Federal Register / Vol. 58, No.. 77 / Friday,. April 23,. 1993 ;/ Notices 
21737 
Recombinant DMA Research: Actions 
under the Guidelines 
AGENCY: National Institutes of Health. 
PHS.DHHS. 
ACTION: Notice of actions under the NTH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
SUMMARY: This notice sets forth eight 
actions to be taken by the Director, 
National Institutes of Health (NIH), 
under the May 7, 1986, NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (51 FR 16958). 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. Nelson A. Wivel, Director, 
Office of Recombinant DNA Activities 
(ORDA), Office of Science Policy and 
Technology Transfer, National Institutes 
of Health, Building 31, room 4B11, 
Bethesda, Maryland 20892, (301) 496— 
9838. 
SUPPLEMENTARY INFORMATION: Today 
eight actions are being promulgated 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
These eight proposed actions were 
published for comment in the Federal 
Register of November 2, 1992 (57 FR 
49584), and February 12, 1993 (58 FR 
8500), and reviewed and recommended 
for approval by the NIH Recombinant 
DNA Advisory Committee (RAC) at its 
meetings on December 3—4, 1992, and 
March 1-2, 1993. 
I. Background Information and 
Decisions on Actions Under the NIH 
Guidelines 
A. Addition of Appendix D-XXXX to 
the NIH Guidelines 
Ln s ietter dated October 5. 1992, Dr. 
Michael J. Welsh, Howard Hughes 
Medical Institution Research 
Laboratories, Iowa City, Iowa, submitted 
a human gene transfer protocol to the 
RAC for formal review and approval. 
The title of this protocol is: Cystic 
Fibrosis Gene Therapy Using an 
Adenovirus Vector: In Vivo Safety and 
Efficacy in Nasal Epithelium. This 
request was published for comment in 
the Federal Register on November 2, 
1992 (57 FR 49584). 
The protocol was reviewed during the 
RAC meeting on December 3—4, 1992. 
By a vote of 16 in favor, 0 opposed, and 
no abstentions, the RAC recommended 
approval of the protocol with the 
following stipulations: (1) Deletion of 
the requirement for the Ela and the rat- 
1 transformation assays from the 
protocol, (2) submission of the complete 
adenovirus vector sequence, and (3) 
incorporation of minor changes in the 
Informed Consent document. 
On December 14, 1992, and February 
15, 1993, Dr. Welsh submitted 
modifications and additional 
information to ORDA as requested by 
the RAC The information was reviewed 
by the primary reviewers, and it was 
determined that the additional 
documentation satisfied the RAC's 
stipulations for approval of the protocol. 
The following section may be added to 
Appendix D: 
“Appendix D-XXXX 
“Dr. Michael J. Welsh, Howard 
Hughes Medical Institute Research 
Laboratories, University of Iowa College 
of Medicine, Iowa City, Iowa, may 
conduct experiments on 3 cystic fibrosis 
(CF) patients £ 18 years of age with mild 
to moderate disease. This Phase I study 
will determine the: (1) In vivo safety and 
efficacy of the administration of the 
replication-deficient type 2 adenovirus 
vector. Ad2/CFTR-1, to the nasal 
epithelium; (2) efficacy in correcting the 
CF chloride transport defect in vivo ; and 
(3) effect of adenovirus vector dosage on 
safety and efficacy." 
I accept this recommendation, and 
Appendix D-XXXX of the NIH 
Guidelines will be added accordingly. 
B. Addition of Appendix D-XXXX1 to 
the NIH Guidelines 
In a letter dated October 7, 1992, Dr. 
Ronald G. Crystal, National Institutes of 
Recombinant DNA Research, Volume 17 
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