01-13846. Medicare Program; Meeting of the Drugs, Biologics, and Therapeutics Panel of the Medicare Coverage Advisory Committee-June 20, 2001

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Notice of meeting.

SUMMARY:

This notice announces a public meeting of the Drugs, Biologics, and Therapeutics Panel (the Panel) of the Medicare Coverage Advisory Committee. The Panel provides advice and recommendations to us about clinical issues. The Panel will hear and discuss presentations from interested persons regarding the use of levo-carnitine in end stage renal disease patients.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).

DATES:

The Meeting: June 20, 2001 from 8 a.m. until 4:30 p.m. E.D.T.

Deadline for Presentations and Comments: June 13, 2001, 5 p.m., E.D.T.

Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires other special assistance or accommodations, are asked to notify the Executive Secretary by June 6, 2001 (see FOR FURTHER INFORMATION CONTACT).

ADDRESSES:

The Meeting: The meeting will be held at The Baltimore Convention Center, Rooms 321 and 322, One West Pratt Street, Baltimore, MD 21201.

Presentations and Comments: Submit formal presentations and written comments to Kimberly A. Long, Executive Secretary; Office of Clinical Standards and Quality; Health Care Financing Administration; 7500 Security Boulevard; Mail Stop S3-02-01; Baltimore, MD 21244.

Website: You may access up-to-date information about this meeting at www.hcfa.gov/​coverage.

Hotline: You may access up-to-date information about this meeting on the HCFA Advisory Committee Information Hotline, 1-877-449-5659 (toll free) or in the Baltimore area [phone].

FOR FURTHER INFORMATION CONTACT:

Kimberly A. Long, Executive Secretary, 410-786-5702.

SUPPLEMENTARY INFORMATION:

On August 13, 1999, we published a notice (64 FR 44231) announcing an earlier meeting of the Drugs, Biologics, and Therapeutics Panel (the Panel) and also describing the Medicare Coverage Advisory Committee (MCAC), which provides advice and recommendations to us about clinical issues. This notice announces the June 20, 2001 public MCAC meeting of the Drugs, Biologics, and Therapeutics Panel.

Current Panel Members

Thomas V. Holohan, M.A., M.D., FACP; Leslie P. Francis, JD, Ph.D.; Judith A. Cahill, M.A.; Michael L. Friedland, M.D.; Kathy J. Helzlsouer, M.D., M.H.S.; Robert C. Johnson, M.S.; Ronald P. Jordan, R.Ph.; Mitchell Sugarman, M.B.A., M.S.; Cathleen M. Dooley, M.A.; Christine M. Grant, JD.

Meeting Topic

The Panel will hear and discuss presentations from interested persons regarding the use of levo-carnitine in end stage renal disease patients.

Procedure and Agenda

This meeting is open to the public. The Panel will hear oral presentations from the public for approximately 2.5 hours. The Panel may limit the number and duration of oral presentations to the time available. If you wish to make formal presentations you must notify the Executive Secretary named in the FOR FURTHER INFORMATION CONTACT section of this notice. In addition, you must submit the following by the Deadline for Presentations and Comments date listed in the DATES section of this notice: a brief statement of the general nature of the evidence or arguments you wish to present and the names and addresses of proposed participants; and a written copy of your presentation to the Executive Secretary before the meeting. We will request that you declare at the meeting whether or not you have any financial involvement with manufacturers of any items or services being discussed (or with their competitors).

After the public and our presentations, the Panel will deliberate openly on the topic. Interested persons may observe the deliberations, but the Panel will not hear further comments during this time except at the request of the chairperson. The Panel will also allow approximately a 30-minute open public session for any attendee to address issues specific to the topic. At the conclusion of the day, the members will vote and the Panel will make its recommendation.

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).

(Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: May 25, 2001.

Jeffrey L. Kang, M.D.,

Director, Office of Clinical Standards and Quality, Health Care Financing Administration.