Federal Register / Vol. 59, No. 127 / Tuesday. July 5, 1994 / Notices 
34505 
Recombinant DNA Activities. National 
Institutes of Health, Building 31, Room 
4B11, Bethesda, Maryland 20892, (301) 
496-9838): 
Section IV-B 4 a (5). Be adequately 
trained in good microbiological 
techniques; 
Section IV-B— 4 -a-(6). Adhere to 
Institutional Biosafety Committee- 
approved emergency plans for handling 
accidental spills and personnel 
contamination; and 
Section IV-B - 4 - a ■ (7). Comply with 
shipping requirements for recombinant 
DNA molecules (see Appendix H for 
shipping requirements and the 
Laboratory ^fety Monograph for 
technical recommendations). 
Section IV-B— 4-b. Submissions by the 
Principal Investigator to the NIH/ORDA 
The Principal Investigator shall: 
Section IV-B— l-b-(l]l. Submit 
information to NIH/ORDA for 
certification of new host-vector 
systems; 
Section IV-B— 4-b-(2). Petition NIH/ 
ORDA, with notice to the Institutional 
Biosafety Committee, for proposed 
exemptions to the NIH Guidelines; 
Section rV-B-4-b-(3). Petition NIH/ 
ORDA. with concurrence of the 
Institutional Biosafety Committee, for 
approval to conduct experiments 
specified in Sections Ill-A and III-B of 
the NIH Guidelines: 
Section rV-B-4-b-(4). Petition NIH/ 
ORDA for determination of containment 
for experiments requiring case-by-case 
review; and 
Section IV-B— 4-b-{5). Petition NIH/ 
ORDA for determination of contaiiunent 
for experiments not covered by the NIH 
Guidelines. 
Section IV-B— 4-c. Submissions by the 
Principal Investigator to the 
Institutional Biosafety Committee 
The Principal Investigator shall; 
Section IV-B— 4-c-(l). Make an initial 
determination of the required levels of 
physical and biological containment in 
accordance with the NIH Guidelines; 
Section IV-B— 4-o-{2). Select 
appropriate microbiological practices 
and laboratory techniques to be used for 
the research: 
Section IV-B-4-c-(3). Submit the 
initial research protocol and any 
subsequent changes (e.g., changes in the 
source of DNA or host-Vector system), 
if covered under 
SecUons lII-A, IIl-B, UI-C, or Ill-D, to 
the Institutional Biosafety Committee 
for review and approval or disapproval; 
and 
Section IV-B-4-c-{4). Remain in 
communication with the Institutional 
{ 106 \ 
Biosafety Committee throughout the 
conduct of the project. 
Section IV-B— 4-d. Responsibilities of 
the Principal Investigator Prior to 
Initiating Research 
The Principal Investigator shall; 
Section IV-B— 4-d-(l). Make available 
to all laboratory staff the protocols that 
describe the potential biohazards and 
the precautions to be taken; 
Section fV-B— 4-d-(2). Instruct and 
train laboratory staff in; (i) the practices 
and techniques required to ensure 
safety, and (ii) the procedures for 
dealing with accidents; and 
Section IV-B— 4— d-(3). Inform the 
laboratory staff of the reasons and 
provisions for any precautionary 
medical practices advised or requested 
(e.g., vaccinations or serum collection). 
Section IV-B— 4-e. Responsibilities of 
the Principal Investigator During the 
Conduct of the Research 
The Principal Investigator shall: 
Section IV-B— 4 - o -(l). Supervise the 
safety performance of the laboratory 
staff to ensure that the required safety 
practices and techniques are employed; 
Section IV-B- 4 - e -(2). Investigate and 
report any significant problems 
pertaining to the operation and 
implementation of containment 
practices and procedures in writing to 
the Biological Safety Officer (where 
applicable), Greenhouse/Animal 
Facility Director (where applicable), the 
Institutional Biosafety Committee, NIH/ 
ORDA, and other appropriate 
authorities (if applicable) (reports to the 
NIH/ORDA shall be sent to the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31, Room 
4Bll, Bethesda, Maryland 20892, (301) 
496-9838); 
Section IV-B- 4 - o (3). Correct work 
errors and conditions that may result In 
the release of recombinant DNA 
materials: and 
Section lV-B- 4 - e (4). Ensure the 
integrity of the physical containment 
(e.g., biological safety cabinets) and the 
biological containment (e.g., purity and 
genotypic and phenotypic 
characteristics). 
Section IV-C. Responsibilities of the 
National Institutes of Health (NIH) 
Section lV-C-1. NIH Director 
The NIH Director is responsible for: (i) 
establishing the NIH Guidelines, (ii) 
overseeing their Implementation, and 
(iii) their final interpretation. The NIH 
Director has responsibilities under the 
NIH Guidelines that involve ORDA and 
the RAC. ORDA’s responsibilities under 
the NIH Guidelines are administrative. 
Advice from the RAC is primarily 
scientific, technical, and ethical. In 
certain circumstances, there is specific 
opportunity for public comment with 
published response prior to final action. 
Section IV-C-1— a. General 
Responsibilities 
The NIH Director is responsible for; 
Section fV-C-l-a— (1). Promulgating 
requirements as necessary to implement 
the NIH Guidelines: 
Section fV-C-l-a— (2). Establishing 
and maintaining the RAC to carry out 
the responsibilities set forth in Section 
rV-C-2 (RAC membership is specified 
in its charter and in Section IV-C-2); 
and 
Section IV-C-1— a-(3). Establishing 
and maintaining ORDA to carry out the 
responsibilities defined in Section IV- 
C-3. 
Section IV-C-l-b. Specific 
Responsibilities 
In carrying out the responsibilities set 
forth in this section, the NIH Director, 
or a designee shall weigh each proposed 
action through appropriate analysis and 
consultation to determine whether it 
complies with the NIH Guidelines and 
presents no significant risk to health or 
the environment. 
Section IV-C-1-1>-(1). Major Actions 
To execute Major Actions, the NIH 
Director shall seek the advice of the 
RAC and provide an opportunity for 
public and Federal agency comment. 
Specifically, the Notice of Meeting and 
Proposed Actions to the NIH Guidelines 
shall be published in the Federal 
Register at least 15 days before the RAC 
meeting (not applicable for Expedited 
Review single patient human gene 
transfer experiments considered under 
Appendix M-Vl). The NIH Director’s 
decision, at his/her discretion, may be 
published in the Federal Register for 15 
days of comment before final action is 
taken. The NIH Director’s final decision, 
along with responses to public 
comments, sh^l be published in the 
Federal Register. The RAC and 
Institutional Biosafety Committee Chairs 
shall be notified of the following 
decisions: 
Section IV-C-l-b-(l)-{a). Changing 
containment levels for types of 
experiments that are specified in the 
NIH Guidelines when a Major Action is 
involved; 
Section IV-C-1 -h-(l)-{b). Assigning 
containment levels for types of 
experiments that are not explicitly 
considered In the NIH Guidelines when 
a Major Action Is Involved; 
Section IV-C-1 -b-{l Me). 
Promulgating and amending a list of 
classes of recombinant DNA molecules 
Recombinant DNA Research, Volume 19 
