E9-11218. Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (#199) entitled “Animal Generic Drug User Fees and Fee Waivers and Reductions.” The purpose of this document is to provide guidance to industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA is issuing this final guidance document for immediate implementation consistent with the agency's good guidance practices (GGPs). Interested persons may submit comments on agency guidances at any time.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.

Submit written comments on the guidance document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

David Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

On August 14, 2008, AGDUFA (Public Law 110-316) was enacted. AGDUFA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and requires FDA to assess and collect user fees for certain applications, products, and sponsors. It also requires the agency to grant a waiver from or a reduction of fees in certain circumstances. Under section 741(d) of the FD&C Act, when certain conditions are met, FDA will waive or reduce fees for generic new animal drugs intended solely to provide for a minor use or minor species indication.

The purpose of the guidance document is to provide guidance on the types of fees FDA is authorized to collect under AGDUFA and how to request waivers and reductions of these fees. It describes the types of fees, the type of fee waiver or reduction available, what information FDA recommends you submit in support of a request for a fee waiver or reduction, how to submit such a request, and FDA's process for reviewing requests.

FDA is issuing this level 1 final guidance document for immediate implementation consistent with FDA's GGPs regulation (21 CFR 10.115). Prior public participation is not feasible because the guidance concerns statutory requirements that FDA must implement immediately. AGDUFA's user fee provisions are already in effect, and it is essential for the agency to provide guidance on how to request fee waivers and reductions as quickly as possible. If FDA receives comments on this final guidance, it will review the comments and revise the guidance if appropriate.

II. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's GGPs regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the fee waiver provisions of AGDUFA. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

FDA concludes that there are no collections of information under the Paperwork Reduction Act of 1995.

IV. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

Persons with access to the internet may obtain the guidance at either http://www.fda.gov/​cvm or http://www.regulations.gov.

Dated: May 7, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.