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Federal Register / Voi. 59, No. 127 / Tuesday, Jul_y 5, 1994 / Notices 
Section IV-E-5-b. Presubmission 
Review 
Any institution not otherwise covered 
by the NIH Guidelines, which is 
considering submission of data or 
information voluntarily to NIH, may 
request presubmission review of the 
records involved to determine if NIH 
will make all or part of the records 
available upon request under the 
Freedom of Information Act. 
A request for presubmission review 
should be submitted to NIH/ORDA 
along with the records involved to the 
Office of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, Room 4B11, Bethesda, Maryland 
20892, (301) 496-9838. These records 
shall be clearly marked as being the 
property of the institution on loan to 
NIH solely for the purpose of making a 
determination under the Freedom of 
Infonnation Act. NIH/ORDA will seek a 
determination from the responsible 
official under DHHS regulations (45 
Code of Federal Regulations, Part 5) as • 
to whether the records involved, for 
some portion) will be made available to 
members of the pubUc under the 
Freedom of Information Act. Pending 
such a determination, the records will 
be kept separate from NIH/ORDA files, 
w'ill be considered records of the 
institution and not NIH/ORDA, and will 
not be received as part of NIH/ORDA 
files. No copies will be made of such 
records. 
NIH/ORDA will inform the institution 
of the DHHS Freedom of Infonnation 
Officer’s determination and follow the 
institution’s instructions as to whether 
some or all of the records involved are 
to be returned to the institution or to 
become a part of NIH/ORDA files. If the 
institution instructs NIH/ORDA to 
return the records, no copies or 
summaries of the records will be made 
or retained by DHHS, NIH, or ORDA. 
The DHHS Freedom of Information 
Officer’s determination will represent 
that official’s judgment at the time of the 
determination as to whether the records 
involved (or some portion) would be 
exempt from disclosure under the 
Freedom of Information Act if at the 
time of the determination the records 
were in NIH/ORDA files and a request 
was received for such files under the 
Freedom of Information Act. 
SectitHi V. Footnotes and References of 
Sections I Through IV 
Section V-A. The original reference to 
organisms as Class 1, 2, 3, 4, or 5 refers 
to the classification in the publication 
Classification of Etiologic Agents on the 
Basis of Hazard, 4th Edition, July 1974, 
U.S. Department of Health, Education, 
and Welfare, Public Health Services, 
Centers for Disease Control and 
Prevention, Office of Biosafety, Atlanta, 
Georgia 30333. The NIH Director, with 
advice of the RAC, may revise the 
classification for the purposes of the 
NLH Guidelines (see Section IV-C-l-b- 
(2)-(e)). The revised list of organisms in 
each class is reprinted in Appendix B. 
Section V-B. Section III describes a 
number of places where judgments are 
to be made. In all these cases, the 
Principal Investigator shall make the 
judgment on these matters as part of his/ 
her responsibility to “make the initial 
determination of the required levels of 
physical and biological containment in 
accordance with the NIH Guidelines” 
(see Section IV-B— 4-c-(l)). For cases 
falling under Sections III-A through IH- 
D, this judgment is to be reviewed and 
approved by the Institutional Biosafety 
Committee as part of its responsibility to 
make an “independent assessment of 
the containment levels required by the 
NIH Guidelines for the proposed 
research” (see Section IV-B-2-b-(l)). 
The Institutional Biosafety Committee 
may refer specific cases to NIH/ORDA 
as part of NIH/ORDA’s functions to 
“provide advice to all within and 
outside NIH" (see Section IV-C-3). 
NIH/ORDA may request advice from the 
RAC as part of the RAC’s responsibility 
for “interpreting the NIH Guidelines for 
experiments to which the NIH 
Guidelines do not specifically assign 
containment levels” (see Section IV-C- 
l-b-(2)-(f)). 
Section V-C. Laboratory Safety at the 
Centers for Disease Control, September 
1974, U.S. Department of Health, 
Education, and Welfare Publication No. 
CDC 75-8118. 
Section V-D. Classification of 
Etiologic i\gents on the Basis of Hazard, 
4th Edition, July 1974, U.S. Department 
of Health, Education, and Welfare, 
Public Health Service, Centers for 
Disease Control. Office of Biosafety, 
Atlcuit^ Georgia 30333. 
Section V-E. National Cancer Institute 
Safety Standards for Research Involving 
Oncogenic Viruses, October 1974, U.S. 
Department of Health, Education, and 
Welfare, Publication No. (NI^ 75-790. 
Section V-F. National Institutes of 
Health Biohazards Safety Guide, 1974, 
U.S. Department of Health, Education, 
and Welfare, Public Health Service, 
NIH, U.S. Government Printing Office, 
Stock Na 1740-00383. 
Section V-G. A. Heilman, M. N. 
Oxman, and R. Pollack (eds.), 1973, 
Biohazards in Biological Research, Cold 
Spring Harbor Laboratory, Cold Spring 
Harbor, NY. 
Section V-H. Purr, A. K., Handbook of 
Laboratory Safety, 2nd ed. The 
Chemical Rubber Co.. Boca Raton, 
Florida, 1990. 
Section V-1. American Public Health 
Association, Bodily, J. L., General 
Administration of the Laboratory, 6th 
ed., “Diagnostic Procedures for 
Bacterial, Mycotic, and Parasitic 
Infections.” New York, 1981. 
Section V-J. H. M. Darlow, Safety in 
the Microbiological Laboratory, in J. R. 
Norris and D. W. Robbins (eds.). 
Methods in Microbiology, Academic 
Press, Inc, New York, New York, 1969, 
pp. 169-204. 
Section V-K. C. M. Collins, E. G. 
Hartley, and R. Pilsworth, The 
Prevention of Laboratory Acquired 
Infection, Public Health Laboratory 
Service, Monograph Series No. 6, 1974. 
Section V-L. Chatigny, M. A, 
“Protection Against Infection in the 
Microbiological Laboratory; Devices and 
Procedmos,” in W.W. Umbreit (ed.). 
Advances in Applied Microbiology, 
Academic Press, New York, New York, 
1961,3:131-192. 
Section V-M. Design Criteria for Viral 
Oncology Research Facilities, U.S. 
Department of Health, Education, and 
Welfare, Public Health Service, NIH, 
DHEW Publication No. (NTH) 75-891, 
1975. 
Section V-N. Kuehne, R. W., 
Biological Containment Facility for 
Studying Infectious Disease, Appl. 
Microbiol. 26:239-243, 1973. 
Section V-O. Runkle, R. B., and G. B. 
Phillips, Microbial Containment Control 
Facilities, Van Nostrand Reinhold, New 
York, 1969. 
Section V-P. Chatigny, M. A., and D. 
I. Clinger, “Contamination Control in 
Aerobiology,” in R. L. Dimmick and A. 
B. Akers (e^.). An Introduction to 
Experimental Aerobiology, John Wiley & 
Sons, New York, 1969, pp. 194—263. 
Section V-Q. As classified in the 
Third Report of the International 
Committee on Taxonomy of Viruses: 
Classification and Nomenclature of 
Viruses, R. E. F. Matthews (ed.). 
Intervirology 12 (129-296). 1979. 
Section V-R. A U-S. Department of 
Agriculture permit is required for the 
importation, interstate movement, and 
release into the enviromnent of certain 
organisms that are plant or animal 
pathogens, whether genetically 
engineered or not Permits are required 
for veterinary biologies and for certain 
plants or microorganisms derived 
through genetic engineering nsing 
genetic sequences from plant pests 
(pathogens). Specific infonnation about 
regulated organisms and procedures for 
obtaining a permit for regulated 
organisms may be obtained from the 
Director, Biotechnology, Biologies, and 
Environmental Protection, Animal and 
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