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Federal Register / Vol. 51, No. 88 / Wednesday, May 7, 1986 / Notices 
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, references 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 
IBC approved under the Guidelines. 
Since commercial 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 ORDA will review the 
membership of an institution's IBC, and 
where it finds the IBC meets the 
requirements set forth in Section IV-B-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 for 
purposes of Section IV-B-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 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. 
VI-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-II-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 t'o 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 tum 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 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, 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-4. Presukmission 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. 
VI-E—l-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. 
The ORDA 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. 
VI-E-4-c. The 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 at 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 
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Recombinant DNA Research, Volume 1 1 
