[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]]

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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 (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 <a href="http://
www.nih.gov/od/orda">http://
www.nih.gov/od/orda</a> 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