[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Page 26399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0254]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: [email protected].

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published the notice of availability for a draft guidance entitled 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interested persons until September 11, 2006, to comment on the draft 
guidance.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'' (Sec.  
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 (Sec.  
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 Sec.  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).

    Dated: April 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8808 Filed 5-8-07; 8:45 am]
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