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Inspections, Compliance, Enforcement, and Criminal Investigations

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State Correspondence

 

Triangle

ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs

ORA-FMD

Document #:

 

Version #:   2.0

Page 1 of 15

Title:

FMD 50 - FDA-State Communication Field Management Directive (FMD)

Date: 

5/2/2011


Sections included in this document

 

1.      Purpose

2.      Scope

3.      Guidelines

4.      Procedure/Responsibilities

5.      Background

6.      Reference/Supporting Documents

7.      Definitions/Glossary

8.      Records

9.      Attachments                                                         

Document and Change History

 

1.      Purpose

 

This Field Management Directive (FMD) identifies specific areas and processes of communication between the Food and Drug Administration (FDA) and state regulatory agency representatives (including local, tribal, and territorial representatives when appropriate; all referenced as “States” in this document) for routine activities, work planning, and emergency situations.

 

This directive, which describes expected communication of FDA with state partners, will be complemented by district/state-specific communication standard operating procedures (SOPs) that are jointly developed between FDA field offices and respective state partners. These SOPs will include procedures for bi-directional communication between FDA and state partners.

 

Together, this Field Management Directive and the district/state-specific communication SOPs should establish a clear, mutual understanding of communication roles, responsibilities, and expectations among state and FDA partners for their work together. Such documented processes are foundational to achieving the broader goal of having effective and robust partnerships between federal and state partners for protecting and promoting public health.

 

2.      Scope

           

This Field Management Director applies to communication in routine, workplanning, and emergency circumstances among the following: 

 

A.     State regulatory agency representatives.

 

B.     FDA Field Offices:

 

1.  Regions: Regional Food & Drug Directors (RFDDs), Directors of Cooperative Programs, or other primary state points of contact, as appropriate for the situation.

 

2.  Districts: District Directors (DDs), Directors of Investigations, Directors of Compliance, Supervisory Consumer Safety Officers, Recall Coordinators, Federal-state relations Coordinators, Consumer Complaint Coordinators, and Emergency Response Coordinators, State Liaisons, or other primary state points of contact, as appropriate for the situation.

 

C.     FDA Headquarters (HQ):

 

1.  Office of Regulatory Affairs (ORA) (e.g., Office of Regional Operations, Division of Federal-State Relations (DFSR), Office of Enforcement (OE)).

 

2.  Centers: Center for Food Safety and Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Tobacco Products (CTP).

 

3.      Guidelines

 

Legal Framework for Information Sharing:

 

A.     Ensure all FDA representatives communicating with state partners are familiar with FDA Information Disclosure Policies and Procedures (http://inside.fda.gov:9003/ORA/InformationDisclosure/ucm207591.htm).

 

B.     Consider compliance with disclosure regulations of the partners involved (e.g., Freedom of Information Act (FOIA), state sunshine laws).

 

C.     Information shared between FDA and state partners is subject to FDA discretion and confidentiality limitations. Regulations governing the sharing of information are in 21 CFR Part 20, including the following:

 

1.      21 CFR 20.88 – Communications with State and local government officials

 

2.      21 CFR 20.91 – Use of data or information for administrative or court enforcement action

 
4.      Procedure/Responsibilities

 

A.     Communication Channels and Information Categories

FDA Field Offices and FDA HQ Offices work directly with state partners to ensure achievement of FDA’s public health mission. Communication takes place through email, telephone, and face to face meetings.

 

FDA field offices and DFSR are the primary contacts with state partners and should keep each other (and any other relevant FDA offices) appraised of all exchanges, as appropriate. Specific positions, roles, etc. would be described in a district/state-specific SOP.

 

1.      District/State-Specific Information

 

FDA Field Offices are the primary interface to share information with state partners on district/state-specific information. FDA Field Offices are also the first lines of response to any inquiries or needs of state partners.

 

2.      National-level Information

 

FDA HQ Offices communicate with state partners for national-level information.

 

a.      DFSR is the primary interface for ORA HQ with states to share information at a national level, including for contracts and grants and with associations (e.g., AFDO, AAFCO).

b.      ORA HQ and Centers communicate with state partners through DFSR or in specified instances and pre-established channels.

 

B.     Routine Communication

 

1.      General Overview

 

FDA Field Offices and FDA HQ Offices work with state partners throughout the year in many ways such as in long-term federal-state programs, contract work, and joint inspections. There are some areas or aspects of this work in which the FDA Field Offices are the primary interface with State partners, and there are others in which FDA HQ Offices are the primary interface.

 

        2.      When FDA Field Offices are the Primary Interface 

 

a.      FDA Field Provides Information to State Partners[*]

FDA Field Provides Information to State Partners

Examples

     

1

Notable changes to FDA initiatives, priorities, or workplans that would impact work conducted by the state.

  • FDA field assignments
  • Changes in agency procedures

2

Updates on requests for follow-up on routine duties, consumer complaints, contracts, etc.

  • Guidance for responding to a new, frequent consumer complaint
  • Contract inspection updates

3

Information and assignments, including through electronic systems/portals.

  • FDA assignments
  • Information pushed out through eSAF

4

Situational awareness on potential events of interest for the state. This includes providing notification of pending or recommended compliance/enforcement actions within 5 working days of completion of any violative inspection.

  • FDA inspections/findings with potential to result in compliance actions
  • Embargo/injunction/ seizure

5

Illness and injury related events involving regulated products and emergency situations. This is described further in “4D. Communication in Emergencies.”

  • Information on outbreaks or emergencies

                                                                                                                                                                                                                    


 

b.      FDA Field Exchanges Information with State Partners

FDA Field Exchanges Information with State

Examples

     

1

Collaborative projects: implementation, execution, and completion.

  • Contracts and grants that have been awarded
  • Cooperative agreements
  • Committees and working groups
  • Assignments

2

Joint inspection activities.

  • Inspectional history
  • Preparation and planning
  • Sampling
  • Utilization of resources
  • Communication of findings, compliance actions

3

Receipt of notable information: FDA Field must inform ORA HQ of significant state actions.

  • Trigger memos

 


 

c.      FDA Field Addresses Inquiries from State Partners[†]

FDA Field Addresses Inquiries from State Partners

Examples

     

1

Inquiries the field office can address must be addressed as expeditiously as possible. A response or expected time of response should be shared with the requestor.

  • Harmonization of firm inventory
  • Contract firm selection
  • Status of assignments or other directed work
  • Press releases, copies of regulations

2

Inquiries the field office cannot address: FDA field office will expeditiously either obtain a resolution to the request or refer the state to the appropriate FDA office for follow-up (e.g., provide referral contact). An acknowledgment of the request detailing a timeline of anticipated response should be shared with the requestor.

  • Agency guidance on a food/device safety issue that is beyond the scope of field office guidance.

 


3.      When FDA HQ Offices are the Primary Interface

 

a.      FDA HQ Provides Information to State Partners[‡]

FDA HQ Provides Information to State Partners

Examples

     

1

DFSR regularly distributes announcements to relevant state organizations in all 50 states (or an appropriate subset of states) through the broadcast system.

  • Recall press releases
  • FDA-wide news (e.g., approvals, enforcement actions such as warning letters or injunctions)
  • Changes in agency organization

2

DFSR holds routine 50-state calls with states to discuss updates and issues of concern (including during emergencies - see “4D. Communication in Emergencies”).

  • Updates/introductions to FDA organizations
  • Recalls
  • Assignments
  • Policy changes

3

DFSR shares weekly updates from FDA with commissioned state officials in all 50 states.

  • FDA Operations Report
  • Report of new potential class 1 recalls

4

DFSR forwards Reportable Food Registry (RFR) reports to commissioned state officials, as appropriate to the report.

N/A

5

DFSR provides State contacts notification of new programs, as necessary.

  • New/status of grants
  • New/status of contracts and options

6

DFSR provides national-level information to associations.

  • AFDO, AAFCO, ASTHO

 

 

b.      FDA HQ Exchanges Information with State Partners[§]

FDA HQ Exchanges Information with State Partners

Examples

     

1

DFSR is the primary contact for state partners for routine FDA activities such as the development of contracts and grants.

  • Training announcements (in conjunction with ORA/Division of Human Resource Development (DHRD) and Regional Training Officers (RTOs))
  • Contract modifications
  • Funding carryover requests
  • Guidance on the implementation of the Manufactured Food Regulatory Program Standards (MFRPS)

2

DFSR addresses state needs, concerns, and questions raised regarding issues such as ongoing processes and programs, state legislation, or state public health advisories.

  • Communication concerns
  • Questions about FDA programs (e.g., Commissioning)
  • Requests for federal witness at state legislative hearings
  • Requests for comments on state regulations
  • Requests to review state public health advisories

3

DFSR communicates with associations, public health commissioners, agriculture commissioners, and other political representatives in the state in consultation with the respective district offices.

  • AFDO, AFDO-affiliates, AAFCO, APHL, NERO, NASDA, NEHA, NACCHO, ASTHO, NALBOH, USAHA, ASTHO, etc.

4

Other ORA HQ Organizations: The Office of the Association Commissioner for Regulatory Affairs and the Office of Regional Operations may communicate with state contacts as needed and other ORA HQ components may communicate with specific, pre-established state contacts. As warranted by the situation, DFSR and/or the respective field office should be copied or included on any communication by these offices.

  • Division of Field Science (e.g., FERN labs)

5

FDA Centers: May communicate with state partners based on established relationships/programs. Communication must be with the pre-designated state point of contact and include (copy) the appropriate regional or district office and DFSR, as warranted by the situation.

  • CFSAN
  • CVM
  • CDER
  • CBER
  • CDRH
  • CTP

 

 

C.     Communication in Workplanning

 

1.      General Overview

 

FDA Field Offices work directly with state partners in Workplanning to determine appropriate activities for the upcoming year. FDA Field Offices have the primary responsibility for working with state partners to ensure effective completion of activities identified for/by the Workplan. FDA HQ will provide support for the workplanning process throughout the year. DFSR will be notified of the initial Fiscal Year (FY) kick off workplanning sessions, which should be scheduled between states and district offices several weeks before the start of the new FY. 

 

The most extensive amount of communication will take place at the beginning of the period of performance for a contract, grant, or assignment, such as when the “Final Workplan” is issued from FDA and these activities are being developed and implemented. Communication will continue throughout the year.

 

2.      Communication During Workplan Development

 

Communication During Workplan Development

Examples

     

1

The FDA District Offices and State Cooperative Program Directors should solicit input from state partners prior to the Workplan assignments. This input may inform the district as it reviews the FDA-wide Field Workplan.

  • Problems identified last year
  • New state priorities this year
  • Updates on/expected resources and capabilities for the year
  • Updated Official Establishment Inventory (OEI) list

2

The FDA District Offices and State Cooperative Program Directors will share District Workplan information relevant to state partners with commissioned state partners as soon as possible to ensure optimal coordination of resources, priorities, and needs.

N/A

3

FDA District Office and State Cooperative Program Directors meet with state partners (together or separate) to establish Workplans and schedule of work (e.g., contracts and partnerships).

  • Meetings among district & program directors

4

State regulatory agencies and FDA Field Offices identify training needs for operational personnel required to support Workplan activities.

  • Meetings among district & program directors
  • Collaboration with DHRD to address planning/ scheduling training

 

3.      Communication During Workplan Completion

 

Communication During Workplan Completion

Examples

     

1

The FDA District Office communicates regularly with the state throughout the year to provide updates on any changes, monitor and assist progress, and address any issues that arise.

  • Workplan changes
  • Discrepancies in timeline or completion rate
  • Adjustments in state resources
  • Assignments which are significant in magnitude or scope to a given state
  • Feedback on state inspections and audits as appropriate

2

DFSR communicates regularly with the state and grant and cooperative agreement recipients throughout the year to provide updates on any changes, assist in progress, and address any issues that arise, individually or on a national basis.

  • Clarify contract terms
  • Facilitate training requirements
  • Effect of a national disaster on Workplans across the nation/ region/district

3

DFSR works with the grant cooperative agreement partners in the states with submission and any follow-up on periodic progress reports.

  • Mid-year/quarterly reports
  • Calls regarding grants/ cooperative agreements
  • Invoicing on contracts, etc.
  • Year-end contract close-out issues.
  • Audit reporting requirements

 

D.  Communication in Emergencies



      
1.      General Overview

 

FDA District[††] Offices are the primary interface to communicate with state partners during an emergency. FDA District Offices are responsible for the inclusion of state partners in updates and other communications, as relevant to state responsibility and involvement in the response. FDA District Offices are also responsible for awareness/information on state activities as they relate to an FDA emergency and for providing information back to HQ, as warranted by the situation.

 

FDA HQ (ORA and Centers) should only communicate with state partners through pre-established channels (e.g., DFSR, pre-established program contacts). Any exceptional communication should be copied to the relevant district contacts (see “2B. Scope”) and any other relevant FDA HQ office.

 

As every situation is different, discretion must be used in identifying the priority level of communication.

 

2.      Priorities

 

a.      Notification of a contained event or potential problem, such as a tampering incident, recall, positive sample, or a potential outbreak or natural disaster that may impact the state authority’s work.

 

The FDA notifies states of findings and discusses potential/emerging response.

 

b.      Notification of a widespread event with significant public health impact. The trigger for this is normally determined by HQ and conveyed to the District Offices. The FDA District Offices immediately contact relevant state officials in the affected states.

 

When requested, the District Office shall report to HQ offices, including detailed information regarding:

1)      Who was contacted at the state

2)      Summaries of state activity throughout the event

3)      A report at the conclusion of the event

 

Examples include potential multistate outbreaks, widespread natural disasters, positive samples with a broad impact, multi-region recalls, etc.


3.      FDA Field Communication with State Partners in Emergencies

 

FDA Field Provides Information to State Partners

Examples

     

1

Situational Awareness:

  1. Districts should immediately notify state partners of any potential events that could be considered emergencies.
  2. Districts and state partners should continually exchange Incident Action Plans (IAPs), situation reports, and other response updates throughout an incident.
  3. Districts and state partners should include each other on conference calls sharing notable updates and communication with firms.
  • Traceback of product leading to the state
  • Positive sample finding in product

2

Response Activities:

  1. Districts and states should follow jointly developed and approved response and communication SOPs.
  2. When using ICS at the district, consider using Unified Command with state partners and/or having both state and federal partners incorporated in the ICS structure.
  3. FDA field offices will exchange regular updates with the state on ongoing response activities and findings. Updates will also be shared with HQ; the frequency of this is determined by incident needs.
  • Adopted and followed Joint Communication SOP
  • Adopted and followed Joint Inspections SOP
  • Share results of samples collected with the state
  • Integrate state participation in a natural disaster response
  • Report received of a suspected problem

3

Recall Activities:

  1. FDA districts will notify state partners immediately of any potential and/or ongoing recall activities that are linked to an illness, injury, or positive sample.
  2. FDA districts and state partners will share the coordination of activities and the exchange of information on all recalls, recall audit checks, or inspections requiring state involvement.
  3. On a case-by-case basis, FDA will share information otherwise exempt from public disclosure to the extent necessary to effectuate a recall, as dictated by 21 CFR 20.91 and directed by OE.
  • Facilitating recall notifications
  • Conducting recall audit checks (avoiding duplication of visits)
  • Coordinating joint inspections
  • Harmonizing inspection data
  • Sharing lot code and distribution information, as necessary


4.      FDA HQ Communication with State Partners in Emergencies

 

FDA HQ Communication with State Partners in Emergencies

Examples

     

1

DFSR:

  1. Ensure that the governors' offices, public health commissioners, agriculture commissioners, and other political representatives in the state have been notified of significant, confirmed emergencies in their states in consultation with the respective district offices.
  2. Maintain state contact lists and contact states as appropriate in emergencies, in addition to those maintained by local FDA Field Offices.
  3. Use the broadcast system and coordinate 50-state calls to provide information to all states on multistate incidents.
  4. Address information requests/needs of the states in addition to those addressed by local FDA Field Offices.
  • 50-state calls to provide updates on ongoing investigations
  • 50-state calls to understand challenges being faced in the course of an emergency
  • Address concerns being raised by an individual state of challenges/needs encountered in the course of an emergency
  • DFSR maintains the Directory of State and Local Officials (DSLO) for national use by the districts and states

2

FDA Centers and State Partners:

  1. Direct communication:
    • FDA Centers should only communicate with state partners through pre-established channels. Any direct communication with the states should also be shared with relevant FDA HQ and Field Offices.
  2. Indirect communication:
    • The FDA Emergency Operations Center (EOC), DFSR, and other entities may include relevant FDA Centers in meetings with state partners, as appropriate.
  • Center communication with contact in region/ district and state during technical calls discussing sampling procedures
  • Center is included on a call with the firm to discuss a violative finding

3

Communication to Press

  1. Press inquiries during an FDA investigation from the public should be addressed by the local FDA contact at the District Office (e.g., public affairs specialist, District Director) and, as appropriate, referred to the FDA Office of Public Affairs (OPA).
  2. The FDA local contact, or designated OPA lead press officer, should work with the state public communications offices to ensure public messaging is harmonized. Field Public Affairs Specialists (PASs) maintain contacts lists of state press officers.
  • Local media requesting information on the FDA’s activities
  • Development of joint press releases between FDA and the state

 

5.      Background

 

Effective and efficient communication among regulatory partners is central to the success of a national integrated food safety system and the protection of public heath. One key relationship in protecting public health is the relationship between federal and state partners. This is evident in the many circumstances in which communication must take place between FDA and its state partners to achieve shared public health goals. For example, effective sharing of information and coordination of efforts (e.g., dividing tasks functionally, geographically, or complementing tools) would optimize ultimate outcomes and use of resources by both FDA and state partners, such as when there is an emergency need to remove a large amount of contaminated product from commerce.

 

Policies and procedures addressing how communication between FDA and state partners should occur in different program areas are described in a variety of reference documents (e.g., manuals, directives). This directive identifies a central picture of this issue, drawing together these different pieces and addressing some areas that have not previously been documented or standardized. This FDA-State Communication directive is needed to ensure appropriate and consistent communication across activities involving and affecting FDA and its state partners. In addition to these written directives and procedures, frequent communication among partners is critical to build, then institutionalize, standing channels of communication that become an integrated and expected part of the way we do business.

 

6.      References/Supporting Documents

 

A.     21 CFR Part 20

1.  21 CFR 20.88: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=20

 

2.  21 CFR 20.91: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=20

 

B.     FDA Disclosure Policies and SOPs

http://inside.fda.gov:9003/ORA/InformationDisclosure/ucm207591.htm

 

C.     Field Management Directives 17, 30, 30A, 37, 76, 119, and 121.

http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/UCM056246

 

D.     Investigations Operations Manual (IOM)

http://www.fda.gov/ICECI/Inspections/IOM/default.htm

 

E.     Regulatory Procedures Manual (RPM)

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm

 

7.      Definitions/Glossary

 

A.     State partners: In this document, a reference to “state partners” includes local, tribal, and territorial representatives when appropriate.

 

8.      Records 

 

            None

 

9.      Attachments

 

            None

 

 

 

 

 

Document History/Change History

 

Version #

Status*

(D,I, R, C)

Date

Author Name and Title

Approving Official Name and Title

1.0

I

8/96

Division of Federal-State Relations

ORA

2.0

R

5/2/2011

Shuen Chai,

Consumer Safety Officer

Joseph Reardon,

DFSR Director

 

* - D: Draft, I: Initial, R: Revision, C: Cancel

 

Version 2.0 Changes:

1.  Title changed from State Correspondence.

 

2.  Format updated to adhere to new FMD Template.

 

3.  The updated version of FMD 50 updates the expected processes for communication among FDA (both field and headquarters offices) and its state partners, accounting for changes in FDA organization, information needs, and technology. This updated document provides significant clarification by providing a more comprehensive description of instances in which FDA-State communication would take place (i.e., in routine work, workplanning, and emergency response situations), delineating specific definitions and key examples for each instance. The updated FMD also incorporates relevant guidance on FDA-State communication from other FDA sources and guidances (e.g., Investigations Operations Manual, Regulatory Procedures Manual).



[*] This description describes this general category of communication. Specific activities that fall under this category may involve or result from additional exchange of information/input with state partners.

[†]This description describes this general category of communication. Specific activities that fall under this category may involve or result from additional exchange of information/input with state partners.

[‡] This description describes this general category of communication. Specific activities that fall under this category may involve or result from additional exchange of information/input with state partners.

[§] This description describes this general category of communication. Specific activities that fall under this category may involve or result from additional exchange of information/input with state partners.

[††] Some emergencies may be more relevant to the Regional Specialist Program areas. In those instances, all references to Districts in this section (“4D. Communication in Emergencies”) apply to the Regions as well.