[Federal Register Volume 66, Number 114 (Wednesday, June 13, 2001)]
[Notices]
[Pages 31938-31939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0224]


Draft Guidance for Industry: Mass Spectrometry for Confirmation 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availability of a draft guidance entitled ``Guidance for Industry: Mass 
Spectrometry for Confirmation of the Identity of Animal Drug 
Residues.'' This draft guidance describes the basic principles the 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 draft document is intended for technical 
professionals familiar with mass spectrometry. A glossary at the end of 
the draft guidance defines key terms used throughout the document.

DATES: Submit written comments by September 11, 2001.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
the office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, e-mail:

[[Page 31939]]

[email protected]. 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title of the draft guidance and the docket number found in brackets in 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: 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

    Section 512 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360b) requires FDA to determine whether each new animal drug 
proposed for use in food-producing animals is safe and effective. In 
some cases, the new animal drugs used in food-producing animals have 
the potential to adversely affect the health of the humans who consume 
food derived from these animals. The sponsor of the new animal drug is 
responsible for establishing the safety of each new animal drug through 
appropriate tests.
    To determine human food safety of new animal drugs, FDA evaluates 
the information/data, identifies and characterizes potential hazards, 
assesses exposure levels and characterizes the overall risk. Through 
this process, FDA establishes an allowable daily intake and tolerances 
(the amount of drug residue allowed in tissues) for each drug. Drug 
sponsors submit to FDA analytical methods that are designed to measure 
the concentration of the proposed drug in the edible tissues at the 
drug's tolerances. Analytical methods are used to monitor the 
tolerances set by FDA. FDA reviews the analytical methods during its 
review of new animal drug applications (21 CFR 514.1(b)(7)).
    Analytical methods may also be used to monitor safe levels as 
established by the agency. Under section 512(a)(4)(B) of the act and 21 
CFR 530.22, the agency may establish a safe level for extra-label use 
of a drug when the agency finds that there is a reasonable probability 
that an extra-label use may result in drug residues in edible tissue of 
the treated animals at a level that may present a risk to the public 
health if it was above the safe level. Under the same provisions, FDA 
may require the development of an acceptable analytical method for the 
quantification of residues above any safe level.
    FDA issues guidance recommending methods of analysis to potential 
sponsors to foster timely and objective review of proposed new animal 
drugs, including the review of analytical methods. In the Federal 
Register of December 31, 1987 (52 FR 49589), FDA announced the 
availability of a set of eight guidance documents entitled ``General 
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals'' (52 FR 49589); revisions to one of the guidances 
were announced in the Federal Register of July 22, 1994 (59 FR 37499). 
These guidances were designed to inform sponsors of the scientific data 
that FDA believes will provide an acceptable basis for determining the 
safety of such compounds, and for designing analytical methods.
    Part V in the above-mentioned set of guidances, entitled 
``Guideline for Approval of a Method of Analysis for Residues,'' 
recommended that sponsors develop rugged methods of analysis designed 
to exceed rather than meet the minimal standards of acceptability. This 
serves two purposes: (1) To lower the number of method of analysis 
submissions that pass desk review but fail interlaboratory studies 
designed to test their effectiveness, and (2) to increase the precision 
and specificity of safety determination by ensuring a higher quality 
assay. The guidance then explained the evaluation criteria and data 
needed for approval of a method of analysis.
    The draft guidance entitled ``Guidance for Industry: Mass 
Spectrometry for Confirmation of the Identity of Animal Drug Residues'' 
is designed to complement part V of ``General Principles for Evaluating 
the Safety of Compounds Used in Food-Producing Animals.'' The purpose 
of this document is to facilitate and expedite coordination between 
FDA's Center for Veterinary Medicine (CVM) and sponsors so the 
development, evaluation, and application of qualitative mass 
spectrometric methods will be completed in a consistent and timely 
manner.
    This draft document is intended for technical professionals 
familiar with mass spectrometry. A glossary at the end of the draft 
guidance defines key terms used throughout the document.
    This draft guidance should be used in the development of new 
methods, the review of methods submitted to CVM, and in the laboratory 
trial of methods submitted to CVM. The document also should help in 
making decisions about appropriate methodology in various regulatory 
situations and ensuring consistency in work done for CVM's purposes.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). This draft 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. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.
    Information collection provisions described in this guidance have 
been approved under OMB control numbers 0910-0032 and 0910-0325.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by 
September 11, 2001. Two copies of any 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. A copy of the draft guidance and received comments may 
be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Comments on the draft guidance may be electronically submitted at 
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Electronic copies of the draft guidance and other 
guidances discussed in this notice may be obtained at http://www.fda.gov/cvm.

    Dated: May 30, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-14813 Filed 6-12-01; 8:45 am]
BILLING CODE 4160-01-S