MEMORANDUM OF UNDERSTANDING (MOU)
BETWEEN
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
DIVISION OF SELECT AGENTS AND TOXINS (DSAT)
AND
THE FOOD AND DRUG ADMINISTRATION (FDA)

 

ARTICLE 1- BACKGROUND

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (Public Law 107-188) requires the Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents and toxins that have the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant products. These biological agents and toxins are referred to as select agents. In accordance with Public Law 107-188, HHS and USDA promulgated the select agent regulations (SAR) found in 42 Code of Federal Regulations (CFR) Part 73, 7 CFR Part 331, and 9 CFR Part 121. The Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS)/Division of Agricultural Select Agents and Toxins are charged with implementing these regulations.

The HHS SAR provide that “[t]he HHS Secretary may exempt from the requirements of this part an investigational product that is, bears, or contains a [HHS] select agent or toxin, when such product is being used in an investigation authorized under any Federal Act and additional regulation under this part is not necessary to protect public health and safety” (42 CFR 73.5(d)). Likewise, the HHS Secretary may exempt an investigational product that is, bears, or contains an overlap select agent or toxin after consultation with the APHIS Administrator (42 CFR 73.6 (d)).

Under the implementing regulations for the Federal Food, Drug, and Cosmetic Act, FDA has the authority to accept or approve an Investigational New Drug application (IND), a request to establish an Investigational New Animal Drug file (INAD), or an Investigational Device Exemption application (IDE) if it meets the requirements of 21 CFR Part 312, 21 CFR Part 511, or 21 CFR Part 812 respectively. DSAT desires to obtain confirmation from FDA regarding whether an IND, INAD, or IDE has been allowed to proceed or approved in order to determine whether an investigational product that is, bears, or contains a select agent or toxin is being used in a clinical investigation pursuant to the Federal Food, Drug, and Cosmetic Act. This information will aid DSAT in determining whether to approve an exemption of an investigational product that is, bears, or contains a select agent or toxin from the HHS SAR requirements. The HHS SAR require DSAT make a determination regarding an application for an exemption within 14 calendar days after receipt.

ARTICLE 2- PURPOSE

The purpose of this Memorandum of Understanding (MOU) is to establish a procedure to allow DSAT to confirm that the FDA has allowed to proceed or approved an IND, INAD, or an IDE for a clinical trial involving the use of an investigational product that is, bears, or contains a select agent or toxin.

This MOU supersedes any previous agreement between DSAT and FDA or any component of the FDA concerning information requested pursuant to the SAR for this purpose.

ARTICLE 3 - PARTY RESPONSIBILITIES

DSAT agrees to:

1. Obtain a signed APHIS/CDC Form 5 (Request for Exemption) from each sponsor requesting an exemption under HHS SAR.
2. Provide the signed APHIS/CDC Form 5 (Request for Exemption) to FDA via email at EUA.OCET@fda.hhs.gov. In the email, DSAT will certify that, to the extent permitted by federal law, the information being requested from FDA will only be used for the purpose of determining whether to approve a request for exemption and that DSAT will not further disclose the records or information without the written permission of the FDA unless otherwise authorized by the sponsor.

FDA agrees to:

1. Send an email to DSAT Associate Director for Policy (ADP), within three business days from the receipt of the information specified in APHIS/CDC Form 5, to confirm the following:

a. whether FDA has allowed to proceed or approved an IND, INAD, or IDE for an investigational product that is, bears, or contains a select agent or toxin, and

b. whether the IND, INAD, or IDE is on hold, withdrawn, or still in effect at the time of the confirmation.

2. Send an email to DSAT ADP within five business days from the receipt of the request to provide an update on the status of an IND, INAD, or IDE for an investigational product that is, bears, or contains a select agent or toxin.

ARTICLE 4 – DESIGNATED POINTS OF CONTACT

For general information concerning this agreement.

A.   For DSAT
      Meredith Parrado
      Associate Director for Policy (ADP)
      CDC, DSAT
      (404) 498-0878
       ish1@cdc.gov

B.   For FDA
      Elizabeth Sadove
      Senior Regulatory Counsel
      Office of Chief Scientist
      (240) 753-3705
      Elizabeth.Sadove@fda.hhs.gov

ARTICLE 5 – INFORMATION SECURITY

DSAT certifies that DSAT will use the information to be provided by FDA only for the purpose of determining whether to approve a request for exemption of the investigational product that is, bears, or contains a select agent or toxin from the requirements of 42
C. F.R. part 73, and that DSAT will not further disclose the records or information without the written permission of FDA unless otherwise authorized by the sponsor.
 

ARTICLE 6 – STATEMENT OF NO FINANCIAL OBLIGATION

Signing this MOU does not constitute a financial obligation on the signatory Parties. Each signatory party to this MOU and their respective agencies and offices will handle their own activities and utilize their own resources, including the expenditure of their own funds, in pursuing these objectives. Each party will carry out its separate activities in a coordinated and mutually beneficial manner.

Nothing in this MOU shall obligate any of the signatory parties to obligate or transfer any funds. Specific work projects or activities that involve the transfer of funds, services, or property among the various signatory parties will require the execution of separate agreements and be contingent upon the availability of appropriated funds. Negotiation, execution, and administration of each such agreement must comply with all applicable statutes and regulations.

ARTICLE 7 – LIMITATIONS OF COMMITMENT

Nothing in the MOU limits or alters the Parties’ authority to implement their respective oversight programs in accordance with federal law.

This MOU and any continuation thereof shall be contingent on the availability of funds appropriated by the Congress of the United States. It is understood and agreed that any monies allocated for purposes covered by this MOU shall be expended in accordance with its terms and the manner prescribed by the fiscal regulations and/or administrative policies of the party making the funds available. If fiscal resources are to transfer, a separate agreement must be developed by the parties.

ARTICLE 8 – THIRD PARTY RIGHTS

This MOU is not intended, and should not be construed, to create any right or benefit, substantive or procedural, enforceable at law or otherwise, against any of the agencies, their parent agencies, the United States, or the officers, employees, agents, or other associated personnel thereof.

ARTICLE 9 – DISPUTE RESOLUTION, AMENDMENT, AND TERMINATION

The Parties will meet at the request of any Party to discuss and review the implementation of this MOU. Where disputes concerning the interpretation, application, or implementation of this MOU arise, the Parties will work in good faith through their authorized representatives to achieve resolution. The Party with the dispute will provide reasonable written notice as to the basis of the dispute and the proposed means of resolution to the other Parties.

This MOU may be amended by mutual written agreement of the Parties. Appendices, Addenda, and Annexes to this MOU may be added or modified upon the mutual written agreement of the Parties.

This MOU may be terminated on sixty (60) days’ written notice by one of the Parties to the other Parties.

ARTICLE 10 – EFFECTIVE DATE AND DURATION

This MOU will become effective on date of final signature and will remain in effect for five years from the date of final signature unless otherwise amended or terminated per section 9 above.

/s/
Samuel Edwin, Ph.D.
Director, Division of Select Agents and Toxins
Date: 06/26/2023

/s/
Namandjé N. Bumpus, Ph.D.
Chief Scientist, U.S. Food and Drug Administration
Date: 06/28/2023