MOU 225-15-012

MEMORANDUM OF UNDERSTANDING
BETWEEN THE NATIONAL ASSOCIATION
OF ATTORNEYS GENERAL AND THE
U.S. DEPARTMENTOF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR TOBACCO PRODUCTS
OFFICE OF COMPLIANCE AND ENFORCEMENT

I. Purpose:

This agreement between the National Association of Attorneys General (NAAG) and the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) to engage in sharing of predecisional nonpublic compliance and enforcement policy information is intended to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements.

II. Authority:

The authorities for entering into the activities described in this MOU are 21 C.F.R. 20.88(e) and 21 C.F.R. 20.88 (e) and (c).

III. Background:

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, regulates the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

NAAG is an organization whose members are state officials, including the Attorneys General of the 50 states and the District of Columbia and the chief legal officers of the commonwealths of Puerto Rico and the Northern Mariana Islands, and the territories of American Samoa, Guam, and the Virgin Islands. NAAG's responsibilities under the Master Settlement Agreement include harmonizing state standards and requirements with respect to tobacco regulation.

To accomplish its mission it may be appropriate for FDA to disclose to the NAAG Center for Tobacco and Public Health (NAAG Tobacco Center) Director and Chief Counsel, NAAG Tobacco Center Counsel-MSA Public Health, two NAAG Tobacco Center Counsels, NAAG Tobacco Center Paralegal,and NAAG Tobacco Center Paralegal & Coordinator ("designated NAAG officials") currently held by Michael Hering, William Lieblich, Tamara Schlinger, Patricia Molteni, Erjona Fatusha, and Lia Metreveli, respectively, predecisional nonpublic information, including documents concerning the FDA's compliance enforcement policy. It may also be appropriate for FDA to disclose to, or receive from designated NAAG officials, other predecisional nonpublic information relevant to either party's activities. Increased information sharing of predecisional nonpublic compliance policy and enforcement information with NAAG will improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements and will contribute to FDA's mission.

IV. Substance of Agreement:

Each party agrees to share with each other predecisional nonpublic compliance policy and enforcement information to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements as appropriate in furtherance of their missions to protect the public health and to reduce tobacco use by minors. Each party agrees to share predecisional nonpublic compliance policy and enforcement information in accordance with the guidelines set forth below.

V. General Provisions and Guidelines

A. Process for Information Sharing upon NAAG's request from FDA:

When, pursuant to this MOU, NAAG requests, from FDA, records, data, reports, or other information, which is publicly available, the request must be in writing, which may be in the form of an informal mail, and need only identify the information requested and the purpose for which the information is requested. The following language is to be included in the written request for information:

"Information is requested by NAAG and will be shared pursuant to the MOU between the FDA and NAAG concerning predecisional nonpublic compliance and enforcement policy related to regulated entities. We agree not to disclose any shared information, in any manner, other than amongst designated NAAG officials, to anyone, including other members of NAAG without your advance written authorization."

With the inclusion of this statement, NAAG would not have to use a particular format or include other pre-specified text.

Also when, pursuant to this MOU, NAAG from FDA, records, data, reports, or other information, which is otherwise not publicly available, a designated FDA official(s) will determine that each provision of predecisional nonpublic compliance policy enforcement information is reasonably necessary to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements.

B. Process for Information Sharing upon FDA's request from NAAG:

When, pursuant to this MOU, FDA requests from NAAG, records, data, reports, or other information, which is otherwise not publicly available, the request must be in writing, which may be in the form of an informal email, and need only identify the information requested and the purpose for which the information is requested. The following language is to be included in the written request for information:

"This information is requested by FDA and will be shared pursuant to the MOU between the FDA and NAAG concerning predecisional nonpublic compliance and enforcement policy related to regulated entities. We agree not to disclose any shared information, in any manner, without your advance written authorization."

With the inclusion of this statement, FDA would not have to use a particular format or include other pre-specified text.

C. Process for Responding when Information is Shared between NAAG and FDA:

When, pursuant to this MOU, requests for records, data, reports, or other information, which is otherwise not publicly available, a response must be in writing, but it, too, can be an informal email that acknowledges transmission of information in response to the request. The following language is to be included in FDA's and NAAG's written response:

'This information is being provided pursuant to the MOU between the FDA and NAAG concerning sharing predecisional nonpublic compliance policy and enforcement information related to regulated entities. This communication and the information included may contain privileged and/or confidential material exempt from public disclosure. This information may not be disclosed or shared in any manner other than in accordance with the MOU between FDA and NAAG without our express written authorization."

With the inclusion of this statement, FDA or NAAG would not have to use a particular format or include other pre-specified text.

D. Access to Information Shared:

Access to the predecisional nonpublic information shared under this MOU shall be restricted to designated NAAG officials, Tobacco Center Director and Chief Counsel, NAAG Tobacco Center Counsel- MSA Public Health, two NAAG Tobacco Center Counsels, NAAG Tobacco Center Paralegal, and NAAG Tobacco Center Paralegal & Content Coordinator, who require access to such information to perform their official duties in accordance with the uses of the information as authorized in this MOU otherwise authorized in writing by FDA. All such personnel shall be advised of the confidential nature of the information.

Access to the predecisional nonpublic information shared under this MOU shall be restricted to FDA/CTP Office of Compliance and Enforcement, Office Director, Office Deputy Directors, Director of the Division of Enforcement and Manufacturing who require access to such information to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless otherwise authorized in writing by NAAG. All such personnel shall be advised of the confidential nature of the information.

E.. FDA and NAAG agree to promptly notify each other of any actual or suspected unauthorized disclosure of any information shared pursuant to this MOU

FDA and NAAG mutually agree that if a Freedom of Information Act (FOIA) (FDA only), subpoena, or court order is received requesting information in which FDA or NAAG isn't the originating office, each party will contact the other party to discuss the appropriate process that should be followed.

VI. Resource Obligations:

All activities undertaken through the MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any party.

VII. Liaison Officers:

For the National Association of Attorneys General:

Michael Hering

NAAG Tobacco Center Director and Chief Counsel