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MOU 225-13-0003

 

MEMORANDUM OF UNDERSTANDING BETWEEN THE
THE NATIONAL INSTITUES OF HEALTH
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
AND THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
 
I.       Purpose:
 
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), both as part of the Department of Health and Human Services, and hereinafter also referred to as "Federal partners", agree to work together to promote initiatives related to the review and use of diagnostic, preventive and therapeutic products for use in oral health care. This MOU provides a framework for coordination and collaborative efforts between the Federal partners. This MOU also provides the principles and procedures by which information exchanges between FDA and NIDCR will take place.
 
II.       Background:
 
FDA and NIDCR are sister agencies within the Department of Health and Human Services (DHHS). Both FDA and NIDCR exist and work to protect and promote the public health but have different responsibilities.
 
FDA is a regulatory agency responsible for protecting the public health through the regulation of food, cosmetics, and medical products, including drugs, biological products, animal drugs, and medical devices. FDA administers the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. 321) and portions of thePublic Health Service Act (see 42 U.S.C. 262), among other statutes. Among its duties, FDA approves pre-market applications, conducts inspections of manufacturing facilities, and monitors post­ marketing adverse events. FDA also initiates civil and criminal litigation to enforce applicable laws and regulations.
 
The NIDCR is an institute of theNational Institutes of Health.(See 42 U.S.C. 281) The mission of the NIDCR is to improve oral, dental, and craniofacial health through research, research training, and the dissemination of healthinformation. (See 42 U.S.C. 285h.) In order to accomplish this goal, the NIDCR is charged  with: performing and supporting basic and clinical research; supporting research training and career development programs to ensure an adequate number of talented, well-prepared and diverse investigators; coordinating and assisting relevant research and research-related activities among all sectors of the research community; and promoting the timely transfer of knowledge gained from research and its implications for health to the public, health professionals, researchers, and policy-makers.


 

 
This agreement has been developed to facilitate interactions between the NIDCR and the FDA regarding improvements in the quality and relevance of pre-clinical and clinical research which is directed to the development and market introduction of safe and effective diagnostics, preventive agents, and therapeutics to improve the diagnosis, prevention and treatment of oral, dental, and craniofacial diseases and disorders. The principal goal of this agreement, to reduce the time between the research and development phase of a product's life cycle and its commercial availability, will be achieved by: (1) facilitating research into the development and market introduction of newly-emerging, safe and effective health care products; and (2) providing complementary support and expertise to enable each agency to optimally fulfill its public health mission. The goal will be attained by establishing a framework to enhance the quality of product-related research and thus facilitate and improve the incorporation of new technologies in safe and effective products. This agreement also sets forth certain working arrangements between both parties that will enable each to fulfill its respective mission more efficiently and effectively.
 
III.        Substance of Agreement:
 
1.  Each Federal partner will establish a principal point of contact to facilitate the actions carried out under this MOU.
 
2.  The Federal partners agree to attend an initial meeting to establish the specific procedures and safeguards necessary to implement this MOU. The initial meeting will take within 30 days of signing and approval of this MOU. Each partner will participate in periodic joint meetings to promote better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for questions and problems that may arise.
 
3.  The Federal partners will work to facilitate and encourage translation from discovery and preclinical research, through clinical research, to clinical products on the market in the United States utilizing their respective authorities and implementation mechanisms.
 
4.  The Federal partners will notify the other partner as soon as possible when issues of significant mutual concern become evident.
 
5.  Each Federal partner will collaborate with the other partner in all investigations of significant mutual concern. Such collaboration may include providing alerts to the other partner when issues are identified; providing technical advice in areas of recognized expertise; providing results of analysis; coordinating health protection information and recommendations provided to the public and exchanging information.
 
6.  The Federal partners will refer to each other any proposed regulations, guidances, or recommendations that may have a significant impact on the other partner for review and comment by that partner before publication.


 

7.  The Federal partners agree to keep each other informed concerning press releases, scientific releases, and publications that may have a significant impact on the other partner.
 
8.  FDA and NIDCR recognize that the followingtypes of non-public informationtransmitted between them in any medium and from any source must be protectedfrom unauthorized disclosure:(1) trade secret and other confidentialcommercial information,such as the informationthat would be protected from publicdisclosure pursuantto Exemption4 of the Freedom of lnformation Act (FOIA); (2) personal privacy information,such as the informationthat would be protected from publicdisclosure pursuantto Exemption6 or 7(c) of the FOIA; or (3) informationthat is otherwise protectedfrom public disclosure by Federal statutes and their implementing regulations(e.g., as applicable, the Trade Secrets Act (18 U.S.C.§ 1905), the Privacy Act (5 U.S.C. § 552a), the Freedom of Information Act (5 U.S.C. § 552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C.301 et seq.), and the Health Insurance Portability and AccountabilityAct (HIPAA), Pub. L. 104-191).
 
9.  FDA and NIDCR agree to promptly notify the relevant Federal partner(s) of any actual or suspected unauthorized disclosure of information shared under this MOU.
 
10. This agreement does not preclude NIDCR or FDA from entering into other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.
 
IV.        General Provisions:
 
Data Sharing Guidelines:
 
As public health agencies within DHHS, FDA and NIDCR are not legally prohibited from sharing with each other most information in the possession of either partner. Both parties recognize and acknowledge, however, that all non-public information shared between FDA and NIDCR, whether in writing or orally, must be protected from any disclosure not authorized by law. See, e.g., 18 U.S.C. § 1905; 5 U.S.C. § 552a; 21 U.S.C. § 331(j); 21 U.S.C. § 360j(c); 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 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 partner information; research proposals, progress reports, and/or unpublisheddata; or national security information. Such safeguards also help ensure compliance by FDA and NIDCR with other applicable laws.
 
To facilitate the sharing of non-public information, FDA and NIDCR 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 partner 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 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.      Before the sharing party provides any non-public information, the requesting party will agree in writing, by using the model request letter (see attachments), not to further disclose any shared non-public information without prior permission from the party sharing the information. 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 for permission before disclosing that information.
 
c.       If the requesting party receives a Freedom of InformationAct (FOIA) request for shared information, the requesting party will: (a) if therequest implicates records from the sharing party in their original form, refer the FOIA request to the sharing party through 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 records 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.
 
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. The shared documents containing non-public information should be stamped "Contains non-public information. Do not disclose without permission of [FDA or NIDCR, whichever is applicable]."
 
e.      The requesting party will promptly notify the contact person or designee of the sharing party if a third party seeks to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, Congressional request, judicial order, subpoena, discovery request.
 
 
 
V.       Resource Obligations:  
 
This MOU represents the broad outline of the Parties' intent to enterinto specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and NIDCR. 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 and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NIDCR operate.
 
VI.        Principal Points of Contact:
 
A. For the NIDCR:
Pamela Mcinnes, DDS, MSc. (Dent)
Director, Division of Extramural Research (DER)
National Institute of Dental and Craniofacial Research (NIDCR) National Institutes of Health (NIH)
6701 Democracy Blvd. Rom. 610
Bethesda, MD 20892-4878
Tel: (301) 443-8618
Fax: (301) 480-8319
 
B. For the FDA/CDRH:
Susan Runner, DDS, MA Branch Chief, Dental Devices CDRH/FDA/ODE
W0-66-2538
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: 301-796-6282
Fax: 301-847-8109
 
VII.        Term, Termination, and Modification:
 
This agreement will be effective when accepted by all participating parties for a period of performance from the date of latest signature for five years. This agreement may be renewed, modified or terminated by mutual written consent by both parties or may be terminated by either party upon a 60 day advance written notice to the other.

 

 
 
APPROVED AND ACCEPTED BY:
THE NATIONAL INSTITUES OF HEALTH
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
 
Martha J. Somerman, DDS, PhD
 
April 17, 2013
 
 
APPROVED AND ACCEPTED BY:
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
 
Jeffrey Shuren, MD, JD
 
May 2, 2013
 
 
 
 Model Language for Information Request                             (Reference: MOU No. 225-13-0003)
 
 
The National Institute for Dental and Craniofacial Research (NIDCR) has requested the following information from the FDA for the following purposes:  [Identify information and purpose]
 
or
 
NIDCR hereby requests the following information from FDA for the following purposes: [Identify information and purpose]
 
NIDCR agrees that it will not further disclose any such information that FDA shares to any other party without prior written permission from FDA and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIDCR and FDA (MOU No. 225-13-0003). Applicable laws may prohibit the further disclosure of such information. See e.g., 21 U.S.C. §§ 331(j) and 360j(c): 18 U.S.C. § 1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; 42 U.S.C. § 241(d).
 
NIDCR will limit dissemination of any shared information to the following NIDCR offices and/or employees: [Identify office(s) and/or employee(s)]
 
 
 
Name                                                                          Date

 
                                                                                                                             Model Language for Information Request                                  (Reference: MOU No., 225-13-0003)
 
 
The Food and Drug Administration (FDA) has requested the following information from the
NIDCR for the following purposes:  
 
[Identify information and purpose]
 
Or
 
FDA hereby requests the following information from NIDCR for the following purposes: [Identify information and purpose]
 
FDA agrees that it will not further disclose any such information that NIDCR shares to any other party without prior written permission written permission from NIDCR and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIDCR and FDA (MOU No. 225-13-0003). Applicable laws may prohibit the further disclosure of such information. See e.g., 21 U.S.C. §§ 331G) and 360j(c); 18 U.S.C. § 1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; 42 U.S.C. § 241(d).
 
FDA will limit dissemination of any shared information to the following NIDCR offices and/or employees: [Identify office(s) and/or employee(s)]
 
 
 
Name                                                                          Date
 
 
                                                                                                                            Model Language for Information Request                                  (Reference: MOU No., 225-13-0003)

 
This letter accompanies agency records that the NIDCR is sharing with the Food and Drug Administration (FDA) in response to FDA's request, dated. These agency records contain one or more of the following categories of non-public information (for some of these categories, further disclosure may be prohibited by law):
 
[NIDCR 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 subject to the Privacy Act;
Intra-agency records (including information protected by the deliberative process, attorney-client, and/or attorney work product privileges);
Records or information compiled for law enforcement purposes; Information protected for national security reasons; or other.
 
FDA will notify the appropriate office of the information-sharing agency if anyone seeks any of the shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, Congressional requests, judicial orders, and discovery requests.
 
FDA has agreed, by this letter or e-mail and by a signed request letter dated
                                      , not to further disclose the above-described information without prior written permission of NIDCR.FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. §§ 331(j) and 360j(c); 18 U.S.C. § 1905; 21 C.F.R. Parts 20 and 21; 45 CF.R. Parts 5 and 5b; 42 U.S.C. § 241(d).
 
 
 
 
Name                                                                          Date
 
 
 
                                                                                                                    Model Language for Information Request                                  (Reference: MOU No., 225-13-0003)

 
This letter accompanies agency records that the FDA is sharing with NIDCR in response to NIDCR's request, dated ___________. These agency records contain one or more of the following categories of non-public information (for some of these categories, further disclosure may be prohibited by law):
 
[FDA 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 subject to the Privacy Act;
Intra-agency records (including information protected by the deliberative process, attorney-client, and/or attorney work product privileges);
Records or information compiled for law enforcement purposes; Information protected for national security reasons; or other.
 
NIDCR will notify the appropriate office of the information-sharing agency if anyone seeks any of the shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, Congressional requests, judicial orders, discovery requests, and litigation complaints or motions.
 
NIDCR has agreed, by this letter or e-mail and by a signed request letter dated
                                      ,not to further disclose the above-described information without prior written permission of FDA. NIDCR acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. §§ 331(j) and 360j(c); 18 U.S.C.
§ 1905; 21 C.F.R. Parts 20 and 21; 45 CF.R. Parts 5 and 5b; 42 U.S.C. § 241(d).
 
 
Name                                                                          Date

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