2011-2441. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions

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 March 7, 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 0910-0540. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

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

Animal Drug User Fees and Fee Waivers and Reductions—(OMB Control Number 0910-0540)—Extension

Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and requires FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from or a reduction of those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled “Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.” This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA's animal drug user fees. The guidance also describes the types of fees and fee waivers and reductions, the information FDA recommends respondents submit in support of a request for a fee waiver or reduction, how respondents may submit such a request, and FDA's process for reviewing requests.

Respondents to this collection of information are new animal drug sponsors. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed—application fees, product fees, establishment fees, or sponsor fees.

In the Federal Register of December 2, 2010 (75 FR 75175), 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 Burden ¹

FD&C Act section	Number of respondents	Annual frequency per response	Total annual responses	Hours per response	Total hours
740(d)(1)(A) Significant barrier to innovation	22	1	22	2	44
740(d)(1)(B) Fees exceed cost	0	1	0	2	0
740(d)(1)(C) Free choice feeds	2	1	2	2	4
740(d)(1)(D) Minor use or minor species	52	1	52	2	104
740(d)(1)(E) Small business	0	1	0	0	0
Request for reconsideration of a decision	5	1	5	2	10
Request for review—(user fee appeal officer)	2	1	2	2	4
Total					166
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA's database system, there are an estimated 250 sponsors of products subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the number of submission types received by FDA in fiscal year 2008.

Dated: January 31, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.