About FDA

MOU 225-09-0009


The purpose of the Memorandum of Understanding (MOU) is to facilitate the sharing of market share information about tobacco manufacturers and importers between the U.S. Department of Agriculture, Commodity Creditor Corporation (OCC), 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 genially and to reduce tobacco use by minors. FDA’s tobacco regulation activities under the FSPTCA will be 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 requires FDA to request USDA, as the appropriate Federal agency, to enter into an MOU that provides for the regular and timely transfer of information on those tobacco products manufacturers and importers who reported to CCC, and who are required to pay fees under FSPTCA. This MOU satisfies that requirement.
Section 1. Definitions.
 For the purposes of this MOU, the following definitions apply:
  • 1.1 FDCA. The term “FDCA” means the Federal Food, Dug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by the Family Smoking Prevention and Tobacco Control Act, Public 111-31 (FSPTCA).
  • 1.2 Disclosure. The term “disclosure” means making information know to any person in any manner.
  • 1.3 FDA. The term “FDA” means the Food and Drug Administration, United States Department of Health and Human Services.
  • 1.4  FDA Official. The term “FDA Official” means the Director of the Division of User Fees of FDA’s Office of Financial Management, or successor position.
  • 1.5  FDA Representative. The term “FDA Representative” means the office or employee of the FDA who is authorized in writing by the FDA Official to receive market share information from USDA on behalf of FDA.
  • 1.6 FETRA. The term “FETRA” means the Fair and Equitable Tobacco Reform Act, Public Law 108-357.
  • 1.7 FSPTCA. The term “FSPTCA” means the Family Smoking Prevention and Tobacco Control Act, Public Law 111-31.
  • 1.8 Inspection. The term “inspection” means any examination of market share information by an FDA representative or other individual.
  • 1.9 Market Share. The term “market share” means the percentage share by class of tobacco product for each manufacturer or importer of a particular class that is used in assessing fees as specified under section 919 of the FDCA.
  • 1.10 Market Share Information. The term “market share information” means: (a) a list of those tobacco manufacturers and importers that reported to USDA, including, to the extent available, their billing addresses, phone numbers, and TINS; and (b) either their individual market share or the data necessary to calculate their individual market share./
  • 1.11 USDA. The term “USDA” means the Commodity Credit Corporation or Farm Service Agency, United States Department of Agriculture.
  • 1.12 USDA Official. The term “USDA Official” means the Director, Fiber, Peanuts and Tobacco Analysis Group, Economic and Policy Analysis, Staff, or successor.
  • 1.13 USDA Representative. The term “USDA Representative” means an officer or employee of the USDA or Farm Service Agency who is authorized in writing to provide market share information to FDA on behalf of USDA. 
Section 2. Introduction
  • 2.1 FDA and USDA are entering into this MOU to facilitate the sharing of market share  information and to ensure such information is properly secured, maintained, accessed, shared and use.
  • 2.2 In furtherance only of implementing the FSPTCA, market share information (whether paper copy, photocopy, microfilm, magnetic media, or any other form), will be used only to the extent necessary to: (1) identify tobacco manufacturers and importers; (2) calculate assessments for tobacco manufacturers and importers subject to assessments under section 919 of the FDCA; and (3) carry out any other duty or responsibility under the FDCA, or to otherwise implement    the FSPTCA, consistent with the terms of this MOU.
  • 2.3  In the interest of Government efficiency and effectiveness, this MOU provides the basis for sharing and use of market share information. The parties to this MOU will explore and adopt mutually acceptable techniques and modes of sharing that comply with all applicable statutes,  regulations, and procedures for protecting the confidentiality and security of market share information. 
Section 3. Responsibilities
  •  3.1  Upon request by the FDA Official, the USDA Representative will provide to the FDA Representative market share information. USDA expects to only provide to FDA information amounting to a list of those tobacco manufacturers and importers that reported to USDA in accordance with FETA, including their billing addresses and TINS, and either their individual market share, or the tax data necessary to calculate their individual market share, for each of    the classes of tobacco products that will be the basis for the USDA assessment percentages under FETRA for the same quarter. USDA will provide this information to FDA only for the  purposes described in Section 2.2 of this MOU.
FDA Responsibilities:
  •  3.2 The FDA Official will make a written request to the USDA Official for the release to FDA of market share information sought. In addition, such written request will include a statement that the information is solely for the purposes described in this MOU and will be used in accordance with this MOU.
  • 3.3 The FDA Representative, to whom market share information has been provided under this MOU, may thereafter share such information with another FDA office or employee or third party to the extent necessary to fulfill the purposes described in Section 2.2 of this MOU and in a manner consistent with the terms of this MOU.
  • 3.4 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 market share information, the FDA Official will advise the USDA Official that such individual is no longer an FDA Representative.
  • 3.5  As an express condition for the inspection and sharing of market share information, 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) submitted to the USDA Official on the same date as the MOU; as more fully described in that SPR, the terms of that SPR describe how market share information will be provided to 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 each year after execution of this Agreement advising of: (1) minor changes to the procedures or safeguards described in the SPR and future actions that could likely affect the Agency’s safeguard procedures; and (2) summarizing the agency’s current efforts to ensure the  confidentiality of USDA information. The SAR will be submitted in the form and manner specified by USDA.
  • 3.6 Upon request from USDA, FDA will permit USDA to review the extent to which FDA is complying with the terms of the SPR.
  • 3.7  FDA recognizes that information is received from USDA contains information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations and must be protected from unauthorized use and disclosure. This includes 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), the Trade Secrets Act (18 USC 1905), and FDA regulation 21 CFR Part 20. FDA further recognizes that market share information is based upon certain records obtained by USDA from tobacco manufacturers and importers, and that disclosure and use of such records may be governed by 26 U.S.C. 6103.
  • 3.8  FDA will inform its representatives and other persons to whom disclosure or inspection of market share information is authorized of the criminal penalties and civil liability for the unauthorized disclosure of market share information. Such notification will be in writing.
  • 3.9  FDA will refer any Freedom of Information Act request for market share information obtained by FDA under this MOU to USDA for processing.
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 FETA and the regulations thereunder at 7 CFR 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, 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 FDA may request USDA to further analyze the data; in that event, FDA and USDA may enter into a reimbursable agreement to cover the cost of such additional analysis of data.
  • 4.5 Any disputes about the implementation of the Agreement or processing of requests will be resolved whenever possible by the FDA and the USDA Officials.
  • 4.6  This MOU will be effective for 6 years from the date of the last signature, or upon the expiration of USDA’s authority to carry out FETRA (excluding any market share information that USDA may    have determined while still authorized to carry out FETRA but not share with FDA prior to the expiration of FETRA authority), unless terminated earlier in accordance with this MOU.

FDA Contact

David Miller
Office of User Fees, Office of the Commissioner, FDA

USDA Contact

Scott Sanford
Farm Service Agency, USDA
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
August 13, 2009
Jonathan Coppess, J.D.
USDA Administrator of the Farm Service Agency
U.S. Department of Agriculture
August 17, 2009

Page Last Updated: 12/15/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English