Memorandum of Understanding Between
the Walter Reed Army Institute of Research and
the Uniformed Services University of the Health Sciences F. Edward Herbert School of Medicine
and
United States Food and Drug Administration

This Memorandum of Understanding (MOU) documents the affiliation among the Walter Reed Army Institute of Research ("Institute"), the F. Edward Hebert School of Medicine ("the School"), and the Food and Drug Administration ("FDA") in the established Clinical Pharmacology Fellowship Training Program ("the Program"). This affiliation permits the coordination of resources to develop a unified program, maximize efficient utilization of government facilities, and strengthen the joint education and research efforts among the parties.

I. BACKGROUND:

Military and civilian elements within the Federal Government are separately empowered and funded by Congressional Acts. In working together, they must accommodate legal and monetary restrictions, and assure that each party receives mission benefit from any Agreements arranged.

II. AUTHORITIES:

A. DOD Instruction 4000.19, Support Agreements, 16 December 2020, 10 USC 2113.

B. FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended (21 U.S.C. § 301 et seq.). In fulfilling its responsibilities under the FD&C Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics.

Ill. PURPOSE AND SCOPE:

The Program consists of two years of training. Fellows may be selected and trained at each level. Fellows shall be Medical Corps Officers on active duty in the United States Army, the United States Navy, the United States Air Force, or the United States Public Health Service. This MOU involves the combined and coordinated efforts of the parties to the MOU, and is only amenable to separation of responsibilities as noted below:

    a. The School and the Institute will coordinate the technical and support personnel involved in the Program. FDA will provide a two to four-month clinical rotation to second-year Fellows and potentially clinical pharmacology staff who have not had this component as part of their training. This rotation will not involve direct interaction with patients or participants, but may include participation in open forum discussions which are publicly available, such as FDA Grand Rounds. Each party will provide qualified civilian or uniformed personnel to serve as mentors. The Institute, School, and the FDA will not compensate or reimburse the other on account of any of the activities, services, or facilities provided by the other in accordance with this agreement.

    b. Academic Appointments:

1. Members of the Institute and FDA's clinical staff, who in accordance with the standards and procedures prescribed by the School for appointment to the faculty of the University's F. Edward Hebert School of Medicine (SOM) qualify by training and performance, may be considered for appropriate appointments to the School's faculty.
2. Qualifying staff members of the Institute and FDA's medical staff, on the approval of the Institute, FDA and the School, through the approved appointment mechanisms of the School, will receive academic titles and have the same rights and privileges as other holders of academic appointments from the School.
3. All members of the Institute and FDA staff holding faculty appointments, in addition to their primary positions in the Institute and FDA, will be considered faculty. They will perform their Institute and FDA staff duties in accordance with the rules and organizational structure, and under the direction of the Institute and FDA. Such members will also coordinate with and report to the appropriate Department Chairperson (or designee) of the School on all academic activities relating to their faculty appointment.
4. Faculty will be responsible for teaching programs at the undergraduate, graduate, and postgraduate level within the teaching service at the Institute, School, and FDA and will coordinate with the Department Chairperson or his/her representative. Faculty will have access to appropriate resources for student education.

    c. The Program Fellows will be directly responsible to and under the direction of the Co-directors of the Program at the School and at the Institute.
 
    d. The Institute and School Co-directors of the Clinical Pharmacology Fellowship Training Program will be responsible for the direction of all Fellows.

    e. Clinical Exposure/Supervision:

1. Fellows and staff shall abide by the policies, rules, regulations of the Institute and FDA. The Parties agree that the Fellows will be considered providers or members of FDA's workforce while performing duties pursuant to this agreement and do not meet the definition of business associates under the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. Section 1320d ("HIPPA"). No business associate agreement between the parties, therefore, is necessary. The Institute will train the Fellows on the protection and privacy of protected health information and will provide evidence of such training to FDA as required. Such training will meet the requirements of HIPAA and its privacy rules, and of DoD Manual 6025.18. School trainees and faculty shall abide by applicable HIPAA policies. No protected healthcare information is anticipated to be exchanged between the Institute, the School, and FDA.
2. While Fellows are not expected to have contact with patients at FDA, if Fellows have such contact, they shall be under the direction of the staff and assigned teaching attending staff who hold faculty appointments.
3. Any FDA staff or Fellows participating in an investigational study under this Program involving human subject must comply with all applicable regulations governing informed consent.
4. Agency coordination will be conducted to provide Institutional Review Board oversight for all human research protocols under this Program.
5. FDA will facilitate assessment of FDA facilities by government agencies or other agencies charged with the responsibility for accreditation of School education programs.
6. FDA will provide necessary education facilities and access to appropriate resources for all Fellows participating in the FDA clinical rotation within the Program.
7. FDA will ensure that Fellows who are accidentally exposed to environmental hazards and/or infectious diseases and/or other occupational injury are treated appropriately and in a timely manner. FDA also will notify the School of the incident involving the Fellow(s).
8. FDA will investigate complaints regarding unprofessional behavior by the Fellow(s). It will forward any findings, conclusions, or recommendations to the School for appropriate action (to include academic or legal action).

    f. FDA's Center for Drug Evaluation and Research (CDER) will arrange the following rotations:

1. CDER's Office of New Drugs (ONO): The Office of New Drugs will work with the co-Directors of the Clinical Pharmacology Fellowship Training Program to schedule a two to four-month internship in the area of interest for second-year Fellows. During this internship, a member (e.g., team lead or reviewer) of the Office of New Drugs review division hosting a Fellow will serve as a mentor to a Fellow during the training period. The Fellows will attend ONO review division briefings and other scientific activities. Fellow review of protocols and study reports will be conducted under appropriate supervision. Involvement of Fellows in these reviews will only be to the extent permitted under applicable statutes and regulations. Fellows will execute and abide by all requirements of the Commitment to Protect Non-Public Information (Form FDA 3398). The internship should be arranged to allow the Fellow to participate in educational activities sponsored by FDA such as the bimonthly scientific seminar, the annual Academics to the Center for Drug Evaluation and Research course and, if possible, the New Drug Application (NOA) or investigational New Drug (IND) review course. The Fellows will be encouraged to conduct reviews of NDAs, Biologic License Applications (BLAs), or INDs to the extent permitted under applicable statutes and regulations. Except under unusual circumstances, each fellow will participate actively in the review of an IND or NOA or BLA application under the mentorship of an FDA reviewer during his/her rotation at FDA.
2. Office of Clinical Pharmacology (OCP): The FDA Office of Clinical Pharmacology will work with the Institute and School Co-Directors of the Clinical Pharmacology Fellowship Training Program to schedule a two- to four-month rotation in the therapeutic area of interest for second-year Fellows. Arrangements for these rotations between OCP and the Co-Directors should be finalized at least 3 months prior to the initiation of a rotation. In addition, the Co-Directors of the Clinical Pharmacology Fellowship Training Program shall provide the FDA Office of Clinical Pharmacology, with information regarding the specific goals and objectives that each of the incoming Fellows would like to attain during the rotation.

During this rotation, a member of the immediate Office of Clinical Pharmacology or the review division hosting the rotation will be assigned as a mentor to the Fellow during the period of training. The Fellows will attend related review division briefings and other scientific activities. Reviews by the Fellow of protocols and study reports will be conducted under appropriate supervision. Involvement of Fellows in these reviews will only be to the extent permitted under applicable statutes and regulations. The rotation should be arranged to allow the Fellow to participate in educational activities sponsored by FDA. The Fellows will be encouraged to participate in reviews of New Drug Applications, Biologic License Application or investigational New Drugs to the extent permitted under applicable statutes and regulations.
 
g. Liability/Contingency - The parties recognize that faculty, staff, and Fellows performing activities pursuant to this agreement remain employees of their respective services and of the United States, and are performing duties within the course and scope of their Federal employment. Consequently, the provisions of the Federal Tort Claims Act (Title 28. USC§ 2671 et seq.), including its defenses and immunities, will apply only and exclusively to allegations of negligence or wrongful acts or omissions by faculty, staff, and Fellows while acting within the scope of their duties as Federal employees, pursuant to this agreement. The primary responsibility for investigating tort claims arising from the period of instruction at FDA shall reside in the General Law Division of the Department of Health and Human Services. FDA will notify the School General Counsel of any actual or potential claim or suit against the School, Institute, and/or FDA that names a member or employee of the School as a party or potential defendant.

h. Publication of any materials where School faculty, Fellows, Institute and/or FDA staff members participated in the development of a scientific and/or clinical project as a result of shared experience must be authorized in accordance with each Parties' Public Affairs Office.

i. The foregoing represents the broad outline of the agreements of the parties to engage in collaborative training efforts. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds and are further subject to applicable statutes and regulations. This MOU does not affect or supersede any existing or future arrangements among the parties and does not affect the ability of the parties to enter into other agreements or arrangements related to this MOU.
 
j. The parties acknowledge and agree that the Fellows shall only be provided access to non-public information as necessary to perform their official duties in accordance with this MOU and any such non-public information is shared by FDA pursuant to 21 CFR 20.85. Sensitive or nonpublic information includes but is not limited to: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7 (c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5USC 552(v)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). Such personnel shall be advised of (1) the necessity to safeguard and limit access to the information, and (2) the administrative and civil penalties for noncompliance contained in applicable federal laws. In addition, the parties agree that the Fellows will execute and abide by all requirements of the Commitment to Protect Non-Public Information (Form FDA 3398) and will provide a copy of a Confidential Financial Disclosure Report (OGE 450) to the Co-Directors of the Clinical Pharmacology Fellowship Training Program. The parties also acknowledge and agree that pursuant to section 3010) of the Food, Drug, and Cosmetic Act, 21 USC 331(j), FDA will not provide to the Fellows, and the Fellows are not authorized to have access to or disclose, any method or process that is entitled to protection as a trade secret.

IV. Eligibility Requirements:

The parties agree that they will abide by all requirements of the American Board of Clinical Pharmacology, including, but not limited to, those involving the supervision of Fellows, Fellows' work hours, and Fellows' work environment. The minimum academic and professional qualifications to enter the program are a Ph.D., MD, 0.0. or Pharm.D, degree from an accredited institution, and, for applicants with the M.D. or 0.0. degree, training, and board eligibility in a medical specialty.

V.

Fellows participating in the MOU should be United States Citizens or Permanent Residents. Regarding the latter, all federal restrictions will be adhered to.

VI. GENERAL PROVISIONS:

A. POINTS OF CONTACT (POCs): The following POCs will be used by the Parties to communicate in the implementation of this MOU. Each Party may change its POC upon reasonable notice to the other Party.

1. For the Institute-

a. Chief of Clinical Pharmacology, Experimental Therapeutics, Clinical Pharmacology Department, 301-319-9418.

b. Support Agreements Manager, Resource Management, 301-319-3116.

2. For the School-

a. COL David Saunders, Director, Division of Clinical Pharmacology, Department of Medicine, david.saunders@usuhs.edu, 301-295-0016

3. For the FDA-

a. Shiew-Mei Huang, PhD Deputy Director, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA; 240-401-0739; ShiewMei.Huang@fda.hhs.gov

b. Padmaja Mummaneni, PhD, Consumer Safety Officer, Clinical Pharmacogeneticist Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA; 301-796-2027; Padmaja.Mummaneni@fda.hhs.gov

B. CORRESPONDENCE: All correspondence to be sent and notices to be given pursuant to this MOU will be addressed to-

1. For the Institute: 503 Robert Grant Ave Silver Spring MD 20910

2. For the School: Jennifer Stecklein, Department of Finance and Manpower, 4301 Jones Bridge Road, A1040C, Bethesda, MD 20814-4799, jennifer.stecklein@usuhs.edu, with a copy to agreements@usuhs.edu.

3. For FDA: Shaniece Bowens, PMP, Project Manager, Strategic Partnership & Technology Transfer (SPT2), Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD-20993, Office Phone: 240-402-7923, Shaniece.Bowens@fda.hhs.gov with a copy to Padmaja.Mummaneni@fda.hhs.gov

or as may from time to time otherwise be directed by the Parties.

C. FUNDS AND MANPOWER. This MOU neither documents nor provides for the exchange of funds or manpower between the Parties, nor does it make any commitment of funds or resources. No provision in this MOU will be interpreted to require obligation or payment of funds.

D. MODIFICATION OF MOU. This MOU may only be modified by the written agreement of the Parties, duly signed by their authorized representatives. This MOU will be reviewed no less often than at the mid-point of its term and around the anniversary of its effective date in its entirety.

E. DISPUTES. Any disputes relating to this MOU will, subject to any applicable law,
 
Executive order, or DoD issuances, be resolved by consultation between the Parties.

F. TERMINATION OF UNDERSTANDING. This MOU may be terminated in writing at will by either Party.

G. TRANSFERABILITY. This MOU is not transferable except with the written consent of the Parties.

H. ENTIRE UNDERSTANDING. It is expressly understood and agreed that this MOU embodies the entire understanding between the Parties regarding the MOU's subject matter, thereby superseding all prior understandings of the Parties with respect to such subject matter.

I. EFFECTIVE DATE. This MOU takes effect upon last signature date.

J. EXPIRATION DATE. This Agreement expires on [01 July 2032].

K. NO THIRD PARTY BENEFICIARIES: Nothing in this MOU, express or implied, is intended to give to, or will be construed to confer upon, any person not a party any remedy or claim under or by reason of this MOU and this MOU will be for the sole and exclusive benefit of the Parties.

L. There shall be no discrimination against any individual engaged in the work covered by this agreement because of race, creed, color, national origin, sexual orientation, ancestry, age, or disability to the extent that Federal laws prohibiting such discrimination apply to the Institute, School and FDA.

VII. INFORMATION ASSURANCE AND DATA MANAGEMENT: 

The parties to this agreement acknowledge the importance of maintaining information security and managing the data exchanged hereunder in compliance with all applicable legal authorities. The parties additionally acknowledge that the information exchanged under this agreement is to be afforded the highest degree of protection practicable. In light of these acknowledgments, the parties agree to the terms below.

a. Data shared under this agreement will include Personal Identifying Information (PII). This data will be retained for the duration of this Agreement, or the period of performance specified on any applicable agreement. Non-PII data will be shared in the following ways: e-mail, electronic file transfer, data stored on portable storage devices, and hard copy. PII data will be managed according to section 5.5.

b. Both parties are responsible for ensuring that their personnel handling the data described above satisfy all necessary training requirements and obtain any requisite clearances to handle said data. Where possible, individuals handling the data for each party must have an obligation as either a Federal employee, Federal contractor or by another stand-alone duty not to disclose this data outside the channels described in this agreement. If there will be any individuals lacking such a duty of confidentiality, that individual must sign a non-disclosure agreement (NOA) before handling the data. NDAs must be furnished to the signatories before any data may be exchanged.

c. Both parties are responsible for ensuring that any data shared is both transmitted and stored in accordance with all applicable legal authorities. Parties will ensure that protections exist for any information system used within the scope of this agreement.

d. Data destruction will be conducted in accordance with applicable legal authorities. Each party to this Agreement is responsible for the destruction of the data in its possession. Any publication or public release of data requires review and approval by both signatories of this agreement, by the respective Public Affairs Office (PAO) and Operational Security before being released.

e. PII Data Management: Under no circumstances will PII (SSN, DOB, etc.) be sent through unencrypted means. Collection of PHI is not authorized under this Agreement. Data transferred between parties will be shared utilizing DoD SAFE or other encrypted, DoD approved systems. Parties will limit the creation, collection, use, processing, storage, maintenance, dissemination, and disclosure of personally identifiable information (PII) maintained to that which is legally authorized, relevant, and reasonably deemed necessary to accomplish a DoD function. Sufficient safeguards will be utilized when sharing PII with other federal and non-federal agencies or entities (including the selection and implementation of particular security and privacy controls) that govern the creation, collection, use, processing, storage, maintenance, dissemination, disclosure, and disposal of the PII. Any change in the electronic collection, use, or storage of data will require a reassessment of this agreement.

VIII. PERSONNEL: 

Each Party is responsible for all costs of its personnel, including; pay and benefits, support, and travel. Each Party is responsible for supervision and management of its personnel.

IX. APROVED:

For WRAIR:

/s/
COL Eli Lozano
COL, MS
Commanding
Date: 01/09/2024
 
For USU:

/s/
Jonathan Woodson, MD, MSS, FACS
Date: 02/05/2024

For FDA:

/s/
Patrizia Cavazzoni, M.D.,
Director Center for Drug Evaluation and Research (CDER)
Date: 12/13/2023

Mid-Point Review Due Date: _

Mid-Point Review completed by: _