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Federal Register / Voi. 55, No. 164 / Thursday, August 23, 1989 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant ONA Advisory 
Committee; Regional Hearings 
Notice is hereby given of seven 
regional hearings of the Recombinant 
DNA Advisory Committee (RAC) on 
"The Future Role of the RAC" to be held 
or. September 13, 14, 21, 27, 23, October 
4, and 15. 1990. 
Purpose 
The regional hearings will be open to 
the public to: 
1. Consider the future role of the RAC 
in the context of the newer techniques in 
molecular genetics, and to determine if 
the current definition of recombinant 
DNA should be changed to encompass 
these techniques; to consider proposals 
wherein more of the review 
responsibilities for research proposals 
are transferred to the local Institutional 
Biosafety Committees, with fewer 
review responsibilities for the RAC 
itself; and to consider whether the 
current system for review should be 
modified to make it more risk-based and 
less process-oriented; and 
2. Solicit through public testimony the 
views of biomedical researchers, 
imiversity faculty and administrators, 
representatives of professional societies, 
representatives of biotechnology 
associations, and other interested 
parties concerning the issues noted 
above plus related matters. 
The current and proposed definitions 
or recombinant DNA are listed below: 
Current definition: (From the National 
Institutes of Health Guidelines for 
Research Involving Recombinant DNA 
Molecules (51 FR 16958)] “In the context 
of these Guidelines, recombinant DNA 
molecules are defined as either (i) 
Molecules which are constructed 
outside living cells by joining natural or 
synthetic DNA segments to DNA 
molecules that can replicate in a living 
cell cr (ii) DNA molecules that result 
from the replication of those described 
in (i) above." 
Proposed definition: "In tbs context of 
these Guidelines, recombinant DNA 
molecules are defined as either: (i) 
Molecules which are constructed 
outside living cells by joining natural or 
sjTithetic DNA segments to DNA 
molecules that can replicate in a living 
cell; or (ii) molecules which are 
constructed inside living cells by joining 
enriched segments of DNA or their 
synthetic equivalents to introcellular 
DNA; or (iii) DNA molecules that result 
from the replication of those described 
in (i) and (ii) above." 
In order to assist the RAC in its future 
deliberations, a list of questions is 
appended below. Your response to these 
questions is requested and your 
participation in the regional hearings is 
an essential part of this important 
information-gathering exercise. 
1. Should the definition of 
recombinant DNA be modified to 
encompass the newer techniques in 
molecular genetics and should the RAC 
increase its purview in keeping with this 
change in definition? 
2. Do the newer techniques in 
molecular genetics pose any new risks 
not seen with the established 
techniques? 
3. Should the RAC consider a plan 
whereby more of the review 
responsibilities are transferred to the 
local Institutional Biosafety Committees 
(IBCs), with fewer review 
responsibilities for the RAC itself? (An 
example w'ould involve adding plant 
pathologists to the IBCs to facilitate 
consideration of protocols which require 
environmental release.) 
4. Under the current system of review, 
a process-oriented approach is used to 
identify those experiments which should 
be evaluated, and a product-based 
approach is used to determine the level 
of risks, and thus the level of 
containment. Is this system adequate or 
should signiHcant changes be 
considered to make the process more 
risk-based? 
5. With the advent of gene therapy 
protocols, is there a perceived need for 
orientation materials to be provided to 
the local Institutional Biosafety 
Committees? 
The above questions are 
representative of some important issues 
which have been identihed, but are not 
meant to restrict the scope of the 
discussions at the regional hearings. If 
there are other matters pertinent to the 
functions of the RAC which seem 
worthy of discussion, please feel free to 
address such at the time of the meetings. 
Meeting Format 
Following a short presentation by the 
Chair of the RAC. a panel comprised of 
members of the RAC. and Senior 
National Institutes of Health Staff from 
the Office of Recombinant DNA 
Activities will spend the remainder of 
the day receiving testimony from public 
witnesses. Each witness will be limited 
to a maximu.m of ten minutes. 
Attendance and the number of 
presentations will be limited to the time 
and space available. Consequently, all 
individuals wishing to attend or to 
present a statement at these public 
meetings should notify in writing Dr. 
Nelson A. Wivel, Director. Office of 
Recombinant DNA Activities. Building 
31. Room 4B11, National Institutes of 
Health. Bethesda, Maryland 20892, FAX 
301-496-9839. Those planning to make a 
presentation should file a one-page 
summary of their remarks with Dr. 
Wivel five days prior to the meeting 
which they wish to attend. A copy of the 
full text of these remarks should be 
submitted for the record at the time of 
the meeting. 
Schedule of Meetings 
The first meeting will be held on 
Thursday, September 13, 1990, from 9 
a.m. to 4 p.m. at the University of 
California of Los Angeles School of 
Medicine, Neuropsychiatric Institute 
(NPI), NPI Auditorium, Room C5-133- 
NPI, 720 Westwood Boulevard, Los 
Angeles. California 90024. The second 
meeting will be held on September 14, 
1990. from 9 a.m. to 4 p.m. at Stanford 
University School of Medicine, Beckman 
Center. Munzer Auditorium. Ground 
Floor, Campus Drive West (300 Pasteur 
Drive). Stanford, California 94305. The 
third meeting will be held on September 
21. 1990. from 10 a.m. to 4 p.m. at the 
University of Chicago Medical Center. 
Dora DeLee Auditorium, 5841 South 
Maryland Avenue, Chicago, Illinois 
60637. Tlie fourth meeting will be held 
on September 27. 1990, from 9 a.m. to 4 
pan. at the Forsyth Dental Center of 
Boston (next to the Museum of Fine 
Arts), Haigh Auditorium, First Floor, 140 
The Fenway, Boston, Massachusetts 
02115. The fifth meeting will be held on 
September 28. 1990, from 9 a.m. to 4 p.m. 
at the Cornell University Medical 
College, Uris Auditorium. 1300 York 
Avenue, New York, New York 10021. 
The sixth meeting will be held on 
October 4, 1990 from 9 a.m. to 4 p.m. at 
the University of Texas Medical School 
at Houston, Room 2.103, 6431 Fannin. 
Houston, Texas 77225. The seventh 
meeting will be held on October 15, 1990 
from 9 a.m. to 4 p.m. at the National 
Institutes of Health, Building 31 C, C 
Wing, Conference Room 6, 9000 
Rockville Pike, Bethesda. Maryland 
20892. 
SUPPLEMENTARY INFORMATION: 
Additional information may be 
obtained by .calling Ms. Becky Lawson, 
Office of Recombinant D.NA Activities, 
National Institutes of Healih, Building 
31, Room 4311, Bethesda, Maryland 
20832, Phone 301-495-3838. FAX 301- 
496-3839. 
OMB's "Mandatory Informalion 
Requirerrients for Federal Assistance 
Program Announcements" (45 FR 39532, 
June 11, 1980) requires a sfatement 
Recombinant DNA Research, Volume 14 
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