Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee); Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee).

General Function of the Committee: To advise the Secretary and the Assistant Secretary for Health concerning its oversight of the conduct of the Ranch Hand study by the U.S. Air Force and to provide scientific oversight of the Department of Veterans Affairs Army Chemical Corps Vietnam Veterans Health Study and other studies in which the Secretary or the Assistant Secretary for Health believes involvement by the committee is desirable.

Date and Time: The meeting will be held on April 30, 2004, from 8 a.m. to 4:30 p.m.

Location: The meeting will be held at the Food and Drug Administration, 5630 Fishers Lane, rm. 1066, Rockville, MD 20857.

Contact Person: Leonard Schechtman, National Center for Toxicological Research, Food and Drug Administration, 5600 Fishers Lane, rm. 16-85, Rockville, MD 20857, 301-827-6696, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512560. Please call the Information Line for up-to-date information on this meeting.

Agenda: The Air Force will provide the following items: (1) Summary of the meeting on long-term studies, (2) proposal for future use of biological samples, (3) reviews of Chapter 1 (Introduction), Chapter 2 (Dioxin Assay/Appendix A), Chapter 3 (Questionnaire Methodology), Chapter 4 (Physical Examination/Appendix B), Chapter 6 (Quality Control/Appendix D), and Chapter 9 (General Health/Appendix F1), and Chapter 17 (Renal/Appendix F9) of the special study relating to the possible long-term health affects of phenoxy herbicides and contaminants.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by April 23, 2004. Oral presentations from the public will be scheduled on April 30, 2004, between approximately 1:30 p.m. to 2:30 p.m. Time allotted for each presentation may be limited.

Those desiring to make formal oral presentations should notify the contact person before April 19, 2004, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Leonard Schechtman at least 7 days in advance of the meeting.

FDA regrets that it was unable to publish this notice 15 days prior to the April 30, 2004, Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee) meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee) meeting were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).