[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Notices]
[Pages 66335-66336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19204]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0441]


Draft Guidance for Industry: Protocols for the Conduct of Method 
Transfer Studies for Type C Medicated Feed Assay Methods; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 66336]]


ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of draft guidance for industry (136) entitled 
``Protocols for the Conduct of Method Transfer Studies for Type C 
Medicated Feed Assay Methods.'' This draft guidance provides our 
recommendations for protocols for conducting the transfer study of a 
single-laboratory validated Type C medicated feed assay method to 
laboratories that have no experience with the test method.

DATES:  Submit written or electronic comments on this draft guidance by 
January 29, 2007, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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 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of the draft guidance and the docket number found in brackets in the 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section for electronic access to the draft guidance document.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:

I. Background

    Section 512(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b) establishes the requirements for a new animal drug 
approval. FDA regulations specify the information you (the sponsor) 
must submit as part of your new animal drug application (NADA) and the 
proper format for the NADA submission (Sec.  514.1 (21 CFR 514.1)). As 
part of your NADA submission, you must describe analytical procedures 
capable of determining the active component(s) of the new animal drug 
within a reasonable degree of accuracy and of assuring the identity of 
such components (21 CFR 514.1(b)(5)(vii)). This includes a description 
of practicable methods of analysis (assay methods) that have adequate 
sensitivity to determine the amount of the new animal drug in the final 
dosage form (21 CFR 514.1(b)(5)(vii)(a)). In the case of a Type A 
medicated article, the Type C medicated feed is a final dosage form 
used to treat the animal. Thus as part of the NADA review process, FDA 
looks at assay methods for determining the amount of a new animal drug 
in Type C medicated feed.
    This draft guidance provides our (the Office of New Animal Drug 
Evaluation or ONADE) recommendations for protocols for conducting the 
transfer study of a single-laboratory validated Type C medicated feed 
assay method to laboratories that have no experience with the test 
method. Many testing laboratories, including state feed laboratories 
and contract laboratories, use Type C medicated feed assay methods to 
determine whether the drug in a medicated feed is within the assay 
limits. The term ``assay limits'' refers to the amount of the drug 
detected when a Type B/C feed is assayed. The limit is a range that is 
codified at 21 CFR 558.4(d). When feed assay values fall within this 
range, it indicates that the feed has been prepared with the correct 
amount of Type A medicated article. Because many different laboratories 
use medicated feed assays, it is important that the assay methods are 
reproducible. Sponsors should conduct method transfer studies to 
evaluate reproducibility. A method transfer study is part of the 
evaluation process for a Type C medicated feed assay method and 
demonstrates the transferability of the feed assay method among 
different laboratories by comparing the results each laboratory obtains 
when using the method to analyze a specific set of feed samples. 
Sponsors may expand the method transfer study to include other 
medicated feed products, such as Top Dress Type C, Free-Choice Type C, 
and Type B medicated feeds.

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 nos. 0910-0032 and 0910-0154.

III. Significance of Guidance

    This draft level 1 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 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 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

    Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Copies of the draft guidance document 
entitled ``Protocols for the Conduct of Method Transfer Studies for 
Type C Medicated Feed Assay Methods'' 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: November 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19204 Filed 11-13-06; 8:45 am]
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