[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]
BILLING CODE 4140-01-P