36 
1 “(C) The Commission shall provide notice, as required 
2 under subparagraphs (A) and (B) by sending, in writing 
3 and through certified mail — 
4 “(i) a copy of the proposed or final regulation; 
5 “(ii) a statement that such proposed or final regu- 
6 lation may supercede the exempt requirement of the 
7 state or political subdivision; 
8 “(Hi) a letter, signed by the Chairman of the 
9 Commission, informing the state or political subdivision 
10 that the Commission has made the determination, 
11 required by subparagraph (B), and the effect of such 
12 determination on the exempt requirement of such state 
13 or political subdivision; 
14 “(iv) a time schedule of when the proposed or final 
15 regulation would become effective. 
16 “(D) For purposes of this paragraph, ‘ exempt require- 
17 ment’ means a requirement of a state or political subdivision 
18 which has been exempt under subsection (b) of section 1813. 
19 “( c) Within two years from the enactment of the Recom- 
20 binant DNA Safety Regulation Act, and updated on an 
21 annual basis thereafter, the Commission, in coordination and 
22 consultation with and after review by the National Com- 
23 mission for the Protection of Human Subjects of Biomedical 
24 and Behavioral Research, shall prepare and transmit to the 
25 Congress a comprehensive study that identifies the basic ethical 
[ 706 ] 
