[Federal Register Volume 62, Number 207 (Monday, October 27, 1997)]
[Notices]
[Pages 55645-55646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0420]


Guidance for Industry on OTC Treatment of Hypercholesterolemia; 
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 document entitled ``OTC Treatment of 
Hypercholesterolemia.'' The guidance is intended to clarify the 
agency's current thinking on the treatment of hypercholesterolemia 
using over-the-counter (OTC) drug products. The agency's Center for 
Drug Evaluation and Research (CDER) believes that drugs for the 
treatment of hypercholesterolemia should not be sold OTC in the United 
States.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
``OTC Treatment of Hypercholesterolemia'' 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 guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Michael Weintraub, Center for Drug 
Evaluation and Research (HFD-105), Food and Drug Administration, 5600

[[Page 55646]]

Fishers Lane, Rockville, MD 20857, 301-827-2250.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``OTC Treatment of 
Hypercholesterolemia.'' Several sponsors have recently expressed 
interest in marketing cholesterol-lowering agents as OTC drug products. 
These requests have raised several regulatory policy and medical 
therapy issues.
    This guidance document represents the agency's current thinking on 
OTC treatment of hypercholesterolemia. 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 an approach 
satisfies the requirement of the applicable statute, regulations, or 
both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). 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 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. Persons with 
access to the Internet may obtain the guidance by using the World Wide 
Web (WWW). For WWW access, go to ``<a href="http://www.fda.gov/cder/guidance/
index.htm">http://www.fda.gov/cder/guidance/
index.htm</a>''.

    Dated: October 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-28298 Filed 10-24-97; 8:45 am]
BILLING CODE 4160-01-F