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ORA FIELD MANAGEMENT DIRECTIVE No. 17B
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PURPOSE
To provide guidance and procedures for field management of Compliance Programs at the district and regional level.
BACKGROUND
ORA must monitor field activities to assure that program objectives are being met or that circumstances justify any deviations from planned program operations. The necessity for careful monitoring is also demonstrated by the situation where failure to complete scheduled operations in a statistically designed program seriously impairs the validity of the entire program.
POLICY
Program operations cannot always be accomplished as planned for two basic reasons. First, higher priority demands take precedence over planned operations. Second, the number of planned operations sometimes may not reflect actual conditions; for example, the number of products of a given commodity are not sufficient to meet the Workplan.
When adjustments to planned activities are necessary, it is essential that the decisions be made at a responsible management level. To carry out this policy, districts and regions must monitor accomplishments for all Compliance Programs and assignments that have planned operations. PODS Table 7 (POVAC) and Table 10 provide data necessary for tracking program accomplishments.
GENERAL GUIDANCE
The Field Workplan provides the field offices with planned operational objectives for each of the Compliance Programs or assignments scheduled for implementation during the year.
When during the course of a fiscal year, changes are necessary in a district's Compliance Program/assignment obligation and these changes involve only such adjustments as substitution of an establishment's products or SMSA's, the district or region will work with the Center to make mutually satisfactory changes. The decisions will then be reduced to writing by the district or region involved, with copies to the appropriate Center office and the Division of Planning, Evaluation and Management (HFC-40), Office of Resource Management.
FIELD REQUESTS FOR CHANGES TO THE FINAL FIELD WORKPLAN
The Field will have thirty days following issuance of the final Field Workplan to review it and to submit requests for changes for those programs which have substantially changed since the issuance of the preliminary Workplan. Requests for changes are to be submitted in the format provided in the attachment. Specific criteria for requesting changes will be sent to the districts and regions when the final Workplan is issued.
ATTACHMENT
Field Management Directive No. 17B
DATE ________________________
REGION ________________________
DISTRICT ________________________
FMD 17B Request No. _____ for FY ________ Workplan
C.P. Title:
Program/Assignment Code(s):
PROPOSED CHANGE
EXPLANATION (JUSTIFICATION)
/S/___________________________________________________
Regional Food and Drug Director (HFR- )
_______________________________________________________________________________
RESPONSE
Request Accepted ___ Request Accepted in Modified Form ___ Request Not Accepted ___
Change will appear in Planning Bulletin # _____ and POVAC dated _____________________
/S/ __________________________________________________
Director, Division of Planning, Evaluation and Management
Date _______________
DISTRIBUTION:
Regional Food and Drug Directors and
District Directors; FDA Headquarters Offices
ISSUED BY:
ORA/ORM/Division of Planning, Evaluation and Management (HFC-40)
AUTHORITY:
ORA
PUBLICATION DATE: 8/96
This page was last updated on: 05/21/99.
