[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Page 28154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13399]


      

[[Page 28153]]

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Part III





Department of Health and Human Services





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National Institutes of Health



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Recombinant DNA Advisory Committee Meeting; Notice

  Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 / 
Notices  

[[Page 28154]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Recombinant DNA Advisory Committee Meeting

    Pursuant to Public Law 92-463, notice is hereby given of a meeting 
of the Recombinant DNA Advisory Committee on June 12-13, 1997. The 
meeting will be held at the National Institutes of Health (NIH), 
Building 31C, 6th Floor, Conference Room 6, 9000 Rockville Pike, 
Bethesda, Maryland 20892, starting on June 12, 1997, at approximately 9 
a.m., and will recess at approximately 5 p.m. The meeting will 
reconvene on June 13, 1997, at approximately 9:00 a.m. and will adjourn 
at approximately 5 p.m. The meeting will be open to the public. Agenda 
items will include: (1) General discussion regarding a Human Gene 
Transfer Protocol #9703-179 entitled: A Phase I Study of Active 
Immunotherapy with Carcinoembryonic Antigen RNA-Pulsed Autologous a 
Human Cultured Dendritic Cells in Patients with Metastatic Malignancies 
Expressing Carcinoembryonic Antigen, Principal Investigator H. Kim 
Lyerly, M.D., Duke University, Durham, North Carolina (Note: NIH Office 
of Recombinant DNA Activities has determined that Recombinant DNA 
Advisory Committee review of the protocol is not necessary, the 
protocol will be reviewed for approval only by the Food and Drug 
Administration); (2) Discussion regarding Genetic Vaccines Against 
Cancer-Related Antigens and Oncogene Proteins; (3) Discussion regarding 
Criteria for RAC Review of Novel Human Gene Transfer Protocols; (4) 
Discussion regarding Streamlined National Institutes of Health and Food 
and Drug Administration Submission Format and Revisions to Appendix M, 
The Points to Consider in the Design and Submission of Protocols for 
the Transfer of Recombinant DNA Molecules into the Genome of One or 
More Human Subjects (Points to Consider); (5) Discussion regarding 
Human Gene Transfer Protocols that are Exempt from NIH Registration 
(Footnote M-VI, Points to Consider); (6) Presentation Regarding 
Definition of Standards for Viral Vector Quantification by Estuardo 
Aguilar-Cordova, Ph.D., Texas Childrens Hospital, Houston, Texas; and 
(7) other matters to be considered by the Committee. Attendance by the 
public will be limited to space available.
    Debra W. Knorr, Acting Director, Office of Recombinant DNA 
Activities, National Institutes of Health, MSC 7010, 6000 Executive 
Boulevard, Suite 302, Bethesda, Maryland 20892-7010, Phone (301) 496-
9838, FAX (301) 496-9839, will provide summaries of the meeting and a 
roster of committee members upon request. Individuals who plan to 
attend and need special assistance, such as sign language 
interpretation or other reasonable accommodations, should contact Ms. 
Knorr in advance of the meeting.
    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 
not only virtually every NIH program but also essentially every Federal 
research program in which DNA recombinant molecule 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.

    Dated: May 14, 1997.
LaVeen Ponds,
Acting Committee Management Officer, NIH.
[FR Doc. 97-13399 Filed 5-21-97; 8:45 am]
BILLING CODE 4140-01-M