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MOU 225-11-0004

                                                                

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
MEMORANDOM OF UNDERSTANDING
between the
Office of Biotechnology Activities, National Institute of Neurological Disorders and Stroke,
and Division of Program Coordination, Planning and Strategic Initiatives, National
Institutes of Health
and the
Office of the Chief Scientist,
U.S.Food and Drug Administration
 
Title of the Agreement: Advancing Regulatory Science through Novel Research and
Science-Based Technologies
 
I. PURPOSE
 
This Memorandum of Understanding (MOU) details the joint responsibilities of the National
Institutes of Health, Office of Biotechnology Activities (NIH/OBA), National Institute of
Neurological Disorders and Stroke (NIH/NINDS) and Division of Program Coordination,
Planning and Strategic Initiatives (NIH/DPCPSI) and the US Food and Drug Administration,
Office of the Chief Scientist (FDA/OCS). It provides a framework for coordination and
collaborative efforts between the parties for implementation of the Advancing Regulatory
Science Initiative. It also provides the principles and procedures by which the Advancing
Regulatory Science Initiative will be managed and shared between OBA/NIH, NINDS/NIH,
DPCPSI/NIH and OCS/FDA.
 
II. BACKGROUND
 
As set forth in other agreements, the NIH will contribute approximately $8.45 million over 3
years and the FDA will contribute approximately $950 thousand over 3 years starting in FY 2010
to support a collaborative effort to encourage the submission of grant applications that propose to study the applicability of novel technologies and approaches to the development and regulatory review of medical products including drugs, biologics and devices.
 
III. WORKPLAN AND RESPONSIBILITIES OF EACH AGENCY
 
A. Coordination and Collaboration Relative to Public Health Activities.
 
The NIH and FDA will follow the respective roles and responsibilities as laid out in the Funding
Opportunity Announcement (FOA) RFA-RM-10-006, http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-10-006.html, and as articulated in Section VI, 2.A.2.1.
 
NINDS agrees to provide programmatic support for awards made through this FOA which
includes: (1) grants management oversight (negotiation, award, and administration of the
projects, and interpretation of Grants Administration policies and procedures); and (2) budgetary
oversight of the awards (authorization of funds available and tracking of annual budget
expenditures); and (3) program administration (scientific, programmatic and technical) - along
with assistance from OBA and in coordination with the FDA.
 
FDA agrees that at least 1 FDA representative will provide expert advice and assistance to the
NIH and/or Principal Investigator who receives an award under this FOA, as needed in areas of
FDA purview.
 
The responsibilities of the NINDS scientific contact, with support from the OBA working group
coordinator and liaison officer, and the FDA representative include (i) interacting in a
cooperative and timely manner to provide feedback to each other and grant applicants once the
funding opportunity announcement is public, (ii) participating in technical assistance calls with
the NIH and grantees (iii) reviewing milestone reports and progress reports and providing report
updates to the Working Group, (iv) helping to develop an agenda for, and participating in at least
2 meetings over the 3 years of the awards along with other NIH and FDA members.
 
Each party will utilize the expertise, resources and relationships of the other in order to increase
its own capability and responsiveness.
 
B. Principles and Procedures for the Sharing of Non-Public Information
 
FDA and NIH agree that the following principles and procedures will govern the sharing of nonpublic information, as resources permit, between the two parties.
 
NIH and FDA agree that there should be a presumption in favor of full and free sharing of
information as relates to the Regulatory Science Initiative. As public health agencies within
DHHS, there are no legal prohibitions that preclude NIH or FDA 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 NIH and FDA, whether written or oral,
must be protected from any further disclosures not authorized by law or regulation. Both parties
recognize that safeguards are needed to protect shared non-public information including, for
example, identities of study participants and other personal privacy information; privileged
and/or pre-decisional agency information; research proposals, progress reports, and unpublished
data; confidential commercial and trade secret information; and 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) and the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq). Such safeguards help ensure NIH/OD's
and FDA/OC's compliance with other applicable laws and regulations.
 
Both parties are committed to respond 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, whether written or oral, will be responsible for protecting that information from any further disclosure without written permission of the party that provided the non-public information. 
 
If records provided by either party under this agreement are the subject of a Freedom of Information Act (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 both parties' records or if the request is for records created by one party that incorporates information provided by the other party, in accordance with the Department of Health and Human Services' FOIA regulations at 45 C.F.R. 5.31 (a)(2), the party receiving the FOIA request will forward all such requests to the Deputy Assistant Secretary for Health (Communications), Department of the Health and Human Services for disposition.
 
IV. PERIOD OF AGREEMENT
 
This MOU becomes effective following the signature of both parties, beginning in FY 2011 and
remains effective through the end of the grant period, approximately September 30, 2013, and
until the time final reports and deliverables are completed by the investigator under the
Advancing Regulatory Science RFA-RM-10-006.
 
The names of NIH/NINDS, NIH/OBA, NIH/DPCPSI and FDA/OCS staff listed below represent the current persons in these assigned roles at the date of signing of this MOU.
 
V. SCIENTIFIC PROGRAM MANAGERS
 
Scientific / Research Contact and Program Official for NIH/NINDS:
 
Danilo Tagle, Ph.D., Program Director, Neurogenetics, 6001 NSC/ Room 2114,6001 Executive
Blvd., Bethesda, MD 20892, Phone (301) 496-5745, Email: tagled@ninds.nih.gov.
 
The NINDS Program Official (PO) is responsible for the scientific, programmatic, and technical aspects of the regulatory science projects which entails, in part, the programmatic review of the milestones and non-competing renewal applications for the cooperative grants awarded in response to RFA-RM-10-006. The PO will have substantial scientific involvement during the conduct of the program through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
 
Scientific / Research Contact for NII-I/DPCPSI:
 
Mary Ellen Perry, Ph.D., Program Leader, Office of Strategic Coordination, 208B, 1 Center
Drive, Bethesda, MD 20892, Phone (301) 496-5082, Email: perryma@mail.nih.gov.
 
The DPCPS1 Scientific Contact represents DPCPSI in overseeing the use of the Common Fund,
providing logistical and programmatic guidance for funding announcement(s), funding plans and reports on progress to NIH Leadership.
 
Scientific / Research Contact for FDA/OCS:
 
Vicki Seyfert-Margolis, Ph.D., Senior Advisor for Science Innovation and Policy, Office of the
Commissioner, Silver Spring, MD 20993, Phone (301) 796-5307, Email: Vicki.seyfert-margolis@fda.hhs.gov.
 
The OCS Scientific Contact will have substantial scientific involvement during the conduct of
the program through technical assistance, including the review of the milestones and certain
reports, providing advice, coordination, and plans for the integration of the findings into practice and guidance.
 
VI. LIAISON OFFICERS
 
Liaison Officers will participate in the management, coordination and oversight of this
agreement. The Liaison Officers will work with the Scientific Contacts to constitute participants from the NIH and FDA for the 2 meetings that will occur over the course of three years. In addition, the Liaison Officers will help facilitate interactions between the NIH and FDA Scientific Contacts with additional NIH and FDA staff needed for internal meetings such as those to discuss grant review procedures, public technical assistance meetings for prospective applicants, helping to resolve any issues or disputes that may arise, and oversee necessary modifications to the agreement.
 
For NIH/OBA
 
Kathy L. Kopnisky, Ph.D.
Associate Director for FDA Relations
Clinical Research, Policy Analysis and Coordination Program
National Institutes of Health
6705 Rockledge Drive
Suite 750/ Room 714
Bethesda, MD 20892-7985
Phone: (301) 435-3259
E-mail: kkopnisk@mail.nih.gov
 
For FDA/OCS
 
Trang Gisler, MS, CCRP, PMP
Senior Program Manager/Project Officer
Office of Chief Scientist
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
W032-4266
Silver Spring, MD 20993-0002
Phone: (301) 796-8749
E-mail: trang.gisler@fda.hhs.gov
 
VII. APPROVAL
 
APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTES OF HEALTH
Office of Science Policy
Office of Biotechnology Activities

Signed by: Amy P. Patterson, M.D.
Acting Associate Director for Science Policy
Office of Science Policy
National Institutes of Health

 
Date: January 7, 2011
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Office of the Chief Scientist

Signed by: Jesse L. Goodman, M.D., M.P.H.
Chief Scientist and Deputy Commissioner for Science & Public Health
Office of the Chief Scientist
U.S. Food and Drug Administration

Date: December 10, 2010
APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTES OF HEALTH
National Institute of Neurological Disorders and Stroke

Signed by: Story Landis, Ph.D.
Director
National Institute of Neurological Disorders and Stroke
National Institutes of Health

 
Date: January 12, 2011
APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTES OF HEALTH
Division of Program Coordination, Planning, and Strategic Initiatives

Signed by: James M. Anderson, M.D.
Director
Division of Program Coordination,
Planning and Strategic Initiatives
National Institutes of Health

Date: January 12, 2011