Fcderai Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
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Other NIH components shall be 
responsible for certifying maximum 
containment (BL4) facilities, inspecting 
them periodically, and inspecting other 
recombinant DNA facilities as deemed 
necessary. 
Section IV-D. Compliance with the Nlti 
Guidelines 
As a condition for NIH funding of 
recombinant DNA research, institutions 
shall ensure that such resecirch 
conducted at or sponsored by the 
institution, irrespective of the source of 
funding, shall comply with the NIH 
Guidelines. The policies on 
noncompliance are as follows: 
All NlH-funded projects involving 
recombinant DNA techniques must 
comply with the NIH Guidelines. Non- 
compliance may result in: (i) 
suspension, limitation, or termination of 
financial assistance for such projects 
and of NIH funds for other recombinant 
DNA research at the institution, or (ii) 
a requirement for prior NIH approval of 
any or all recombinant DNA projects at 
the institution. 
All non-NIH funded projects 
involving recombinant DNA techniques 
conducted at or sponsored by an 
institution that receives NIH funds :or 
projects involving such techniques must 
comply with the NIH Guidelines. 
Noncompliance may result in; (i) 
suspension, limitation, or termination of 
NIH funds for recombinant DNA 
research at the institution, or (ii) a 
requirement for prior NIH approval of 
any or all recombinant DNA projects at 
the institution. 
Information concerning 
noncompliance with the NIH Guidelines 
may be brought forward by any person. 
It should be delivered to both NIH/ 
ORDA and the relevant institution. The 
institution, generally through the 
Institutional Biosafety Gommittee, shall 
take appropriate action. The institution 
shall forward a complete report of the 
incident recommending any further 
action to the Office of Recombinant 
DNA Activities, National Institutes of 
Health, Building 31, Room 4B11, 
Bethesda, Maryland 20892, (301) 496- 
9838. 
In cases where NIH proposes to 
suspend, limit, or terminate financial 
assistance because of noncompliance 
with the NIH Guidelines, applicable 
DHHS and Public Health Service 
procedures shall govern. 
Section IV-E. Voluntary Compliance 
Section lV-E-1. Basic Policy 
Individuals, corporations, and 
institutions not otherwise covered by 
the NIH Guidelines are encouraged to 
do so by following the standards and 
procedures set forth in Sections I 
through rv. 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 NIH 
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 NiH Guidelines. 
Since commercial organizations have 
special concerns, such as protection of 
proprietary data, some modifications 
and explanations of the procedures are 
provided in Sections IV-E-2 tlirough 
rV-E-5-b in order to address these 
concerns. 
Section IV-E-2. Institutional Biosafety 
Committee Approval 
It should be emphasized that 
emplo)Tnent of an Institutional 
Biosafety Committee member solely for 
purposes of membership on the 
Institutional Biosafety Committee does 
not itself make the member an 
institutionally affiliated member. Except 
for the unaffiliated members, a member 
of an Institutional Biosafety Committee 
for an institution not otherwise covered 
by the NIH Guidelines may participate 
ip the review and approval of a project 
in which the member has a direct 
financial interest so long as the niember 
has not been, and does not expect to be, 
engaged in the project. Section f\'-B-2- 
a-(4) is modified to that exient for 
purposes of these institutions. 
Section IV-E-3. Certification of Host- 
Vector Systems 
A host-vector system may be 
proposed for certification by the NIH 
Director in accordance with the 
procedures set forth in Appendix 1 II. 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 FV-E-5-a w'ill 
be issued only after consultation with 
the institution as to the content of the 
notice. 
Section IV-E— 4. Requests for 
Exemptions and Approvals 
Requests for exemptions or other 
approvals as required by the NIH 
Guidelines should be submitted based 
on the procedures set forth in Sections 
I through IV. 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 IV-E-5-a will 
be issued only after consultation with 
the institution as to the content of the 
notice. 
Section lV-E-5. Protection of 
Proprietary Data 
Section fV-E-5-a. General 
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 or financial information 
that is obtained from a person and that 
is privileged or confidential.” Under 18 
U.S.C. 1905, it is a criminal offense for 
an officer or employee of the U.S. or any 
Federal department or agency to 
publish, divulge, disclose, or make 
known “in any maimer 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 
RAC are “special Government 
employees.” 
In submitting to NIH for purposes of 
voluntary compliance with the NIH 
Guidelines, an institution may designate 
those items of information which the 
institution believes constitute trade 
secrets, privileged, confidential, 
commercial, or financial information. 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. 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 NIH Director is 
necessary to protect against an 
imminent hazard to the public or the 
environment. 
[7CJ8] 
Recombinant DNA Research, Volume 19 
