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: June 8-9, 2004.

Times: June 8, 2004, 8 a.m. to 6 p.m., June 9, 2004, 8 a.m. to 6 p.m.

Agenda: Review of human gene transfer protocols for use of: (1) Inactivated Saccharomyces cerevisiae expressing three different mutated Ras oncoproteins in subjects with solid tumors that express mutated Ras; (2) a plasmid-delivered myelin basic protein (hMBP) cDNA given either alone or with atorvastatin in subjects with multiple sclerosis; (3) an AAV-vector based product in subjects with alpha-1 antitrypsin deficiency; (4) the SERCA2a gene administered during Ventricular Assist Device support in subjects with heart failure; and (5) the intravesical delivery of a conditionally replicating oncolytic adenovirus after failure of Bacillus Calmette-Guerin failure in transitional cell carcinoma of the bladder. The RAC meeting also includes the Data Management report and an update on OBA protocol 0104-488 entitled: “A phase I open-label clinical trial of the safety and tolerability of single escalating doses of autologous CD4 T cells transduced with VRX496 in HIV positive subjects” presented by Dr. Boro Dropulic VIRxSYS Corporation, Gaithersburg, Maryland.

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

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

This notice is being published less than 15 days prior to the meeting date because of scheduling problems with presenters at the meeting.

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.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loam Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program, National Institutes of Health, HHS)