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  1. Domestic MOUs

MOU 225-21-007

MEMORANDUM OF AGREEMENT
between the
DEPARTMENT OF HOMELAND SECURITY/FEDERAL EMERGENCY MANAGEMENT AGENCY (FEMA)
and the
UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA)

I. Parties

The parties to this Agreement are the Department of Homeland Security/Federal Emergency Management Agency (FEMA) and the United States Food and Drug Administration (FDA). The primary mission of FEMA is to reduce the loss of life and property and protect the Nation from all hazards, including natural disasters, acts of terrorism, and other man-made disasters, by leading and supporting the Nation in a risk-based, comprehensive emergency management system of preparedness, protection, response, recovery, and mitigation. The primary mission of FDA is protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

II. Specific Activities

In support of the primary mission of FEMA, FDA agree to provide emergency storage for COVID-19 vaccine vials (Vaccines) currently stored at the FEMA Community Vaccination Center located at 160-02 Liberty Ave., Jamaica, N.Y. 11433 (hereinafter York College). In the event of an emergency, the FDA will permit FEMA to use its facility with an ultra-low temperature (ULT) freezer (Facility) to store vaccines. The FDA will maintain the ULT freezer between -96 and -60 degrees Celsius and provide FEMA 24-hour access to the Facility.

III. Authority

  1. Robert T. Stafford Disaster Relief and Emergency Assistance Act, P.L. 93-288, as amended (Stafford Act): 42 U.S.C. § 5121 et seq.
  2. Sections 503, 504, and 507 of the Homeland Security Act of 2002, Pub. L. No. 107- 296, Title V (2002) (codified as amended at 6 U.S.C. §§ 313, 314, and 317)

IV. Purpose

This Agreement outlines the ways in which FEMA and the FDA will cooperate to carry out their respective responsibilities with respect to the fight against COVID-19 and, more specifically, FEMA major disaster declaration FEMA-DR-4480-NY. FEMA is currently assisting in the administration of the Covid-19 vaccines at various sites throughout the state of New York, including the site located at York College. The vaccines must be stored at -96 and -60 degrees as required by the CDC Provider Use Agreement as well as the Emergency Use Authorization granted by the FDA.

This Agreement sets forth the terms by which FDA will provide FEMA access to two ULT freezers in the event of an emergency/exigent situations impacting FEMA’s ability to safely and effectively maintain and secure vaccines at the required temperature at the York College vaccination site.

At York College, FEMA is currently using two (2) ULT Freezers, a 12 cubic foot and a 4 cubic foot unit and both freezer units are connected to the backup generator at the site.

The intent of this MOU is to ensure a continuity plan for these lifesaving drugs in the event these freezer(s) fail to maintain the required temperature for any reason. Safely transporting the vaccine to the FDA facility will ensure the viability of the vaccine for the maximum usable shelf life (manufacturers expiration date).

V. Responsibilities

  1. Both FEMA and FDA agree:
    1. To identify and document primary responsible parties for each location, to include contact information.
    2. To provide a list of contacts that can respond and support emergency movement of vaccines from the current FEMA location at York College to the FDA location at 158-15 Liberty Avenue, New York, NY 11433, 7 days a week, 24 hours per day.
    3. To provide inventory of transferred and maintained vaccines under emergency scenarios including, but not limited to cold chain temperature records.
    4. That during transport and throughout the duration of storage under emergency scenarios, monitor, maintain, and document temperature in accordance with CDC guidelines. FEMA uses Digital Data Loggers to ensure a history of temperature is maintained.
    5. This is a no-cost Agreement, and the responsibilities set forth herein do not involve any transfer or reimbursement of funds between the Parties.
  2. DHS/FEMA Responsibilities:
    1. Maintain and provide FDA an emergency contact list of responsible parties for this agreement with one (1) business day of this agreement being signed.
    2. Provide FDA a primary point of contact that will report vaccine inventory at York College. This report will be provided everyMonday by 9:00AM, to include estimated inventory for the next 7 days. Inventory will be by “tray” and each tray holds 195 vials of vaccine.
    3. Contact FDA staff immediately when an emergency arises requiring access and storage of vaccines under this agreement.
    4. Transport the vaccines to the FDA facility with approved freezers/refrigerators in accordance with CDC guidelines.
    5. Assist in placing the vaccines into the FDA provided ULT freezers and validate the amount of vaccines being stored under this agreement.
    6. Provide FDA with daily updates on potential hazards that may create an emergency, and timelines associated with either FEMA’s recovery of the vaccines, or the continued storage requirement timeframe.
    7. Coordinate vaccine retrieval and provide necessary information to FDA for the continued Vaccine storage or retrieval.
    8. Provide staff, transportation, and freezers/refrigeration needed to retrieve all vaccines, or a portion thereof, from the FDA facility once it is deemed safe to store at York College or an alternate FEMA-managed facility.
  3. FDA Responsibilities:
    1. Maintain and provide FEMA an emergency contact list of responsible parties for this agreement with one (1) business day of this agreement being signed.
    2. Provide FDA staff to support emergency access to FDA facility. Access must be provided 24 hours a day, seven (7) days a week.
    3. Assist in placing vaccines into the FDA provided ULT and validate the amount of vaccines being stored under this agreement.
    4. Provide FEMA with daily updates to include confirmation the ULT has retained temperatures for vaccine storage in accordance with CDC/FDA guidelines.
    5. Support the recovery of vaccine by FEMA by providing access to the FDA facility as required.
    6. With the exception of the cost to transport the vaccines to and from the FDA facility, use of these FDA freezers while storing vaccines during the pendency of the emergency/exigent situation, will be at no cost to FEMA.

VI. Points of Contact

  1. FEMA
    Alejandro De La Campa, Division Supervisor, FEMA,
    Alejandro.DeLaCampa@fema.dhs.gov (787) 406-2952.
  2. FDA
    John Leazer, Laboratory Director, Northeast Food and Feed Laboratory,
    USFDA 158-15 Liberty Ave, Jamaica, NY 11433, john.leazer@fda.hhs.gov,
    (Office) 718-340-7093, (Cell) 646-256-5015.

VII. Other Provisions

  1. Nothing in this Agreement is intended to conflict with existing law or regulation or the directives and authorities of DHS/FEMA or HHS/FDA. If a term of this agreement is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions of this agreement shall remain in full force and effect.
  2. Nothing in this Agreement is intended to restrict the authority of either party to act as provided by statute or regulation.
  3. This Agreement, upon execution, contains the entire agreement of the parties and no prior written or oral agreement, express or implied, shall be admissible to contradict the provisions of this Agreement.
  4. Any information shared under this Agreement will comply with the Privacy Act, and to the extent required and allowable, the Freedom of Information Act (FOIA), and any other applicable statute, Executive Order, or regulation.
  5. The use of Federal facilities, supplies and services undertaken under this Agreement will be in compliance with regulations promulgated by FEMA under the Stafford Act guaranteeing non-discrimination and prohibiting duplication of benefits. (See 44 CFR 206.11 and 206.191.)

  6. This Agreement is between FEMA and FDA and does not confer or create any right, benefit, or trust responsibility, substantive or procedural, enforceable at law or equity, by any third person or party (public or private) against the United States, its agencies its officers, or any person; or against FEMA and FDA, their officers or employees or any other person.

    This Agreement creates neither a partnership nor a joint venture, and neither party has the authority to bind the other. This agreement is not intended to be enforceable in any court of law or dispute resolution forum.

  7. The parties will use or display each other’s name, emblem, or trademarks only in the case of particular projects and only with the prior written consent of the other party. The Department of Homeland Security (DHS) seal is protected by 18 U.S.C. §§ 506, 701, and 1017, among other laws, and use of the seal is controlled by the DHS Office of Public Affairs through DHS Management Directive No. 0030 (MD 0030). Written permission is required to use the DHS Seal. Any party to this agreement that is not a Federal entity may only use an official DHS seal or logo upon written permission from DHS.
  8. Liability: The parties to this agree to be responsible for the negligent or wrongful acts or omissions of their respective employees arising under this agreement. The parties agree -- subject to any limitations imposed by law, rule, or regulation -- to cooperate in good faith to resolve any claims promptly and, whenever appropriate, without litigation. For all claims or suits arising under this agreement, each party’s designated legal representatives will, within (7) calendar days of receipt, provide each other’s designated legal representatives copies of any documents memorializing such claims. Nothing in this Agreement shall be construed as a waiver of any sovereign immunity of the United States. Any claims arising from actions related to this Agreement are subject to applicable Federal law, including the Public Readiness and Emergency Preparedness Act and the Secretary for the Department of Health and Human Service’s declaration for COVID-19 countermeasures, 42 USC 247d-6d, 85 FR 15198 (March 17, 2020), as amended, and the Federal Tort Claims Act (FTCA), 28 U.S.C. §§ 1346 (b), 2671-2680.
  9. This Agreement is not a fiscal or funds obligation document. Any services, equipment or personnel provided to FEMA to accomplish the goals anticipated under this agreement are done so without expectation of reimbursement or the payment of fees related to the provision of such services, equipment or personnel unless otherwise agreed. Any specific work or activity that involves the transfer of funds, services, or property among the parties will require execution of a separate agreement and will be contingent upon the availability of appropriated funds. Such activities must be independently authorized by appropriate statutory or other authority. This Agreement does not provide such authority.
  10. Any ancillary reimbursement agreements must be in writing and signed by both parties.
  11. This Agreement, upon execution, contains the entire agreement of the parties and no prior written or oral agreement, express or implied, shall be admissible to contradict the provisions of this Agreement.

VIII. Effective Date

The terms of this Agreement will become effective upon the signature of both parties.

IX. Modification

This Agreement may be modified upon the mutual, written consent of the parties.

X. Termination

The terms of this Agreement, as modified with the consent of both parties, will remain in effect until May 20, 2021, or until FEMA’s mission is deemed complete. The Agreement may be extended by mutual written agreement of the parties. Either party upon 14 days written notice to the other party may terminate this Agreement.

XI. Approved By

/S/

Lai Sun Yee
Branch Director, FEMA
Date: 05/06/2021

/S/

Jim Sigg
Deputy Commissioner for Operations / Chief Operating Officer, FDA
Date: 05/07/2021

 
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