[Federal Register Volume 59, Number 215 (Tuesday, November 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27575]
[[Page Unknown]]
[Federal Register: November 8, 1994]
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Recombinant DNA Research: Proposed Actions Under the Guidelines
Agency: National Institutes of Health (NIH), PHS, DHHS.
Action: Notice of Proposed Actions Under the NIH Guidelines for
Research Involving Recombinant DNA Molecules (59 FR 34496).
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Summary: This notice sets forth proposed actions to be taken under the
NIH Guidelines for Research Involving Recombinant DNA Molecules (59 FR
34496). Interested parties are invited to submit comments concerning
these proposals. These proposals will be considered by the Recombinant
DNA Advisory Committee at its meeting on December 1-2, 1994. After
consideration of these proposals and comments by the Recombinant DNA
Advisory Committee, the Director of the National Institutes of Health
will issue decisions in accordance with the NIH Guidelines.
Dates: Comments received by November 22, 1994, will be reproduced and
distributed to the Recombinant DNA Advisory Committee for consideration
at its December 1-2, 1994, meeting.
Addresses: Written comments and recommendations should be submitted to
Dr. Nelson A. Wivel, Director, Office of Recombinant DNA Activities,
Suite 323, 6006 Executive Boulevard, MSC 7052, Bethesda, Maryland
20892-7052, or sent by FAX to 301-496-9839.
All comments received in timely response to this notice will be
considered and will be available for public inspection in the above
office on weekdays between the hours of 8:30 a.m. and 5 p.m.
For Further Information Contact: Background documentation and
additional information can be obtained from the Office of Recombinant
DNA Activities, Suite 323, 6006 Executive Boulevard, MSC 7052,
Bethesda, Maryland 20892-7052, Phone 301-496-9839, FAX to 301-496-9839.
SUPPLEMENTARY INFORMATION: The NIH will consider the following actions
under the NIH Guidelines for Research Involving Recombinant DNA
Molecules:
I. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Drs. Venook and Warren
In a letter dated October 3, 1994, Drs. Alan Venook and Robert
Warren of the University of California, San Francisco, San Francisco,
California, submitted a human gene transfer protocol entitled: Gene
Therapy of Primary and Metastatic Malignant Tumors of the Liver Using
ACN53 Via Hepatic Artery Infusion: A Phase I Study to the Recombinant
DNA Advisory Committee for formal review and approval.
II. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Dr. Gluckman
In a letter dated October 6, 1994, Dr. Jack Gluckman of the
University of Cincinnati Medical Center, Cincinnati, Ohio, submitted a
human gene transfer protocol entitled: Intratumoral Injection of Herpes
Simplex Thymidine Kinase Vector Producer Cells (PA317/G1Tk1SvNa.7) and
Intravenous Ganciclovir for the Treatment of Locally Recurrent or
Persistent Head and Neck Cancer to the Recombinant DNA Advisory
Committee for formal review and approval.
III. Addition to Appendix D of the NIH Guidelines Regarding a Human
Gene Transfer Protocol/Dr. Hersh, et. al.
In a letter dated September 16, 1994, Drs. Evan Hersh, Emmanuel
Akporiaye, David Harris, Alison Stopeck, Evan Unger, James Warneke, of
the Arizona Cancer Center, Tucson, Arizona, submitted a human gene
transfer protocol entitled: Phase I Trial of Interleukin-2 Plasmid DNA/
DMRIE/DOPE Lipid Complex as an Immunotherapeutic Agent in Solid
Malignant Tumors or Lymphomas by Direct Gene Transfer to the
Recombinant DNA Advisory Committee for formal review and approval.
IV. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Drs. Grossman and Woo
In a letter dated September 27, 1994, Drs. Robert Grossman and
Savio Woo of the Baylor College of Medicine & Methodist Hospital,
Houston, Texas, submitted a human gene transfer protocol entitled:
Phase I Study of Adenoviral Vector Delivery of the HSV-TK Gene and the
Intravenous Administration of Ganciclovir in Adults with Malignant
Tumor of the Central Nervous System to the Recombinant DNA Advisory
Committee for formal review and approval.
V. Addition to Appendix D of the NIH Guidelines Regarding a Human
Gene Transfer Protocol/Dr. Clayman
In a letter dated October 5, 1994, Dr. Gary Clayman of the MD
Anderson Cancer Center, Houston, Texas, submitted a human gene transfer
protocol entitled: Clinical Protocol for Modification of Tumor
Suppressor Gene Expression in Head and Neck Squamous Cell Carcinoma
(HNSCC) with an Adenovirus Vector Expressing Wild-type p53 to the
Recombinant DNA Advisory Committee for formal review and approval.
VI. Addition to Appendix D of the NIH Guidelines Regarding a Human
Gene Transfer Protocol/Drs. Dorkin and Lapey
In a letter dated October 11, 1994, Dr. Henry Dorkin of the New
England Medical Center, Boston, Massachusetts, and Dr. Allen Lapey of
Massachusetts General Hospital, Harvard Medical School, Boston,
Massachusetts, submitted a human gene therapy protocol entitled:
Adenovirus Mediated Gene Transfer for Cystic Fibrosis: Safety of Single
Administration in the Lung to the Recombinant DNA Advisory Committee
for formal review and approval.
VII. Report on Minor Modifications to NIH-Approved Human Gene
Transfer Protocols
Dr. LeRoy Walters, Chair of the Recombinant DNA Advisory Committee,
will present an update on minor modifications to NIH-approved human
gene transfer protocols.
VIII. Working Group on Data Management
Dr. Brian Smith, Chair of the Working Group on Data Management,
will provide a summary of the reports submitted to the Office of
Recombinant DNA Activities by the principal investigators of NIH-
approved protocols, and make recommendations regarding actions to be
taken in the event of non-reporting.
IX. Amendments to Appendix B of the NIH Guidelines Regarding
Updating the Classification of Microorganisms/Fleming
In a letter dated June 24, 1993, Dr. Diane Fleming, President of
the Mid-Atlantic Biological Safety Association requested updating
Appendix B, Classification of Microorganisms on the Basis of Hazard.
The Mid-Atlantic Biological Safety Association submitted an updated
list of the classification of microorganisms for the Committee to
review which included the latest taxonomy and agent risk group
classifications as defined by the Centers for Disease Control and
Prevention. This request was published for public comment in the
Federal Register (August 18, 1994, 58 FR 44098).
During the September 9-10, 1993, meeting, the Recombinant DNA
Advisory Committee recommended by consensus that the current
classification of etiological agents described in the Biosafety in
Microbiological and Biomedical Laboratories, 3rd edition, May 1993,
U.S. Department of Health and Human Services, should be endorsed by the
Committee. The Committee retains the option to adopt any modification
to the CDC listing. The Committee recommended that the revised Appendix
B, Classification of Microorganisms on the Basis of Hazard, submitted
by Dr. Fleming should not be adopted until the Committee receives
letters of concurrence from both the Centers for Disease Control and
Prevention and the NIH Division of Safety.
In a telephone call on October 20, 1994, Dr. Fleming stated that
Appendix B, Classification of Microorganisms on the Basis of Hazard,
would be reviewed by experts from the Centers for Disease Control and
Prevention and the American Society for Microbiology. The revised
Appendix B will be submitted to the Committee for the December 1-2,
1994, meeting for review and discussion. If accepted, the revised
Appendix B will be published in the Federal Register for public
comment, and voted on during the March 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: October 31, 1994.
Daryl A. Chamblee,
Acting Deputy Director for Science Policy and Technology Transfer.
[FR Doc. 94-27575 Filed 11-7-94; 8:45 am]
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