3-10 - WORK SHARING

3-10-1 - Purpose and Policy

This section sets out FDA’s authority, policy, format, and responsibilities to establish collaborative efforts with state and local agencies, whether or not those efforts are formalized in work-sharing agreements. On a case-by-case basis, the information in this section may be applicable to work-sharing agreements with other Federal government agencies.

FDA initiates and enters into cooperative work-sharing programs with other government agencies whenever such cooperation ensures overall consumer protection and effectively utilizes the expenditure of resources. The efforts may be written or unwritten. FDA should routinely evaluate whether unwritten working arrangements between districts and state or local government agencies, should be formalized in writing.

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3-10-2 - Authorities

1. FDA and state or local cooperative efforts
   Section 702(a) of the Federal Food, Drug, and Cosmetic Act (the FD& C Act) authorizes the Secretary to commission state and local officials to conduct examinations and investigations for purposes arising under the Act. 21 U.S.C. Section 702(a). Section 311(a) of the Public Health Service Act (states that the Secretary "…shall cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations ..."). 42 U.S.C. Section 311(a).
2. FDA and other Federal government cooperative efforts
   Section 702(a) of the Federal Food, Drug, and Cosmetic Act (the FD& C Act) as amended by Public Law 107-188, (The Public Health Security and Bioterrorism Preparedness and Response Act of 2002) (The BT Act)) FDA is authorized to commission other Federal officials to conduct investigations under the Act pursuant to a memorandum of understanding (MOU) between the Secretary and the head of the other Federal Department or agency.)

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3-10-3 - Confidentiality

FDA’s preference is that information shared during the cooperative effort be in a form appropriate for public dissemination under FOIA, but that is not always possible or efficient. Regardless of whether the cooperative effort is set out in writing, FDA should not share non-public information with a state or local government agency unless that sharing is carried out under the procedures for 21 CFR §20.88 or a written agreement that contains provisions that included or refer to those procedures. (For sharing non-public information with non-HHS Federal government agencies, consider 21 C.F.R § 20.85.) A written agreement should refer to the provisions of FDA’s laws and procedures regarding the sharing of non-public information. The sharing of non-public information pursuant to an informal arrangement should also be conducted according to FDA’s laws and procedures for such sharing, and FDA should notify the receiving party of that information.

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3-10-4 - Work Sharing Agreements

FDA may formalize work-sharing agreements by entering into Partnership Agreements, Inter-agency Agreements, and Memoranda of Understanding (MOU's) between (FDA), and other federal or state, and foreign government agencies. Some work-sharing agreements are covered under Staff Manual Guides (SMG) 2810, 2820, and 2830. FDA shares non-public information under an agreement with FDA regulations and procedures by FDA must follow its laws and procedures to share non-public under an agreement.

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3-10-5 - Alternatives to Work Sharing Agreements

Where a work-sharing agreement between FDA and a federal, or state authority is not in effect, FDA should promote cooperation between state and federal authorities to the greatest extent possible. To this end, FDA regional management can use an "Exchange of Correspondence," which is essentially an exchange of letters/memoranda in which each agency (FDA and state) sets forth those selective program areas where each believes a cooperative work-sharing effort is appropriate. FDA also may enter into contracts with state government agencies to carry out its mission.

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3-10-6 - Agreement Format and Content

1. Format
   To insure that there is a relatively uniform national approach in the development and implementation of these agreements, consider using the basic format in Exhibit 3-15. On a case-by-case basis, FDA may adapt this model for use as an agreement with a non-FDA Federal government agency.
   The model offers some "boilerplate" language that may be used in developing the terms of agreement. Contact DFSR if you are interested in adding to, deleting, or modifying the provisions in the model form, especially if the changes involve FDA policy or enforcement of statutes(s), the sharing of non-public information, or continued maintenance of confidentiality of non-public information. Some variations may require headquarters’ or OCC concurrence. DFSR also might consult with Contact ORA’s Office of Resource Management (ORM) (HFC-10).
   
   
2. Content
   
   1. Subject of agreement. The subject matter of an agreement may vary, but must be within the regulatory jurisdiction of the Parties. Each Party should comply with its legal responsibilities under such an agreement, e.g., it may be appropriate for the agreement to provide that the Parties retain independent responsibility over some aspect of the work covered by the agreement. The Parties should decide how they will apportion work. For example, under an agreement, one Party might agree to collect product samples for analysis by the other Party.
   2. Goals. Each agreement should describe significant, mutually beneficial, realistic, and practical goals (anticipated outcome) and related activities necessary to accomplish the goal(s) and indicate whether a time frame applies. To measure the extent to which goals are met, each agreement may include a mechanism to monitor in-process activities (output measurement) and contain a means by which the Parties may conduct a final evaluation. It is helpful to set out the anticipated benefits (ultimate outcomes) of reaching the goal. The extent of description may vary.
   3. Resource commitments. An agreement might have provisions about resources because both Parties must be able to contribute a portion of the resources necessary to accomplish the terms of the agreement. For those reasons the Parties should discuss prior to entering into an agreement the expenditure of resources likely to be required for the division of labor agreed upon, the priorities each Party expects to assign to the tasks, and if any, competing regulatory considerations.
   4. Confidentiality provisions.
   5. Quality assurance provisions. A work-sharing agreement should provide that a quality assurance evaluation might be performed at the request of either Party to ensure that the agreement is being carried out efficiently and effectively in the interest of each Party. To this end, the Parties should meet periodically (annually or semi-annually) to conduct such an evaluation. See Exhibit 3-15, Model Agreement Format Joint Planning, Option a or b. While no formal reporting format is required, the agreement should include and the parties should agree to the method of exchange (e.g., by memorandum, discussion during program review and planning conference(s), etc.).
   6. Duration of the agreement.
   7. Designation of agency official authorized to sign the agreement. For agreements with state or local government agencies, either the Regional or District Food and Drug Director, at the option of the RFDD, may sign the agreement for FDA. The Federal MOU under the BT Act will indicate the signatory.

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3-10-7 - Record Keeping

1. Copies
   The FDA component that is taking the lead in developing the work sharing agreement should prepare two copies of the work-sharing agreement for FDA, in addition to a copy for the non-FDA Party. When the Parties sign the agreement, the sponsor will submit a signed original under cover memorandum to DFSR. For state and local government agreements, the regional office will maintain one original signed copy of the agreement. Any subsequent modification or renewal to the agreement should be documented and an original signed copy forwarded to DFSR, see Exhibit 3-16, Model Addendum. For agreements with other Federal government agencies, contact ORM for advice on the number of copies, etc.
2. Official repository
   The Division of Contracts and Grants Management, Office of Administration, State Contracts and Assistance Agreements Branch (HFA-520) (DCGM/SCAAB) is designated as the official repository for agreements with state or local agencies. DCGM/SCAAB maintains a current listing of all MOU's and agreements. One original, plus one copy will be transmitted by DFSR to DCGM/SCAAB. The signed original will be the official repository copy. Send an electronic file of the agreement, preferably in Word, to DFSR. DCGM/SCAAB will assign a control I.D. number (prefix 225) to the agreement and return the copy document to DFSR with the assigned control number denoting the official repository's receipt of the agreement. For agreements with other Federal government agencies, contact ORM for advice on the official repository for those agreements.

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3-10-8 - References

For further information related to Partnership Agreements and Contracts with states, other federal agencies, industry, educational institutions and associations see ORA’s websites:

Partnership Agreements: http://www.fda.gov/ora/partnership_agreements/default.htm.

State Contract: http://www.fda.gov/ora/Partnership_Agreements/contracts/default.htm.

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