[Federal Register Volume 64, Number 220 (Tuesday, November 16, 1999)]
[Notices]
[Page 62209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0486]


Physician and Patient Labeling for Progestational Drug Products; 
Warnings and Contraindications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking its 
previously issued guidance texts for physician and patient labeling for 
progestational drug products that were published in the Federal 
Register of January 12, 1989 (54 FR 1243). A notice announcing FDA's 
intention to revoke these guidance texts was published in the Federal 
Register on April 13, 1999 (64 FR 18035). FDA received no comments on 
this notice. The guidance texts, which supplied physician and patient 
labeling for progestational drug products as a class, are no longer 
needed for the reasons discussed in the proposed rule on progestational 
drug products published in the Federal Register on April 13, 1999 (64 
FR 17985). For additional information, see the final rule on 
progestational drug products that appears elsewhere in this issue of 
the Federal Register.

EFFECTIVE DATE: November 16, 2000.

FOR FURTHER INFORMATION CONTACT: Diane V. Moore, Center for Drug 
Evaluation and Research (HFD-580), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4260.


    Dated: November 4, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-29855 Filed 11-15-99; 8:45 am]
BILLING CODE 4160-01-F