53908 Federal Register / Vol. 62, No. 200 / Thursday, October 16, 1997 / 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 December 15–16, 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 December 15, 1997, at

approximately 9 a.m., and will recess at

approximately 5 p.m. The meeting will

reconvene on December 16, 1997, at

approximately 9:00 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.

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.

Dated: October 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27311 Filed 10–15–97; 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

(NIH Guidelines).

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. These proposals will be

considered by the Recombinant DNA

Advisory Committee (RAC) at its

meeting on December 15–16, 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 the

proposed actions. Comments received

by December 8, 1997, will be

reproduced and distributed to the RAC

for consideration at its December 15–16,

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, Phone 301–496–

9838, FAX 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. The Office of Recombinant

DNA Activities web site is located at

http://www.nih.gov/od/orda for further

information about the office.

I. Supplementary Information

The NIH will consider the following

actions under the NIH Guidelines for

Research Involving Recombinant DNA

Molecules (NIH Guidelines):

I–A. Amendment to Appendix M–I,

Submission Requirements—Human

Gene Transfer Experiments, Under the

NIH Guidelines

During the June 12–13, 1997, RAC

meeting, the following motions were

approved by the Committee:

(1) A motion was made that Appendix

M–I, Submission Requirements—

Human Gene Transfer Experiments,

should be amended to require

investigators to submit documentation

verifying that a human gene transfer

protocol has been submitted to an

appropriate Institutional Biosafety

Committee (IBC). Evidence of IBC

notification shall be provided at the

time the protocol is submitted to ORDA.

The motion passed by a vote of 8 in

favor, 1 opposed, and no abstentions.

(2) A motion was made to delete the

requirement for submission of IBC and

Institutional Review Board (IRB)

approvals at the time of ORDA

submission from Appendix M–I,

Submission Requirements—Human

Gene Transfer Experiments, of the NIH

Guidelines. The motion passed by a vote

of 7 in favor, 0 opposed, and 1

abstention.

On September 10, 1997, a letter was

received from the American Biological

Safety Association requesting that the

public comment period for the proposed

actions under the NIH Guidelines

published in the Federal Register on

August 20, 1997 (62 FR 44387) be

extended for an additional 60 days.

During the September 12, 1997, RAC

meeting, the RAC was scheduled to vote

on the proposed actions to delete prior

IBC and IRB approvals from the

submission requirements, and to require

investigators or sponsors to provide

evidence of protocol submission to IBC.
Federal Register / Vol. 62, No. 200 / Thursday, October 16, 1997 / Notices 53909

Considering the request by the

American Biological Safety Association

to extend the public comment period,

the RAC decided to modify the language

of the proposed actions and to publish

the revised version in the Federal

Register for an additional 60 days.

A motion was made by the RAC to

amend the proposed actions published

in the Federal Register on August 20,

1997, regarding the submission

requirements as follows:

‘‘The RAC recommends that final

approvals from IBC and IRB should be

withheld until after NIH/ORDA

provides the IBC and IRB with RAC

concerns (if any), and (1) NIH/ORDA

notification that the protocol is exempt

from full RAC review, or (2) NIH/ORDA

notification that the protocol has

triggered full RAC review. Human gene

transfer protocols shall not be initiated

prior to submission of final IBC and IRB

approvals to NIH/ORDA.’’

The motion passed by a vote of 10 in

favor, 0 opposed, and 2 abstentions.

I–B. Amendments to Institutional

Biosafety Committee (IBC) Approvals of

Experiments Involving Transgenic

Rodents Under Section III of the NIH

Guidelines

Section III–C–4, Experiments

Involving Whole Animals, of the NIH

Guidelines stipulates that all transgenic

animal experiments are subject to IBC

approval before initiation. In a

correspondence dated April 22, 1997,

Dr. George Gutman, an IBC

representative of the University of

California, Irvine, California, inquired

whether experiments involving

production or use of transgenic mice

under Biosafty Level 1 containment

could be initiated simultaneous with

IBC notification. Current requirements

under the NIH Guidelines require that

IBC approval be obtained prior to

initiation of such experiments.

The RAC discussed this issue during

its June 1997 meeting, recommending

that this requirement be changed to

initiation simultaneous with IBC

notification. The RAC agreed that the

requirement for IBC approval prior to

initiation is unnecessary and

recommended that the NIH Guidelines

should be amended such that: (1) The

generation of transgenic rodents at the

Biosafety Level 1 containment (not all

animals ) can be initiated simultaneous

with IBC notification, and (2) the

purchase and use of transgenic rodents

should be exempt from the NIH

Guidelines. A motion was made that

these proposed changes to the NIH

Guidelines should be published it the

Federal Register for consideration at the

September 12, 1997, RAC meeting. The

proposed action would allow: (1) The

generation of transgenic rodents that

require Biosafety Level 1 containment to

be included under Section III–D,

Experiments that Require IBC Notice

Simultaneous with Initiation; and (2)

the purchase and use of transgenic

rodents should be exempt from the NIH

Guidelines. The motion passed by a vote

of 9 in favor, 0 opposed, and no

abstentions.

On September 10, 1997, a letter was

received from the American Biological

Safety Association requesting that the

public comment period for the proposed

actions under the NIH Guidelines

published in the Federal Register on

August 20, 1997 (62 FR 44387) be

extended for an additional 60 days.

During the September 12, 1997, RAC

meeting, the RAC was scheduled to vote

on the issues surrounding the

amendments to IBC approvals of

experiments involving transgenic

rodents. Considering the request by the

American Biological Safety Association

to extend the public comment period,

the RAC decided to modify the language

of the proposed actions and to publish

the revised version in the Federal

Register for additional public comment

as requested by the American Biological

Safety Association. The RAC accepted

the proposed actions with the deletion

of two words ‘‘and use’’ from the

language, ‘‘the purchase and use of

transgenic rodent * * *’’ A motion was

made by the RAC to accept the

amendments to the NIH Guidelines with

regard to: (1) The generation of

transgenic rodents at the Biosafety Level

1 containment (not all animals) can be

initiated simultaneously with IBC

notification, and (2) the purchase of

transgenic rodents should be exempt

from the NIH Guidelines. The motion

passed by a vote of 11 in favor, 0

opposed, and no abstentions.

II. Proposed Actions Regarding

Amendments to the NIH Guidelines

The NIH will consider the following

proposed actions under the NIH

Guidelines:

II–A. Proposed Amendments to Section

III–C–4, Experiments Involving Whole

Animals

[Section III–C are experiments that

require Institutional Biosafety

Committee approval before initiation.]

Section III–C–4–c is proposed to be

amended to read:

‘‘Section III–C–4–c. Exceptions under

Section III–C–4.

‘‘Section III–C–4–c–(1). Experiments

involving the generation of transgenic

rodents that require BL1 containment

are described under Section III–D–3,

Experiments Involving Transgenic

Rodents.

‘‘Section III–C–4–c–(2). The purchase

of transgenic rodents is exempt from the

NIH Guidelines under Section III–E,

Exempt Experiments (see Appendix C–

VI, The Purchase of Transgenic

Rodents).’’

II–B. Proposed Amendments to Section

III–D, Experiments That Require

Institutional Biosafety Committee

Notice Simultaneous With Initiation

Section III–D–3 is proposed to be

amended to read:

‘‘Section III–D–3. Experiments

Involving Transgenic Rodents

‘‘This section covers experiments

involving the generation of rodents in

which the animal’s genome has been

altered by stable introduction of

recombinant DNA, or DNA derived

therefrom, into the germ-line (trangenic

rodents). Only experiments that require

BL1 containment are covered under this

section; experiments that require BL2,

BL3, or BL4 containment are covered

under Section III–C–4, Experiments

Involving Whole Animals.’’

II–C. Proposed Amendments to

Appendix C, Exemptions Under Section

III–E–6

A new section, Appendix C–VI, is

proposed to read:

‘‘Appendix C–VI. The Purchase of

Transgenic Rodents

‘‘The purchase of transgenic rodents

for experiments that require BL1

containment are exempt from the NIH

Guidelines.’’

[The old Appendix C–VI, Footnotes and

References of Appendix C, will be

renumbered to Appendix C–VII through

Appendix C–VII–E.]

II–D. Proposed Amendments to

Appendix M, The Points To Consider in

the Design and Submission of Protocols

for the Transfer of Recombinant DNA

Molecules Into the Genome of One or

More Human Subjects (Points To

Consider)

Appendix M–I is proposed to be

amended to read:

‘‘Appendix M–I. Submission

Requirements—Human Gene Transfer

Experiments

‘‘Investigators must submit the

following material 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 (see exemption in Appendix

M–IX–A, Footnotes of Appendix M).

Proposals will be submitted in the
53910 Federal Register / Vol. 62, No. 200 / Thursday, October 16, 1997 / Notices

following order: (1) Scientific abstract;

(2) non-technical abstract; (3) Responses

to Appendix M–II through Appendix

M–V, Description of the Proposal,

Informed Consent, Privacy and

Confidentiality, and Special Issues (the

pertinent responses can be provided in

the clinical protocol or as an appendix

to the clinical protocol); (4) clinical

protocol (as submitted to the local IBC

and IRB); (5) Informed Consent

document prepared for IRB submission

(see Appendix M–III, Informed

Consent); (6) a letter stating that

submission has been made to the IBC;

(7) appendices (including tables, figures,

and manuscripts); and (8) curricula

vitae for each key professional person in

biographical sketch format.

Note: The final approvals from IBC and IRB

should be withheld until after NIH/ORDA

provides IBC and IRB with RAC concerns (if

any), and (1) NIH/ORDA notification that the

protocol is exempt from full RAC review, or

(2) NIH/ORDA notification that the protocol

has triggered full RAC review. Human gene

transfer protocols shall not be initiated prior

to submission of final IBC and IRB approvals

to NIH/ORDA.

III. Addition to Appendix D of the NIH

Guidelines Regarding a Human Gene

Transfer Protocol/Dr. Crystal

In a letter dated August 25, 1997, Dr.

Ronald Crystal of New York HospitalCornell Medical Center, New York, New

York, submitted a human gene transfer

protocol entitled: Systemic and

Respiratory Immune Response to

Administration of an Adenovirus Type

5 Gene Transfer Vector (AdGVCD.10)

(NIH Protocol 9708–209) to NIH/ORDA

in accordance with Appendix M–I,

Submission Requirements—Human

Gene Transfer Experiments, of the NIH

Guidelines. Dr. Crystal requested

permission to present a brief overview

of relevant data during the September

12, 1997, RAC meeting, prior to the

RAC’s final recommendation on the

necessity for full RAC review. The RAC

agreed to allow Dr. Crystal to give a brief

presentation on the relevant data.

Following the September 12, 1997, RAC

meeting, the RAC noted that there were

a significant number of issues

remaining; therefore, the protocol

should be discussed by the full RAC at

its next scheduled meeting.

IV. Discussion on Novel Gene Transfer

Technologies

The RAC will have a discussion on

novel gene transfer technologies.

Presentations may include herpesvirus

vectors and human artificial

chromosomes.

OMB’s ‘‘Mandatory Information

Requirements for Federal Assistance

Program Announcements’’ (45 FR

39592) 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 to be not 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: October 8, 1997.

Lana R. Skirboll,

Associate Director for Science Policy,

National Institutes of Health.

[FR Doc. 97–27312 Filed 10–11–97; 8:45 am]

BILLING CODE 4140–01–M