7 
with the concurrence of the HEW Office of General Counsel and the 
Public Health Service. Mr. Chairman, I would like to submit for the 
record my decision, the supporting analyses, and all of the comments 
received. These documents are compiled in Recombinant DNA Research 
Volume 2 , Documents Relating to "NIH Guidelines for Research Involving 
Recombinant DNA Molecules , " June 1976-November 1977. 
In response to the question in your letter, the Harvard investi- 
gators who reported on inducing a bacterium to produce insulin were 
funded by the NIH, and the university has filed a patent application 
under its IPA. Several other patent applications have been filed in 
the recombinant DNA area. I am enclosing a list for the record, Mr. 
Chairman. 
Also, in your letter of invitation you asked me to comment on the 
fact that in March 1977 NIH introduced the phrase "patentable material" 
r • 
into its standard justification for closing peer review meetings 
pursuant to exemption 4 of the Federal Advisory Committee Act (FACA). 
The Federal Advisory Committee Act used to include the same exemptions 
contained in the Freedom of Information Act (FOIA) . 
Passage of the Government in the Sunshine Act, effective in March 
1977, eliminated the Federal Advisory Committee's use of FOIA exemptions 
and substituted the Sunshine Act's exemptions as reasons for closing 
advisory committee meetings. This change did not alter NIH’s basic 
approach in using exemption 4. While the Sunshine Act became the source 
of exemptions in place of the Freedom of Information Act, exemption 4 is 
[Appendix B — 251] 
