[Federal Register Volume 71, Number 124 (Wednesday, June 28, 2006)]
[Notices]
[Pages 36813-36814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0254]


Draft Guidance for Industry: Analytical Methods Description for 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availability of draft guidance for industry (137) entitled 
``Analytical Methods Description for Type C Medicated Feeds.'' This 
draft guidance provides our recommendations for describing methods for 
analyzing new animal drugs in Type C medicated feeds.

DATES: Submit written or electronic comments on this draft guidance by 
September 11, 2006 to ensure their adequate consideration in 
preparation of the final document. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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    Submit written comments on the draft guidance to the Division of 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identified with the full title of the draft guidance and the docket 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Rebecca L. 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:

[[Page 36814]]

I. Background

    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 draft guidance provides recommendations for 
describing methods for analyzing new animal drugs in Type C medicated 
feeds. This draft guidance applies to instrumental methods only (e.g., 
High Pressure Liquid Chromatography, Gas Chromatography. For guidance 
on other methods (e.g., microbiological methods) you should contact the 
center.

II. Paperwork Reduction Act of 1995

    This draft 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.

III. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, will represent 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.

IV. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding this draft 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. 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

    Copies of the draft 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: June 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5860 Filed 6-27-06; 8:45 am]
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