[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 ``http://www.fda.gov/cder/guidance/
index.htm''.
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
