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Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
member has a direct Financial interest so 
long as the member has not been and 
does not expect to be engaged in the 
project. Section IV-B-2-d is modified to 
that extent for purposes of these 
institutions. 
Vl-C. Certification of Host-Vector 
Systems. A host-vector system may be 
proposed for certification by the 
Director, NIH, in accordance with the 
procedures set forth in Appendix I-Il-A. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a host-vector system which is 
designated by the institution as 
proprietary under Section VI-E-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-D. Requests for Exemptions and 
Approvals. Requests for exemptions or 
other approvals required by the 
Guidelines should be requested by 
following the procedures set forth in the 
appropriate sections in Parts I-IV of the 
Guidelines. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a request for an exemption or 
other approval which is designated by 
the institution as proprietary under 
Section VI-E-1 will be issued only after 
consultation with the institution as to 
the content of the notice. 
VI-E. Protection of Proprietary Data. 
In general, the Freedom of Information 
Act requires Federal agencies to make 
their records available to the public 
upon request. However, this requirement 
does not apply to, among other things, 
“trade secrets and commercial and 
financial information obtained from a 
person and privileged or confidential.” 
18 U.S.C. 1905, in turn 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 authorized 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 "special Government employees." 
VI-E-1. In submitting information to 
NIH for purposes of complying 
voluntarily with the Guidelines, an 
institution may desianate thosd items of 
information which the institution 
believes constitute trade secrets, 
privileged, confidential commercial, or 
financial information. 
VI-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 judgment of the Director, NIH, is 
necessary to protect against an 
imminent hazard to the public or the 
environment. 
VI-E-1. Presubmission Review. 
VI-E-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. 
ORDA will then seek a determination 
from the HHS Freedom of Information 
Officer, the responsible official under 
HHS regulations (45 C.F.R. 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. 
VI-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 of 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 official’s judgement 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 ORDA files and a request were 
received for them under the Act. 
Appendix A — Exemptions Under 
Section III— D — 4 
Section III— D— 4 states that exempt 
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 IV-C-l-b- 
(l)-(c))- 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. 
(Classification of Bergey’s Manual of 
Determinative Bacteriology, 8th edition. 
R.E. Buchanan and N.E. Gibbons, 
editors. Williams and Wilkins Company: 
Baltimore, 1974.) 
Sublist A 
1. Genus Escherichia 
2. Cenus Shigella 
3. Genus Salmonella (including Arizona) 
4. Genus Enterobacter 
5. Genus Cilrobacter (including Levinea ) 
6. Genus Klebsiella 
7. Genus Erwinia 
8. Pseudomonas aeruginosa, Pseudomonas 
putida and Pseudomonas fluorescens 
9. Serratia marcescens 
10. Yersinia enterocolitica 
Sublist B 
1. Bacillus subtilis 
2. Bacillus lichenifonnis 
3. Bacillus pumilus 
4. Bacillus globigii 
5. Bacillus niger 
6. Bacillus nato 
7. Bacillus amyloliguefaciens 
8. Bacillus aterrimus 
Sublist C 
1. Streptomyces aureofaciens 
2. Streptomyces rimosus 
3. Streptomyces coelicolor 
Sublist D 
1. Streptomyces griseus 
2. Streptomyces cyaneus 
3. Streptomyces venezuelae 
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