[Federal Register: April 27, 2007 (Volume 72, Number 81)]
[Notices]
[Page 21032-21033]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap07-62]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: rebecca.owen@fda.hhs.gov.
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published a notice of availability for a draft guidance entitled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://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's 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: April 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8042 Filed 4-26-07; 8:45 am]
BILLING CODE 4160-01-S