OMB Meeting Book - Jan. 11, 2018

OMB Meeting Book

31

I would keep all but Baig 

In agreement with CSO  recommendations 

In  agreement 

In agreement  with suggestions  3 (1 per resolved  suggestion) 

Disagreement: Abstentions Result 

8 

0 

1 

ERP Roster formed as presented 

7. ERP for SPDS Kratom Methods including recommended chair, Brian Schaneberg  (Starbucks)  In  agreement  In agreement  with suggestions  Disagreement: Abstentions  Result  9  2 (1 per resolved  suggestion)  0  1  ERP Roster formed as presented 

Suggestions/Comments:   Suggestions 

Resolution 

Please check if Mr. Schaneberg is willing to chair  all 6 ERPs (amino acids, protein, ginger, vitamin K,  folin C, and kratom). If he is willing to chair all  ERPs, then I agree with the ERP for SPDS Kratom  Methods without suggestions.  ‐ There is a one alone method proposed, no  alternative to compare with at least one other  analytical option, couldn't it be launched a  second period for new methods submission ... ? 

Brian Schaneberg did agree to chair all six (6)  SPDS ERPs.  

Not an issue as long as the method is measured  against the SMPR  

8. ERP for SPDS Vitamin K Methods including recommended chair, Brian Schaneberg  (Starbucks)  In  agreement  In agreement  with suggestions  Disagreement: Abstentions Result  9  2 (1 per resolved  suggestion)  0  1  ERP Roster formed as presented 

Suggestions/Comments:   Suggestions 

Resolution 

Please check if Mr. Schaneberg is willing to chair all 6 ERPs  (amino acids, protein, ginger, vitamin K, folin C, and kratom). If  he is willing to chair all ERPs, then I agree with the ERP for SPDS  Vitamin K Methods without suggestions.  ‐ There is a one alone method proposed, no alternative to  compare with at least one other analytical option, couldn't it be  launched a second period for new methods submission ... ? 

Brian Schaneberg did agree to  chair all six (6) SPDS ERPs.  

Not an issue as long as the  method is measured against the  SMPR  

4 

01/10/2018