[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Page 67725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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.

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: 


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published a notice of availability for a draft guidance entitled 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giving interested persons until July 12, 2004, to comment on the draft 
guidance. FDA received no comments on the draft guidance and no 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).

    Dated: October 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22222 Filed 11-7-05; 8:45 am]