2016_Tribal_Inspection_RFP.pdf

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING PAGE OF PAGES

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

CODE7. ISSUED BY 8. ADDRESS OFFER TO (If other than item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishings the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in until local time

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR

INFORMATION

CALL:

A. NAME B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER EXTENSION

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. PAGE(S)DESCRIPTION

A B C D E F G H

I

J

K

L

M EVALUATION FACTORS FOR AWARD

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

LIST OF ATTACHMENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECS./WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS(%)

DATEAMENDMENT NO.AMENDMENT NO. DATE

15A. NAME AND

ADDRESS

OF OFFER-

OR

CODE FACILITY 16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

15B. TELEPHONE NUMBER

AREA CODE NUMBER EXTENSION

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER SUCH

ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL OPEN COMPETITION:

10 U.S.C. 2304 (c) ( )41 U.S.C. 3304(a)

24. ADMINISTERED BY (If other than Item 7)

26. NAME OF CONTRACTING OFFICER (Type or print)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

25. PAYMENT WILL BE MADE BY

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

CODE

ITEM

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214 (c)

SEALED BID (IFB)

NEGOTIATED (RFP)

(Hour) (Date)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

N/A 1 60

DHHS/FDA/OAGS/DSAAG/State Contracts Branch 5630 Fishers Lane, Room 2024, HFA-500 Rockville, MD 20857

FDA-16-SOL-1160806

(see block 7) 1:00 pm

Yared Girmai yared.girmai@fda.hhs.gov

2-4 5-24 25-29 29-33 33-42 33-42 59-60

49-59

45-46

43-45

05/31/2016

240 4027581

02/26/2016

G-3

Office of Financial Services 10903 New Hampshire Avenue, WO32 Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002

46-49

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 CONTRACT TYPE

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

B.2 CONTRACT PRICE

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

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

No. of Inspections Price Per Inspection Total

Inspection Type Undercover Buy Advertising & Labeling 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.

Task QTY Price Total Program Management 12 Months Training/Travel

B.3 CONTRACT PRICE - OPTIONS

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

a. Inspections – the Contractor shall be paid the following fixed-price for completed

Undercover Buy Advertising & Labeling Compliance Follow-Up Complaint Follow-Up

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

Training/Travel

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

c. Inspections – the Contractor shall be paid the following fixed-price for completed

Undercover Buy Advertising & Labeling Compliance Follow-Up Complaint Follow-Up

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

Training/Travel

B.4 TRAVEL AND OTHER COSTS

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

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

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

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

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

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

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

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

B. Travel claims shall be submitted and included with the monthly invoices for approval.

Listed below is a description of receipts required as attachments to the invoice to support travel claims:

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

2. Lodging receipt;

3. Parking/tolls receipt;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi travel.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 BACKGROUND

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, adding a new chapter granting the Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also amended the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) to grant FDA authority to regulate certain health warnings that must appear on smokeless tobacco products.

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

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

A. APPLICABLE LAWS AND REGULATIONS

FEDERAL FOOD, DRUG, AND COSMETIC ACT

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

• 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:

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

o 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:

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

o 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;

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

o 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;

o 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.

C.2 PURPOSE/OBJECTIVE

The purpose of this work is to:

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

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

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

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

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

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

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

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

This Contract is designed to obtain Tribal government (herein referred to as “Contractor”) assistance in inspecting retailers that sell covered tobacco products and in surveillance of other entities that fall under the scope of the provisions cited in Section C.1.

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

C.3 SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described Section C, Description, Specifications, Work Statement.

Except as otherwise specified in the Contract, the Contractor shall provide support in accordance with the timelines stated in the implementation plan. Section J, Attachment 1 contains a list of materials necessary for conducting FDA tobacco compliance check inspections. The Contractor shall be compensated on a fixed-price basis as outlined in section B of the contract.

C.3.1 TOBACCO COMPLIANCE CHECK INSPECTION PROGRAM

RESPONSIBILITIES

A. Contractor/Subcontractor

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

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

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

B. Program Management/Coordination

The Contractor shall designate a Program Coordinator who will be responsible from overall coordination, gathering information and evidence, and communicating with FDA. This position should be the main point of contact for FDA. The Contractor shall also designate a backup/alternate Program Coordinator so that the Government will always have a point of contact.

C. Inspections

The Contractor shall conduct compliance check inspections through any health, food, or drug officer/employee of any Tribe or political subdivision thereof. These individuals must be United States citizens and be able to be commissioned as officers of the United States Department of Health and Human Services (HHS), FDA, under the authority of the FD&C Act.

Inspectors may be requested to testify as witnesses in administrative hearings for a minimum of five (5) years after each inspection and are required to be available for testimony during the period of performance of this contract. The Program Coordinator will retain current contact information on all inspectors who leave the program for at least five (5) years after their departure. The Program Coordinator shall 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.

In general, the commissioning process begins with a background investigation, including a fingerprint check, credit check, and childcare check facilitated by FDA. Several parties within HHS may be involved in the process, with oversight by the Center for Tobacco Products (CTP).

Any of these parties may contact the Contractor for additional information to facilitate the process. Upon clearance of the fingerprint check, a person may be commissioned while the background investigation continues.

The Contractor must submit contact information for the person(s) or entity most familiar with their agency’s background investigation procedure as well as that of any Subcontractor(s), if applicable. Upon award of the Contract, FDA’s Office of Security Operations (OSO) will discuss the Contractor’s or Subcontractor’s background clearance requirements with the respective security contact to assess whether its existing background investigation is equivalent to the FDA’s requirement which is a Federal Level 5 Minimum Background Investigation (MBI), Public Trust Background Investigation. Additionally, OSO will evaluate the clearances currently held by each individual required to have a background check under the Contract. If OSO determines that any additional element or information is needed to complete the required clearances, OSO will facilitate this process.

Within 30 days of being awarded the contract, the Contractor shall provide the information for the available employees to be commissioned/receive background investigations, and subsequently, immediately upon identifying new staff it wishes to have commissioned. (See Section F.2 – Deliverables). More specifically, the Contractor shall provide FDA with each such person’s name, work address, work number or cell number, and email address. The Contractor will be required to input each Minor’s unique identification number into FDA’s Tobacco Inspection Management System (TIMS) once the Contractor receives access. The Minor’s unique identification number shall be generated by the Contractor to protect the confidentiality of the Minor. The Contractor must maintain information cross-referencing each unique identification number to a specific minor. The Contractor shall notify FDA if any of the employee information above changes.

Receiving a commission signifies that the employee has accepted a position of public trust and must comply with all applicable federal laws and ethical standards. Each FDA commission is issued for a period of five years. Employees and/or Subcontractors are responsible for immediately notifying their Program Coordinator of any event or occurrence that could affect or change their status. The status of a background investigation may be continuously monitored by the Contractor, the Program Coordinator, and FDA.

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

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

• The abuse or misuse of the commission;

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

• A conflict of interest;

• Change in criminal or credit history;

• Substance abuse; or

• Behavior that may discredit FDA.

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

E. Information Regarding Minors

Minors are an integral part of conducting compliance check inspections to ensure compliance with the provision cited in Section C.1.

The Contractor shall keep at least one photo on file of each Minor involved in the Program. In order to document the Minors’ appearance, the Contractor may determine that they should be photographed with frequent regularity and/or prior to conducting any undercover buy 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.3.5, 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 must obtain permission from the Minor's parents/legal guardian and school, unless home schooled or otherwise not enrolled, if the Minor is going to conduct undercover buy 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 may be requested to testify as witnesses in administrative hearings for a minimum of five (5) years after each inspection.

FDA needs to retain current contact information on all Minors who leave the program for at least five (5) years after their departure. The minor information must be provided upon request to FDA at the end of the period of performance of the contract. The Program Coordinator will annually confirm the contact information for Minors who have left the program. 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 proof of such immunity upon request from FDA.

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

F. Conflicts of Interest

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

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

Certification and Disclosure

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. Offerors shall disclose any relationships constituting a conflict of interest in their proposal.

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

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

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

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

C.3.2 TOBACCO COMPLIANCE CHECK INSPECTION PROGRAM TRAINING

A. Initial Training for Contractors who have not previously held an FDA Tobacco Compliance Check Inspection Contract

FDA officials will provide the initial FDA Tobacco Compliance Check Inspection Program training materials and conduct the initial training of the Program Coordinator, Backup Program Coordinator, and Inspectors. These individuals must be commissioned by FDA before reviewing the training materials. The Program Coordinator shall ensure that all Inspectors are trained and begin conducting compliance check inspections within 14 days of successfully completing their initial training with FDA trainers. 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. 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.

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.

B. Maintenance of Training Records and 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 prior within two months or FDA may prevent the inspector from performing contract duties involving the procedures at issue.

C. 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. FDA will approve in-person training for the Program Coordinator and one additional official working on the FDA tobacco retail inspection program.

C.3.3 IDENTIFICATION AND SELECTION OF RETAILERS

A. Retail Outlet List

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

Within 60 days after award, the Contractor shall supply FDA with a detailed, accurate, and comprehensive electronic list of retail outlets in the Contractor’s jurisdiction. The source(s) of the list and why the list is considered to be comprehensive must be included. A description and the results of any coverage studies completed or other methods used to assess the accuracy and completeness of the list of retail outlets must also be included. The retail outlet list must contain, at a minimum, the retail outlet name, physical address, mailing address (including zip codes), unique ID number, as well as the name and mailing address of the legal owner(s) of the retail outlet, if available. The retail outlet list should be submitted as a spreadsheet compatible with Excel and should not contain duplicate records for any retail outlet. See Section J, Attachment 2 for the required format for the retail outlet list. FDA may request assistance from the Contractor in researching and updating ownership information on a case-by-case basis. The Contractor is responsible for making changes to their retail outlet list contained in the TIMS system, after consulting with FDA and obtaining guidance from FDA. An example of this change is updating the business status of a retail outlet to “out of business.” The Contractor shall provide updated retail outlet lists to FDA as they become available throughout this contract’s period of performance. The Contractor shall update its retail outlet list in TIMS and certify to FDA that the current retail outlet information in TIMS is up to date on an annual basis.

If the Contractor does not currently have a list of retail outlets, access to a list, or cannot readily develop one, FDA may have the ability to work with outside sources to assist in developing the retail outlet list. This request must be made in writing to FDA within one (1) week of contract award.

B. Selection of Retailers for Compliance Check Inspections

The Contractor is responsible for deciding which retail outlets shall be inspected from the list of retail outlets. However, such inspection strategies are subject to review by the FDA COR who may require the Contractor to amend such strategies to conform to the requirements set forth below.

In identifying which retailers to inspect in each jurisdiction, the Contractor shall consider several factors, including areas that are considered at higher risk for regulatory violations, such as: (1) areas with high rates of youth cigarette smokers, (2) areas where youth report easy access to cigarettes, (3) areas located in close proximity to middle and high schools, or (4) regions with lower socioeconomic populations (historically associated with market targeting).

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

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

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

If the Contractor chooses to conduct FDA compliance check inspections along with other tobacco enforcement efforts, the compliance check inspections must follow FDA’s compliance check inspection protocol and must be conducted by the FDA Inspectors under this Contract.

Additionally, FDA data cannot be disclosed to anyone not commissioned by FDA. A commissioned officer will have to facilitate the transfer of inspection results, but cannot charge the time spent doing so to this contract. FDA funds shall be used for all work required to conduct an FDA retail compliance check inspection but cannot be used to support any Contractor work beyond the FDA inspectional requirements (e.g., filling out non-FDA inspection forms, or obtaining and documenting additional evidence for a charge specific to state, territorial, Tribal or local law).

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

The Contractor must conduct inspections of 80% to 100% of the retailers in its jurisdiction.

Follow-up visits shall only be conducted at FDA’s request and following FDA’s guidance.

C. Entities Not Included on Retail Outlet Lists

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

• Sells regulated tobacco products;

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

• Is open for business.

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

C.3.4 FDA’S TOBACCO INSPECTION MANAGEMENT SYSTEM

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

The 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.

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, a Contractor's approach for conducting the work, and the availability of handheld devices.

The Contractor must 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 Section 3.5 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 publically available on the FDA external website, no other data resulting from Federal tobacco retailer compliance check inspections, including data in the TIMS, may be shared with entities outside of FDA. The prohibition of the release, publication, or disclosure of non-public information except under specific circumstances, is covered under FDA Form 3398, Contractor's Commitment to Protect Non-Public Information Agreement. All Contractor staff who are directly involved in the inspection program or have access to data gathered under this program must sign the FDA Form 3398.

C.3.5 COMPLIANCE CHECK INSPECTIONS

Overview of General Inspection Procedures

The Contractor shall arrange tobacco compliance check inspections of retailers that sell or advertise tobacco products to determine whether those retailers are complying with the Tobacco Control Act and the implementing regulations (See Section C.1.A). Generally, the Contractor shall carry out two (2) types of tobacco compliance check inspection assignments: (1) undercover buy, to determine a retail outlet’s compliance with age and photo identification requirements; and (2) advertising and labeling, to cover other provisions of the Tobacco Control Act. In some instances, FDA may request that both types of assignments be conducted within a short timeframe (specified during training) of each other at a particular retail outlet.

The Contractor shall assign compliance check 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.

Each Inspector shall conduct and document 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.

After consulting with and receiving approval from FDA, the Inspectors and Minors may utilize debit cards or pre-paid credit cards provided and managed by the Contractor to purchase evidence during an inspection. The debit or pre-paid credit card system shall create an electronic record that documents the date, location, and amount of the purchase, and limit the amount able to be charged over a given time period to only what may be necessary to purchase evidence. The Contractor shall preserve the transaction records and upload a screenshot or scanned copy of the transaction record to TIMS as part of the evidence of the inspection.

If the retail outlet is found to be out of compliance, FDA may request assistance from the Contractor in researching 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 is responsible for the collection, handling, sealing, documentation, storage, and submission of evidence pursuant to FDA protocol to ensure that evidence is maintained in a manner that shall allow FDA to use the evidence to support an enforcement action.

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

The Contractor shall ensure the procedures and standards for data and evidence security are followed. This shall include but is not limited to ensuring anonymity of compliance check inspection participants, confidentiality of data and evidence collection, and transmission and storage of property and evidence. Further details shall be provided in the FDA Tobacco Compliance Check Inspection Program training once staff associated with the Contract have undergone a background check and have been cleared and/or commissioned.

1. Undercover Buy Assignments

The Contractor shall follow FDA protocol for conducting compliance check assignments. FDA recommends that undercover buy assignments be conducted by teams comprised of two adults (two inspectors or one inspector with one chaperone) and a Minor, but at a minimum, undercover buy assignments shall be conducted by teams comprised of at least one Inspector and a Minor.

The Minor must be supervised at all times, with limited exceptions. If exceptions are expected, the potential circumstances must be submitted to and approved by the COR in advance. 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 personally witnessed the violation. An inspector shall only conduct an unobserved undercover buy assignment (where the inspector cannot see the transaction) if the inspector must do so to keep from being recognized by the retailer. 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 shall 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 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.

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

Enforcement of the jurisdictional violation will not be funded under this Contract, including the issuing of a mandated citation.

2. Advertising and Labeling Assignments

The Contractor shall conduct compliance check assignments 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 should 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.

3. Timing of Routine Compliance Check Inspections

If a Contractor wants to conduct one of each type of routine compliance check inspection at a particular retail outlet in a year, they must go through the majority of their inventory of retail outlets once with either an undercover buy or advertising and labeling assignment, and then return to do the other type of inspection assignment after most outlets were initially visited.

However, there will be circumstances when FDA will instruct the Contractor to conduct both undercover buy and advertising and labeling assignments within a short timeframe of each other at a specified retail outlet to expeditiously initiate and support a potential enforcement action.

The timing of the assignments is discussed further in the FDA training program.

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. FDA will provide specific instructions regarding the conduct of follow-up inspections during the initial training sessions.

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.

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.