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ORA Field Management Directive FMD #56

Subject: ORA Weekly Management Review

Area: Operations Management

Date: February 2001

PURPOSE:

This FMD provides guidance for submitting the ORA Weekly Management Review concerning field activities of interest to other ORA units.

PROCEDURE:

Each Regional Food and Drug Director (RFDD) will send a management review covering significant activities within the region to Senior ORA headquarters and field managers no later than 1:00 p.m., Washington, DC, time each Wednesday. If Wednesday is a holiday, the review is due on Tuesday.

FORMAT:

Address the review to the Director, Office of Regional Operations (HFC-100) and transmit it via electronic mail to: RFDDs, DDs, Directors of Regional Laboratories, and the Directors of ORO, OCI, OE, and ORM.

General Instructions:

    1. Be particularly sensitive to the need to exclude detailed information on pending regulatory recommendations or Grand Jury 6(e)/criminal material from all sections of the report. Significant activities should be reported once all regulatory actions are closed.
    2. Do not list by name the employees who performed the reported activities, unless the individual is being recognized for unusual accomplishments (e.g., someone receives an award from the Federal Executive Board or is selected as an officer of a prestigious scientific society.)
    3. Typical day-to-day activities, such as routine Warning Letters, individual import detentions, and speeches should not be reported. While these actions are essential ORA functions, we all know they happen and, therefore, need not list them.
    4. Reports should not exceed 5 pages in length.

The headings to be used and examples of items to be covered under each heading are:

  1. Hot Items and Early Alerts

    2. Include issues of an emergency nature and/or early information on activities that have a potential for widespread agency or industry impact.

  2. Action Items

    3. Identify issues which may need prompt attention by headquarters. ORA headquarters will follow up in response to these items and notify appropriate field managers of steps taken to resolve them.

  3. Program Operations

Include information on significant and/or precedent-setting actions (except for material subject to Rule 6(e) secrecy provisions), inspections, detentions, etc. Be succinct and show the involved District(s) and the subject of each item in the "lead-in" to the item. For example:

SEA-DO CONDUCTS ASIAN HERBAL PRODUCT BLITZ: SEA-DO is conducting a joint blitz with U.S. Customs of herbal remedies from Asia to identify items which misdeclared in an attempt to circumvent automatic detention procedures. Twenty-five entries have been detained since the start of this partnership on 8/19/95.

The program headings should be in the following order:

    1. Foods and Cosmetics
    2. Human Drugs
    3. Biologics
    4. Veterinary Drugs
    5. Medical Devices and Radiological Health
    6. Health Fraud
  1. General
    1. Public Affairs
    2. Cooperating Officials
    3. Administrative Management
    4. Contact with Elected Officials
    5. Details to Headquarters
    6. Vacancy Announcements by District (for at least positions classified as GS-13 or higher)
    7. Other
  1. Work Schedule

Describe for the week beginning on the following Monday, the work schedule for the RFDDs, DDs, and Regional Laboratory Directors (i.e., who is on duty/leave, where the person will be if on official travel, and who will be in charge during any absences.)