RFP_final_rev_2.pdf

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BACKGROUND/OBJECTIVES

A. 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 minors. The Tobacco Control Act also amended the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) to grant FDA authority to regulate certain health warnings that must appear on smokeless tobacco products.

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 contract and any extensions thereto.

B. OBJECTIVES

The purpose of this work is to:

1. Facilitate the enforcement of the provisions cited in Section C with respect to tobacco retailers.

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

3. Collect, document, and preserve evidence of inspections and investigations.

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

5. 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 Contract and any extensions thereto.

C. APPLICABLE LAWS AND REGULATIONS

REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES

AND SMOKELESS TOBACCO 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 has reissued this rule, which is codified at 21 Code of Federal Regulations (CFR) Part 1140. The Contractor shall conduct tobacco inspections for compliance

Page | 3 with certain provisions of these regulations with respect to retail outlets on behalf of FDA. For illustration purposes, some, not all, of the provisions in 21 CFR Part 1140 that are subject to inspection by the Contractor under this Contract include:

• Age and Photo Identification Restrictions – Retailers:

o May not sell regulated tobacco products to anyone younger than 18 years of age;

o Must verify that any person under age 27 purchasing regulated tobacco products is at least

18 years old or older 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 (except in facilities where the retailer ensures no person younger than 18 is permitted to enter);

o May not sell cigarettes, cigarette tobacco, or smokeless tobacco using self-service displays (except in facilities where the retailer ensures no person younger than 18 is permitted to enter);

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 sell flavored cigarettes.

SYNAR REGULATION

In addition to the Tobacco Control Act, the Department of Health and Human Services works to limit youth access to tobacco through the Synar Regulation. The Synar Regulation, which is administered by the Substance Abuse and Mental Health Services Administration’s Center for Substance Abuse Prevention (SAMHSA/CSAP), requires the 50 states, the District of Columbia and 8 U.S. territories (American Samoa, Guam, Palau, Federated States of Micronesia, U.S. Virgin Islands, Puerto Rico, Marshall Islands and Commonwealth of the Northern Mariana Islands) to:

• Have in effect a law prohibiting any manufacturer, retailer, or distributor of tobacco products from selling or distributing such products to any individual younger than age 18;

• Enforce this law;

• Conduct annual, unannounced inspections (referred to as the Synar survey) in a way that provides a valid probability sample of tobacco sales outlets accessible to minors;

• Negotiate interim targets and a date to achieve a noncompliance rate (or retailer violation rate) of no more than 20 percent (SAMHSA required that each state reduce its retailer violation rate (RVR) to 20 percent or less by FY 2003); and

• Submit an annual report detailing state activities to enforce its law.

The annual Synar survey is separate from the FDA inspections under this Contract.

The Contractor shall provide the services described in Section C, Description, Specifications, Work Statement. Except as otherwise specified in the Contract, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for, or incident to, the performance of the work set forth herein.

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B.2 CONTRACT PRICE

The Contractor shall be paid a fixed-price per inspection and a fixed-price for program management. Any required non-inspection travel will be reimbursed in accordance with the Federal Travel Regulations.

The Contractor shall provide total prices for the number of required inspections in each jurisdiction listed below. Offerors should propose a price for each type of inspection listed below and a total price based upon the number of inspections.

TOTAL FIXED PRICE:

a. Inspections – the Contractor shall be paid the following fixed-price for completed inspections as follows:

No. of Inspections Price Per Inspection Total

Inspection Type Contractor Directed

Contractor-Directed Undercover Buy

FDA-Directed Inspections

(within 60 days)

Advertising & Labeling

b. Program Management – The Contractor shall be paid a fixed-price per month for program management.

Task QTY Price Total Program Management 12 Months

c. Non-inspection Related Travel – All non-inspection travel shall be cost reimbursement. All non-inspection related travel shall be approved by Contracting Officer.

Task Not to Exceed Total

Non-inspection Related Travel

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B.3 CONTRACT PRICE - OPTIONS

Option Period I – (dates shall be inserted at award)

No. of Inspections Price Per Inspection Total

c. Non-inspection Related Travel - All non-inspection travel shall be Cost

Reimbursement. All non-inspection related travel shall be approved by Contracting Officer.

Task Not to Exceed Total

Non-inspection Related Travel

Option Period II – (dates shall be inserted at award)

No. of Inspections Price Per Inspection Total

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c. Non-inspection Related Travel - All non-inspection travel shall be Cost Reimbursement. All non-inspection related travel shall be approved by Contracting Officer.

Task Not to Exceed Total Non-inspection Related Travel

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B.4 TRAVEL AND OTHER DIRECT COSTS

A. The Contractor shall not exceed $_TBD, for the Base Period; $*(TBD) for Option Period

I $*(TBD and $*(TBD) for Option Period II.. Any non-inspection related domestic travel incurred directly and specifically in the performance of this Contract, claimed by the Contractor, and accepted by the Contracting Officer shall be reimbursed as described below.

Domestic non-inspection related travel expenses incurred by the Contractor in direct performance of the Contract shall be paid provided such travel is necessary for the performance of this Contract and the cost does not exceed:

1. The lowest customary standard, coach, or equivalent airfare offered during normal business hours for air travel except when such accommodations: 1) require circuitous routing, 2) require travel during unreasonable hours, 3) excessively prolong travel, 4) result in increased costs that would offset transportation savings, 5) are not reasonably adequate for the physical or medical needs of the traveler, or 6) are not reasonably available to meet mission requirements. In order for costs in excess of customary standard or coach airfare to be considered allowable, the applicable exception must be documented and justified.

2. Costs of rail travel by most direct route, coach-class accommodations.

3. The prevailing mileage rate set forth in the Federal Travel Regulation (FTR) or reasonable actual expenses for travel by motor vehicle in effect on date of travel.

Travel by motor vehicle, including rented automobile, shall be reimbursed on a reasonable actual expense basis, or at the Contractor’s option, on a mileage basis at the prevailing FTR rate, plus any toll or ferry charges.

4. The prevailing rates set forth in the FTR for lodging, meals and incidental expenses.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 SCOPE OF WORK

Independently and not as an agent of the 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 may be required to coordinate the work under this Contract with other tobacco enforcement activities. Attachment 1 contains a list of materials necessary for conducting FDA tobacco compliance check inspections.

FDA is anticipating inspection services in the jurisdictions listed in the table below. The number and types of inspections required to be conducted for the base period and option year for each jurisdiction are listed below. Inspection amounts shall be the same in the base period and Option year 1and 2.

Note: A separate contract award is anticipated for each state. A single Contractor may receive awards to conduct inspections in multiple states; however each state will be awarded separately A Separate proposal must be submitted for each state that the Contractor is seeking to be awarded a contract.

Jurisdiction

Contractor Directed

Inspections

UBs

UBs A&Ls

Alaska 250 100 100 Florida 8000 3500 3500 Louisiana 3800 1500 1500 Nebraska 800 250 250 Nevada 750 250 250 New Mexico 925 350 350 New York 6000 2000 2000 North Dakota 300 125 125 Oregon 1600 700 700 South Dakota 350 150 150 Tennessee 2000 700 700 U.S. Virgin Islands 100 50 50 Utah 500 150 150 Wyoming 300 125 125 Oklahoma 1197 513 513

TECHNICAL REQUIREMENTS

C.1.1 TOBACCO RETAIL COMPLIANCE CHECK INSPECTION PROGRAM

RESPONSIBILITIES

A. Contractor/Subcontractor

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The Contractor shall be an entity capable of employing, or subcontracting with an entity capable of employing, individuals who can be commissioned by FDA to conduct inspection. 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.

Any subcontractor must act as an agent for the Prime Contractor and employees of the subcontractor serving as inspectors will be required to undergo the commissioning process described below.

B. Program Coordinator/Backup Program Coordinator

The Contractor shall designate a Program Coordinator who shall be responsible for overall coordination, gathering information and evidence, and communicating with FDA. The Program Coordinator shall be responsible for all aspects of the program management work described herein.

This position should be the main point of contact for FDA. The Contractor shall also designate a backup/alternate Program Coordinator so the Government will always have a point of contact. In the event that the PC and BPC are not available, the Contractor shall designate and notify the COR of a point of contact with authority to make decisions on behalf of the PC/BPC. The Program Coordinator and backup/alternate Program Coordinator together shall equal at least one (1) Full Time Equivalent (FTE). The Program Coordinator must account for the majority percentage of the FTE. For the purposes of this contract an FTE is equal to 2080 hours.

C. Inspectors

The Contractor shall conduct compliance check inspections through any health, food, or drug officer/employee of any State, Territory, or political subdivision thereof. These individuals must be United States citizens and be 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 the FD&C Act.

Due to logistics and associated expenses, FDA recommends, to the extent practicable, the use of no more than thirty (30) Inspectors. If logistically possible, FDA prefers a majority of the Inspectors conducting the FDA compliance check inspections be dedicated on a full-time basis.

If the Contractor utilizes part-time Inspectors, those inspectors must maintain regular performance of inspections in order to remain active on this contract. Inspectors that do not perform a minimum of 10 inspections per month will 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 Program Coordinator will maintain current contact information on all Inspectors who leave the program and this information shall be turned over to the Government at the end of the contract period. The Program Coordinator will annually confirm the contact information for Inspectors who have left the program.

The Contractor shall maintain current contact information for all inspectors and minors currently employed by the Contractor. The contractor shall provide FDA with contact information as needed by FDA. The Contractor shall annually verify current contact information for all inspectors and minors 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 minors shall be provided to FDA. Additionally FDA may request individual contact information that shall be Page | 10 provided within 5 days of the request.

D. Background Investigations/Commissioning Process

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 Program Coordinators, Backup Program Coordinators, Chaperones (staff dedicated to overseeing the safety of the Minors), 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. Minors will not be commissioned and will not undergo a background investigation by

FDA.

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 any) as well as that of the Subcontractor(s).

FDA’s Office of Security Operations (OSO) will discuss the Contractor’s or Subcontractor’s background clearance requirements with the respective security contact to assess whether the entity’s existing background investigation is equivalent to the FDA’s requirement which is a Federal Level 5 Minimum Background Investigation (MBI), 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.

Within three weeks of being awarded the contract the Contractor shall provide the information for the available employees and Subcontractors to be commissioned/receive background investigations, and subsequently, immediately upon identifying new staff it wishes to have commissioned. More specifically, the Contractor shall provide FDA with each such person’s name, work address, work phone number or cell phone number, and email address. The Contractor shall notify FDA if any of the employee information above changes.

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. Employees and/or Subcontractors are responsible for immediately notifying their Program Coordinator of any event or occurrence that could affect or change their status.

The issuance of a commission is discretionary, and FDA may revoke a commission at any time.

Reasons for revocation may include, but are not limited to:

• 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; or

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• Behavior that may discredit FDA.

Upon separation of a commissioned employee or subcontractor employee, the Contractor shall ensure the commissioning credentials and/or certificates and all equipment are returned to the FDA as instructed by the COR.

E. Information Regarding Minors

Minors are an integral part of conducting compliance check inspections. The Contractor shall acquire Minors age 16 or 17 to participate in the program.

The Contractor shall keep at least one photo on file of each Minor involved in the Program. In order to document the Minors’ appearance, the Contractor may determine that they should be photographed with frequent regularity and/or prior to conducting any undercover buy assignments.

FDA protocol does not require Minors to carry photo identification for the undercover buy assignments. However, the Contractor may determine that Minors should carry valid photo identification and present identification if requested. Such decisions are left to the discretion of the Contractor. The Contractor must ensure that all minors follow the chosen protocol consistently.

The Contractor, rather than FDA, has the oversight responsibility for Minors involved in the Program. The Contractor shall ensure that the Minors are within the required age range by obtaining a copy of their birth certificates and or other government-issued identification and 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 Minors are to remain as confidential as possible. However, in the event of possible enforcement or judicial action, the Minor's identity may be revealed and the Minor may need to provide a declaration and/or give oral testimony in a hearing. The Contractor must inform the Minors that they may be needed to testify as witnesses in administrative hearings during the period of performance of the contract. This information must be contained in the parental/legal guardian consent form. The Program Coordinator shall maintain current contact information on all Minors who leave the program and this information shall be turned over to the Government at the end of the contract period. The Program Coordinator will annually confirm the contact information for Minors who have left the program.

All participating Minors shall have a Medical Release signed by a parent or legal guardian authorizing emergency medical treatment if necessary while under the supervision of a commissioned officer or chaperone. Supervising adults shall have an original of the Medical Release in the field whenever a minor is participating in inspections or training.

The Contractor shall secure a grant of immunity from the proper authorities prior to using Minors in any jurisdiction where it would be illegal to use Minors to conduct undercover buy assignments or where a minor’s possession of tobacco products is illegal. The Contractor shall provide written proof of such immunity to FDA. FDA will determine adequacy prior to contractor conducting inspections in any jurisdiction.

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

Page | 12 for Minors. Proof of insurance, including automobile liability coverage for commissioned officers and chaperones transporting Minors, shall be maintained by the Contractor and made available to FDA upon request.

The Contractor shall input each Minor’s unique identification number into FDA’s Tobacco Inspection Management System (TIMS) once the Contractor receives access. The Minor’s unique identification number shall be generated by the Contractor to protect the confidentiality of the Minor. The Contractor shall maintain information cross-referencing each unique identification number to a specific minor.

F. Conflicts of Interest

The Program Coordinator and individuals conducting compliance check inspections or responsible for compliance information or evidence are considered “covered persons” who shall not have significant financial interests in “covered companies.” Covered companies include: (1) any company that the covered person inspects; (2) any company whose compliance information and/or evidence the covered person is responsible for gathering, maintaining, or reporting; or (3) any manufacturer, distributor, or importer of tobacco products.

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 jurisdiction must immediately notify FDA of the possible conflict of interest. The jurisdiction must investigate all possible conflicts of interest and provide findings to the COR within 90 days of learning of the possible conflict of interest.

These requirements are contractual, and do not alter, modify, or replace obligations imposed on the Program Coordinators or Commissioned Officers by any applicable federal law or ethical standard.

C.1.2 PROGRAM MANAGEMENT TASKS

The Contractor shall conduct all program management tasks through its Program Coordinator and Backup Program Coordinator or designated administrative personnel. These tasks include, but are not limited to, the following areas as described in detail elsewhere in the statement of work:

• Serving as the primary point of contact with FDA;

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• Ensuring that personnel use FDA issued equipment to maintain program files, communicate with FDA, and manage the FDA program;

• Facilitating background checks and the commissioning process, and securing signed FDA Form 3398’s for all Contractor employees;

• Securing and maintaining all required information and documents regarding minors;

• Ensuring no contract personnel has conflicts of interest;

• Attending initial, refresher, and in-person trainings;

• Providing training to inspectors and minors, and maintaining training records;

• Adding retailers to and editing existing retailer data in the Tobacco Inspection Management

System (TIMS) to maintain an up-to-date list;

• Selecting retailers for inspection and creating inspection assignments;

• Reviewing inspection results, storing and maintaining chain of custody of evidence, and otherwise facilitating inspections;

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

• Implementing, maintaining, and performing all work necessary under the quality control plan;

• Creating and submitting monthly reports and invoices;

• Securing former inspectors as experts where necessary; and

• Performing all other non-inspection functions that are necessary to ensure the program is able to obtain or maintain capacity to conduct inspections.

C.1.2.A TOBACCO RETAIL INSPECTION PROGRAM TRAINING

1. Training for Contractors and Subcontractors

FDA officials will provide training regarding the FDA Tobacco Compliance Check Inspection Program to the Program Coordinator, Backup Program Coordinator, and Inspectors. Inspectors must be commissioned by FDA before accessing any training materials. The Program Coordinator 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 or online learning management system. The Contractor must ensure that all parts of the FDA Tobacco Compliance Check Inspection Program training are followed as prescribed.

FDA will conduct mandatory quarterly conference calls/training (approximately 2 hours each) for the Program Coordinator and Backup Program Coordinator to review topics related to inspection procedures, new policies, and contractual updates. Additional conference calls may be scheduled as necessary.

FDA will provide two mandatory virtual refresher trainings to Inspectors each year to review topics related to inspection procedures and new policies that will last approximately 1 hour each.

When identified by the Contractor or FDA, inspectors that make multiple and/or repeated procedural errors shall undergo additional training. The Contractor shall provide FDA with a plan within two business days on how it intends to address inspector errors that are identified. The Contractor shall notify FDA when this issue resolved.

No inspection participant may conduct inspections prior to passing FDA provided training.

Additional training from FDA may be provided to the Contractor upon the Contractor’s request in order to refresh Contractor knowledge of the retail inspection program.

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2. Training for Minors

The Contractor shall train minors and shall institute its own training methods in addition to ensuring that each minor completes the required FDA minor module. The Contractor’s training program may include mock undercover buy inspections so newly recruited Minors may observe experienced Minors conduct undercover buy inspections before conducting them on their own.

Each Minor must complete the required FDA minor training prior to conducting any inspections.

Inspectors shall review each inspection with the minor and advise them of any necessary corrections prior to moving to the next inspection.

3. Program Coordinator In-Person Training

FDA may conduct in-person training for Program Coordinators during the base year or option year of this contract. If held, this training is expected to cover two to three full working days and be held in the Washington, D.C. metropolitan area. If offered by FDA, it is mandatory that the Program Coordinator attend this in-person training. The attendance of the Backup Program Coordinator(s) is highly recommended by FDA. FDA anticipates that this training will occur approximately every three years.

C.1.3. IDENTIFICATION AND SELECTION OF RETAILERS

1. Retail Outlet List

A retailer is any person, government, or entity who sells regulated tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays of tobacco products are present, as referenced in 900(14) of the FD&C Act. A retail outlet is a location where a retailer sells tobacco products or operates a self-service display of tobacco products, which includes vending machines. These retail outlets may include, but are not limited to, supermarkets, convenience stores, bars, clubs, restaurants, gas stations, newsstands, mobile food trucks, or mobile carts that sell tobacco products.

FDA currently possesses a list of the tobacco retailers located in the subject jurisdiction and will provide it to the contractor on award. Within 60 days after award, the Contractor shall assess the FDA supplied electronic list of retail outlets and revise and/or add establishments to create an accurate, non-duplicative, and complete list. The source(s) used to assess and revise the list and description of whether the list is considered to be comprehensive must be included. A description and the results of any coverage studies completed or other methods used to assess the accuracy and completeness of the list of retail outlets must also be included. The Contractor shall confirm that the retail outlet list does not contain any retail outlets that are located on Tribal Land. The retail outlet list must contain, at a minimum, the retail outlet name, physical address (including city, state or territory, and zip code), and unique ID number (assigned by FDA when added to TIMS). The Contractor is responsible for making changes to their retail outlet list contained in the TIMS system, after consulting with FDA and obtaining guidance from FDA. The Contractor shall provide lists with additional establishments (after confirming that the establishments are not already in TIMS) to FDA throughout the Contract period of performance. The Contractor shall provide updates to the retail outlet list to FDA Quarterly in the corresponding Monthly Reports or certify that the current retail outlet list is the most up-to-date list available, and all corrections have been previously submitted. See Attachment 2 for the current required format for the retail outlet list. The format is subject to change based on program needs.

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Entities Not Included on Retail Outlet Lists

Entities discovered to sell regulated tobacco products but are not in the TIMS database shall be added to TIMS. Before the entity is added, the Program Coordinator shall verify that the entity:

• Sells regulated tobacco products;

• Is not already in the TIMS database; and

• Is open for business.

2. Selection of Retailers for Contractor Directed Inspections

For Contractor Directed inspections, the Contractor shall decide which retail outlets shall be inspected from the list of retail outlets in TIMS. In identifying which retailers to inspect in each jurisdiction, the Contractor shall consider several factors, including areas that are considered at higher risk for regulatory violations, such as: (1) areas with high rates of youth cigarette smokers,

(2) areas where youth report easy access to cigarettes, (3) areas located in close proximity to middle and high schools, or (4) regions with lower socioeconomic populations (historically associated with market targeting). For retailers that are found to be non-violative during Contractor Directed inspections, the Contractor shall not conduct more than one inspection of said retailer in a twelve month period.

The Contractor shall ensure that the commissioned inspectors conduct tobacco compliance check inspections at a variety of different locations (urban, suburban, rural, and racial and ethnic minority communities) and outlet types throughout the jurisdiction. The Contractor shall ensure that retail outlets in racial and ethnic minority communities are covered during the Contract period. This requirement is consistent with the statutory requirements set out in Section 105 of the Tobacco Control Act, which requires FDA to enforce the “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” on promotion and advertising of menthol and other cigarettes targeted to youth, including youth in racial and ethnic minority communities.

The Contractor shall also provide the FDA COR with any information, as it becomes available, regarding any entities or events that may be considered a “Qualified Adult Only Facility” or any entities that are distributing free samples of smokeless tobacco products or other tobacco products for advertising, marketing or promotional purposes as defined in 21 CFR Part 1140.16(d)(2)(iii).

For each retailer inspected, the Contractor shall ensure the inspector records all inspectional information pertaining to that visit before beginning the next inspection or by the end of the day, if it is the last inspection of the day.

The Contractor shall conduct inspections in the jurisdiction evenly distributed throughout the year for the base period and each subsequent option period.

C.1.4. FDA’S TOBACCO INSPECTION MANAGEMENT SYSTEM (TIMS)

FDA’s Tobacco Inspection Management System (TIMS) can work in conjunction with a specific handheld device that shall be provided by FDA and allows for the electronic transmission of information. FDA will not consider contractor provided devices. The TIMS Application provides

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FDA and Contractors with a front-end web interface for accessing and managing FDA tobacco inspection assignment information and related processes. The handheld device currently provided to Inspectors by FDA is an iPhone. FDA will provide the service plans for these devices.

The Contractor shall notify the FDA COR and the TIMS Helpdesk immediately of any hardware and software problems so that FDA can work with the Contractor to resolve them.

The Program Coordinator is responsible for ensuring that Inspectors submit data to FDA as defined in C.1.5 through C.1.7, below. FDA will work with the Contractor to ensure designated staff is able to access TIMS and inspection assignments, submit inspection information to FDA, and access appropriate data for the Contractor’s inspectional and reporting needs.

Beyond what is publicly available on the FDA external website, no other data resulting from Federal tobacco retailer compliance check inspections, including data in TIMS, may be shared with entities outside of FDA. The prohibition of the release, publication, or disclosure of non-public information, except under specific circumstances, is covered under FDA Form 3398, Contractor's Commitment to Protect Non-Public Information Agreement. All Contractor staff who are directly involved in the inspection program or have access to data gathered under this program must sign the FDA Form 3398.

C.1.5. COMPLIANCE CHECK INSPECTIONS

A. Overview of General Inspection Procedures

The Contractor shall arrange tobacco compliance check inspections of retailers that sell or advertise tobacco products to determine whether those retailers are complying with the Tobacco Control Act and the implementing regulations (See Section B.1.C.). Generally, the Contractor shall carry out two (2) types of tobacco compliance check inspection assignments: (1) undercover buy assignments, to determine a retailer’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.

Of the Contractor Directed inspections the Contractor performs under this contract, 100% shall be undercover buy assignments.

The Contractor shall assign compliance check inspection assignments of identified retail outlets to Inspectors via TIMS. FDA may request that certain retail outlets or areas be inspected. FDA may also ask the Contractor to ensure compliance check inspections are conducted in specific areas at certain times.

The Contractor shall ensure each Inspector conducts and documents each assignment according to FDA protocol (provided during training). Documentation of the inspection requires the Inspector to:

(1) record the findings on a compliance check inspection form, which will be provided by FDA via the handheld device; (2) collect physical evidence (e.g., tobacco products purchased by the minor) or take photographs using the handheld device; and (3) record any additional observations as instructed by FDA.

If the retail outlet is found to be out of compliance, FDA may request assistance from the Contractor in verifying the ownership information of a particular retail outlet and may need inspectors to return

Page | 17 to the retail outlet to obtain further information and evidence.

The Contractor shall ensure proper collection, handling, sealing, documentation, storage, and submission of evidence pursuant to FDA protocol to ensure that evidence is maintained in a manner that shall allow FDA to use the evidence to support an enforcement action. The Contractor shall store evidence for the duration of the contract and shall perform a single transfer of all evidence to FDA or an FDA contractor prior to the end of the contract.

The Program Coordinator shall review the results of certain assignments in accordance with FDA protocols and submit the results to FDA via TIMS.

The Contractor shall ensure the procedures and standards for data and evidence security is followed.

This shall include but is not limited to ensuring anonymity of compliance check inspection participants, confidentiality of data and evidence collection, and transmission and storage of property and evidence. Further details regarding the inspection procedures shall be provided in the FDA Retail Inspection Program training once staff associated with the Contract have a background check and have been cleared and/or commissioned.

1. FDA Directed and Contractor Directed Undercover Buy Inspections

Section C.1 indicates the number of FDA directed undercover buy inspections and the number of contractor directed undercover buy inspections for each jurisdiction. The Contractor shall ensure that FDA protocol for conducting compliance check inspections is followed. Generally, undercover buy inspections shall be conducted by teams comprised of an Inspector and a Minor. The Minor must be supervised at all times, with limited exceptions. It is FDA’s preference that Inspectors accompany Minors into the retail establishment during undercover buy inspections. Inspectors shall position themselves so that they can observe Minors during the entire undercover buy inspection to ensure that they can complete a narrative report attesting that they have witnessed the violation. An inspector shall only conduct an unobserved undercover buy assignment (where the inspector cannot see the transaction) if the inspector’s presence would compromise the inspection.

Minors are required to complete narrative reports for all inspections they conducted.

A representative mix of 16 and 17 year old Minors who look their age should be used. The Minor group should also reflect a representative mix of male and female Minors and should reflect the racial/ethnic composition of the population where the undercover buy is conducted.

The Contractor shall ensure that Minors used in the undercover buy inspections are not related to the Inspectors conducting the inspection of a specific retail outlet or the Chaperone, if one is present.

The Contractor shall ensure that undercover buy inspections using Minors are conducted during the hours deemed safe by the Program Coordinator.

If it is required under the law of the Contractor’s jurisdiction to issue a citation after a violation, the Contractor shall not issue the citation until all compliance check inspections for that day are completed and the Minor is returned to his/her proper end location. However, if two Inspectors (or an Inspector and a chaperone) are used for an undercover buy inspection, one Inspector may issue the jurisdiction’s required citation after the minor is returned to his/her proper end location, or removed from the retail outlet and under the supervision of the second Inspector (or chaperone).

The Contractor shall take every precaution to ensure the safety of the minor. Enforcement of the jurisdictional violation will not be funded under this Contract, including the issuing of a mandated citation.

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The Contractor shall conduct no more than one Contractor Directed Undercover Buy inspections at a particular retail outlet in a year.

2. FDA Directed Advertising and Labeling Inspections

The Contractor shall conduct compliance check inspections to determine retailer compliance with the provisions of the Tobacco Control Act and the implementing regulations, other than the age and photo identification requirements. The Contractor shall conduct advertising and labeling inspections separately from the undercover buy assignments. The Contractor shall develop a system to allow an Inspector to purchase a potentially violative tobacco product during an advertising and labeling inspection. A Minor shall not accompany an Inspector during an advertising and labeling inspection.

Inspectors will be required to provide his/her FDA credentials during this type of compliance check assignment. FDA will assign all Advertising and Labeling inspections and will provide a timeframe for completion of assignments. If both an Advertising and Labeling and Undercover Buy inspection have been assigned by FDA, the Advertising and Labeling assignment should be completed first.

75% of inspections shall be completed within 90 days, 15% shall be completed within 30 days and 10% shall be completed within 5 days of assignment. Contractor may be required to conduct hand delivery of documents to a retailer rather than conduct a compliance check inspection. All A&L assignments that must be completed within 5 days will require hand delivery of documents or an abbreviated inspection to determine whether the establishment is selling tobacco products. Up to 20% of these inspections will require the contractor to develop a system to allow an Inspector to purchase a potentially violative tobacco product.

3. Data Transmission

FDA will supply the Contractor with laptops to designated Program employees and handheld devices to Inspectors. The Contractor shall ensure inspectors use these devices to record compliance check inspection data and manage compliance check inspection work.

The Contractor shall ensure inspectors submit the results of each compliance check inspection at a minimum at the end of each inspection day for review.

C.1.6. REVIEWING COMPLIANCE CHECK INSPECTION RESULTS AND

ASSISTING WITH ENFORCEMENT ACTIONS

The Program Coordinator shall review the results of compliance check inspections to ensure the quality and completeness of the evidence. All compliance check related work shall be performed by the program coordinator or back-up program coordinator on an FDA-provided laptop. Within 48 hours of receiving the compliance check inspection assignment results from the Inspector, the Program Coordinator shall submit a recommendation for the inspection results in their queue and make appropriate updates to establishment records electronically through the TIMS system to FDA.

Although a retailer may be in violation of the laws of a jurisdiction in addition to federal violations, the Contractor’s recommendations to FDA shall be based solely on violations of the Tobacco Control Act and the implementing regulations.

The results of completed retailer compliance check inspections are available to the public on FDA’s website.

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1. Compliance Check Inspection Inquiries

If the inspection data or evidence submitted by the Program Coordinator requires clarification or is not sufficient, FDA may require that the Program Coordinator and/or the Inspector provide clarification and/or collect additional evidence to complete the review of an inspection.

Within 48 hours of receiving a request FDA, the Program Coordinator shall provide the FDA Requestor with information about a compliance check inspection and investigation unless citing extenuating circumstances.

2. FDA Enforcement Actions

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: (1) issuance of a Warning Letter, (2) imposing an administrative civil money penalty (CMP) or a No-Tobacco-Sale Order (NTSO), (3) initiating judicial actions, such as a seizure or injunction, or (4) initiating criminal prosecution.

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 from witnesses. In addition, if requested, the Inspector and Minor 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.

The Contractor shall maintain all original inspection records and evidence in its files for FDA for the length of the contract. If the tobacco compliance check inspection Contract with the Contractor expires or is not continued before the five-year period, the COR will provide instructions for transfer of these records and evidence. These files, which are considered FDA files subject to Federal Freedom of Information Act (FOIA) requirements, shall be secured and maintained separate and apart from other files. These records include all documents and items created and collected during and after Compliance Check Inspections, including Compliance Check Inspection Forms, evidence, photographs, etc.

Apart from FDA enforcement actions for violations of the Tobacco Control Act and its implementing regulations, jurisdictional enforcement actions may be pursued against retail outlets that are found to have also violated the law of that jurisdiction. These efforts must be coordinated with the FDA COR and not compromise FDA’s compliance check inspection procedures, data, or evidence. Additionally, the Contractor shall furnish information regarding retailer compliance with the jurisdiction’s laws, including jurisdictional enforcement actions, where violations are found during FDA inspections, as soon as practicable after inspections are completed.

C.1.7 CONTRACT TRANSITION OUT

The Contractor shall initiate the transition out of contracted activities and services to the Government thirty (30) days prior to the conclusion of the contract.

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The Contractor shall gather and return if necessary the following items using FDA-provided shipping label(s):

• FDA issued iPhones with each phone’s accessories (including cases, chargers, and/or styluses) from each inspector with a list of the inventory.

• Physical evidence and associated inspections records (including assignment number) with a completed inventory log.

• All files pertaining to minors and inspectors.

• All government furnished equipment and any other equipment purchased with government funds.

• Regulatory notebooks, properly labeled based on FDA provided protocol and procedures.

• Unused FDA materials to include but not limited to Form FDA 482 and evidence bags.

The Contractor shall provide the completed inventory log of physical evidence and FDA-issued iPhones to the COR with the date that the packages are being shipped to FDA.

C.1.8. QUALITY CONTROL PLAN

The Contractor shall develop and maintain a quality control plan that lists specific actions that will be performed to assure the quality of the Contractor’s work as well as the frequency of those actions and the individual to whom those actions are assigned. Revised quality control plans shall be submitted to the COR within 30 days of any changes or deviations to the original Quality Control Plan submitted with the proposal. The Quality Control Plan shall be used to monitor Contractor performance and to ensure that the quality of the information submitted is complete and accurate. The Contractor is responsible for implementing a plan to ensure that:

• FDA funds under this contract are only used for FDA tobacco enforcement activities.

The plan shall include, but is not limited to describing how:

o Time dedicated to contract work is recorded.

o An inventory of Government-furnished equipment and equipment purchased in support of the contract is established and maintained.

• Evidence is properly collected, documented, and stored in a location accessible only by program staff.

• The number of incomplete or inaccurate submissions and/or evidence documentation is minimized. The plan shall include, but is not limited to describing how:

o Areas needing improvement will be identified and remedied.

o Corrective actions will be implemented and communicated to FDA.

• All communications concerning compliance check inspection procedures are…