[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Notices]
[Pages 28935-28936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11355]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

[[Page 28936]]

    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, 
[email protected].

    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)


    Dated: May 12, 2004.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 04-11355 Filed 5-18-04; 8:45 am]
BILLING CODE 4140-01-M