For Federal, State, Local, Tribal, and Territorial Officials

FDA Contacts for Regulatory Partners

Office of Partnerships

The Office of Partnerships (OP) coordinates with ORA, Office of International Programs, FDA’s Intergovernmental Affairs staff, and 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.

Call:

301-796-5390

Write to:

Office of Partnerships
12420 Parklawn Drive
ELEM 3033
Rockville, MD 20857
Fax: 301-827-3588

 

Please click on the links below for more information regarding:

Other OP Contacts: 

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

Tell us how we’re doing! Submit feedback to the Office of Partnerships: OP.Feedback@fda.hhs.gov

 

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Intergovernmental Affairs

The Intergovenmental Affairs Staff is responsible for 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.

 

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Office of Strategic Planning and Operational Policy (OSPOP)

Reach out to the Office of Strategic Planning and Operational Policy to find an FDA representative that manages information sharing agreements (20.88's). Please contact OSPOP’s Disclosure Policy Branch by mail, phone, or email:

Office of Strategic Planning and Operational Policy
Division of Information Disclosure Policy

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

 

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. 


About the Offices

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 the Agency’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 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 Office of Food and Veterinary Medicine, the Office of Medical Products and Tobacco, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine; and 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 with the Immediate Office provides for the internal administration of OP while also providing technical and administrative support to the remaining branches. 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). The Partnership Services Group supports the commissioning and credentialing of state, local, and territorial officials. Working with OP management and staff, the Partnership Services Group facilitates the development and implementation of the Office’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 Partnership Services.

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 coordinates, develops, and manages ORA contracts, grants, and cooperative agreements related to human and animal food, medical products and regulatory science. 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.

The Produce Group within the DPIA Immediate Office oversees the State Produce Implementation Cooperative Agreement Program. 

DPIA includes two branches – the Human and Animal Food Branch and the Laboratory, Medical Products, and Innovation Branch.

  • Human and Animal Food (HAF) Branch
    The Human and Animal Food Branch with DPIA coordinates, develops, and manages ORA contracts, grants and cooperative agreements related to human and animal food regulation and nationalregulatory program standards implementation. The Animal Food Group within the HAF Branch oversees contracts and grants related to animal food.

  • Laboratory, Medical Products, and Innovation Branch
    The Laboratory, Medical Products, and Innovation Branch within DPIA coordinates, develops, and manages ORA contracts, grants, and cooperative agreements related to laboratory accreditation and integration, medical device regulation, and other external collaboration that supports ORA’s mission. 

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

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 IFSS.

The International and Federal Engagement Group within DI coordinates international activities within ORA in collaboration with the Office of International Programs (OIP) and 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 that are 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 with Centers and external alliances and associations to implement a system of continuous improvement and training for regulatory program standards. There are two groups within DSI – the Manufactured Food Standards Group and the Animal Feed Standards Group – that provide technical support and guidance to states enrolled in the MFRPS and AFRPS, respectively.

For nonprogram-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. 

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Intergovernmental Affairs 

The intergovernmental Affairs Staff within the Office of Policy, Planning, Legislation, and Analysis is the lead staff dedicated with working with state and tribal governments within the Office of the Commissioner. The purpose of this staff is to coordinate across FDA Offices, Centers, and/or Directorates to respond to inquiries from states and to engage in proactive outreach to states on important FDA policy issues; and to develop and maintain relationships with policymaking state and tribal partners, including state officials such as governors, attorneys generals, and state legislators, national associations representing those state officials, and tribal governments and tribal organizations.
 

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Office of Strategic Planning and Operational Policy

Office of Strategic Planning and Operational Policy (OSPOP) provides data-driven evaluation and planning to improve ORA decisions, programs, and performance. In addition to developing the ORA workplan, OSPOP analyzes and evaluates operational performance outcomes, their impact and overall accomplishments. We collaborate with the Centers and FDA stakeholders to provide policy analysis and regulatory decisions that are strategic, responsive to risks, aligned with the needs of a large and decentralized workforce, and that can be effectively implemented. OSPOP develops ORA policy and coordinates sharing public and non-public information with foreign governments, federal agencies, state and local government agencies, the public, and other stakeholders. OSPOP also facilitates the development of ORA’s strategic priorities and goals.
 

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Page Last Updated: 06/27/2017
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