17 
stringency of the safety requirements by revision under subsection 
102(a) (2) and which should properly be exempted under subsection 
102(b). 
102 (o). Registration 
All recombinant DNA activities in progress on the tenth day after 
the date of enactment must be registered with the Secretary within ten 
days from the date the administrative regulations promulgated under 
subsection 102(d) go into effect. Any activity which is undertaken 
subsequent to the date of enactment must be registered at the time it is 
commenced. Such registration is to be carried out in accordance with 
the administrative regulations promulgated by the Secretary under 
subsection 102(d). 
Such registration requires that the name of the individual or entity 
responsible for the conduct of a recombinant DNA activity, identifica- 
tion of the place or places where such activity is to be conducted, a 
description of the activity and assurances to the Secretary that the 
safety requirements in effect under this act will be observed, be re- 
ported to the Secretary. 
The degree of detail required for the description of each recombinant 
DNA activity is left to the discretion of the Secretary. However, it is 
the committee’s intent that such description include sufficient technical 
information to enable an independent reviewer to determine which 
provisions of sections II and III of the NIH Guidelines would apply 
to that particular activity. It must also enable a technically competent 
reviewer to estimate the potential hazard to the health of both workers 
and the general public and the risk to the environment, to the extent 
that current knowledge of potential hazards would permit such a 
judgment. While the overall design of the activity should be included, 
it is, not the intent of the Committee that details of research designs 
and protocols not relevant to safety consideration be required to be 
submitted. 
It is recognized that, in some instances, information relevant to risk 
and safety may be proprietary or a registrant may wish such infor- 
mation to be held in confidence. Therefore the administrative regula- 
tions promulgated under subsection 102(d) should include such provi- 
sions as necessary to protect the disclosure of proprietary data. Any 
lists of registered recombinant DNA activities made available to the 
public or published by the Secretary need not include confidential or 
proprietary information. 
102(d)- Administrative regulations 
The Secretary must} within 90 days after enactment, issue proposed 
regulations for the administration of the requirements of section 102 
and section 105 (Inspections). At present, section IV of the NIH 
Guidelines (Roles and Responsibilities) specifies how sections III and 
IV will be administered to NIH grantees. While the regulations to 
be promulgated under this section may supersede section IV, it is in- 
tended that this section continue to govern the administration of the 
NIH. safety standards for those activities which are currently under 
the NIH Guidelines, at least until such time that the regulations pro- 
mulgated by the Secretary under section 102 (d) become final, 
It is the view of the committee that the appropriate portions of 
the administrative requirements of section IV of the NIH Guide- 
[Appendix B — 147] 
