[Federal Register Volume 63, Number 90 (Monday, May 11, 1998)]
[Notices]
[Pages 26018-26019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12327]



[[Page 26017]]

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Part IV





Department of Health and Human Services





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National Institutes of Health



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Recombinant DNA Research: Actions Under the Guidelines; Notice

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

[[Page 26018]]



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).

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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.

[[Page 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