33130 
NOTICES 
of the committee are in the process of 
being formalized for the benefit of the 
scientific community and the public. 
NIH Components. A new section in 
the PRG-NIH now describes all other 
functions of NIH. including the re- 
sponsibilities of the Office of Recom- 
binant DNA Activities <ORDA). It 
should be noted that the responsibility 
of the peer review groups (study sec- 
tions) for an independent assessment 
of the recombinant DNA research pro- 
tocols has been eliminated. This re- 
sponsibility would be solely ORDA's in 
conjunction with the local institution- 
al biosafety committee. 
Several commentators urged new re- 
sponsibilities for ORDA and additional 
personnel to fulfill them. Some recom- 
mended that the Office be responsible 
for inspecting and certifying laborato- 
ries at the P3 level. Currently NIH has 
the responsibility for certifying only 
P4 facilities. At present NIH operates, 
at the Frederick Cancer Research 
Center in Frederick. Md.. and at NIH 
in Bethesda the only P4 facilities in 
this country. Responsibilities for certi- 
fication falls to NIH because of the 
special nature of P4 faciliiies. P3 fa- 
cilities. on the other hand, do not re- 
quire special expertise at the national 
level, and there is no need for them to 
be nationally certified. As specified, 
the local institution has and should 
have responsibility for monitoring and 
certifying PI. P2. and P3 facilities. 
Several commentators urged an in- 
creased flow of information to the 
public and scientific community alike. 
ORDA is playing a key role in dissemi- 
nating information through the Re- 
combinant DNA Technical Bulletin. 
This is a new publication that at- 
tempts to link investigators involved in 
recombinant DNA research, both in 
the United States and abroad, with 
the active advisory groups and organi- 
zations. In light of comments received, 
the bulletin will include in the future 
far more information for institutional 
biosafety committees and for the sev- 
eral advisory groups at the national 
and social levels. 
In response to another suggestion, 
ORDA will be as available as possible 
to State and local governments for 
technical advice. Currently ORDA 
serves as a clearinghouse for informa- 
tion related to recombinant DNA ac- 
tivities internationally, nationally, and 
locally. 
Registration and compliance 
It has become clear over the 2 years 
of administration of the guidelines 
that a new section must be added on 
general requirements for registration 
with NIH. This should apply not only 
to NIH grantees and contractors, but 
also to the private sector on a volun- 
tary basis. Further. In light of the 
review of DHEW policies on the pat- 
enting of recombinant DNA research 
inventions, a section on disclosure of 
information is also necessary. Finally, 
as suggested, a section on compliance 
with the guidelines is needed. Thus 
new sections C and D on registration 
(including disclosure of information) 
and compliance have been added to 
the roles and responsibilities section of 
the PRG NIH. These provisions, rec- 
ommended in many comments on the 
guidelines and at the December public 
hearing, are necessary in the absence 
of legislation. 
Registration. A number of commen- 
tators asked that the guidelines speci- 
fy the requirements for registration. 
Accordingly, a new r subsection has 
been added delineating the elements. 
If other requirements need be added, 
notice will be given of any change. All 
projects subject to the guidelines must 
be registered with ORDA. Voluntary 
registration for the private sector is 
provided in the revision, in response to 
suggestions by private-sector represen- 
tatives. 
Disclosure. Many comments, as pre- 
viously noted, were directed to the 
protection of proprietary information. 
A new subsection outlining the ele- 
ments for protection of proprietary 
data is Included in response to these 
suggestions. 
One commentator urged that no pat- 
ents be granted for recombinant DNA 
research. 
Shortly after the release of the 
Guidelines in 1976. NIH received a 
letter requesting a review of DHEW 
policies relating to the patenting of re- 
combinant DNA research Inventions. 
The letter prompted NIH to revtew 
current patent regulations governing 
institutional patent agreements and to 
consider how recombinant DNA re- 
search inventions should be handled 
under those terms. On the basis of ex- 
tensive Department and Interagency 
Committee review. It was agreed that, 
at least for the present, recombinant 
DNA research inventions developed 
under DHEW, NIH support should 
continue to be administered within 
current HEW patent agreements. 
Each agreement, however, would re- 
quire assurance of compliance with 
the physical and biological contain- 
ment standards set forth in the Guide- 
lines as a condition for the granting of 
a license. 
Policy on Noncompliance. A com- 
mentator urged that a system of fines 
be spelled out. Monetary fines, more 
appropriate for regulations under leg- 
islation. will not be specified or as- 
sessed under the Guidelines; NIH has 
no current authority to impose fines. 
It will, however, suspend, limit, or ter- 
minate a grant or contract for non- 
compliance. A commentator recom- 
mended that penalty procedures be 
specified. Should it be necessary to 
suspend, limit, or terminate a grant, 
appropriate HEW procedures will be 
followed. 
In summary. Part IV of the Guide- 
lines on Roles and Responsibilities has 
been substantially revised in response 
to suggestions from many commenta- 
tors. The PRG NIH now provides even 
more opportunity for advice from the 
local to the national level. The spirit 
of cooperation and effective overview- 
will be enhanced by the PRG-NIH at 
the local level between the research 
community and the public and at the 
national level among Federal agencies, 
the scientific community, and the pri- 
vate sectors. 
Proposed Action. Environmental Impact 
Assessment 
The recommendations of the Recom- 
binant Advisory Committee have been 
carefully weighed, along with other 
public and scientific comments re- 
ceived on the Roles and Responsibil- 
ities section. In general, the PRG- 
RAC proposals have been adopted in 
the PRG NIH. with certain modifica- 
tions based on issues raised by the Di- 
rector's Advisory Committee and other 
commentators. The issues considered 
by the Director and a discussion of 
them follow. 
The Draft EIS on the original 
Guidelines published in 1976 elicited a 
number of recommendations that 
greater detail be provided on NIH im- 
plementation of the Guidelines for 
NIH grantees and contractors. They 
also recommended extending the 
Guideline standards to ail public and 
private sectors where such research is 
being conducted. More specifically, 
commentators expressed the following 
concerns. 
•That the membership of institu- 
tional biohazards committees (IBCs) 
should include specialists in popula- 
tion dynamics, ecology, and other dis- 
ciplines; 
•That the Draft EIS did not empha- 
size relevant safety training for labo- 
ratory personnel; 
•That the NIH Guidelines had a far 
too limited scope, not reaching re- 
search in the non-Federal sectors; 
•That the termination of NIH funds 
for violation of the Guidelines may 
not be the best sanction; 
•That the Inspection, certification, 
and surveillance processes might not 
insure compliance; 
•That more attention should be 
given to medical surveillance and epi- 
demiologic measures in the event of 
possible Infection of the laboratory 
worker or contamination of the envi- 
ronment; and 
•That local and State authorities be 
involved in the review and contain- 
ment processes at the local level. 
These comments were specifically 
addressed in the Final EIS. It was 
FEDERAL REGISTER, VOL 43, NO. 14*— FRIDAY, JULY 28, 1978 
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