[Federal Register Volume 68, Number 92 (Tuesday, May 13, 2003)]
[Notices]
[Pages 25617-25618]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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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