[Federal Register: June 28, 2006 (Volume 71, Number 124)]
[Notices]
[Page 36813-36814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn06-97]
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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Draft Guidance for Industry: Analytical Methods Description for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availability of draft guidance for industry (137) entitled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draft guidance provides our recommendations for describing methods for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DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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Submit written comments on the draft guidance to the Division of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identified with the full title of the draft guidance and the docket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://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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.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:
[[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://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).
/A>).
Dated: June 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5860 Filed 6-27-06; 8:45 am]
BILLING CODE 4160-01-S