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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Introduction to the Field Management Directives Manual

 

PURPOSE 

The Field Management Directives (FMD) Manual is the primary vehicle for distributing procedural information/policy on the management of Office of Regulatory Affairs (ORA) field activities. The manual is issued on the authority of the Associate Commissioner for Regulatory Affairs (ACRA) and is intended as INTERNAL GUIDANCE directed to field managers. 

BACKGROUND 

The first manual providing guidance to field staff was implemented in 1970 and titled Field Policy Directives. By the end of 1972, the manual's title was changed to Field Management Directives. 

The Field Management Directives Manual was originally intended to transmit field policy information from headquarters to the field. The scope was later broadened to include both policy and procedural information. The manual continues to provide field managers with guidance on the management of field activities in both program and operational areas. 

RESPONSIBILITY 

  • Office of Regulatory Affairs 

The ACRA approves all new or revised FMDs. 

  • Issuing Offices 

Responsibility for a particular directive rests with the office which develops it (new directive) or revises/cancels it (for those directives no longer current/germane). Issuing offices are responsible for content. The designated issuing offices are: 

- Associate Commissioner for Regulatory Affairs

- Office of Regional Operations

- Office of Resource Management

- Office of Enforcement

- Office of Criminal Investigations

- Office of Resource Management 

Within the Office of Resource Management, the Division of Management Operations (DMO) coordinates the proposed document action by obtaining any necessary clearances for new or revised policy. After all revisions have been completed by the issuing office, DMO prepares camera copy, forwards the document through the printing process, and ensures distribution to both field and headquarters FDA personnel. 

CLEARANCE PROCEDURE 

All FMDs must be cleared by the issuing office, other offices or centers affected, and the ACRA. The Division of Management Operations coordinates and maintains all clearance records. 

CONTENTS/FORMAT 

The manual contains instructions on how to manage various activities of the field installations. This information includes the following subject areas: 

- Operations Management - information on managing particular aspects of the operation of a field office.

- Program Management - information on managing particular aspects of individual FDA programs.

- State Program Management - information on the conduct of contacts with state officials and coordination of activities with states. 

In the past, FMDs were organized numerically within the following sections:

- Operations Management

- Program Management

- Planning and Budget Guidance

- State Program Management

- Manual Maintenance 

The revised manual has been reorganized to eliminate all subordinate sections. The FMDs now are arranged in numerical order only, beginning with FMD #13 and ascending to the newly issued FMD #144. Missing FMD numbers indicate canceled FMDs since the numbers of canceled FMDs are not reassigned; they are retired. 

A list of canceled FMDs is also provided. However, this list is not historically all-inclusive. It identifies only those FMDs canceled since the last manual index, dated 8/15/88, was distributed. The manual contains a numeric index and two versions of an abbreviated subject index, in alphabetical order and in FMD order. 

DISTRIBUTION 

Copies of the manual or copies of individual FMDs are available through the Management Control and Review Branch (HFC-23), Division of Management Operations, at (301) 443-3350. Printed copies of new or revised FMDs are distributed as issued between complete manual publications.

 

Last updated:  5-21-99