RFI-TRIBAL INSPECTION PROGRAM.docx

Food and Drug Administration Center for Tobacco Products Tribal Commercial Tobacco Retailer 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 Tribal Retailers (American Indian and Alaska Native tribe) to conduct retail inspections in their jurisdictions under the authority of 41 U.S.C. 3304(a)(5). Potential contractors for this program shall only be an agency, subdivision, or an entity that is considered a part of the tribal government it represents. Examples of appropriate agencies may include public health departments, or food or drug agencies.

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.

To implement the FD&C Act, FDA currently has contracts with U.S. state and territorial governments to conduct inspections of tobacco retailers. FDA has a goal of establishing a contract, where feasible, with American Indian and Alaska Native tribes to conduct retail inspections in their jurisdictions. Potential Contractors shall be an agency, subdivision, or an entity that is considered a part of the tribal government it represents. Examples of appropriate agencies may include public health departments, or food or drug agencies. Other entities that may be considered include inter-tribal councils or entities owned by the tribe. To be considered, potential Contractors should provide information indicating how the entity is a part of the tribe it represents.

The Contractor shall conduct commercial 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.

III. TASK

1. Program Management/Coordination

The Contractor shall designate a primary point of contact (POC) who will be responsible for overall coordination, gathering information and evidence, and communicating with FDA. The POC shall respond within ten (10) business days to all requests made by the FDA. This position shall be the main point of contact for FDA. The POC must be available up to 5 hours per week. 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 18-20;

· Conducting background checks for Underage Purchasers ages 18 – 20 and providing

· Securing and maintaining all required information and documents regarding Underage Purchasers;

· Ensuring no contract personnel have conflicts of interest;

· If required, obtain written consent from the tribe to perform inspections on tribal land prior to conducting inspections;

· 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

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

2. Compliance Check Inspections

Provide Retail Outlet List

The Contractor shall supply FDA with a detailed, accurate, and comprehensive electronic list of retail outlets. A retailer is any 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 commercial 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 Inspectors 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 may need to coordinate these inspections so that they are conducted within 14 days of a corresponding inspection. In some infrequent instances FDA may request inspections to be completed within 15 calendar days or 5 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 aged 18 – 20. The Contractor shall ensure that all Underage Purchasers aged 18 – 20 sign a Commitment to Protect Non-Public Information Agreement.

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 POC, 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 seven (7) 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.

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), (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 FDA as an agency, subdivision, or an entity may be considered a part of the tribal government it represents.

2. UEI Number

3. Tribal Organization Name and Jurisdiction

4. 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 contract must be registered on the SAM located at http://www.sam.gov/index.asp.

7. A response to the capabilities questions below.

V. CAPABILITY QUESTIONS

1. Are you interested in contracting with FDA for the tasks described in this RFI in fiscal year 2025 or subsequent fiscal years?

2. Are there any aspects of these tasks that might be difficult to perform in your territory? If so, do you have any alternative suggestions to how the tasks could be completed that would make performance less difficult?

3. Please describe how your entity qualifies as a part of your tribe. Such information could include: (1) the method of the entity's creation; (2) the entity's purpose; (3) the entity's structure, ownership, and management, including the amount of control the Tribe has over the entity; (4) whether the Tribe intended for [the entity] to have tribal sovereign immunity; (5) the financial relationship between the Tribe and the entity; and (6) whether the purposes of tribal sovereign immunity are served by granting [the entity] immunity.

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

5. How many commercial tobacco retailers are eligible for compliance check inspections within your jurisdiction?

6. Assuming a maximum of 1 undercover buy and 1 advertising and labeling inspection per year per retailer in your jurisdiction, how many undercover buy and advertising and labeling inspections are you capable of performing in a 12 month period?

7. Please briefly describe your capabilities for efficiently managing the administration of a federal contract with FDA. These activities include regular 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, and ensuring inspectors complete the commissioning process.

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

9. If this work was offered under Public Law 93-638, Indian Self-Determination and Education Assistance Act, would it increase your interest in performing this work?

10. How long will it take you to respond to a solicitation of this magnitude?

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 April 5, 2024, to Janice.Heard@fda.hhs.gov.

Please include the following in the Subject Line of the email: Response to the Request for Information for the Tribal Inspection 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 to 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).