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ORA FIELD MANAGEMENT DIRECTIVE No. 64

Subject:
Epidemiological Investigations Alert Reporting Procedures		 Area:
Operations Management		 Date:
6/1/95 Revised

PURPOSE

To provide information to all headquarters, regional and district personnel of the procedures for providing prompt notification to FDA/headquarters/field and/or other cooperating agencies, about illness, injury, disease, or adverse reaction complaints.

GENERAL

The primary function of the epidemiological alert system is to make it possible to act immediately to protect the public from contaminated or defective FDA-regulated products.

The epidemiological alert system centralizes the complaint and adverse reaction notifications at the Epidemiological Investigations Branch (EIB). In this Branch, complaints are compiled by product and firm name which allows for quick assessment in determining if a significant problem is developing relative to a particular product or firm.

This Branch utilizes surveillance information from many sources including all of the complaint, adverse reaction, product defect and radiation incidents registry systems being used by the various centers and ORO, as well as other Federal agencies, Canadian health officials and industry. It can also provide information, usually within minutes, concerning a product or incident to evaluate what follow-up may be necessary. It allows for headquarters coordination and timely information being available to everyone with a need to know, including the field offices, the centers, ORO, Press Office and the Office of the Commissioner.

PROCEDURES

1. District/Field Office Actions

a. District Contacts

The individuals identified by the districts, in keeping with the instructions of the RPM Chapters 5-10 Emergency Procedures will be the district contacts.

b. Epidemiological Alert Reports

All illness, injury, disease, or adverse reactions should be followed up and reported, as required by the emergency procedures, to Epidemiological Investigations Branch, by FAX, telephone, EMS, or similar systems.

c. Hard Copy Reports

Follow the instructions outlined by the Emergency Procedures.

d. Investigational Instructions

Refer to IOM Chapter 9, Special Operations, for investigative procedures. All illness, injury, disease, or adverse reaction complaints shall be followed up on a high-priority basis.

2. Epidemiological Investigations Branch Actions

a. Epidemiological Alerts

The initial complaint alerts are often received by FDA headquarters from consumers and other sources outside FDA. These complaints are referred to the Epidemiological Investigations Branch, ORO (HFC-161). If an illness, injury, disease, or adverse reaction is involved, EIB will notify the field by phone immediately.

b. Liaison System - Epidemiological Investigations Branch 24 Hour Telephone Contacts

To assure prompt reporting and follow-up at all times (after hours, weekends, holidays), an after-hours FDA answering service is used.

Normal Duty Hours

Division of Emergency and
Epidemiological Operations . . . 301-443-4667 OR 301-443-1240

After Hours Answering Service

202-857-8400
301-443-1240
301-443-4667

EIB will advise the appropriate center when any injury/illness investigation reaches a Stage II presumptive status.

EIB will coordinate the field information with the appropriate FDA offices, other government offices, foreign government offices, and trade associations when necessary.

c. Evaluation

EIB will monitor and notify the field of any new developments.

3. Investigative Terminology

The terminology used to describe the status of the stage of the investigations is outlined in 5-10-30 of the Emergency Procedures.

MATERIAL SUPERSEDED

Field Management Directive No. 64, dated 1/30/87.

MATERIAL CROSS REFERENCE

FMD No. 119 - Consumer Product Complaints System

IOM Sub Chapter:

        910 - (Investigation of Foodborne Outbreaks)

        920 - (Investigation - Injury & Adverse Reactions Biologics, Drugs, Devices and Cosmetics)

        171.42 - (USDA Agreements)

        171.44 - (CDC Cooperation)

RPM Chapter 5-10 Emergency Procedures (ORA)

EFFECTIVE DATE

Upon receipt of this directive.

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

ISSUED BY:                 ORA/ORO/Division of Emergency and Investigational Operations (HFC-130)

AUTHORITY:                ORA

PUBLICATION DATE: 8/96

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