Solicitation 75F40126R00040.pdf

75F40126R00040

FDA Third Party Tobacco Retailer Inspection Services (Region 4)

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BACKGROUND/OBJECTIVES

1. BACKGROUND

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act or TCA) into law (Public Law 111-31). The mniTobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted the Food and Drug Administration (FDA) authority to regulate the manufacture, marketing, sale, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. FDA conducts compliance check inspections of tobacco retail establishments to help determine a retailer’s compliance with federal laws and regulations, including the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, and associated regulations.

To the extent feasible, FDA will contract with a state or U.S. territory to conduct compliance check inspections of tobacco retailers, as required under 21 U.S.C.

372(a)(l)(B)(i). FDA issues contracts with a state or U.S. territory to assist with compliance check inspections of retail establishments. FDA has a goal of establishing a contract, where feasible, with every state and U.S. territory. When FDA could not contract with states and U.S. territories, FDA has awarded contracts to third-party entities that are able to hire commissionable inspectors to do compliance check inspections of tobacco retailers in those jurisdictions. FDA currently requires third-party, tobacco retailer inspection services. Task orders will be issued under this required Indefinite Delivery Indefinite Quantity (IDIQ) Contract to perform the requirements identified in this Performance Work Statement (PWS).

FDA intends to establish contracts, where feasible, to support tobacco retailer inspection activities within designated jurisdictions. This Indefinite Delivery Indefinite Quantity (IDIQ) contract provides for tobacco retailer inspection services and related support services as described in Section C, PWS.

2. OBJECTIVES

The purpose of this IDIQ contract is to:

1. Conduct inspections of retailers that sell and advertise any regulated tobacco products to determine compliance with the provisions cited in Section C and submit inspection results to FDA.

2. Collect, document, and preserve evidence of inspections.

3. Support FDA in any enforcement or judicial actions, including coordinating the drafting and execution of declarations by the inspectors, arranging for their testimony if necessary, and furnishing evidence and narrative reports by the Inspectors and Underage Purchasers who participated in inspections.

4. Respond to inquiries by FDA concerning inspections, data, and other information associated with this program.

The Contractor shall assist FDA in implementing the provisions of the FD&C Act as amended by the Tobacco Control Act, and other applicable statutory and regulatory provisions applicable to retailers during the term of this IDIQ.

3. APPLICABLE LAWS AND REGULATIONS

REGULATIONS RESTRICTING THE SALE, DISTRIBUTION, AND

ADVERTISING OF REGULATED TOBACCO PRODUCTS TO PROTECT

CHILDREN AND ADOLESCENTS

The Tobacco Control Act required FDA to reissue the 1996 final rule, "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents." The FDA reissued this rule, which is codified at 21 Code of Federal Regulations (CFR) Part 1140 on June 22, 2010. These regulations established restrictions on the sale, distribution, and use of cigarettes and smokeless tobacco, to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with tobacco use. On August 8, 2016, the FDA regulation deeming additional tobacco products within FDA’s jurisdiction went into effect.

On December 20, 2019, the FD&C Act was amended to increase the federal minimum age of sale of tobacco products to 21 years of age.

The Contractor shall conduct tobacco inspections for compliance with certain provisions of the FD&C Act and these regulations with respect to retail outlets on behalf of FDA. For illustration purposes, some, not all, of the provisions that are subject to inspection by the Contractor under this IDIQ include, but are not limited to:

• Age and Photo Identification Restrictions - Retailers:

o May not sell regulated tobacco products to anyone younger than 21 years of age.

o Must verify the age of any person under age 30 purchasing regulated tobacco products by means of photo identification containing the bearer's date of birth.

• Advertising and Labeling Restrictions - Retailers:

o May not sell regulated tobacco products using vending machines.

o May not sell cigarettes, cigarette tobacco, or smokeless tobacco using self-service displays.

o May not break open cigarette or smokeless tobacco packages to sell products in smaller amounts such as single cigarettes (also called "loosies").

o May not sell cigarette packages containing fewer than 20 cigarettes.

o May not distribute or cause to be distributed free samples of regulated tobacco products, except for samples of smokeless tobacco products in the limited circumstances defined by the regulations.

o May not display advertisement for cigarettes tobacco/roll-your own tobacco, electronic nicotine delivery system (ENDS) / e-liquid products, or hookah tobacco, unless each advertisement bears a required warning statement specified by the regulations.

o May not sell flavored cigarettes.

o May not sell or distribute “new” tobacco products that lack the required marketing authorization.

Synar Regulation

In addition to the Tobacco Control Act, the Department of Health and Human Services (HHS) works to limit youth access to tobacco through the Synar Regulation. The Synar Regulation is administered by the Substance Abuse and Mental Health Services Administration’s Center for Substance Abuse Prevention (SAMHSA/CSAP), for all applicable regions.

The annual Synar survey is separate from the FDA inspections under this Contract. The funds used for the FDA State Tobacco Retail Compliance Check Inspection Program are restricted, by statute, for use only for FDA tobacco inspection efforts.

B.2 CONTRACT TYPE AND PRICE SCHEDULE

B.2.1 IDIQ CONTRACT STRUCTURE

This is a single award IDIQ contract under which FDA may issue task orders for tobacco retailer inspection services and related support. This contract utilizes a hybrid performance-based structure. Payment under each Contract Line Item Number (CLIN) is contingent upon successful achievement of the performance standards identified in Section C.

Task orders issued under this IDIQ may utilize Firm-Fixed-Price (FFP), Cost- Reimbursement (CR), Time-and-Materials (T&M), and/or Labor-Hour (LH) pricing arrangements, as appropriate to the specific task order requirement and in accordance with FAR Part 16.

The contract type applicable to each task order or Contract Line Item Number (CLIN) will be determined at the time of task order issuance.

B.2.2 ANTICIPATED USE OF CONTRACT TYPES

Inspection CLINs are FFP and payable upon Government acceptance of inspections meeting those standards. Task orders shall be structured as FFP to the maximum extent practicable.

Other contract types, including CR, T&M, and LH, may be utilized where the nature, scope, or level of effort cannot be reasonably defined in advance. If FFP is determined to be unsuitable, the Government may authorize the use of alternative contract types subject to the conditions below:

• CR: May be used when the nature or extent of the work cannot be sufficiently determined to permit reasonable FFP pricing. CR CLINs may include program management activities, non-inspection travel, other direct costs (ODCs), and witness testimony compensation. All CR costs shall comply with FAR Part 31 and applicable cost principles. Task orders shall be established with applicable Not-to-Exceed (NTE) ceilings.

• T&M: T&M CLINs may be used only when it is not possible to accurately estimate the duration or extent of the work and neither FFP nor CR is suitable. T&M task orders shall establish ceiling prices in accordance with FAR 16.601.

• LH: LH CLINs may be used when labor requirements can be identified but the extent of effort cannot be reasonably estimated. LH task orders shall establish ceiling labor hours and shall be justified in accordance with FAR 16.602.

B.2.3 CONTRACT MINIMUM AND MAXIMUM

The Contractor guaranteed minimum of $10,000.00 is anticipated to be satisfied upon task order contract award. The maximum value of all task orders issued under this IDIQ shall not exceed $33,500,00.00. The contract minimum and maximum value(s) over five

(5) years and awarded under this contract are shown below:

Region 4 Contract

Minimum Maximum

Contract Value over 5 years

Alaska, Arizona, California, Colorado, Hawaii, Idaho, $10,000 $33,500,000.00

Montana, Nevada, Oregon, New Mexico, Utah, Washington, Wyoming.

B.2.4 TRAVEL

Contractor personnel may be required to travel to fulfill the requirements of this contract, as specified in each task order. For task orders requiring travel, specific travel requirements will be included in the Task Order’s request for proposal. Travel shall not commence without prior written consent from the Contracting Officer and Contracting Officer’s Representative

(COR).

If authorized in the task order, travel cost will be reimbursed at actual cost in accordance with the limitations set forth in FAR Subpart 31.205-46, Travel Costs and the Federal Travel Regulations (FTR). Profit shall not be applied to travel costs. To the extent authorized by the task order, Contractors may apply indirect costs to travel in accordance with its established accounting practices, consistent with FAR 31.2. Any required non-inspection travel is Not-to-Exceed (NTE): $10,000 per jurisdiction.

B.3 PRICING

B.3.1 INSPECTION UNIT PRICES (FFP)

The Contractor shall propose a fully burdened FFP unit price for each inspection type:

1) Undercover Buy (UB)

2) Advertising & Labeling (A&L)

The proposed unit price shall be fully burdened and include all costs directly associated with performing the inspection, including inspector labor, underage purchaser coordination, local inspection-related travel, inspection scheduling and coordination, evidence handling, training, supplies, and all applicable indirect costs. The proposed unit prices shall not include separately priced Program Management CLIN costs. These proposed unit prices shall establish the maximum ceiling rates applicable to future task orders issued under this IDIQ. Offerors may propose different unit prices for each contract year.

B.3.2 PROGRAM MANAGEMENT

The contract type applicable to Program Management and the number of hours required will be specified at the task order level. The price/cost for Program Management shall consist of fully loaded labor rates for the Program Coordinator (PC), Backup Program Coordinator (BPC) and costs related to locating Underage Purchasers and inspectors that have left the program. PC labor shall be ≥ 51% of combined PC/BPC effort. The price/cost shall include all fringe benefits, overhead, G&A, and administrative costs associated with program management.

The contract type for Program Management may be:

• FFP,

• CR,

• LH, or

• T&M, The Contractor shall propose:

• monthly FFP pricing for Program Management and

• fully burdened hourly labor rates for Program Management labor categories.

Note: The proposed CR rates are for cost estimation purposes and will be used to calculate estimated costs and NTE amounts in CR task orders. Actual reimbursement will be based on allowable costs incurred in accordance with FAR Part 31.

B.3.3 OTHER DIRECT COSTS (ODCs), TRAVEL, AND WITNESS

TESTIMONY (CR)

Non-inspection travel, ODCs, and witness testimony costs may be reimbursed on a Cost-Reimbursement basis when authorized by the task order.

All reimbursable costs:

• must be allowable, allocable, and reasonable;

• require prior CO/COR approval where applicable; and

• shall be subject to applicable Not-to-Exceed (NTE) ceilings established in the task order.

Travel reimbursement shall comply with FAR 31.205-46 and applicable Federal Travel Regulations (FTR). Profit shall not be applied to travel or ODC reimbursements.

B.3.3.1 Non-Inspection Travel, ODCs, and Witness Testimony – Cost Reimbursement (Line Item 0003)

The Contractor shall only be reimbursed for allowable, allocable, and reasonable costs for performance of non-inspection related travel, ODCs, and Witness Testimony related costs.

B.3.3.2 Non- Inspection Travel

The Contractor shall include costs for the PC and BPC to travel to the closest FDA offices to receive equipment, background checks, and security clearances/badges. Non-inspection travel costs shall only be included in task orders where this travel is anticipated. Non-inspection travel shall not exceed $10,000 per jurisdiction.

*Non- Inspection Travel per Jurisdiction

Not-to- Exceed Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year

$10,000 $10,000 $10,000 $10,000 $ I 0,000

B.3.3.3 Other Direct Cost (ODC)

Other Direct Cost (ODC) per entire Region

No-to- Exceed Year

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year

$100,000 $100,000 $100,000 $100,000 $100,000

ODC shall include other allowable costs not included in the fixed price per inspection. ODCs include supply purchases, (for example, file cabinets, secure evidence storage, Wi-Fi, postage, hardware, and connectivity), necessary to perform this requirement. Prior approval for ODC purchases shall be obtained from the CO and COR. All documentation including the approval must be provided to FDA when invoicing. Purchases that are not approved by the COR and CO will not be reimbursed.

B.3.3.4 Witness Testimony Compensation

Compensation for Witness Testimony

Not-to- Exceed Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year 5

REGION 4 $10,000 $10,000 $10,000 $10,000 $10,000

Witness testimony cost for Inspectors and Underage Purchasers shall not exceed $50,000 for the life of the IDIQ. Compensation for witness testimony costs will be reimbursed based on hourly labor rates. Compensation is based on the amount of time testifying. Typically, witness testimony will be conducted via teleconference during normal business hours.

The time required to testify as a witness and provide oral testimony may be up to five (5) hours per enforcement action that may require witness testimony.

B.3.3.5 Unallowable Costs

Notwithstanding Clause 52.216-7, Allowable Cost and Payment, and Clause 52.244-2, Subcontracts, of the Federal Acquisition Regulation (FAR), unless otherwise expressly provided elsewhere in the Contract or in any modification thereto, the cost of the following items or activities shall be unallowable as direct costs:

• Acquisition by purchase or lease of any interest in real property.

• Special rearrangement or alteration of facilities.

• Purchase, lease, or rental of any item of general purpose such as office furniture or office equipment (including data tapes).

• Travel to foreign countries; and food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel Regulations; and

• Costs associated with non-FDA provided training to include registration, travel, and lodging costs.

B.4 PAYMENT

B.4.1 FFP INSPECTION PAYMENTS

FFP inspection CLINs shall be paid based on the number of inspections completed and accepted by the Government during the invoicing period.

The Government is obligated to pay only for inspections successfully completed and accepted in accordance with Section E.

B.4.2 OTHER CONTRACT TYPES

Payments for CR, LH, or T&M CLINs shall be made in accordance with the applicable FAR clauses incorporated into the contract and the pricing arrangement identified in the task

B.5 INITIAL TASK ORDER

The Government intends to issue an Initial Task Order concurrent with award of the IDIQ contract. The Initial Task Order will be based on the requirements for Alaska, as provided in Section J, Attachment 5, and shall be priced using the labor categories, contract-year labor rates, and ODCs awarded under the IDIQ contract. The Initial Task Order will serve as a benchmark for evaluating the reasonableness and consistency of pricing proposed for subsequent task orders. Subsequent task orders will be priced using the labor categories and contract-year labor rates established under the IDIQ contract.

B.6 IDIQ CEILING RATES AND PRICES

To facilitate rapid task order issuance and ensure price reasonableness, the Contractor shall propose ceiling rates and prices for the contract types that may be used in task orders. These ceiling rates will be incorporated into the IDIQ contract at award and will serve as the maximum rates/prices that may be used in any task order.

Note: Actual rates/prices used in specific task orders may be negotiated below these ceilings based on the specific requirement, market conditions, or other factors.

However, no task order shall include rates or prices exceeding these IDIQ ceiling amounts without a bilateral modification to the IDIQ contract.

SECTION C- DESCRIPTION/SPECIFICATIONS/PERFORMANCE WORK

STATEMENT

C. 1 GENERAL

C.1.1 SCOPE OF WORK (HYBRID PERFORMANCE-BASED)

Independently, and not as an agent of the Federal Government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. The Contractor shall coordinate the work under this contract with other tobacco enforcement activities as requested. All work will be performed in accordance with the terms of this contract and any Task Order issued hereunder.

Attachment 1 - Material List contains a list of materials necessary for conducting FDA tobacco compliance check inspections. FDA is anticipating inspection services in the region listed in the table below. The estimated number of inspections per period of performance will be provided in each task order for the respective jurisdiction. The actual number of retailers in each jurisdiction varies.

This requirement utilizes a hybrid PWS in accordance with FAR Subpart 37.6. To the maximum extent practicable, the contract is performance based, and requirements are expressed in terms of required outcomes, measurable performance standards, Acceptable Quality Levels (AQLs), and Government surveillance methods.

However, due to statutory, regulatory, evidence handling and inspector commissioning requirements associated with FDA tobacco compliance inspections, certain elements of the work are prescriptive and must be performed in accordance with Federal law (21 U.S.C. § 372), FDA policies and procedures, and evidentiary standards required for enforcement actions. These prescriptive elements are necessary to ensure compliance with statutory and regulatory mandates and cannot be specified solely through performance outcomes. This hybrid approach ensures Contractor flexibility in achieving outcomes and strict compliance where required by law or regulation.

C.1.2 PERFORMANCE OBJECTIVES

The following performance objectives describe the intended outcomes of this requirement and provide a high-level framework for Contractor performance under this contract. These objectives are not separately priced requirements but are reflected in the tasks and deliverables defined throughout this Performance Work Statement:

1. Conduct compliant tobacco retail inspections in accordance with the FD&C Act and FDA protocols.

2. Collect, preserve, and transmit accurate inspection data and evidence suitable for administrative or judicial enforcement.

3. Maintain commissioned and qualified personnel.

4. Ensure timely reporting, responsiveness, and program management oversight.

5. Protect confidential information, maintain evidence integrity, and safeguard

Government-furnished property.

The Contractor shall coordinate work under this contract with other tobacco enforcement activities as directed by FDA. All work shall be performed in accordance with the terms of this contract and applicable task orders. FDA is anticipating inspection services in the region listed in the table below. The estimated number of inspections per period of performance will be provided in each task order for the respective jurisdiction. The actual number of retailers in each jurisdiction varies.

C.1.3 GEOGRAPHIC SCOPE

Region Jurisdictions

Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, Oregon, New Mexico, Utah, Washington, Wyoming.

The estimated number of inspections will be specified at the task order level for each jurisdiction. The actual number of retailers varies by jurisdiction.

There is no guarantee that the Contractor will receive task orders for all jurisdictions or states located within a region.

Region 4 – Alaska Task Order

Inspections

UB A&L

Alaska 250 100

*Number of Undercover Buys and Advertising and Labeling is based off the Initial task

C.2 TECHNICAL REQUIREMENTS

C.2.1 CONTRACTOR RESPONSIBILITIES

The Contractor shall be capable of employing individuals who can be commissioned in accordance with Section 702(a)(l)(A) of the FD&C Act (21 U.S.C. § 372(a)(l)(A)) to conduct inspections. Specifically, the Contractor, its employees, and/or subcontractor shall be capable of performing the requirements of this contract. Non-commissioned Contractor personnel shall assume only administrative, planning, and logistical functions that may be performed without a commission. This encompasses all functions except performing inspections.

Employees of any subcontractor serving as inspectors will be required to undergo the commissioning process described below.

The Contractor shall provide all personnel, management, coordination, and support necessary to perform tobacco retail compliance check inspections and associated support services under this contract and applicable task orders. The Contractor shall ensure that 100% of inspectors performing inspections under this contract should meet the requirements to be commissioned in accordance with Section 702(a)(l)(A) of the FD&C Act (21 U.S.C. § 372(a)(l)(A)) prior to conducting inspections.

Performance Standards:

• 99% of required inspection support functions performed in accordance with contract requirements

• 99% of task order requirements performed within required timeframes

• Contractor staffing and support functions maintained at a level sufficient to meet inspection, reporting, and evidence requirements

AQL:

• 99% compliance with the performance standards identified above.

• 100% compliance with mandatory contract requirements and mandatory statutory, regulatory, safety, security, and certification requirements.

Surveillance Method:

• COR or designee monitoring

• Review of reports, deliverables, and staffing records

• Task order performance review

Prescriptive Requirements:

Specifically, the Contractor shall be capable of performing all requirements under this contract, including inspection support, program management, reporting, evidence handling, personnel administration, and responsiveness to FDA requests. Non-commissioned personnel may only perform administrative, planning, and logistical functions that do not require FDA commission. Subcontractor personnel performing inspections must satisfy the same applicable requirements as prime contractor personnel, including commissioning and background requirements where applicable.

C.2.2 BACKGROUND INVESTIGATIONS/COMMISSIONING PROCESS

Performance Requirement: Personnel Eligibility

The Contractor shall ensure that all inspectors, key personnel, subcontractors, and underage purchasers (those who are ages 18-20 years of age) shall satisfy background investigation, applicable eligibility, and commissioning requirements before participating in the program.

Performance Standards:

• 100% of required personnel complete required background investigations before participating in program

• 100% of required commissioning documentation is submitted before personnel begin inspection duties

• 100% of employment status changes reported within two (2) business days.

• 100% of credentials returned within five (5) business days of personnel separation.

AQL:

• 100% compliance with all performance standards

Surveillance Method:

• COR or designee review of staffing and clearance records

• Verification of credential return and personnel status notifications

Prescriptive Requirements:

Prior to carrying out compliance check inspection activities, all Inspectors must be commissioned by FDA. The Contractor shall provide the information for the available employees and Subcontractors to be commissioned/receive background investigations, and immediately upon identifying new staff it wishes to have commissioned.

The Contractor shall provide the COR with all necessary information for Commissioning, including a list that contains the following information for each potential Commissioned Officer: Full Legal Name, current employer, current job title, expected role in the program, full physical work address (PO Box will not be accepted), work number, cell number, and email address. The Contractor shall notify the FDA COR of any changes of employment status within two (2) business days and return the Commissioned Officers credentials within five (5) business days of the Officer no longer working under this Contract.

The Contractor shall provide the COR with required information for all employees and subcontractors who will perform work under this contract and require commissioning and/or a background investigation. The Contractor shall submit this information prior to the individual participating in the program or performing inspection duties under the contract. For personnel hired after contract award, the Contractor shall submit the required information within two (2) business days of assigning the individual to perform work under this contract. The Contractor shall ensure that all personnel satisfy applicable eligibility, background investigation, and commissioning requirements before participating in the program. The Contractor shall ensure all personnel meet eligibility requirements prior to participation.

For each potential commissioned officer, the Contractor shall provide the COR at a minimum:

• full legal name

• current employer

• current job title

• expected role in the program

• full physical work address (PO Box will not be accepted)

• work telephone number

• cell telephone number

• email address

The Contractor shall ensure personnel status changes are communicated to the FDA COR.

The Contractor shall notify the FDA COR of any employment status change within two (2) business days of the status change and shall return commissioned officer credentials within five (5) business days of the separation from then contract.

All personnel under this contract or subcontracts who will have access to non-public information shall undergo required background investigation and sign the 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.

The Contractor shall submit contact information for the person(s) or entity most familiar with their organization's background investigation procedure. If applicable, the Contractor must also provide security contact information for individuals that the Contractor intends to subcontract. FDA's Office of Security Operations (OSO) conducts a Tier 2 - Federal Level 5 Moderate Risk Public Trust Background Investigation.

Additionally, OSO will evaluate the clearances currently held by each individual required to have a background check under the Contract. If OSO determines that any additional element or information is needed to complete the required clearances, OSO will facilitate this process.

Candidates that do not complete and submit the required paperwork within 60 calendar days of receipt from OSO will be removed from the commissioning process. FDA will not consider resubmission of candidates who are removed from the commissioning process.

Receiving a commission signifies that the employee has accepted a position of public trust and must comply with all applicable federal laws and ethical standards. Each FDA commission is issued for a period of five years. The Contractor is responsible for immediately notifying the COR of any event or occurrence that could affect or change an employee or subcontractor commissioning status, including but not limited to the reasons for revocation outlined below.

The issuance of a commission is discretionary, and FDA may revoke a commission at any time. FDA may recommend removal of the commission if an inspector repeatedly fails to follow FDA procedures.

Other reasons for revocation may include, but are not limited to:

• Repeated failure to follow FDA procedures.

• The abuse or misuse of the commission.

• The transmittal of confidential information from a commissioned officer to individuals who are not employees or commissioned officers of HHS.

• A conflict of interest.

• Change in criminal or credit history.

• Substance abuse.

• Failure to notify FDA regarding any event or occurrence that could affect or change their status such as a change in job; or

• Behavior that may discredit FDA.

Upon separation of a commissioned employee or subcontractor employee, the Contractor shall ensure FDA receives written notification of the commissioned employee’s separation within two (2) business days of notice given by or to the commissioned employee, including the reason for the separation, and the commissioning credentials and all government furnished equipment (GFE) shall be returned to FDA within five (5) business days as instructed by the COR.

C.2.3. KEY PERSONNEL: PROGRAM COORDINATOR/BACKUP PROGRAM

COORDINATOR

Performance Requirement:

The Contractor shall maintain effective key personnel coverage sufficient to ensure continuous operational oversight, communication, and program continuity.

Performance Standards:

• PC or BPC is available during normal business hours

• Responds to FDA inquiries within two (2) business days.

• Maintain accurate official inspector and underage purchaser rosters

• Maintains accurate personnel eligibility and commissioning records.

• 98% compliance with PC/BPC availability and response time requirements.

• 100% accuracy of official inspector and underage purchaser rosters

• 100% accuracy of personnel eligibility and commissioning records

• COR or designee review of communications and reports

• Review of rosters and staffing updates

Prescriptive Requirements:

The Contractor shall designate a Program Coordinator (PC) and a Backup Program Coordinator (BPC). The PC shall serve as the primary point of contact for FDA and shall be responsible for overall contract coordination, collection of required information and documentation, communications with FDA, and all aspects of program management work described in Section C.2. The BPC shall serve as the alternate point of contact and shall perform the responsibilities of the PC during periods when the PC is unavailable.

The PC and BPC shall be employees of the Prime Contractor. The Contractor shall maintain continuous coverage for these functions throughout contract performance and shall provide sufficient staffing to successfully perform all program management requirements. The Contractor shall acknowledge FDA inquiries within two (2) business days and notify the COR of any changes to the PC, BPC, Inspectors, Underage Purchasers, or their contact information.

C.2.4 INSPECTORS

The Contractor shall maintain a qualified inspector workforce capable of performing assigned inspections in accordance with FDA requirements.

Performance Standards:

• 100% of inspections performed by FDA-commissioned inspectors

• Inspector staffing maintained at levels sufficient to meet task order requirements and deadlines

• Current required contact information for inspectors and underage purchasers is maintained and updated

AQL:

• Zero inspections conducted by inspectors who have not been commissioned by

FDA

• 99% compliance with task order staffing requirements

• 100% accuracy of required inspector and underage purchaser contact information

• COR or designee review of inspection assignments and staffing records

• TIMS review

• Monthly report review

The Contractor shall ensure that compliance check inspections are conducted only by persons who are United States citizens and 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)(l)(A) of the FD&C Act (21 U.S.C. § 372(a)(l )(A)), which includes any health, food, or drug officer or employee of the State, Territory, or political subdivision thereof.

Due to logistics and associated expenses, the Contractor shall have no more than thirty

(30) Inspectors. Inspectors must maintain regular performance of inspections to remain active on a task order within this contract. Inspectors that do not perform a minimum of l 0 inspections per month in their respective jurisdictions may be deactivated from the program.

The Contractor shall inform all Inspectors that they may be needed to testify as witnesses in administrative hearings during the period of performance of the contract. The Contractor shall maintain current personal contact information for all inspectors and Underage Purchasers currently employed by the Contractor (e.g., phone number and email address)

The Contractor shall annually verify current contact information for all inspectors and Underage Purchasers who were employed within the past five years but are no longer employed by the Contractor, and the most recent contact information for such inspectors and Underage Purchaser shall be provided to FDA. Additionally, FDA may request individual contact information for inspectors who have left the program that shall be provided within two (2) business days of the request.

C.2.5 UNDERAGE PURCHASERS

The Contractor shall recruit, manage, protect, and maintain an underage purchaser program that complies with legal, procedural, safety, and documentation requirements

Performance Standards:

• Age verification documentation maintained

• Required parental or guardian consents secured before participation by minors

• Required legal immunity secured before performance where applicable

• Required insurance coverage maintained before any inspection activity

• Required background checks completed for underage purchasers ages 18 to 20 prior to performing work under the contract

• Maintain an underage purchaser pool representing each required age group (16–20).

AQL:

• Zero inspections involving underage purchasers conducted without required parental/guardian consent, legal immunity (where applicable), insurance, or required background checks.

• 100% compliance with required documentation

• 100% compliance with age group representation requirements.

• COR review of supporting records

• Site visit review

Underage Purchasers are integral to conducting compliance check inspections. The Contractor, rather than FDA, has the oversight responsibility for Underage Purchasers involved in the Program. The Contractor shall recruit a mix of Underage Purchasers ages 16 to 20 to participate in the program. The Contractor must recruit Underage Purchasers from each age group. Underage Purchasers who are 16 or 17 years-old are also minors, and as such, have special protections that are discussed below. 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 (1) photo on file for each Underage Purchaser involved in the Program and a copy of a valid photo identification (ID) card. FDA protocol does not require Underage Purchasers to carry photo identification for the undercover buy assignments. However, the Contractor may determine that the Underage Purchaser should carry valid photo identification and present identification if requested.

Such decisions are left to the discretion of the Contractor. The Contractor shall ensure that all Underage Purchasers follow the chosen protocol consistently.

The Contractor shall ensure that the Underage Purchasers are within the required age range by obtaining a copy of their birth certificates and/or other government-issued identification and for Minors, an original parental/legal guardian consent form. The Contractor shall obtain written permission from the Minor's parents/legal guardian and school, unless home schooled or otherwise not enrolled if the Minor is going to conduct undercover buy assignments during school hours.

Identities of Underage Purchasers are to remain as confidential as possible. The Contractor shall inform the Underage Purchaser (and if the Underage Purchaser is a Minor, their parents/legal guardians) that the Underage Purchaser may be needed to testify as witnesses in administrative hearings during and after the period of performance of the contract. This information must be documented (in the parental/legal guardian consent form if the Underage Purchaser is a minor). The Contractor shall maintain current contact information on all Underage Purchasers who are currently employed by the Contractor or leave the program, and this information shall be turned over to the Government annually.

All participating Minors shall have a Medical Release form signed by a parent or legal guardian authorizing emergency medical treatment, while under the supervision of a commissioned officer or chaperone as required by the laws within the jurisdiction.

Supervising adults shall have access to the Medical Release for minors in the field whenever a minor is participating in inspections or training.

The Contractor shall secure a grant of immunity from the proper authorities in any jurisdiction where it would be illegal to use Underage Purchasers to conduct undercover buy assignments or where a purchaser’s possession of tobacco products is illegal, prior to using Underage Purchasers in those jurisdictions. The proper authorities would be those authorities that may grant immunity to Underage Purchasers from prosecution under applicable law. The Contractor shall provide proof of such immunity upon request from

FDA.

The Contractor shall ensure that all Underage Purchasers are insured against accidents or other injuries. If the Underage Purchaser are not covered under the Contractor's current insurance policy, the Contractor shall purchase the necessary insurance. The Contractor shall not conduct inspections until such insurance is secured for Underage Purchasers.

Proof of insurance, including automobile liability coverage for commissioned officers and chaperones transporting Underage Purchaser, shall be maintained by the Contractor, and made available to FDA upon request.

The Contractor shall generate a unique identification number for each Underage Purchaser and maintain cross-reference records in order to protect the identify of each Underage Purchaser. The Contractor shall enter required Underage Purchaser’s unique identification number into FDA’s Tobacco Inspection Management System (TIMS) prior to participation. The Contractor shall update TIMS with each Underage Purchaser’s unique identification number, and date of birth prior to the Underage Purchaser beginning work on this contract. For Underage Purchasers ages 18-20, the Contractor shall update TIMS with confirmation of completion of required background check.

C.2.6 CONFLICTS OF INTEREST

Performance Requirement

The Contractor shall ensure that all covered personnel remain free from actual, potential, or apparent conflicts of interest and comply with all applicable conflict of interest requirements. The PC, BPC, and individuals participating in compliance check inspections or responsible for compliance information or evidence are considered “covered persons”.

• Actual, potential, or apparent conflicts of interest are disclosed to the COR immediately in writing.

• Conflict of interest Investigation findings are submitted to the COR within 30 calendar days of identification.

• 100% compliance

• COR review of disclosures, investigations, and mitigation actions

Covered personnel include: 1) PC; 2) BPC; 3) inspectors; and 4) personnel responsible for compliance information or evidence.

Covered companies include: (1) any company that the covered person inspects; (2) any company for which compliance data or evidence is collected; or (3) any tobacco manufacturer, distributor, or importer.

Examples of significant financial interests include:

• The covered person or a close family member owns stock in a covered company, other than through ownership of shares of a mutual fund that invests in a covered company. ·

• The covered person or a close family member serves as an employee, trustee, officer, or director of a covered company.

In addition, a covered person shall not participate personally or substantially in any matter under the Contract that may significantly affect that person's own financial interests or the financial interests of:

• His or her spouse or minor child.

• An organization in which he or she serves as an officer, director, trustee, general partner or employee.

• His or her general partner; or

• A person with whom he or she is negotiating for or has an arrangement concerning prospective employment.

Upon discovery of a possible conflict of interest involving an employee or a subcontractor's employee, the Contractor shall immediately notify FDA in writing.

The Contractor shall investigate all possible conflicts of interest and provide findings to the COR within 30 days of learning of the possible conflict of interest. FDA reserves the right to determine whether the possible conflict of interest precludes the inspector from conducting inspections under this contract.

The above-mentioned requirements are contractual, and do not alter, modify, or replace obligations imposed on the Contractor and its PCs, or Commissioned Officers by any applicable federal law or ethical standard.

C.2.7 PROGRAM MANAGEMENT TASKS

The Contractor shall manage program operations to ensure timely reporting, maintenance of required program records, equipment accountability, and personnel training in accordance with contract requirements.

• Monthly reports submitted by the 10th business day

• Required equipment inventory submitted quarterly and within 10 business days of FDA requyest

• Required personnel training completed and maintained

• 98% compliance with reporting and deliverable timeframes

• 100% completion of required personnel training

• 100% submission of required equipment inventories

• COR review of reports and deliverables

Prescriptive Requirements

The Contractor shall conduct all program management tasks through its key personnel, the PC and BPC, or designated administrative personnel in the absence of the PC and BPC. The key personnel shall serve as the primary point of contact with FDA. These tasks include, the following areas as described in detail elsewhere in the PWS:

a. Recruiting, hiring, and training all Contractor and subcontractor employees involved with conducting tobacco retail compliance check inspections.

b. Facilitating the processing of background investigations and FDA Commissions, providing timely notification of personnel changes to FDA, and ensuring timely execution of any required follow-up actions related to onboarding new Contract personnel (e.g., initiating background investigations) or processing outgoing personnel (e.g., return of credentials and equipment) (C.2.2).

c. Securing a signed FDA Form 3398 for each Contractor employee and a substantially similar agreement from each subcontractor who is or will be involved in the inspection program under this Contract or who has or will have access to any non-public information arising under or related to this Contract (TIMS/Confidentiality section).

d. Securing and maintaining all required information and documents pertaining to inspectors, and Underage Purchasers, including maintaining current contact information for currently employed and former inspectors, and Underage Purchasers who participated in inspections within the past five (5) years (C.2.4 and C.2.5).

e. Securing and maintaining a grant of immunity for Underage Purchasers from the proper authorities, as appropriate (C.2.5).

f. Monitoring and providing immediate notification to FDA of any actual, apparent, or potential conflicts of interest for any Contractor or subcontractor personnel, and otherwise ensuring that all contractual requirements relating to conflicts of interest are met (C.2.6).

g. Facilitating timely completion of all training requirements for all employees or subcontractor employees under this Contract.

h. Ensuring all contractual requirements for inspection procedures are communicated, implemented, and followed by all Contractor and subcontractor employees.

i. Ensuring that an inventory of all FDA-issued equipment assigned to the Contractor (including mobile devices) is completed and submitted to FDA quarterly and within ten (10) business days of FDA’s request. The inventory shall include who is assigned the equipment. FDA must be alerted within one

(1) business day if FDA-issued equipment protocol is not followed or if FDA-issued equipment is lost or stolen

j. Storing and maintaining chain of custody of evidence according to FDA guidelines, and otherwise facilitating inspections (Evidence Handling Section).

k. Coordinate with FDA on responses to press inquiries and press announcements on the FDA Tobacco Compliance Check Inspection Program and its results.

l. Reviewing inspection results submitted by inspectors and reports provided by FDA to monitor inspection quality and ensure conformity with acceptability requirements in the contract.

m. Proactively informing FDA of any issues and problems that should be addressed in order for the overall effective accomplishment of task order goals. Corrective actions that need to be taken by the Contractor shall be clearly defined and communicated to FDA and have identified dates for completion.

n. Assisting FDA with post-inspection follow-up, if required.

o. Securing current and former inspectors as witnesses, where necessary.

p. Submitting monthly reports and invoices (Monthly Reporting/Invoices Section)

C.2.8 LOCATING INSPECTORS AND UNDERAGE PURCHASERS

The Contractor shall locate former inspectors and underage purchasers and coordinate their availability for enforcement support.

Performance Standards:

• Contact information provided within 10 business days

• Reasonable effort documented when unsuccessful

AQL:

• 100% compliance

Surveillance Method:

• COR review

Prescriptive Requirements The Contractor shall obtain and verify current contact information for Inspectors and Underage Purchasers, previously affiliated with FDA's inspection program, who are no longer affiliated with the program. The Contractor shall contact and coordinate with former inspectors and Underage Purchasers to be available to provide FDA specific knowledge related to inspections conducted by the inspector and serve as witnesses in litigation or other actions regarding past inspections.

a. FDA will initiate the request to locate former CTP inspectors by providing the Contractor at minimum a full name and the state or territory where the former staff member worked.

b. The Contractor shall contact any potential matches to verify that they have found the correct person.

c. The Contractor shall provide to the FDA all available contact information for the staff member to include work address, home address, email address, work phone number, home phone number, cell phone number, and name of current employer.

d. At a minimum, the Contractor shall provide a valid phone number at which FDA can contact the former staff member.

e. The Contractor shall provide the contact information within 10 business days of

FDA's request.

f. If the Contractor cannot locate the former staff member, the Contractor shall document the steps taken to attempt to locate the former staff member within 10 business days of FDA’s request.

g. The Contractor shall coordinate meetings and information collection between FDA and former inspectors and Underage Purchasers.

h. The Contractor shall compensate the designated individuals for the time these individuals spend assisting FDA which will be specified at the individual task level.

The FDA does not expect more than a reasonable effort to locate inspectors and Underage Purchasers. Reasonable effort shall be defined as internet research and direct contact through telephone and/or email.

C.2.9 COMMUNICATION AND DATA TRANSMISSION

The Contractor shall maintain secure, timely, and compliant communication and data handling practices.

Performance Standards:

• Responses to FDA within 2 business days

• Secure use of Government systems

• 98% responsiveness

• COR monitoring

FDA will provide government furnished equipment: laptops for PC and BPC and iPhones for inspectors. The Contractor shall use only government furnished equipment. The Contractor shall maintain program data only on Government systems. The Contractor shall use only government furnished equipment to maintain program files, communicate with FDA, and manage the FDA program.

The Contractor shall ensure Inspectors use the iPhones to record compliance check inspection data and manage compliance check inspection work, including proper use of handheld devices by Underage Purchasers. The Contractor shall ensure devices are not used for personal activities.