Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry (#183) entitled “Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduction.” This guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003 (ADUFA).
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies of the guidance document to the Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), 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.fda.gov/dockets/ecomments. Comments should be identified with the full title of the guidance document and the docket number found in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dave Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
In the Federal Register of August 17, 2006 (71 FR 47502), FDA published the notice of availability of the draft guidance entitled “Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver and Reductions” giving interested persons until October 31, 2006, to submit comments. FDA received no comments.
ADUFA (Public Law 108-130) amended the Federal Food, Drug, and Cosmetic Act (the act) and requires the 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.
This guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of ADUFA. These procedures may be modified in the future as FDA gains more experience with waiver requests.
To qualify for waiver consideration, a written request to the agency for a waiver/reduction, including under the fees exceed costs waiver provision, must be submitted no later than 180 days after the fee is due (section 740(i) of the act (21 U.S.C. 379j-12(i))).
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the topic. The document does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approaches may be used as long as they satisfy the requirements of the applicable statutes and regulations. Start Printed Page 10768
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of information found in Guidance for Industry #170. These collections of information are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and have been approved under OMB Control No. 0910-0540.
Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the 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 the 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 CVM home page (http://www.fda.gov/cvm) or the Division of Dockets Management Web site http://www.fda.gov/ohrms/dockets/default.htm.Start Signature
Dated: March 1, 2007.
Assistant Commissioner for Policy.
[FR Doc. E7-4322 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S