National Toxicology Program

[Federal Register: July 11, 2001 (Vol. 66, No. 133)]
[Notices]
[Pages 36294-36295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

National Institute of Environmental Health Sciences (NIEHS)

National Toxicology Program (NTP)

Peer Review Panel for the Up-and-Down Procedure (UDP): Notice of Meeting

Summary

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a public teleconference meeting of the Up-and-Down Procedure (UDP) independent scientific peer review panel (Panel). The teleconference is scheduled for Tuesday, August 21, 2001, from 10:00 a.m.- 12:00 p.m. EDT. The agenda for this meeting will focus on a discussion of the following: (1) the revised draft Up-and-Down Procedure (UDP), modified in response to recommendations from the July 2000 Panel meeting; (2) a proposed procedure for calculating the confidence interval for the estimated LD50; and (3) a software program to aid in dose selection, test-stopping decisions, calculation of an estimated LD50, and calculation of a confidence interval around the LD50.

Following the Panel meeting, a final report of the Panel’s findings and recommendations will be published and made available to the public through the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). In accordance with Public Law 106-545, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will develop and forward test recommendations on the UDP to Federal agencies for their consideration. The ICCVAM/ recommendations will also be made available to the public through the NICEATM.

Background, including the availability of review materials, can be found in previous Federal Register notices (see FR Volume 66, Number 121, pages 33550-33552; FR Volume 65, Number 34, pages 8385-8386; and FR Volume 65, Number 106, pages 35109-35110). The Federal Register notice (Volume 66, Number 121) invites written public comments on the materials being discussed at the Panel meeting. Comments received by the August 6, 2001 deadline will be made available to the Panel prior to the August 21 teleconference.

Meeting information

Panel members will participate in the meeting via teleconference. The teleconference will originate from Room 3162, 3rd Floor, NIEHS, 79 T.W. Alexander Drive, Bldg. 4401, Research Triangle Park, NC and NICEATM staff will be on hand to coordinate the teleconference. The public is invited to attend with attendance limited only by the space available in Room 3162. To attend this meeting, please contact Ms. Loretta Frye, NICEATM, NIEHS, 79 Alexander Drive, Bldg. 4401, P.O. Box 12233, EC-17, Research Triangle Park, NC 27709; telephone (919) 541-3138; fax (919) 541-0947; or email frye@niehs.nih.gov. Arrangements to attend the meeting, including the need for special accommodation (e.g., wheelchair access), should be made with the NIEHS/NICEATM staff by 12:00 noon EDT on Tuesday, August 14, 2001.

Request for Public Comment

While written public comments are requested and preferred, there will be an opportunity for oral public comments. For this teleconference meeting, oral comments by individual speakers will usually be limited to no more than three minutes per speaker. Persons registering to make oral comments are asked to provide their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization. To facilitate planning for the meeting, persons interested in providing formal oral comments are asked to notify Ms. Loretta Frye (contact information provided above) in writing (email, fax, or mail) no later than 12:00 noon EDT on Tuesday, August 14, 2001. Persons registering to make oral comments are asked, if possible, to provide a copy of their statement to Ms. Loretta Frye by August 14, to enable review by the Panel and NICEATM staff prior to the meeting.

Dated: July 3, 2001

Samuel H. Wilson, M.D.
Deputy Director, National Institute of Environmental Health Sciences

[Billing Code 4140-01-P]

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