60098 
NOTICES 
retary of HEW and the Assistant Sec- 
retary for Health, as well as to the Di- 
rector. NIH. 
Pending the expansion and restruc- 
turing of the RAC. no changes will be 
made in these Guidelines and no deci- 
sions will be made requiring the RAC's 
prior review and advice. 
Federal Interagency Advisory Com- 
mittee and Recombinant DNA Re- 
search. A meeting of the Federal 
Interagency Advisory Committee and 
Recombinant DNA Research was held 
on October 12. 1978. to consider 
agency comments on the proposed re- 
vised Guidelines and proposed roles 
for the committee. Several agency rep- 
resentatives noted that under the dis- 
cretion granted in the Guidelines, cog- 
nizance should be taken of Federal 
agency roles. Enhancement of the 
roles for Federal agencies other than 
NIH was discussed with the commit- 
tee. This Included the proposal of non- 
voting membership on the RAC. as 
noted above, and nominations from 
the agencies for potential voting mem- 
bers. As defined under the new proce- 
dures promulgated in part IV. all Fed 
era! agencies through their members 
will have an opportunity to participate 
In the RAC proceedings and may file 
written comments concerning RAC ac- 
tivities. Interagency Advisory Commit- 
tee members mill receive RAC agendas 
and Federal Register notices. 
In additions to participating in the 
proceedings of the RAC. all agencies 
represented on the Federal Inter- 
agency Advisory Committee are now 
afforded an opportunity to request a 
meeting of that committee to consider 
RAC actions In light of their concerns. 
Some RAC actions, like a recommen- 
dation to release recombinant organ- 
isms into the environment, will un- 
doubtedly necessitate a meeting of the 
Interagency Advisory Committee to 
provide Information and seek concen- 
sus. Periodic meetings of this commit- 
tee will also continue to be held for 
evaluation of recombinant technol- 
ogies and their regulation under the 
Guidelines. (For reference, a list of 
the agencies represented on the Inter- 
agency Advisory Committee is present- 
ed In Appendix II.) 
Scienti/c Counselors for OR DA 
ORDA will provide consultation to 
Federal agencies regarding the Guide- 
lines. and a board of scientific counsel- 
ors from all Federal agencies that sup- 
port or conduct recombinant DNA 
work will advise ORDA on the activi- 
ties of the Office of the Director. 
ORDA. and the RAC. A key task for 
the board will be to ensure a common 
registry of all federally funded recom- 
binant DNA research. 
The DHEW Committee expressed 
the wish that Federal cooperation con- 
tinue. and stronly endorsed the new 
responsibilities of the Federal agencies 
under the revised Guidelines. 
RESPONSIBILITIES OP NIH (SPECIFIC) 
Office of the Director 
The principal issues here relate to 
the standards and procedures for gov- 
erning the discretion of the NIH Di- 
rector under the Guidelines. All of the 
responsibilities that the Guidelines 
assign to the Director are now grouped 
under "general responsibilities" (for 
promulgating rules and overseeing im- 
plementation of the Guidelines) and 
"specific responsibilities," which In- 
clude the opportunity for public and 
Federal agency comments. This new 
organization clearly delineates the re- 
sponsibilities and the procedures and 
standards to govern the exercise of 
discretion based on the advice of the 
RAC and ORDA. 
The DHEW Committee discussed 
the need for periodic review and as- 
sessment of NIH's experience In con- 
ducting and supporting recombinant 
DNA research. Accordingly, it was 
agreed that appropriate language 
should be Inserted in the Guidelines 
that the Director, at the end of 36 
months from their Implementation, 
will report on the Guidelines and NIH 
experience under them in consultation 
with the RAC and the Federal Inter- 
agency Committee. He will solicit 
public comment on the draft before 
transmitting the final report with re- 
sponse to comments to the Assistant 
Secretary for Health and the Secre- 
tary. HEW. 
In addition, the Director is now re- 
sponsible for supporting training pro- 
grams in laboratory safety for IBC 
members. Biological Safety Officers, 
Principal Investigators, and laboratory 
stafr. 
Recombinant Advisory Committee 
A major concern of the witnesses at 
the September 15 hearing, and of the 
commentators on the proposed revised 
Guidelines, was related to the compo- 
sition of the RAC. as discussed above. 
The new procedures clearly guide the 
discretion of the committee and pro- 
vide for full public and Federal agency 
participation. The responsibilities of 
the RAC have been enhanced, with 
full access to the public and the Feder- 
al agencies. As I stated In my Decision 
of July 1978 accompanying the pro- 
posed Guidelines, the task for all RAC 
members has been enormous and their 
work and spirit of cooperation have 
been exemplary. I look forward to con- 
tinued cooperation with Dr. Jane 
Setlow. Chairman, and all of the com- 
mittee members. Their assistance is 
vital to the integrity of this research 
under the Guidelines. 
Office of Recombinant DNA Activities 
The majority of comments concern- 
ing ORDA focused on the office's 
oversight responsibility. The issues 
concerning delegation of authority to 
the IBC's and the role of ORDA in 
registering not only recombinant DNA 
activities but other data relating to 
health surveillance have been dis- 
cussed in the previous section on local 
institutions. 
There were several comments con- 
cerning the need for increased staffing 
for ORDA to meet the new responsi- 
bilities under the Guidelines. Addi- 
tional staff has been provided, and 
there will be need for more in light of 
the new responsibilities of the Recom- 
binant Advisory Committee to solicit 
public and Federal agencies' com- 
ments. 
As noted previously in the section on 
the Interagency Committee, a board 
of scientific counselors from the other 
Federal agencies that conduct or sup- 
port recombinant DNA research will 
be established as advisory to ORDA. 
This board is created in response to 
suggestions from Federal agencies for 
some mechanism to ensure uniformity 
in Interpretations and determinations 
made under the Guidelines where dis- 
cretion is granted. An early task of the 
board will be to assist in creating and 
maintaining a registry for all recom- 
binant DNA activities funded by the 
Federal Government. The board will 
also assist ORDA's Director in for- 
warding to the RAC all requests from 
other Federal research agencies for 
action on such matters as certification 
of new host-vector systems. We are. in 
fact, trying to ensure a capability for 
uniform interpretation and implemen- 
tation of the Guidelines throughout 
the Federal sector. 
Another commentator urged that a 
time-frame be set for Implementing 
the new standards and procedures. 
This request is a most important one. 
In anticipation of the release of the 
Guidelines, procedures have been 
drawn up for meeting the new require- 
ments. Dr. WJlllam Gartland, Director 
of ORDA, has sent a letter to all insti- 
tutions. IBC chairmen, and Principal 
Investigators, specifying the measures 
to be taken within the next three 
months to implement the new Guide- 
lines effectively. 
Registration. Here the principal 
comments came from the Federal 
agencies and private industry. The 
proposed revised Guidelines require 
the institutions that receive NIH 
funds for recombinant DNA research 
to register all recombinant DNA pro- 
jects. irrespective of the source of 
funding. Representatives from Federal 
research agencies pointed out that in- 
stitutions should not be required to 
register with NIH if they are already 
registering with the Federal agency 
that supports the work. Accordingly. 
FEDERAL REGISTER, VOL 43. NO. 347— FRIOAY. DECEMBER 33. 197$ 
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