[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Notices]
[Page 26399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my07-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0254]
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 the guidance for industry (137) entitled
``Analytical Methods Description for Type C Medicated Feeds.'' This
guidance provides our recommendations for describing methods for
analyzing new animal drugs in Type C medicated feeds.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the 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 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 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Rebecca 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 June 28, 2006 (71 FR 36813), FDA
published the notice of availability for a draft guidance entitled
``Analytical Methods Description for Type C Medicated Feeds'' giving
interested persons until September 11, 2006, to comment on the draft
guidance. With the exception of one general comment regarding medicated
feed, FDA received no specific comments on the guidance. The final
guidance has not been substantively changed from the draft version.
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 guidance provides recommendations for
describing methods for analyzing new animal drugs in Type C medicated
feeds. This guidance applies to instrumental methods only (e.g., high
pressure liquid chromatography, gas chromatography). For information on
other methods (e.g., microbiological methods) you should contact the
Center for Veterinary Medicine (CVM).
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance represents
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.
III. 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 numbers 0910-0032 and 0910-0154.
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
Copies of the 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: April 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8808 Filed 5-8-07; 8:45 am]
BILLING CODE 4160-01-S