59614 
Federal Register / VoL 58, N<x, 215 / Tuesday, November 9, 1993 / Notices 
XVL Presentation on Informed Consent 
Issues 
Dr. Gary Ellis, Director, Office for 
Protection from Research Risks, 
National Institutes of Health, Bethesda, 
Maryland, will address informed 
consent issues. Dr. Doris Zallen, Chair 
of the Working Group an Informed 
Consent, will lead a discussion 
concerning gene therapy protocols and 
informed consent. 
XVTL Update on Cystic Fibrosis 
Protocol/Dr. Crystal 
Dr. Ronald G. Crystal of the National 
Institutes of Health, Bethesda, 
Maryland, will present an update on his 
protocol entitled: A Phase I Study, in 
Cystic Fibrosis Patients, of the Safety , 
Toxicity , and Biological Efficacy of a 
Single Administration of a Replication 
Deficient, Recombinant Adenovirus 
Carrying the cDNA of the Normal 
Human Cystic Fibrosis Transmembrane 
Conductance Regulator Gene in the 
Lung. 
OMB’s “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 
39592, June 11, 1980) requires a 
statement concerning the official 
government programs contained in the 
Catalog of Federal Domestic Assistance. 
Normally, NIH lists in its 
announcements the number and title of 
affected individual programs for the 
guidance of the public. Because the 
guidance in this notice covers not only 
virtually every NIH program but also 
essentially every Federal research 
program in which DNA recombinant 
molecule techniques could be used, it 
has been determined not to be cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition, NIH could 
not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NIH Guidelines. In Heu of the 
individual program fisting, NIH invites 
readers to direct questions to the 
information address above about 
whether individual programs fisted in 
the Catalog of Federal Domestic 
Assistance are affected. 
Dated: November 2, 1993. 
Deryl A. Chamblee, 
Acting Deputy Director for Science Policy and 
Technology Transfer. 
[FR Doc 93-27572 Filed 11-6-93; 8:45 am) 
BILLING CODE 4140-01 -M 
[508] 
Recombinant DNA Research, Volume 18 
