[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Notices]
[Page 67725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no05-45]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0146]
Guidance for Industry: Validation of Analytical Procedures 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 a final guidance for industry (135) entitled
``Validation of Analytical Procedures for Type C Medicated Feeds.''
This guidance represents the agency's current thinking on the
characteristics that should be considered during the validation of non-
microbiological analytical procedures for the analysis of drugs in Type
C medicated feeds included as part of original and supplemental new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) for Type A medicated articles submitted to FDA.
This guidance is the first in a series of three guidances that will
discuss assay methods for Type C medicated feeds.
DATES: Submit written or electronic comments on agency guidance
documents 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. 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: Mary G. Leadbetter, Center for
Veterinary Medicine (HFV-141), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6964, e-mail:
mleadbet@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 28, 2004 (69 FR 23209), FDA
published a notice of availability for a draft guidance entitled
``Validation of Analytical Procedures for Type C Medicated Feeds''
giving interested persons until July 12, 2004, to comment on the draft
guidance. FDA received no comments on the draft guidance and no
substantive changes were made in finalizing this guidance document.
II. Paperwork Reduction Act of 1995
According to the Paperwork Reduction Act of 1995, a collection of
information must display a valid OMB control number. The existing valid
OMB control numbers for this information collection are 0910-0032 and
0910-0154. This guidance contains no new collections of information.
III. 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.
IV. Comments
As with all FDA's guidances, the public is encouraged to submit
written or electronic comments with new data or other new information
pertinent to this guidance. FDA periodically will review the comments
in the docket, and where appropriate, will amend the guidance. The
agency will notify the public of any such amendments through a notice
in the Federal Register.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments should be identified with the
docket number found in brackets in the heading of this document. A copy
of the document 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 ``Validation of Analytical
Procedures 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: October 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22222 Filed 11-7-05; 8:45 am]
BILLING CODE 4160-01-S