38068 
NOTICES 
between the scientific and the public 
policy implications, public members 
now serve on the RAC and additional 
public members may be added. Cur- 
rent public members are Dr. Emmette 
S. Redford. Ashbel Smith Professor of 
Govemement and Public Affairs. 
Lyndon B. Johnson School of Public 
Affairs. University of Texas at Austin; 
and Dr. LeRoy Walters. Director, 
Center for Bioethics. Kennedy Insti- 
tute, Georgetown University. Both 
have served the public Interest well 
and have done a superb job as have all 
members of the committee. The task 
for all RAC members has been enor- 
mous and their work and spirit of co- 
operation have been exemplary. 
In order to ensure fairness, and sen- 
sitivity to the public commentators, 
solicitation of nominations for open- 
ings on the RAC will be in accord with 
the recommendations of the NIH 
Grants Peer Review Study Team con- 
cerning announcements of vacancies 
on committees. Thus. NIH will pub- 
lish. periodically, an announcement of 
upcoming vacanices on the RAC with 
Instructions on how to submit nomina- 
tions. By this means I will be able to 
consider carefully a wide spectrum of 
nominations and assure appropriate 
representation suited to the needs of 
this committee. 
One commentator suggested that 
representatives from Federal agencies 
serve on the RAC. Several agencies, in- 
cluding the National Science Founda- 
tion. the Department of Energy, and 
the Department of Agriculture, have 
liaison representatives who come regu- 
larly to the RAC meetings and. of 
course, the Federal Interagency Com- 
mittee is kept fully informed of the ac- 
tivities of this committee. 
It was also recommended by a com- 
mentator that the NIH finance the 
cost of attendance at RAC meetings 
by interest members of the public. For 
the present I do not believe such a 
policy is necessary, especially in light 
of the responsibilities of the DAC for 
public oversight where public wit- 
nesses may be Invited and their ex- 
penses paid (as they were at the De- 
cember 1977 hearing). All RAC meet- 
ings are announced in the Federal 
Register and are open to the public. 
In sum. the operations of the RAC 
have been more c> A arly detailed in the 
PRG-NIH. The procedures for the se- 
lection of members and the operations 
of the committee have been, or are in 
the process of being, formalized for 
the benefit of the scientific communi- 
ty and the public. 
NIH Components. A new section now 
describes all other functions of the 
NIH Including the responsibilities of 
the Office of Recombinant DNA Activ- 
ities (ORDA). Several commentators 
at the public hearing in 1976 urged 
that the NIH create an office to co- 
ordinate recombinant DNA activities. 
On the basis of these suggestions. 
ORDA was created and Dr. William 
Gartland was named Director. Since 
its creation. ORDA has done a splen- 
did job in fulfilling very difficult tasks 
in the implementation of the NIH 
Guidelines. Dr. Garland, who also 
serves as Executive Secretary to the 
RAC. has provided a focus for coordi- 
nation of activities within the NIH 
and with institutional biosafety com- 
mittees. 
It is important to note that the re- 
sponsibility of the NIH peer review 
groups (e g., study sections) for an in- 
dependent assessment of the recom- 
binant DNA research protocols has 
been eliminated. This responsibility 
will now solely be that of ORDA in 
conjunction with the Institutional bio- 
safety committee. In the 1V4 years of 
our experience, such review by NIH 
peer review groups has been found to 
be unnecessary and an additional 
burden on these groups. 
Several commentators urged new re- 
sponsibilities for ORDA and additional 
personnel to fulfill them. Several 
urged that ORDA be responsible lor 
Inspecting and certifying laboratories 
at the P3 level. At the present time P4 
facilities are operating at the Freder- 
ick Cancer Research Center in Freder- 
ick. Md. and at the NIH in Bethcsda, 
Md; no other P4 facilities for recom- 
binant DNA research are in operation 
nationally. The NIH has the responsi- 
bility under the Guidelines to certify 
P4 facilities because of their special 
nature. However, a P3 facility does not 
require special expertise at a national 
level; and there is no need for national 
certification of P3 facilities. As speci- 
fied. the local Institution has responsi- 
bility for monitoring and certifying fa- 
cilities from the PI to the P3 level and 
that, indeed, should be a local respon- 
sibility. 
Several commentators urged greater 
dissemination of information to the 
public and scientific community alike. 
ORDA has a key responsibility for the 
dissemination of Information through 
the "Recombinant DNA Technical 
Bulletin.” The Bulletin is a new publi- 
cation that attempts to link investiga- 
tors Involved in recombinant DNA re- 
search. both in the United States and 
abroad, with the advisory groups and 
organizations active in this area. In 
light of comments received, the Bulle- 
tin will include more information for 
institutional biosafety committees, as 
well as for the advisory groups at the 
national and local levels. It was sug- 
gested that ORDA provide advice to 
state and local governments, and to 
the most practical extent. ORDA will 
be available to state and local govern- 
ments for technical advice. In large 
part, ORDA serves as a clearinghouse 
for Information related to recombin- 
ant DNA activities internationally, na- 
tionally, and locally. 
Registration and Compliance ( Gener- 
al ) 
Over the past 2 years in the adminis- 
tration of the NIH Guidelines, it has 
been clear to me that a new section 
should be added on the general re- 
quirements for registration of activi- 
ties with the NIH, not only for NIH 
grantees or contractors, but also, on a 
voluntary basis, for the private sector. 
Further, in light of the review of HEW 
policies on the patenting of recombin- 
ant DNA research inventions, a section 
on disclosure of information was also 
necessary. And finally, as suggested, a 
section on compliance with the Guide- 
lines was needed. Thus, new sections C 
and D have been added under "Roles 
and Responsibilities" covering Regis- 
tration (including disclosure of infor- 
mation) and Compliance. Many com- 
ments on the Guidelines over the past 
1V4 years and at the public hearing in 
December 1977 urged that these provi- 
sions be added, and in my view, they 
are necessary in the absence of legisla- 
tion. Further. If legislation were to 
pass, these provisions could serve as a 
model for the regulations to be pro- 
mulgated on the basis of the legisla- 
tion. As in 1976, I believe the Guide- 
lines should not become regulations 
without new legislation specifically 
mandating this. 
Registration and Compliance ( Spe- 
cific ) 
Section IV-C has been added provid- 
ing the elements for registration. 
Other requirements may need to be 
added; notice will be given of any 
change in the requirements. All pro- 
jects subject to the Guidelines must be 
registered with ORDA. A mechanism 
for voluntary registration by the pri- 
vate sector has been provided in re- 
sponse to suggestions by private sector 
representatives. A requirement for 
registration is that the registrant must 
agree to abide by the standards of the 
Guidelines. 
Many comments were directed to the 
protection of proprietary information. 
A new section outlining the elements 
for protection of proprietary data has 
been included in response to these sug- 
gestions. 
One commentator urged that no pat- 
ents be granted for recombinant DNA 
research inventions. Shortly after the 
release of the Guidelines in 1976, NIH 
received a letter requesting a review of 
HEW policies relating to the patenting 
of recombinant DNA research inven- 
tions. The letter prompted NIH to 
review current patent regulations gov- 
erning existing institutional patent 
agreements and to consider how re- 
combinant DNA research inventions 
should be handled under the terms of 
those agreements. On the basis of ex- 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
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