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*From OMB June 30-July 1 OMB meeting, Chicago, IL
Modified Method Submission*
Method Modification
Response sent to
applicant
Applicant submits
final modified
method
CSO reviews
CSO summary and
copy of modified
method sent to
OMB
OMB Review
OMB Accepts?
Method
Modification
Approved
Yes
Stakeholders
notified
CSO reviews and
addresses concerns
YES
Reason for rejection
sent to CSO
NO
CSO Drafts response
to applicant
Modification posted
for comments
(60-90 days)
Comments
received
Change to OMA
No
YES
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