43426 
Federal Register / Vol. 59, No. 162 / Tuesday, August 23, 1994 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Notice of Meeting 
Pursuant to Public Law 92—463, 
notice is hereby given of a meeting of 
the Recombinant DNA Advisory 
Committee on September 12-13, 1994. 
The meeting will be held at the National 
Institutes of Health, Building 31C, 6th 
Floor, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20892, starting on September 12, 1994, 
at approximately 9 a.m., and will recess 
at approximately 6 p.m. The meeting 
will reconvene on September 13, 1994, 
at approximately 8:30 a.m. and will 
adjourn at approximately 5 p.m. The 
meeting will be open to the public to 
discuss Proposed Actions under the NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules (59 FR 
34496) and other matters to be 
considered by the Committee. The 
Proposed Actions to be discussed will 
follow this notice of meeting. 
Attendance by the public will be limited 
to space available. Members of the 
public wishing to speak at this meeting 
may be given such opportunity at the 
discretion of the Chair. 
In accordance with the provision set 
forth in sec. 552b(c)(4), Title 5, U.S.C. 
and sec. 10(d) of Pub. L. 92—463, the 
meeting will be closed to the public on 
September 12 from 5 p.m., to 
approximately 6 p.m., for the review, 
discussion, and evaluation of 
proprietary information which is a part 
of a human gene therapy research 
proposal. The proposal and the 
discussion could reveal confidential 
trade secrets or commercial property 
such as patentable material. 
Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, - 
National Institutes of Health, Building 
31. Room 4B11, Bethesda, Maryland 
20892, Phone (301) 496-9838, FAX 
(301) 496-9839, will provide materials 
to be discussed at this meeting, roster of 
committee members, and substantive 
program information. Individuals who 
plan to attend and need special 
assistance, such as sign language 
interpretation or other reasonable 
accommodations, should contact Dr. 
Wivel in advance of the meeting. A 
summary of the meeting will be 
available at a later date. 
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: August 3, 1994. 
Susan K. Feldman, 
Committee Management Officer. NIH. 
(FR Doc 94-20825 Filed 8-22-94; 8:45 am) 
BILLING CODE 4141-01-M 
Recombinant DNA Research: 
Proposed Actions Under the 
Guidelines 
AGENCY: National Institutes of Health, 
PHS, DHHS. 
ACTION: Notice of Proposed Actions 
Under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(59 FR 34496). 
SUMMARY: This notice sets forth 
proposed actions to be taken under the 
National Institutes of Health (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 
September 12-13, 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 
September 5. 1994, will be reproduced 
and distributed to the Recombinant 
DNA Advisory Committee for 
consideration at its September 12-13, 
1994. meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities (ORDA), 
Building 31, Room 4B11, National 
Institutes of Health, Bethesda, Maryland 
20892, 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, Building 31, Room 4B11, 
National Institutes of Health, Bethesda, 
Maryland 20892, (301) 496-9838. 
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/Dr. Crystal 
In a letter dated July 18, 1994, Di. 
Ronald Crystal of the New York 
Hospital-Comell Medical Center, New 
York, New York, submitted a human 
gene transfer protocol entitled: 
Evaluation of Repeat Administration ol 
a Replication Deficient, Recombinant 
Adenovirus Containing the Normal 
Cystic Fibrosis Transmembrane 
Conductance Regulator cDNA to the 
Airways of Individuals w/Cystic 
Fibrosis 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/Drs. Isner and Walsh 
In a letter dated July 5, 1994, Drs. 
Jeffrey M. Isner and Kenneth Walsh of 
the St. Elizabeth’s Medical Center, Tufts 
University. Boston, Massachusetts, 
submitted a human gene transfer 
protocol entitled: Arterial Gene Transfer 
for Therapeutic Angiogenesis in Patients 
with Peripheral Artery Disease 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. Gluckman 
In a letter dated July 15, 1994, Dr. Jack 
L. 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/ 
GlTklSvNa.7) and Intravenous 
Ganciclovir for the Treatment of Locally 
[2] 
Recombinant DNA Research, Volume 20 
