[Federal Register: November 14, 2006 (Volume 71, Number 219)]
[Notices]
[Page 66335-66336]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no06-46]
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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Draft Guidance for Industry: Protocols for the Conduct of Method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availability of draft guidance for industry (136) entitled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 This draft guidance provides our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DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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of the draft guidance and the docket number found in brackets in the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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section for electronic access to the draft guidance document.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: rebecca.owen@fda.hhs.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) and from the Division of Dockets Management Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-S