4782 Federal Register / Vol. 62, No. 21 / Friday, January 31, 1997 / Notices

participate in biomedical research.

Increase the exposure of K–12 students,

their teachers and the public to the life

sciences. Construct or renovate

biomedical research facilities.

Biomedical research investigators

supported by the NIH require a broad

array of technologies, tools and

materials for their research. The NCRR

plays a key role in addressing trans-NIH

research issues, such as access to stateof-the-art instrumentation and

technologies; containment of the

escalating costs of highly sophisticated

research; development of appropriate,

specialized research models; efforts to

remedy the shortage of clinical and

minority investigators; and efforts to

improve the research infrastructure.

To ensure the continued relevance of

its strategic plan, the NCRR seeks input

to the following questions in terms of

the issues described above:

(A) What are the most important

research trends that will drive

biomedical research?

(B) What research resources and

technologies will be critical in

addressing these trends and meeting

biomedical investigators’ needs?

(C) What strategies will eliminate

barriers to progress and enhance access

to research resources and technologies?

(D) Who would you recommend to

serve as a panel member for NCRR’s

strategic planning process? Please list

the name, degree, position title,

department, institution name and

address, phone and fax numbers, and

specific area of expertise for each person

recommended.

We have provided a user-friendly

response form at NCRR’s Strategic

Planning Survey Web site: <http://

www.ncrr.nih.gov/survey.htm>; or you

may mail your response to the Office of

Science Policy, NCRR/NIH, One

Rockledge Center, 6705 Rockledge Drive

MSC 7965, Suite 5046, Bethesda, MD

20892–7965; FAX 301–480–3654.

Dated: January 22, 1997.

Ruth L. Kirschstein,

Deputy Director, NIH.

[FR Doc. 97–2482 Filed 1–30–97; 8:45 am]

BILLING CODE 4140–01–M

Recombinant DNA Research: Action

Under the Guidelines

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice of Action under the NIH

Guidelines for Research Involving

Recombinant DNA Molecules (59 FR

34496, 59 FR 40170, 60 FR 20726, 61 FR

1482, 61 FR 10004).

SUMMARY: This notice sets forth an

action taken by the Director, National

Institutes of Health (NIH), under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules.

FOR FURTHER INFORMATION CONTACT:

Additional information can be obtained

from Ms. Debra Knorr, Acting Director,

Office of Recombinant DNA Activities

(ORDA), Office of Science Policy,

National Institutes of Health, MSC 7010,

6000 Executive Boulevard, Suite 302,

Bethesda, Maryland 20892–7010, (301)

496–9838.

SUPPLEMENTARY INFORMATION: Today’s

action is being promulgated under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules. The

action was proposed and published for

comment in the Federal Register of July

8, 1996 (61 FR 35774), then revised and

proposed for comment in the Federal

Register of November 22, 1996 (61 FR

59726), and reviewed and

recommended for approval by the NIH

Recombinant DNA Advisory Committee

(RAC) at its meeting on December 9,

1996.

I. Background Information and

Decision on Action Under the NIH

Guidelines

A. Amendments to Section IV–C–2 of

the NIH Guidelines Regarding the

Recombinant DNA Advisory Committee

On July 8, 1996, the Director, NIH,

published a Notice of Intent to Propose

Amendments to the NIH Guidelines for

Research Involving Recombinant DNA

Molecules (NIH Guidelines) Regarding

Enhanced Mechanisms for NIH

Oversight of Recombinant DNA

Activities in the Federal Register (61 FR

35774). In the Notice of Intent, the NIH

Director requested public comment on

proposed mechanisms to enhance

scientific, ethical, and societal oversight

of human gene transfer research under

the NIH Guidelines. Specifically, in

part, the termination of the RAC and the

establishment of the Office of

Recombinant DNA Activities Advisory

Committee (OAC) consisting of 6–10

members.

Comments in support of termination

of the RAC reflected an interest in

making substantive changes in the role

of the RAC. Most of these comments

supported the proposed restructuring of

the functions of the RAC and did not

specifically endorse termination of RAC.

Opposing comments focused on the

historical importance of retaining the

RAC as an internationally recognized

forum for public discussion of the

science, safety, and ethics of human

gene therapy research. These authors

articulated the critical role that the RAC

plays in maintaining public confidence

in human gene therapy research.

The importance of the continuation of

the RAC, per se, was underscored by

comments which specifically addressed

the establishment of the OAC. Of the 53

comments which addressed this issue,

12 expressed support and 41 expressed

opposition. The majority of comments

submitted in opposition to the OAC

stated that the proposed functions of the

OAC could be accomplished by the

RAC, or by a restructured version of the

RAC. Several authors emphasized that,

absent the historic credibility of the

RAC, the OAC might suffer from an

inability to attract and motivate the type

of expertise and judgement needed for

this important public forum.

On November 22, 1996, the NIH

Director published Notice of Proposed

Actions Under the NIH Guidelines for

Research Involving Recombinant DNA

Molecules in the Federal Register (61

FR 59726). In these Proposed Actions,

in part, the NIH Director proposed

retaining the RAC, while modifying its

roles and responsibilities relevant to

human gene therapy research and

reducing the membership from 25

members to 15 members, and requested

comments.

During the December 9, 1996,

meeting, the RAC, which had reviewed

the comments received, approved the

overall concepts in the Proposed

Actions. The RAC specifically approved

reducing the membership of the RAC

from 25 members to 15 members. The

motion passed by a vote of 12 in favor,

0 opposed, and 2 abstentions.

The action is detailed in Section II—

Summary of Action. I accept this

recommendation to reduce the

membership of the RAC from 25

members to 15 members, and the NIH

Guidelines will be amended

accordingly.

II. Summary of Action

A. Amendments to Section IV–C–2,

Recombinant DNA Advisory Committee

(RAC)

In Section IV–C–2, the first paragraph

is amended to read:

‘‘Section IV–C–2. Recombinant DNA

Advisory Committee (RAC)

‘‘The RAC is responsible for carrying

out specified functions cited below as

well as others assigned under its charter

or by the DHHS Secretary and the NIH

Director. The RAC consists of 15

members including the Chair, appointed

by the DHHS Secretary or his/her

designee, at least 8 of whom are selected

from authorities knowledgeable in the

fields of molecular genetics, molecular
Federal Register / Vol. 62, No. 21 / Friday, January 31, 1997 / Notices 4783

biology, recombinant DNA research, or

other scientific fields. At least 4

members of the RAC shall be persons

knowledgeable in applicable law,

standards of professional conduct and

practice, public attitudes, the

environment, public health,

occupational health, or related fields.

Representatives from Federal agencies

shall serve as non-voting members.

Nominations for the RAC may be

submitted to the Office of Recombinant

DNA Activities, National Institutes of

Health/MSC 7010, 6000 Executive

Boulevard, Suite 302, Bethesda,

Maryland 20892–7010, (301) 496–9838.

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.

Effective Date: January 23, 1997.

Harold Varmus,

Director, National Institutes of Health.

[FR Doc. 97–2485 Filed 1–30–97; 8:45 am]

BILLING CODE 4140–01–M

Public Health Service

National Institute of Environmental

Health Sciences; National Toxicology

Program; Fiscal Year 1996 Annual Plan

Now Available

The National Toxicology Program

(NTP) announces the availability of

National Toxicology Program; Fiscal

Year 1996 Annual Plan, solicits

comments on it, and urges all interested

persons to propose chemicals for

possible toxicological evaluation.

The eighteenth edition consists of two

parts. First, the National Toxicology

Program; Fiscal Year 1996 Annual Plan

describes FY 1996 NTP plans in

research, applied studies, methods

development and validation efforts, as

well as resources and FY 1995 program

accomplishments. Second, the Review

of Current DHHS, DOE, and EPA

Research Related to Toxicology FY 1996

lists chemicals being studied by the

various Department of Health and

Human Services (DHHS) agencies, the

Department of Energy (DOE), and the

Environmental Protection Agency

(EPA), and describes toxicology research

and toxicology methods currently being

developed by these agencies.

The format for the FY 1996 Annual

Plan differs somewhat from previous

years in that there are two versions.

New is the Fiscal Year 1996 Annual

Plan Summary which was prepared in

response to a perceived need for a

briefer and simpler version. The

summary version is being sent to the

larger mailing list and in response to

general requests for information about

the National Toxicology Program. The

full version is similar to previous

Annual Plans in length and detail and

will be sent with the companion

document, the Review of Current DHHS,

DOE, and EPA Research Related to

Toxicology FY 1996.

Background

The National Toxicology Program was

established within the Public Health

Service of the Department of Health and

Human Services in November 1978. The

continuing broad goals of the NTP are

to coordinate and strengthen DHHS

basic and applied toxicology research

and methods development and

validation, and to provide toxicological

information for use by health research

and regulatory agencies and others in

protecting the public health. Overall

objectives are to:

• broaden the spectrum of toxicological

information obtained on selected

chemicals;

• develop and validate more sensitive

and specific test methods;

• develop improved strategies for

generating scientific data that

strengthen the scientific foundation

for risk assessments; and

• communicate NTP plans and results

to government agencies, the medical

and scientific communities, and the

public.

To achieve these objectives, a

balanced program, which uses chronic

bioassays, short-term tests, collection

and application of mechanistic

information, model development,

alternative methods, and human

studies, has been created.

The NTP coordinates selected

toxicology activities of the National

Institute of Environmental Health

Sciences (NIEHS), National Institutes of

Health; the National Center for

Toxicological Research, Food and Drug

Administration; and the National

Institute for Occupational Safety and

Health, Centers for Disease Control and

Prevention. The Director of the NTP is

also the Director of the National

Institute of Environmental Health

Sciences.

Primary program oversight is

provided by the NTP Executive

Committee, which links DHHS health

research institutes and centers with

Federal health regulatory agencies to

ensure that the basic and applied

toxicology research and development

activities are responsive to regulatory

and public health needs. Agencies

represented on the Executive Committee

are:

• Agency for Toxic Substances and

Disease Registry

• Consumer Product Safety Commission

• Environmental Protection Agency

• Food and Drug Administration

• National Cancer Institute

• National Institute for Occupational

Safety and Health

• National Institute of Environmental

Health Sciences

• National Institutes of Health

• Occupational Safety and Health

Administration

The NTP Board of Scientific

Counselors provides scientific oversight,

advising the NTP Director and the NTP

Executive Committee on scientific

content and evaluating the scientific

merit and overall quality of NTP

science. The Board has two standing

Subcommittees, the Biennial Report on

Carcinogens Subcommittee and the

Technical Reports Review

Subcommittee. The members are

appointed by the Secretary, DHHS.

Scientific activities are divided into

several major program areas:

Carcinogenesis; genetic toxicology; risk

assessment research; alternative

methods; and toxicology. The latter area

covers activities in immunologic,

neurobehavioral, and respiratory

toxicologies, as well as reproductive and

developmental toxicology. There are

special projects on studying toxicities of

AIDS therapeutics and toxicity of

Superfund chemicals. Program and

project leaders, along with addresses

and telephone numbers, are identified

in the Annual Plan.