DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
December 27, 1978 
On December 15, 1978, Secretary of Health, Education, and Welfare 
Joseph A. Califano, Jr., approved release by the National Institutes 
of Health of revised NIH Guidelines for research involving recombinant 
DNA molecules. Enclosed are the documents as published in the Federal 
Register of Friday, December 22, 1978. These include: (1) a Preface 
by HEW Secretary Califano; (2) a Decision of the Director, NIH, on the 
revised Guidelines; (3) NIH Guidelines for Research Involving Recombinant 
DNA Molecules (revised); and (4) FDA Notice of Intent to Require 
Compliance with the NIH Guidelines. 
As you know, the original Guidelines for such research were issued 
on June 23, 1976, and a revision proposed by NIH was published in the 
Federal Register on July 28, 1978. The Secretary then established a 
Departmental review committee consisting of Mr. Peter Libassi, the 
Department's General Counsel, as Chairperson; Dr. Fredrickson as Vice- 
Chairperson; Dr. Julius B. Richmond, Assistant Secretary for Health; and 
Dr. Henry Aaron, former Assistant Secretary for Planning and Evaluation. 
The DHEW Committee held a public hearing on September 15 and 
reviewed all public comments on the July 28 revision. On the basis 
of that review, the Comnittee substantially revised the NIH proposal, 
clarifying local and national responsibilities and standards for 
decision-making. 
Concurrent with publication of these documents in the Federal 
Register is the issuance of a notice of intent by the Food and Drug 
Administration to set requirements for compliance with the NIH 
Guidelines in conducting recombinant DNA research in the private 
sector. The Secretary has directed the FDA Commissioner and the NIH 
Director to prepare a plan of action for implementation of the NIH 
Guidelines in the private sector under FDA authorities. The Secretary 
has also requested the Administrator of the Environmental Protection 
Agency to develop requirements comparable to those of FDA. 
Please let me know if you have any questions concerning these 
documents . 
Donald S. Fredrickson, M.D 
Director 
Enclosures 
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