1) Take the quoted parts of proposed rules in part 8 and put them together. (In some cases, there are options, so pick one in each case. You know, like a menu in a Chinese restaurant where you get one appetizer, one main dish, etc.)
2) Now you have the outlines of a rule that will go into this thing called the Federal Register, once all is said and done.
3) It's not complete-as-is, but the FDA can then tweak it w/o going through this whole process all over again. Like adding flesh on bones.
Roger, are you kidding me...? SMH. The first recommendation is what they are going to use as a rule, a 'MARK" that they impose everything else as..." I did read this and understand what you are saying. With slight argument, I 'get' what's being said. (said status)