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MOU 225-16-018

MEMORANDUM OF UNDERSTANDING
AMONG THE FOOD AND DRUG ADMINISTRATION
AND THE NATIONAL INSTITUTES OF HEALTH
AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION
AND THE OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND
RESPONSE I BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY FOR DEVELOPMENT OF INNOVATIVE TECHNOLOGIES TO IDENTIFY
ANTIMICROBIAL-RESISTANT BACTERIA
 
I.                 PURPOSE
 
This Memorandum of Understanding (MOU) among the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Office of the Assistant Secretary for Preparedness and ResponseIBiomedical Advanced Research and Development Authority (BARD A), and the Centers for Disease Control and Prevention (CDC) provides a framework for coordination and collaborative efforts to spur innovation in the development of diagnostic devices that would be of great clinical and public health utility in combating the development and spread of bacteria that are resistant to antimicrobial drugs. NIH, BARDA, FDA, and CDC are sometimes referred to herein individually as a "party" and together as the "parties."
 
II. BACKGROUND
 
Antimicrobial resistance (AMR) has been identified as an increasingly serious threat to global public health. AMR is resistance of a microorganism to an antimicrobial drug that was previously effective, making standard treatments ineffective. The use and misuse of antimicrobial drugs accelerates the emergence of drug-resistant strains.
The global public health community has prioritized the goal of addressing the AMR threat  1] and the U.S. has made addressing this threat a priority. In April2014, The President's Council of Advisors on Science and Technology (PCAST) held a public meeting on AMR and has prepared a major report on the problem.2 The Department of Health and Human Services' public health agencies, including CDC, FDA, BARD A, and NIH, have made addressing the AMR threat a priority.
 
NIH is the lead agency within HHS for conducting and supporting early biomedical research relating to mechanisms, diagnosis, treatment, control, and prevention of AMR.
 
BARDA is an office within the Office of the Secretary of HHS that supports the advanced research and development and procurement of needed medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical counter measures, against a broad array of public health threats, whether natural or intentional in origin, including AMR.FDA is charged with assuring the safety, effectiveness, and security of medical products, including vaccines and other biologics, drugs and devices, and plays a vital regulatory role in product development and post-market surveillance. The FDA has a role in preventing and alleviating shortages primarily of medically necessary products since these can have public health consequences. In addition, FDA's regulatory science program is actively engaged in exploring solutions to complex scientific regulatory problems and in identifying situations inwhich the application of new science could simplify or speed product development and/or the regulatory process.
 
CDC is the lead agency in HHS for tracking antimicrobial resistance, preventing antimicrobial resistant infections, and improving antibiotic use.
 
Executive Order 13676, [3] "Combating Antibiotic-Resistant Bacteria," issued on September 18, 2014, identifies the need for rapid, point of care diagnostic tests capable of identifying AMR microorganisms. Such diagnostic tests will allow for the timely, appropriate treatment of patients, and mitigate the misuse of antimicrobial drugs, and/or facilitate the enrollment of subjects in clinical trials to test new antimicrobial drugs.
 
Toward this end, NIH through the National Institute of Allergy and Infectious Diseases and BARDA are planning to co-sponsor a prize contest designed to spur development of AMR diagnostic tests that would be of great utility in combating the development and spread of antibiotic-resistant bacterial infections (the Contest) and, through that Contest, to award a monetary prize in connection with the development of one or more diagnostic(s) that meet predefined award criteria (the Award). This means, among other things, that NIH and BARDA intend to share responsibilities for drafting and publishing the Contest notice in the Federal Register; for implementing and running the Contest; and for selecting and awarding Contest winners.
 
FDA and CDC, through the National Center for Emerging and Zoonotic Infectious Diseases, are collaborating with NIH and BARDA to support this effort as more fully described below.
 
II.               AUTHORITY
 
FDA has authority to enter into this agreement pursuant to section 11003(b) and (c) of the Federal Food, Drug, and Cosmetic Act. NIH has authority to enter into this agreement pursuant to sections 301 and 402 of the Pub1ic Health Service (PHS) Act. BARDA has authority to enter into this agreement pursuant to sections 301 and 319L of the PHS Act. CDC has authority to enter into this agreement pursuant to section 301 of the PHS Act.
 
NIH and BARDA intend to co-sponsor the Contest and fund the Award pursuant to and in accordance with the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, codified at 15 USC section 3719.
 
 
III.              PROPOSED EFFORT/OBJECTIVES
 
NIH, BARDA, FDA, and CDC intend to collaborate and coordinate efforts to spur development of AMR diagnostic tests that would be of great utility in combating the development and spread of antibiotic-resistant bacterial infections. To that end, this MOU delineates the roles and responsibilities of FDA, NIH, BARD A, and CDC for:
 
• Meeting the common needs for the development and innovation of technologies to combat AMR infections;
 
• Spurring innovation toward the development of one or more accurate, affordable, rapid diagnostic tests to identify bacteria that cause certain infections resistant to antimicrobial drugs at the point-of-care; and
 
• Sharing certain nonpublic information.
 
V. WORKPLAN AND RESPONSIBILITIES
 
In support of their efforts to develop and run the Contest, NIH and BARDA intend that the collaboration established by this MOU will support and inform the following goals:
 
• Defining the requirements and eligibility criteria, including the ideal diagnostic characteristics, for the Award;
 
• Establishing a process for receiving, reviewing, and determining the eligibility of Contest proposals; and
 
• Establishing a process to evaluate and adjudicate eligible Contest proposals. To that end, FDA will, among other things:
 
• Help define the requirements, eligibility, evaluation/judging criteria, including the ideal diagnostic test characteristics for the A ward;
 
• Share with the other parties hereto general information about diagnostics known to be in development and considered by FDA to be relevant and contributory to the proposed objectives;
 
• Participate in the initial announcement and public relations campaign, which will recognize FDA as a supporting participant while also making clear the limitations of FDA's involvement;
 
• Provide advice on the evidence necessary to meet FDA standards generally; and
 
• Assist in the establishment of a process for evaluating proposals for the A ward.
 
To that end, CDC will, among other things:
 
• Help define the requirements, eligibility, evaluation/judging criteria, including the ideal diagnostic test characteristics for the A ward;
 
• Assist in defining the requirements and eligibility criteria, including the ideal diagnostic characteristics, for the A ward, and in so doing, will share with the other parties hereto general information about diagnostics known to be in development;
 
• Assist in establishing a process for receiving, reviewing, and determining the eligibility; and
 
• Assist in evaluation of applications and providing of feedback to applicants.
 
The parties agree that FDA will have no role in selecting the winner(s) and shall be insulated from the decision-making process regarding individual submissions for the A ward including, but not limited to, decisions relating to the selection of the winning submission(s).
 
The parties further agree that nothing in this MOU prohibits FDA from engaging with contestants (e.g., researchers, investigators, manufacturers, sponsors) in a manner that is consistent with FDA's regulatory authority and ordinary practice. Accordingly, should a individual Award contestant seek feedback from FDA, such as a request to review device design and study protocols, such feedback can be provided under FDA's established procedures and practices for providing such advice.
 
VI. GENERAL PROVISIONS
 
This is an internal Government agreement among FDA, NIH, BARDA, and CDC and does not confer any rights or benefits to any person or party. This MOU does not include any commitment by any agency to contribute or exchange or transfer any resources~ including funds, under this MOU. FDA and CDC will not contribute financially toward the Award. This MOU does not affect or supersede any existing or future agreements or arrangements between or among the parties. This MOU and any associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the parties operate.
  1. Confidentiality:
 
FDA, NIH, BARDA, and CDC intend for the following principles and procedures to govern the sharing of nonpublic information, as resources permit, among the parties.
 
All parties recognize and acknowledge that all other nonpublic information shared between or among the parties, whether written or oral, must be protected from any further disclosures or use not authorized by law or regulation. All parties will establish safeguards to ensure that any nonpublic information shared under this MOU is protected from unauthorized disclosure or use including, but not limited to: (1) information that is classified to protect national security that
falls within the scope of Exemption 1 of the Freedom of Information Act, 5 U.S.C. § 552 (FOIA); (2) confidential commercial and trade secret information that falls within the scope of Exemption 4 of the FOIA; (3) personal privacy information that falls within the scope of Exemption 6 or 7(C) of the FOIA; and (4) privileged and/or pre-decisional agency information, research proposals, progress reports, and unpublished data, or information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., FOIA, Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act, Pub. L. 104-191). Such safeguards help ensure compliance with other applicable laws and regulations and should include the marking of any materials as "confidential" prior to disclosure or the use of encryption technologies when appropriate.
 
If records provided by any party under this agreement are the subject of a FOIA request submitted to the party that received the records, that party will refer the FOIA request and relevant records to the party that provided the records for processing. If the FOIA request seeks two or more parties' records or if the request is for records created by one party that incorporates information provided by one or both other parties, in accordance with the Department of Health and Human Services' FOIA regulations at 45 C.F.R. Part 5, the party receiving the FOIA request will forward all such requests to the respective FOIA offices for NIH, FDA, BARDA, and/or CDC for disposition.
  1. Integrity of Regulatory Decision-Making Process:
FDA participation is predicated on the parties' mutual understanding that FDA's support for the Award is consistent with the activities identified within this MOU, and that FDA must avoid even the appearance that the Award grant and decision-making process may influence FDA regulatory decision-making concerning product clearance, approval or permission to commence or conduct clinical trials. FDA employees may participate in general Award-related discussions (e.g., regarding evaluation criteria), however they will not participate in decision-making regarding individual submissions or the grant of the Award.
 
VII. POINTS OF CONTACT
 
The names of FDA, NIH, BARDA, and CDC staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Additional FDA, NIH, BARD A, and CDC staff may be drawn to provide scientific expertise as needed.
 
For FDA:
 
Luciana Borio, M.D.
Acting Chief Scientist
Food and Drug Administration
301-796-8510
Luciana.Borio@fda.hhs.gov
 
• For NIH:
 
James M. Anderson, M.D., Ph.D.
Deputy Director for Program Coordination, Planning, and Strategic Initiatives
National Institutes of Health
301 -402-9852
 
• For BARDA:
 
Robin Robinson, Ph.D.
Deputy Assistant Secretary and Director,
Biomedical Advanced Research and Development Authority
202-205-5331
 
For CDC:
 
Beth P. Bell, M.D., M.P.H.
Director, National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
404-639-3967
 
VIII. SCHEDULE/MILESTONES
 
The provisions of this MOU will be regularly reviewed by all parties and amended as necessary if and to the extent agreed upon by all parties and memorialized in a written amendment to the MOU that has been signed by an authorized representative of each party.
 
IX. SECURITY
 
It is anticipated that activities covered by this MOU will be unclassified. In the event an exchange of classified information is necessary, FDA, NIH, BARD A, and CDC will coordinate their efforts to properly safeguard the information.
 
X. EFFECTIVE DATE, DURATION, TERMINATION
 
This MOU becomes effective upon the signature of authorized representatives of all parties and will remain in effect for 5 years, unless earlier terminated.
 
This MOU may be terminated by any party, as to that party, upon 60 days written notice to the other parties. In the event of such termination, the non-terminating parties may agree to continue to perform under the MOU without the terminating party or may agree to terminate the MOU in its entirety.
 
This MOU may be terminated by any party immediately upon written notice in the event that a Federal statute is enacted or a regulation is issued that materially affects this MOU. The parties may consider the development of a new MOU as needed.
 
All parties agree to take actions under this collaboration that are consistent with existing laws and regulations, and that nothing in this MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by the parties including, but not limited, to the PHS Act and the Federal Food, Drug, and Cosmetic Act. Further, nothing contained in this MOU constitutes a mandate or a requirement that is in addition to the mandates or requirements imposed on any party by Federal statutes and regulations.
 
[1] "Antimicrobial resistance: global report on surveillance 2014," World Health Organization (April 2014). 
[2] 79 FR 26735 (May 9, 20 14); 79 FR 31109 (May 30, 20 14); "Report to the President on Combating Antibiotic Resistance," Executive Office of the President, President's Council of Advisors on Science and Technology (September 2014).
[3] Executive Order 13676, "Combating Antibiotic-Resistant Bacteria" (September 18, 2014 ).
 
XI. APPROVAL
 
James M. Anderson, M.D., Ph.D.
Deputy Director for Program Coordination, Planning, and Strategic Initiatives
National Institutes of Health
 
March 14, 2016
 
Richard Hatchett, M.D.
Office of the Assistant Secretary for Preparedness and Response
Biomedical Advanced Research and Development
 
May 19, 2016
 
Luciana Borio, M.D.
Acting Chief Scientist
Food and Drug Administration
 
November 18, 2015
 
Beth P. Bell, M.D., M.P.H.
Director, National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
 
March 11, 2016