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Federal Re^ster / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
financial information obtained &om a 
person and privileged or confidential.” 
18 U.S.C. 1905. in him makes it a crime 
for an officer or employee of the United 
States or any Federal department or 
agency to publish, divulge, disclose, or 
make known “in any manner or to any 
extent not authorize by law any 
information coming to him in the course 
of his employment or official duties or 
by reason of any examination or 
investigation made by, or return, report 
or record made to or filed with, such 
department or agency or officer or 
employee thereof, which information 
concerns or relates to the trade secrets, 
[or processes ... of any person, firm, 
partnership, corporation, or 
association.” This provision applies to 
all employees of the Federal 
Government including special 
Government employees. Members of the 
Recombinant DNA Advisory Committee 
are ”spedal Government employees.” 
Vl-^1. In submitting information to 
NIH for purposes of compMng 
voluntarily with the Guidelines, an 
institution may designate those items of 
information which the institution 
believes constitute trade secrets or 
privileged or confidential commerical or 
nnancial information. 
Vl-E-2. If NIH receives a request 
under the Freedom of Information Act 
for information so designated. NIH will 
promptly contact the institution to 
secure its views as to whether the 
information (or some portion) should be 
released. 
VI-E-3. If the NIH decides to release 
this information (or some portion) in 
response to a Freedom of Information 
request or otherwise, the institution will 
be advised: and the actual release will 
not be made until the expiration of 15 
days after the institution is so advised, 
except to the extent that earlier release, 
in the judgement of the Director, NIH, is 
necessary to protect against an 
imminent hazard to the public or the 
environment. 
Vl-E-4. Presubmission Review. 
VI-F.-4-a. Any institution not 
otherwise covered by the Guidelines, 
which IS considering submission of data 
or information voluntarily to NIH. may 
request presubmission review of the 
records involved to determine whether, 
if the records are submitted. NIH will or 
will not make part or all of the records 
available upon request under the 
Freedom of Information Act. 
Vl-E-4-b. A request for 
presubmission review should be 
submitted to ORDA, along with the 
records involved. These records must 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 Information Act. 
OROA will then seek a determination 
from the HHS Freedom of Information 
Officer, the responsible official under 
HHS regulations (45 CFR Part 5), as to 
whether the records involved (or some 
portion) are or are not available to 
members of the public under the 
Freedom of Information Act. Pending 
such a determination, the records will 
be kept separate from ORDA files, will 
be considered records of the institution 
and not ORDA and will not be received 
as part of ORDA files. No copies will be 
made of the records. 
V1-E-4-C. ORDA will Inform the 
Institution of the HHS Freedom of 
Information Officer's determination and 
follow the institution's instructions as to 
whether some or all the records 
involved are to be returned to the 
Institution or to become a part of ORDA 
files. If the institution instructs ORDA to 
return the records, no copies or 
summaries of the records will be made 
or retained by HHS, NIH, or ORDA 
VI-E-4-d. The HHS Freedom of 
Information Officer's determination will 
represent that offidal's judgement, as of 
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 
ORDA flies and a request was received 
from them under the Act. 
Appendix A. — Exemptions Under Ill-D-4 
Section Ill-D-4 slalet that exemption from 
these Guidelines are "certain specified 
recombinant DNA molecules that consist 
entirely of DNA segments from different 
species that exchange DNA by known 
physiological processes, though one or more 
of the segments may be a synthetic 
equivalent A list of such exchangers will be 
prepared and periodically revised by the 
Director. NIH. with advice of the RAC. after 
appropriate notice and opportunity for public 
comment (See Section rV-E-l-b-{l)-(d).) 
Certain classes are exempt as of publication 
of these Revised Guidelines. The list is in 
Appendix A." 
Under section III-D-4 of these Guidelines 
are recombinant DNA molecules that are (1) 
composed entirely of DNA segments from 
one or more of the organisms within a sublist 
and (2) to be propagated in any of the 
organisms within a sublist. (Classiflcation of 
Bergey'a Manual of Determinative 
Bacteriology, eighth edition. R. E. Buchanan 
and N. E. Gibbons, editors. Williams and 
Wilkins Company: Baltimore, 1974.) 
Subhat ,4 
1. Genus Eacherichia 
2. Genus Shigella 
3. Genus Salmonella (including Arizona) 
4. Genus Enterobacter 
5. Genus Citrobacter (including Levineo) 
6. Genus Klebaiello 
7. Genus Erwinia 
8. Pseudomonas aeruginosa. Pseudomonas 
putida and Pseudomonas fluorescens 
9. Serratia marcescens 
10. Yersinia enterocolilica 
Subliat B 
1. Bacillus aub tills 
2. Bacillus licbeniformis 
3. Bacillus pumilua 
4. Bacillus globigii 
5. Bacillus niger 
8. Bacillus nato 
7. Bacillus amyloliquefaciena 
8. Bacillus aterrimua 
Subliat C 
1. Streptomyces aureofaciena 
2. Streptomyces rimosua 
3. Streptomyces coelicolor 
Subliat D 
1. Streptomyces griaeua 
2. Streptomyces cyaneua 
3. Streptomyces venezuelae 
Subliat E 
One way transfer of Streptococcus mutana 
or Streptococcus lactia DNA into 
Streptococcus sanguis. 
Sublist F 
1. Streptococcus sanguis 
2. Streptococcus pneumoniae 
3. Streptococcus faecalia 
4. Streptococcus pyogenes 
Appendix B.— Classification of 
Microorganisms on the Basis of Hazard 
L Classification of Eliologic Agents on the 
Basis of Hazard (1) 
A. Class 1 Agents 
All bacterial, parasitic, fungal, viral, 
rickettsial, and chlamydial agents not 
included in higher classes. 
B. Class 2 Agents 
1. Bacterial Agents 
Actinobacillua — all species except A. mallei, 
which is in Class 3 
Arizona hinshawii — all sterotypes 
Bacillus anthracia 
Bordetella — all species 
Borrelia recurrentis, B. vincenti 
Clostridium botulinum. 
Cl. chauvoei. Cl. baemolyticum. 
Cl. bistolyticum. Cl. novyi 
Cl. septicum. Cl. tetoni 
Corynebacterium diptheriae, 
C. equi, C baemolyticum, 
C. pseudoluberculoaia 
C. pyogenes, C. renale 
Diplococcus (Streptococcus) pneumoniae 
Erysipehtbrix insidiosa 
Escherichia call — all enteropathogenic 
serotypes 
Haemophilus ducreyi, H. influenzae 
Herellae vaginicola 
Klebsiella — all species and all serotypes 
Leptospira interrogans — all serotypes 
Listeria — all species 
Mima polymorpha 
Moraxella — all species 
Mycobacteria — all species except those 
listed in Class 3 
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