Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

6

Memo  Date: 

February 6, 2019 

To: 

OMB Working Group on Application Notes Certification 

From: 

Scott Coates, AOAC 

Re: 

Application Notes Certification Program (tentatively “Reviewed and Recognized”   certification) 

Thank you OMB Working Group members for agreeing to review this proposed program for the review  of Application Notes to be provisionally known as “Reviewed and Recognized” (R 2 ) certification program.   There are 3 parts to this memo:  1) the cover memo (which you are reading) to give some context to the  proposal; 2) a summary; and 3) draft policies and procedures.  Background  Last year, AOAC staff brain‐stormed on new potential products and services that might be useful for our  community and, also provide additional revenue streams for AOAC.  We started with 12 ideas, which  were widdled down to 8 ideas to explore.  AOAC staff organized a series of one‐on‐one calls with AOAC  members representing potential clients for the new potential products and services.  Based on these  conversations the list of potential products and services was further refined to four, one of which was  the Application Notes Certification mark.  During our conversations with potential clients it became clear that some form of recognition of  application notes could be very useful and valuable.  Currently, the primary avenue for recognition of  methods based on instruments / equipment is the Official Methods program.  This is great, but can  require a rather large investment in time and expense for the collaborative study.  Several of the  surveyed companies opined that an Application Notes Certification mark could serve a function for  much quicker recognition of methods with new platforms.  In fact, some clients became quite excited at  the possibility of incorporated the Application Notes Certification program into their development  process and be able to use the Application Notes Certification mark when a new product is rolled out.  The Application Notes Certification would also benefit method users in that AOAC will evaluate the  application note and its claims against real data, and thus have more confidence in selecting a new  platform based on application note claims.  We envision that the review process would be an analog of the Performance Tested Methods  (PTM)  program.  The PTM review evaluates the veracity of performance claims in a test kit package insert.  The  R 2  program would evaluate the veracity of performance claims in an application note.  It is also envisioned that R 2   program would lead to Official Methods application just as many approved  PTMs go on to Official Methods .  Pricing has not been settled yet.  We think the R 2  programwill have a similar role and value as PTM  certification, and plan to use the PTM pricing model once the program is established. 

04/05/2019