[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
