75 
subject to the Agency’s jurisdiction. This authority would extend to 
research on regulated products where recombinant DXA is involved. 
The Agency could, under existing authority, require any firm seeking 
approval of a product which may be the end product of recombinant 
DXA research to certify to the Agency that it has complied with the 
Xational Institutes of Health (XIIT) Guidelines on recombinant 
DXA. For example, certification could be required for- biologies, re- 
quests for certification could be required in petitions, such as new drug 
applications, license applications for biologies, requests for 
certification of antibiotics, and notices of claimed investigational ex- 
emption of a new drug. In addition, FDA under its investigational 
authorities may inspect firms making such certification to assure that 
they do, in fact, comply with the XIH guidelines. The Agency does 
have a number of regulatory sanctions it could bring to bear on any 
firm not in compliance with the Guidelines. These range from a denial 
of the petition to court actions. 
3. Preemption of Federal Statutes 
The Interagency Committee recommended in its report that HEW 
be the locus for the regulation of recombinant DXA activities. This 
is a sound suggestion, since a lead agency is essential to avoid dupli- 
cation and to ensure uniform implementation of any DXA legislation. 
The Administration’s bill provides that the proposed authority would 
‘‘not affect the authority of any Federal agency to regulate under any 
other Act activities involving recombinant DXA.” However, because 
the primary basis for controlling recombinant DXA activities is based 
on the potential threat to public health, other agencies should consult 
with HEW when those regulatory activities involve DXA. 
The Department continues to support legislation to promote regula- 
tion of recombinant DXA activities as submitted to the Congress by 
this Department. We appreciate the contribution you and your Sub- 
committee have made to rational decisionmaking in this sensitive pol- 
icy area. If we may assist in any way in your continuing work in this 
area please call on us. 
Sincerely, 
Joseph A. Califano, Jr. 
Round Another Helix in the Legislative Helter-Skelter 1 
The latest twist in Congress’ current attempts to draw up a re- 
combinant DXA bill is a move which means that there may be no bill 
at all. According to his staff aides, Senator Edward Kennedy has now 
decided that no bill is necessary, a sentiment which is the polar oppo- 
site of his position last year but identical to that of the year before. 
Xo one is predicting where Kennedy, or at least his staff aides, will 
be next week; but on present showing there may perhaps — but not 
definitely — be no Senate action this session and therefore no legisla- 
tion at all. 
The prospect is welcomed by scientists who oppose government regu- 
lation of research in principle, but is causing concern to those who 
hoped through legislation to preempt state and local authorities from 
1 Science magazine vol. 200, May 19, 1978. 
23-S90 — 78 7 
[Appendix B — 334] 
