Overview for External Stakeholders: 

FY 2019 Consolidation of Fiduciary Responsibilities for 

Office of Regulatory Affairs (ORA) Contracts, Grants, and 

Cooperative Agreements

Summary

In FY 2019, the FDA ORA will transfer the day-to-day financial management of contracts, grants, 

and cooperative agreements from ORA’s Office of Partnerships (OP) to ORA’s Office of 

Management (OM).

Q.) Why is ORA consolidating the day-to-day financial management of ORA contracts, grants, 

cooperative agreements, and interagency agreements in OM?

A.) The consolidation supports the plan of Melinda K. Plaisier, FDA Associate Commissioner for 

Regulatory Affairs, to lead the evaluation of ORA's contracts and grants structure and prepare a 

plan to modify the structure to enhance efficiencies by the end of FY 2019. It also improves 

efficiencies and performance of ORA processes, procedures, and practices for managing 

contracts, grants, cooperative agreements, and interagency agreements.

Q.) When will ORA complete the consolidation?

A.) For inspection contract programs including human food, animal food (feed), eggs, and 

medical devices, as well as the milk drug residue contract, ORA plans to complete the 

consolidation by March 2019. For the grant/cooperative agreement programs, ORA plans to 

complete the consolidation by May 2019.

Q.) How will the consolidation of fiduciary responsibilities in OM impact me?

A.) OM will manage budget and award adjudication responsibilities while OP maintains 

programmatic responsibilities. Therefore, both OM and OP personnel will be included on phone 

calls, emails, and other communications concerning your contract and/or cooperative 

agreement. 

FDA’s Office of Acquisitions and Grants (OAGS) will send you revised contract award notices 

and/or grant notices of award. You will notice that OM personnel will assume the Contracting 

Officer’s Representative (COR) designation on the contracts with OP personnel listed as 

technical advisors. For grants/cooperative agreements, OM will be identified as the project 

officer (also known as program official) on the notice of award. OP personnel will be identified 

as project managers. 

Q.) What will be the responsibilities of OM, OP, Office of Acquisition and Grant Services 

(OAGS), and the District/Division for management of the contracts?

A.) The responsibilities for OAGS and the District/Division will remain the same. 
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The OM COR will manage the contract invoice adjudication process, contract modification 

process, assisting with contract negotiations, and officially submitting the CPARS evaluation 

with input from the Districts and OP.

OP will continue to lead decision-making for contracts and grants/cooperative agreements.

Q.) Will the consolidation affect how the local FDA Districts and Divisions and state, local, 

tribal, territorial, laboratory, and association partners work together?

A.) No, the consolidation will not affect how the local FDA Districts and Divisions and state, 

local, tribal, territorial, laboratory, and association partners work together.

Q.) What types of questions should I direct to the COR, project officers/program officials, 

project managers, and state liaisons?

A.) For grants/CAPs, the OP project manager will communicate to grantees the appropriate 

points of contacts at the beginning of the budget period. If subsequent questions develop, you 

may contact your OP project manager who will direct you to the appropriate point of contact.

For contracts, the District/Division State Liaison will continue to be the first point of contact.

For FDA training course registrations, OP State Training Coordination Services 

(mailboxstatetraining@fda.hhs.gov) will continue to be the first point of contact.

Q.) Who should I include in my email when submitting a contract invoice to FDA?

A.) All invoices must be submitted directly to FDA Vendor Payments Team 

fdavendorpaymentsteam@FDA.GOV with a carbon copy to the OM COR.