3. Work plans for the organization`s components within the FDA/CDER and deED/OD: any exchange of information between federal partners or their organizational components, with the exception of those approved in Sections VI and VII, must be consistent with a written and approved work plan describing the exchange of specific information and the terms of such an exchange (“work plan”). Federal partners may approve work plans at periodic Section III.A.1 meetings, with the agreement of an agent of each federal partner, or on another method agreed upon by an agent of each federal partner. All workplans must comply with applicable laws and under this agreement. Once a work program has been approved by an authorized official of each federal partner, as demonstrated by their signatures on the order of initial work, federal partners can immediately begin exchanging information in accordance with this work plan. The requirements of this contract, including the number and frequency of meetings required in Section III.A.1, as well as the obligation to protect and protect Section IV information, may be removed or amended by a reciprocal written agreement between the Director of CDER and the Administrator of the DEA, but none of the federal partners may waive the requirements or restrictions imposed by federal law. Requirements for all related work plans may be removed or amended by the reciprocal written agreement of the Director of the CDER and the Assistant Administrator, OD, or by delegated officials, in accordance with the same restrictions. The non-application or compliance by federal partners with a requirement of this agreement (or a requirement for a work plan approved in it) should not be construed as a waiver of the requirement and cannot be considered an amendment or modification of the agreement (or a work plan approved in it). Federal partners ensure that information shared under this agreement is used and disclosed exclusively in accordance with applicable laws, regulations and guidelines. Access to information shared under this agreement is limited to authorized employees and contractors of federal partners who require access to their official duties in accordance with the information approved by this agreement and all related work programs. These staff will inform on (1) the need to protect and restrict access to information, as well as (2) administrative, civil and criminal penalties for non-compliance with applicable federal laws.
Contracting parties of federal partners who have access to information shared under this agreement sign the Schedule A confidentiality agreement. Each federal partner maintains the confidentiality agreements signed by its contractual partners. If, as a health professional, you have received complaints or sanctions from the DEA regarding your practice of prescribing, handling, registering various controlled substances, the DEA may enter into a pharmaceutical agreement with you (or with your institution) that outlines a plan for such registration, manipulation or prescribing in the future. While this agreement is intended to bring your practice into line with the Controlled Substances Act (CSA), this agreement can be restrictive or inconvenient in many respects. That`s why you need an experienced lawyer who understands your needs and rights.