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ORA FIELD MANAGEMENT DIRECTIVE No. 17

Subject: ORA Field Assignments-Guidelines for Issuance by Headquarters

Area: Operations Management

Date: 05/08/08 Revised

PURPOSE

This Field Management Directive (FMD) provides guidance on the clearance and issuance of assignments to ORA field units.

BACKGROUND

To ensure the appropriate and efficient use of FDA resources, assignments requesting work by ORA field units, whether from an ORA headquarters unit or a Center, must be developed, cleared, and issued in a reasoned and timely manner. Each assignment should clearly indicate what is needed, why, by when, from where the resources to accomplish the task will come, an estimate of costs, the estimated time to complete it, and how/to whom/when the results are to be reported.

Assignments vary in priority. Assignments are designated "routine, "high," and "top" priority to easily communicate to the field units the priority of assignments for use in managing their workloads.

Routine priority assignments should be covered when district resources allow, but generally within the next 3 - 12 months.

High priority assignments take priority over all other field work of the Center issuing the assignment.  Timeframes for the completion of the assignment are established by the issuing Center and are included in the assignment.

Top priority assignments take priority over all other field work, including the work of the issuing Center, the other centers, and headquarters, due to public health or other concerns.  Top priority assignments should be addressed upon receipt by the district and completed before all other district work.

NOTE:  For issues that should be followed up during the next routine inspection of a firm, at an unspecified future date, the Center should submit a memo to the district for inclusion in the establishment's file jacket.

The Associate Commissioner for Regulatory Affairs has delegated authority to the Director, Office of Regional Operations (HFC-100), to provide final clearance for assignments that require ORA concurrence prior to issuance to ORA field units.  Assignments that do not require ORA concurrence, should be entered into FACTS and issued by the Center or other FDA headquarters unit directly to the regions and districts that are to accomplish the work.

ORA CLEARANCE

ORA clearance is required for "top" priority assignments, "high" priority assignments, and assignments issued to multiple districts. 

ORA clearance is not required when all of the following conditions are met:

  • The specific type of work is already identified in the workplan under a specific program assignment code (PAC), i.e. an established program that is accomplished through the annual issuance of assignments by the centers and reported using PACs for which resources are included in the workplan and resource expenditure can be tracked.
  • The assignment is "routine" priority; and
  • The assignment is issued to a single district. 

ORA clearance may not be required for the revision to an existing, cleared assignment, but ORO should be notified of the reason for and extent of the revision and provided a copy of the revised assignment in advance of its issuance.

NOTE: This FMD does not apply to those assignments relating to the pre-approval process, associated with user fees, or associated with agency crisis or emergency response activities.

ORA CLEARANCE PROCEDURES

  • A draft assignment that requires ORA clearance should be sent via electronic means to the Special Assistant to the Director, ORO (HFC-102).  Supporting documents should also be provided.  Attachments or other materials essential for review that are not available electronically should be faxed or hand delivered.  In urgent situations, such as top priority assignments or assignments with short timeframes for completion, phone concurrence with subsequent exchange of documentation may be appropriate.
  • HFC-102 will determine the necessary distribution within ORA headquarters and to the appropriate Field Committee Chair(s) during the clearance process.  If included, the Field Committee Chair will determine the extent of distribution within the committee and will provide consolidated comments to HFC-102 in a timely manner. 
  • HFC-102 will ensure a timely response to a Center's request for clearance of an assignment.  
    • Generally, top priority assignments will be responded to within 1 business day. 
    • Generally, high priority single district assignments will be responded to within 3 business days.
    • Generally, high priority and routine multi-district assignments will be responded to within 12 business days.
  • HFC-102 will consolidate comments received and will provide substantive comments to the Center that reflect ORA's position.  To the extent possible, recommendations or revisions to resolve the issues identified by the ORA reviewers will be provided to the Center.
  • After consideration of the content requirements defined below and all comments received, ORA/ORO will provide a final decision (concurrence, concurrence with comment, or non-concurrence) to the issuing Center.  If concurrence is not granted, a written explanation will be provided.  If ORA requests a revision of the assignment, the process will be repeated to the extent that an ORA review will determine whether all significant issues have been addressed.  Whenever possible, conference calls will be held to resolve outstanding issues, in order to expedite the clearance process.
  • Upon concurrence, an ORA concurrence number will be provided. This number must be included in the assignment issued by the Center in FACTS.
  • When the ORA review indicates that the region/district does not have sufficient resources to accomplish the assignment, the Center and ORA may negotiate with another region/district or Center to obtain adequate resources or redistribute resources within that program area.
  • All appropriately issued field assignments are to be considered workload commitments.  A district that is unable to complete an assignment within established timeframe for any reason (e.g., budget, priority, manpower constraints, etc.) shall advise HFC-102 and the Center assignment contact.  Efforts will be made between ORA and the Center to reassign the work and resources and/or to provide acceptable flexible alternatives to meet assignment objectives.

DEVELOPMENT OF ASSIGNMENTS

Centers, ORA headquarters units, and the ORA Field Committees are encouraged to work together in preparing assignments.  Such contacts serve to minimize the need to revise assignments and may help identify ways to reduce the resources needed to accomplish the assignment.  For example, the ORO/Division of Import Operations and Policy can assist with the development of import sampling strategies based on historical product entry data that better assures the success of assignment objectives.  In addition, ORO/Division of Field Science can help establish validated methods and identify laboratories equipped and staffed to perform any desired analyses. ORA representatives assigned to work with a Center to prepare an assignment will have authority to represent ORA and will be responsible for assuring that their advice and concurrences reflect ORA's position. 

Centers are also encouraged to provide their annually established program priorities at the beginning of each fiscal year. This provides ORA insight into the kinds of assignments to expect from the Center.  When a Center issues an assignment that does not agree with these established priorities, ORA may request justification for the assignment and consider the resource implications on established priorities.

For assignments that issue during the last six months of the fiscal year, the Center should contact ORA/ORM/Division of Planning, Evaluation and Management for a review of remaining fiscal year resources to determine whether the assigned region/district has the necessary resources to accomplish the assignment and any other outstanding assignments.  If necessary, the assignment should state what planned work is to be cancelled to provide resources for the assignment.

Multiple FDA assignment-driven visits to the same establishment over a period of months may result in the inefficient use of FDA resources and create poor relations with the regulated industry.  Therefore, Centers are encouraged to develop internal coordination mechanisms to minimize multiple requests, sometimes issued by different Center units, to a district to perform work at the same location.  In addition, the Centers should review the inspection history information in FACTS when selecting firms for assignment.  This review should include noting any seasonable variations of production to ensure that the assignment can be completed in that time frame.  To assist Centers in recognizing circumstances requiring improved coordination, upon receipt of such an assignment, ORA will report to the appropriate Center any multiple visits to the same location that appear to be inefficient or problematic.

ASSIGNMENT CONTENT REQUIREMENTS

To ensure that all assignments indicate what is needed, why, by when, from where the resources to accomplish the task will come, the estimated time to complete the assignment, and how/to whom/when the results are to be reported, they should include:

  • The assignment priority, as defined above;
  • The ORA concurrence number, when applicable;
  • The FACTS assignment number;
  • Information sufficient to identify the firm, including the firm name, complete address, telephone number, FEI number, and all other identifiers such as U.S. license, NDA/ANDA, IND, and similar application numbers (when multiple firms are listed, this information should be provided in an alphabetized list, grouped by district, or in an electronic file format which can be sorted by ORA and the field unit);
  • A statement that the status of the firms involved in the assignment have been checked in FACTS and, if a site has been recently inspected, a notation that this fact has been considered in the development of the assignment;
  • The product code and full description of product, including lot number(s)/code(s), if available;
  • A brief background section that states why the assignment is needed and explains any deviation from established Center program priorities;
  • A description of what is to be accomplished (e.g., inspection, domestic or import sample collection/analysis), including appropriate compliance program to be used, specific areas for coverage and/or issues to be addressed;
  • Reference to the appropriate inspection/investigation/sampling guidance (for assignments that will require a deviation from established guidance or will require special equipment, please contact ORO/Division of Field Investigations);
  • As applicable, a request to call the Center contact prior to initiating the inspection in order to answer any questions or to clarify any requests delineated in the assignment.  For example, if the assignment involves a manufacturer of unapproved products or unusual issues (e.g., unusual factual, legal, or strategic issues; unusual processes, applications, firm history, or company aspects).

    NOTE:  For multi-district assignments that involve unusual issues, ORO is available upon request to set up a conference call with the involved Center(s) and districts to coordinate the understanding of the assignment across multiple Agency components.

  • Inclusion, as attachments, of any/all documents specifically referenced in the assignment (this does not include readily available FDA references like CPGMs, the RPM, the IOM, etc);
  • For sampling assignments
    • any special analytical concerns (e.g., use of aseptic sampling technique, the use of a specific analytical method or reagent) and an estimate of associated costs;
    • the identity of the servicing laboratory, if the National Sample Distributor (NSD) is not to be utilized (this may be confirmed by ORO/Division of Field Science);
    • for import sampling assignments, the Center must contact ORO/Division of Import Operations and Policy to ensure that the necessary electronic entry screening criteria are entered in OASIS;
    • a realistic estimate of the cost per sample;
  • A regulatory strategy or the guidance to be used if regulatory/administrative follow-up is required;
  • The identification of a Center assignment contact person, including their email address and telephone/fax numbers (ORA HQ unit contacts that may be able to address inspection or laboratory issues may be included, as well);
  • FACTS data and investigation/inspection/sample reporting instructions;
  • PAC(s) to be used to report work
  • In those instances where a new assignment-specific PAC, under which no resources have been planned, is needed by the Center and deemed essential to evaluate accomplishments, the assignment will state what planned work is to be cancelled to provide resources for the assignment;

    NOTE:  PACs are issued by ORA's Program Evaluation Branch

  • A realistic estimate of the resources, in hours, needed to accomplish the work (this should include the time for the ORA employee(s) to prepare for/accomplish/report on the assignment, but does not include time to travel to the firm);
  • A target completion date (e.g., sample collections by 10/30/2008, sample analyses within 90 days of receipt).

ISSUANCE OF ASSIGNMENTS

An information copy of all top and high priority and multi-district assignments issued (without attachments) should be sent by electronic or hardcopy means to HFC-102, HFC-130, and to the Chair of the ORA Field Committee that corresponds to the issuing Center (refer to FMD 30).

Assignments not requiring ORA clearance are to be issued in FACTS by the Center directly to the Director of Investigations Branch of the action district.  Send one copy when the body of the assignment is issued electronically.  Send the original plus two (2) copies to the District Director when the assignment is issued by hard copy.

QUESTIONS/PROBLEMS

If there is any question about whether ORA concurrence is required or was obtained for a specific assignment, contact the Special Assistant to the Director, ORO (HFC-102), 301-827-0961 (FAX 301-443-1778) for assistance.

If a region or district has a question about the content of or anticipates or encounters problems with an assignment, it should contact the Center contact person indicated in the assignment to attempt to resolve the issue.

If a region or district cannot resolve a matter with the Center, it may request assistance from ORA Headquarters or the appropriate ORA Field Committee

In rare circumstances, it may be necessary for ORA HQ, through the Director, ORO, to place an assignment in abeyance due to conflicting workload priorities or issues in the assignment pending resolution with the Center.  ORA will attempt to resolve the situation with the Center before placing the assignment in abeyance and will promptly notify the Center of any abeyance decision. ORA will provide a written explanation of the decision to place an assignment in abeyance when the decision is made without Center input.