RFP_Tobacco_Retailer_inspections_amend1.pdf

SOL#75F40119R00065

FDA Tobacco Retailer Inspection Services (FY19 IDIQ)

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. Under the Tobacco Control Act, establishments engaged in the retail sale of FDA-regulated tobacco products (“retailers”) are subject to FDA inspections to document compliance with applicable provisions of the FD&C Act and implementing regulations issued by FDA.

To the extent feasible, FDA will contract with a state or territory to conduct compliance check inspections of tobacco retailers, as required under 21 U.S.C. 372(a)(1)(B)(i). Task orders under this Indefinite Delivery Indefinite Quantity (IDIQ) contract.

B. OBJECTIVES

The purpose of this IDIQ contract is to conduct inspections of tobacco product retailers to gather evidence of and document any potential violations of applicable provisions of the FD&C Act and its implementing regulations, and to provide related support services to FDA during enforcement actions based upon the evidence gathered during such inspections. FDA will utilize the information and evidence obtained during inspections to determine whether retailers violated any applicable requirements and to pursue enforcement actions.

This requirement is being solicited as a Total Small business set-aside under North American Industry Classification System Code (NAICS) 541990 – All Other Professional, Scientific and Technical Services. Small Business Administration (SBA) size standard is $15.0 M.

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:

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;

SYNAR REGULATION

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

Virgin Islands, Puerto Rico, Marshall Islands and Commonwealth of the Northern Mariana Islands) to:

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

• Enforce this law;

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

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

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

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

B.2 CONTRACT TYPE AND PRICE

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

A. The Contract Type is Indefinite Delivery Indefinite Quantity (IDIQ). All Task Orders issued will hybrid task orders.

B. The Contractor guaranteed minimum will be satisfied with the issuance of Task Order 1 for each region. Task Order 1 will be issued at time of award.

C. The contract minimum and maximum value(s) over five (5) years and awarded under this contract are shown below: No other regions will be added.

Region Contract Minimum (Task Order 1 value)

Maximum Contract Value over 5 years

REGION 1 $TBD $9,000,000.00

REGION 2 $TBD $26,000,000.00

REGION 3 $TBD $26,000,000.00

REGION 4 $ 5,000 $ 35,000,000.00

REGION 5 $TBD $3,000,000.00

D. The Contractor shall be paid a firm fixed-price per inspection type. Price per inspections price shall include cost necessary to perform inspections, including inspection related travel.

E. Any required non-inspection travel is Not-to-Exceed (NTE): $10,000 per region. All travel must be reviewed/approved by the Contracting Officer Representative (COR) prior to traveling and reimbursed is in accordance with the Federal Travel Regulations (FTR).

F. All program management will be paid by a fixed hourly rate. Loaded Hourly Rates – If proposed, the fixed hourly rate listed is "loaded" and shall only include the following:

Salary cost or consulting fee of the individual providing the services; Payroll costs (fringe benefits, FICA, etc.); Indirect costs applicable to labor; and Profit or fee, if any;

Documentation of actual program management hours must be submitted when invoicing.

Documentation must be acceptable to FDA.

G. The Contractor shall provide a fixed price per inspection for the entire region.

Offerors should propose a price for each type of inspection listed below.

REGION:

FIRM FIXED PRICED CONTRACT LINE ITEM (CLIN) (PER REGION)

1. Conducting retail inspections and providing related support services

Firm Fixed Firm Fixed Firm Fixed Firm Fixed Firm Fixed price per price per price per price per price per Inspection Inspection Inspection Inspection Inspection Year 1 Year 2 Year 3 Year 4 Year 5

Inspection Type Contractor Directed Contractor-Directed Undercover Buy

FDA-Directed Inspections Undercover Buy

Advertising & Labeling

LABOR HOUR (CLIN)

2. Program Management/Non-Inspection Travel (PER REGION)

Year 1 Year 2 Year 3 Year 4 Year 5 Program Management $ per hour $ per hour per hour per hour

$ per hour

Program Management – Program Management is: Labor Hour

COST REIMBURSEMENT (CLIN’s)

3. Non- Inspection Travel

Not-to- Exceed Year

Not-to-Exceed Year 2

Not-to- Exceed Year

Not-to- Exceed Year 4

Not-to- Exceed Year

*Non-Inspection Travel $10,000 $10,000 $10,000 $10,000 $10,000

4. Other Direct Cost

Exceed Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year 5

Other Direct Cost (ODC) $6,000 $ 6,000 $6,000 $ 6,000 $ 6,000

Prior approval of purchases must be received from Contracting Officer Representative and Contracting Officer/Contract Specialist. Documentation must be provided to FDA when invoicing.

5. Locating Inspectors and Minors

Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year 5

Locating Inspectors and Minors

$ 15,000

$15,000

Compensation for locating witnesses will be reimbursed based on actual expenses.

Documentation must be submitted to Contracting Officer Representative (COR) for reimbursement along with invoice for reimbursement.

6. Testimony compensation

Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year 5

Compensation for Witness Testimony

$10,000 $10,000 $10,000 $10,000 $10,000

Compensation for witness testimony will be reimbursed based on actual expenses incurred.

Compensation is based on the amount of time testifying. Typically, witness testimony will be conducted via teleconference during normal business hours. Any travel related expenses for testimony must be submitted to COR for approval and will be reimbursed according to Federal Travel Regulation (FTR).

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C. 1 SCOPE OF WORK

Independently, and not as an agent of the Federal Government, the Contractor shall assist with the facilitation of compliance check inspections by conducting inspections of tobacco retailers and providing related support services for retailer inspections conducted by FDA personnel. All work will be performed in accordance with the terms of this contract and any Task Order issued hereunder. Attachment 1 – Material List contains a list of materials necessary for conducting FDA tobacco compliance check inspections. FDA is anticipating inspection services in the regions listed in the table below.

Region List of jurisdictions in the region 1* Connecticut, Delaware, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, 2* Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin 3* Alabama, Arkansas, District of Columbia, Georgia, Florida, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, US Virgin Islands, Virginia, West Virginia

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

5 Puerto Rico

*There is no guarantee to the contractor that they will receive a task order to conduct inspections or other services listed in the contract in all the states located within a region*

Region* Contractor Directed

Inspections FDA-Directed Inspections

UBs

UBs

A&Ls

Region 1 600 400 400 Region 2 6,000 3,000 3,000 Region 3 2,500 750 750 Region 5 0 450 450

*The required minimum for each regional contract will be satisfied with the issuance of Task 1 for each region

TECHNICAL REQUIREMENTS

C.1.1 TOBACCO RETAIL COMPLIANCE CHECK INSPECTION PROGRAM

RESPONSIBILITIES

A. CONTRACTOR

The Contractor shall be capable of employing individuals who can be commissioned in accordance with Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)) to conduct inspections. Specifically, the Contractor, its employees, and/or subcontractor shall be capable of performing the requirements of this contract. Non-commissioned Contractor personnel shall assume only administrative, planning, and logistical functions that may be performed without a commission. This encompasses all functions except performing inspections.

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

B. 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 PCs, BPCs, 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., Attachment #4

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. Individuals may be commissioned preliminarily until final security clearance of the individual.

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

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

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

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

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.

C. PROGRAM COORDINATOR/BACKUP PROGRAM COORDINATOR

The Contractor shall designate a Program Coordinator (PC) who shall be responsible for overall coordination, gathering information and evidence, and communicating with FDA. The PC 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 Program Coordinator (BPC) so the Government will always have a point of contact. In the event that the PC and BPC are not available, the Contractor shall designate and notify the COR of a point of contact with authority to make decisions on behalf of the PC/BPC. The PC and backup/alternate PC together shall equal at least one (1) Full Time Equivalent (FTE) per task. The PC must account for the majority percentage of the FTE. For the purposes of this contract an FTE is equal to 2080 hours. The Program Coordinator, Backup Program Coordinator or designated alternate shall be available at all times during business hours to communicate with the FDA.

The Contractor shall inform the COR when there are any changes to the information for Program Coordinator, Backup Program Coordinator, Inspectors, Administrative Assistants, Chaperones, Commissioned Officers, or Minors (e.g., phone number, e-mail address, status, change of personnel, etc.).

D. INSPECTORS

The Contractor shall conduct compliance check inspections through persons who are United States citizens and who are also able to be commissioned as officers of the United States Department of Health and Human Services (HHS), Food and Drug Administration, under the authority of Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)), which includes any health, food, or drug officer/employee of the State, Territory, or political subdivision thereof.

The contractor must be able to provide commissionable individuals to conduct these inspections.

To be commissionable, the inspector must be a health, food, or drug officer/employee of the State, Territory, or political subdivision listed in Section C.1, Table 1, Scope of Work. In addition to meeting the FDA requirement regarding commissionable inspectors, the contractor must identify and meet all jurisdictional specific requirements necessary to perform tobacco compliance check inspections. The contractor shall submit the specific jurisdiction statute that addresses tobacco compliance check inspections along with supporting information on how the contractor is capable of addressing the statutory requirements. If the jurisdiction requires individuals with specialized credentials or approval by a specific entity within the jurisdiction, the contractor must provide a plan on how it will meet these requirements.

For ease of program administration and management, there shall be no more than thirty (30) active Inspectors in each jurisdiction (i.e., each state or territory). Inspectors must maintain regular performance of inspections in their respective jurisdictions in order to remain active on a task order within this contract. Inspectors that do not perform a minimum of 10 inspections per month in their respective jurisdictions will be deactivated from the program.

The Contractor shall inform all Inspectors that they may be needed to testify as witnesses in administrative hearings during the period of performance of the contract. The PC 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 PC will annually confirm the contact information for Inspectors who have left the program.

The Contractor shall maintain current contact information for all inspectors and minors currently employed by the Contractor. The contractor shall provide FDA with contact information as needed by FDA. The Contractor shall annually verify current contact information for all inspectors and minors who were employed within the past five years but are no longer employed by the Contractor, and the most recent contact information for such inspectors and minors shall be provided to FDA. Additionally, FDA may request individual contact information that shall be provided within five (5) business days of the request.

E. INFORMATION REGARDING MINORS

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

The Contractor shall keep at least one photo on file of each Minor involved in the Program.

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

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

Identities of Minors are confidential and will not be released absent a judicial order to do so. In the event of a judicial order to reveal a Minor’s identity, the Minor may be requested to provide a written declaration and/or give oral testimony in a hearing. The Contractor must inform the Minors that they may be needed to provide written declarations and/or testify as witnesses in administrative hearings and related court proceedings related to FDA tobacco retail inspections they conducted within the past five years. This information must be contained in the parental/legal guardian consent form. The PC shall maintain current contact information on all Minors who leave the program, and this information shall be turned over to the Government at the end of the contract period. The PC will annually confirm the contact information for Minors who have left the program.

All participating Minors shall have a Medical Release form 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 form in the field whenever a minor is participating in inspections or training.

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

The Contractor shall ensure that all Minors are insured against accidents or other injuries. If the Minors are not covered under the Contractor's current policy, the Contractor shall purchase the necessary insurance. The Contractor shall not conduct inspections until such insurance is secured for Minors. Proof of insurance, including automobile liability coverage for commissioned officers and chaperones transporting Minors, shall be maintained by the Contractor and made available to FDA upon request.

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

F. CONFLICTS OF INTEREST

The PC, Backup PC, designated alternate, and any other 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 contractor must immediately notify FDA of the possible conflict of interest. The contractor 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 PCs, Backup PCs, designated alternate, or Commissioned Officers by any applicable federal law or ethical standard.

C.1.2 PROGRAM MANAGEMENT TASKS

1. The Contractor shall conduct all program management tasks through its PC and BPC or designated administrative personnel. The Contractor shall provide program management services to ensure the quality, timeliness, and accuracy of its work under this Contract and the applicable Task Order(s). Program management also includes budget, schedule, and quality management of each Task Order and all services and deliverables provided thereunder. Representative activities include:

a. Developing, maintaining, and implementing a quality control plan (QCP) for the Task Order. The QCP shall include quality assurance and quality control activities to include: Periodic reviews of deliverables and delivered information (including all inspection results, data, documents, and photos delivered to FDA) by persons different than those preparing or collecting the deliverables or delivered information.

b. Maintenance of Quality Assurance (QA) records detailing the findings of those reviews.

c. Accuracy: Work product, deliverables, and delivered data (including but not limited to all reports, inspection results, data, documents, and photos delivered to FDA) shall be accurate in presentation and technical content.

d. Clarity: Work product, deliverables, and delivered data shall be clear and concise.

e. Consistency to Requirements: All services, work product, deliverables, and delivered data must satisfy all requirements of this contract and the applicable Task Order.

f. Timeliness: All services, work product, deliverables, and delivered data shall be submitted by the due date specified in this contract and the applicable Task Order.

g. Format: All work product and deliverables shall be submitted in formats and media mutually agreed upon prior to submission.

h. Mitigation: Risks and other performance issues must be mitigated as they arise.

i. Reviewing inspection results submitted by inspectors to ensure conformity with quality and acceptability requirements in the IDIQ and task order.

Inspection results are submitted into FDA systems electronically by inspectors within timeframes specified by FDA.

j. Providing monthly program status reports to FDA. The contents and format of monthly program status reports will be specified at the Task Order level.

k. Providing additional inspection details regarding compliance check inspections within two business days of a request from the Contracting Officer’s Representative (COR).

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

Maintaining designated Key Personnel, one Program Coordinator and one Backup Program Coordinator to serve as the primary points of contact with FDA and the key personnel responsible for program management for each Task Order.

m. Inspection services shall be provided in accordance with the terms of the applicable Task Order, including inspection quantities, period of performance, and place of performance.

n. The contractor shall provide the necessary staff to conduct inspections. This includes ensuring that inspections are conducted in accordance with individual jurisdictional requirements. Additionally, the Contractor shall secure a grant of immunity from the proper authorities in each 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 prior to using Minors in those jurisdictions. The proper authorities would be those authorities that may grant immunity to Minors from prosecution under applicable law. The Contractor shall provide proof of such immunity upon request from FDA.

o. The contractor shall conduct compliance check inspections through individuals commissioned in accordance with Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)), i.e., any health, food, or drug officer/employee of the State, Territory, or political subdivision thereof, duly commissioned as an officer of the Department of Health and Human Services.

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

q. Securing a signed FDA Form 3398 for each Contractor employee and subcontractor who is or will be involved in the inspection program under this Contract or who has or will have access to any non-public information arising under or related to this Contract. This must be done prior to allowing any contractor or subcontractor employee to work on this contract.

r. Securing and maintaining all required information and documents pertaining to inspectors and minors, including maintaining current contact information for currently-employed and former inspectors and minors who participated in inspections within the past five years.

s. Monitoring and providing timely notification to FDA of any actual, apparent, or potential conflicts of interest for any Contractor or subcontractor personnel, and otherwise ensuring that all statutory and contractual requirements relating to conflicts of interest are met, as stated in Section H – Special Contract requirements (Conflict of Interest). This includes submitting an annual certification in writing to the COR that the contractor remains in compliance with conflict of interest requirements and that all relevant disclosures of information have been made.

t. Facilitating timely implementation and completion of all training requirements for all employees or subcontractor employees under this Contract.

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

v. Ensuring completion of all inspection assignments and submission of all deliverables per the Task Order.

2. SITE VISIT:

FDA anticipates conducting site visits at the contractor’s facility to review all aspects of the compliance check inspection program and ensure compliance with the contract during the period of performance of this contract. FDA shall provide the contractor with a minimum of 72 hours’ notice prior to any planned visit. All documents and logs will be reviewed. PC and BPC must be present during a planned site visit.

C.1.3 TOBACCO RETAIL INSPECTION PROGRAM TRAINING

A. TRAINING

In order to conduct inspections on behalf of FDA, contractor personnel must understand and become familiar with FDA systems, processes, and procedures. FDA has developed training for all persons conducting inspections under a task order. This training must be completed in addition to any internal training that the contractor provides its staff. The contractor is entirely accountable for performance of the services listed in this IDIQ and shall determine the appropriate level of training for its staff.

All persons designated as key personnel for the contract or a task order, and all Contractor and subcontractor personnel performing inspections under a task order, must complete an initial training course provided by FDA prior to performing any work under the Contract.

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 electronically. The Contractor must ensure that all parts of the FDA Tobacco Compliance Check Inspection Program training are followed as prescribed. The training will address issues including: how to use FDA’s TIMS application and FDA-furnished handheld devices and computers; required protocols and procedures for conducting inspections, completing inspectional forms and narrative reports, obtaining all required information and photographs, submitting inspection results and evidence to FDA, and the importance of protecting non-public information and potential consequences of unauthorized disclosure of non-public information.

FDA will conduct mandatory training sessions to present topics related to inspection procedures, new policies, and contractual updates to the Program Coordinators, Backup Program Coordinators, and Inspectors. Each training sessions will be conducted via teleconference or webinars. FDA will provide up to 24 hours of training during each period of performance of each task order.

Inspectors that make multiple and/or repeated procedural errors shall undergo corrective training.

The Contractor shall provide FDA with a plan, within two business days of notification, regarding how it intends to address inspector errors that are identified, including the training provided. The Contractor shall notify FDA when the plan has been successfully implemented.

No inspector or minor may conduct inspections prior to passing FDA provided training.

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

B. TRAINING FOR MINORS

The Contractor shall train minors and shall institute its own training methods in addition to ensuring that each minor completes the required FDA minor training module. The Contractor’s training program may include mock undercover buy inspections so newly recruited Minors may observe experienced Minors conduct undercover buy inspections before conducting them on their own. Each Minor must complete the required FDA minor training prior to conducting any inspections. Inspectors shall review each inspection with the minor and advise them of any necessary corrections prior to moving to the next inspection.

C. PROGRAM COORDINATOR IN-PERSON TRAINING

FDA anticipates conducting in-person training for PCs approximately every three years, which may occur during the period of a task order of this contract. This training may be up to three full workdays and may be held in the Washington, D.C. metropolitan area. If offered by FDA during any period of a task order of this contract, personal attendance by each PC is mandatory. The attendance of the Backup PC(s) is also highly recommended.

C.1.4. IDENTIFICATION OF RETAILERS

A. RETAIL OUTLET LIST

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

FDA currently possesses a list of the tobacco retailers located in the subject jurisdictions within the regions and will provide it to the contractor at the contract kickoff meeting. Within sixty

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

The format is subject to change based on program needs.

B. ENTITIES NOT INCLUDED ON RETAIL OUTLET LISTS

Entities discovered to sell regulated tobacco products but are not in the TIMS database shall be added to TIMS within 21 days after award see Deliverable Schedule F.3. Before the entity is added, the PC shall verify that the entity:

• Sells regulated tobacco products;

• Is not already in the TIMS database; and

• Is open for business.

C.1.5. FDA’S TOBACCO INSPECTIONS MANAGEMENT SYSTEM (TIMS)

FDA’s TIMS can work in conjunction with a specific handheld device that shall be provided by FDA and allows for the electronic transmission of information. FDA will not consider contractor provided devices. The TIMS Application provides FDA and Contractors with a front-end web interface for accessing and managing FDA tobacco inspection assignment information and related processes. The handheld device currently provided to Inspectors by FDA is an iPhone. FDA will provide the service plans for these devices.

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

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

Beyond what is publicly available on the FDA external website, no other data resulting from Federal tobacco retailer compliance check inspections, including data in TIMS, may be shared with entities outside of FDA. The prohibition of the release, publication, or disclosure of non-public information, except under specific circumstances, is covered under FDA Form 3398, Contractor's Commitment to Protect Non-Public Information Agreement. All Contractor a n d s u b c o n t r a c t o r staff who are directly involved in the inspection program or have access to data gathered under this program must sign the FDA Form 3398.

On an annual basis, the Contractor shall brief all employees, subcontractors regarding the sensitivity of the information to be handled under the contract and of the responsibility to protect

it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized source. The Contractor shall conduct an updated briefing annually and shall submit a report, electronically or hard copy, to the Contracting Officer and COR within ten (10) days after the briefing. The report shall include: (1) an outline of the briefing, (2) a copy of any briefing materials, (3) the date the briefing was conducted, and (4) the names of the attendees.

C.1.6 CONDUCT COMPLIANCE CHECK INSPECTIONS

A. OVERVIEW OF GENERAL INSPECTION PROCEDURES

The Contractor shall conduct inspections of retailers that sell regulated tobacco products to verify retailer compliance with applicable statutory and regulatory requirements and, when applicable, document potential non-compliance and obtain relevant evidence.

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

The Contractor shall also provide the FDA Contracting Officer’s Representative

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

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

The Contractor shall conduct all inspections in accordance with the procedural protocols and requirements established by FDA in initial and refresher trainings.

Inspection services shall be provided in accordance with the terms of the applicable Task Order, including inspection quantities, period of performance, and place of performance. This IDIQ encompasses Contractor directed Undercover Buy Inspections, FDA directed Advertising and Labeling inspections, and FDA directed Undercover Buy inspections.

The Contractor shall arrange tobacco compliance check inspections of retailers that sell or advertise tobacco products to determine whether those retailers are complying with the Tobacco Control Act and the implementing regulations (See Section B.1.C.).

Generally, the Contractor shall carry out two (2) types of tobacco compliance check inspection assignments: (1) undercover buy assignments, to determine a retailer’s compliance with age and photo identification requirements; and (2) advertising and labeling, to cover other provisions of the Tobacco Control Act. In some instances, FDA may request, in advance, that both types of assignments be conducted within a short timeframe of each other at a particular retail outlet.

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

The contractor shall provide the necessary staff to conduct inspections. This includes ensuring that inspections are conducted in accordance with individual jurisdictional requirements. Additionally, the Contractor shall secure a grant of immunity from the proper authorities in each 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 prior to using Minors in those jurisdictions. The proper authorities would be those authorities that may grant immunity to Minors from prosecution under applicable law. The Contractor shall provide proof of such immunity upon request from FDA.

The contractor shall conduct compliance check inspections through inspectors commissioned in accordance with Section 702(a)(1)(A) of the FD&C Act (21 U.S.C.

§ 372(a)(1)(A)).

The Contractor shall ensure each Inspector conducts and documents each assignment according to FDA protocol (provided during training). Documentation of the inspection requires the Inspector to: (1) record the findings on a compliance check inspection form, which will be provided by FDA via the handheld device; (2) collect physical evidence (e.g., tobacco products purchased by the minor) and take photographs using the handheld device; and (3) record any additional observations as instructed by FDA.

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

B. CONTRACTOR DIRECTED AND FDA DIRECTED UNDERCOVER BUY

INSPECTIONS

Undercover Buy inspections are undercover inspections involving purchase of a regulated tobacco product by a minor (ages 16-17 or age otherwise specified by FDA in the event of an applicable change to minimum age requirements specified in the FD&C Act and/or its implementing regulations) who is supervised by an inspector.

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 potential 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 conduct that are indicative of a potential violation.

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

The Contractor shall ensure that Minors used in the undercover buy inspections are not related to the Inspectors conducting the inspection of a specific retail outlet or the Chaperone, if one is present. The Contractor shall ensure that inspectors are aware of the hours deemed safe by the PC to conduct undercover buy inspections using Minors.

1. Contractor Directed Undercover Buy - Contractor shall utilize FDA TIMS system to issue Inspection assignments. Subject to the terms of the task order, the Contractor may determine the date of issuance, retailer location (selected from the retailer list), and timeframe for completion of contractor-directed inspections. However, the Contractor’s assignment discretion is subject to any limiting terms in the Task Order, such as the following contractual requirements:

a. The Contractor shall not assign or conduct these inspections at a retailer location where one contractor-directed inspection has been completed within the previous 365 calendar days. Task orders may specify the number and location of contractor-directed inspections to be completed during a task order period, and the Contractor shall comply with these requirements at the task order level.

b. The Contractor shall assign or conduct these inspections only within the area or areas specifically designated by FDA. FDA will notify the Contractor in writing of the scope of said areas. FDA retains the sole right to define what constitutes an area. FDA retains the sole right to expand or contract, at any time, any area or areas within the jurisdiction.

c. These inspections shall be completed within 90 calendar days of assignment.

d. Alternatively, the Contractor may be responsible for identifying retailers to inspect in each jurisdiction. In identifying which retailers to inspect in each jurisdiction, the Contractor shall prioritize geographic areas with a higher risk for regulatory violations, such as: (1) areas with high rates of youth tobacco use, and (2) areas where youth report easy access to tobacco products.

2. FDA directed UB inspections - Inspection assignments will be conducted at retailer locations selected by FDA. FDA shall determine the date of issuance and retailer location for completion of these FDA directed inspections. These inspections shall be completed within 90 calendar days of assignment.