26018 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Recombinant DNA Research: Actions

Under the Guidelines

AGENCY: National Institutes of Health

(NIH), PHS, DHHS.

ACTION: Notice of Actions Under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules (NIH

Guidelines).

SUMMARY: This notice sets forth actions

to be taken by the Director, National

Institutes of Health, 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, 62 FR 53335, 62 FR 56196, 62 FR

59032, and 63 FR 8052).

FOR FURTHER INFORMATION CONTACT:

Background documentation and

additional information can be obtained

from the Office of Recombinant DNA

Activities (ORDA), National Institutes of

Health, MSC 7010, 6000 Executive

Boulevard, Suite 302, Bethesda,

Maryland 20892–7010, Phone 301–496–

9838, FAX 301–496–9839. The ORDA

web site is located at http://

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

information about the office.

SUPPLEMENTARY INFORMATION: Today’s

actions are being promulgated under the

NIH Guidelines for Research Involving

Recombinant DNA Molecules (NIH

Guidelines). The proposed actions were

published for comment in the Federal

Register on February 11, 1998 (63 FR

7054), and reviewed by the NIH

Recombinant DNA Advisory Committee

(RAC) at its meeting on March 10, 1998.

I. Amendment to Appendix M–I,

Submission Requirements—Human

Gene Transfer Experiments, Under the

NIH Guidelines Regarding Electronic

Submission of Protocols

I–A. Background Information and

Decisions on Actions Under the NIH

Guidelines

Appendix M–I, Submission

Requirements—Human Gene Transfer

Experiments, of the NIH Guidelines,

stipulates requirements for submission

of documents to ORDA. In January 1998,

Dr. C. Estuardo Aguilar-Cordova, a

member of the RAC, participated in a

pilot test with ORDA staff regarding

electronic submission of documents to

ORDA. In this test, the documents

submitted electronically included a

human gene transfer protocol; responses

to Appendices M–II through M–V,

Points to Consider in the Design and

Submission of Protocols for the Transfer

of Recombinant DNA Molecules into

One or More Human Subjects (Points to

Consider); and the ORDA registration

document. The 82-page electronic

submission, including tables,

satisfactorily proved the efficiency and

effectiveness of using this method for

submission of protocols.

ORDA recognizes that electronic

submission of documents is an accepted

standard of practice within the scientific

community; therefore, this practice is

not novel. The practice of using this

medium to submit formal protocols to

ORDA, however, is novel and requires

amendments to the NIH Guidelines. As

a result, ORDA proposed to amend

Appendix M–I of the NIH Guidelines to

provide guidance to investigators

regarding optional electronic

submission procedures.

Electronic submission of human gene

transfer protocols to ORDA offers

several distinct advantages over the

current practice of submitting protocols

by printed matter, including: (1) ORDA

can review protocols more

expeditiously because they are received

immediately; (2) electronic submission

allows ORDA to search protocols

electronically for keywords or phrases;

(3) registration tasks performed at ORDA

will be reduced substantially because

the investigator has already completed

most of the registration document as

part of the electronic submission; and

(4) ORDA can facilitate RAC review of

the protocol by forwarding the complete

protocol to RAC members electronically.

Appendix M–I is proposed to read:

‘‘Appendix M–I. Submission

Requirements—Human Gene Transfer

Experiments

‘‘Investigators must submit the following

material (see exemption in Appendix M–

VIII–A, Footnotes of Appendix M) to 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. Investigators may

submit this material electronically and can

obtain specific instructions from the ORDA

home page (http://www.nih.gov/od/orda)

regarding electronic submission

requirements. For all submissions, whether

printed or electronic, ORDA will confirm

receipt within three working days after

receiving the submission. Investigators

should contact ORDA if they do not receive

this confirmation.

‘‘Proposals in printed form and/or in an

electronic version shall be submitted to NIH/

ORDA in the following order: (1) Scientific

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

Responses to Appendix M–II through M–V,

Description of the Proposed, Informed

Consent, Privacy and Confidentiality, and

Special Issues (the pertinent responses can be

provided in the protocol or as an appendix

to the protocol); (4) clinical protocol as

approved by the local Institutional Biosafety

Committee and Institutional Review Board;

(5) Informed Consent document as approved

by the Institutional Review Board (see

Appendix M–III, Informed Consent); (6)

appendices (including tables, figures, and

manuscripts); and (7) curricula vitae—no

more than two pages for each key

professional person in biographical sketch

format.

‘‘All submissions must include

Institutional Biosafety Committee (IBC) and

Institutional Review Board (IRB) approvals

and their deliberations pertaining to your

protocol. IBC approval must be obtained from

each institution at which recombinant DNA

material will be administered to human

subjects (as opposed to each institution

involved in the production of vectors for

human application and each institution at

which there is ex vivo transduction of

recombinant DNA material into target cells

for human application). Because these

written IBC and IRB approvals require

appropriate signatures, investigators cannot

submit them electronically. Investigators

should submit these signed approvals either

by mail or by facsimile trnasmission.

‘‘Investigational New Drug (IND)

applications shall be submitted to the FDA in

the format described in 21 CFR, Chapter I,

Subchapter D, Part 312, Subpart B, Section

23, IND Content and Format. Submissions to

the FDA should be sent to the Division of

Congressional and Public Affairs, Document

Control Center, HFM–99, Center for Biologics

Evaluation and Research, 1401 Rockville

Pike, Rockville, Maryland 20852–1448.

‘‘Note: NIH/ORDA will accept submission

material at any time. However, if a protocol

is submitted less than eight weeks before a

scheduled RAC meeting and subsequently is

recommended for public discussion by the

full RAC, the public discussion of that

protocol will be deferred until the next

scheduled RAC meeting. This eight-week

period is needed to ensure adequate time for

review by the committee members.’’

During the March 10, 1998, RAC

meeting, a motion was made that the

RAC accept the proposed action

published in the Federal Register of

February 11, 1998 (63 FR 7054) to

permit submission of human gene

transfer protocols to ORDA for

registration in an optional electronic

format, as opposed to the printed

materials. The motion passed by a vote

of 9 in favor, 0 opposed, and 1

abstention.

The actions are detailed in Section I–

B—Summary of Actions. I accept the

RAC recommendations, and the NIH

Guidelines will be amended

accordingly.
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Notices 26019

I–B. Summary of Actions

I–B–1. Amendments to Appendix M–I.

Submission Requirements—Human

Gene Transfer Experiments

Appendix M–I is to be amended to

read:

‘‘Section M–I. Submission

Requirements—Human Gene Transfer

Experiments

‘‘Investigators must submit the following

material (see exemption in Appendix M–

VIII–A, Footnotes of Appendix M) to 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. Investigators may

submit this material electronically and can

obtain specific instructions from the ORDA

home page (http://www.nih.gov/od/or/orda)

regarding electronic submission

requirements. For all submissions, whether

printed or electronic, ORDA will confirm

receipt within three working days after

receiving the submission. Investigators

should contact ORDA if they do not receive

this confirmation.

‘‘Proposals in printed form and/or in an

electronic version shall be submitted to NIH/

ORDA in the following order: (1) Scientific

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

Responses to Appendix M–II through M–V,

Description of the Proposal, Informed

Consent, Privacy and Confidentiality, and

Special Issues (the pertinent responses can be

provided in the protocol or as an appendix

to the protocol); (4) clinical protocol as

approved by the local Institutional Biosafety

Committee and Institutional Review Board;

(5) Informed Consent document as approved

by the Institutional Review Board (see

Appendix M–III, Informed Consent); (6)

appendices (including tables, figures, and

manuscripts); and (7) curricula vitae—no

more than two pages for each key

professional person in biographical sketch

format.

‘‘All submissions must include

Institutional Biosafety Committee (IBC) and

Institutional Review Board (IRB) approvals

and their deliberations pertaining to your

protocol. IBC approval must be obtained from

each institution at which recombinant DNA

material will be administered to human

subjects (as opposed to each institution

involved in the production of vectors for

human application and each institution at

which there is ex vivo transduction of

recombinant DNA material into target cells

for human application). Because these

written IBC and IRB approvals require

appropriate signatures, investigators cannot

submit them electronically. Investigators

should submit these signed approvals either

by mail or by facsimile transmission.

‘‘Investigational New Drug (IND)

applications shall be submitted to the FDA in

the format described in 21 CFR, Chapter I,

Subchapter D, Part 312, Subpart B, Section

23, IND Content and Format. Submissions to

the FDA should be sent to the Division of

Congressional and Public Affairs, Document

Control Center, HFM–99, Center for Biologics

Evaluation and Research, 1401 Rockville

Pike, Rockville, Maryland 20852–1448.

‘‘Note: NIH/ORDA will accept submission

material at any time. However, if a protocoal

is submitted less than eight weeks before a

scheduled RAC meeting and subsequently is

recommended for public discussion by the

full RAC, the public discussion of that

protocol will be deferred until the next

scheduled RAC meeting. This eight-week

period is needed to ensure adequate time for

review by the committee members.’’

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 virtually every NIH and 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 Guideline. 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: April 30, 1998.

Harold Varmus,

Director, National Institutes of Health.

[FR Doc. 98–12327 Filed 5–8–98; 8:45 am]

BILLING CODE 4140–01–M