Federal Register / Vol. 47. No. 102 / Wednesday, May 26, 1982 / Notices 
23121 
applicable], and the IBC any significant 
problems pertaining to the operation 
and implementation of containment 
practices and procedures; 
IV-B-5-€-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
IV-B-5-e-{4). Ensuring the integrity of 
the physical containment (e.g., biological 
safety cabinets) and the biological 
containment (e.g., purity, and genotypic 
and phenotypic characteristics). 
IV-C. Responsibilities ofNIH. 
IV-C-1. Director. The Director, NIH, is 
responsible for (i) establishing the NIH 
Guidelines for Research Involving 
Recombination DNA Molecules, (ii) 
overseeing their implementation, and 
(iii) their bnal interpretation. 
The Director has responsibilities 
under the Guidelines that involve the 
NIH Office of Recombinant DNA 
Activities (ORDA) and the Recombinant 
DNA Advisory Committee (RAC). 
ORDA's responsibilities under the 
Guidelines are administrative. Advice 
from the RAC is primarily scientific and 
technical. In certain circumstances, 
there is specific opportunity for public 
comment, with pi^lished response, 
before final action. 
rV-C-l-a. General Responsibilities of 
the Director, NIH. The responsibilities 
of the Director shall include the 
following: 
rV-C-l-a-(l). Promulgating 
requirements as necessary to implement 
the Guidelines; 
IV-C-l-a-(2). Establishing and 
maintaining the RAC to carry out the 
responsibilities set forth in Section IV- 
C-2. The RAC’s membership is specified 
in its charter and in Section IV-^2; 
rV-C-l-a-(3). Establishing and 
maintaining O^A to carry out the 
responsibilities defined in Section IV-C- 
3; and 
IV-C-l-a-(4). Maintaining the Federal 
Interagency Advisory Committee on 
Recombinant DNA Research established 
by the Secretary, HEW (now HHS), for 
advice on the coordination of all Federal 
programs and activities relating to 
recombination DNA, including activities 
of the RAG ^ 
IV-C-l-b. Specific Responsibilities of 
the Director, NIH. In carrying out the 
responsibilities set forth in this Section, 
the Director or a designee shall weigh 
each proposed action, through 
appropriate analysis and consulation, to 
determine that it complies with the 
Guidelines and presents no significant 
risk to health or the environment. 
lV-C-l-b-(l). Major Actions. To 
execute major actions the Director must 
seek the advice of the RAC and provide 
an opportunity for public and Federal 
agency comment Specifically, the 
agenda of the RAC meeting citing the 
major actions will be published in the 
Federal Register at least 30 days before 
the meeting, and the Director will also 
publish the proposed actions in the 
Federal Register for comment at least 30 
days before the meeting. In addition, the 
Director’s proposed decision, at his 
discretion, may be published in the 
Federal Register for 30 days of comment 
before final action is taken. The 
Director’s final decision, along with 
response to the comments, will be 
published in the Federal Register and 
the Recombinant DNA Technical 
Bulletin. The RAC and IBC chaiipersons 
will be notified of this decision. 
IV-C-l-b-(l)-(a). Changing 
containment levels for types of 
experiments that are specified in the 
Guidelines when a major action is 
involved: 
IV-C-l-b-(l)-(b). Assigning 
containment levels for types of 
experiments that are not explicitly 
considered in the Guidelines when a 
major action is involved: 
IV-C-l-b-(l)-(c). I^omulgating and 
amending a list of classes of 
recombinant DNA molecules to be 
exempt from the Guidelines because 
they consist entirely of DNA segments 
from species that exchange DNA by 
known physiological processes, or 
otherwise do not present a significant 
risk to health or the environment; 
IV-C-l-b-(l)-(d). Pennitting 
experiments speciBed by Section Ill-A 
of the Guidelines; 
IV-C-l-b-(l)-(e). Certifying new host- 
vector systems, with the exception of 
minor modifications of already certified 
systems (the standards and procedures 
for certification are described in 
Appendix I-II-a. Minor modifications 
constitute, for example, those of minimal 
or no consequence to the properties 
relevant to containment): and 
IV-C-4-4. Other NIH Components. 
Other NIH components shall be 
responsible for certifying P4 facilities, 
inspecting them periodically, and 
inspecting other recombination DNA 
facilities as deemed necessary. 
IV-C-l-b-(l)-(f). Adopting other 
changes in tl^ Guidelines. 
IV-C-l-b-(2). Lesser Actions. To 
execute lesser actions, the Director must 
seek the advice of the RAC. The 
Director’s decision will be transmitted to 
the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin: 
IV-C-l-b-(2)-(a). Interpreting and 
determining containment levels, upon 
request by ORDA; 
IV-C-l-b-(2Hb)* Changing 
containment levris for experiments that 
are specified in the Guidelines (see 
Section III); 
IV-C-l-J>-(2)-{c). Assigning 
containment levels for experiments not 
explicitly considered in Guidelines; 
IV-C-l-b-(2)-{d). Revisiflg the 
“Classification of ^ologic Aunts’’ for 
the purpose of these Guidelines [1], 
rV-C-l-b-{3). Other Actions. The 
Director’s decision will be transmitted In 
the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin: 
IV-C-l-b-(3)-(a). Interpreting the 
Guidelines for eiqjeriments to which the 
Guidelines specifically assign 
containment levels; 
IV-G-l-b-(3)-(b). Setting containment 
under Section Bl-l^l-d and Sectin 10- 
B— 3— d; 
IV-C-^l-h-(3)-{c). Approving minor 
modifications of aheady certified host- 
vector systems (the standards and 
procediues for such modifications are 
described in Appendix I-H); 
rV-C-l-b-(3)-(d). Decertifying 
already certified host-vector systems; 
IV-C-l-b-(3-(e). Adding new entries 
to the list of molecules toxic for 
vertebrates (see Appendix F); 
IV-C-l-b-(3}-(f). Approving the 
cloning of toxin ^nes in host-vector 
systems other than E. coli K-12 (See 
Appendix F); and 
rV-C-l-b-(3)-(g). Determining 
appropriate containment conditions for 
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