Ill- A. Policy. 
III-B. Requirements and Procedures 
for NTH-Supported Research in 
Countries with Guidelines. 
III- C. Requirements Regarding Coun- 
tries Which Have Not Adopted 
Guidelines. 
IV. Registration of Recombinant DNA 
Projects. 
IV. -A. NIH-Supported Projects. 
IV- E. Required Registration of Non- 
NIH Projects. 
IV-C. Voluntary Registration of Non- 
NIH Projects. 
IV-D. Procedures for Registration. 
IV- E. Review. 
V. Lowering of Containment Levels for 
Purified DNA and Characterized 
Clones. 
V- A. Purified DNA Other Than Plas- 
mids, Bacteriophages, and Other 
Viruses. 
V- B. Characterized Clones of DNA Re- 
combinants. 
VI. Exceptions and Exemptions to the 
Guidelines. 
VI- A. Exceptions. 
VI-B. Exemptions 
VI-C. Requests for Exceptions and Ex- 
emptions. 
VII. Illustration of Memorandum of 
Understanding and Agreement. 
Appendix C— NTH Polices and Admin- 
istrative Procedures fop. Experi- 
ments Subject to the NIH Guide- 
lines 
The policies and procedures in this 
appendix appiy only to recombinant 
DNA research subject to the NIH 
guidelines (see Ft. I of the guidelines). 
These policies and procedures are 
mandatory for all recombinant DNA 
research conducted at institutions re- 
ceiving any funds for recombinant 
DNA research from NIH. This appen- 
dix supersedes previous announce- 
ments published in the October 17, 
1977. and February 15, 1978. issues of 
the NIH Guide for Grants and Con- 
tracts and previous notices placed in 
application kits for Public Health 
Service research and training grants. 
This appendix contains NIH policies 
and procedures in effect as of the date 
of publication of the final revised 
guidelines. These policies and proce- 
dures can be superseded by subsequent 
issuances. For current NIH policies, 
contact the NIH Office of Recombin- 
ant DNA Activities (ORDA). 
I. General Requirements. 
A. Institutional Biosafety Commit- 
tee U BCD. Each institution at which 
recombinant DNA research subject to 
the guidelines is being conducted must 
have a standing biosafety committee. 
Suggestions for the composition of 
such a committee are discussed under 
Part IV of the guidelines, which also 
NOTICES 
discusses the roles and responsibilities 
of principal investigators and institu- 
tions. A roster of the members of the 
Institutional Biosafety Committee 
(IBC) must be submitted to NIH. 
The minim tun information must in- 
clude the names, addresses, occupa- 
tions. qualifications, and curricula 
vitae of the chairperson and members 
of the committee. This information 
must be submitted to: Office of Re- 
combinant DNA Activities, National 
Institutes of Health. Room 4A52, 
Building 31, Bcthesda, Md. 20014. 
The membership of IBC’s is subject 
to review by ORDA for compliance 
with recommendations stated in the 
guidelines. It is the responsibility of 
each institution to update this infor- 
mation at least annually. As stipulated 
in the guidelines, ORDA will assist in 
the formation of an Area Biosafety 
Committee (ABC) when appropriate. 
Such a committee will be necessary 
when additional expertise from out- 
side a given institution is necessary for 
the IBC to fulfill its functions. 
B. Approval and Registration of Pro- 
jects. Central to the implementation of 
the guidelines is the review of pro- 
posed projects by the IBC. When the 
IBC has approved the project, the ex- 
periments may be initiated (except for 
experiments requiring F4 physical 
containment, which require prior NIH 
approval: special procedures cover 
NIH awards, see sec. II-D below). The 
institution is responsible for register- 
ing approved projects with NIH. 
ORDA will review approved projects 
and notify investigators and institu- 
tions of the results of such review. 
(See sec. II-B for requirements for 
competing and noncompeting NIH ap- 
plications. See sec. II-E for changes in 
ongoing projects, and Pt. TV for infor- 
mation on registration.) 
II. Requirements and Procedures for 
NIH-Supported Projects. This section 
describes policies and procedures lor 
projects supported by NiH. 
A. Memorandum of Understanding 
and Agreement (MU A). Each applica- 
tion to the National Institutes of 
Health for a project which involves ex- 
periments subject to the NIH guide- 
lines for recombinant DNA research 
(see sec. I-E of the guidelines) must be 
accompanied by an MUA prepared in 
the format shown in the attached il- 
lustration. Applicants are urged to 
follow the sequence and format of the 
illustration as closely as possible. 
An application submitted to NIH 
without an attached MUA is incom- 
plete and will not be reviewed until a 
properly executed MUA is provided. 
1. Contents of an MUA. An MUA 
must contain the following sections: 
a. Description. A description of each 
proposed project, and the name of the 
individual investigator responsible for 
33091 
the research if other than the princi- 
pal investigator. 
Descriptions must Include informa- 
tion on: 
(1) source(s) of DNA, 
(2) nature of inserted DNA se- 
quences, and 
(3) hosts and vectors to be used. 
The descriptions must be sufficient 
to provide information about the ex- 
periments without need for reference 
to other documents. Each perform- 
ance site must be identified with the 
name(s) of the organization, city, and 
State. Ordinarily, no more than two 
pages of description for each series of 
experiments are necessary. 
b. Assessment of Containment 
Levels. An assessment of the physical 
and biological containment levels re- 
quired by the current NIH guidelines 
for each series of experiments. 
c. Statement by Principal Investiga- 
tor. A specific brief statement by the 
principal investigator agreeing to 
abide by the provisions of the NIH 
guidelines and the requirements con- 
tained in this appendix concerning 
shipment and transfer of recombinant 
DNA materials (see sec. II-F of this 
appendix). 
The principal investigator must also 
attest to the accuracy of the informa- 
tion in the MUA (see illustration in 
this appendix). 
d. Information concerning IBC 
review: 
(1) When facilities are in existence, a 
certification is required indicating that 
the IBC has reviewed the facilities and 
the proposed project(s) and found 
them to be in compliance with the 
NTH Guidelines, this Appendix, and 
other specific NIH instructions. The 
date of the IBC review must be speci- 
fied. 
(2) When facilities are proposed or 
are under construction or renovation 
at the time of the application, an as- 
surance in lieu of a certification must 
be provided. The assurance indicates 
that the IBC has reviewed the pro- 
posed project and the plans for the fa- 
cilities proposed or under construction 
or renovation. The assurance must in- 
clude a statement that recombinant 
DNA experimentation will not occur 
until the completed facility has been 
reviewed by the IBC and an amend- 
ment to the MUA (i.e., the certifica- 
tion described in subparagraph (1)), 
has been submitted to NIH. 
NoTE:Some MUA's may have to in- 
corporate a certification as well as an 
assurance if there are both certified 
facilities and facilities under construc- 
tion or renovation. 
e. Statement P-egarding Continuing 
Compliance. A statement by the ap- 
propriate institutional official that the 
IBC will insure compliance with the 
Guidelines throughout the duration of 
the project. 
FEDERAL REGISTER, VOL. 43, NO. 146 — FRIDAY, JULY 28, 1978 
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