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II. How to Develop Partnership Agreements

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 II. How to Develop Partnership Agreements

PARTNERSHIP DEVELOPMENT

This content was last updated in October 2002.

 Timeframes:

The field is encouraged to structure existing working relationships as partnership agreements to provide for an integrated, seamless system of consumer protection. Opportunities will also occur for short-term agreements, say to emphasize a particular program area over a period of time.

Each region should have a system of soliciting new partnership projects or updating existing partnership projects. A call for projects should be accomplished at the beginning of each fiscal year. Each region should have a list of prioritized, approved projects in hand when DFSR announces the availability of funds. This usually occurs around the beginning of the calendar year.

  1. October: Regional offices request partnership projects
  2. December: Regional offices review and prioritize projects
  3. January: DFSR announces availability of funding
  4. August: All funds firmly obligated
  5. September: Projects conclude
  6. January: Annual Evaluations of prior year’s Partnerships

Some agreements do not conclude in September, but continue past the close of the federal fiscal year. The fiscal year funding, however, always concludes on or before September 30. Most partnerships should be renewed on an annual basis.

Regional offices should track the expenditure of partnership funds and consider sending reminders to obligate and disperse partnership funds. Funds that will not be used by the cut off date in August may be reallocated to other projects. Funds that are not firmly obligated by the August cut off date will be returned to DFSR.

 Resource considerations:

Each partner should consider a variety of funding sources when money is needed to further a partnership. Within FDA the following are examples of funding possibilities.

  • Partnership funds (Previously 393/Purchase Order).
  • District operating budget.
  • Regional operating and/or central funds.
  • Reprogramming of monies from existing contracts.
  • Partnership funding requests to Associate Commissioner for Regulatory Affairs.
  • Partnership funding requests to individual FDA Centers.

Non-FDA partner agencies may also have funding sources available to them that should be considered as possibilities for implementing the partnership.

 Inspections under Partnership:

Wherever possible, inspections should be performed under contracts, not partnership agreements. We will strive to transfer existing partnership inspections that are FDA annual obligations to contracts.

All Partnership Agreements/Activities that require the partnering agency to conduct inspections that count towards FDA's annual obligations MUST receive the same oversight (AUDITS) that are required of a contract inspection. (See OIG Report: "FDA Oversight of State Food Firm Inspections: A Call for Greater Accountability, June 2000 OEI-01-98-00400 and Federal-State Field Committee minutes). In addition to being subject to an audit, these inspections would also be subject to the reviewing district’s QMS/QAP plans and must be reviewed and evaluated under those procedures.

 When training is a needed resource:

Potential sources for training include:

  • FDA Districts and Regions.
  • Division of Human Resource Develop/Office of Regulatory Affairs.
  • FDA Centers.
  • Non-FDA Partners.
  • Industry Associations.
  • Colleges and Universities.
  • Private Contractors.
  • AFDO & Affiliates.
     Administrative Issues:
    • Purchasing/Accounting: FDA District Offices must work closely with the regional and/or districts office’s financial management unit (purchasing agents and accounting personnel) to assure compliance with all financial rules. DFSR identifies necessary codes and procedures annually.
    • Large Purchase Orders: Purchase orders over $25,000 must be reviewed by the FDA contracts office and will require special handling such as a sole source justification.
    • Loaned Equipment: follow Staff Manual Guide 2620.4, Personal Property Management, to loan government-owned equipment to nonfederal organizations.
    • Tracking numbers: DFSR assigns each approved partnership agreement a tracking number. Signed/dated copies of approved partnership agreements must be sent immediately to DFSR for number assignment. DFSR does not assign tracking numbers to “partnership activities”.
    • Regional offices should have a system to track the expenditure of partnership funds. Offices should consider sending reminders to obligate and disperse these funds. Funds that will not be used by the cut off date in August may be reallocated to other projects. Funds that are not firmly obligated by the August cut off date will be returned to DFSR
    • Audits: Districts must establish procedures to ensure that the required numbers of audits are completed of the State during the partnership year. These include audits and joint inspections with State employees.
    • Quality Assurance: Partnership agreements and activities are subject to the quality assurance programs of each district and regional office.
    • Do’s and Don’ts: See Restrictions
     Using ORA Field Committees:

    The Senior Associate Commissioner for Regulatory Affairs (SACRA) has established a system of Advisory Committees in the major agency program areas and in other areas of management concern. These committees were established to provide a formal mechanism for review, analysis and development of policy statements and recommendations to or on behalf of the ACRA and other ORA managers and are titled "Field Committees". Field Committees are chaired by a District Director (DD) with a Regional Food and Drug Director (RFDD) serving in an advisory role. Field Management Directive (FMD) #30 contains a current listing of ORA Field Committees and their respective Chairpersons, as well as a description of their activities.

    On a routine basis, Field Committees meet with management representatives of their Center counterparts to identify issues of concern to either party and to develop appropriate plans, program modifications, issue papers, and develop other initiatives of mutual interest for consideration by the ACRA and/or respective Center Directors.

    As part of ORA's development and implementation of partnerships, partnership originating offices are responsible for initiating discussions with Center and other appropriate headquarters personnel regarding partnership activities. However, in support of this initiative and as programmatic changes dictate, the ORA Field Committees will:

    1. Serve as the link between ORA components and the Centers to ensure the communication of partnership program information and the resolution of policy issues that impact upon partnership arrangements. In this capacity, Field Committee Chairs will assist personnel of the partnership originating office in resolving policy and/or procedural issues in partnerships under development. A listing of Center and ORA Partnership Contacts (individual names and numbers) for the Partnership Initiative is attached.
    2. Serve in a consultative capacity to ORA Field and headquarters components in the development of partnership agreements. Field committee chairs are to be consulted (verbally, electronically, or in writing) by personnel of the partnership originating office during the early stages of partnership agreement development to insure conformance with program objectives and to ascertain the need for Field Committee involvement. Field Committee Chairs are to be kept informed of partnership activities (objectives, goals, & results) within their responsible program area by the partnership originating office. This notification may be in the form of informational copies of partnership agreements, activity summaries, or other mechanism selected by the Chair.
    3. Identify, and develop policies to enhance partnership development. Field Committee Chairs, in consultation with Center personnel, should seek to develop partnership strategies to accomplish program objectives.
    4. Where possible, facilitate the acquisition of resources to support partnership initiatives. This may involve joint coordination with Center personnel to reprogram resources within a specific program area.
     Quality Assurance Requirements:

    The ORA Partnership program is subject to quality assurance programs at the regional and district office levels. Each region should have a system in place that, as a minimum:

    • Defines responsibilities
    • Assures the appropriateness of partnership activities and agreements
    • Addresses audit procedures of state personnel, and
    • Manages the partnership funds allocated to field office

    The field quality assurance programs should assure that these important activities are carried out properly.

     Step-by-Step Instructions for Partnership Agreements:

    Following are specific process steps that should be taken to develop partnerships. A recommended format for the written document is included.

    Agreements must be focused to accomplish specific program objectives, within specified time frames and within available or planned resources. This is to ensure adequate funding of partnership activities. Annual renewal is recommended for longer-term initiatives, and for integrated partnership agreements.

    1.  Restrictions:
      • The region/district should not use partnership funds to purchase state inspections, even when no FDA/state contract exists.
      • FDA's state contract funds may not be used to reimburse states for enforcement of their own laws, purchase orders for state embargoes, legal actions (such as formal hearings), court costs, etc.
      • Partnership funds may not be used for routine district-funded operations with the states, e.g. work planning meeting attendance, travel to present training, etc.
      • Up to 10% of partnership funds can be used by the ORA field personnel for travel to support partnership agreements/activities.
      • Partnership funds are NOT to be use for travel of other federal agency personnel (i.e. USDA, EPA, CDC, etc.).
      • Partnership funds are NOT to be used for purchase of equipment/supplies for FDA personnel or offices
      • Partnership funds CANNOT be used to support any activities associated with a cooperative agreement (grant) with the state program/agency.
      • Partnership funds are NOT to be used to pay to send state staff to state Association or other national conferences that may have received Small Conference Grants for that purpose from DFSR. (AFDP, NEHA, NICMS, ISSC, CFP, NERO). Please check with DFSR for currently funded Small Conference Grants.
    2.  Establish policies of the Partnership.
      1. Obtain FDA regional and district office management understanding and commitment to the partnership concept.
      2. Establish a mutually agreeable policy of cooperation with partner agencies.
        • Indicate FDA support from local management.
        • Solicit cooperating agency agreement.
        • Establish agreement with face-to-face meetings between top management of respective agencies (i.e., RFDD/DD, State/Local, Department or Agency Directors, Commissioners, Secretaries) or by other similarly effective means.
    3.  Identification of program areas for partnership.
      1. Local management teams of cooperating agencies meet to identify mutual program priorities for partnership consideration.
      2. Mechanism is established for regular interaction between cooperating agencies.
      3. Specific FDA and cooperating agency contacts (either groups or individuals are identified for project coordination and management purposes).
      4. Assurances are developed that statutory authorities are available to accomplish agreement goals.
    4.  Formalizing the Partnership Agreement
      1. Agreement objectives/goals (performance & outcome) are established.
      2. Identify specific program area for partnering along with appropriate priorities.
      3. Identify resources needed to be used to accomplish objectives such as:
        • Personnel.
        • Money.
        • Time.
        • Equipment.
        • Training.
      4. Describe follow-up action anticipated as a result of work effort such as:
        • Enforcement.
        • Administrative Sanction.
        • Legal.
        • Publicity.
        • Industry Training.
      5. List responsibilities:
        1. FDA (be specific) such as:
          • Supply Training.
          • Supply Equipment.
          • Supply and share Information.
          • Conduct Inspections ( where appropriate)
          • Evaluate Inspections.
          • Analyze Samples.
          • Evaluate Work Results.
          • Audits.
        2. QMS/QAP evaluations partnership work.
      6. Cooperating agency (be specific) such as:
        • Provision of training.
        • Supply of equipment.
        • Supply and share information.
        • Conduct inspections. (where appropriate)
        • Evaluate inspections.
        • Analyze samples.
        • Evaluate work results.
      7. Agreement on performance measurements. Each agreement will have two types of measurements. a. Outputs (number of activities). For example: Number of activities vs. planned. Number of samples analyzed vs. planned. Number of people trained. b. Outcomes (consequences of outputs). For example: Increase Compliance level (% or other). Decrease in violations identified. Increase in Voluntary compliance. Decrease in Average cost of activity. Increase in Quality & Quantity of goods in commerce.
    5.  Evaluation of agreement results.
      1. Interim (in-process) monitoring.
        • Frequency/milestones at which progress is measured.
        • Purpose of interim assessments.
        • Who is responsible?
        • Assessment of extent of progress on output and outcome measurements.
        • Conduct as face-to-face discussion with partner agency coordinators.
        • In-process adjustment identified (as needed) and implemented.
      2. Final evaluation.
        • Done at completion.
        • Performed jointly by partners.
        • Assess degree to which goals were met (outputs vs. outcomes).

        EXAMPLE:

        • Rate of accomplishment.
        • Number of violative goods removed from commerce
        • Resources saved by work activity.
        • Was increased level of coverage of industry achieved?
        • Conclusion (were goals met?).
        • Follow-up recommendations; e.g. continue/modify/eliminate.
      3. Quality Assurance
        • Field identifies responsibilities
        • Assures appropriate goals of partnership
        • Addresses audit procedures for states
        • Manages funds
    6.  Format of a Partnership Agreement
      1. Statement of agreement to establish partnership.
      2. Partnership purpose and goals.
        • Identify specific timeframes-beginning-ending periods.
        • List anticipated outcomes.
      3. Program area and activities.
        • Identification of program area and priority.
        • Cooperating agency contacts.
        • Affirmation that there is a statutory basis for partnership activity.
      4. Responsibilities. Anticipated output activities of partners.
        • Identify FDA responsibilities.
        • Identify cooperating agency responsibilities.
      5. Resources planned to carry out partnership.
      6. Assessment mechanisms. Based on anticipated output activities and anticipated outcomes.
        • Interim (time frames).
        • Final (time frames).
      7. Conclusions and Recommendations. Review of activities and accomplishments. Provides for a final report including a discussion of results of partnering efforts along with recommendations for follow-up action if warranted.
      8. Signatures of responsible parties.
    7.  Reporting & Routing of Partnership Information
      1. Partnership Originating Office(s). All ORA Components (Field and HQ) will/as necessary:
        • Assume primary responsibility for keeping all appropriate parties (ORA, Centers, Committees) informed as to the purpose, objective, and intent of partnerships (FMD30-Committees Attachment B-Program Center and ORA Contacts).
        • Work with Field Committees to facilitate the resolution of programmatic and policy issues.
        • Maintain current files of their ongoing and signed/dated formal partnership agreements.
        • Maintain appropriate records/files to track partnership accomplishments, related activities (meetings/training/etc.).
        • Prepare and maintain annual and/or final partnership evaluation reports.
      2. Field reporting requirements:
        • Partnership Evaluations are required annually for partnership agreements and partnership activities which involve funding over $1,000. See Attachment E - Partnership Evaluation Form. District and regional offices are encouraged to optionally report special partnership activities that they want to bring to the attention of the SACRA or for which they want credit in the annual summary. Reports are due by January 30th for the prior fiscal year.
        • Submit informational copies of signed partnership agreements within their respective regions.
        • Submit copies of all signed/dated partnership agreements immediately to ORO/DFSR. DFSR will assign a tracking number to all approved partnerships agreements. This does not include partnership activities. Text should be in MS Word format.
        • Submit copies of annual and/or final evaluation reports for partnership agreements to ORO/DFSR.
      3. When requested, submit informational copies of partnership agreements to specific ORA Field Committees (Chairs - unless otherwise directed) responsible for the target program within the partnership initiative.
      4. ORA’s Division of Federal State Relations (DFSR) will:
        • Serve as a repository for partnership information, partnership agreements, and evaluations.
        • Help promote partnership successful activities in multiple venues wherever possible.
        • Establish, maintain, and monitor a partnership database to facilitate information searches and perform specific data retrieval, as requested.
        • work directly with partnership originating offices to ensure prompt and accurate reporting of partnership information
        • Facilitate the dissemination of partnership information through the Internet and other suitable means to cover the nature and scope of current partnership initiatives.
        • DFSR will summarize evaluations in annual report to the ACRA, et. al.
      5. Requests for special funding (and other resources) in support of Partnership Activities shall be directed as indicated:
        • HQ components: to respective HQ Office, if necessary HQ Office to ORO/DFSR.
        • Field components: to respective Regional Office(s) for first consideration. If necessary, Regional Offices will submit individual or consolidated request to ORO/DFSR.

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