[Federal Register Volume 62, Number 198 (Tuesday, October 14, 1997)]
[Notices]
[Page 53335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27093]
[[Page 53335]]
-----------------------------------------------------------------------
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 (NIH), 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.
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 action is 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 of February 14, 1997 (62 FR 7108), and reviewed by
the NIH Recombinant DNA Advisory Committee (RAC) at its meeting on
March 6, 1997.
I. Background Information and Decisions on Actions Under the NIH
Guidelines
In a letter dated December 2, 1995, Dr. Kenneth I. Berns
(President), Dr. Gail Cassel (Chair, Public and Scientific Affairs
Board), and Dr. Diane O. Fleming (Chair, Subcommittee on Laboratory
Safety) of the American Society for Microbiology (ASM) requested that
Equine morbillivirus, Sabia, and Flexal be added to Appendix B of the
NIH Guidelines. The Centers for Diseases Control and Prevention (CDC)
has developed a list of select agents identified as potential weapons
for biological terrorism. These select agents are subject to Federal
regulation 42 CFR Part 72, published by CDC on October 24, 1996, in the
Federal Register (61 FR 55190). This regulation promulgates the final
rule of additional requirements for facilities transferring or
receiving select agents. Most of the biological agents in the select
agents list are already included in Appendix B except these three
agents requested for inclusion by ASM. In a letter dated December 20,
1996, ORDA asked Dr. Flemming to clarify the proper Risk Group
classification of these three viruses. In her letter dated February 3,
1997, Dr. Fleming stated that Flexal virus should be listed as a Risk
Group 3 agent based on the classification recommended in the CDC/NIH
publication entitled: Biosafety in Microbiological and Biomedical
Laboratories, 3rd Edition, 1993. Sabia virus and Equine morbillivirus
have not been formally classified in this publication. Dr. Fleming
stated that she has consulted with Dr. Michael P. Kiley, Chairman of
the Subcommittee on Arboviral Laboratory Safety (SALS) of the American
Society for Tropical Medicine and Hygine, with regard to the proper
Risk Group classification of these two viruses. Dr. Kiley recommended
that Sabia and Equine morbillivirus should be classified as Risk Group
4 agents. Risk Group 4 agents are handled under Biosafety Level 4
physical containment, because they are likely to cause serious or
lethal human disease for which preventive or therapeutic interventions
are not available.
The ASM request was reviewed by Brian R. Murphy, M.D., Head,
Respiratory Viruses Section, NIH, and Stephen E. Straus, M.D., Chief,
Laboratory of Clinical Investigation, NIH. Dr. Murphy presented his
review and Dr. Straus' written review at the March 6-7, 1997, RAC
meeting. Dr. Murphy and Dr. Straus concurred with the ASM request with
regard to the classification of these three viruses.
The RAC deliberated the issue at the March 6-7, 1997, RAC meeting.
A motion was made by the RAC to amend: (1) Appendix B-III-D, Risk Group
3 (RG3)--Viruses and Prions, to include Flexal, an arenavirus, and (2)
Appendix B-IV-D, Risk Group 4 (RG4)--Viral Agents, to include Sabia, an
arenavirus, and Equine morbillivirus, a paramyxovirus. The motion
passed by a vote of 8 in favor, 0 opposed, and no abstentions.
I accept the RAC recommendations, and the NIH Guidelines will be
amended accordingly.
II. Summary of Actions
A. Appendix B-III-D, Risk Group 3 (RG3)--Viruses and Prions, will
be amended to include Flexal, an arenavirus.
B. Appendix B-IV-D, Risk Group 4 (RG4)--Viral Agents, will be
amended to include Sabia, an arenavirus, and Equine morbillivirus, a
paramyxovirus.
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 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: September 30, 1997.
Harold Varmus,
Director, National Institutes of Health.
[FR Doc. 97-27093 Filed 10-10-97; 8:45 am]
BILLING CODE 4140-01-M