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38714 Federal Register / Vol. 66, No.

143 / Wednesday, July 25, 2001 / Notices

This notice announces a forthcoming Dated: July 19, 2001. formal oral presentations should notify
meeting of a public advisory committee Linda A. Suydam, the contact person before August 9,
of the Food and Drug Administration Senior Associate Commissioner. 2001, and submit a brief statement of
(FDA). The meeting will be open to the [FR Doc. 01–18478 Filed 7–24–01; 8:45 am] the general nature of the evidence or
public. BILLING CODE 4160–01–S
arguments they wish to present, the
Name of Committee: Anesthetic and names and addresses of proposed
Life Support Drugs Advisory participants, and an indication of the
Committee. DEPARTMENT OF HEALTH AND approximate time requested to make
General Function of the Committee: HUMAN SERVICES their presentation.
To provide advice and Notice of this meeting is given under
recommendations to the agency on Food and Drug Administration the Federal Advisory Committee Act (5
FDA’s regulatory issues. U.S.C. app. 2).
Date and Time: The meeting will be Gastroenterology and Urology Devices
Dated: July 19, 2001.
held on September 13 and 14, 2001, Panel of the Medical Devices Advisory
from 8 a.m. to 5 p.m. Committee; Notice of Meeting Linda A Suydam,
Location: University of Maryland, Senior Associate Commissioner for Policy.
Shady Grove Campus, multi-purpose AGENCY: Food and Drug Administration, [FR Doc. 01–18425 Filed 7–24–01; 8:45 am]
room, Bldg. 9630, Gudelsky Dr., HHS. BILLING CODE 4160–01–S
Rockville, MD. ACTION: Notice.
Contact: Kimberly Littleton Topper,
Center for Drug Evaluation and Research This notice announces a forthcoming DEPARTMENT OF HEALTH AND
(HFD–21), Food and Drug meeting of a public advisory committee HUMAN SERVICES
Administration, 5600 Fishers Lane (for of the Food and Drug Administration
express delivery, 5630 Fishers Lane, rm. (FDA). The meeting will be open to the Food and Drug Administration
1091), Rockville, MD 20857, 301–827– public.
[Docket No. 01D–0281]
7001, or FDA Advisory Committee Name of Committee: Gastroenterology
Information Line, 1–800–741–8138 and Urology Devices Panel of the Medical Devices; A Pilot Program to
(301–443–0572 in the Washington, DC Medical Devices Advisory Committee. Evaluate a Proposed Globally
area), code 12529. Please call the General Function of the Committee: Harmonized Alternative for Premarket
Information Line for up-to-date To provide advice and Procedures; Draft Guidance for
information on this meeting. recommendations to the agency on Industry and FDA Staff; Availability
Agenda: On both days, the committee FDA’s regulatory issues.
will discuss the medical use of opiate Date and Time: The meeting will be AGENCY: Food and Drug Administration,
analgesics in various patient held on August 17, 2001, from 9:30 a.m. HHS.
populations, including pediatric to 5 p.m. ACTION: Notice.
patients and patients with chronic pain Location: Corporate Bldg., conference
room 20B, 9200 Corporate Blvd., SUMMARY: The Food and Drug
of nonmalignant etiology, as well as the
Rockville, MD. Administration (FDA) is announcing the
risk to benefit ratio of extending opiate
Contact: Jeffrey W. Cooper, Center for availability of the draft guidance
treatment into these populations. It will
Devices and Radiological Health (HFZ– entitled ‘‘A Pilot Program to Evaluate a
also address concerns regarding the
470), Food and Drug Administration, Proposed Globally Harmonized
abuse potential, diversion and
9200 Corporate Blvd., Rockville, MD Alternative for Premarket Procedures.’’
increasing incidence of addiction to
20850, 301–594–1220, ext. 121, or FDA This draft guidance is intended to assist
opiate analgesics, especially to the
Advisory Committee Information Line, the medical device industry and FDA
modified release opiate analgesics.
Procedure: Interested persons may 1–800–741–8138 (301–443–0572 in the staff in implementing a pilot premarket
present data, information, or views, Washington, DC area), code 12523. review program that may reduce some
orally or in writing, on issues pending Please call the Information Line for up- of the burden on manufacturers
before the committee. Written to-date information on this meeting. associated with current conflicting
submissions may be made to the contact Agenda: The committee will discuss, format and content requirements in
person by August 17, 2001. Oral make recommendations, and vote on a different countries. The proposed pilot
presentations from the public will be premarket approval application for a program will evaluate the utility of two
scheduled between approximately 1 device for the treatment of fecal documents created by the Global
p.m. and 2 p.m. on September 13, 2001, incontinence. Background information Harmonization Task Force (GHTF),
and between approximately 9 a.m. and and questions for the committee will be Study Group 1 (SG1), entitled
10 a.m. on September 14, 2001. Time available to the public on August 16, ‘‘Summary Technical Documentation
allotted for each presentation may be 2001, on the Internet at http:// for Demonstrating Conformity to the
limited. Those desiring to make formal www.fda.gov/cdrh/panelmtg.html. Essential Principles of Safety and
oral presentations should notify the Procedure: Interested persons may Performance of Medical Devices
contact person before August 17, 2001, present data, information, or views, (STED)’’ and ‘‘Essential Principles of
and submit a brief statement of the orally or in writing, on issues pending Safety and Performance of Medical
general nature of the evidence or before the committee. Written Devices’’ (Essential Principles). The
arguments they wish to present, the submissions may be made to the contact GHTF is a voluntary group of
names and addresses of proposed person by August 9, 2001. Oral representatives from national medical
participants, and an indication of the presentations from the public will be device regulatory authorities and the
approximate time requested to make scheduled between approximately 10 regulated industry. This guidance is
their presentation. a.m. and 10:30 a.m., and between neither final nor is it in effect at this
Notice of this meeting is given under approximately 3:30 p.m. and 4 p.m. time.
the Federal Advisory Committee Act (5 Time allotted for each presentation may DATES: Submit written or electronic
U.S.C. app. 2). be limited. Those desiring to make comments concerning this draft

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