[Federal Register Volume 68, Number 92 (Tuesday, May 13, 2003)]
[Notices]
[Pages 25617-25618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-11771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0224]


 Guidance for Industry: Mass Spectrometry for Confirmation of the 
Identity of Animal Drug Residues; 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 guidance ([numsign]118) entitled ``Guidance For 
Industry: Mass Spectrometry for Confirmation of the Identity of Animal 
Drug Residues.'' This guidance describes the basic principles the 
agency recommends for development, evaluation, or application of 
qualitative mass spectrometric methods for confirming the identity of 
new animal drug residues. This guidance document is intended for 
technical professionals familiar with mass spectrometry. A glossary at 
the end of the guidance defines key terms used throughout the document.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document 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 
document to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Once on this site, select ``Docket No. 01D-0224 Guidance for Industry: 
Mass Spectrometry for Confirmation of the Identity of Animal Drug 
Residues'' and follow the directions. Comments should be identified 
with the full title of the guidance document and the docket number 
found in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  David N. Heller, Center for 
Veterinary Medicine (HFV-510), Food and Drug Administration, 8401 
Muirkirk Rd., Laurel, MD 20708, 301-827-8156, e-mail: 
dheller@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 13, 2001 (66 FR 31938), FDA 
published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry: Mass Spectrometry for Confirmation of 
the Identity of Animal Drug Residues'' giving interested persons until 
September 11, 2001, to submit comments. FDA considered all comments 
received and, where appropriate, incorporated them into the guidance. 
The guidance differs from the draft guidance in the following ways:
    [sbull] There is further clarification of interference testing, 
control samples, system suitability, minimum signal strength in full 
scan analysis, recommended rate of false negatives, and number of 
residue-incurred samples for validation. (The recommendation in the 
1994 revision of CVM Guidance [numsign]3 for a smaller number of 
incurred samples for interlaboratory method trials has not been CVM's 
practice for some years. CVM is currently revising Guidance 
[numsign]3.)
    [sbull] Additional definitions were provided for comparison 
standard, control sample exact mass measurement, false positive rate, 
false negative rate, limit of confirmation, and validation. Other 
revisions in the glossary definitions were made to make the definitions 
consistent with definitions in existing regulations.
    [sbull] Use of the terms ``acceptability range'' and ``precursor 
ion'' is now consistent.
    [sbull] General recommendations on the subject of exact mass 
measurements have been added. Until specific standards for exact mass 
measurements in animal drug residue analysis are generally accepted, 
their use will be evaluated on a case-by-case basis. The Center for 
Veterinary Medicine (CVM) of FDA may modify this document if a more 
generally accepted standard for confirmation of animal drug residues 
using exact mass measurements is developed in the future.
    The purpose of this guidance document is to facilitate and expedite 
coordination between CVM and sponsors so the development, evaluation, 
and application of qualitative mass spectrometric methods will be 
completed in a consistent and timely manner. This guidance document is 
intended for technical professionals familiar with mass spectrometry. A 
glossary at the end of the guidance defines key terms used throughout 
the document.
    This guidance should be used: (1) In the development of new 
methods, (2) the review of methods submitted to

[[Page 25618]]

CVM, and (3) in the laboratory trial of methods submitted to CVM. The 
document should also help in making decisions about appropriate 
methodology in various regulatory situations and ensuring consistency 
in work done for CVM's purposes.
    Information collection provisions described in this guidance have 
been approved under OMB control numbers 0910-0032 and 0910-0325.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's animal drug residues. The document does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. Alternative methods may be used as long as they satisfy 
the requirements of the applicable statutes and regulations.

III. Comments

    As with all of FDA's guidance, 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 
public will be notified of any such amendments through a notice in the 
Federal Register.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cvm.

    Dated: May 5, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11771 Filed 5-12-03; 8:45 am]
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