Final RFI State Tobacco Inspections Program.pdf

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Food and Drug Administration Center for Tobacco Products

State Retail Tobacco Compliance Inspections Program Request for Information

I. DESCRIPTION

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Compliance and Enforcement is seeking information for services for which the Government intends to solicit and negotiate with ONLY state organizations under the authority of 41 U.S.C.

3304(a)(5). Potential contractors for this program shall only be an agency of a State/Territory government with the authority to conduct retail tobacco compliance check inspections within the jurisdiction. Examples of appropriate agencies may include public health departments, or food or drug agencies. FDA will award one contract per jurisdiction.

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This request for information does not commit the Government to contract for any supply or service whatsoever. Further, the Food and Drug Administration is not at this time seeking proposals and will not accept unsolicited proposals.

Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense.

II. BACKGROUND

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, adding a new chapter granting the Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by Underage Purchasers.

On August 8, 2016, the FDA regulation deeming additional tobacco products within FDA’s jurisdiction went into effect.

FDA currently has contracts with many of the U.S. States and Territorial governments to conduct retail inspections of tobacco retailers within their jurisdictions. The Contractor shall conduct tobacco retail inspections for compliance with certain provisions of the FD&C Act and these regulations with respect to retail outlets on behalf of FDA. Inspectors shall be persons who are United States citizens and who are also able to be commissioned as officers of the United States Department of Health and Human Services (HHS), Food and Drug Administration, under the authority of Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)), which includes any health, food, or drug officer/employee of the State, Territory, or political subdivision thereof.

Fiscal Year 2024 - 2029 Contract Type

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The Type of Contract will be a 5-year Indefinite Delivery Indefinite Quantity (IDIQ) Contract. All Task Orders issued will be cost reimbursement. Task Orders will be issued throughout the period of performance of the IDIQ. The number of inspections to be completed may be different in each task order. Typically, FDA will issue task orders for a twelve-month period of performance.

However, period of performance on each task order may range from a few months up to the entire length of the IDIQ period of performance as determined by the circumstances in each jurisdiction and FDA requirements.

The guaranteed minimum will be satisfied with the issuance of Task Order 1 for each jurisdiction.

Task Order 1 will be issued at time of award off the IDIQ for a specified period.

III. TASKS (STATEMENT OF WORK EXCERPT)

1. Program Management/Coordination

The Contractor shall designate the Key Personnel: one Program Coordinator (PC) and a Backup Program Coordinator (BPC), if one is designated by the contractor. The PC shall be the primary point of contact (POC) who will be responsible for overall coordination, gathering information and evidence, and communicating with FDA. The PC, BPC or designated alternate POC shall respond to CTP inquiries within two (2) business days. The PC’s level of effort must account for a larger portion of the program management than the level of effort by the BPC. Program Management involves the following activities:

• Facilitating background checks and the commissioning process, and securing signed

FDA Form 3398’s for all employees, including Underage Purchasers ages 18-20;

• Conducting background checks for Underage Purchasers ages 18–20 and providing confirmation to FDA prior to those individuals participating in inspections;

• Securing and maintaining all required information and documents regarding Underage

Purchasers;

• Ensuring no contract personnel have conflicts of interest;

• Attending initial, and refresher training, providing training to inspectors and Underage

Purchasers, and maintaining training records;

• The Contractor will provide information to FDA for adding retailers to and editing existing retailer data in the Tobacco Inspection Management System (TIMS) to maintain an up-to-date list;

• Storing and maintaining chain of custody of evidence, and otherwise facilitating inspections;

• Creating and submitting monthly status reports when inspections occur;

• Securing former inspectors as experts where necessary; and,

• Assisting FDA with post-inspection follow-up if required;

2. Compliance Check Inspections

Provide Retail Outlet List

The Contractor shall maintain an updated existing retailer’s list that will be supplied by the FDA with a detailed, accurate, and comprehensive electronic list of retail outlets. A retailer is any

3 | P a g e person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays of tobacco products are permitted under 21 C.F.R. Part 1140, as referenced at 21 C.F.R. §1140.3. A retail outlet is a physical location where a retailer sells tobacco product or operates a self-service display of tobacco product, which includes vending machines. These retail outlets may include, but are not limited to, supermarkets, convenience stores, bars, clubs, restaurants, casinos, gas stations.

Assigning and Conducting Inspections

The Contractor shall arrange tobacco compliance check inspections of retailers that sell or advertise commercial tobacco products to determine whether those retailers are complying with the Tobacco Control Act and the implementing regulations. Generally, the Contractor shall carry out two (2) types of tobacco compliance check inspection assignments: (1) undercover buy, to determine a retail outlet’s compliance with age and photo identification requirements; and (2) advertising and labeling, to cover other provisions of the Tobacco Control Act. In some instances, FDA may request that both types of assignments be conducted within a short timeframe (specified during training) of each other at a particular retail outlet.

The FDA will assign compliance check inspections of identified retail outlets to the Contractor via

TIMS.

FDA will request that certain retail outlets or areas to be inspected. The Contractor may determine the date of assignment, retailer location (selected from the retailer list). However, such inspection strategies are subject to review by the FDA who may require the Contractor to amend such strategies. FDA will administrate assignment of all inspections. The Contractor shall complete most inspections within 90 calendar days. The Contractor shall ensure these inspections are conducted within 14 days of a corresponding inspection. In some infrequent instances, FDA may request inspections to be completed within 5 calendar days or 15 calendar days.

For each retailer inspected, the Inspector shall record all inspectional information pertaining to that visit before moving on to the next inspection or at a minimum at the end of each inspection day for review.

3. Administration Duties

Commissioning

Prior to carrying out compliance check inspection activities, all Inspectors must be commissioned by FDA. All other employees under this Contract, or under any subcontract, including the Point of Contact (staff dedicated to overseeing the safety of the Underage Purchasers ages 16 - 17), administrative personnel, and supervisors will be subject to a background investigation and will be required to sign a Commitment to Protect Non-Public Information Agreement. Underage Purchasers will not be commissioned and will not undergo a background investigation by FDA.

However, the Contractor shall conduct background investigations of Underage Purchasers ages 18

– 20. The Contractor shall ensure that all Underage Purchasers ages 18 – 20 sign a Commitment to Protect Non-Public Information Agreement.

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In general, the commissioning process begins with a background investigation, including a fingerprint check, credit check, and childcare check facilitated by FDA. Several parties within HHS may be involved in the process, with oversight by the Center for Tobacco Products (CTP).

Any of these parties may contact the Contractor for additional information to facilitate the process.

Upon clearance of the fingerprint check, a person may be commissioned while the background investigation continues.

Within 30 calendar days of being awarded a contract, the Contractor shall provide the information for the available employees to be commissioned/receive background investigations.

Training

FDA officials will provide training regarding the FDA Tobacco Compliance Check Inspection Program to the Program Coordinator, Backup Program Coordinator, Inspectors and Underage Purchasers. Inspectors must be commissioned by FDA before accessing any training materials. The Contractor shall ensure that all Inspectors have taken and passed the FDA Tobacco Compliance Check Inspection Program Training before beginning initial inspections. Out-of-state travel is not anticipated for FDA-provided inspector training. Training will be conducted via teleconference, video conference, online learning management system, or via mobile device applications. The Contractor must ensure that all parts of the FDA Tobacco Compliance Check Inspection Program training are followed as prescribed. FDA will provide up to 24 hours of training during each year of the contract.

Information Regarding Underage Purchasers

Underage Purchasers are an integral part of conducting compliance check inspections to ensure compliance with tobacco laws and regulations. The Contractor shall recruit Underage Purchasers ages 16 to 20 to participate in the program. The Contractor shall conduct background checks on all Underage Purchasers ages 18 – 20, prior to working on the program.

The Contractor shall keep at least one photo on file of each Underage Purchaser involved in the Program. Underage Purchasers are to remain as confidential as possible. FDA needs to retain current contact information on all Underage Purchasers who leave the program for at least five (5) years after their departure.

The Contractor shall generate a unique identification number for each newly recruited Underage Purchaser and provide FDA the unique identification numbers at least fourteen (14) calendar days prior to the scheduled purchase attempt(s), with corresponding date of birth, gender, and state of legal residence to protect the confidentiality of the Underage Purchaser. The Contractor must secure and maintain confidential information, cross-referencing each unique identification number to a specific Underage Purchaser. The Contractor shall notify FDA if any of the Underage Purchaser information above changes.

FDA Enforcement Actions

Traditionally, FDA reviews the compliance check inspection recommendations and the accompanying evidence submitted by the Contractor.

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If FDA determines that enforcement action shall be taken against a retailer, FDA has several enforcement tools that it may use, including, for example: (1) issuance of a Warning Letter, (2) imposing an administrative civil money penalty (CMP) and/or a no-tobacco-sale order (NTSO), and (3) initiating judicial actions, such as a seizure or injunction.

If FDA takes enforcement action, the Contractor shall assist FDA with any needed follow-up related to the compliance check inspections. For example, the Contractor shall be responsible for securing prompt and continuing cooperation for cases that proceed to a hearing. The Inspector must remain available to testify as a witness and provide oral testimony following any compliance check inspection in support of an FDA enforcement action and shall provide such testimony upon request.

IV. REQUIRED SUBMISSION DATA

Please provide the following business information:

1. Information demonstrating that you are an eligible contractor and your authority to contract with the FDA as an agency or political subdivision of a State/Territory of the United States.

2. Unique Entity Identifier (UEI) Number

3. State/Territory Organization Name

4. State/Territory Organization Address

5. Point of Contact, phone number, website and email address

6. Type of organization under NAICS, as validated via the System for Award

Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at http://www.sam.gov/index.asp.

7. Response to the capability questions below.

V. CAPABILITY QUESTIONS

1. Please briefly describe your capability of managing and staffing this requirement with a PC, BPC, or POC, inspector(s) and underage purchaser(s). What sources would you use for staffing to ensure that inspectors meet the commissioning requirements?

2. Please briefly describe your capabilities for efficiently managing the administration of a federal contract with FDA. These activities include monthly invoice submission, submission of monthly reports, timely responding to FDA inquiries for follow up, maintaining evidence collected from inspections, managing government property, completing training, performing background checks on Underage Purchasers ages 18 – 20, and ensuring inspectors complete the commissioning process.

3. Are there any aspects of administration of a federal contract that might be difficult to perform in your state/territory?

4. Please provide the agency’s authority to perform the requirements within the jurisdiction.

http://www.sba.gov/ http://www.sam.gov/index.asp

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5. Does a subcontractor perform any of the work related to this requirement? If so, what percentage of the work is being performed by a subcontractor.

6. Is the PC and/or BPC an employee of the prime contractor? If not, what is the rationale?

7. Is the subcontractor a large or small business, a combination or other?

8. Please provide any comments about the Statement of Work Excerpt above?

VI. RESPONSE INSTRUCTIONS

Please submit the required submission data and your responses to the capability questions via e-mail before 11:00 AM Eastern Time on December 13, 2023, to Michele.Jackson@fda.hhs.gov.

Please include the following in the Subject Line of the email: The State of XXXX Response to the Request for Information for the Retail Tobacco Compliance Inspections Program

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Government Point of entry. However, responses to this notice are not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).