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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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8-6 - HEADQUARTERS OPERATING PROCEDURES

8-6 - HEADQUARTERS OPERATING PROCEDURES
      8-6-1 - FDA Emergency Operations Center
      8-6-2 - Center Emergency Coordination Units
      8-6-3 - Office Of Regulatory Affairs
      8-6-4 - Federal-State Relations/ORO

  8-6 - HEADQUARTERS OPERATING PROCEDURES

  8-6-1 - FDA Emergency Operations Center

The FDA Emergency Operations Center will monitor all emergency alerts/investigations and serve as the agency-wide and inter-agency focal point for 24 hour, 7 day communications concerning developing and active emergency situations.

  1. Emergency Alerts

    Initial emergency alerts received by FDA headquarters units from consumers and other sources outside FDA will be reported to the EOC. If potential danger to health is involved, the EOC will notify the field by phone immediately. If an investigation is requested by another headquarters unit, procedures established in FMD #17 allow requests to be issued directly to the action district or field office with copies to the appropriate RFDD, ORA unit and other center or office indicated. See also 8-4.

  2. EOC 24 Hour Telephone Contacts

    After hours, or when the command center is not in operation, calls can be made to the 24-hour emergency number, handled by the answering service. In the event that calls are designated as an emergency by the caller, the answering service will contact the late duty officer (LDO) or alternate late duty officer (ALDO) by cell phone and/or pager.

    FDA Emergency Operations 24-hour telephone number: 866-300-4374.

  3. Headquarters Coordination

    The EOC will immediately advise the appropriate field office, the center emergency coordination unit and the Office of Regulatory Affairs of significant emergency alerts or when any investigation reaches presumptive status. The Office of Public Affairs (OPA) will also be notified when public press coverage is ongoing or imminent. The Office of Legislative Affairs (OLA) will be alerted when there is or may be congressional interest. The EOC will forward to DFSR copies of all reports from field offices pertaining to state and local activities/actions/agreements; and any press releases issued. (e.g.: information required under 8-5-1, 8-5-4, 8-5-5-1, etc.). The EOC will prepare periodical updating status reports on such alerts/investigations. These reports will be hand carried to HF-1, HF-4, HFC-1 and HFC-100/101. Electronic mail will be used to distribute additional copies to other headquarters offices, responsible centers and to other appropriate units.

    All reports required by the Department on disasters, civil disorders, or other emergencies will be prepared by the EOC for distribution within ORA Headquarters and the appropriate office within DHHS.

  4. Interagency Liaison

    The EOC will coordinate information concerning emergencies with headquarters offices of other Federal agencies in accordance with Section 8-7 of this chapter. When commerce with Canada or Mexico is involved, coordination will be by the EOC in cooperation with the Office of International Programs (OIP). When other foreign governments are involved, the EOC will advise OIP so that office may establish and coordinate with the EOC the maintenance of communication channels.

  8-6-2 - Center Emergency Coordination Units

All centers will maintain an emergency coordination function which will serve as the focal point for intra-center communications with the EOC. Centers will be responsible for scientific evaluations and for policy decisions, in cooperation with ACRA, in their respective program areas. Centers will continue ongoing interagency liaison activities to the extent possible as emergency coordination with other agencies is managed pursuant to 8-7.

Each center has identified the office listed in 8-5-5 to serve as its coordination unit. These units (except for CDRH/Radiation Programs Branch) are located in the center's Office of Compliance to facilitate any recall and/or case development activities which may be associated with an emergency. The Radiation Programs Branch is a focal point for radiological emergencies involving releases of radiation or radioactive materials which could impact FDA-regulated products or require the use of FDA-regulated products to mitigate the impact of the release.  The Radiation Programs Branch is located in the Division of Mammography Quality and Radiation Programs/CDRH.

  1. Inter-Office Communications 

    The center's emergency coordination function will provide a telephone number which will be the contact number for communications with the EOC during any stage of an emergency. It shall be equipped with a speaker phone and situated in a room or office suitable for a small meeting.

  2. After Hours Communication

    Each center emergency coordination function will provide the EOC with a call list, which will provide 24 hour/7 day coverage. (A continuing effort will be made to evaluate various electronic communications systems to supplant the call lists.)

  3. Reporting

    Center emergency coordinators will maintain concise chronology of center activities similar to that which field coordinators maintain (see 8-5-4). When the copy of the final report (8-5-5) is received from the lead district, the center will use its chronology during its review of the district report. The Center will then send any comments to the EOC before the EOC prepares a final report on the emergency.

  8-6-3 - Office Of Regulatory Affairs

The Office of Crisis Management/EOC will serve as the focal point for emergency operations and communications within the Office of the Commissioner. Any information received by ORA will be discussed as appropriate with the Office of Crisis Management, Commissioner and Deputy Commissioner for Operations and with other Deputy Commissioners both during business and non-business hours. This does not, when appropriate, preclude the immediate reporting of significant emergency information to the Commissioner/Deputy Commissioner for Operations by the Director of Office of Regional Operations, Center Directors, or by the Director or Deputy Director, EOC.

  1. Policy Statements

    The Office of Crisis Management and the Associate Commissioner for Regulatory Affairs or designee, working with the responsible centers and ORO, will develop/issue/approve any new or revised regulatory policy which is required by an emergency situation.

  2. ORA Call List

    The order in which EOC staff should call ORA personnel during non-business hours is:

    1. Associate Commissioner for Regulatory Affairs
    2. Director, Office of Regional Operations
    3. Deputy Associate Commissioner for Regulatory Affairs
    4. Assistant Commissioner for Regulatory Affairs
    5. Director, Office of Enforcement
    6. Director, Office of Resource Management

  8-6-4 - Federal-State Relations/ORO

The Division of Federal-State Relations (DFSR), in cooperation with the regions or districts, will coordinate Agency interaction with state and local agencies in emergency situations.

DFSR will maintain FDA's rapid communication system to state governments, major municipalities and poison control centers. DFSR will also continue the ORO/State Association efforts to develop uniform emergency operational guidelines.

  1. In emergency situations, DFSR will:
    1. Ensure that the governors' offices have been notified of significant confirmed emergencies in their states;
    2. Notify all states of confirmed emergencies involving two or more states. Indicate potential or problem products entering commerce; and,
    3. Prepare (or distribute) information requested by states for their emergency roles, and assure that states are fully advised as to what action the agency can recommend to them under the circumstances of the specific emergency.
  2. As routine functions, DFSR will:

    Maintain a directory showing the responsibilities of major state organizations; names, telephone numbers, and addresses of key state personnel, and other information needed to quickly enlist nation-wide state and local assistance to FDA's emergency operations.