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MOU 225-15-008

MEMORANDUM OF UNDERSTANDING ON THE CONCURRENT ACCESS TO THE
TOBACCO TRANSITION ASSESSMENT PROGRAM (TTAP) SYSTEM
CONTAINING TOBACCO MARKET SHARE INFORMATION
BETWEEN THE FOOD AND DRUG ADMINISTRATION,
U.S.DEPARTMENTOF HEALTH AND HUMAN SERVICES
AND THE COMMODITYCREDIT CORPORATION and FARM SERVICE AGENCY
U.S. DEPARTMENT  OF AGRICULTURE
 
The purpose of this Memorandum of Understanding (MOU) is to facilitate concurrent access to the United States Department of Agriculture's (USDA) Tobacco  Transition Assessment  Program (TTAP)  application and to ensure proper data protection  and safeguards of market share information about tobacco manufacturers and importers between the USDA, Commodity  Credit Corporation (CCC), Farm Service Agency (collectively, "USDA" unless otherwise noted) and the U.S. Department  of Health and Human Services, Food and Drug Administration  ('FDA") for the purpose of implementing the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.
 
The FSPTCA grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. FDA's tobacco regulation activities under the FSPTCA are funded through user fees paid by tobacco product manufacturers and importers. Fees are assessed for various classes of tobacco products based on their market share. Fees for individual manufacturers and importers are, in turn, based on their percentage share of the appropriate class.
 
The FSPTCA required FDA initially to enter into an MOU with USDA, as the appropriate Federal agency, that provided for the regular and timely transfer of information from those tobacco product manufacturers and importers who reported to CCC, and who were required to pay fees under FSPTCA. In August 2009, FDA and USDA entered into MOU Number 225-09-0009 to satisfy that requirement.
 
Beginning not later than fiscal year 2015, USDA will no longer receive data from domestic tobacco product manufacturers and importers. However, the FSPTCA requires that FDA ensure it is able to determine market share information and assess user fees. On July 10, 2014: FDAissued a final rule, codified at 21 C.F.R. Part 1150, requiring the submission of information to FDA that will allow FDA to carry out the FSPTCA's requirement to determine market share information and assess user fees. To facilitate its efforts to carry out this mandate, FDA entered into an agreement with USDA under which USDA provides FDA with access to and services in connection with FDA's use of the TTAP application to store, manage, and calculate individual entity market share and assess user fees.


 

Section 1. Definitions.
 
For the purposesof this MOU, the following definitions apply:
 
1.1       TTAP. The term "TTAP"means the Tobacco Transition Assessment Program. The TTAP is owned  by the USDA  and is an electronic application for which  the FDA  is reimbursing the USDA via an Inter-Agency Agreement to  be utilized by the FDA  to store,  manage, and calculate individual entity  marketshare. The data used to calculate the individual entity market share is confidential and highly sensitive.
 
1.2      FDCA. The term “FDCA"means the Federal Food,Drug, and CosmeticAct (21 U.S.C. 301 et seq.), as amended by the Family Smoking Preventionand Tobacco Control Act, PublicLaw 111-31 (FSPTCA).
 
1.3      Disclosure. The term "disclosure"means making information known to any person in any manner.
 
1.4      FDA.The term "FDA" means the Food and Drug Administration, United States Department of Health and Human Services.
 
1.5        FDA Official. The term “FDA Official" means the Director of the Division of Financial Management of FDA'sCenter for Tobacco Products (CTP), or successor, or delegate.
 
1.6      FDA Representative. The term "FDA representative" means the officer or employee of the FDA/CTP who is authorized to access TTAP.
 
1.7  FETRA. The term "FETRA" means the Fair and Equitable Tobacco Reform Act, Public Law 108-357.
 
1.8    FSPTCA. The term "FSPTCA"means the Family Smoking Prevention and Tobacco Control Act, Public Law 111 -31.
 
1.9      Inspection. The term ‘‘inspection"means any examination of market share information by an FDA representative or other individual.
 
1.10 Market Share. ''marketshare" means  the percentageshare  by class  of tobacco product for each  manufacturer or importerof a particular class  that is used in assessing fees as specifiedunder section  9I 9 of the FDCA.The term
 
1.11  Market Share Information. The term "marketshare information'' means: (a) a list of those tobacco manufacturersand importers that reported to USDA or the FDA, including, to the extent available, their billing addresses, phone   
          numbers, and TINs; and (b) either their individual market share or the data necessaryto calculate their individual market share.

 

1.12  USDA. The term "USDA” means the Commodity Credit Corporationor Farm Service Agency, United States Department of Agricuhure.
 
1.13 USDA Official. The term "USDA Official" means the Director, Fiber, Peanuts and Tobacco Analysis Group, Economic and Policy Analysis Staff or successor.
 
1.14 USDA  Representative.The term "USDA representative" means an officer or employee of the USDA or Farm Service Agency whois authorized to access TTAP.
 
Section 2. Introduction.
 
2.1       FDA and USDA are entering into this MOU to allow tor concurrent access to the TTAP application and to ensure that the proprietary market share information stored within the application is properly secured, maintained,
accessed, shared, and used by both the USDA and the FDA. FDA needs access to the TTAP application to carry out its statutory mandate to determine market share informationand assess user fees.  USDA needs access to the TTAP application in order to carry out its duties under its Interagency Agreement with FDA and to complete remaining work stemming from USDA's former stewardship of market share information prior to fiscal year 2015.
 
2.2         ln the interest of Government efficiency and effectiveness, this MOU provides the basis for the concurrent utilization of TTAP. The parties to this MOU will adopt data protection and safeguarding procedures as described in the Safeguard Procedures Report attached as Appendix A to this MOU that comply  with all applicable statutes, regulations, and procedures  for protecting  the confidentiality and security of market share information.
 
Section 3. Responsibilities. USDA Responsibilities.
 
3.1       The USDA Official will notify the FDA Official of the name(s) of the USDA Representative(s). Upon any change in employment, duties, or relevant matters affecting a USDA Representative's right of access to TTAP, the USDA Official will advise the FDA Official that such individual is no longer an USDA Representative.
 
As an express condition for the inspection of market share information and concurrent access to the TTAP, USDA agrees to comply with the safeguards and requirementsdescribed below:
 
(a)  The USDA Official will comply with the terms of the Safeguard Procedures Report (SPR) attached as Appendix A to this MOU; as more fully described in that SPR, the terms describe how market share information will be safeguarded by the USDA and how it will be protected by USDA from unauthorized disclosure or access.
 
(b)  The USDA Official  will furnish an annual Safeguard  Activity Report  (SAR) to the FDA Official  by September 30 of each year after execution of this Agreement  advising of:  (1) any minor changes to the procedures or safeguards described  in the SPR and future actions that could likely affect the USDA's safeguard  procedures;  and (2) summarizing the USDA'scurrent  efforts to ensure the confidentiality of FDA information. The SAR will be submitted in the form and manner specified by FDA.
 
(c) USDA will agree in writing that it will not further disclose market share information or any confidential commercial information acquired pursuant to FETRA,except with FDA'swritten permission.
 
3.3      Upon request by FDA, USDA will permit FDA to review the extent to which USDA is complying with the terms of the SPR.
  
FDA Responsibilities:
 
3.1        The FDA Official will notify the USDA Official of the name(s) of the FDA Representative(s). Upon any change in employment, duties, or relevant matters affecting an FDA Representative's right of access to TTAP, the FDA Official will advise the USDA Official that such individual is no longer an FDA Representative.
 
3.2      As an express condition for the inspection of market share information and concurrent access to the TTAP, FDA agrees to comply with the safeguards and requirements described below:
 
(a)  The FDA Official will comply with the terms of the Safeguard  Procedures Report (SPR) as attached  as Appendix  A to this MOU; as more fully described  in that SPR, the terms describe  how market share information win be safeguarded by the FDA and how it will be protected  by FDA from unauthorized disclosure or access.
 
(b)  The FDA Official  will furnish an annual Safeguard  Activity  Report (SAR)  to the USDA Official  by September 30 of each year after execution  of this Agreement advising  of:  (1) any minor changes to the procedures or safeguards described  in the SPR and future actions that could likely affect the FDA's safeguard  procedures;  and (2) summarizing the FDA'scurrent efforts  to ensure the confidentiality of USDA information. The SAR will be submitted in the form and manner specified by USDA.


 

3.3       Upon request by USDA, FDA will permit USDA to review the extent to which FDA is complyingwith the terms of the SPR.
 
Section 4. Administration. Reimbursement for Services. Termination,and Modification of Agreement.
 
4.1      The provisions  of this MOU are subject to the applicable  provisions of the FDCA, implementing regulations, published procedures of the parties hereto, and other applicable  provisions of Federal statutes and regulations, including FETRA and the regulations thereunder at 7 CPR Part 1463.
 
4.2       This MOU may be terminated or suspended by USDA or FDA due to changes in applicable Federal laws, any unauthorized use or disclosure of market share information furnished pursuant to this MOU or other substantial noncompliance with the terms of this MOU by either party, or for other good cause as determined by USDA or FDA. Termination or suspension will be accomplished upon 90 days written notice to the other party except that, and only when sufficient grounds exist to justify such action as determined by USDA or FDA, this MOU may be terminated or suspended upon less than 90 days written notice.
 
4.3       This MOU may be modified or extended only by mutual, written agreement.
 
4.4        Any disputes about the implementation of the Agreement or concerns of data protection will be resolved whenever possible by the FDA and USDA Officials.
 
4.5      This MOU will be effective for 6 years from the date of last signature, or upon the expiration of the FDA's utilization of TTAP, or when TTAP is no longer being accessed by any USDA Representative; unless terminated earlier in accordance with this MOU.
 
APPROVED:
 
Mitchell Zeller
 Food and Drug Administration
U.S. Department of Health and Human Services
 
March 6, 2015
 
Farm Service Agency
Commodity Credit Corporation
U.S. Department of Agriculture
 
March 16, 3015

 

 
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