Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
6743 
IV— E— 1— b— (5). The Director, at the end 
of 36 months from the time these 
Guidelines are promulgated, will report 
on the Guidelines, their administration, 
and the potential risks and benefits of 
this research. In doing so, the Director 
will consult with the RAC and the 
Federal Interagency Committee. Public 
comment will be solicited on the draft 
report and taken into account in 
transmitting the final report to the 
Assistant Secretary for Health and the 
Secretary, HEW. 
IV-E-2. Recombinant Advisory 
Committee. The NIH Recombinant DNA 
Advisory Committee (RAC) is 
responsible for carrying out specified 
functions cited below as well as others 
assigned under its charter or by the 
Secretary, HEW, the Assistant Secretary 
for Health, and the Director, NIH. 
The members of the committee shall 
be chosen to provide, collectively, 
expertise in scientific fields relevant to 
recombinant DNA technology and 
biological safety — e g., microbiology, 
molecular biology, virology, genetics, 
epidemiology, infectious diseases, the 
biology of enteric organisms, botany, 
plant pathology, ecology, and tissue 
culture. At least 20 percent of the 
members shall be persons 
knowledgeable in applicable law, 
standards of professional conduct and 
practice, public attitudes, the 
environment, public health, occupational 
health, or related fields. Representatives 
from Federal agencies shall serve as 
nonvoting members. Nominations for the 
RAC may be submitted to the NIH 
Office of Recombinant DNA Activities. 
All meetings of the RAC will be 
announced in the Federal Register, 
including tentative agenda items, 30 
days in advance of the meeting, with 
final agendas (if modified) available at 
least 72 hours before the meeting. No 
item defined as a major action under 
Section IV— E— 1 — b — (1) may be added to 
an agenda after it appears in the Federal 
Register. 
IV-E-2-a. The RAC shall be 
responsible for advising the Director. 
NIH. on the actions listed in Section IV- 
E-l-b -(1) and -(2). 
1V-E-3. The Office of Recombinant 
DNA Activities. ORDA shall serve as a 
focal point for information on 
recombinant DNA activities and provide 
advice to all within and outside NIH, 
including Institutions, Biological Safety 
Committees. Principal Investigators. 
Federal agencies, State and local 
governments, and institutions in the 
private sector. ORDA shall carry out 
such other functions as may be 
delegated to it by the Director, NIH, 
including those authorities described in 
Section IV-E-l-b-(3). In addition ORDA 
shall be responsible for the following: 
IV-E-3-a. Review and approval of 
Institutional Biosafety Committee (IBC) 
membership: 
IV-E-3-b. Registration of recombinant 
DNA projects: and 
IV-E-3-c. Review of Memoranda of 
Understanding and Agreement (MUAs), 
and approval of those that conform to 
the Guidelines. In so doing, ORDA shall: 
IV-E-3-c-(l). Conduct an independent 
evaluation of the containment levels 
required for the research covered by 
these Guidelines: 
IV-E-3-c-(2). Determine whether the 
physical and biological containment 
levels approved by the IBC are in 
accordance with the requirement of the 
Guidelines: 
IV-E-3-c-(3). Notify Institutions and 
the IBC chairperson in a timely fashion 
when MUAs (including changes in 
ongoing projects) do not conform to the 
Guidelines, and inform them of 
corrective measures to be taken: 
IV-E-3-c-(4). Publish in the Federal 
Register: 
I V-E-3-c-(4 )— (a). Announcements of 
Recombinant DNA Advisory Committee 
(RAC) meetings and agendas 30 days in 
advance, with publication of the 
Director's proposed decision for 30 days 
of public and Federal agency comment 
followed by a published response, on 
any action listed in Section IV-E-l-b- 
(1); and 
IV-E-3-c-(4)-(b). Announcements of 
RAC meetings and agendas 30 days in 
advance on any action listed in Section 
IV-E-l-b-(2). 
Note. — If the agenda for an RAC meeting is 
modified, ORDA shall make the revised 
agenda available to anyone, upon request, at 
least 72 hours in advance of the meeting. 
IV-E-3-c-{5). Publish the 
Recombinant DNA Technical Bulletin; 
and 
IV-E-3-c-(6). Serve as executive 
secretary to the RAC. 
IV-E-4. Other NIH Components. 
Other NIH components shall be 
responsible for: 
IV-E-4-a. Awarding no grant or 
contract involving recombinant DNA 
techniques unless a properly executed 
MUA has been received; 
IV-E-4-b. Certifying P4 facilities, 
inspecting them periodically, and 
inspecting other recombinant DNA 
facilities as deemed necessary; and 
IV-E-4-c. Announcing and 
distributing certified HV2 and HV3 host- 
vector systems (see Section II-E-3). 
(See Administrative Practices 
Supplement for additional information 
on the administrative procedures of 
ORDA and other NIH components.) 
IV-F. Registration 
IV-F-1. Required Registration. 
Institutions receiving NIH funds for 
recombinant DNA projects shall inform 
NIH of all recombinant DNA projects at 
the Institution. A non-NIH project, after 
approval by the Institutional Biosafety 
Committee, shall be registered with NIH 
within 30 days of initiation. Applications 
for NIH projects must be accompanied 
by a Memorandum of Understanding 
and Agreement (MUA). 
For information on MUAs or 
equivalent documents that must be 
submitted for registration of 
recombinant DNA projects, see the 
Administrative Practices Supplement 
(APS). 
IV-F-2. Federal Agency Registration. 
Institutions at which recombinant DNA 
research projects funded by other 
Federal agencies are conducted need 
not register such projects with NIH 
when the Federal agency maintains a 
registry and provides such information 
to NIH. Registration of non-NIH-funded 
research with the NIH Office of 
Recombinant DNA Activities (ORDA) is 
described in the APS. (The information 
required is similar to that in an MUA for 
NIH-supported research.) 
IV-F-3. Voluntary Registration and 
Certification. Any institution that is not 
required to comply with the Guidelines 
may nevertheless register recombinant 
DNA research projects with NIH by 
submitting the appropriate information 
to ORDA. NIH will accept requests for 
certification of host-vector systems 
proposed by the institution. The 
submitter must agree to abide by the 
physical and biological containment 
standards of the NIH Guidelines. 
IV-F-4. Disclosure of Information. 
Institutions are reminded that they 
should consider applying for a patent 
before submitting information to DHEW 
which they regard as potentially 
proprietary. (Provisions for protection of 
proprietary information as permitted 
under current DHEW authorities are 
discussed in Part VI of these 
Guidelines.) 
IV-G. Compliance. As a condition for 
NIH funding of recombinant DNA 
research, Institutions must ensure that 
such research conducted at or 
sponsored by the Institution, 
irrespective of the source of funding, 
shall comply with these Guidelines. The 
policies on noncompliance are as 
follows: 
IV-G-1. All NIH-funded projects 
involving recombinant DNA techniques 
must comply with the NIH Guidelines. 
Noncompliance may result in (i) 
suspension, limitation, or termination of 
financial assistance for such projects 
and of NIH funds for other recombinant 
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