I.        Purpose:

 

The Food and Drug Administration (FDA), as part of the Department of Health and Human Services and the Federal Bureau of Prisons (BOP), as part of the Department of Justice, both United States Federal Government entities and hereinafter also referred to as "federal partners," agree to work together to promote safety initiatives related to the review and use of FDA-regulated drugs, biologics, and medical devices, including dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act (the FD&C Act) (see 21 U.S.C. 321) and the Public Health Service Act (see 42 U.S.C. 262).

 

The purpose of this MOU is to enhance knowledge and efficiency by providing for the      sharing of information and expertise between the federal partners (e.g., BOP participation in FDA’s, Drug Safety Oversight Board (DSB) Center for Drug Evaluation and Research’s (CDER)).

 

 

a.      Further enhance information sharing efforts through more efficient and robust inter-agency activities.

b.      Promote efficient utilization of tools and expertise for product risk identification, validation and analysis.

c.      Build infrastructure and processes that meet the federal partners’ common needs for evaluating the safety, efficacy, utilization, and reporting requirements of drugs, biologics, and medical devices.

 

II.      Background:

 

FDA is authorized to enforce the FD&C Act, as amended (21 U.S.C. 301, et seq.).  In fulfilling its responsibilities under the FD&C Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products.  FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.  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 with BOP will greatly contribute to FDA’s mission.

 

It is the mission of BOP to protect society by confining offenders in the controlled environments of prisons and community-based facilities that are safe, humane, cost-efficient, and appropriately secure, and that provide work and other self-improvement opportunities to assist offenders in becoming law-abiding citizens.

 

III.     Substance of Agreement:

 

a.      Each federal partner will establish a single agency liaison to facilitate the actions carried out under this MOU.  The liaisons will be organizationally aligned under the Office of the FDA Commissioner and BOP Assistant Director, Health Services Division.

b.      BOP and FDA 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 MOU.  Periodic meetings will be scheduled thereafter on a quarterly basis. BOP and FDA agree not to share information under this MOU unless, and until, adequate procedures and safeguards agreed upon by both federal partners are established and implemented.

c.       BOP and FDA agree that any initial request for information will be made by and transmitted to the agency liaisons designated according to Section 3.a. of this MOU. Subsequent communications pertaining to that issue may occur between other staff as approved by the liaisons.

d.      BOP and FDA agree that either may decide not to share information or expertise in response to a particular request for information made according to the procedures established under Section 3.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.  In the event both partners cannot reach consensus on a decision to share or not share information, the issue will be referred to FDA’s Office of the Chief Counsel and a Senior Counsel from the BOP’s Commercial Law Branch for a final decision.

e.      FDA and BOP agree to establish reasonable timelines for responding to information requests and to refer instances of delays to the agency liaisons for resolution.

f.       FDA and BOP agree to promptly notify the other federal partner of any actual or suspected unauthorized disclosure of information shared under this MOU.

 

IV.     General Provisions:

 

a.      FDA and BOP recognize that information transmitted between them, in any medium and from any source, that contains any of the following types of information must be protected from unauthorized disclosure: (1) confidential commercial information, such as the 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., 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), 38 U.S.C. § 5701, 38 U.S.C. § 5705, 38 U.S.C. § 7332, the FD&C Act, and the Health Insurance Portability and Accountability Act (HIPAA) (Pub. L. 104-191).

b.      The parties will establish proper safeguards to ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable laws and regulations. Access to the information shared under this MOU shall be restricted to authorized FDA and BOP employees, agents, and officials who require access to perform their official duties in accordance with the uses of information as authorized by 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 agents requiring access to the information shared under this agreement will be required to sign a business associate agreement by which they will commit to keep the information confidential.

c.       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: 

1.      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.

2.      The requesting party will agree in writing, by using the model request letter (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 release ability 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. 

3.      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.). A model transmittal letter is attached. The shared documents containing non-public information should be stamped “Do not disclose without permission of FDA/ BOP”, whichever is applicable. 

4.      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.

5.      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.

 

V.      Resource Obligations: 

 

This MOU represents the broad outline of the federal partners’ intent to enter into specific agreements for collaborative efforts in areas of mutual interest to FDA and BOP. 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 partners. This MOU does not create binding, enforceable obligations against any party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and BOP operate.

 

VI.     Effect of MOU on Existing Statutes and Regulations:

FDA and BOP 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 BOP and FDA, including, but not limited to: title 38 of the United States Code, the Public Health Service Act, and the FD&C Act.  Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on either FDA or BOP that is additional to the mandates or requirements imposed on BOP or FDA by federal statutes and regulations.
 

VII.     Liaison Officers:

 

FDA and BOP will designate respective liaisons to oversee the administration of, and adherence to, the content of this MOU.  These liaisons shall include one or more designated individuals from BOP’s Health Services Division and FDA's Office of the Commissioner, CDER, Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER). Each party may designate new liaisons by notifying the other party's liaison in writing. If an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the party affected will name a new liaison within two (2) weeks and notify the other party through the designated liaison.

 

VIII.   Term, Termination, and Modification:

 

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until 3 years.  This agreement may be modified by mutual consent or terminated by either party upon 60 days written notice.  This agreement may be modified by mutual consent or terminated by either party immediately upon written notice in the event that a federal statute is enacted or regulations are issued by either federal partner that materially affects this MOU.   FDA and BOP staff involved in implementing the MOU will provide regular and consistent oversight and reevaluation of all terms and conditions contained herein.

 

RADM Newton E. Kendig

Assistant Director Health Services Division

 

November 19, 2012

  

 

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

HHS Food and Drug Administration

 

November 13, 2012

 

 

 

 

MEMORANDUM OF UNDERSTANDING BETWEEN THE

FEDERAL BUREAU OF PRISONS U.S. DEPARTMENT OF JUSTICE AND THE

FOOD AND DRUG ADMINISTRATION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

This is an amendment to the  Memorandum of Understanding (MOU)  225-08-8003 (Amendment2)*** to extend the  termination date of this  agreement for  an additional five years to beginning November 20, 2015  to November 19, 2020. The time extension is permissible under Section VIII, Term, Termination, and Modification. The purpose of the time extension is to provide for continuity in the collaboration.

 

All other content of the MOU Number 225-08-8003 (Amendment 2)*** executed on November 19, 2012, remains unchanged.

 

 

 

Janet Woodcock

Director

Center for Drug Evaluation and Research

 

May 11, 2015

 

 

 

 

RAD Newton E. Kendig

Assistant Director

Health Services Division

 

May 11, 2015

 

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[***] This amendment was incorrectly identified as being associated with MOU 225-08-8003.  In fact, this amendment was made to MOU 225-14-015.