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ORA FIELD MANAGEMENT DIRECTIVE No. 105

Subject:
Import Program Managers
Area:
Operations Management
Date:
9/27/95 Revised

PURPOSE

To describe the responsibilities of the Import Program Manager.

BACKGROUND

In 1971 the position of Import Program Manager (IPM) was created. The primary role of the IPM was to serve as the district contact with the Division of Import Operations and Policy (DIOP) and with the compliance offices in headquarters. The purpose was to ensure field responsiveness to national import issues. Over the years the goal has remained the same, but in many instances not only is the IPM the headquarters contact, but he or she also plans, monitors and coordinates district import activities.

More than ever, agency management identifies imports as a high priority obligation which requires expert management. The Import Program Manager is looked upon as the principal resource person regarding district import matters and must be involved in all aspects of the District's import operations.

OBJECTIVES

The objectives of defining the responsibilities of the Import Program Manager are:

1. To increase effectiveness of import coverage.
2. To maintain district uniformity with national import procedures.
3. To facilitate management support of the IPM; and the IPM's responsiveness to district and regional management.
4. To facilitate transition of import activities through implementation of district computerization (OASIS).

ORGANIZATIONAL LOCATION OF THE IPM

The Import Program Manager should be accountable to the district director either through direct line management or by established district arrangements. In some districts the IPM may be a supervisory employee. The management of import operations should be a full-time position in some districts, while in others it may account for a lesser commitment. Factors such as the volume of imports, geographic span of control in the district and local Customs arrangements, may determine the organizational location of the IPM.

KNOWLEDGE REQUIRED BY THE POSITION

The IPM should have knowledge of:

1. Pertinent FDA laws and regulations.
2. ORA's import work plan and objectives.
3. Import Alerts and Import Bulletins.
4. FDA's import policies, regulatory procedures, agency guidance, enforcement approaches and import compliance programs.
5. U.S. Customs regulations and policies.
6. District operational units SOP's in regards to tracking import samples through collection, analysis and compliance disposition.
7. Procedures used by local importers and brokers.
8. Knowledge of all import related tracking/computer systems, i.e., FIARS, IDS, LISTS, OASIS, EEPS, ISIS.

RESPONSIBILITIES OF THE IPM

A. Coordination Of:

1. District import problems with the appropriate headquarters unit.
2. District import problems with other districts/regional staff.
3. Import training for district staff.
4. Import training for brokers, trade associations or other non FDA organizations.
5. Quality audit reviews of district import activities and Customs Service Filer evaluations.
6. Import investigations activities with supporting laboratories.

B. Principal District Contact With:

1. The Division of Import Operations and Policy personnel.
2. The importer, broker and trade community.
3. U.S. Customs and other agencies.

C. Intra District Responsibilities:

1. Advise district management of Import developments.
2. Develop written standard operating procedures (SOPs).
3. Develop local import strategies.
4. Monitor entry review process to ensure effectiveness.
5. Gather and disseminate import materials and information to the district staff.
6. Recommend Import Alerts/Import bulletins when appropriate.
7. Monitor the reconditioning of detained goods and the exportation of refused goods.
8. Assist in the development of the district's import work plan and evaluation (an example could be the District Pesticide Sampling Plan).
9. Maintain district uniformity with national import policies/procedures.

SCOPE OF RESPONSIBILITIES

The IPM may be contacted directly by DIOP for assistance and performance of any responsibility described in this FMD. At all times, it is the responsibility of the IPM to keep district management advised of new or on going activities and accomplishments. IPMs are responsible for participating in the red phone conference calls. This includes providing agenda topics/items of interest, discussing emerging problems, and exchanging ideas on effective ways of improving operations/workload.

HEADQUARTERS RESPONSIBILITIES

DIOP will provide the IPMs with general information regarding import guidance, procedures, agency policy and proposed revisions to import information directives. This information will generally be disseminated during weekly mailings to the IPMs or red phone conference calls.

Additionally, DIOP may require feedback from the IPMs in order to revise procedures, initiate, clear, issue or cancel import information directives (Import Alerts, and Import Bulletins.)


DISTRIBUTION:              Regional Food and Drug Directors and District Directors; FDA Headquarters Offices

ISSUED BY:                    ORA/ORO/Division of Import Operations (HFC-170)

AUTHORITY:                   ORA

PUBLICATION DATE:    8/96

This page was last updated on: 05/21/99.