents: Respondents to this collection of information are applicants that wish to submit a request for review of a scientific dispute.

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.

In the Federal Register of July 13, 2011 (76 FR 41264), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1—Estimated Annual Reporting Burden¹

21 CFR Section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
10.75	1	3	3	10	30
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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.

Dated: October 4, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.