Memorandum of Understanding Between the United States Army Medical Research And Materiel Command (USAMRMC) And United States Food And Drug Administration (FDA)
The purpose of this Memorandum of Understanding (MOU) is to establish a training program in the form of an inter-agency detail between the Food and Drug Administration (FDA) and the Unit ed States Army Medical Research and Materiel Command (USAMRMC) (referred to individually as the "Party" and collectively as the "Parties") to support their shared interests in the training of scientific and medical personnel in medical product development and FDA's regulatory processes. Candidate detailees will be selected by USAMRMC and approved by FDA. The experience gained by the selected detailee through this inter-agency detail will benefit the parties by strengthening future USAMRMC medical product and medical countermeasure submissions and improving regulatory interactions between the parties. Through this program the parties will be better equipped to facilitate the development, availability, and approval of safe and effective medical products.
1. FDA has authority to enter into this agreement pursuant to sections 1003(b) and (c) of the Federal Food, Drug, and Cosmetic (FD&C Act) (21 Unit ed States Code (U.S.C) 393(b) and (c)).
2. USAMRMC has authority to enter into agreements to train its military and civilian employees through details, fellowships, rotational assignments, and on exchange tours for training from other federal agencies. Department of Defense Instruction (DODI) 4000.19 Support Agreements (April 25, 2013); Department of Defense Directive 1322.18 Military Training (January 13, 2009); DODI 1400.25 Chapter 410 Department of Defense (DoD) Civilian Personnel Management System: Training, Education, and Professional Development (September 13, 2013); DODI 1322 .16 Fellowships, Legislative Fellowships, Internships, Scholarships, Training-With-Industry, and Grants Provided to DoD or DoD Personnel for Education and Training (October 12, 2016); DODI 1000.17 Detail of DoD Personnel to Duty Outside the Department of Defense (October 30, 2013).
1. FDA is authorized to enforce 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, biologics, veterinary products, medical devices, and radiological products and the safety and security of foods, dietary supplements, and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within USAMRMC will greatly contribute to FDA's mission.
2. The mission of USAMRMC is to responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter. USAMRMC provides medical knowledge and materiel life-cycle management to protect, treat, and optimize Warfighter health and performance across the full spectrum of operations. USAMRMC provides research and development in a variety of areas, including infectious diseases, combat casualty care, operational medicine, regenerative medicine and chemical and biological defense. The medical, chemical, and biological research at USAMRMC supports the mission of the DoD Chemical and Biological Defense Program (CBDP) to provide chemical and biological defense capabilities in support of national military strategies. USAMRM C also holds the Army's primary responsibility for developing medical solutions for infectious disease threats and shares responsibility for the development of countermeasures against chemical and biological warfare agents. A major part of the USAMRMC mission is to develop drugs, vaccines, and devices from early discovery and development stages to regulatory approval and marketing. As such, the Army needs personnel trained and experienced in the scientific and regulatory aspects of medical product development which would be facilitated by the training and experience gained at FDA.
IV. Substance of Agreement:
1. Description of research, training, and educational activities
Detailees will complete required training where applicable and participate in regulatory review activities. Each detailee will have an FDA Mentor. FDA Mentors and detailees should jointly submit a training plan outlining both training and regulatory review activities planned for the detailees to FDA Program Manager within the Office of the Chief Scientist. Additionally, in consultation with the detaliees , FDA Mentors should develop a list of appropriate internal and external courses and training opportunities for inclusion in the detailees training plan. Detailees will attend FDA Orientation to include FDA 101, Computer Security Training, and Ethics Training.
At the conclusion of the program, detailees will schedule an exit interview with their FDA Mentors and FDA Program Manager. A summary of topics discussed during these interviews, with emphasis on feedback regarding the perceived impact of the program on both the detailees and FDA Mentor, and describing both successful areas and areas in need of improvement, should be sent to the FDA Program Manager and USAMRMC Program Manager within six (6) weeks of the program completion.
2. Roles and Responsibilities of the Partner(s)
A. FDA agrees to:
1. Advise the detailees of their obligation to comply with all applicable FDA rules, policies and regulations including but not limit ed to those related to conflict of interest, the handling of proprietary and/or non- public information, and timekeeping policies;
2. Provide an up to one (1) -year, non-reimbursable, detail to help perform medical product reviews within a medical product Center (Center for Biologics Evaluation and Research (CSER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH} or function as a Project Officer within the CDER as par t of an interdisciplinary scientific review team. In addition, a detailee may perform duties as assigned with the Office of the Chief Scientist, however, such duties will not include involvement in any enforcement activities;
3. Provide building access, adequate office materials to include, desk, computer, network connectivity, Blackberry (if applicable), badge and general office supplies;
4. Provide the use of FDA equipment, as necessary, for the regular performance of the review duties including, when feasible, the use of FDA library, study areas, office space, and cafeteria facilities;
5. Advise the USAMRMC Program Manager of incidents that call into question, in a material way, the abilities, ethical standards or professional judgment of the det ailee;
6. Designate a FDA Program Manager responsible for the coordination and administrative aspects of the detailee' s position;
7. Designate a FDA Mentor responsible for ensuring that the appropriate supporting documentation and approvals are secured, as well as assigning and supervising the work of the detailee during the detail;
8. Evaluate the performance of the detailee at the mid-point and program conclusion and make the completed evaluation forms available upon request by the USAMRMC Program Manager.
B. USAMRMC agrees to:
1. Provide qualified candidates to FDA for consideration:
i. For a position of Project Officer within the CDER, an advanced degree (e.g., Masters, Doctorate) in a Health Science;
ii. For a position of Engineer in the CDRH, an advanced degree (e.g., Masters, Doctorate) in Health Science or Engineering is preferred; but a Bachelor of Science in Engineer ing will be also be considered;
iii. For any other position, a Doctorate in a Health Science.
2. Provide an application package to include the candidate detailee' s Curriculum Vitae, a recommendation by the current supervisor, most recent performance rating of record, and a statement of interest from the candidate;
3. Maintain overall supervisory responsibility for detailee;
4. Maintain timekeeping responsibility for detailee;
5. Conduct final assessment of detailee's training with FDA;
6. Provide Worker's Compensation coverage for detailee participating in the training program;
7. Maintain and advise assigned detailee to maintain the confidentiality of all proprietary and/or non-public information (as discussed in section V subsection 5 below); and
8. Maintain salary, support, travel, and benefits for the detailee while detailed to FDA.
9. Require personnel to meet and maintain force readiness posture. The Program Manager or designee will help ensure personnel remain available for exercise or deployment.
10. Maintain the right to recall detailees from FDA based upon mission and deployment readiness needs, and will notify FDA of the reassignment at least sixty (60) days prior to movement.
V. General Provisions:
1. Conflict of Interest:
Participants in activities under this MOU will be expected to abide by conflict of interest rules and policies as specified by FDA. This may require participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and/or have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so conflicting assignments can be avoided consistent with Department of Health and Human Services/FDA requirements. If before, or during, the performance of the activities under the MOU, the detailee believes that a potential or actual conflict exists, he or she must notify the appropriate authorities within USAMRMC, their FDA mentor, and contact the designated FDA official listed on the MOU so the necessary action(s) can be undertaken. A determination will be made by FDA on whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. The parties to the MOU shall avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions. Additionally, the FDA mentor will help ensure that the detailee does not participate in the review of any USAMRMC product submission while on detail at FDA.
A. Exchange of Funds: None of the activities outlined in this MOU currently require the exchange of funds between the parties. In the event the transfer of funds is required in the future, the parties may enter an interagency agreement by Section 601 of the Economy Act of 1932, as amended (31
B. Liability: While detailed to the program and while performing duties pursuant to this memorandum, FDA employees perform duties within the course and scope of the Federal employment. Consequently, the provisions of the Federal Tort Claims Act (28 U.S.C. 1346(b), 2671- 2680), including its defenses and immunities, will apply to allegations of negligence or wrongful acts or omissions by FDA employees while they are acting within the scope of their duties by this MOU.
Detailees will not be permitted to serve on FDA advisory panels reviewing a product for which they provided consultative or review services. Detailees will also agree that they will be disqualified from any FDA decisions regarding approval of products that result directly from activities conducted under this MOU. The statutory provisions about former and post federal employment restrictions will apply to the participants in this program.
4. Citizenship and Security Clearance:
Detailee participating in the MOU will be United States citizens or permanent residents (security clearances for permanent residents shall be current and valid for the entire year of the detail). Regarding the permanent residents, all federal restrictions will be adhered to. Information may be obtained from participants by the agency for security clearance or access to FDA facilities and offices.
Information obtained may be shared with other Federal agencies for the above purposes and in fulfillment of official responsibilities as disclosure is permitted by law.
5. Protection of Nonpublic Information:
A. Detailees will be required to signa Commitment to Protect Non-public Information agreement (FDA Form 2096, included in Attachment B). When access to proprietary and/or non-public information in the files of FDA is required in performing official duties, the detailee will agree and certify in writing that they shall not further release, publish, or disclose such information and that they shall prot ect such information by the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentialit y of proprietary and/or non-public information.
B. No data will be exchanged under this Agreement. If, at any point, the parties amend this agreement in a manner that would require the exchange of data, that amendment must address how the parties will ensure information security and data management. Any public release related to this agreement requires review and approval by both signatories of this agreement and by the appropriate Public Affairs and Security Offices before being issued.
6. Intellectual Property Guidelines:
"Invention" refers to any subject matter or discovery patentable under Title 35 of the U.S.C. and conceived or first reduced to practice under the activities of this MOU. "Intellectual Property" refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of this MOU. Rights to Inventions or Intellectual Property developed under this MOU will be addressed in separate project-specific development and
Implementation agreements among the parties. lnventorship will be governed by United States law. In the case of sole inventorship, ownership will be governed by the policies of the employer of the Invention. In the case of joint lnventorship, ownership of Inventions will be jointly owned.
Inventions made under a Federal grant or contract will be subject to the Bayh-Dole Act. Accordingly, employees who work on any project under this MOU shall be required to sign an agreement that effects a present assignment of their future inventions. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party.
VI. Resource Obligations:
This MOU represents the broad outline of the parties' present intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to parties. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU supersedes the MOU between USAMRMC and FDA, effective February 14, 2009. This MOU does not affect or supersede any other existing or future agreements or arrangements between the parties. This MOU does not create binding, enforceable obligations against either party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the parties operate.
VI. Program Managers:
Individual's name: CPT Armand L. Balboni
Organization: United States Army Medical and Materiel Development Activity
Title: Deputy Director, Division of Regulated Activities and Compliance
Address: 1430 Veterans Drive, Fort Detrick, MD 21702
Telephone Number: 301-619-8049
Individual's name: MAJ Mara Kreishman-Deitrick, Ph.D.
Organization: Walter Reed Army Institute of Research
Title: Associate Director for Drug Development and Deputy Director Experimental Therapeutics Branch, Military Malaria Research Program (MMRP)
Address: 503 Robert Grant Avenue, Rm 2A04, Silver Spring, MD 20910 Telephone Number: 301-319-7420
Individual's name: CDR Anthony Garza
Organization: Office of Counterterrorism and Emerging Threats, Office of Chief Scientist, Office of the Commissioner
Title: Senior Program Manager
Address: 10903 New Hampshire Ave., Silver Spring, MD 20993
Telephone Number: 301-796-8247
Each party may designate new liaisons at any time by notifying the others party'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 party will name a new liaison within two (2) weeks and notify the other party through the designated administrative liaison.
VIII. Terms, Termination, and Modification:
1. Effective Date:This MOU becomes effective upon the entry of the parties' final signatures and shall remain in effect until 30 September 2026.
2. Review of Agreement: The parties jointly agree to review the terms and conditions of t his MOU at the end of the first year and every 3 subsequent years from the effective date or earlier if requested by any party.
3. Modification/Termination of Agreement: This agreement may be modified or terminated by mutual written consent by the parties' program managers or may be terminated by either party program managers upon a ninety (90) day advance written notice to the other.
4. Disputes: Any disputes relating to this MOU will be resolved by consultation between the parties.
Approved and accepted for FDA
Carmen T. Maher
Rear Admiral, US Public Health Service
Acting Assistant Commissioner for
Acting Director, Office of Counterterrorism and Emerging Threats
Approved and accepted for USAMRMC
Barbara R. Holcomb
Major General, US Army