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MOU 225-12-0015

 

MEMORANDUM OF UNDERSTANDING
Between
Food and Drug Administration
And
Office of the Assistant Secretary for Preparedness and Response
 
1. Preamble
 
The Food and Drug Administration (FDA) and the Office of the Assistant Secretary for Preparedness and Response (ASPR) (including the Biomedical Advanced Research and Development Authority (BARDA)), each as part of the Department of Health and Human Services, and hereinafter also collectively referred to as "Federal Partners," agree to work together to provide a framework for coordination and collaborative efforts related to the development and availability of drugs, biologics, and devices, as defined by the Federal Food, Drug, and Cosmetic Act (FD&C) Act (21 U.S.C. §§ 321 et seq) and section 351 of the Public Health Service (PHS) Act (42 U.S.C. § 262) (hereafter referred to as "medical products") regulated by FDA for use as medical
countermeasures in public health medical emergencies.
 
2. Purpose and Goals
 
The purpose of the MOU is to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal Partners. The goals of the collaboration are to explore ways (inter alia) to:
 
a.    Further enhance information sharing efforts through more efficient and robust interagency activities.
b.    Promote efficient utilization of resources and expertise for development of safe and effective medical products regulated by FDA for use as medical countermeasures.
c.    Develop collaborative processes that meet the common needs for supporting medical product development and innovation.
d.    Assist the industry so they may assist product development with core technical expertise and regulatory guidance, build manufacturing infrastructure and surge capacity for medical products regulated by FDA for use as medical countermeasures.
 
3.  Authority
 
FDA has authority to enter into this agreement pursuant to sections 1003(b) and (c) of the FD&C Act) (21 U.S.C. §§ 393(b) and (c)). ASPR has authority to enter into this agreement pursuant to sections 319L(c), 281 1(b)(3) and 281 1(b)(4)(A) of the PHS Act (42 U.S.C. §§ 247d-7e(c), 300hh-10(b)(3) and 300hh-10(b)(4)(A)).
 
4.  Substance of the Agreement - Responsibilities/Activities/Information Sharing
 
a.    Each Federal Partner will establish a principal point of contact to facilitate the actions carried out under this MOU.
 
b.    FDA and ASPR agree to attend an initial meeting to establish the specific procedures and safeguards necessary to implement this MOU. The initial meeting will take place within 30 days of signing and approval of this MIOU. Periodic meetings will be scheduled thereafter on an as needed basis. FDA and ASPR agree not to share information under this MOU unless, and until, adequate procedures and safeguards are established and implemented by each Federal Partner within its respective agency. 
 
c.    FDA and ASPR agree that each initial request for information will be made by and transmitted to the Federal Partner principal points of contact designated according to Section 4.a. of this MOU. Subsequent communications pertaining to the information request may occur between other staff as designated by the Federal Partner principal points of contact.
 
d.    FDA and ASPR agree that any Federal Partner may decide not to share information or expertise in response to a particular request for information made according to the procedures established under Section 4.b., or to limit the scope of information and expertise sharing in response to a particular request.  A decision not to share information in response to a specific request may be based on several factors, including, for example, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding Federal Partner’s priorities, or legal restrictions. There is, however, a presumption in favor of sharing information in furtherance of the purposes of this MOU. FDA and ASPR further agree that either Federal Partner may on its own initiative elect to share information with then other Partner pursuant to procedures established under section 4.b., above. In the event that the Federal Partners can not reach consensus at the POC level on a decision to share or not share information, the issue will be referred for ASPR, to the ASPR Division Directors, and, for FDA, to the Director(s) of the affected product Center(s) for review and resolution.
 
e.    FDA and ASPR agree to establish reasonable timelines for responding to information requests and to refer instances of delays to the Federal Partner point of contact for resolution.
 
f.     FDA and ASPR recognize that the following types of information transmitted between them in any medium and from any source must be protected from unauthorized use and disclosure: (1) trade secret and other confidential commercial information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., the Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5U.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.), the Health Insurance Portability and Accountability Act (HIPAA) (Pub, L. No. 104-191), Section 319L(e) of the PHS Act (42 U.S.C. § 247d-7e(e)), and disclosure restrictions subject to 41 U.S.C. 42 (Procurement Integrity Act) and 48 C.F.R 3.104 (Federal Acquisition Regulation).
 
g.    The procedures established under Section 4.b. must include proper safeguards against unauthorized use and disclosure of the information exchanged under this MOU. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used solely in accordance with Trade Secrets Act (18 U.S.C. § 1905), the FD&C Act (21 U.S.C. §§ 301 et seq.) the Privacy Act of 1974(5 U.S.C. § 552a), the Freedom of Information Act (5 U.S.C. § 552), and their implementing regulations, as well as the HIPAA Privacy Rule (45 C.F.R. Parts 160 and 164)as applicable, and disclosure restrictions subject to 41 U.S.C. 423 (Procurement Integrity Act) and 48 C.F.R 3.104 (Federal Acquisition Regulation).
 
FDA and ASPR agree to promptly notify the other Federal Partner of any actual or suspected unauthorized disclosure of information shared under this MOU.
 
h.    Access to the information shared under this MOU shall be restricted to authorized FDA and ASPR employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards required to protect the information, and (3) the administrative, civil and criminal penalties for noncompliance contained in applicable Federal laws.
 
Contractors, their subcontractors, and/or agents of parties participating in discussions covered by this MOU will be permitted to participate in discussions and to receive information under this MOU only if they have signed an agreement by which such contractor, subcontractor, or agent will commit to keep the information confidential. Individuals (e.g., contractors’ employees or agents) shall be required, prior to receiving any such information, to sign a Confidentiality Commitment.
 
i. If a Federal Partner that has received information under this MOU receives a Freedom of Information Act (FOIA) request for information shared by the other Federal Partner pursuant to this MOU, it will refer the request to the information-sharing Federal Partner for that Federal Partner to respond directly to the requestor regarding the releasability of the information. In such cases, the Federal Partner making the referral will notify the requestor that a referral has been made and that a response will issue directly from the information sharing Federal Partner.
 
j. The Federal Partners further agree that nothing in this MOU shall be construed to prevent a disclosure required by law, regulation, or legal process. Notwithstanding this provision, should information shared pursuant to this MOU be subpoenaed or otherwise ordered through a legal process, the Federal Partner to whom the subpoena or order is directed will notify an Authorized Official of the other Federal Partner immediately and the Partners shall consult on the appropriate response to the request. This MOU does not prohibit disclosure of information that is available publicly or when authorized in writing by the information owner.
 
k. The Federal Partners agree that termination of this MOU does not relieve either of the Federal Partners of their confidentiality obligations established under this MOU, including their obligations to safeguard and limit access to all information provided pursuant to this MOU as applicable.
 
l. All information provided by FDA or ASPR shall be used solely for the purposes outlined in Section 2. If FDA or ASPR wish to use the information provided by the other Federal Partner under this MOU for any purpose other than those outlined above, the requesting Federal Partner shall make a written request to the other Federal Partner describing the additional purposes for which it seeks to use the information. If the Federal Partner receiving this request determines that the request to use the information provided hereunder is acceptable, it shall provide the requestor with written approval of the additional use of the information.
 
5. Conflict of Interest
 
Executive Order 12674, Standards of Ethical Conduct for Employees of the Executive Branch, and individual agencies’ standards of conduct contain rules and regulations which govern the ethical issues applicable to Government employees. Federal law prohibits a Federal employee from participating personally and substantially in any particular matter in which the employee has a financial interest. Absent an exemption, the restriction also applies to financial interests of an employee’s spouse; minor child; partner; organization in which he or she is serving as officer, director, trustee, partner or employee; and any person or organization with whom the employee is negotiating or has any arrangement concerning prospective employment. Ethics requirements applicable to Federal personnel also broadly prohibit employees from engaging in a financial transaction using nonpublic information, and prohibit the improper use of nonpublic information to further his/her own private interest or that of another, whether through advice or recommendation, or by knowing unauthorized disclosure. In addition, HHS Supplemental Standards of Ethical Conduct impose additional conditions, such as unique prohibited-holdings regulations for certain FDA personnel. Each Federal Partner will assure that its representatives to any discussion under this MOUdo not have a prohibited financial conflict of interest through personal or family investments in a sponsor, or a competitor to the sponsor, who will be affected by FDA decisions. If at any time prior to or during the performance of activities under this MOU, a person becomes aware that a potential or actual conflict exists, that person must notify the appropriate authorities within his or her own agency, and that Federal Partner agency must contact the appropriate project manager of the counterpart agency designated pursuant to paragraph 7.b of this MOU so that any necessary actions can be undertaken.
 
6. Integrity of Regulatory Decision-Making Process
 
FDA employees generally will not participate in discussions or decision-making under this MOU regarding the terms of procurement of, contracting for, or investment in a medical product. FDA representatives may participate in discussions to provide FDA’s current thinking on scientific or regulatory issues within FDA’s areas of responsibility and expertise. FDA participation is predicated on a mutual understanding that Federal Partner meetings under this MOU provide a forum for a mutual exchange of opinions and ideas, and that the Federal Partners must avoid any appearance that procurement, contracting, or investment considerations may influence FDA regulatory decision-making concerning product approval or authorization.
 
7. General Provisions
 
a. Effect on Existing Statutes and Regulations
 
FDA and ASPR agree to take actions under this collaboration that are consistent with existing laws and regulations, and that nothing in the MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by FDA and ASPR including but not limited to relevant provisions of the PHS Act and the FD&C Act. Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on FDA or ASPR that is additional to the mandates or requirements imposed on FDA or ASPR by Federal statutes and regulations.
 
b. Resource Obligations
 
FDA and ASPR will designate respective personnel to oversee the administration of, and adherence to, the content of this MOU. These project managers shall include one or more designated individuals from any of the following: FDA’s Office of the Commissioner (OC), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Drug Evaluation and Research (CDER), and from ASPR’s Divisions).
 
FDA and ASPR will make reasonable efforts to provide the necessary staff to implement this MOU in an efficient and effective manner.
 
8. Assessment Mechanisms
 
FDA and ASPR staff involved in implementing the MOU will provide regular and consistent oversight and reevaluation of all terms and conditions contained herein.
 
9. Terms,Termination or Modification
 
This MOU becomes effective upon the signature of both FDA and ASPR and will remain in effect for 5 years, unless otherwise terminated. This agreement may be modified by mutual written consent or terminated by either party upon 60 days written notice. This agreement may be modified by consent of both Federal Partners or terminated by either party immediately upon written notice in the event that a Federal statute is enacted or a regulation is issued by a Federal Partner that materially affects this MOU.
 
10. Points of Contact
 
For CBER:
Cynthia L. Kelley, M.S.
Senior Advisor for Counterterrorism and Medical Countermeasures
Office of the Center Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852
 
Alternate:
Mary A. Malarkey
Director, Office of Compliance and Biologics Quality
 
For CDRH:
Murray Malin, MD
Acting Director, Medical Countermeasures
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
U.S. Food and Drug Administration
Silver Spring, MD 20993
 
Alternate:
Nancy Pluhowski
External Expertise and Partnerships, Office of the Center Director
 
For CDER:
Rosemary Roberts, MD
Director, Office of Counter-terrorism and Emergency Coordination
Center for Drugs Evaluation and Research
U.S. Food and Drug Administration
Hillandale, Room 2128
Silver Spring, MD 20993
 
Alternate:
Brad Leissa, MD
Deputy Director, Office of Counter-terrorism and Emergency Coordination
 
ForOC:
Alan Liss, PhD.
Office of Counterterrorism & Emerging Threats
Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
 
For ASPR:
Debra Yeskey, Pharm.D.
Director, Regulatory and Quality Affairs Division
Office of Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Room 638G
Washington, D.C. 20201
 
Alternate:
R. Thomas Waif, M.S.
Director, Division of Manufacturing Facilities and Engineering
Office of Biomedical Advanced Research and Development Authority
 
Approved and Accepted
for the Department of Health and Human Services
Signed by: Edward Gabriel, MPA, EMT-P, CEM
Principal Deputy Assistant Secretary for Preparedness and Response
Date: March 12, 2012
Approved and Accepted
for the U.S. Food and Drug Administration
Jesse Goodman, MD, MPH
Chief Scientist and Deputy Commissioner of Science and Public Health
Date: March 21, 2012