Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry (#137) entitled “Analytical Methods Description for Type C Medicated Feeds.” This guidance provides our recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds.

DATES:

Submit written or electronic 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.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. Submit electronic comments to http://www.fda.gov/dockets/ecomments . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Rebecca Owen, Center for Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9842, e-mail: rebecca.owen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 28, 2006 (71 FR 36813), FDA published the notice of availability for a draft guidance entitled “Analytical Methods Description for Type C Medicated Feeds” giving interested persons until September 11, 2006, to comment on the draft guidance. With the exception of one general comment regarding medicated feed, FDA received no specific comments on the guidance. The final guidance has not been substantively changed from the draft version.

Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) establishes the requirements for new animal drug approval. FDA regulations in part 514 (21 CFR part 514) specify the information you must submit as part of your new animal drug application (NADA) and the proper format for the NADA submission. As part of your NADA submission, you must include a “detailed description of the collection of samples and the analytical procedures to which they are subjected” (§ 514.1(b)(5)(vii)). This should include a description of practicable methods of analysis which have adequate sensitivity to determine the amount of the new animal drug in the final dosage form (§ 514.1(b)(5)(vii)(a)). This guidance provides recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. This guidance applies to instrumental methods only (e.g., high pressure liquid chromatography, gas chromatography). For information on other methods (e.g., microbiological methods) you should contact the Center for Veterinary Medicine (CVM).

II. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the agency's current thinking on the 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 alternate method may be used as long as it satisfies the requirements of 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 § 514.1 have been approved under OMB control numbers 0910-0032 and 0910-0154.

IV. Comments

Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should 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

Copies of the guidance document entitled “Analytical Methods Description for Type C Medicated Feeds” may be obtained from the CVM home page ( http://www.fda.gov/cvm ) and from the Division of Dockets Management Web site ( http://www.fda.gov/ohrms/dockets/default.htm ).