[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Notices]
[Pages 7054-7056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3492]
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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).
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SUMMARY: This notice sets forth proposed actions that NIH plans to
consider 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).
NIH invites all interested parties to submit comments concerning these
proposals. The Recombinant DNA Advisory Committee (RAC) will consider
these proposals at its meeting on March 10, 1998. After consideration
of these proposals and comments by the RAC, the NIH Director will issue
decisions according to the NIH Guidelines.
DATES: Comments received by March 2, 1998 will be reproduced and
distributed to the RAC for consideration at its March 10, 1998,
meeting.
ADDRESSES: Interested parties should submit written comments and
recommendations 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 ORDA offices on
weekdays between the hours of 8:30 a.m. and 5:00 p.m.
FOR FURTHER INFORMATION CONTACT: Interested parties can obtain
background documentation and additional information 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. Proposed Actions Regarding Amendments to the NIH Guidelines
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 Regarding Electronic
Submission of Protocols
In January 1998, Dr. C. Estuardo Aguilar-Cordova, a member of the
RAC, participated in a pilot test with ORDA staff regarding electronic
submission 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
therefore requires amendments to the NIH Guidelines. As a result, ORDA
proposes 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 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 2 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 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.
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
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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 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.
Date: January 28, 1998.
Lana R. Skirboll,
Associate Director for Science Policy, National Institutes of Health.
[FR Doc. 98-3492 Filed 2-10-98; 8:45 am]
BILLING CODE 4140-01-P
