OMB Meeting Book (June 25-26, 2015)

Modified Method Submission*

CSO summary and copy of modified method sent to OMB

Applicant submits final modified method

Method Modification Response sent to applicant

OMB Review

CSO reviews

CSO Drafts response to applicant

Reason for rejection sent to CSO

OMB Accepts?

NO

Yes

Method Modification Approved

Modification posted for comments (60-90 days)

Comments received

Stakeholders notified

Change to OMA

No

YES

YES

CSO reviews and addresses concerns

Modified Method Submission 1. Applicant submits the final modified method (with any supporting documentation) 2. To assist the OMB review , the CSO reviews the submission and prepares a packet to submit to the OMB, which may include: a. Summary of data b. Copy of the modified method (with the changes from the current method tracked) c. Notation of any deficiencies form the modification response 3. CSO package is sent to the OMB for review a. All OMB members will review the method modification package. b. The OMB chair will typically appoint at least 2 OMB members to lead the discussion of the modification. These members will have experience with the method/technology and will perform an in-depth review. c. At this point, the OMB may also decide to consult with additional SMEs. 4. Based on the review and discussion, the OMB comes to a consensus: a. The OMB may accept the method modification as submitted. b. The OMB may not accept the method modification as submitted. The reasons for not accepting must be clearly defined. The reasons and any recommendations will be forwarded to the applicant

*From OMB June 30-July 1 OMB meeting, Chicago, IL