Office of the Director, National Institutes of Health; Notice of Meeting

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Recombinant DNA Advisory Committee.

The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting.

Name of Committee: NIH Recombinant DNA Advisory Committee (RAC).

Dates: March 9-11, 2004.

Times:

March 9, 2004, 1 p.m. to 6 p.m.

March 10, 2004, 8 a.m. to 6 p.m.

March 11, 2004, 8 a.m. to 3 p.m.

Agenda: Review of human gene transfer protocols for use of: (1) Beta-nerve growth factor (NGF) in Alzheimer's Disease; (2) conditionally replication-competent adenovirus in glioma and (3) in ovarian and extraovarian cancer; (4) an oncolytic Double-Deleted Vaccinia Virus (double deletion of the thymidine kinase and vaccinia growth factor genes and insertion of cytosine deaminase and somatostatin receptor cDNAs) into superficial injectable tumors; (5) Streptococcus mutans lactic acid-deficient effector strain (A2JM) as an aid in the protection against dental caries; and (6) adenylyl cyclase VI gene transfer for Congestive Heart Failure. The RAC meeting also includes the Data Management report, an update on OBA protocol #0104-469 entitled: “Subthalamic GAD Gene Transfer in Parkinson Disease Patients Who Are Candidates for Deep Brain Stimulation” presented by Dr. Michael Kaplitt, New York Hospital-Weill Medical College of Cornell University, New York, NY and Dr. Mathew J. During, and a discussion of investigator responses to RAC recommendations as required by Appendix M-I-C-1 of the NIH Guidelines.

Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, Maryland 20814.

Contact Person: Stephen M. Rose, PhD, Executive Secretary, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892, 301-496-9838, sr8j@nih.gov.

Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

Information is also available on the Institute's/Center's home page: http://www4.od.nih.gov/oba/,, where an agenda and any additional information for the meeting will be posted when available.

OMB's “Mandatory Information Requirements for Federal Assistance Program Announcements” (45 FR 39592, June 11, 1980) requires a statement concerning the official government programs contained in the Catalog of Federal Domestic Assistance. Normally NIH lists in its announcements the number and title of affected individual programs for the guidance of the public. Because the guidance in this notice covers virtually every NIH and Federal research program in which DNA recombinant molecules techniques could be used, it has been determined not to be cost effective or in the public interest to attempt to list these programs. Such a list would likely require several additional pages. In addition, NIH could not be certain that every Federal program would be included as many Federal agencies, as well as private organizations, both national and international, have elected to follow the NIH Guidelines. In lieu of the individual program listing, NIH invites readers to direct questions to the information address above about whether individual programs listed in the Catalog of Federal Domestic Assistance are affected.