[Federal Register Volume 65, Number 47 (Thursday, March 9, 2000)]
[Notices]
[Page 12556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0835]


Draft Guidance for Industry on Conjugated Estrogens, USP: LC-MS 
Method for Both Qualitative Chemical Characterization and Documentation 
of Qualitative Pharmaceutical Equivalence; 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availability of a draft guidance for industry entitled ``Conjugated 
Estrogens, USP: LC-MS Method for Both Qualitative Chemical 
Characterization and Documentation of Qualitative Pharmaceutical 
Equivalence.'' This draft guidance is intended to provide 
recommendations to applicants who wish to submit a new drug application 
or abbreviated new drug application for a natural source conjugated 
estrogens solid oral dosage form. This guidance provides a description 
of the liquid chromatography-mass spectrometry (LC-MS) method that can 
be used to address both qualitative chemical characterization and 
qualitative pharmaceutical equivalence (PE).

DATES: Submit written comments on the draft guidance by June 8, 2000. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Wallace P. Adams, Center for Drug 
Evaluation and Research (HFD-350), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5651.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Conjugated Estrogens, USP: LC-MS 
Method for Both Qualitative Chemical Characterization and Documentation 
of Qualitative Pharmaceutical Equivalence.'' Chemical characterization 
and PE of natural source conjugated estrogens involve both qualitative 
and quantitative aspects. Qualitative aspects of both chemical 
characterization and PE involve detection and measurement of certain of 
the components in conjugated estrogens. The recommended methodology, 
LC-MS, is applicable to both the drug substance and/or solid oral 
dosage forms. This draft guidance provides a description of the LC-MS 
method developed by the Division of Testing and Applied Analytical 
Development/Office of Pharmaceutical Science/Center for Drug Evaluation 
and Research for both the qualitative chemical characterization and 
documentation of qualitative PE of natural source conjugated estrogens. 
Interpretation of the data for PE is beyond the scope of this guidance 
and will be addressed in a separate document. Quantitative aspects of 
chemical characterization and PE use the gas chromotography (GC) 
(flame-ionization detector) and high-pressure liquid chromotography 
(HPLC) (ultraviolet detector) assays described in a draft proposed 
Conjugated Estrogens, USP, monograph (http://www.fda.gov/cder/drug/
monographs/default.htm), and they are not the subject of this guidance.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on this LC-MS method 
for both qualitative chemical characterization and documentation of 
qualitative pharmaceutical equivalence of conjugated estrogens, USP. 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 statutes, 
regulations, or both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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. The draft 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.

    Dated: March 1, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5751 Filed 3-6-00; 2:58 pm]
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