5937S 
Federal Register / Vol. 46. No. 233 / Friday, December 4, 1981 / Notices 
(29) Murray. N. E.. and K. Murray (1974). 
Manipulation of Restriction Targets in Phage 
Lambda to Form Receptor Chromosomes for 
DNA Fragments. Nature 251. 476-481. 
[30] Rambach. A., and P. TioUais (1974). 
Bocteriophage Having EcoRI Endonuclease 
Sites Only in the Non-Essential Region of the 
Genome. Ptac. Nat. Acad. Sd.. USA 71. 3927- 
3930. 
(27) Blattner. F. R.. B. G. Williama. A. E. 
Bleche. K. Deimiston-Tbompson. H. E. Faber. 
L A. Furlong D. ). Cunwald D. O. Kiefer. D. 
D. Moore. J. W. Sbumm. E. L Sheldon, and O. 
Smithies (1977). Charon Phages: Safer 
Derivatives of Bacteriophage Lambda for 
DNA Cloniag. Science 196. 163-169. 
[32] Oonogbue. D. J.. and P. A. Sharp (1977). 
An Improved Lambda Vector Construction of 
Mode! Recombinants Coding fur Kanamycin 
Resistance. Gene 7. 209-227. 
(23) Leder. P„ D. Tiemeier and L Enquist 
(1977). EK2 Derivatives of Bacteriophage 
lambda Useful in the Cloning of DNA from 
Higher Organisms: The gt VV£S System. 
Science 196. 175-177. 
(3JA) Skalka. A. (1978). Current Status of 
Coliphage EK2 Vectors. Gene 3. 29-35. 
[33B] Szybalski. W.. A. Skalka. S. 
Gottesman. A. Campbell, and D. Botstein 
(1978). Standardized Laboratory Tests for 
EK2 Certification. Gene 3. 38-38. 
[34] (DelHed) 
(35) DeHned as observable under optimal 
laboratory conditions by transformation, 
transduction, phage infection, and/or 
con)ugdlion with transfer of phage, plasmid, 
and/or chromosomal genetic information. 
Note that this defuution of exchange may be 
less stringent than that applied to exempt 
organisms under Section l-E— I. 
[36-4S] (Deleted) 
[49] A subset of non-conjugative plasmid 
vectors are also poorly mobiluable (e.g.. 
pBR322. pBR313). Where practical these 
vectors should be employed. 
[50] [Deleted] 
VI. Voluntary Compliance 
VI-A. to VI-E. (Deleted) 
Vl-F. Protection of Proprietary Data. 
In general, the Freedom of Information 
Act requires Federal agencies to make 
thier records available to the public 
upon request. However, this requirement 
does not apply to. among other things, 
"trade secrets and commercial and 
rinancial 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." 
Vl-F-1. In submitting information to 
NIH for purposes of complying 
voluntarily with the Guidelines, an 
institution may designate those items of 
information which the institution 
believes constitute trade secrets or 
privileged or confidential commercial or 
financial information. 
VI-F-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. 
Vl-F-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. 
Vl-F-4. The following information will 
usually be considered publicly available 
information, consistent with the need to 
protect proprietary data: 
a. The names of the institution and 
principal investigator. 
b. "nie location where the experiments 
will be performed. 
c. The host-vector system. 
d. The source of the DNA. 
e. The level of physical containment. 
VI-F-5-a. Any institution, which is 
considering submission of data or 
information vountarily 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-F-5-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 HEW Freedom of Information 
Officer, the responsible official under 
HEW 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-F-5-C. ORDA will inform the 
institution of the HEW 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 HEW, NIH, or ORDA. 
Vl-F-5-d. The HEW Freedom of 
Information Officer’s determination will 
represent that official’s judgment, 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 files and a request were received 
from them under the Act. 
Appendix A. — Exemptions Under I-E-4 
Section l-E-4 slates 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 Recombinant 
DNA Advisory Committee, after 
appropriate notice and opportunity for 
public comment (see Section IV-E-l-b- 
(l)-{d).) Certain classes are exempt as of 
publication of these Revised Guidelines. 
The list is in Appendix A." 
Under exemption I-E-4 of these 
revised 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 af 
Determinative Bacterialogy, eighth 
edition. R.E. Buchanan and N.E. 
Gibbons, editors. Williams and Wilkins 
Company; Baltimore. 1974.) 
Sublist /I 
1. Genus Escherichia 
2. Genus Shigella 
3. Genus Salmonella (including Arizona) 
4. Genus Enterohacter 
5. Genus Citrobacter (including Levinea) 
6. Genus Klebsiella 
7 Genus Erwinia 
[267] 
