and the  FOOD AND DRUG ADMINISTRATION

 

 

This Memorandum of Understanding (MOU) is entered into by and between the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), and the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) (collectively “the Parties”). The purpose of this MOU is to allow FDA/CDRH to offer assistance to the NIH Centers for Accelerated Innovations (NCAI) grantees with the regulatory processes involved in technology development and commercialization.

 

 

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.  The agency also is responsible for   the safety and security of foods, dietary supplements, cosmetics, products that give off electronic radiation, and for regulating tobacco products.  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 the NIH/NHLBI will greatly contribute to FDA’s mission.

NIH has authority to enter into this MOU pursuant to sections 301 and 402 of the Public Health Service Act.

 

 

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. 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.

The NCAI will (1) solicit and select promising emerging technologies (e.g., drugs, therapeutics, biologics, preventatives, diagnostics, devices, tools) and (2) facilitate their translation to commercialized products that can improve patient care and enhance health. The NCAI will nurture the development of high priority early-stage technologies within the NIH/NHLBI’s mission in a manner consistent with business case development and regulatory requirements by providing (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, and (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.

 

IV.          SCOPE

 

1.       Each Party will establish a principal point of contact to facilitate the actions carried out under this MOU.

 

2.       The Parties will work to facilitate and encourage translation from bench-top research to clinical products on the market in the United States through the Federal grant process.

 

3.       The Parties will work together to provide regulatory feedback and resources, including educational services, training, and mentorship for NCAI grantees developing medical devices for therapeutic or diagnostic purposes (as feasible depending on the number of applicants, type of assistance, and method of assistance delivery).

 

4.       FDA/CDRH will serve, in an advisory capacity, as a representative on the NCAI Program Steering Committee and the NHLBI Technology Review Committee.

 

5.       The Parties will consult with each other before issuing press or scientific releases or publications that may have a significant impact on the other.

 

6.       The Parties agree to promptly notify the relevant party of any actual or suspected unauthorized disclosure of information shared under this MOU.

 

7.       The Parties may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request.

 

8.       This MOU does not preclude the Parties from entering into other agreements, which may set forth procedures for special programs that can be handled more efficiently and expertly by other agreements.

 

9.       The NIH/NHLBI will administer all NCAI grants. No funds will be transferred between the Parties under this MOU.

 

 

Data Sharing Guidelines:

 

As sister agencies within HHS, FDA and NIH can generally share non-public information in the possession of either agency with each other. Both parties recognize and acknowledge, however, that all non-public information shared between FDA/CDRH and NIH/NHLBI, whether in writing or orally, should be protected from further disclosure without permission from the sharing agency, and that disclosing certain information, such as trade secrets and confidential commercial information, outside HHS may be prohibited by law. See, e.g., 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. §§ 331(j) and 360j(c); 42 U.S.C. § 241(d); 21 CFR parts 20 and 21; 45 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; and research proposals, progress reports, and/or unpublished data. Such safeguards also help ensure compliance by FDA/CDRH and NIH/NHLBI with applicable laws and regulations. Furthermore, neither FDA/CDRH nor NIH/NHLBI will provide any non-public information, including trade secrets and confidential commercial information, to the NCAI grantees.

 

To facilitate the sharing of non-public information, the Parties will implement procedures to ensure that such sharing is appropriate and that the recipient Party will guard the confidentiality of all non-public 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) from the other Party (Sharing Party) will be responsible for protecting that information from any unauthorized disclosure. 

 

Provisions for sharing of non-public information in accordance with applicable statutes or regulations 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 the Requesting Party will send an update to the request letter to the Sharing Party and will wait to receive the Sharing Party’s consent before distributing the information to those additional employees. The unit official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.

 

b.      Before the Sharing Party provides any non-public information, the Requesting Party will agree in writing, by using the attached model request letter (Attachment A1)(or a reasonable, mutually agreed upon variation), not to further disclose any shared non-public information, including disclosure in publications and public meetings, without prior permission from the party sharing the information, unless required by law. If the Requesting Party wishes to further disclose shared information that the Sharing Party has designated as non-public to any other party, such as other federal agencies, states, foreign governments, or the 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. 

 

c.       If the Requesting Party receives a Freedom of Information Act (FOIA) request for shared information, the Requesting Party will: (a) if the request implicates documents from the Sharing Party in their original form, refer the FOIA request to the information-sharing contact person or designee for the Sharing Party to respond directly to the FOIA requester, and notify the FOIA requester of the referral and that a response will issue directly from the Sharing Party; or (b) if the request implicates documents authored by the Requesting Party that incorporate information from shared documents, consult with the Sharing Party about how to respond to the FOIA request through the information-sharing contact person or designee for the Sharing Party. The Requesting Party will not indicate to the FOIA requester whether the Sharing Party has responsive records or releasable records. 

 

d.      The Sharing Party will include a transmittal letter along with any information shared. The transmittal letter will indicate the type of non-public information contained in the shared materials (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter is attached (Attachment A2). The shared documents containing non-public information should be stamped with “This document contains non-public information. Do not disclose without permission of [Sharing agency].” 

 

e.      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, Congressional request, judicial order, subpoena, or discovery request.

 

f.        The Parties agree to promptly notify each other of any actual or suspected unauthorized disclosure of information under this MOU

 

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/CDRH and NIH/NHLBI. All activities undertaken pursuant to this 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 between the Parties and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable statutes, rules, regulations, or policies under which FDA and NIH operate.

 

 

Murray Sheldon, MD

Associate Director for Technology and Innovation

FDA, Center for Devices and Radiological Health

WO66-5438

10903 New Hampshire Avenue

Silver Spring, MD 20993

301-796-5443

 

Jodi Black, PhD

Deputy Director, Division of Extramural Research Activities

NIH, National Heart Lung and Blood Institute

6701 Rockledge Drive, Room 7104

Bethesda, MD 20892-7924 (express mail zip:  20817)

301-496-5861

 

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

 

 

This agreement, when accepted by the Parties, will have an effective period of performance from the date of the latest signature until December 31, 2019 and may be modified or terminated by mutual written consent of the Parties or may be terminated by either Party upon a thirty day advance written notice to the other.

 

 

 

Attachment A1 -- Model Language for Information Sharing Request from Participating Partner(s)

 

MOU Control No. (Insert number)

 

Process for Information Sharing

 

Pursuant to Section IV of the Memorandum of Understanding (MOU) entered into by the Food and Drug Administration (FDA) and the National Heart, Lung, and Blood Institute (NHLBI), any Federal partner “may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request.” Nothing in the process described below changes Section IV.

 

When, under the current MOU, staff at FDA or NHLBI request for the other agency information that may contain confidential material, the request should be in writing, which includes an informal email, and need only identify the subject for which information is requested. Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:

 

“Information that is shared under this request will be under the FDA-NHLBI Memorandum of Understanding. We agree not to disclose any shared information in any manner without your written permission or as required by law with advance notice to the originating agency.” With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.

 

A response to a request should also be in writing and can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful, it would not be required for purposes of responding to a request. However, the following language should be included in the response:

 

“Pursuant to the FDA-NHLBI Memorandum of Understanding, this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner without our express written consent or as required by law with advance notice to the originating agency.” With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.
 

 

Attachment A2 -- Model Transmittal Letter for Information Sharing Request from NIH/NHLBI to FDA/CDRH

 

MOU Control No. (Insert number)

 

This letter accompanies agency records that the National Institutes of Health, National Heart, Lung, and Blood Institute (NIH/NHLBI) is sharing with the Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) in response to FDA/CDRH’s request, dated ________. These agency records contain one or more of the following categories of nonpublic information, which include information the public disclosure of which may be prohibited by law.

 

[NIH/NHLBI checks applicable items below]

 

____     Trade secrets;

____     Confidential commercial or financial information;

____     Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;

____     Information contained in records subject to the Privacy Act;

____     Information contained in inter-agency or intra-agency memoranda (including information protected by the deliberative process,

____     Records or information compiled for law enforcement purposes; or

____     Other.

 

FDA/CDRH shall notify the appropriate office of the information-sharing agency if there are any attempts to obtain such shared non-public information by compulsory process, including, but not limited to, Freedom of Information Act requests, Congressional requests, judicial orders, subpoenas, discovery requests, and litigation complaints or motions.

 

FDA/CDRH has agreed, by this letter or e-mail and by a signed request letter dated ___________________, not to disclose the above-described shared non-public information without prior written permission of NIH/NHLBI. FDA/CDRH acknowledges that applicable laws and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C. § 552; 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. §§ 331(j) and 360j(c); 42 U.S.C. § 241(d); 21 CFR Parts 20 and 21; 45 CFR Parts 5 and 5b. 

 

FDA/CDRH has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CDRH and NIH/NHLBI (MOU no. [Insert number here])

 

 

__________________________________                     _______________________

Name                                                                                                    Date