NOTICES 
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Office of tho Secretory 
NIH PROPOSED REVISED GUIDELINES FOR 
RECOMBINANT DNA RESEARCH 
Hooring 
Notice Is hereby given of a public 
hearing on September 15, 1978, In the 
Department of Health, Education, and 
Welfare, Hubert H. Humphrey Build- 
ing. Room 529 A. In Washington, D.C. 
The meeting will take place 9 a.m. to 4 
p.m., and the entire hearing will be 
open to the public. Attendance by the 
public will be limited to space availa- 
ble. 
The purpose of the hearing Is to 
secure public comment on revisions 
that have been proposed by the Na- 
tional Institutes of Health to the NIH 
guidelines for research Involving re- 
combinant DNA molecules. The pro- 
posed revised guidelines were pub- 
lished In the Federal Register on 
July 28, 1978. 
A Department of Health. Education, 
and Welfare review committee, estab- 
lished by Secretary Joseph A. Cali- 
fano, Jr., will hear the comments on 
the proposed revisions. This commit- 
tee consists of: Mr. F. Peter Libassi, 
the Department's General Counsel 
(chairperson); Dr. Donald S. Freder- 
ickson, the Director of NIH (vice 
chairperson): Dr. Julius Richmond, 
Assistant Secretary for Health; and 
Dr. Henry Aaron. Assistant Secretary 
for Planning and Evaluation. 
Public comment is sought on the sci- 
entific and procedural aspects of the 
proposed guidelines. Among the issues 
commentators are Invited to address 
are the following: 
The strength of the evidence that 
supports the proposed revisions: 
The strength of the evidence that 
supports maintenance of restrictions 
on this type of research; and 
The specific scientific and research 
containment procedures that the pro- 
posed revisions require. 
Comments are also Invited on sec- 
tions in the proposed revisions con- 
cerned with administration of the 
guidelines. Including: 
The procedures for future changes 
In the guidelines; 
The procedures for permitting oth- 
erwise prohibited experiments and for 
exempting classes of research from 
the guidelines; 
The standards for the exercise of ad- 
ministrative discretion under the 
guidelines: and 
The composition of the Depart- 
ment's Recombinant DNA Advisory 
Committee and of the institutional 
biohazard committees. 
In order to assure that everyone 
wishing to make an oral presentation 
has the opportunity to do so, presenta- 
tions should not exceed 10 minutes In 
length. Individuals are encouraged to 
provide summaries of their testimony 
In advance of the hearing, and to 
submit written comments In addition 
to, or In lieu of, an oral presentation. 
Comments and testimony should be 
confined to the proposed revisions. In- 
dividuals who wish to testify should 
write Richard Riseberg, DHEW Office 
of General Counsel. National Insti- 
tutes of Health, Building 31, Room 
2B50, Bethesda, Md. 20014, by Sep- 
tember 10, 1978. 
Dated: August 10, 1978. 
F. Peter Libassi, 
General Counsel 
[FR Doc 78-22946 Filed 8-15-78; 8:45 am) 
FIDCBAl REGISTER, VOL 43, NO. 139— WEDNESDAY, AUGUST 16, 1978 
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