27206 Federal Register / Vol. 60, No. 98 / Monday, May 22, 1995 / 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 June 8–9, 1995. 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 June 8, 1995, at

approximately 9 a.m., and will recess at

approximately 6 p.m. The meeting will

reconvene on June 9, 1995, 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.

Dr. Nelson A. Wivel, Director, Office

of Recombinant DNA Activities,

National Institutes of Health, MSC 7052,

6006 Executive Boulevard, Suite 323,

Bethesda, Maryland 20892–7052, 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: May 15, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–12406 Filed 5–19–95; 8:45 am]

BILLING CODE 4140–01–M

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).

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

June 8–9, 1995. 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 June 1,

1995, will be reproduced and

distributed to the Recombinant DNA

Advisory Committee for consideration

at its June 8–9, 1995, meeting.

ADDRESSES: Written comments and

recommendations should be submitted

to Dr. Nelson A. Wivel, Director, Office

of Recombinant DNA Activities,

National Institutes of Health, MSC 7052,

6006 Executive Boulevard, Suite 323,

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, National Institutes of Health,

MSC 7052, 6006 Executive Boulevard,

Suite 323, Bethesda, Maryland 20892–

7052, Phone 301–496–9838, 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. Curiel and

Alvarez

In a letter dated January 5, 1995, Drs.

David T. Curiel and Ronald D. Alvarez

of the University of Alabama,

Birmingham, Alabama, submitted a

human gene transfer protocol entitled: A

Phase I Study of Recombinant

Adenovirus Vector-Mediated Delivery of

an Anti-erbB–2 Single-Chain (sFv)

Antibody Gene for Previously Treated

Ovarian and Extraovarian Cancer

Patients to the Recombinant DNA

Advisory Committee for formal review

and approval at its March 6–7, 1995,

meeting. Due to reviewers’ comments

before the March 1995 meeting, the

protocol was not forwarded to the

committee.

In a letter dated April 12, 1995, Drs.

David T. Curiel and Ronald D. Alvarez

of the University of Alabama,

Birmingham, Alabama, submitted a

revised protocol to the Recombinant

DNA Advisory Committee for formal

review and approval at its June 8–9,

1995, meeting.

II. Addition to Appendix D of the NIH

Guidelines Regarding a Human Gene

Transfer Protocol/Dr. Curiel

In a letter dated April 13, 1994, Dr.

David Curiel of the University of

Alabama, Birmingham, Alabama,

submitted the human gene transfer

protocol entitled: Phase I Trial of a

Polynucleotide Vaccine to Human

Carcinoembryonic Antigen in Patients

with Metastatic Colorectal Cancer to the

Recombinant DNA Advisory Committee

for formal review and approval at its

June 9–10, 1994, meeting. During the

June 1994 meeting, the committee

approved the protocol by a vote of 10 in

favor, 4 opposed, and no abstentions.

Approval was contingent on the review

and approval by the primary reviewers

of a revised Informed Consent document

(as approved by the Institutional Review

Board). On June 29, Dr. Curiel submitted

an Institutional Review Board approved

Informed Consent Document. The

primary reviewers approved the revised