Tobacco_FY15_RFP_-FFP_-_2.13.15.pdf

SOLICITATION, OFFER

AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF PAGES

1 | 66

2. CONTRACT NUMBER

3. SOLICITATION NUMBER

FDA-15-Tobacco-

1143093

4. TYPE OF SOLICITATION

[ ] SEALED BID (IFB)

[ X] NEGOTIATED (RFP)

5. DATE ISSUED

February 27, 2015

6.REQUISITION/PURCHASE NUMBER

7. ISSUED BY CODE

8. ADDRESS OFFER TO (If other than Item 7)

Type of Contract: Firm-Fixed Price DHHS/FDA/OAGS/DASG/State Contracts Branch

5630 Fishers Lane, Room 2129, HFA-500 Rockville, MD 20857

Period of Performance: ______________ to ______________

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

SOLICITATION

9. Sealed offers in original and 1 copy for furnishing 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 5630 Fishers Lane, Rm 2129, Rockville, MD 20857 until 1:00 PM EASTERN local April 10, 2015.

(Hour) (Date)

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 NFORMATION

CALL:

A. NAME: Robert Coonley

B. TELEPHONE (NO COLLECT CALLS)

C. E-MAIL ADDRESS

Robert.Coonleyi@fda.hh s.gov

AREA CODE

NUMBER

402-7611

EXT.

11. TABLE OF CONTENTS

(X)

SEC.

DESCRIPTION

PAGE (S)

(X)

SEC.

DESCRIPTION

PAGE (S)

PART I - THE SCHEDULE

PART II - CONTRACT CLAUSES

X

A

SOLICITATION/CONTRACT FORM

I

CONTRACT CLAUSES

B

SUPPLIES OR SERVICES AND

PRICES/COSTS

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

C

DESCRIPTION/SPECS./WORK STATEMENT

J

LIST OF ATTACHMENTS

D

PACKAGING AND MARKING

PART IV - REPRESENTATIONS AND INSTRUCTIONS

E

INSPECTION AND ACCEPTANCE

K

REPRESENTATIONS, CERTIFICATIONS, AND

OTHER STATEMENTS OF OFFERORS

F

DELIVERIES OR PERFORMANCE

G

CONTRACT ADMINISTRATION DATA

L

INSTRS., CONDS., AND NOTICES TO

OFFERORS

H

SPECIAL CONTRACT REQUIREMENTS

M

EVALUATION FACTORS FOR AWARD

OFFER (Must be fully completed by offeror)

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

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 price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR

PROMPT PAYMENT

10 CALENDAR DAYS (%)

20 CALENDAR DAYS (%)

30 CALENDAR DAYS (%)

CALENDAR DAYS %

(See Section I, Clause 52-232-8)

1. ACKNOWLEDGMENT OF

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

AMENDMENT NO.

DATE

AMENDMENT NO.

15A. NAME AND

CODE

FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER (Type or print)

ADDRESS OF

OFFEROR

15B. TELEPHONE NUMBER

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE -

ENTER

[ ] SUCH ADDRESS IN SCHEDULE

17. SIGNATURE

18. OFFER DATE

AREA CODE

NUMBER

EXT.

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 AND OPEN

COMPETITION:

[ ] 10 U.S.C. 2304(c)( ) [ X ] 41 U.S.C. 253(c)( 5 )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(1 copy unless otherwise specified)

ITEM

G-3

24. ADMINISTERED BY (If other than item 7) CODE

25. PAYMENT WILL BE MADE BY CODE

Office of Financial Services 10903 New Hampshire Avenue

WO32 Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD

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

STANDARD FORM 33 (REV. 9-97)

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

FDA-15-Tobacco-1143093

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BACKGROUND/OBJECTIVES

A. BACKGROUND

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

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

B. OBJECTIVES

The purpose of this work is to:

1. Facilitate the enforcement of the provisions cited 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 and its results.

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

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

The FDA State 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 state, territory, tribal, or local 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 B.1.

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

C. APPLICABLE LAWS AND REGULATIONS

FEDERAL FOOD, DRUG, AND COSMETIC ACT

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

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

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

OTHER APPLICABLE FEDERAL STATUTES

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

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

REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES

AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS

The Tobacco Control Act required FDA to reissue the 1996 final rule, "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents." The FDA has reissued this rule, which is codified at 21 Code of Federal Regulations (CFR) Part 1140. The Contractor shall conduct tobacco inspections for compliance with certain provisions of these regulations with respect to retail outlets on behalf of FDA. For illustration purposes, some, not all, of the provisions in 21 CFR Part 1140 that are subject to inspection by the Contractor under this Contract include:

• Age and Photo Identification Restrictions – Retailers:

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;

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. However, several states have been able to coordinate these two (2) programs in order to maximize resources.

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

B.2 CONTRACT PRICE

The Contractor shall be paid a fixed-price per inspection, a fixed-price for the program management task, and fixed-price for completed training/travel in accordance with the statement of work.

The Contractor shall provide total prices for the minimum number of required inspections in each jurisdiction listed below. The pricing information provided in the table below will be used for evaluation purposes only. Offerors should propose to perform as many inspections as is feasible in each jurisdiction. Pricing information should be included for the total number of inspections proposed beyond the minimum.

Of the Routine inspections the Contractor performs under this contract, 75% shall be undercover buy assignments and 25% shall be advertising and labeling assignments, if possible.

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.

c. Training/Travel - the Contractor shall be paid the following fixed-price for completed training/travel as follows.

Task QTY Price Total

Program Management 12 Months Training/Travel - -

B.3 CONTRACT PRICE - OPTIONS

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

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

Training/Travel - -

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

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

Training/Travel - -

B.4 TRAVEL AND OTHER DIRECT COSTS

A. The Contractor shall be paid total fixed prices, for the Base Period; $*(TBD) for Option Period I; and $*(TBD) for Option Period II for all domestic travel as described below, incurred directly and specifically in the performance of this Contract, claimed by the Contractor, and accepted by the Contracting Officer.

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

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

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

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

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

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

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. The Contractor may be required to coordinate the work under this Contract with other tobacco enforcement activities. Attachment 1 contains a list of materials necessary for conducting FDA tobacco compliance check inspections.

FDA is seeking proposals for inspection services in Alaska, District of Columbia, Florida, Idaho, Louisiana, Montana, Nebraska, Nevada, New York, North Dakota, Oregon, South Carolina, South Dakota, United States Virgin Islands, Utah, Vermont, and Wyoming. The Offeror shall propose to inspect no less than 20% of the retail outlets in the State and no more than 100% of retail outlets in the state. The number of retailers contained in this chart are placeholder values that shall be used for proposal purposes only. The actual number of retailers in each jurisdiction may vary.

STATE NUMBER OF RETAILERS

Alaska 400 Florida 35,500 Idaho 1,600

Louisiana 7,500 Montana 1,500 Nebraska 1,500 Nevada 2,000

New York 20,000 North Dakota 1,850

Oregon 3,000 South Carolina 5,700 South Dakota 1,500

United States Virgin Islands

Utah 1,700 Vermont 1,000 Wyoming 1,000

TECHNICAL REQUIREMENTS

C.1.1 TOBACCO RETAILCOMPLIANCE CHECK INSPECTION PROGRAM

RESPONSIBILITIES

A. Contractor/Subcontractor

The Contractor shall be an agency or subdivision of a state, territory, local, or 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 Coordinator/Backup Program Coordinator

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

C. Inspectors

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

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

Inspectors shall be available to testify as witnesses in administrative hearings during the period of performance of the contract. The Program Coordinator will maintain current contact information on all Inspectors who leave the program and this information shall be turned over to the Government at the end of the contract period. The Program Coordinator will annually confirm the contact information for Inspectors who have left the program.

D. Background Investigations/Commissioning Process

Prior to carrying out compliance check inspection activities, all Inspectors must be commissioned by FDA. All other employees under this contract, or under any subcontract, including the Program Coordinators, Backup Program Coordinators, Chaperones (staff dedicated to overseeing the safety of the Minors), administrative personnel, and supervisors will be subject to a background investigation and will be required to sign a Commitment to Protect Non-Public Information Agreement. Minors will not be commissioned and will not undergo a background investigation by FDA.

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

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

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

Within three weeks of being awarded the contract the Contractor shall provide the information for the available employees and Subcontractors to be commissioned/receive background investigations, and subsequently, immediately upon identifying new staff it wishes to have commissioned. . More specifically, the Contractor shall provide FDA with each such person’s name, work address, work number or cell number, and email address. The Contractor must maintain information cross-referencing each unique identification number to a specific minor.

The Contractor shall notify FDA if any of the employee information above changes.

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

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

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

• The abuse or misuse of the commission;

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

• A conflict of interest;

• Change in criminal or credit history;

• Substance abuse; or

• Behavior that may discredit FDA.

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

E. Information Regarding Minors

Minors are an integral part of conducting compliance check inspections to ensure compliance with the provision cited in Section C.1.A. The Contractor shall keep at least one photo on file of each Minor involved in the Program. In order to document the Minors’ appearance, the Contractor may determine that they should be photographed with frequent regularity and/or prior to conducting any undercover buy assignments. FDA protocol does not require Minors to carry photo identification for the undercover buy assignments. However, the Contractor may determine that Minors should carry valid photo identification and present identification if requested. Such decisions are left to the discretion of the Contractor.

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

Identities of Minors are to remain as confidential as possible. However, in the event of possible enforcement or judicial action, the Minor's identity may be revealed and the Minor may need to provide a declaration and/or give oral testimony in a hearing. Minors must be available to testify as witnesses in administrative hearings for a minimum of five (5) years after each inspection.

The Program Coordinator will retain current contact information on all Minors who leave the program for at least five (5) years after their departure. The Program Coordinator will annually confirm the contact information for Minors who have left the program. This information must be contained in the parental/legal guardian consent form.

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

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

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

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

F. Conflicts of Interest

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

Examples of significant financial interests include:

• The covered person or a close family member owns stock in a covered company, other than through ownership of shares of a mutual fund that invests in a covered company.

• The covered person or a close family member serves as an employee, trustee, officer, or director of a covered company.

In addition, a covered person shall not participate personally or substantially in any matter under the Contract that may significantly affect that person's own financial interests or the financial interests of:

• His or her spouse or minor child;

• An organization in which he or she serves as an officer, director, trustee, general partner or employee;

• His or her general partner; or

• A person with whom he or she is negotiating for or has an arrangement concerning prospective employment.

Upon discovery of a possible conflict of interest involving an employee or a subcontractor’s employee, the jurisdiction must immediately notify FDA of the possible conflict of interest. The jurisdiction must investigate all possible conflicts of interest and provide findings to the COR within 90 days of learning of the possible conflict of interest.

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

C.1.2. TOBACCO RETAIL INSPECTION PROGRAM TRAINING

1. Initial Training for Contractors and Subcontractors

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

2. Training for Minors

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

3. Maintenance of Training Records and Annual Refresher Training

The Contractor shall ensure that each Program Coordinator, Backup Program Coordinator, Inspector, and Minor shall have their initial training documented and, at a minimum, receive annual refresher training. The Contractor shall provide training results to FDA upon completion ensuring that they receive passing scores before these individuals are permitted to begin inspections. The Contractor shall maintain training records for the Program Coordinator and all compliance check inspection participants under this Contract, including Minors. FDA will consider requests for additional training by the Contractor and will provide additional training as FDA deems appropriate.

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

4. Program Coordinator In-Person Training

FDA may conduct an in-person training for Program Coordinators during the base period of performance and annually thereafter. If held, this training is expected to cover two full working days and be held in the Washington, D.C. metropolitan area. If offered by FDA, it is mandatory that the Program Coordinator attend this in-person training if it is held by FDA. The attendance of the Backup Program Coordinator(s) or another FDA approved Contractor representative is highly recommended by FDA. FDA anticipates that this training will occur annually.

C.1.3. IDENTIFICATION AND SELECTION OF RETAILERS

1. Retail Outlet List

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

FDA currently possesses a list of the tobacco retailers located in the subject State and will provide it to the contractor on award. Within 60 days after award, the Contractor shall assess the FDA supplied electronic list of retail outlets and revise and/or add establishments to create an accurate and complete list. The source(s) used to assess and revise the list and description of whether the list is considered to be comprehensive must be included. A description and the results of any coverage studies completed or other methods used to assess the accuracy and completeness of the list of retail outlets must also be included. The Contractor shall confirm that the retail outlet list does not contain any retail outlets that are located on Tribal Land. The retail outlet list must contain, at a minimum, the retail outlet name, physical address (including city, state or territory, and zip code), unique ID number. 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 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 with each Monthly Report or certify that the current retail outlet list is the most up to date list available, and all corrections have been previously submitted. See Attachment 2 for the required format for the retail outlet list.

2. Selection of Retailers for Compliance Check Inspections

The Contractor shall decide which retail outlets shall be inspected from the list of retail outlets.

However, such inspection strategies will be 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, FDA plans to consider several factors, including areas that are considered at higher risk for regulatory violations, such as: (1) areas with high rates of youth cigarette smokers, (2) areas where youth report easy access to cigarettes, (3) areas located in close proximity to middle and high schools, or (4) regions with lower socioeconomic populations (historically associated with market targeting).

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

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

For each retailer inspected, the Contractor shall ensure the inspector records all inspectional information pertaining to that visit as soon as practicable and before moving on to the next inspection (Task 4. FDA’s Tobacco Inspection Management System (TIMS)).

The Contractor must conduct inspections at [TBD at time of award (must be a minimum of 20% of retailers and maximum of 100% of retailers]. The Contractor shall conduct inspections in the state, evenly distributed throughout the year for the base period and each subsequent option period. Follow-up visits shall only be conducted at FDA’s request and following FDA’s guidance.

3. Entities Not Included on Retail Outlet Lists

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

• Sells tobacco products;

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

• Is open for business.

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

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

FDA’s Tobacco Inspection Management System (TIMS) can work in conjunction with a specific handheld device that shall be provided by FDA in a majority of circumstances and allows for the electronic transmission of information. FDA will not consider contractor provided devices. The TIMS Application provides FDA and Contractors with a front-end web interface for accessing and managing FDA tobacco inspection assignment information and related processes. Inspectors not using the handheld device for data submission shall submit paper forms to their Program Coordinator or enter data using a computer. The handheld device currently provided to Inspectors by FDA is an iPhone. FDA will provide the service plans for these devices. If an Inspector or Contractor is not issued a handheld device by FDA, they will be trained to use paper forms.

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

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

The Program Coordinator is responsible for ensuring that Inspectors submit data to FDA as defined in C.1.5 through C.1.7,below. FDA 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. Contractors using paper forms need to coordinate with FDA for data entry.

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

C.1.5. COMPLIANCE CHECK INSPECTIONS

A. Overview of General Inspection Procedures

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

Of the inspections the Contractor performs under this contract, 75% shall be undercover buy assignments and 25% shall be advertising and labeling assignments. Should this ratio of inspection types eliminate or significantly reduce the need for employees that the State previously hired for the specific purpose of working on its FDA State Tobacco Compliance Check Inspection Program, the State shall immediately notify the FDA COR of such in writing.

If FDA determines, either independently or based upon a State’s submission, the need to alter the required ratio of undercover buy to advertising and labeling assignments, it may do so after notifying the Contractor of such an alteration. The ratio of required assignments shall not be reduced below 50% undercover buy to 50% advertising and labeling assignments based upon a State’s submission alone. The Contractor shall notify the FDA in the Monthly Report of any difficulties or obstacles encountered in meeting this requirement or due to an alteration of this requirement.

The Contractor shall assign compliance check inspection assignments of identified retail outlets to Inspectors via the designated handheld device, computer, or a manual process if using paper forms. FDA may request that certain retail outlets or areas be inspected. FDA may ask the Contractor to ensure compliance check inspections are conducted in specific areas at certain times.

The Contractor shall ensure each Inspector conducts and documents each assignment according to FDA protocol (provided during training). Documentation of the assignment requires the Inspector to: (1) record the findings on a compliance check inspection form, which will be provided by FDA via the handheld device, a computer, or a paper form; (2) prepare a narrative report revealing potential violations (according to the FDA template); (3) collect evidence, such as tangible items of potentially violative tobacco products or photographs of conditions observed via the handheld device or a digital camera; and (4) record any additional observations as instructed by FDA.

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 verifying the ownership information of a particular retail outlet and may need inspectors to return to the retail outlet to obtain further information and evidence.

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

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

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

1. Undercover Buy Assignments

The Contractor shall ensure that FDA protocol for conducting compliance check inspections is followed. Generally, undercover buy assignments shall be conducted by teams comprised of an Inspector and a Minor. The Minor must be supervised at all times, with limited exceptions. If Inspectors accompany Minors during undercover buy assignments, Inspectors shall position themselves so that they can observe Minors during the entire undercover buy assignment to ensure that they can later complete a narrative report attesting that they have witnessed the violation. 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 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 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 shall not accompany an Inspector during an advertising and labeling assignment to ensure that Minors’ identities remain anonymous. In most circumstances, the Inspector will be required to provide his/her FDA credentials during this type of compliance check assignment.

3. Timing of Routine Compliance Check Inspections

The Contractor shall conduct one routine compliance check inspection at a particular retail outlet in a year, either an undercover buy or advertising and labeling assignment. 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…