PROPOSED RULES 
60135 
ceming the use of recombinant DNA 
submitted to FDA. In many cases, 
such information would fall within the 
protection of section 301(J) of the act 
as information obtained under FDA's 
authority regarding research on, or 
the premarketing approval of, regulat- 
ed products. Other information would 
be prohibited from disclosure under 18 
U.S.C. 1905. In either circumstance, 
FDA’s regulations proscribe public dis- 
closure of the information, as they do 
of all information within 5 U.S.C. 
552(b)(4). (See 21 CFR 20.61.) 
Disclosure of information concern- 
ing recombinant DNA to NIH, or to 
the Recombinant Advisory Committee 
(RAC), would not affect its status 
under FDA regulations. The regula- 
tions (21 CFR 20.85) provide that in- 
formation otherwise exempt may be 
disclosed to "other Federal govern- 
ment departments and agencies” 
under a suitable agreement restricting 
further disclosure. Disclosure of this 
type does not require disclosure to any 
other person (21 CFR 20.86(b». More- 
over, disclosure to NIH of information 
within section 301(j) of the act is not 
inconsistent with that statute, which 
requires only that information not be 
released outside HEW. 
The Commissioner notes that a tech- 
nical amendment to § 20.84 of the 
public information regulations may be 
required to make clear that exempt in- 
formation obtained from FDA may be 
disclosed by NIH to RAC. Any such 
amendment would restrict such fur- 
ther disclosure to RAC, whose mem- 
bers are retained by NIH as special 
government employees. 
The Commissioner invites public 
comment on ( 1 ) the authority and role 
of FDA with regard to the use of re- 
combinant DNA techniques to develop 
and manufacture products that are 
under its jurisdiction, and (2) whether 
existing protections for proprietary in- 
formation are adequate with respect 
to information that may be submitted 
to the agency concerning recombinant 
DNA research. # : 
The Commissioner also invites com- 
ments on the following: 
1. Are the measures described above 
the most appropriate? Will they afford 
the public adequate protection with- 
out undue interference in scientific re- 
search and product development? 
What impact would this regulatory ap- 
proach have on the development of re- 
combinant DNA techniques for com- 
mercial production? 
2. Are the NIH guidelines suited to 
an industrial setting or do they need 
to be revised and, if so, in what re- 
spects? For example, is there interest 
in using a host-vector system other 
than E. coli K-12, which is already ap- 
proved under the NIH guidelines? 
3. Which of the procedural require- 
ments of the NIH Guidelines are inap- 
propriate for an industrial setting? In 
what way should they be revised? 
4. Would any special policies with re- 
spect to compliance with, and enforce- 
ment of, the contemplated regulations 
be required? 
Comments are invited not only on 
these questions but on any other ques- 
tions raised by the contemplated 
action. 
Interested persons may, on or before 
February 20, 1979, submit to the Hear- 
ing Clerk (HFA-305), Food and Drug 
Administration, Rm. 4-65, 5600 Fish- 
ers Lane, Rockville, MD 20857, written 
comments regarding this notice of 
intent. Four copies of all comments 
should be submitted, except that indi- 
viduals may submit single copies of 
comments. Comments should be iden- 
tified with the Hearing Clerk docket 
number found in brackets in the head- 
ing of this document. Comments may 
be seen in the above office between 9 
a.m. and 4 p.m., Monday through 
Friday. 
Dated: December 13, 1978. 
Donald Kennedy, 
Commissioner of Food and Drugs. 
[FR Doc. 78-35534 Filed 12-21-78; 8:45 am] 
I 
FEDERAL REGISTER, VOL. 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
