Substance of Agreement. A. Exchange of information for jurisdictional issues For the purpose of expediting the resolution of jurisdictional issues, APHIS and FDA agree to provide each other all information that has been submitted to their respective agencies regarding the product or issue to be decided as long as the release of such information has been authorized by the appropriate party. In order to comply with restrictions that limit sharing and/or discussing confidential business information (CBI), which includes confidential commercial information and trade secrets, the agency that brings forth the issue/question for resolution will be responsible for notifying the applicant of the uncertainty of jurisdictional authority, and the agency that wishes to reveal the information will be responsible for securing from the applicant authorization to share CBI with the other party. Alternatively, applicants may be requested by either agency to submit materials/information concerning products that pose jurisdictional questions to each agency. Such information will be provided to the liaison officers of the agencies, who are named in paragraph V of this MOU.
Substance of Agreement a. Investigation of Complaints Relating to Compounded Human Drug Products Distributed Outside the State
Substance of Agreement. The substance of this Agreement will be disclosed in the Joint Announcement attached hereto as Schedule 3-B, which shall be issued as set forth in clause 2.4.3, and also in the Offer Documents, the Reasoned Position Statement and furthermore as required by the Applicable Rules. 79 / 107
Substance of Agreement. A. FSIS agrees to:
Substance of Agreement. The parties commit to continue working closely together in order to implement the attached Strategic Plan for the Pine Ridge Shared Visions Housing Initiative. (please see attachment 1)
Substance of Agreement. The goals and expected results of this collaboration are to: • Highlight both the need for a modern bioinformatics platform to support regulatory review and communication and the challenges of developing this platform. • Share progress on data standards development and implementation between regulators and regulated industries. • Discuss and share practices that will ensure effective and efficient regulatory review of data submissions. • Discuss and develop needs and specifications for proposed new tools and solutions. • Describe best practices (process, tools), implementation experiences, and the subsequent impact of computational technologies on organizational performance. • Discuss and find solutions to common needs of FDA, industry and academia in the drug development and review lifecycle.
Substance of Agreement. As noted above, this agreement charts a general course of interaction between the NIDR and three of FDA’s product centers that encompasses the following areas:
Substance of Agreement. The Point of Contact (POC) will receive a $400.00 stipend at end of the NKYAB program provided they have met certain criteria. Please place initials beside each statement acknowledging that the stipend is contingent upon the completion of: Signed MOA agreement Completed W-9 tax form Attendance at monthly NKYAB meetings Ensuring students met regularly back at school Informed school administration & shared successes publically Supported students with final project presentation
Substance of Agreement. A. The Direction de la Qualite, Service Veterinaire d'Hygiene Alimentaire, Ministry of Agriculture The Direction de la Qualite, Service Veterinaire d'Hygiene Alimentaire (SVHA) of the Ministry of Agriculture of the Republic of France, is the agency of the French government responsible for inspecting those caseins, caseinates, and mixtures thereof that are intended for export. Such inspection is necessary for consumer protection. To fulfill its responsibilities under this agreement, SVHA will direct its activities to ensure that caseins, caseinates, and mixtures thereof that are intended for export to the United States are fit for human consumption in that they comply with the requirements of the Food, Drug, and Cosmetic Act of the United States and of this agreement. SVHA will inspect and analyze samples of these caseins, caseinates, and mixtures thereof to ensure that they comply with these requirements. To discharge its responsibilities regarding caseins, caseinates, and mixtures thereof and to fulfill its commitment under this agreement, SVHA will:
