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  1. FDA Memoranda of Understanding

MOU 225-12-0023

MOU 225-12-0023

 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
MEMORANDUM OF UNDERSTANDING
between the
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
NATIONAL INSTITUTES OF HEALTH
and the CENTER FOR DRUG EVALUATION AND RESEARCH
UNITED STATES FOOD AND DRUG ADMINISTRATION
 
HL-13-23
 
I.      PURPOSE
 
This Memorandum of Understanding (MOU) is entered into by and between the United States Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) (collectively the Parties). The purpose of this Collaboration is for the FDA/CDER to offer assistance to the NIH Centers for Accelerated Innovations (NCAI) grantees intending to develop drugs for commercialization with regulatory guidance on technology development. Each party, operating under its own authority, intends to have specific roles in promoting this shared interest. This MOU provides a framework for coordination and collaborative efforts between the parties to maintain and enhance agency effectiveness while avoiding duplication of efforts to achieve this common goal. It also provides the principles and procedures by which the parties intend to manage and share expertise and information in order to increase interagency collaboration. 
 
II.      AUTHORITY
 
The FDA has authority to enter into this MOU pursuant to sections 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act. The NIH has authority to enter into this MOU pursuant to sections 301 and 402 of the Public Health Service Act.
 
III.      BACKGROUND
 
Cardiovascular and lung diseases account for 3 of the 4 leading causes of death, 4 of the 10 leading causes of infant death, $382 billion in health care dollars per year, and 22% of the total economic costs of illness, injuries, and death in the United States. Over twenty-three million blood transfusions are performed each year in the United States at the cost of approximately $10 billion dollars. Although NIH investments in biomedical research amounting to billions of dollars a year have led to great advances in scientific tools and biological insights, numerous barriers often inhibit their translation into commercial products that benefit the American public. They include (1) a gap in funding on a national level between support for basic research discoveries and the scientific proof of feasibility or validation studies that are required for early stage technology development; (2) a lack of knowledge and understanding by investigators about how new technologies are brought to market; and (3) a lack in many Technology Transfer/Licensing Offices (TTO) of sufficient levels of the technology development and commercialization resources that are required for early stage technology development. A new approach is required to enable early stage collaboration among academia, government, non-profit organizations, and industry to de-risk the translation of academic discoveries so that the private sector will be willing to proceed with the further steps that are needed for commercial development.
 
IV.      SCOPE
 
NHLBI and CDER intend to collaborate on alleviating barriers that often inhibit biomedical research translation into commercial products that benefit the American public. NHLBI and CDER intend to assume their respective roles and responsibilities as follows:
 
1.       CDER will:
 
a.       Offer regulatory guidance and resources, including educational services, training and mentorship (as feasible depending on the number of applicants, type of assistance, and method of assistance delivery) to NCAI grantees in an effort to help facilitate the commercialization process in a manner that is generally not greater than that otherwise routinely provided to regulated entities by FDA;
 
b.      Serve, in an advisory capacity, on the NCAI Program Steering Committee and on the NHLBI Technology Review Committee.
 
2.       The NCAI will:
 
a.       Solicit and select promising emerging technologies (e.g., drugs, therapeutics, biologics, preventatives, diagnostics, devices, tools), and facilitate their translation to commercialized products that can improve patient care and enhance health;
 
b.      Nurture the development of high priority early-stage technologies within the NHLBI’s mission in a manner consistent with business case development and regulatory requirements by offering:
1.       Funding for product definition studies (e.g., feasibility studies, prototype development, or proof-of-concept studies).
2.       Unified and coordinated access to expertise in areas required for early technology development, including scientific, regulatory, reimbursement, business, legal, and project management.
3.       Training and hands-on experience in entrepreneurism.
 
Establishing public – private partnerships and leveraging non-federal resources will be critical for the success of the NCAI. 
 
The NHLBI will administer all NCAI grants. No funds will be transferred between the Parties under this MOU. 
 
V.      OTHER PROVISIONS
 
Nothing in this MOU is intended to conflict with law, regulation, executive order or presidential directive, or the legislative mandates, regulations, or policies of the Department of Health and Human Services (DHHS). If a term of this MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions of this MOU shall remain in full force and effect. This MOU shall be interpreted and implemented in a manner that respects and complies with (and does not abrogate) the statutory and regulatory responsibilities of each agency.
 
VI.      DATA SHARING GUIDELINES
 
As public health agencies within DHHS, there are no legal prohibitions that preclude FDA/CDER or NHLBI from sharing with each other most information in the possession of either agency. Both parties recognize and acknowledge, however, that all non-public information shared between FDA and NHLBI whether in writing or orally, must be protected from any disclosure not authorized by law or regulation. See, e.g., 18 U.S.C. § 1905; 5 U.S.C. 552; 5 U.S.C. § 552a; 21 U.S.C. § 331(j); 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 42 CFR Parts 5 and 5b. Safeguards are needed to protect shared non-public information, such as trade secrets and confidential commercial information; identities of study participants and other personal privacy information; privileged and/or pre-decisional agency information; research proposals, progress reports, and/or unpublished data; or national security information. Such safeguards also help ensure compliance by FDA and NHLBI with applicable laws and regulations. 
 
To facilitate the sharing of non-public information, FDA/CDER and NHLBI will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information received. Both parties are committed to responding to requests for information in a complete and timely manner, consistent with budgetary and resource constraints, and to the extent permitted by law, regulation, and agency policy and practice. The party receiving shared non-public information (requesting party) will be responsible for protecting that information from any unauthorized disclosure. 
 
Provisions for sharing of non-public information in accordance with applicable statutes, regulations, or policies are set out below:
 
The requesting party will comply with the following conditions: 
 
a.       The requesting party will limit the dissemination of shared non-public information it receives to internal unit offices and/or employees that have been identified in its written request. If the requesting party determines that employees other than those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied to the sharing party before the requesting party distributes the information to those employees. The unit official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
 
b.      The requesting party will agree in writing, by using the model request letter attached (Attachments A1 and A2) (or a reasonable, mutually agreed upon variation), not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings. If the requesting party wishes to disclose shared information that the sharing party has designated as non-public, the requesting party will ask the sharing party whether the information’s non-public status has changed, and if so, will first obtain written confirmation and permission from the sharing party before disclosing that information. If the requesting party receives a Freedom of Information Act (FOIA) request for shared information, the requesting party will: (a) refer the FOIA request to the information-sharing contact person or designee for the sharing party to respond directly to the FOIA requester regarding the releaseability of the information, and (b) notify the FOIA requester of the referral and that a response will issue directly from the sharing party. The requesting party will leave all final disclosure decisions up to the sharing party, including decisions on whether the records are responsive and whether they must be disclosed. Accordingly, the requesting party will not indicate to the FOIA requester whether the sharing party has responsive records or releasable records. If either Party receives a FOIA request for information that combines information originating from both the sharing Party and the requesting Party, the Party shall refer the FOIA request to the Public Health Service Freedom of Information Officer.
 
c.       The sharing party will include a transmittal letter along with any agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). Model transmittal letters are attached (Attachments A3 and A4). The shared documents containing non-public information should be stamped “Do not disclose without permission of [FDA or NHLBI]”, with the name in the brackets being that of the sharing party. 
 
d.      The requesting party will promptly notify the contact person or designee of the sharing party of any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.
 
e.      The requesting party will notify the sharing party before complying with any judicial order that compels the release of shared non-public information, so that the parties may determine the appropriate measures to take, including, where appropriate, legal action.
 
VII.   RESOURCE OBLIGATIONS
 
This MOU represents the broad outline of the parties’ intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA/CDER and NHLBI. All activities undertaken pursuant to 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 Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NHLBI operate.
 
 
VIII.  TERMINATION AND MODIFICATION
 
This MOU becomes effective following the signature of both parties and remains effective until December 31, 2019. It may be modified by mutual consent of the parties. The MOU may be terminated by either party upon a 90-day advance written notice to the other. At the time of this MOU’s expiration, the parties may consider the extension of this MOU or the development of a new MOU as needed.   The parties will review this MOU within three years from the effective date to determine whether it should be revised, renewed, or canceled.
 
IX.    AGENCY CONTACTS
 
FDA (CDER) Point of Contact:
Norman Stockbridge, MD, PhD
Director, Division of Cardiovascular and Renal Products
301-796-2240
 
NHLBI Point of Contact:
              Jodi Black, PhD
Deputy Director, Division of Extramural Research Activities
301-435-0260
 


X.     APPROVAL
 
 
John Jenkins, MD                                                        Stephen C. Mockrin, Ph.D
Director, Office of New Drugs                                    Director, Division of Extramural Research
FDA/CDER                                                                 NHLBI
 
February 16, 2015                                                       November 12, 2014                                      
 
                                                                                     Gary H. Gibbons, MD
                                                                                     Director
                                                                                     NHLBI
 
                                                                                     December 9, 2014