[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Notices]
[Pages 21032-21033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0441]


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.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance for industry (136) entitled 
``Guidance for Industry: Protocols for the Conduct of Method Transfer 
Studies for Type C Medicated Feed Assay Methods.'' This 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 agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), 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. Submit electronic comments on the guidance 
document to http://www.fda.gov/dockets/ecomments. Comments should be 
identified with the full title of the guidance and the docket number 
found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 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

    In the Federal Register of November 14, 2006 (71 FR 66335), FDA 
published a notice of availability for a draft guidance entitled 
``Guidance for Industry: Protocols for the Conduct of Method Transfer 
Studies for Type C Medicated Feed Assay Methods'' giving interested 
persons until January 29, 2007, to comment on the draft guidance. No 
comments were received. Therefore, the final guidance has not been 
substantively changed from the draft version.
    Section 512(b) of the Federal Food, Drug, and Cosmetic Act (the 
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 guidance provides 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 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 level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

[[Page 21033]]

This guidance 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

    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

    Persons with access to the Internet may obtain the guidance at 
CVM's Web site (http://www.fda.gov/cvm) and from the Division of 
Dockets Management's Web site http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8042 Filed 4-26-07; 8:45 am]
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