2010-21981. Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a Level 2 guidance for industry #201 entitled “Small Entities Compliance Guide—The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This small entities compliance guide aids industry in complying with the requirements of the final rule that published in the Federal Register of December 6, 2007. This regulation establishes administrative procedures and criteria for index listing a new animal drug for use in a minor species as provided by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS).

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

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

FOR FURTHER INFORMATION CONTACT:

Joan Gotthardt, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., MPN2, rm. N371, Rockville, MD 20855, 240-276-9090, email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a Level 2 guidance for industry #201 entitled “Small Entities Compliance Guide—The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This guidance aids industry in complying with the requirements of the final rule published in the Federal Register of December 6, 2007 (72 FR 69108) (the indexing regulation).

FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This document is intended to provide guidance to small businesses on the requirements of section 572 of the MUMS act. Congress, in enacting MUMS, sought to encourage the development of animal drugs that are currently unavailable to minor species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major species afflicted with uncommon diseases or conditions (minor uses). The indexing regulation establishes procedures and criteria for index listing a new animal drug for use in a minor species.

II. Significance of Guidance

This level 2 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 this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in section 572 of the MUMS act have been approved under OMB Control No. 0910-0620.

IV. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen 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/​AnimalVeterinary/​default.htm or http://www.regulations.gov.

Dated: August 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.