human gene therapy, including both somatic cell and germ 
line therapy. The term "major actions" in Section IV-C-l-b 
of these Guidelines includes all such proposals. The HEAC 
chairperson shall be notified of all final decisions by the 
Director, NIH, on all such proposals in the same manner as 
the RAC and IBC chairpersons are notified of certain final 
decisions under Section IV-C-l-b- ( 1) . 
Amend Section IV-C-1 to read as follows: Amend the second 
sentence to read as follows: 
The Director has responsibilities under the Guidelines 
that involve ORDA, the RAC and the HEAC. 
After the third sentence of § IV-C-1, add: 
Advice from the HEAC is primarily on the ethical, 
philosophical, social, economic, and eugenic implications 
and impacts of human genetic therapy. 
Amend § IV-C-l-b by striking all of the language after 
"Guidelines" and inserting language thereafter so that the text 
of the provision reads as follows: 
In carrying out the responsibilities set forth in this 
section, the director or a designee shall weigh each 
proposed action through appropriate analysis and 
consultation to determine that it complies with the 
Recombinant DNA Research, Volume 13 
[461] 
