Inspections, Compliance, Enforcement, and Criminal Investigations
Import Program Managers
Import Program Managers
|Date Revised: |
February, 10 2010
The purpose of this FMD is to describe the responsibilities of the Import Program Manager (IPM).
The Import Program Manager was created in 1971. 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.
The objectives of defining the responsibilities of the Import Program Manager are:
- To increase effectiveness and efficiencies of import coverage.
- To maintain district uniformity with national import procedures and policies.
- To facilitate management support of the IPM; and the IPM's responsiveness to district, regional and HQ management.
- To facilitate import operations by assuring that procedures and policies are developed and implemented and that district computerized systems such as MARCS are utilized correctly and that any additional needs are conveyed to DIOP.
ORGANIZATIONAL LOCATION OF THE IPM:
The Import Program Manager must either be a manager who has responsibility for District import operations, or be a non-bargaining import specialist. The IPM 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 may be a full-time position in some districts, while in others Districts it may account for a lesser commitment. Factors such as the volume of imports, geographic span of control in the district and local U.S. Customs and Border Protection (CBP) arrangements, may determine the organizational location of the IPM.
KNOWLEDGE REQUIRED BY THE POSITION:
The IPM should have knowledge of:
- Pertinent FDA laws and regulations.
- ORA's import work plan and objectives.
- Import Alerts and Import Bulletins.
- FDA's import policies, regulatory procedures, agency guidance, enforcement approaches and import compliance programs.
- CBP regulations and policies.
- District operational unit SOPs regarding tracking import samples through collection, analysis and compliance disposition; to include referral of cases to other offices within ORA such as OCI, and/or other Federal Agencies.
- Procedures used by local importers and brokers.
- Knowledge of all import related tracking/computer systems, i.e., MARCS, CMS, ORADSS, and center databases.
RESPONSIBILITIES OF THE IPM:
A. Coordination Of:
- District import issues with appropriate headquarters unit.
- District import issues with other districts/regional staff.
- Import training for district staff.
- Import strategic planning with senior management.
- Import training for brokers, trade associations or other non FDA organizations.
- Conduct and/or advise on quality audit reviews of district import activities and Filer evaluations.
- Conduct and/or helps strategize on investigations related to public health emergencies such as outbreaks which involve imported products.
- Principal District Contact With:
- The Division of Import Operations and Policy personnel.
- The importer, broker and trade community.
- CBP and other government agencies (may be delegated to on-site Supervisory personnel, if the IPM is physically located away from the Port of Entry).
C. Intra District Responsibilities:
- Advise district management of Import developments and issues.
- Convey any import topics to the Import Advisory Committee (IAC) representative within their region to be included in the IPM monthly call.
- Assist in the development of standard operating procedures (SOPs), if appropriate.
- Develop local import strategies.
- Coordinates District programs for monitoring the entry review process to ensure effectiveness and efficiency. Also makes the appropriate corrections based on national or local QA programs.
- Gather and disseminate import materials and information to the district staff.
- Recommend Import Alerts/Import bulletins when appropriate.
- Coordinate District programs for monitoring the reconditioning of detained goods and the destruction/exportation of refused goods.
- Assist in the development of the district's import work plan and evaluation (an example could be the District Pesticide Sampling Plan).
- Maintain district uniformity with national import policies/procedures.
SCOPE OF RESPONSIBILITIES:
At all times, it is the responsibility of the IPM to keep district management advised of new or ongoing activities and accomplishments.
IPMs are responsible for participating in the monthly IPM conference calls and submitting topic items to their regional IAC representative. This includes submitting topic/items of interest to their regional IAC representative, discussing emerging issues/problems, and exchanging ideas on effective ways of improving operations/workload, to be discussed on the monthly IPM call.
The IPM may be contacted directly by DIOP for assistance and performance of any responsibility described in this FMD.
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 via the monthly IPM conference calls.
DIOP will make available Regional Activities Mangers (RAMs), for use by the IPMs as a specific conduit between the District and DIOP.
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.)