FDA-15-SOL_PR.doc

FDA-SOL-1146302-PR

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FDA-SOL-1146302-PR

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 below 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 below 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 and its results.

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.

C. 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:

· 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.”

· Section 911 (a): “No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.”

OTHER APPLICABLE FEDERAL STATUTES

The provisions of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) to be enforced under the resultant Contract are referenced in Section 204 of the Tobacco Control Act. Section 204 provides that advertisements and packages of smokeless tobacco products must bear one of four specified warning label statements (warnings), and the warning area must occupy at least a specified percentage of the packaging (30%) and advertising (20%). Additionally, the warnings must be in either black text on a white background, or white text on a black background. The burden is generally on retailers to ensure that for smokeless tobacco advertising or packaging supplied to the retailer, a warning appears on the smokeless tobacco packages and advertisements on display in their outlets and that the retailers do not materially alter the warnings.

The provisions of the Federal Cigarette Labeling and Advertising Act (FCLAA) applicable under the resultant Contract are in Section 201 of the Tobacco Control Act. Section 201 requires FDA to issue regulations related to the promotion and advertising of cigarettes. Upon implementation of these regulations, the Contractor will inspect for violations of these provisions.

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 provisions in 21 CFR Part 1140 that are subject to inspection by the Contractor under this Contract include:

· Age and Photo Identification Restrictions – Retailers:

· May not sell covered tobacco products to anyone younger than 18 years of age;

· Must verify that any person under age 27 purchasing covered 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:

· May only sell covered tobacco products in direct, face-to-face transactions, with limited exceptions;

· May not have impersonal modes of sales at their facility (e.g., vending machines or self-service displays that enable direct access by consumers to covered tobacco products) unless they ensure that persons younger than 18 years of age are not present or permitted to enter the facility at any time;

· May not break or otherwise open packages of cigarettes to sell or distribute single cigarettes or any package with less than 20 cigarettes;

· May not break or otherwise open any covered tobacco product package to sell or distribute any quantity of the covered tobacco product that is smaller than the smallest package distributed by the manufacturer for individual use;

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

B.2

CONTRACT PRICE

The Contractor shall be paid a fixed-price per inspection, a fixed-price for 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 – (actual dates shall be inserted at award) (12 months) Total Fixed Price:

Puerto Rico

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

Inspection Type

Undercover Buy

Compliance Follow-Up

Complaint Follow-Up

Other Directed Inspections & Assignments

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

B.3

CONTRACT PRICE - OPTIONS

Option Period I – (actual dates shall be inserted at award) (12 months) Total Fixed Price:

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

Inspection Type

Undercover Buy

Compliance Follow-Up

Complaint Follow-Up

Other Directed Inspections & Assignments

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

Option Period II – (actual dates shall be inserted at award) (12 months) Total Fixed Price:

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

Inspection Type

Undercover Buy

Compliance Follow-Up

Complaint Follow-Up

Other Directed Inspections & Assignments

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

B.4

TRAVEL AND OTHER COSTS

A.

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

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 requires inspection services in Puerto Rico. The offeror shall propose to inspect no less than 20% of the retail outlets in the State and no more than 100% of retail outlets in the state.

TECHNICAL REQUIREMENTS

C.1.1 TOBACCO RETAILCOMPLIANCE CHECK INSPECTION PROGRAM RESPONSIBILITIES

A.

Contractor The Contractor shall be capable of employing or subcontracting with individuals who are bilingual (Spanish and English) and can be commissioned by FDA to conduct inspections.

Specifically, the Contractor, its employees and/or subcontractor shall be capable of performing the requirements of this contract in Puerto Rico, a jurisdiction in which Spanish is the principal language, and must also be capable of interacting and communicating with FDA staff and FDA systems in the English language.

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. Insurance for minors is factored in as a direct cost that is allocated to the fixed price for undercover buy inspections and compliance follow up inspections or as a general and administrative (G&A) expense.

The Government reserves the right to prohibit Contractor personnel from working under this Contract for performance issues and conflicts at any time.

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. Together the Program Coordinator and backup/alternate Program Coordinator shall equal at least one (1) FTE. The Program Coordinator must account for the majority percentage of the FTE.

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.

Inspectors must be available 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.

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 but are required to sign a Commitment to Protect Non-Public Information Agreement.

In general, the commissioning process begins with a background investigation, including a fingerprint check, credit check, and childcare check facilitated by FDA. Several parties within HHS may be involved in the process, with oversight by the Center for Tobacco Products (CTP). Any of these parties may contact the Contractor for additional information to facilitate the process. Upon clearance of the fingerprint check, a person may be commissioned while the background investigation continues.

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 seven calendar days of award, 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. (See Section F.3, 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 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. 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.A. 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 (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, Undercover Buy Assignments) by obtaining a copy of their birth certificate and identification (if available) and an original parental/legal guardian consent form. The Contractor shall 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 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. Minors must be available 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 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. This information must be contained in the parental/legal guardian consent form.

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 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 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. TOBACCO RETAIL INSPECTION PROGRAM TRAINING

1.

Initial Training for Contractors and Subcontractors FDA officials will provide the FDA Tobacco Compliance Check Inspection Program training materials and conduct the initial training of the Program Coordinator, Backup Program Coordinator, and Inspectors. Inspectors must be commissioned by FDA before reviewing the training materials. The Program Coordinator shall ensure that all Inspectors have taken and passed the FDA Tobacco Compliance Check Inspection Program Training before beginning inspections. FDA shall work with the Program Coordinator to determine the best means for training the Inspectors. Out-of-state travel is not anticipated for this initial training. Training will be conducted via teleconference or via online learning management system. The Contractor must ensure that all parts of the FDA Tobacco Compliance Check Inspection Program training are followed as prescribed. No inspector shall be permitted to commence inspections prior to earning a passing grade on the initial training test.

2.

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 Online Learning Management System minor training module. The Contractor’s training program may include mock undercover buy assignments so newly recruited Minors may observe experienced Minors conduct undercover buy assignments before conducting them on their own.

3.

Maintenance of Training Records and Annual Refresher Training 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. FDA will consider requests for additional training by the Contractor and will provide additional training as FDA deems appropriate.

Inspectors that make multiple and/or repeated procedural errors shall undergo mandatory refresher training and testing upon FDA’s request. The Inspector must attain a passing score on the test within two months or FDA may prevent the inspector from performing contract duties involving the procedures at issue.

4.

Program Coordinator In-Person Training

FDA may conduct an in-person training for Program Coordinators during the base period of performance and annually thereafter. If held, this training is expected to cover two 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 if it is held by FDA. The attendance of the Backup Program Coordinator(s) or another FDA approved Contractor representative is highly recommended by FDA. Offerors should anticipate that this training will occur annually.

C.1.3. IDENTIFICATION AND SELECTION OF RETAILERS

1.

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 self-service displays of tobacco products are permitted, 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 State 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 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, mailing address (including zip codes), the state or territory in which the retail outlet is located, unique ID number, as well as the name and mailing address of the legal owner(s) of the retail outlet, if available. 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, as they become available, to FDA throughout the Contract period of performance. The Contractor shall provide updates to the retail outlet list to FDA with each Quarterly Report 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 required format for the retail outlet list.

2.

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 with the requirements set forth below.

In identifying which retailers to inspect in each jurisdiction, FDA plans to 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 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. FDA will provide some criteria for assisting Contractors in defining racial and ethnic minority communities and will work with Contractors to meet the statutory requirements.

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 as soon as practicable and before moving on to the next inspection (Task 4. FDA’s Tobacco Inspection Management System (TIMS)).

The Contractor shall conduct # of inspections TBD at time of award (a minimum of 20%, maximum of 100% as described in Section C.1) of the retail outlets in the state, evenly distributed throughout the year for each contract period of performance. Follow-up visits shall only be conducted at FDA’s request and following FDA’s guidance.

3.

Entities Not Included on Retail Outlet Lists

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

· Sells tobacco products;

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

· Is open for business.

Upon determination that the entity is not on the list, the Contractor shall enter the entity information, verify the above requirements, and submit the entity information to FDA.

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 in a majority of circumstances and allows for the electronic transmission of information. FDA will not consider contractor provided devices. The TIMS Application provides FDA and Contractors with a front-end web interface for accessing and managing FDA tobacco inspection assignment information and related processes. Inspectors not using the handheld device for data submission shall submit paper forms to their Program Coordinator or enter data using a computer. The handheld device currently provided to Inspectors by FDA is an iPhone. FDA will provide the service plans for these devices. If an Inspector or Contractor is not issued a handheld device by FDA, they will be trained to use paper forms. If it is deemed that an inspector will be receiving a handheld device to facilitate inspections, FDA will provide the handheld device within two weeks of the inspector’s completion of training.

FDA will work with the Contractor to determine whether they will use handheld devices, computers, or paper forms. Some of the factors that will be considered by FDA in making this determination include, but are not limited to, the number of Inspectors that the Contractor plans to use, the percentage of time those Inspectors dedicate to the FDA program, as well as the Contractor's differing approaches for conducting the work.

The Contractor shall notify the FDA COR 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 shall 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. Contractors using paper forms need to coordinate with FDA for data entry.

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

1.

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 undercover buy assignments, to determine a retailer’s compliance with age and photo identification requirements.

The Contractor shall assign compliance check inspection assignments of identified retail outlets to Inspectors via the designated handheld device, computer, or a manual process if using paper forms. FDA may request that certain retail outlets or areas be inspected. FDA may 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 assignment requires the Inspector to: (1) record the findings on a compliance check inspection form, which will be provided by FDA via the handheld device, a computer, or a paper form; (2) prepare a narrative report revealing potential violations (according to the FDA template); (3) collect evidence, such as tangible items of potentially violative tobacco products or photographs of conditions observed via the handheld device or a digital camera; and (4) 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 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 to ensure the quality and completeness of the evidence 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 commissioned.

2.

Undercover Buy Assignments The Contractor shall ensure that FDA protocol for conducting compliance check inspections is followed. Generally, undercover buy assignments shall be conducted by teams comprised of an Inspector and a Minor. The Minor must be supervised at all times, with limited exceptions. If Inspectors accompany Minors during undercover buy assignments, Inspectors shall position themselves so that they can observe Minors during the entire undercover buy assignment to ensure that they can later complete a narrative report attesting that they have witnessed the violation. In certain circumstances, Minors will be required to complete narrative reports regarding 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 minors must be bilingual (Spanish and English) in order to be capable of performing the requirements of this contract in Puerto Rico, a jurisdiction in which Spanish is the principal language, and capable of interacting and communicating with FDA staff and FDA systems in the English language.

The Contractor shall ensure that Minors used in the undercover buy assignments are not related to the Inspectors. The Contractor shall ensure that undercover buy assignments using Minors are conducted during the hours deemed safe by the Program Coordinator.

The Contractor may be required to coordinate some of its undercover buy assignments with FDA personnel. This coordination is not anticipated to cause any meaningful impact upon the Offeror’s inspection plan.

3.

Advertising and Labeling Assignments The Contractor shall conduct advertising and labeling assignments as a complaint follow-up inspection and as part of compliance follow-up 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 assignments 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 assignment 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 assignment.

4.

Compliance 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 or when the evidence collected by the jurisdiction does not conform to FDA protocols and procedures. When a retail outlet is found to be out of compliance, more than one follow-up assignment can be expected. Generally, these follow-up assignments must be completed by the Contractor within ninety (90) days of receipt of the follow-up inspection request from FDA. The Contractor may need to coordinate these inspections with FDA personnel conducting routine advertising and labeling assignments in the jurisdiction. FDA will provide specific instructions regarding the conduct of follow-up inspections during the initial training session. Pricing for a compliance follow-up inspection will require a contractor to consider that they will be performing both an undercover buy inspection and an advertising and labeling inspection that resulted from a previous violation.

5.

Complaint Follow-Up Inspections FDA may issue complaint follow-up 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 assignments are issued. The level of effort required to perform these inspections will be similar to that required to perform an undercover buy or advertising and labeling assignment. CTP estimates, but not guarantee or otherwise limit, that an average of five complaint follow up inspections will be required per jurisdiction per contract year. Pricing for a complaint follow up will require a contractor to consider that they will be performing either an undercover buy inspection or an advertising and labeling inspection that will be initiated at FDA’s request.

6.

Other Directed Inspections and Assignments FDA may direct the Contractor to conduct other specific assignments scheduled on a date agreed upon by the Contractor and FDA, but no later than 90 days after assignment by FDA. The contractor shall be capable of performing a directed inspection 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 assignments. These assignments may include, but are not limited to, tasks similar to in-person service of difficult to deliver retailer correspondence on an infrequent basis. CTP estimates, but not guarantee or otherwise limit, that no more than 10 other directed inspections and assignments will be required per contract year.

7.

Data Transmission FDA will supply the Contractor with handheld devices (if applicable), paper forms, and access to TIMS for recording information related to each compliance check inspection. The Contractor shall ensure inspectors record compliance check inspection data and manage compliance check inspection work.

The Contractor shall ensure inspectors submit the results of each compliance check assignment for review by the Program Coordinator, including the narrative report and evidence, if applicable, within 48 hours after the compliance check assignment was initiated.

C.1.6. REVIEWING COMPLIANCE CHECK INSPECTION RESULTS AND ASSISTING WITH ENFORCEMENT ACTIONS

The Program Coordinator shall review the results of compliance check inspection assignments 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 the inspection assignment results and recommendation electronically through the TIMS system to FDA using the FDA-provided laptop.

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

Compliance Check Inspection Inquiries If the inspection data and 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 closeout of an inspection.

Within 48 hours of receiving a request from the FDA COR, the Program Coordinator shall provide the FDA COR 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) and/or a no-tobacco sale order, (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. PROGRAM MANAGEMENT TASKS

The Contractor shall conduct all program management tasks through its Program Coordinator and Backup Program Coordinator. 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;

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

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

· Ensuring no contract personnel have 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 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;

· Securing former inspectors as experts where necessary; and

· Performing all…