60126 
NOTICES 
IV-D-5-a-( 1 ). Initiate or modify no 
recombinant DNA research subject to 
the Guidelines until that research, or 
the proposed modification thereof, has 
been approved by the Institutional 
Biosafety Committee (IBC) and has 
met all other requirements of the 
Guidelines and the Administrative 
Practices Supplement (APS), and 
make changes to conform if the NIH 
Office of Recombinant DNA Activi- 
ties' (ORDA's) review so requires; 
IV-D-5-a-(2). Report within 30 days 
to the IBC and NIH (ORDA) all sig- 
nificant problems with and violations 
of the Guidelines and all significant 
research-related accidents and ill- 
nesses; 
IV-D-5-a-(3). Report to the IBC and 
to NIH (ORDA) new information bear- 
ing on the Guidelines; 
IV-D-5-a-(4). Be adequately trained 
in good microbiological techniques; 
TV-D-5-a-(5). Adhere to IBC-ap- 
proved emergency plans for dealing 
with accidental spills and personnel 
contamination; and 
IV-D-5-a-(6). Comply with shipping 
requirements for recombinant DNA 
molecules. (See Section II-C for ship- 
ping requirements. Laboratory Safety 
Monograph for technical recommen- 
dations, and the APS for administra- 
tive instructions and procedures. The 
requesting laboratory must be in com- 
pliance with the NIH Guidelines and 
under appropriate review by its IBC, 
and the sending investigator must 
maintain a record of all shipments of 
recombinant DNA materials.) 
IV-D-5-b. Submissions by the PI to 
NIH. The PI shall: 
IV-D-5-b-( 1 ). Submit information to 
NIH (ORDA) in order to have new 
host-vector systems certified; 
rV-D-5-b-f2). Petition NIH, with 
notice to the EBC, for exemptions to 
these Guidelines (see Sections I-E-4 
and I-E-5 and, for additional informa- 
tion on procedures, the APS); and 
IV-D-5-b-<3). Petition NIH, with 
concurrence of the EBC, for exceptions 
to the prohibitions under these Guide- 
lines (see Section I-D and, for addi- 
tional information on procedures, the 
APS). 
IV-D-5-c. Submissions by the PI to 
the IBC. The PI shall: 
IV-D-5-c-(l). Make the initial deter- 
mination of the required levels of 
physical and biological containment in 
accordance with the Guidelines; 
IV-D-5-c-(2). Select appropriate mi- 
crobiological practices and laboratory 
techniques to be used in the research; 
IV-D-5-c-(3-). Submit the initial re- 
search protocol (and also subsequent 
changes — e.g., changes in the source of 
DNA or host- vector system, which re- 
quire a new of revised Memorandum 
of Understanding and Agreement) to 
the IBC for review and approval or 
disapproval; and 
FEDERAL 
IV-D-5-c-<4). Remain in communica- 
tion with the IBC throughout the con- 
duct of the project. 
IV-D-5-d. PI Responsibilities After 
Approval but Prior to Initiating the 
Research. The PI is responsible for: 
rV-D-5-d-(l). Making available to 
the laboratory staff copies of the ap- 
proved protocols that describe the po- 
tential biohazards and the precautions 
to be taken; 
IV-D-5-d-(2). Instructing and train- 
ing staff in the practices and tech- 
niques required to ensure safety and 
in the procedures for dealing with ac- 
cidents; and 
IV-D-5-d-(3). Informing the staff of 
the reasons and provisions for any pre- 
cautionary medical practices advised 
or requested, such as vaccinations or 
serum collection. 
IV-D-5-e. PI Responsibilities During 
the Conduct of the Approved Research. 
The PI is responsible for: 
IV-D-5-e-(l). Supervising the safety 
performance of the staff to ensure 
that the required safety practices and 
techniques are employed; 
IV-D-5-e-(2). Investigating and re- 
porting in writing, to ORDA, the Bio- 
logical Safety Officer (where applica- 
ble), and the EBC any significant prob- 
lems pertaining to the operation and 
implementation of containment prac- 
tices and procedures; 
IV-D-5-e-<3). Correcting work errors 
conditions that may result in the re- 
lease of recombinant DNA materials; 
IV-D-5-e-<4). Ensuring the integrity 
of the physical containment (e.g., bio- 
logical safety cabinets) and the bio- 
logical containment (e.g., purity, and 
genotypic and phenotypic characteris- 
tics); and 
IV-D-5-e-(5). Publications. Pis are 
urged to include, in all publications re- 
porting on recombinant DNA research, 
a description of the physical and bio- 
logical containment procedures em- 
ployed. 
IV-E. Responsibilities of NIH 
IV-E-1. Director. The Director, NIH, 
is responsible for (i) establishing the 
NIH Guidelines in recombinant DNA 
research, (ii) overseeing their imple- 
mentation, and (iii) their final inter- 
pretation. 
The Director has a number of re- 
sponsibilities under the Guidelines 
that involve the NIH Office of Recom- 
binant DNA Activities (ORDA) and 
the Recombinant DNA Advisory Com- 
mittee (RAC). ORDA’s responsibilities 
under the Guidelines are administra- 
tive. Advice from the RAC is primarily 
scientific and technical. In certain cir- 
cumstances, there is specific opportu- 
nity for public comment, with pub- 
lished response, before final action. 
IV-E-l-a. General Responsibilities 
of the Director, NIH. The responsibil- 
ities of the Director shall include the 
following: 
REGISTER, VOL 43, NO. 247— FRIDAY, DECEMBER 
[ 48 ] 
IV-E-l-a-( 1). Promulgating require- 
ments as necessary to implement the 
Guidelines; 
EV-E-l-a-(2). Establishing and main- 
taining the RAC to carry out the re- 
sponsibilities set forth in Section IV- 
E-2. The RAC's membership is speci- 
fied in its charter and in Section IV-E- 
2 . 
IV-E-l-a-(3). Establishing and main- 
taining ORDA to carry out the respon- 
sibilities defined in Section IV-E-3; 
and 
IV-E-l-a-(4). Maintaining the Fed- 
eral Interagency Advisory Committee 
on Recombinant DNA Research estab- 
lished by the Secretary, HEW, for 
advice on the coordination of all Fed- 
eral programs and activities relating to 
recombinant DNA, including activities 
of the RAC. 
EV-E-1 -b. Specific Responsibilities 
of the Director, NIH. In carrying out 
the responsibilities set forth in this 
Section, the Director shall weigh each 
proposed action, through appropriate 
analysis and consultation, to deter- 
mine that it complies with the Guide- 
lines and presents no significant risk 
to health or the environment. 
rV-E-l-b-(l). The Director is respon- 
sible for the following major actions 
(For these, the Director must seek the 
advice of the RAC and provide an op- 
portunity 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 deci- 
sion, at his discretion, may be pub- 
lished 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 Reg- 
ister and the Recombinant DNA Tech- 
nical Bulletin. The RAC and IBC 
chairpersons will be notified of this 
decision): 
IV-E-I-b-GMa). Changing contain- 
ment levels for types of experiments 
that are specified in the Guidelines 
when a major action is involved; 
IV-E-l-b-<l)-(b). Assigning contain- 
ment levels for types of experiments 
that are not explicitly considered in 
the Guidelines when a major action is 
involved; 
IV-E-l-b-GMc). Certifying new 
host-vector systems, with the excep- 
tion of minor modifications of already 
certified systems [The standards and 
procedures for certification are de- 
scribed in Section II-D-2-a. Minor 
modifications constitute, for example, 
those of minimal or no consequence to 
the properties relevant to contain- 
ment. See the Administrative Pr?c- 
22, 1978 
