[Federal Register Volume 62, Number 200 (Thursday, October 16, 1997)]
[Notices]
[Pages 53908-53910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27312]
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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 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.
[[Page 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
[[Page 53910]]
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
Hospital-Cornell 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
