alza resea 
MEMORANDUM 
23 November 1976 
TO: 
FROM: 
Project Leaders, 
Area Directors, 
Management Committee 
J. Urquhart 
_£*y,7.,_ »>*.*.•< 
SUBJECT: ALZA's Conformance to the NIH Guidelines on 
Recombinant DNA Research* 
As you know, v/e currently have neither research nor 
development activity in the area of molecular biology, and 
thus the NIH guidelines have no immediate impact upon our 
work. Yet, in a broader sense they do, in several ways. 
They establish a valuable precedent for the intelligent, 
informed, responsive, and well-articulated making of public 
policy in areas where complex technology intersects with 
intense public concern and attention by the mass media. In 
particular they represent a valuable model in the area of 
laboratory practice for constructive regulation without 
obstruction to- innovation. I would hope that other federal 
agencies — the FDA, EPA, OHSA, EEOC, SEC, and FTC — whose 
actions bear, in one way or another, upon ALZA's work, would 
emulate the care, confidence, and skill with which the NIH 
has gone about setting these guidelines. They are a model 
of enlightened, constructive regulation. 
In another sense, one can foresee that practical appli- 
cations of molecular biology in medicine will outstrip the 
rudimentary technology of drug administration represented in 
tablets, capsules, injectables, ointments, and eyedrops. 
We can anticipate that, insofar as ALZA continues to lead 
the revolution in the technology for controlled continuity 
in drug delivery, we shall be very much involved in reducing 
to practice the principles of molecular biology. 
ALZA therefore will utilize the NIH guidelines on recom- 
binant DNA research, irrespective of the sources of funding 
for any such. work. Before any such work is undertaken, the 
individual in charge must initiate a request for a review 
of the type described in the NIH regulation and receive 
approval for such work. No capital expenditures or personnel 
requisitions are to be made for such work in anticipation 
of the results of this review. 
*Fed. Reg . , Wed., July 7, 1976. Part II: DHEW , NIH 
JU: sst 
JU : 1 : B-17 
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