44386 Federal Register / Vol. 62, No. 161 / Wednesday, August 20, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Office of Recombinant DNA Activities;

Notice of Gene Therapy Policy

Conference

Notice is hereby given of a Gene

Therapy Policy Conference entitled:

Human Gene Transfer—Beyond Lifethreatening Disease, on September 11,

1997. The conference will be held at the

Bethesda Holiday Inn Hotel, 8120

Wisconsin Avenue, Bethesda, Maryland,

20814, starting on September 11, 1997,

at approximately 8:00 a.m., and will

recess at approximately 5:30 p.m. The

conference will be open to the public

and free of charge; however, registration

is required. Registration is available

online at http://www.nih.gov/od/orda

or you can contact Dr. Elham-Eid

Alldredge, REDA International, 11141

Georgia Avenue, Suite 517, Wheaton,

Maryland 20902, Phone 301–946–9790,

Fax 301–946–1911. Dr. Alldredge will

provide conference information upon

request. Individuals who plan to attend

and need special assistance, such as

sign language interpretation or other

reasonable accommodations, should

contact Dr. Alldredge in advance of the

meeting.

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 3577). One significant

component of the NIH Director’s

proposal was to establish Gene Therapy

Policy Conferences (GTPC). These

conferences are intended to offer the

unique advantage of assembling

numerous participants who possess

significant scientific, ethical, and legal

expertise and/or interest that is directly

applicable to specific recombinant DNA

issues. In order to enhance the depth

and value of scientific and ethical/social

discussion, each GTPC will be devoted

to a single issue relevant to scientific

merit and/or safety as it relates to

research on the use of novel gene

delivery vehicles and applications to

human gene therapy, novel applications

of gene transfer, or relevant ethical/

social implications of a particular

application of gene transfer technology.

The findings and recommendations of

each GTPC will be made available to

multiple Department of Health and

Human Services (DHHS) components,

including the Food and Drug

Administration (FDA) and the Office of

Protection from Research Risks (OPRR).

The NIH Director anticipates that this

expanded public policy forum will

serve as a model of interagency

communication and collaboration,

concentrated expert discussion of novel

scientific issues and their potential

societal implications, and enhanced

opportunity for public discussion of

specific issues and the potential impact

of such applications on human health

and the environment.

At its March 6–7, 1997 meeting, the

RAC recommended that the first Gene

Therapy Policy Conference (GTPC)

should be held to discuss the scope of

ethical and scientific issues regarding

genetic enhancement and the inclusion

of normal subjects in human gene

transfer protocols.

The first CTPC is scheduled for

September 11, 1997. The title of this

first GTPC is: Human Gene Transfer—

Beyond Life-threatening Disease. The

tentative topics for discussion during

this conference are: (1) Scientific

prospects for enhancement through gene

therapy. This topic will cover the

following issues: (a) Historical

perspective, current state, and

theoretical feasibility; (b) prospects for

‘‘preventive’’ gene therapies that

enhance organ or system function; and

(c) assessing the long-term safety and

efficacy of enhancement gene therapies.

(2) The treatment/enhancement

distinction: conceptual, ethical and

social issues. This topic will cover the

following issues: (a) Ethical and social

concerns; and (b) conceptual

clarification of treatment/enhancement

distinction, and (3) Development of a

‘‘treatment/enhancement’’ distinction as

part of a guidance document. This topic

will cover the following issues: (a)

Operational criteria for treatment/

enhancement distinction; (b) current

regulatory significance of the

distinction; and (c) development of a

guidance framework/document.

The findings and recommendations of

this conference will be submitted in the

form of a report to the NIH Director.

Dated: August 11, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–22028 Filed 8–19–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Recombinant DNA Advisory

Committee; Notice of Meeting

Pursuant to Pub. L. 92–463, notice is

hereby given of a meeting of the

Recombinant DNA Advisory Committee

on September 12, 1997. 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, 1997, at

approximately 9 a.m., and will recess 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.

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 summaries of the meeting

and a roster of committee members

upon request. 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.

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.