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Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
sequences, therefore, generally demands a 
compensatory deletion of viral sequences. It 
may be possible to introduce very short 
insertions (50-100 base pairs) without 
rendering the viral vector defective. In such a 
situation, the requirement that the viral 
vector be defective is not necessary, except 
in those cases in which the inserted DNA 
encodes a biologically active polypeptide. 
It is desired but not required that the 
functional anatomy of the vector be known — 
that is, there should be a clear idea of the 
location within the molecule of: 
(i) the sites at which DNA synthesis 
originates and terminates, 
(ii) the sites that are cleaved by restriction 
endonucleases, and 
(iii) the template regions for the major gene 
product. 
If possible the helper virus genome should: 
(i) be integrated into the genome of a stable 
line of host cells (a situation that would 
effectively limit the growth of the vector 
recombinant to such cell lines) or 
(ii) consist of a defective genome, or an 
appropriate conditional lethal mutant virus, 
making vector and helper dependent upon 
each other for propagation. 
However, neither of these stipulations is a 
requirement. 
45. Review by NIH on a case-by-case basis 
means that NIH must review and set 
appropriate containment conditions before 
the work may be undertaken. NIH actions in 
such case-by-case reviews will be published 
in the Recombinant DNA Technical Bulletin. 
46. Provided the inserted DNA sequences 
are not derived from eukaryotic viruses. In 
the latter case, such experiments will be 
evaluated on a case-by-case basis. 
47. >99% pure; otherwise as for shotgun 
experiments. 
VI. Voluntary Compliance 
VI-A. Basic Policy. Individuals, 
corporations, and institutions not 
otherwise covered by the Guidelines are 
encouraged to do so by following the 
standards and procedures set forth in 
Parts I-IV of the Guidelines. In order to 
simplify discussion, reference hereafter 
to “institutions” are intended to 
encompass corporations, and 
individuals who have no organizational 
affiliation. For purposes of complying 
with the Guidelines, an individual 
intending to carry out research involving 
recombinant DNA is encouraged to 
affiliate with an institution that has an 
Institutional Biosafety Committee 
approved under the Guidelines. 
Since commerical organizations have 
special concerns, such as protection of 
proprietary data, some modifications 
and explanations of the procedures in 
Parts I-IV are provided below, in order 
to address these concerns. 
VI-B. IBC Approval. The NIH Office 
of Recombinant DNA Activities (ORDA) 
will review the membership of an 
institution’s Institutional Biosafety 
Committee (IBC) and, were it finds the 
IBC meets the requirements set forth in 
Section IV-C-2, will give its approval to 
the IBC membership. 
It should be emphasized that 
employment of an IBC member solely 
for purposes of membership on the IBC 
does not itself make the member an 
institutionally affiliated member of 
purposes of Section IV-D-2-a. 
Except for the unaffiliated members, a 
member of an IBC for an institution not 
otherwise covered by the Guidelines 
may participate in the review and 
approval of a project in which the 
member has direct financial interest, so 
long as the member has not been and 
does not expect to be engaged in the 
project. Section IV-2-d is modified to 
that extent for purposes of these 
institutions. 
VI-C. Registration. Upon approval of 
a recombinant DNA research project by 
the IBC, an institution may register the 
project by submitting to ORDA the 
information required in the 
Administrative Practices Supplement. 
VI-D. 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 Section II-D-2-a. 
Institutions not otherwise covered by 
the Guidelines will not be subject to 
Section II-D-3 by complying with these 
procedures. 
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-F-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-E. Requests for Exceptions, 
Exemptions, Approvals. Requests for 
exceptions from prohibitions, 
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 exception, 
exemption, or other approval which is 
designated by the institution as 
proprietary under Section VI-F-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-F. 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 
[ 38 ] 
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-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. 
VI-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. 
VI-F-4. Projects should be registered 
in accordance with procedures specified 
in the Administrative Practices 
Supplement. 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. The 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 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 
