Proposal #	No Action	Passed as Submitted	Passed as Amended		Proposal #	No Action	Passed as Submitted	Passed as Amended
101			X*		125	X
102	X				126			X
103		X			127			X*
104	X				128			X*
105	X				129		X
106			X		130	X
107	X
108	X
109	X
110	X
111	X
112	X
113			X
114			X*
115			X*
116			X*
117			X*
118		X
119			X
120			X*
121			X
122	X
123			X
124			X

* Passed with Substitute Solution

 

Council II

Only those Proposals which were passed (either passed as submitted
or passed as amended) are shown here:  Council II Proposals

! NOTE: In the August 29, 2011 letter to the Conference Chair John Miller, the FDA did not concur with Proposal 209. On October 5, 2011, the NCIMS Executive Board accepted the FDA non-concurrence and agreed to address the issue at the next conference.

The Proposals highlighted in green are the ones to which editorial changes were made
at the request of FDA (none in 2011).

Proposal #	No Action	Passed as Submitted	Passed as Amended		Proposal #	No Action	Passed as Submitted	Passed as Amended
201	X				225		X**
202	X				226		X**
203	X				227		X**
204	X				228		X**
205			X		229		X**
206	X				230		X**
207	X				231		X**
208			X		232		X**
209		X !			233		X**
210			X		234		X**
211	X				235			X
212			X		236			X
213	X				237		X
214			X		238			X
215			X		239	X
216		X			240	X
217		X			241		X
218			X		242			X
219			X**		243			X
220	X				244	X
221	X				245	X
222		X			246		X
223	X				247		X
224		X**			248		X**

**Passed to 2400 series form process

Council III

Only those Proposals which were passed (either passed as submitted
or passed as amended) are shown here:  Council III Proposals

Attachments to Proposal 301 are included here:

2011-301 Attachment 1 - Procedures, 2011-301 Attachment 2 - PMO, 2011-301 Attachment 3 - MMSR.

 

The Proposals highlighted in green are the ones to which editorial changes were made
at the request of FDA (none in 2011).

Proposal #	No Action	Passed as Submitted	Passed as Amended		Proposal #	No Action	Passed as Submitted	Passed as Amended
301		X			309		X
302	X				310	X
303			X		311	X
304	X				312			X
305	X				313			X
306	X
307	X
308		X