FDA Contacts for Regulatory Partners

Office of Partnerships

The Office of Partnerships (OP) coordinates with FDA's Office of International Programs, as well as FDA's Intergovernmental Affairs staff, and the various FDA centers on collaborations with federal, state, local, tribal, territorial, and international regulatory and public health partners to ensure cohesive and uniform application of agency policy.

Office of Partnerships
12420 Parklawn Drive
Element Bldg 3030
Rockville, MD 20857
Fax: 301-827-3588

Please click on the links below for more information regarding:

Other OP Contacts

OP State Training Coordination: StateTraining@fda.hhs.gov
Commissioning/Credentialing: Statecommissioning@fda.hhs.gov
Partnership for Food Protection (PFP): PFP@fda.hhs.gov

Intergovernmental Affairs

The Intergovenmental Affairs Staff is responsible for Freedom of Information Act (FOIA), FDA testimony, and FDA position affidavit inquiries from state, local, tribal, and territorial regulatory officials.

Intergovernmental Affairs
10903 New Hampshire Avenue
White Oak, Building One
Silver Spring, MD 20993

Contact: IGA@fda.hhs.gov

FOIA, FDA testimony, and FDA position affidavit inquiries from state, local, tribal, and territorial regulatory officials can be directed to the following mailbox: StateAndTribalInquiries@fda.hhs.gov.

For more information about the Intergovernmental Affairs Staff, please visit their webpage.

Concerns?

If you have a dispute with a program office, please contact that program office to resolve. If all attempts to reach resolution with the office fails, please feel free to contact the FDA or ORA Ombudsman.

FDA Ombudsman: ombuds@oc.fda.gov

About the Office of Partnerships

Office of Partnerships

The Office of Partnerships (OP) provides advice and counsel to the Associate Commissioner for Regulatory Affairs (ACRA), and other Office of Regulatory Affairs (ORA) leaders on policies and programs related to the development, coordination, and evaluation of agency partnerships with other federal, state, local, tribal, and territorial regulatory and public health agencies and international partners. OP develops, implements, coordinates, and evaluates FDA's federal-state program policy. OP serves as the ORA focal point for the coordination of cooperative relationships with federal, state, local, tribal, territorial, and international regulatory and public health agencies and associations.

OP coordinates with ORA, Office of International Programs, FDA’s Intergovernmental Affairs staff, and FDA centers on collaborations with federal, state, local, tribal, territorial, and international regulatory and public health partners to ensure cohesive and uniform application of agency policy.

OP liaises with the FDA Office of Food Policy and Response, the Office of Medical Products and Tobacco, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine, as well as provides support to the national Integrated Food Safety System (IFSS) through the Partnership for Food Protection, national associations, and alliances.

Partnership Services Group

The Partnership Services Group (PSG) within the Immediate Office provides for the internal administration of OP while also providing technical and administrative support to the OP divisions. It supports travel and other administrative functions for state officials related to ORA-funded activities. It also coordinates training for state regulatory officials in collaboration with the ORA Office of Training, Education and Development (OTED). PSG supports the commissioning and credentialing of state, local, and territorial officials. Working with OP management and staff, PSG facilitates the development and implementation of OP's strategic plan and standard operating procedures (SOPs) to advance the mission and initiatives of FDA and OP. Budget management, travel monitoring, website maintenance, and data trending and analysis are also performed by PSG.

OP includes three Divisions – the Division of Integration (DI), the Division of Partnership Investments and Agreements (DPIA), and the Division of Standards Implementation (DSI).

Division of Partnership Investments and Agreements (DPIA)

The Division of Partnership Investments and Agreements (DPIA) serves as the primary focal point for coordination of the programmatic aspects of ORA’s non training-focused contracts, grants, cooperative agreements, and partnership agreements with state, local, tribal, and territorial regulatory and public health agencies, national associations, international partners, and other awardee organizations. DPIA works collaboratively with ORA's Office of Management to coordinate, develop, and manage ORA's contracts, grants, and cooperative agreements with state, local, tribal, territorial, and association regulatory and public health partners. Funding is provided to partners to perform inspections, sample collections, and audits on FDA's behalf and to build infrastructure and capacity of human and animal food regulatory programs and laboratories.

DPIA collaborates across FDA centers and FDA Office of Acquisitions and Grants Services (OAGS) and other federal agencies to ensure cohesive and uniform application of regulations and policies related to the administration of contracts, grants, cooperative and partnership agreements, and international funded and non-funded agreements. DPIA collaborates with the Office of Human and Animal Food Operations' Audit Staff to ensure appropriate oversight of the performance of select cooperative agreements.

DPIA includes the Immediate Office, Human and Animal Food Branch, the Laboratory, Medical Products, and Innovation Branch, and the Produce Group.

Immediate Office
The Immediate Office coordinates, develops, and manages contracts and cooperative agreements related to laboratory accreditation and integration, MQSA, medical devices, partnership agreements, and other external collaboration that support the mission of ORA.
Human and Animal Food (HAF) Branch
The Human and Animal Food Branch (HAF) within DPIA coordinates, develops, and manages ORA contracts, grants and cooperative agreements related to human and animal food regulation and national regulatory program standards implementation.
Laboratory, Medical Products, and Innovation Branch
The Laboratory, Medical Products, and Innovation Branch (LMPI) within DPIA coordinates, develops, and manages ORA contracts, grants and cooperative agreements related to laboratory, MQSA, and technology.
Produce Group
The Produce Group within DPIA coordinates, develops, and manages the ORA State Produce Implementation and National Produce Safety cooperative agreements.

Division of Integration (DI)

The Division of Integration (DI) formulates strategies for addressing conflicts or duplication related to integration of federal, state and local activities. DI reviews practices, procedures, and processes relative to implementation of an IFSS. DI fosters collaborative food safety networks and provides high level support to food safety integration counterparts including other countries, Partnership for Food Protection, FDA centers, national associations, and alliances.

The Integration Group within DI measures and tracks national integration and develops, tracks, and reports on performance measures for programs, processes, cooperative agreements, and grants that directly foster mutual reliance and an IFSS.

The International and Federal Engagement Group within DI coordinates international activities within ORA in collaboration with the Office of International Programs (OIP) and FDA centers to promote consistency.

Division of Standards Implementation (DSI)

The Division of Standards Implementation (DSI) develops and revises regulatory program standards such as the Manufactured Food Regulatory Program Standards (MFRPS) and Animal Feed Regulatory Program Standards (AFRPS). DSI provides technical support and guidance to states implementing or considering implementation of regulatory program standards. DSI collaborates with ORA’s Office of State Cooperative Programs and FDA centers to provide technical support and guidance for cooperative program areas. DSI collaborates across ORA and FDA centers, as well as with external alliances and associations to implement a system of continuous improvement and training for regulatory program standards.

DSI provides technical support to state Rapid Response Teams (RRTs) and Food Protection Task Forces.

The Manufactured Food Regulatory Program Standards Group within DSI provides technical support and guidance to states enrolled in the MFRPS.

The Animal Feed Regulatory Program Standards Group within DSI provides technical support and guidance to states enrolled in the AFRPS.

The Produce Regulatory Program Standards Group within DSI provides technical support and guidance to states enrolled in the State Produce Implementation Cooperative Agreement Program.

For non-program-related inquires specific to the Office of Partnerships, please call the main OP number. For all other inquires not related to the Office of Partnerships or its contract and grant programs, please call 1-888-INFO-FDA.

Division of Information Disclosure Programs (DIDP)

DIDP advances public health through information sharing and ensures that FDA and ORA are sharing critical information to the fullest permissible extent and prevents protected information from being inadvertently disclosed.

DIDP reviews proposed guidance documents, regulations, final regulations, and other Agency documents relative to the practice and policies of sharing agency information.

DIDP reviews, establishes, coordinates, and collaborates with other ORA offices, Centers, and agency stakeholders on interagency information sharing agreements, including agreements with other federal agencies, state and local agencies, and international organizations. DIDP provides training on information agreements to stakeholders.

DIDP serves as the FDA focal point for handling testimony requests, processing legal demands, subpoenas, court orders, information disclosure review of Memoranda of Understandings (MOUs), and litigation matters within the purview of the Agency.

DIDP coordinates Freedom of Information Act (FOIA) activities and prepares responses to FOIA requests.

Disclosure Policy Branch
12420 Parklawn Drive, Suite 4141
Rockville, MD 20857
Main: 301-796-8185
Contact: ORAInfoshare@fda.hhs.gov