NOTICES 
33(29 
committees, nou stressed was the 
need for public notice of all meetings, 
and for procedures to ensure public 
participation In the exercise of respon- 
sibilities by the NIH Re- comblnant 
Advisory Committee (RAC), the Office 
of the NIH Director, and the Advisory 
Committee to the Director (DAC). 
Several commentators specifically 
urged that the Guidelines spell out 
procedures- - 
• To develop and promulgate the 
list of “non-novel experiments” and to 
amend the list; 
• To certify host-vector systems; 
• To permit the Director, on the 
advice of the RAC, to grant exceptions 
from prohibited experiments (as for 
risk-assessment studies), and 
• To modify the Guidelines In the 
future. 
There were also suggestions that 
guidance be given on how to deal with 
infractions of the guidelines. Specifi- 
cally, one commentator suggested that 
procedures should outline in detail - 
•Bow charges of noncompliance 
could be brought, 
•How charges of noncompliance 
would be evaluated, 
•What opportunities would be pro- 
vided for the principal investigator 
and his Institution to defend them- 
selves against charges, and 
•What procedures would be availa- 
ble before the termination of funding 
or other penalties are invoked. 
Because of the RAC’s key role in the 
development and monitoring of NIH 
recombinant I)NA policies, a number 
of comments were directed to the com- 
mittee’s nature and functions. Many 
commentators focused on its member- 
ship, urging that the guidelines define 
procedures for the nomination and se- 
lection of members. Suggestions for 
potential membership included more 
representation for certain scientific 
disciplines, such as virology and micro- 
biology; greater representation from 
the occupational and environmental 
health and safety community; and 
more public representation, including 
perhaps a “dissenter” from current 
NIH policies. 
A number of comments concerned 
RAC operations. The committee was 
urged to formalize schedules so that 
all concerned would know when meet- 
ings would be held over the next 2 to 3 
years. Further, it was urged that no- 
tices and complete agendas be placed 
in the Federal Register for each 
meeting, that all documents for com- 
mittee consideration be made available 
to the public, and that the NIH pay 
for public witnesses to attend RAC 
meetings. 
In response to these comments, part 
IV of the PRO NIH has been reorga- 
nized extensively. The responsibilities 
from the local to the national level are 
more clearly stated and defined. For 
NIH responsibilities, procedures sug- 
gested by commentators have been 
specified to afford opportunity for 
public comment. A special appendix to 
the PRG NIH includes relevant imple- 
mentation documents from ORDA 
that explain the administration of the 
NIH guidelines at the local and na- 
tional levels. 
Part IV of the PRO NIH has more 
clearly defined a structure for respon- 
sibilities at those levels, with opportu- 
nity for public and scientific participa- 
tion. It formalizes a process that has 
been occurring informally. Flexibility, 
however, remains essential to avoid 
unnecesary and protracted delays in 
decisionmaking. Clearly, a full pano- 
ply of clearance procedures, including 
a public hearing, is not essential for 
most of the functions under the guide- 
lines. For many functions, the need 
for public review can be met through 
publication in the Federal Register. 
For certain responsibilities, comment 
may be solicited. Because procedures 
by which policies will be developed at 
the national and local levels are of key 
importance, notice is required for 
major policy Initiatives. 
Application to (he Private Sector. 
Several commentators spoke on the 
application of the NIH guidelines to 
the private sector. Specifically, NIH 
was urged to provide voluntarily to 
private industry - 
•Advice on interpretation of the 
guidelines, 
•Registration of projects, 
•< 'ertif ication of host-vector sys- 
tems, 
•Advice on the operation of institu- 
tional biosafety committees, and 
•Protection for patent and propri- 
etary information. 
In June 1976 representatives of pri- 
vate Industry were invited to NIH to 
be briefed on the guidelines about to 
be released. Since their release, NIH 
has held several other meetings with 
representatives from the private 
sector. Commerce Department repre- 
sentatives on the Interagency commit- 
tee played a leading role In working 
with private industry on adoption of 
the safety standards of the NIH guide- 
lines. All relevant Industries have 
agreed to abide by those standards. 
However, many of the services pro- 
vided to NIH grantees and contractors 
have not been extended to the private 
sector. In large part, efforts to do so 
have been held in abeyance because of 
possible Federal legislation. 
After carefully considering the com- 
ments at the p ublic hearing and in let- 
ters received, NIH will extend certain 
added services to the private sector in 
several of the areas suggested by the 
commentators. It Is still Important, de- 
spite proposed legislation, that the 
NIH provide for mechanisms to allow 
private-sector participation. Further, 
if legislation is enacted, the NIH 
guidelines will serve as the basis for 
regulation that will encompass private 
industry. Thus, a new section has been 
added to part IV that provides the op- 
portunity for industry’s participation 
in a voluntary fashion. 
Office of the Director. As suggested 
by the commentators, the responsibil- 
ities of the Director have been 
grouped, for purposes of clarity, under 
specific heading "Office of the Direc- 
tor, NIH" in the PRG NIH. For many 
of the responsibilities cited- including 
revision of the guidelines, certification 
of host vector systems, and authority 
for exemptions and exceptions- -appro- 
priate notice and opportunity for 
public comment is specified. This op- 
portunity for comment will provide 
structure for the exercise of discretion 
by the Director. 
The PRG RAC clarified the rele- 
vant responsibilities of the NIH Direc- 
tor and RAC with regard to the certifi- 
cation of host-vector systems. Those 
concepts are adopted in the PRG— 
NIH. 
Recombinant Advisory Committee. 
Many commentators have made sug- 
gestions concerning the structure, 
function, and scope of responsibility of 
the RAC. The emphasis in RAC mem- 
bership has been on ensuring relevant 
scientific representation. It is essential 
that the committee have the technical 
expertise necessary to develop, modify, 
and interpret the guidelines in light of 
scientific evidence. Representative 
have been added from scientific disci- 
plines, such as botany, to ensure a 
broad scientific overview. As a bridge 
between the implications for science 
and public policy, public members now 
serve on the committee, and additional 
public members may be added. Cur- 
rent public members are Dr. Emmette 
S. Redford, Ashbel Smith, professor of 
government and public affairs at the 
Lyndon B. Johnson School of Public 
Affairs, University of Texas, at Austin, 
and Dr. LeRoy Walters, director for 
the Center of Bioethics, Kennedy In- 
stitute, Georgetown University. 
In order to insure fairness and sensi- 
tivity to the public commentators, pro- 
cedures for nomination to the RAC 
will be in accord with the report by 
the NIH Grants Peer Review Study 
Committee. Thus, NIH will publish an 
announcement of upcoming vacancies 
periodically, with instructions on how 
to submit nominations. By this means, 
a wide spectrum of nominations will 
be considered to assure appropriate 
representation suited to the RAC’s 
needs. 
In brief, the operations of the RAC 
have been more clearly detailed in the 
PRG NIH. The procedures for the se- 
lection of members and the operations 
FEDERAL RE6KTER, VOL 43, NO. 146— FRIDAY, JULY », 1978 
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