7108 Federal Register / Vol. 62, No. 31 / Friday, February 14, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Recombinant DNA Advisory

Committee; Meeting

Pursuant to Pub. L. 92–463, notice is

hereby given of a meeting of the

Recombinant DNA Advisory Committee

on March 6–7, 1997. The meeting will

be held at the National Institutes of

Health, Building 31C, 6th Floor,

Conference Room 10, 9000 Rockville

Pike, Bethesda, Maryland 20892,

starting on March 6, 1997, at

approximately 9 a.m., and will recess at

approximately 5 p.m. The meeting will

reconvene on March 7, 1997, 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.

Ms. 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 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 Ms. Knorr 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: January 30, 1997.

Paula N. Hayes,

Acting Committee Management Officer,

National Institutes of Health.

[FR Doc. 97–3736 Filed 2–12–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

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.

SUMMARY: This notice sets forth

proposed actions to be taken under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules (59 FR

34496, amended 59 FR 40170, 60 FR

20726, 61 FR 1482, 61 FR 10004, 62 FR

4782). Interested parties are invited to

submit comments concerning these

proposals. There proposals will be

considered by the Recombinant DNA

Advisory Committee (RAC) at its

meeting on March 6–7, 1997. After

consideration of these proposals and

comments by the RAC, the NIH Director

will issue decisions in accordance with

the NIH Guidelines.

DATES: Interested parties are invited to

submit comments concerning this

proposal. Comments received by

February 27, 1997, will be reproduced

and distributed to the RAC for

consideration at its March 6–7, 1997,

meeting. After consideration of this

proposal and comments by the RAC, the

NIH Director will issue decisions in

accordance with the NIH Guidelines.

ADDRESSES: Written comments and

recommendations should be submitted

to Debra Knorr, Office of Recombinant

DNA Activities, National Institutes of

Health, MSC 7010, 6000 Executive

Boulevard, Suite 302, Bethesda,

Maryland 20892–7010, or by FAX to

301–496–9839.

All comments received in 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 7010, 6000 Executive Boulevard,

Suite 302, Bethesda, Maryland 20892–

7010, Phone 301–496–9838, FAX 301–

496–9839.

SUPPLEMENTARY INFORMATION: The NIH

will consider the following actions

under the NIH Guidelines for Research

Involving Recombinant DNA Molecules:

I. Amendment to the Overall

Procedures for Human Gene Transfer

Protocols

I–A. Notice of Intent

On July 8, 1996, the NIH Director

published a Notice of Intent to Propose

Amendments to the NIH Guidelines for

Research Involving Recombinant DNA

Molecules Regarding Enhanced

Oversight of Recombinant DNA

Activities (61 FR 35774). This Notice of

Intent proposed modifications in NIH

oversight of human gene transfer

research. Specifically, it was proposed

that the RAC would be terminated and

that all approval responsibilities for

recombinant DNA experiments

involving human gene transfer would be

relinquished to the Food and Drug

Administration (FDA), which retains

statutory authority for such approval.

Under this revised oversight structure, a

newly created ORDA Advisory

Committee (OAC) would preserve

continued public accountability for

recombinant DNA research. To ensure

quality and efficiency of public

discussion of the scientific merit and

the ethical issues relevant to gene

therapy clinical trials, it was proposed

that the NIH Director implement a

regular series of Gene Therapy Policy

Conferences (GTPC). Finally, the

proposal assured the continuation of the

publicly available comprehensive NIH

database of clinical trials with human

gene transfer, including reporting of

adverse events.

In response to the Notice of Intent, the

NIH received 71 written comments (90

signatures) reflecting a broad spectrum

of public opinion on the proposed

changes. Comments were received from

a variety of stakeholders, including

individuals representing academia,