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  1. Domestic MOUs

MOU 225-23-006

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION, GUAM DEPARMENT OF PUBLIC HEALTH AND SOCIAL SERVICES, AND GUAM CUSTOMS AND QUARANTINE AGENCY

I. PURPOSE

This Partnership Agreement (PA) is entered into by and among the Guam Department of Public Health and Social Services (DPHSS), the Guam Customs and Quarantine Agency (CQA), and the U.S. Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA), Office of Import Operations (OIO), Office of Regulatory Science (ORS), and Office of Criminal Investigations (OCI), each referred to as a “Partner” and together referred to as “the Partners.”

The purpose of this PA is to formalize the Partners’ mutual commitment to coordinate on activities related to oversight of imported drug, medical device, biological product, tobacco product, food, and cosmetic products in support of their respective public health and consumer protection missions.  This oversight helps to prevent fraudulent and potentially dangerous products from entering supply chains, thereby advancing the objectives of the Health Care Fraud and Abuse Control Program (HCFAC) to combat fraud and abuse in healthcare programs. This PA applies to imported commodities regulated by the Partners and will support FDA in the enforcement of the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 262).

This PA does not affect or supersede any existing or future agreements, arrangements, contracts, or cooperative agreements among the Partners and does not affect the ability of any Partners to enter into other agreements or arrangements related to this PA.

II. DURATION OF AGREEMENT

This PA covers a period of three (3) years from the date of final signature by all the Partners, pending available funds. This time frame will give the Partners sufficient time to measure the program outcomes that result from the PA, propose modifications to the PA if warranted, and renew the PA by consent of all the Partners. Review of the PA and goals will be conducted annually, either face-to-face or virtually. This PA may only be amended or modified in writing with the consent of all the Partners. Any Partner may propose an amendment or modification to this PA for all the Partners to review and agree upon. Any modifications or amendments made to the agreement will be maintained by the Partners for future reference.

This PA is effective from the date of signature of all the Partners and shall remain in effect for the duration of the three (3) years unless any Partner terminates the PA upon thirty (30) days advanced written notice to all the other Partners.

III. DEFINITIONS and ACRONYMS 

C.F.R.: Code of Federal Regulations
CQA: Guam Customs & Quarantine Agency
DPHSS: Guam Department of Public Health & Social Services 
DWCI: Division of West Coast Imports
FDA: U.S. Food and Drug Administration
FERN: Food Emergency Response Network https://www.fernlab.org/
FSMA: FDA Food Safety Modernization Act 
FSVP: Foreign Supplier Verification Program 
HCFAC: Health Care Fraud and Abuse Control Program
IFSS: Integrated Food Safety System
Imported commodities: Drugs, devices, biological products, tobacco products, foods, and cosmetics which are being imported or offered for import into the United States, as defined by the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (42 U.S.C. § 262). 
GAP: Good Agricultural Practices
GLP: Good Laboratory Practices 
GMP: Good Manufacturing Practice
HHS: U.S. Department of Health and Human Services
OCI: FDA Office of Criminal Investigations 
OIO: Office of Import Operations 
ORA: FDA Office of Regulatory Affairs 
ORS: FDA Office of Regulatory Science
Partnership: Collaboration, cooperation
PA: Partnership Agreement
Proficiency: Skill, expertise, competence
VQIP: Voluntary Qualified Importer Program

IV. GOALS, OBJECTIVES, AND INTENDED OUTCOME

This PA formalizes the Partners’ commitment to collaborate on activities intended to help determine the need and best option for establishing a permanent FDA presence in the Pacific territories to ensure a more secure supply chain by addressing threats from the importation of fraudulent, misbranded, or adulterated commodities.  In carrying out this agreement, the Partners will coordinate efforts in support of the Partners’ public health missions.  An initial goal is to support regulatory oversight of imported commodities for which each Partner has statutory responsibilities.  This leads to more secure supply chains and advances HCFAC’s purpose to combat fraud and abuse in health care.  The intent is to carry out the collaborative activities under this agreement  and determine health care fraud and abuse impacts. To evaluate these impacts, the Partners will research health care fraud and abuse interventions and metrics, document insights into the current state of health care fraud and abuse issues in the Pacific territories; quantify any deterrent effects of the collaborative activities conducted under this agreement; and determine which of these can be supported through a greater FDA presence on Guam and further mutual reliance.

Collaborative work and resource optimization may include:

A. Collaborative assignments 
B. Baseline documentation
C. Enhanced and coordinated investigatory communication and activities for imported commodities
D. Identification of opportunities for laboratory engagement
E. Criminal investigative engagement
F. Partner training
G. Educational and community outreach
H. PA monitoring, assessment, and evaluation

The Partners will collaboratively identify training opportunities, surveillance projects, exercises, communication and outreach, and other activities that strengthen relationships among the Partners, within the import community, and across public health sectors. The Partners will identify and define objectives, audiences, requirements, coordination, oversight, and execution for these activities.

All the Partners agree that nothing in this PA relieves any party from its responsibilities to protect public health and safety nor any regulatory responsibilities granted to their respective agencies.

A. Conduct Collaborative Activities:

ORA staff from the OIO, ORS, and OCI will work jointly with staff of the Guam Department of Public Health and Social Services, Division of Environmental Health and Guam Customs and Quarantine Agency to gain insight into the impacts on supply chain security and health care fraud and abuse described above and identify any causal links between the collaborative activities and changes in health care fraud and abuse.  This effort will include researching health care fraud and abuse interventions and metrics, gaining insights into the current concerns regarding these issues in the Pacific territories, quantifying deterrent effects of the activities conducted under this agreement, and determining which efforts can be supported through a greater FDA presence on Guam and further mutual reliance.

These activities will necessitate the use of space within the Guam Department of Public Health and Social Services, Division of Environmental Health.  The terms of the space agreement will be captured in a separate memorandum of understanding.

B. Document Baseline of FDA Support:

From the experience gained through the collaborative activities, engagement with stakeholders, and research, FDA will document the baseline of FDA support that will have the most impact from a presence in Guam on supply chain security and safety of imported commodities to better improve our intelligence related to importation and transshipment within the Pacific Region; gain understanding of needs related to regulatory, laboratory, and criminal investigation capacity and capability, as well as potential impacts of enhanced support; enhance engagement in the region; and prevent harmful products from entering interstate commerce within the United States and its Pacific Territories, which protects public health and reduces the incidence of health care fraud and abuse. 

C. Enhance and Coordinate Investigatory Communication and Activities for Imported Commodities:

The increasingly global nature of imported commodities necessitates the use of risk-analysis principles in decision-making to address threats to public health, facilitate FDA and territorial-regulated commodity protection, and strengthen food defense. This PA is intended to enhance import product safety through activities that may encompass but are not limited to:
 

  1. Conducting and coordinating joint operations to identify additional impacts to public health and potential for adulterated or fraudulent products to enter the United States and its Pacific Territories, contributing to health care fraud and abuse
  2. Clarifying regulatory roles
  3. Identifying potential for and implementing optimized use of personnel, equipment, and facilities to ensure rapid sharing of critical information
  4. Providing operational support
  5. Enhancing electronic communication tools
  6. Utilizing legally recognized agreements such as information disclosure agreements pursuant to 21 C.F.R. § 20.88, where applicable, to better coordinate information sharing, such as:

a. Critical information about emergencies, recalls, product sampling, inspectional findings, and surveillance work (obtained under section 801 of the Act)

b. Information on emerging situations for which Partners have jurisdiction

c. Anticipated risk-based priorities

  1. Managing emergency response resources to provide training and exercises to further support prompt, coordinated, and effective investigatory operations, and analysis of samples during imported commodity investigations and foodborne illness outbreaks. The Partners will provide support for joint emergency response with multidisciplinary expertise in epidemiology, microbiology, chemistry, radiological, sanitation, and environmental science. Training may address, but is not limited to:

a. Responding to large-scale outbreak of contaminated imported food or other emergencies to protect public health

b. Responding to intentionally adulterated or contaminated imported commodities including terrorist events

D. Identify Opportunities for Laboratory Engagement:

  1. Identify needed resources to support screening and analytical confirmation of identified potential legal and regulatory violations that could impact public health and detection of health care fraud and abuse 
  2. Conduct joint operations to further identify public health issues
  3. Establish joint engagements for relevant association, industry, and trade outreach
  4. Document emerging public health issues and laboratory support which is currently available and additional support that is necessary to provide proper oversight
  5. Identify personnel, resources, limitations, and training needs for sustainable operations located on Guam
  6. Launch initial laboratory operations to support the analysis of imported commodities through screening and analytical confirmation of potential regulatory violations

E. Criminal Investigative Engagement:

The Partners will collaborate to gain an understanding of the criminal activity related to FDA-regulated products that impact the Pacific Region and potential efforts that could support enhanced protection against health care fraud and abuse.  Cultivate capacity building by establishing and further developing regulatory and law enforcement engagement capabilities related to FDA and Public Health law and regulations. 

F. Conduct Partner Training:

This PA aims to enhance the proficiency and competency, particularly in public health and issues related to health care fraud and abuse, of staff members in partnering agencies. Activities may encompass but are not limited to:

  1. Leveraging training resources to enhance import operation uniformity, competence, communication, and cooperation
  2. Leveraging FERN, territorial, and FDA training resources, materials, and space, when possible
  3. Notifying all the Partners of upcoming training courses and opportunities
  4. Sharing of available training sites
  5. Integrating FDA and Guam training faculty on Guam, when feasible, to best utilize expertise and increase communications and mutual understanding

G. Conduct Educational and Community Outreach:

The goal of this portion of the PA is to outline education and outreach program
activities by describing approaches, processes, and tools that facilitate the exchange of scientific, technical, and regulatory information. This does not include the exchange of nonpublic information.

This PA provides a basis for cooperative education and training. Integrating academic and regulatory science into outreach and training will help industry comply with FDA laws and regulations. A focus of this activity will be to increase knowledge of effective, available practices that promote import safety throughout the supply chain and enhance the use of risk analysis models and tools for decision making associated with imported commodities.

Outreach and educational activities may focus on any area of regulated commodities and programs. Initial efforts will emphasize the impacts on public health and HCFAC in areas such as:

  1. Importation of FDA-regulated products
  2. Import safety related to pathogens, contaminants, allergens, and toxins
  3. Regulations, regulatory science, and policies throughout the supply chain
  4. Risk management and consumer behavior
  5. Imported illicit, unapproved, and counterfeit drug interdiction efforts
  6. Importer criteria, verification, and certification programs
  7. GMP

H. PA Monitoring, Assessment, and Evaluation:

  1. The Partners will attempt to meet at least annually to evaluate the progress of the PA during the completed period(s)
  2. The Partners will evaluate whether the PA enhances sharing of resources to meet each Partner’s mission
  3. The Partners will document a connection to the causal link and deterrent effects related to HCFAC
  4. As necessary and appropriate, the Partners will evaluate, and review materials provided by each Partner
  5. The Partners will identify, establish, and monitor key mutual reliance metrics for performing an annual evaluation of this PA
  6. The Partners will collectively provide an “Annual Evaluation fillable.pdf” which includes ongoing outputs and outcomes

V. RESPONSIBILITIES

FDA PARTNERS:

FDA ORA Office of Import Operations, Division of West Coast Imports (DWCI) will serve as an educational and technical resource for all the Partners to help support accountability, commitment to public health, communication, integrity, respect, and quality within their import programs. With these core values emphasized, both consumer protection and public health will be enhanced. DWCI will also support the information collection and documentation of needs and potential impact to improve intelligence regarding imported commodities entering the U.S. mainland, Hawaii, and U.S. Territories and build sustainable regulatory capacity and capability on Guam and enhance support for the U.S. Pacific Territories (Guam, Commonwealth of Northern Mariana Islands, and American Samoa).

FDA ORA Office of Regulatory Science will support the information collection and documentation of needs and potential impact to provide a conduit for FDA laboratory engagement to support the analysis of imported commodities.

FDA ORA Office of Criminal Investigations will inform on criminal operations through direct engagement in the Pacific Region.

GUAM PARTNERS:

Guam Department of Public Health and Social Services, Division of Environmental Health:

  1. Will ensure proper information sharing agreements with FDA are in place to pursue operationalizing shared activities
  2. Will provide space, time, and resources to support engagement, collaborative opportunities, and understanding of needs and areas for greatest public health impact
  3. Will identify collaborative opportunities, such as identifying potential issues that the Partners may encounter (e.g., COVID-19), and develop strategies to minimize and prevent future risk/problems

Guam Customs and Quarantine Agency:

  1. Will ensure proper information sharing agreements with FDA are in place to pursue operationalizing shared activities
  2. Will identify collaborative opportunities, such as participating in training and education, conducting outreach, assisting in imported product investigations, and collaborating in emergency response activities

JOINT:

  1. The Partners will work together to develop a three-year strategic plan that outlines how to implement the PA
  2. Signatories for each Partner will assign coordinators, as needed, for each goal of this agreement
  3. Coordinators will ensure progress, clear lines of communication, and appropriate dissemination of information to managers
  4. The Partners will identify, establish, and monitor key mutual reliance metrics with assistance from the FDA ORA Office of Partnerships
  5. The Partners will complete a joint annual evaluation report, with support from the FDA ORA Office of Partnerships, which includes ongoing PA outputs and outcomes to document program accomplishments and areas for enhancement

VI. RESOURCES

Resources will be identified to accomplish objectives and may include as needed, but are not limited to:

  1. Personnel
  2. Time
  3. Equipment lending
  4. Space utilization
  5. Training
  6. Databases and technological transfer
  7. Guidance and technical support
  8. Identifying funding, equipment, and technology sources/opportunities

The Partners agree to demonstrate mutual commitment to shared goals and objectives within their operational and fiscal resource constraints. There is no intended or implied funding associated with this PA. Nothing in this agreement obligates any of the Partners to any current or future expenditure of resources.

VII. LEGAL STATUS

No consideration has been given or received by either Partner to this PA. This PA is not legally binding and does not constitute a promise on the part of either Partner for performance. It does not create a legally enforceable contract and the Partners agree that no remedies at law or equity will be sought by either Partner for non-performance of this PA. This PA does not impose additional legal duties, rights, benefits, responsibilities, or remedies of either the Partners or of a third party. This PA imposes no duty on either Partner to act or to refrain from acting.

VIII. INFORMATION DISCLOSURE 

Access to non-public information, where appropriate, shall be governed by separate Information Sharing Agreements in accordance with 21 C.F.R. Part 20. Under 21 C.F.R. § 20.88 (20.88 agreement), state agencies must agree and certify in writing that they shall not further release, publish, or disclose FDA non-public information, and that they shall protect such information from public disclosure. No proprietary data, trade secrets, or personal privacy information shall be disclosed among the Partners unless permitted by applicable law. 

To confirm the applicability of an existing 20.88 agreement, to enter into a 20.88 agreement, and prior to sharing any FDA-provided information, the Partners shall contact ORA’s Office of Strategic Planning and Operational Policy, Division of Information Disclosure Policy by sending a request via email to ORAInfoshare@fda.hhs.gov.

IX. ASSESSMENT AND EVALUATION

The Partners will review the PA and goals annually. The Partners will make all reasonable attempts to meet, at a minimum annually, to discuss the current PA, evaluate its usefulness, and make modifications, as needed. During the annual review and evaluation meeting, the Partners will jointly prepare options for follow-up. If new areas for developing PA activities are identified and agreed upon, this PA may be revised to reflect them. 

X. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of the FDA or the Government of Guam. Each Partner will use and manage its own funds in carrying out the purpose of this PA. Permanent transfers of funds or items of value are not authorized under this PA. 

XI. CONCLUSION AND RECOMMENDATION

The Partners agree to the provisions written in this PA, subject to availability of resources.

Approved and Accepted for the U.S. Food and Drug Administration:

/s/
Dan Solis, MHA
Assistant Commissioner for Import Operations 
FDA Office of Regulatory Affairs 
Office of Import Operations 
Date: 10.18.2023

Approved and Accepted for Guam:

/s/
Joshua Franquez Tenorio
Acting Governor of Guam
Date: 10.18.2023

Signatories for the U.S. Food and Drug Administration:

/s/
Erik P. Mettler, MPA, MPH
Assistant Commissioner for Partnerships and Policy 
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy
Date: 10.10.2023

/s/
Justin Green, MBA
Assistant Commissioner for Criminal Investigations
FDA Office of Regulatory Affairs
Office of Criminal Investigations
Date: 10.10.2023

/s/
Paul Norris, DVM
Director
FDA Office of Regulatory Affairs
Office of Regulatory Science
Date: 10.10.2023

Signatories for Guam:

/s/
Ike Q. Peredo
Director
Guam Customs and Quarantine Agency
Date: 10.18.2023

/s/
Arthur U. San Agustin, MHR
Director 
Guam Department of Public Health & Social Services
Date: 10.18.2023

/s/
M. Thomas Nadeau
Chief Environmental Public Health Officer
Division of Environmental Health 
Guam Department of Public Health & Social Services
Date: 10.18.2023
 

 
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