Tribal_Retailer_Inspections_RFP.pdf

TRIBAL TOBACCO RETAILER INSPECTIONS

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 CONTRACT TYPE

The Contractor shall be paid on a fixed price basis for work completed in accordance with the statement of work.

B.2 CONTRACT PRICE

The Contractor shall be paid a fixed-price per inspection. The program management task and travel/training expenses will be reimbursed based on actual incurred costs for work completed in accordance with the statement of work.

For each jurisdiction in which services will be provided the contractor shall submit total prices for program management and inspections using the format below.

Base Period – (dates shall be inserted at award) 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

INSPECTIONS

Undercover Buy Advertising & Labeling

FDA DIRECTED

Follow-Up Complaint Follow-Up Other Directed Inspections & Assignments

b. Program Management and Non-Inspection Travel – All non- inspection travel and

Program Management shall be cost reimbursement. All non-inspection related travel shall be approved by the Contracting Officer. the Contractor shall be paid on actual incurred costs for work completed in accordance with the statement of work.

Task Price Total

Program Management Training/Non-Inspection Travel

B.3 CONTRACT PRICE - OPTIONS

Option Period I – (dates shall be inserted at award) Total Fixed Price: $ ________________________

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

Inspection Type

CONTRACTOR

d. Program Management and Non-Inspection Travel – All non- inspection travel and

Training/Travel

Option Period II – (dates shall be inserted at award) Total Fixed Price: $ __________________

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

Inspection Type

CONTRACTOR

f. Program Management and Non-Inspection Travel – All non- inspection travel and

Training/Travel

B.4 TRAVEL AND OTHER COSTS

A. The Contractor shall be reimbursed, not to exceed $*(TBD) for the Base Period; $*(TBD) for Option Year I;

and $*(TBD) for Option Year II for all domestic travel as described below, incurred directly and specifically in the performance of this Contract, claimed by the Contractor, and accepted by the Contracting Officer.

Domestic travel expenses incurred by the Contractor in direct performance of the Contract shall be reimbursed 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.

B. Travel claims shall be submitted and included with the monthly invoices for approval. Listed below is a description of receipts required as attachments to the invoice to support travel claims:

1. Copy of common carrier ticket reflecting class of travel, dates of travel, and amount of fare;

2. Lodging receipt;

3. Parking/tolls receipt;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi travel.

Other Direct 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:

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

2. Special rearrangement or alteration of facilities;

3. Purchase, lease, or rental of any item of general purpose such as office furniture or office equipment

(including data tapes);

4. Travel to foreign countries; and

5. Food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel

Regulations.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 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.

FDA currently has contracts with most of the U.S. state and territorial governments to conduct retail inspections of the retailers in their jurisdictions. This Request for Proposals (RFP) is to obtain the services of the governments of federally- recognized Indian Tribes to assist FDA in conducting tobacco retail inspections within their jurisdictions, with the goal of protecting the public health, including reducing tobacco use by minors.

A. APPLICABLE LAWS AND REGULATIONS

FEDERAL FOOD, DRUG, AND COSMETIC ACT

Some of the provisions of the FD&C Act, as amended by the Tobacco Control Act, to be enforced under the resultant Contract are as follows:

a. Section 906(d): “The Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product if the Secretary determines that such regulation would be appropriate for the protection of the public health.” 21 U.S.C. § 387f(d)(1)

b. Section 907(a)(1)(A): “a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.” 21 U.S.C. § 387g(a)(1)(A).

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 with certain provisions of these regulations with respect to retail outlets on behalf of FDA. For illustration purposes, some, not all, of the regulatory requirements 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.

C.2 PURPOSE/OBJECTIVE

The purpose of this work is to:

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

2. Conduct inspections of retailers that sell and advertise regulated tobacco products to determine compliance with the provisions cited above in Section C.1. and submit observations and 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. Coordinate with FDA on responses to press inquiries and press announcements on the FDA Tobacco Compliance Check Inspection Program.

6. 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.

The FDA Tobacco Compliance Check Inspection Program is being performed through a series of contracts rather than grants. Grants are a form of financial assistance or economic aid. The resultant Contract is a binding agreement for which FDA and the United States Federal Government (herein referred to as the “Government”) receive services from Contractors, and Contractors submit invoices upon the satisfactory completion of the services.

This Contract is designed to obtain the assistance of the Tribal government (or legal entity, organization, or consortium representing one or more Tribal governments) (herein referred to as “Contractor”) in inspecting retailers that sell regulated tobacco products and in surveillance of other entities that fall under the scope of the provisions cited in Section C.1.

Funds under this Contract must be used to supplement not supplant Contractor tobacco enforcement funds. The funds used for the FDA Tobacco Compliance Check Inspection Program are restricted, by statute, for use only for FDA tobacco inspection efforts.

C.3 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 in this Section. Except as otherwise specified in the Contract, the Contractor shall provide support in accordance with the timelines stated in the implementation plan. Section J, Attachment 1 contains a list of materials necessary for conducting FDA tobacco compliance check inspections. The Contractor shall be compensated as outlined above.

C.3.1 TOBACCO COMPLIANCE CHECK INSPECTION PROGRAM RESPONSIBILITIES

A. Contractor/Subcontractor

The Contractor shall be an agency or subdivision of a Tribal government. Examples of appropriate agencies may include: public health departments, food, or drug agencies.

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.

The Federal Government reserves the right to prohibit Contractor personnel, commissioned or non-commissioned, from working under this Contract for performance issues and conflicts at any time.

B. Program Management/Coordination

The Contractor shall designate a Program Coordinator who will be responsible for overall coordination, gathering information and evidence, and communicating with FDA. The Program Coordinator shall respond within five (5) business days to all requests made by the FDA. This position shall be the main point of contact for FDA.

C. Inspectors

The Contractor shall conduct compliance check inspections through any health, food, or drug officer/employee of any Tribe 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), FDA, under the authority of the FD&C Act.

Inspectors may be requested to testify as witnesses in administrative hearings for a minimum of five (5) years after each inspection and are required to be available for testimony during the period of performance of this Contract. 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 period of performance of the contract but are no longer employed by the Contractor. The most recent contact information for such inspectors and minors shall be provided to FDA at the end of the contract period. Additionally, FDA may request individual contact information that shall be 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 must submit contact information for the person(s) or entity most familiar with their agency’s background investigation procedure as well as that of any Subcontractor(s), if applicable. Upon award of the Contract, 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 its 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 30 days of being awarded the Contract, the Contractor shall provide the information for the available employees to be commissioned/receive background investigations, and subsequently, immediately upon identifying new staff it wishes to have commissioned. (See Section F.2 – Deliverables). More specifically, the Contractor shall provide FDA with each such person’s name, work address, work number or cell number, and email address. The Contractor will be required to 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 must maintain information cross-referencing each unique identification number to a specific minor. 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 status of a background investigation may be continuously monitored by the Contractor, the Program Coordinator, and FDA.

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:

• 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

• 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 to ensure compliance with the provision cited in Section C.1.

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 inspections.

FDA protocol does not require Minors to carry photo identification for the undercover buy inspections. 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, or the designated person or entity, 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 (See Section C.3.5, Undercover Buy Inspections) by obtaining a copy of their birth certificate and identification (if available) and an original parental/legal guardian consent form. The Contractor must obtain 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 inspections during school hours. Additionally, Minors cannot be related to the Program Coordinator or to any inspector or chaperone with whom they are conducting an undercover buy inspection.

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. Minors may be requested to testify as witnesses in administrative hearings for a minimum of five (5) years after each inspection. Information regarding the requirements for minor testimony must be contained in the parental/legal guardian consent form. FDA needs to retain current contact information on all Minors who leave the program for at least five (5) years after their departure. The minor information must be provided upon request to FDA at the end of the period of performance of the Contract. 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 inspections or where a minor’s possession of tobacco products is illegal. The Contractor shall provide proof of such immunity upon request from FDA.

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 will not be permitted to conduct inspections until such insurance is secured for Minors. Proof of insurance, including automobile liability coverage for commissioned officers and chaperones transporting Minors, shall be maintained by the Contractor and available to FDA upon request.

The Contractor will be required to 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 must maintain information cross-referencing each unique identification number to a specific minor.

F. Conflicts of Interest

The purpose of this provision is to safeguard against actual, apparent, and potential conflicts of interest on the part of the Contractor and its employees. Contractors performing work under this Contract must avoid actions that would cause a reasonable person to question the impartiality of the Contractor.

Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the Contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage. Please also see FAR 9.501 for further definition of conflict of interest.

Certification and Disclosure

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the

Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject Contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. Offerors shall disclose any relationships constituting a conflict of interest in their proposal. The disclosure statement must address actual, apparent, and potential organizational conflicts of interest within the offeror’s entire corporate umbrella, including parent companies, sister companies, affiliates, subsidiaries, and other interests held by the offeror; generally limited up to third tier relations unless there are potential conflict of interest concerns related to more distant affiliates. The disclosure statement must include past, present, or planned interests bearing on whether the Contractor (including its chief executives and directors, or any proposed consultant or subcontractor) has a conflict of interest. Specifically, Offerors must disclose governmental entities or employees within those entities that have a financial interest in tobacco retailers or manufacturers. Further, Offerors must make a disclosure if employees are related to persons with financial interests in tobacco retailers.

c. Offerors who are determined to have a conflict of interest will be provided an opportunity to submit a plan which describes how any such conflicts will be avoided, mitigated, or neutralized. The Agency will determine an Offeror’s eligibility for award based on the information provided. The Offeror shall not receive an award unless the conflict can be avoided, mitigated, neutralized, or otherwise resolved through the inclusion of a special contract clause or other appropriate means.

d. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this Contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

e. The Government reserves the right to exercise any remedy available at law or equity, including termination of the Contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

C.3.2 TOBACCO COMPLIANCE CHECK INSPECTION PROGRAM TRAINING

A. 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. 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 is resolved.

The Contractor shall ensure that each Program Coordinator, Backup Program Coordinator, Inspector, and Minor shall have their initial training documented and, at a minimum, receive annual refresher training. The Contractor shall provide training results to FDA upon completion and maintain training records for the Program Coordinator and all compliance check inspection participants under this Contract, including Minors. FDA must receive documented passing scores on Inspector’s tests before these individuals are permitted to begin inspections. 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 to refresh Contractor knowledge of the retail inspection program.

B. Training for Minors

The Contractor is responsible for minor training and shall institute its own training methods in addition to ensuring that each minor completes the required FDA provided training prior to conducting any inspections. 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.

D. Program Coordinator In-Person Training

FDA may conduct in-person training for Program Coordinators during the contract. FDA anticipates that in-person training will occur approximately every three years. 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. FDA will approve in-person training for the Program Coordinator and Backup Program Coordinator

C.3.3 IDENTIFICATION AND SELECTION OF RETAILERS

A. Retail Outlet List

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

As part of the proposal, the Contractor shall supply FDA with a detailed, accurate, and comprehensive electronic list of retail outlets in the Contractor’s jurisdiction. The source(s) of the list and why 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 retail outlet list must contain, at a minimum, the retail outlet name, physical address, mailing address (including zip codes), unique ID number (if the jurisdiction has one), as well as the name and mailing address of the legal owner(s) of the retail outlet, if available. The retail outlet list should be submitted as a spreadsheet compatible with Excel and should not contain duplicate records for any retail outlet. See Section J, Attachment 2 for the required format for the retail outlet list. FDA may request assistance from the Contractor in researching and updating ownership information on a case-by-case basis. 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. An example of this change is updating the business status of a retail outlet to “out of business.” The Contractor shall provide updated retail outlet lists to FDA as they become available throughout this Contract’s period of performance. The Contractor shall update its retail outlet list in TIMS and certify to FDA on an annual basis that the current retail outlet information in TIMS is up-to-date.

B. Selection of Retailers for Compliance Check Inspections

The Contractor is responsible for deciding which retail outlets shall be inspected from the list of retail outlets.

However, such inspection strategies are subject to review by the FDA COR who may require the Contractor to amend such strategies to conform to the requirements set forth below.

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).

The Contractor shall ensure that its commissioned employees or subcontractors conduct tobacco compliance check inspections at a variety of different locations and outlet types throughout its jurisdiction. Inspections on tribal lands and jurisdictions are consistent with the plan developed under Section 105 of the Tobacco Control Act.

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).

FDA reserves the right to request the Contractor to conduct compliance check inspections in specific areas at certain times.

If the Contractor chooses to conduct FDA compliance check inspections along with other tobacco enforcement efforts, the compliance check inspections must follow FDA’s compliance check inspection protocol and must be conducted by the FDA Inspectors under this Contract. 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. Additionally, FDA data cannot be disclosed to anyone not commissioned by FDA. FDA funds shall be used for all work required to conduct an FDA retail compliance check inspection but cannot be used to support any Contractor work beyond the FDA inspectional requirements (e.g., filling out non-FDA inspection forms, or obtaining and documenting additional evidence for a charge specific to state, territorial, Tribal or local law).

For each retailer inspected, the Inspector shall record all inspectional information pertaining to that visit as soon as practicable and before moving on to the next inspection. (See Section C.3.4, FDA’s Tobacco Inspection Management System (TIMS)).

The Contractor must conduct inspections of 80% to 100% of the retailers in the jurisdiction. The Contractor shall use the retail list provided with the proposal to determine the number of inspections to be proposed in the jurisdiction. Follow-up visits shall only be conducted at FDA’s request and following FDA’s guidance.

C. Entities Not Included on Retail Outlet Lists

Entities that are likely to sell tobacco products but that are not on the Contractor’s retail outlet list shall be added to the retail outlet list by the Contractor. Before the entity is added to the list, the Program Coordinator or Inspector shall verify that the entity:

• Sells regulated tobacco products;

• Is not on the Contractor’s current retail outlet list; and

• Is open for business.

After verifying the above requirements, the Contractor shall enter the retail outlet information into TIMS.

C.3.4 FDA’S TOBACCO INSPECTION MANAGEMENT SYSTEM

FDA’s Tobacco Inspection Management System (TIMS) can work in conjunction with a specific handheld device that shall be provided by FDA in a majority of circumstances and allows for the electronic transmission of information. FDA will not consider contractor provided devices. The handheld device currently provided to Inspectors by FDA is an iPhone. FDA will provide the service plans for these devices.

The TIMS Application provides FDA and Contractors with a front-end web interface for accessing and managing FDA tobacco inspection information and related processes.

The Contractor must 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 Section 3.5 below. FDA shall work with the Contractor to ensure designated staff is able to access TIMS, 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 from 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.3.5 COMPLIANCE CHECK INSPECTIONS

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 C.1.A). Generally, the Contractor shall carry out two (2) types of tobacco compliance check inspection assignments: (1) undercover buy, to determine a retail outlet’s compliance with age and photo identification requirements; and (2) advertising and labeling, to cover other provisions of the Tobacco Control Act.

In some instances, FDA may request that both types of assignments be conducted within a short timeframe (specified during training) of each other at a particular retail outlet.

The Contractor shall assign compliance check inspections of identified retail outlets to Inspectors via TIMS. FDA may request that certain retail outlets or areas be inspected.

Each Inspector shall conduct and document each inspection according to FDA protocol (provided during training).

Documentation of the inspection requires the Inspector to:

(1) Record the findings using an FDA handheld device;

(2) Collect evidence via the handheld device, such as tangible items of potentially violative tobacco products or photographs of conditions observed; and

(3) Record any additional observations as instructed by FDA.

Inspectors and minors shall use cash to purchase evidence unless the Contractor obtains approval from FDA to use any other payment method.

If the retail outlet is found to be out of compliance, FDA may request assistance from the Contractor in researching the ownership information of the retail outlet and may need inspectors to return to the retail outlet to obtain further information and evidence.

The Contractor is responsible for the 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 Program Coordinator shall review the results of certain inspections to ensure the quality and completeness of the evidence 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 are 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 shall be provided in the FDA Tobacco Compliance Check Inspection Program training once staff associated with the Contract have undergone a background check and have been cleared and/or commissioned.

1. Undercover Buy Inspections

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 shall be used. The Minor group should also reflect a representative mix of male and female Minors and should reflect the racial and ethnic composition of the population where the undercover buy inspection is conducted.

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.

2. 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 inspections.

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 should not accompany an Inspector during an advertising and labeling inspection to ensure that Minors’ identities remain anonymous.

In most circumstances, the Inspector will be required to provide his/her FDA credentials during this type of compliance check inspection.

3. Timing of Routine Compliance Check Inspections

If a Contractor wants to conduct one of each type of routine compliance check inspection at a particular retail outlet in a year, they must go through the majority of their inventory of retail outlets once with either an undercover buy or advertising and labeling inspection, and then return to do the other type of inspection after most outlets were initially visited. The Contractor shall conduct no more than one routine Undercover Buy and one routine Advertising & Labeling inspection at a particular retail outlet in a year. All follow-up inspections shall be completed within 90 days. Additionally, 10% shall be completed within 15 days of assignment. There will be circumstances when FDA will instruct the Contractor to conduct both undercover buy and advertising and labeling inspections within a short timeframe of each other at a specified retail outlet. The timing of the inspections is discussed further in the FDA training program.

4. Follow-up Inspections

FDA will assign follow-up compliance check inspections for retail outlets found to be out of compliance with the Tobacco Control Act and/or the implementing regulations. When a retail outlet is found to be out of compliance, more than one follow-up inspection can be expected. Generally, these follow-up inspections must be completed by the Contractor within ninety (90) days of receipt of the follow-up inspection request from FDA. FDA will provide specific instructions regarding the conduct of follow-up inspections during the initial training sessions.

5. Complaint Inspections

FDA may issue complaint inspection requests to the Contractor after CTP, Office of Compliance and Enforcement receives complaints from the public of potential violations that may pose a public health risk or other regulatory concern. Specific compliance check inspections and investigations assigned by FDA shall be scheduled and completed as agreed upon by the Contractor and FDA, but no later than ninety (90) days after assigned by FDA.

FDA will provide specific instructions regarding the conduct of follow-up inspections during the initial training session and when inspections are issued.

6. Other Directed Inspections and Assignments

FDA may direct the Contractor to conduct other specific assignments and will provide specific deadlines for completion of assignments. The Contractor shall be capable of performing a directed inspection or assignment within 5 business days of notification from CTP if necessary. The level of effort required to perform directed inspections and assignments will be similar to the level of effort required to perform undercover buy inspections.

These assignments may include, but are not limited to, hand delivery of documents to a retailer, or an abbreviated inspection to determine whether the establishment is selling tobacco products.

7. Data Transmission

FDA will supply the Contractor with laptops for designated Program employees and handheld devices for 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.3.6. REVIEWING COMPLIANCE CHECK INSPECTION RESULTS AND ASSISTING WITH

ENFORCEMENT ACTIONS

The Program Coordinator shall review the results of compliance check inspections to ensure the 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 5 business days of receiving the compliance check inspection results from the Inspector, the Program Coordinator or Backup-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, the Contractor’s recommendation to FDA shall be based solely on the Tobacco Control Act and the implementing regulations.

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

1. Compliance Check Inspection Inquiries

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

Within 5 business days of receiving a request from FDA, the Contractor shall provide the FDA requestor with information about a compliance check inspection and investigation unless extenuating circumstances exist.

2. FDA Enforcement Actions

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

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

(5) years from the date of the inspection. 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. The Contractor shall not dispose of any original inspection records or evidence unless directed by FDA, and the Contractor shall only dispose of or transfer any inspection records or evidence in accordance with FDA instructions.

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…