[Federal Register: April 28, 2004 (Volume 69, Number 82)]
[Notices]               
[Page 23209]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap04-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0146]

 
Draft Guidance for Industry: Validation of Analytical Procedures 
for Type C Medicated Feeds

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availability of a draft guidance for industry (135) entitled 
``Validation of Analytical Procedures for Type C Medicated Feeds.'' 
This draft guidance represents the agency's current thinking on the 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 the 
FDA. This draft guidance is the first in a series of three guidances 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DATES: Submit written or electronic comments on the draft guidance by 
July 12, 2004, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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 (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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document. 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Submit electronic comments on the draft guidance via the Internet at 
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with the full title of the draft guidance and the docket number found 
in brackets in the heading of this 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

    This draft guidance document provides assistance and 
recommendations to industry on how to consider the various validation 
characteristics for each analytical procedure used in medicated feed 
assays submitted as part of original and supplemental NADAs and ANADAs.

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 draft guidance contains no new collections of 
information.

III. Significance of Guidance

    This draft Level 1 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 written comments to the Division of Dockets Management (see 
ADDRESSES) regarding this draft guidance document. 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 draft 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: April 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9566 Filed 4-27-04; 8:45 am]

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