Transmittal Notice 87-03

BACKGROUND

The IHS Research Director, J. Kenneth Fleshman,. M.D., Office of Health Program Development, Tucson, Arizona, has been notified by the Food and Drug Administration that certain changes are required in Chapter 7 of the Indian Health Manual to put the IHS Research Program in compliance with existing Federal regulations.

Having reviewed the relevant FDA regulations, as well as appropriate Departmental regulations, we have taken this opportunity to propose modifications and changes to the impacted sections of the Indian Health Manual.  Because of the necessity to put the Research Program in compliance as quickly as possible, we are proposing interim changes to be effective immediately while the rest of Chapter 7 is being reviewed for other necessary revisions and modifications.  All of Part 1 Chapter 7 is being reprinted in its entirety.

MATERIAL TRANSMITTED

Part 1 - Chapter 7 in its entirety.

Table of Contents.

MATERIAL SUPERSEDED

Part 1 - Chapter 7, TN 82.4, dated March 22, 1982, in its entirety.

MANUAL MAINTENANCE

Remove superseded chapter and file the attached material in its place.  Log and file transmittal notice in appropriate section.