MOU 225-25-013

MEMORANDUM OF UNDERSTANDING BETWEEN THE NATIONAL INSTITUTE OF HEALTH NATIONAL LIBRARY OF MEDICINE (NIH-NLM) AND THE FOOD AND DRUG ADMINISTRATION HUMAN FOODS PROGRAM (FDA-HFP) REGARDING THE NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION (NCBI) - PATHOGEN DETECTION

I. PURPOSE

This Memorandum of Understanding (MOU) establishes a collaborative framework between two Agencies within the U.S. Department of Health and Human Services (DHHS): the National Library of Medicine (NLM), National Center for Biotechnology Information (NCBI), at the National Institutes of Health (NIH), and the Food and Drug Administration (FDA), Human Foods Program (HFP)—hereinafter referred to individually as a “Partner” and collectively as the “Partners.”

The purpose of this MOU is to support and advance pathogen genomic surveillance for food safety through coordinated activities involving the storage, analysis, standardization, validation, and timely sharing of whole genome sequencing (WGS) data and associated metadata. Specifically, this MOU outlines the collaboration supporting HFP’s GenomeTrakr network and helps ensure continued alignment between HFP’s food safety mission and NCBI’s infrastructure and data stewardship capabilities.

This MOU is intended to assist in improving the quality, accessibility, and utility of pathogen genomic data for foodborne disease regulatory and outbreak response. The MOU reflects a mutual understanding between Partners committed to maintaining a robust and transparent data ecosystem that supports evidence-based decision-making to improve food safety.

II. BACKGROUND

FDA’s Human Foods Program is responsible for protecting public health by ensuring the safety and security of the U.S. food supply, among other regulatory responsibilities. Within this mandate, HFP’s GenomeTrakr Program oversees genomic surveillance of pathogens relevant for food safety in food products, production environments, and agricultural settings. Whole genome sequence (WGS) data collected from this effort informs weekly regulatory actions within HFP, including import alerts, warning letters, follow-up inspections, and recall activities (i.e., the removal or prevention of contaminated products from the marketplace, thereby helping to ensure a safe food supply). The WGS data generated under the GenomeTrakr Program is also integral to traceback and outbreak investigations.

NCBI supports this mission by maintaining the data infrastructure for storing and managing genomic data and associated metadata collected through HFP’s surveillance efforts. NCBI’s Pathogen Detection (PD) platform provides automated cluster analysis for identifying clonal relationships among isolates, as well as multiple genomic characterization tools relevant to food safety (e.g., virulence and antimicrobial resistance gene predictions). Results are made available through the Pathogen Detection Isolates Browser and Rapid Reports, enabling timely regulatory decision making by HFP.

This MOU memorializes the ongoing collaboration between HFP and NCBI to sustain and continuously advance the American Government’s capacity for foodborne pathogen genomic surveillance. It reflects a shared commitment to maintaining and improving the data systems, analytical tools, and interagency coordination necessary to strengthen food safety and protect public health.

III. LEGAL AUTHORITY

The authorities to enter this framework MOU are:

FDA: 21 U.S.C. § 393(b) and (c) [Sections 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)]
NIH/NLM/NCBI: 42 U.S.C. § 286 [Section 465 of the Public Health Service Act]

IV. OBJECTIVES AND RESPONSIBILITIES

The Partners share two primary goals to support and improve federal capabilities for NCBI’s Pathogen Detection services and resources:

Maintain and expand existing data management and analysis pipelines for the timely identification of clonal relationships and genomic characterization tools for foodborne bacterial isolates using the Pathogen Detection platform.
Support and implementation of HFP’s metadata update requests, ensuring coordination with the NCBI’s data repositories (e.g. SRA, BioSample, BioProject, and GenBank).

To achieve the goals, the Partners have the following objectives:

Strengthen collaboration between HFP and NCBI by jointly establishing priorities and coordinating activities.
Establish a routine meeting series between the Partners.
Continue NCBI participation in routine HFP meetings, including monthly calls and participation in the GenomeTrakr annual meeting (when applicable).
Promote transparency and recognition of the partnership through acknowledgement in relevant public presentations and written materials.
Improve the metadata update requests process by HFP and the GenomeTrakr laboratories to the NCBI’s data repositories (SRA, BioSample, GenBank, Pathogen Detection).

The responsibilities of the partners include:

Develop and implement joint action plans to achieve the objectives outlined in this MOU.
Define and establish metrics to measure progress and success of collaboration.
Maintain direct communication pathways across organizational levels to support coordination and information exchange.
Document and share best practices to improve data management, analysis, and submission workflows.
Coordinate initiatives to identify and implement operational efficiencies across NCBI’s Pathogen Detection platform and HFP’s genomic surveillance programs.
Collaborate on the development and delivery of training and outreach to support data submitters, analysts, and other stakeholders engaged in pathogen surveillance using the Pathogen Detection platform.

V. FUNDING

This MOU represents the broad outline of the Partners' present intent to enter specific agreements for collaborative efforts in areas of mutual interest to the HFP and NCBI. All activities undertaken through the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Partners. This MOU does not create binding, enforceable obligations against any Partner. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the HFP and the NLM operate.

VI. GENERAL PROVISIONS

A. This MOU reflects an internal understanding between HFP and NCBI and does not confer any rights or benefits to any person or Partners.
B. This MOU is non-exclusive. Nothing in this MOU prevents either Partner from entering into similar agreements with other entities.
C. This MOU does not create a joint venture or similar relationship between the Partners. Neither Partner shall have the right or authority to act on behalf of, or bind the other Partner in any matter.
D. This MOU does not impose legally binding requirements on either Partner. If deemed necessary, the Partners may develop guidance documents to support implementation of this MOU, consistent with applicable statutory and regulatory authorities.
E. Nothing in this MOU constitutes final agency action on any issue. Any actions contemplated by this MOU are to be carried out in an appropriate administrative process by the acting Partner in accordance with all applicable laws and regulations.
F. This MOU applies only to HFP and NCBI and does not confer any rights, impose obligations, or direct actions by entities outside of the Partners.

VII. INFORMATION SHARING

A. Joint Responsibilities

Subject to compliance with applicable laws, regulations, policies, and privileges, including those relating to conflict of interest, medical peer review, and the protection of patient data, this MOU commemorates the following responsibilities for both FDA/HFP and NIH/NLM/NCBI:

Each Party shall establish a principal point of contact at the agency to facilitate any actions carried out under this MOU;
Jointly, through email or other written communication, the Parties shall establish the specific procedures and safeguards necessary to implement this MOU.

This agreement does not preclude NIH/NLM/NCBI or FDA/HFP from entering into other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.

B. General Principles and Procedures for the Exchange of Non-Public Information

Subject to compliance with applicable laws, regulations, policies, and privileges, including those relating to conflict of interest, medical peer review, and the protection of patient data, FDA/HFP and NIH/NLM/NCBI agree that the following principles and procedures will govern the exchange of nonpublic information between the two agencies.

As fellow agencies within HHS, FDA and NIH can generally share information in the possession of either agency with each other. Both Partners recognize and acknowledge, however, that it is essential that any confidential information that is shared between FDA and NIH, whether in writing or orally, cannot be further shared unless authorized by law. See e.g., 21 U.S.C. § 331(j); 18 U.S.C. § 1905; 5 U.S.C. 552; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b, and 42 U.S.C. § 241(d). Safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information; patient identities and other personal privacy information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure FDA's and NIH’s compliance with applicable laws, regulations, and policies. The sharing of identifiable patient information and national security information is not contemplated by this MOU.

C. Exchanges of Non-Public Information Between the Two Parties

To facilitate the sharing of non-public information between the Parties, both Parties are committed to responding to requests for information in a timely manner, consistent with budgetary and resource constraints, and in accordance with applicable laws, regulations, and agency policies and practices. Provisions for the sharing of non-public information, both written and oral, are set out below.

The Requesting Party must specify, in writing, which may include informal written communication, e.g., email, the information requested and a brief statement of why the information is being requested. This written communication should include the following template language: ‘This request is made pursuant to MOU No. 225-25-013, between FDA/HFP and NIH/NLM/NCBI.” The Requesting Party should also state that it agrees not to further disclose any non-public information shared between the Parties.
The Sharing Party should include a transmittal letter along with any agency information shared with the other Party to the MOU, indicating the type of information being shared (e.g. confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter from FDA to NIH is set forth in Appendix A. A model transmittal letter from NIH to FDA is set forth in Appendix B. Upon mutual agreement, the Parties may agree, in writing, to share non-public information over a specified period of time.

D. Non-Public Information Exchanges: Public Health Emergency

In cases where a Party to this MOU needs to obtain certain information as soon as possible due to emergency circumstances, such as an outbreak of an illness, the Requesting Agency shall so indicate orally or through informal written communication, e.g., email, to the other Party. The Requesting agency shall agree to protect any such information from unauthorized disclosure.

In the case of emergency circumstances, as soon as is practicable, the Parties to this MOU shall document their sharing of any non-public information.

E. FOIA And Other Third-Party Requests for Shared Information

If any Partner to this MOU receives a FOIA request for information shared by the other Party, it shall: (a) if the request implicates documents from the Sharing Party in their original form, refer the FOIA request to the Sharing Party for a response, without indicating to the FOIA requester whether the Sharing Party has responsive records or releasable records; or (b) if the request implicates documents received from the Sharing Party and then incorporated into document[s] by the Receiving Party, the Parties shall consult about how best to respond to the FOIA request. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25.

Any Partner to this MOU shall promptly notify the other Party if there is any attempt by a third party, including requests by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information by processes, including, but not limited to a voluntary request, subpoena, discovery request, or litigation complaint or motion. The Parties shall consult before complying with any request to obtain shared non-public information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action. Any partner to this MOU shall promptly notify the other Party if there is an inadvertent disclosure of information shared under this MOU so that appropriate remedial actions may be taken.

VIII. PROGRAM/LIAISON OFFICERS

A Program Officer/Manager for each Partner (see the designations below) will be responsible for facilitating exchanges of information and expeditiously informing other interested parties within each respective organization on matters requiring prompt attention. Contact Information for both Partners is provided below:

Program Officer/Manager for the FDA/HFP’s GenomeTrakr Program:
Individual's name: Ruth Timme
Organization: FDA/HFP/OLOAS/OSCCS/GTCSS
Title: Acting Director, GenomeTrakr & Computational Science
Email Address: ruth.timme@fda.hhs.gov

Program Officer/Manager for NLM-NCBI’s Pathogen Detection:
Individual's name: William Klimke
Organization: Organization: NIH/NLM/NCBI
Title: Unit Chief, Pathogen Detection
Email Address: klimke@ncbi.nlm.nih.gov

Each Partner may designate new liaisons at any time by notifying the other Partner's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Partners will name a new liaison within two (2) weeks and
notify the other Partner through the designated administrative liaison.

IX. EFFECTIVE DATE, TERMINATION, AND MODIFICATION

This MOU will be effective on the date of the last signatory to the agreement. This agreement may
be modified or terminated by mutual written consent by the partners or may be terminated by either Partner upon a 60 day advance written notice to the other. The Partners will review this agreement and goals annually. The Partners will make all reasonable attempts to meet, at a minimum annually,
to discuss the current agreement, 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 agreement activities are identified and agreed upon, this agreement may be revised to reflect them. Revisions to the agreement may be submitted for consideration and approval by the appropriate agency signatories.

Any Partner on its initiative may submit a proposed amendment or modification in writing for review.
Modifications and amendments will be tracked and documented throughout the duration of the agreement and will be reviewed at least annually during the annual review and maintained for
historical purposes.

Signed,

/s/
Kyle Diamantas
Deputy Commissioner for Human Foods
Human Foods Program, Food and Drug Administration
Date: 08/25/2025

/s/
Kis Hale
Director, Office of Laboratory Operations and Applied Science
Human Foods Program, Food and Drug Administration
Date: 08/22/2025

/s/
Erik Mettler
Assistant Commissioner for Integrated Food Safety Systems
Human Foods Program, Food and Drug Administration
Date: 08/22/2025

/s/
Todd Danielson
Associate Director for Administrative Management
National Library of Medicine, National Institutes of Health
Date: 08/25/2025

/s/
Kim D. Pruitt
Acting Director, Nat’l Center for Biotechnology Info.
National Library of Medicine, National Institutes of Health
Date: 08/25/2025

/s/
Heriberto Rivera Arocho
Chief Financial Officer
National Library of Medicine, National Institutes of Health
Date: 08/25/2025

Appendix A

Model Transmittal Letter from FDA/HFP to NIH/NLM/NCBI

Reference MOU: #225-25-013

This letter accompanies agency records that the Food and Drug Administration (FDA), Human Foods Program (HFP), is sharing with the National Institutes of Health (NIH), National Library of Medicine (NLM), National Center for Biotechnology Information (NCBI). These agency records contain one or more of the following categories of non-public information, prohibited from further disclosure by NIH/NLM/NCBI]:

[FDA/HFP checks applicable items below]

non-public information belonging to a third party/entities other than FDA, including
__trade secrets;
__confidential commercial or financial information;
__information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
__information subject to the Privacy Act.
non-public information belonging to FDA, including
__ intra-agency records, e.g. documents commemorating FDA deliberative process;
__ records or information compiled for law enforcement purposes.

NIH shall notify FDA if there are any attempts by third parties, including Congress, the Office of the Inspector General, or the Government Accountability Office, to obtain shared information, including but not limited to Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions. NIH shall notify FDA before complying with any judicial order that compels the release of such information so that FDA/HFP may take appropriate measures, including filing a motion with the court or an appeal.

NIH has agreed not to further disclose this information without prior written approval from FDA/HFP. NIH acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See e.g., 21 U.S.C. §331(j) 360j(c); 18 U.S.C. §1905, 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5 and 5b and 42 U.S.C. §241(d).

Appendix B

Model Transmittal Letter from NIH/NLM/NCBI to FDA/HFP

Reference MOU: #225-25-013

This letter accompanies agency records that the National Institutes of Health (NIH), National Library of Medicine (NLM), National Center for Biotechnology Information (NCBI), is sharing with the Food and Drug Administration (FDA), Human Foods Program (HFP). These agency records contain one or more of the following categories of non-public information, prohibited from further disclosure by FDA/[FDA component]:

[NIH/[NIH component] checks applicable items below]

non-public information belonging to a third party/entities other than NIH, including
__trade secrets;
__confidential commercial or financial information;
__information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
__information subject to the Privacy Act.
non-public information belonging to NIH, including
__ intra-agency records, e.g. documents commemorating NIH deliberative process;
__ records or information compiled for law enforcement purposes.

FDA shall notify NIH if there are any attempts by third parties, including Congress, the Office of the Inspector General, or the Government Accountability Office, to obtain shared information, including but not limited to Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions. FDA shall notify NIH before complying with any judicial order that compels the release of such information so that NIH/NLM/NCBI may take appropriate measures, including filing a motion with the court or an appeal.

FDA has agreed not to further disclose this information without prior written approval from NIH/NLM/NCBI. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See e.g., 21 U.S.C. §331(j) 360j(c); 18 U.S.C. §1905, 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5 and 5b and 42 U.S.C. §241(d).