SF33.pdf

75F40121R00031

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

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

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 92

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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.

(Date)(Hour) local timeuntildepository located in copies 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

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

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

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

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

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

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

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

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

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)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

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

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

123929207/01/2021 X

DSAAG

DHHS/FDA/OAGS/DSAAG

ATTN: Daytona Philpotts 4041 Powder Mill Road Beltsville MD 20705

Type of Contract - Cost Reimbursement

1400 ET 07/31/2021

DAYTONA H PHILPOTTS 301

Daytona.Philpotts@fda.hhs

.gov796-6488

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X

X

X

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PAGE(S)

MADELINE R. BRYANT

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

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

1-2 3-7

8-26 27 - 28 28 - 33 33 - 40 40 - 57

58 - 75

76 - 80

80 - 88

88 - 89

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 92

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75F40121R00031

(A) (B) (C) (D) (E) (F)

U.S. Territory Tobacco Retail Compliance Check

Inspection Program

U.S. Territory Tobacco Retail Compliance

Inspections - Base Period (8-months)

Period of Performance: 09/30/2021 to 05/29/2022

U.S. Territory Tobacco Retail Compliance

Inspections - Option Period 1 (12-months)

(Option Line Item)

Period of Performance: 05/30/2022 to 05/29/2023

U.S. Territory Tobacco Retail Compliance

Inspections - Option Period 2 (12-months)

(Option Line Item)

Period of Performance: 05/30/2023 to 05/29/2024

U.S. Territory Tobacco Retail Compliance

Inspections - Option Period 3 (12-months)

(Option Line Item)

Period of Performance: 05/30/2024 to 05/29/2025

U.S. Territory Tobacco Retail Compliance

Inspections - Option Period 4 (4-months)

(Option Line Item)

Period of Performance: 05/30/2025 to 09/29/2025

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

Solicitation No. 75F40121R00031

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 or TCA) into law (Public Law 111-31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted FDA authority to regulate the manufacture, marketing, sale, and distribution of tobacco products to protect public health, generally, and to reduce tobacco use by minors. On June 22, 2010, FDA issued regulations that establish restrictions on the sale, distribution, and use of cigarettes and smokeless tobacco, to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with tobacco use. On August 8, 2016, the FDA regulation deeming additional tobacco products within FDA’s jurisdiction went into effect.

B. OBJECTIVES

The purpose of this contract is to:

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

2. Conduct inspections of retailers that sell and advertise any regulated tobacco products to determine compliance with the provisions cited in Section C and submit 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, arranging for their testimony if necessary, and furnishing evidence and narrative reports by the

Inspectors and Underage Tobacco Purchasers who participated in inspections.

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

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

C. APPLICABLE LAWS AND REGULATIONS

REGULATIONS RESTRICTING THE SALE, DISTRIBUTION, AND ADVERTISING

OF REGULATED TOBACCO PRODUCTS 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 reissued this rule, which is codified at 21 Code of Federal Regulations

(CFR) Part 1140 on June 22, 2010. These regulations established restrictions on the sale, distribution, and use of cigarettes and smokeless tobacco, to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with tobacco use. On August 8, 2016, the FDA regulation deeming additional tobacco products within FDA’s jurisdiction went into effect.

On December 20, 2019, the FD&C Act was amended to increase the federal minimum age of sale of tobacco products to 21 years of age.

The Contractor shall conduct tobacco inspections for compliance with certain provisions of the

FD&C Act and these regulations with respect to retail outlets on behalf of FDA. For illustration purposes, some, not all, of the provisions that are subject to inspection by the Contractor under this Contract include, but are not limited to:

• Age and Photo Identification Restrictions – Retailers:

o May not sell regulated tobacco products to anyone younger than 21 years of age;

o Must verify that any person under age 27 purchasing regulated tobacco products is at least 21 years old or older by means of photo identification containing the bearer’s date of birth.

• Advertising and Labeling Restrictions – Retailers:

o May not sell regulated tobacco products using vending machines (except in facilities where the retailer ensures no person younger than 18 is permitted to enter);

o May not sell cigarettes, cigarette tobacco, or smokeless tobacco using self-service displays (except in facilities where the retailer ensures no person younger than 18 is permitted to enter);

o May not break open cigarette or smokeless tobacco packages to sell products in smaller amounts such as single cigarettes (also called “loosies”);

o May not sell cigarette packages containing fewer than 20 cigarettes;

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

o May not display advertisements for cigarette tobacco/roll-your-own tobacco, electronic nicotine delivery system (ENDS) / e-liquid products, or hookah tobacco, unless each advertisement bears a required warning statement specified by the regulations o May not sell flavored cigarettes

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, is administered by the Substance Abuse and Mental Health Services Administration’s Center for

Substance Abuse Prevention (SAMHSA/CSAP), for 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).

The annual Synar survey is separate from the FDA inspections under this Contract. The funds used for the FDA State Tobacco Compliance Check Inspection Program are restricted, by statute, for use only for FDA tobacco inspection efforts.

B.2 CONTRACT TYPE AND PRICE SCHEDULE

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. The

Contractor shall be reimbursed for allowable, allocable, and reasonable costs for performance of these services.

The Contractor shall be paid on a cost-reimbursement basis for work completed. The cost is subject to the provisions of the Limitation of Cost, and the Allowable Cost and Payment clauses in Section I, Contract Clauses.

Authorized Travel and Per Diem shall be reimbursed in accordance with the Federal Travel

Regulation (FTR) in effect at the time the travel is authorized by the agency. All travel requirements must be met using the most economical form of transportation available and must be scheduled sufficiently in advance to take advantage of offered discount rates unless waived by the Contracting Officer.

Authorized/required non-inspection travel (travel outside of conducting inspections, i.e.

computer refresh or Program Coordinator (PC) Conference) is Not-to-Exceed (NTE): $20,000 per year. All travel must be reviewed/approved by the Contracting Officer Representative (COR) prior to traveling and reimbursement is in accordance with the Federal Travel Regulations

(FTR).

Other Direct Cost is Not-to-Exceed (NTE): $100,000 per year. Prior approval of purchases must be received from the Contracting Officer. Documentation must be provided to FDA when invoicing. Offerors shall propose Other Direct Costs (ODC’s) that may be necessary to perform the requirements of the contract (i.e., office supplies, postage, hardware, connectivity, software, maintenance, etc). Offerors must include supporting documentation to support each ODC proposed (competitive bids, catalog prices, quotes, receipts, etc). This supporting documentation shall be used to facilitate analysis to determine the ODC’s are fair and reasonable. Failure to submit supporting documentation will delay the acquisition process.

The estimated cost to the Government for full performance of the contract under the Base Period

(09/30/2021 – 05/29/2022) of this contract is $ TBD.

Period of Performance Total Estimated Cost

Base Period $ TBD

Non-Inspection Travel NTE $20,000

Other Direct Cost (ODC) NTE $67,000

B.3 OPTIONS

If the Government exercises its option pursuant to the Option clause of this contract, the

Government’s estimated contract amount for each of the option periods is as follows:

Option Period I – (05/30/2022 – 05/29/2023) - 12 months

The estimated cost to the Government for full performance of the contract under Option Period I of this contract is $ TBD.

Option Period I $ TBD

Other Direct Cost (ODC) NTE $100,000

Option Period II – (05/30/2023 – 05/29/2024) - 12 months

The estimated cost to the Government for full performance of the contract under Option Period II of the contract is $TBD.

Option Period II $ TBD

Option Period III – (05/30/2024 – 05/29/2025) - 12 months

The estimated cost to the Government for full performance of the contract under Option Period III of this contract is $TBD.

Option Period III $ TBD

Option Period IV – (05/30/2025 – 09/29/2025) - 4 months

The estimated cost to the Government for full performance of the contract under Option Period IV of this contract is $TBD.

Unallowable Costs

Notwithstanding Clause 52.216-7, Allowable Cost and Payment, and Clause 52.244-2, Subcontracts, of the Federal Acquisition Regulation (FAR), unless otherwise expressly provided elsewhere in the Contract or in any modification thereto, the cost of the following items or activities shall be unallowable as direct costs:

• Acquisition by purchase or lease of any interest in real property; Special rearrangement or alteration of facilities;

• Purchase, lease, or rental of any item of general purpose such as office furniture or office equipment (including data tapes);

• Travel to foreign countries; and food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel Regulations; and

• Costs associated with non-FDA provided training to include registration, travel, and lodging costs.

Option Period IV $ TBD

Other Direct Cost (ODC) NTE $35,000

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 to do all things necessary for the performance of the work described below. The Contractor shall coordinate the work under this Contract with other tobacco enforcement activities, as requested.

Attachment 1 contains a list of materials necessary and/or required for conducting FDA tobacco compliance check inspections.

The FDA is seeking inspection services in the jurisdiction listed in the table below. The estimated number of inspections per period of performance required to be conducted for each jurisdiction are listed below. The actual number of retailers in each Jurisdiction varies.

FDA-Directed Undercover Buy Inspections

FDA-Directed Advertising & Labeling (A&L) Inspections

CNMI Base Period 170 70 CNMI Option Period 1 250 100 CNMI Option Period 2 250 100 CNMI Option Period 3 250 100 CNMI Option Period 4 85 35

TECHNICAL REQUIREMENTS

C.1.1 TOBACCO RETAIL COMPLIANCE CHECK INSPECTION PROGRAM

RESPONSIBILITIES

A. Contractor

The Contractor shall be capable of employing individuals who can be commissioned in accordance with Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)) to conduct inspections. Specifically, the Contractor, its employees, and/or subcontractor shall be capable of performing the requirements of this contract. Non-commissioned Contractor personnel shall assume only administrative, planning, and logistical functions that may be performed. This encompasses all functions except performing inspections. The Contractor, its employees, and any subcontractor serving as inspectors will be required to undergo the commissioning process described below.

B. Background Investigations/Commissioning Process

Prior to carrying out compliance check inspection activities, all Inspectors must be commissioned by FDA. All other employees under this contract, or under any subcontract, including the Program Coordinators (PC), Backup Program Coordinators (BPC), Chaperones

(staff dedicated to overseeing the safety of the Underage Tobacco Purchasers), 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.

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 2 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.

Prior to performing any work on behalf of HHS/FDA, 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. The Contractor shall certify that the persons it submits for commissioning meet the requirements of Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. §

372(a)(1)(A)) to conduct inspections. More specifically, the Contractor shall provide FDA with each such person’s name, current employer, current job title, work address, work phone number or cell phone number, and email address. The Contractor shall notify FDA if any of the employee information above changes.

Receiving a commission signifies that the employee has accepted a position of public trust and must comply with all applicable federal laws and ethical standards. Each FDA commission is issued for a period of five years. Employees and/or Subcontractors are responsible for immediately notifying their PC of any event or occurrence that could affect or change their status, such as a change in job title.

The issuance of a commission is discretionary, and FDA may revoke a commission at any time. FDA may recommend removal of the commission if an inspector repeatedly fails to follow FDA procedures. Other reasons for revocation may include, but are not limited to:

• The abuse or misuse of the commission;

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

• A conflict of interest;

• Change in criminal or credit history;

• Substance abuse;

• Failure to notify FDA regarding any event or occurrence that could affect or change their status, such as a change in job title; or

• Behavior that may discredit FDA.

Upon separation of a commissioned employee or subcontractor employee, the Contractor shall ensure:

• FDA receives written notification of the commissioned employee’s separation within one business day of notice given by or to the commissioned employee, including the reason for the separation; and

• the commissioning credentials and all equipment are returned to the FDA within 5 business days as instructed by the COR.

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 above.

C. Key Personnel: Program Coordinator (PC)/Backup Program Coordinator (BPC)

The Contractor shall designate the Key Personnel: Program Coordinator (PC) and the Backup

Program Coordinator (BPC).

The PC 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.

The PC and BPC must be employed directly by the Prime Contractor and shall not be employed by a subcontractor. The PC shall be the main point of contact (POC) for FDA. The

Contractor shall also designate a BPC as an alternate POC to allow the Government consistent communication. In the event that the PC and BPC are not available, the Contractor shall designate and notify the COR of a POC with authority to make decisions on behalf of the

PC/BPC. The PC and BPC together shall equal one (1) Full Time Equivalent (FTE). The PC must account for the majority percentage of the FTE. For the purposes of this contract, an FTE is equal to 2080 hours. The PC, BPC or designated alternate shall respond to CTP inquiries within two (2) business days.

The Contractor shall inform the COR when there are any changes to the information for PC, BPC, Inspectors, Administrative Assistants, Chaperones, Commissioned Officers, or Underage

Tobacco Purchasers (e.g., phone number, e-mail address, status, change of personnel, etc.).

Training requirements for the Retail Inspection Program Key Personnel are addressed in

Section C.1.3.1.

D. Inspectors

The Contractor shall conduct compliance check inspections through persons who are United

States citizens and who are also commissioned as officers of the United States Department of

Health and Human Services (HHS), Food and Drug Administration, under the authority of

Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)), which includes any health, food, or drug officer/employee of the State, Territory, or political subdivision thereof. The

Contractor shall certify that the persons it submits for commissioning meet this commissioning criteria.

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.

If the Contractor utilizes part-time Inspectors, those inspectors must maintain regular performance of inspections in order to remain active on this contract. Inspectors that do not perform a minimum of 10 inspections each month will be deactivated from the program.

The Contractor shall inform all Inspectors that they may be needed to testify as witnesses in administrative hearings during the period of performance of the contract. The Contractor shall maintain current personal contact information for all inspectors and underage tobacco purchasers currently employed by the Contractor. The Contractor shall provide FDA with contact information as requested by FDA within two (2) business days of request.

The Contractor shall annually verify current contact information for all inspectors and underage tobacco purchasers who were employed within the past five years but are no longer employed by the Contractor, and the most recent contact information for such inspectors and underage tobacco purchasers shall be provided to FDA COR or designee at the end of the contract period. Additionally, FDA may request individual contact information for Inspectors and/or underage tobacco purchasers that have left the program that shall be provided within two (2) business days of the request.

Training requirements for the Retail Inspection Program Inspectors are addressed in

Section C.1.3.1.

E. Information Regarding Underage Tobacco Purchasers

Underage Tobacco Purchasers are integral to conducting compliance check inspections. The

Contractor shall recruit a mix of Underage Purchasers ages 16 to 20 to participate in the program. The Contractor must recruit underage purchasers from each age group.

Underage Tobacco Purchasers who are 16 or 17 years-old are also minors, and as such, have special protections that are discussed below.

The Contractor shall keep at least one photo on file of each Underage Tobacco Purchaser involved in the Program and a valid photo ID, if available. FDA protocol does not require

Underage Tobacco Purchasers to carry photo identification for the undercover buy assignments. However, the Contractor may determine that Underage Tobacco Purchasers should carry valid photo identification and present identification if requested. Such decisions are left to the discretion of the Contractor. The Contractor must ensure that all Underage

Tobacco Purchasers follow the chosen protocol consistently.

The Contractor, rather than FDA, has the oversight responsibility for Underage Tobacco

Purchasers involved in the Program. The Contractor shall ensure that the Underage Tobacco

Purchasers are within the required age range by obtaining a copy of their birth certificate and/or other government-issued identification and for Minors, 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 Underage Tobacco Purchasers are to remain as confidential as possible. The

Contractor must inform the Underage Tobacco Purchasers (and, if the Underage Tobacco

Purchaser is a Minor, their parents/legal guardians) that the Underage Tobacco Purchaser may be needed to testify as witnesses in administrative hearings during and after the period of performance of the contract. This information must be documented (in the parental/legal guardian consent form, if the Underage Tobacco Purchaser is a minor). The PC shall maintain current contact information on all Underage Tobacco Purchasers who are currently employed by the Contractor or leave the program and this information shall be turned over to the

Government annually, at the end of the contract period, or when requested.

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 access to 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 in each jurisdiction where it would be illegal to use Underage Tobacco Purchasers to conduct undercover buy assignments or where a purchaser’s possession of tobacco products is illegal prior to using

Underage Tobacco Purchasers in those jurisdictions. The proper authorities would be those authorities that may grant immunity to Underage Tobacco Purchasers from prosecution under applicable law. The Contractor shall provide proof of such immunity upon request from FDA.

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

The Contractor shall input each Underage Tobacco Purchaser’s unique identification number into

FDA’s Tobacco Inspection Management System (TIMS) once the Contractor receives access.

The Underage Tobacco Purchaser’s unique identification number shall be generated by the

Contractor to protect the identity of the Underage Tobacco Purchaser. The Contractor shall maintain information cross-referencing each unique identification number to a specific Underage

Tobacco Purchaser.

Training requirements for the Retail Inspection Program Underage Tobacco Purchasers are addressed in Section C.1.3.2.

F. Conflicts of Interest

The PC, BPC 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 Contractor must immediately notify FDA in writing of the possible conflict of interest. The jurisdiction must investigate all possible conflicts of interest and provide findings to the COR within thirty (30) calendar days of learning of the possible conflict of interest. FDA reserves the right to determine whether the possible conflict of interest precludes the inspector from conducting inspections.

The above-mentioned requirements are contractual, and do not alter, modify, or replace obligations imposed on the Contractor and its PCs or Commissioned Officers by any applicable federal law or ethical standard.

C.1.2 PROGRAM MANAGEMENT TASKS

The Contractor shall conduct all program management tasks through its PC and BPC or designated administrative personnel in the absence of the PC and BPC. These tasks include, but are not limited to, the following areas as described in detail elsewhere in the statement of work:

• Facilitating processing of background investigations and FDA Commissions, providing timely notification of personnel changes to FDA, and ensuring timely execution of any required follow-up actions related to onboarding new Contract personnel (e.g., initiating background investigations) or processing outgoing personnel (e.g., return of credentials and equipment) (C.1.1.B);

• Providing the necessary staff (Inspectors and Underage Tobacco Purchasers) to conduct inspections (C.1.1.B);

• Maintaining designated Key Personnel, one PC and one BPC, to serve as the primary points of contact with FDA and the key personnel responsible for program management

(C.1.1.C);

• Securing and maintaining all required information and documents pertaining to inspectors, and underage tobacco purchasers, including maintaining current contact information for currently-employed and former inspectors, and underage tobacco purchasers who participated in inspections within the past five years (C.1.1.D);

• Securing and maintaining a grant of immunity for Underage Tobacco Purchasers from the proper authorities, as appropriate (C.1.1.E);

• Monitoring and providing immediate notification to FDA of any actual, apparent, or potential conflicts of interest for any Contractor or subcontractor personnel, and otherwise ensuring that all contractual requirements relating to conflicts of interest are met (C.1.1.F);

• Performing all other non- inspection functions that are necessary to ensure the program is able to obtain or maintain capacity to conduct inspections (C.1.2);

• Ensuring all contractual requirements for inspection procedures are communicated, implemented, and followed by all Contractor and subcontractor employees (C.1.2);

• Ensuring that an inventory of all FDA-issued equipment assigned to the Contractor

(including mobile devices) is completed and submitted to FDA quarterly and within ten

(10) business days of FDA’s request. The inventory should include who is assigned the equipment. FDA must be alerted within one (1) business day if FDA-issued equipment is lost or stolen (C.1.2);

• Storing and maintaining chain of custody of evidence according to FDA guidelines, and otherwise facilitating inspections (C.1.2);

• Coordinate with FDA on responses to press inquiries and press announcements on the

FDA Tobacco Compliance Check Inspection Program and its results (C.1.2);

• Implementing, maintaining, and performing all work necessary under the quality control plan (C.1.2);

• Facilitating timely implementation and completion of all training requirements for all employees or subcontractor employees under this Contract (C.1.3);

• Ensuring that program staff uses FDA-issued equipment according to FDA protocol

(e.g., FDA-issued equipment is never taken out of the country) (C.1.5);

• Securing a signed FDA Form 3398 for each Contractor employee and a substantially similar agreement from each subcontractor who is or will be involved in the inspection program under this Contract or who has or will have access to any non-public information arising under or related to this Contract (C.1.5);

• Reviewing inspection results submitted by inspectors to ensure conformity with quality and acceptability requirements in the contract (C.1.7);

• Ensuring completion of all inspection assignments and submission of all deliverables

(C.1.7);

• Ensuring that personnel use Government Furnished Property (GFP) to maintain program files, communicate with FDA, and manage the FDA program (C.1.7.2);

• Assisting FDA with post-inspection follow-up, if required (C.1.7.2);

• Securing current and former inspectors as witnesses, where necessary (C.1.7.2); and

• Creating and submitting timely monthly reports and invoices (C.1.9).

Quality Control Plan

The Contractor shall develop and maintain a Quality Control Plan (QCP) that lists specific actions that will be performed to assure the quality of the Contractor’s work as well as the frequency of those actions and the individual to whom those actions are assigned. The QCP shall be submitted to the COR within ten (10) business days of award. Revised quality control plans shall be submitted to the COR within thirty (30) calendar days of any changes or deviations. The QCP shall be used to monitor Contractor performance and to ensure that the quality of the information submitted is complete and accurate. The Contractor is responsible for implementing a plan to ensure that:

• FDA funds under this contract are only used for FDA tobacco enforcement activities.

The plan shall include, but is not limited to describing how:

o Time dedicated to contract work is recorded.

o An inventory of Government-furnished equipment and equipment purchased in support of the contract is established and maintained.

• Evidence is properly collected, documented, and stored in a location accessible only by program staff.

• The number of errors in submissions and/or evidence documentation is minimized. The plan shall include, but is not limited to describing how:

o Areas needing improvement will be identified and remedied.

• Corrective actions identified as a part of the QCP shall be implemented and communicated to FDA within five (5) business days.

• All communications concerning compliance check inspection procedures received are disseminated according to the timelines set forth in the Statement of Work and followed by Program employees including inspectors in the field.

• The Contractor provides required submissions within the timeframes outlined in the contract and responds within two (2) business days to FDA inquiries.

• The Contractor performs inspections that follow the policies and procedures as documented by FDA during initial training, refresher training, and through correspondence, and provides a plan for coming into compliance any time inspections do not meet these standards.

• All Program employees:

o Have documented all required trainings (including Underage Tobacco Purchasers);

o Remain knowledgeable about current procedures; and o Abide by Program changes needed to maintain accountability, enforcement, and efficiency of Program operations.

Upon discovery or notice of a problem by FDA involving incomplete or erroneous submissions or evidence documentation, the Contractor must acknowledge the issue, determine the cause, take appropriate corrective action, and notify the FDA within five (5) business days.

The Contractor shall abide by Program changes needed to maintain efficiency of Program operations and accuracy of compliance check inspection data and evidence. Such changes may include, but are not limited to, compliance check inspection procedures, evidence collection, training, report submissions, and IT system improvements (e.g. updating software applications).

C.1.3. TOBACCO RETAIL INSPECTION PROGRAM TRAINING

1. Training for Contractors and Subcontractors

The COR will provide information regarding the FDA Tobacco Compliance Check Inspection

Program training to the PC, BPC, and Inspectors. Inspectors must be commissioned by FDA before accessing any training materials. The PC shall ensure that all Inspectors have taken and passed the FDA Tobacco Compliance Check Inspection Program Training before beginning any inspections. Out-of-state travel is not anticipated for FDA-provided inspector training.

Training will be conducted via teleconference, video conference, online learning management system, or via mobile device applications. The Contractor must ensure that all parts of the

FDA Tobacco Compliance Check Inspection Program training are followed as prescribed.

FDA will conduct mandatory training sessions to present topics related to inspection procedures, new policies, and contractual updates to the Program Coordinators, Backup

Program Coordinators, and Inspectors. Each training session will be conducted via teleconference or webinars. FDA will provide up to 24 hours of training during each period of performance.

Inspectors that make multiple and/or repeated procedural errors shall undergo corrective training. The Contractor shall provide FDA with a plan, within two (2) business days of notification, regarding how it intends to address inspector errors that are identified, including the training provided. The Contractor shall notify FDA when the plan has been successfully implemented.

No inspection participant may conduct inspections prior to successfully passing the initial FDA provided training, as well as the biannual Inspector Refresher Training (IRT). If the IRTs for inspectors is not completed and passed before each biannual deadline, the inspector’s access to conducting inspections will be restricted until successful completion of the IRT and passing of the exam has been verified by FDA. Additional training from FDA may be provided to the Contractor upon the Contractor’s request to refresh Contractor knowledge of the retail inspection program.

Any training or certification costs outside of the FDA Tobacco Compliance Program will not be covered by the funds under this contract. This is to include training required by the jurisdiction to maintain status as an employee of the jurisdiction.

2. Training for Underage Tobacco Purchasers

The Contractor shall train Underage Tobacco Purchasers with its own instituted training methods, in addition to ensuring that each underage purchaser completes the required FDA

Underage Tobacco Purchasers training. The Contractor’s training program may include mock undercover buy inspections so newly recruited underage purchasers may observe experienced underage purchasers conduct undercover buy inspections before conducting them on their own.

Each underage purchaser must successfully complete the required FDA underage purchaser training prior to conducting any inspections.

3. Key Personnel Training

Key Personnel must undergo FDA Administrative training prior to beginning work on the contract.

FDA may conduct in-person training for PCs during the period of performance of this contract. If held, this training is expected to cover two to three full working days and be held in the Washington, D.C. metropolitan area. If offered by FDA, it is mandatory that the PC attend this in-person training. The attendance of the BPC(s) is highly recommended by FDA.

C.1.4. IDENTIFICATION AND SELECTION OF RETAILERS

1. Retail Outlet List

A retailer is any person, government, or entity who sells regulated tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays of tobacco products are present, as referenced in section 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, vape shops, or mobile carts that sell tobacco products.

FDA currently possesses a list of the tobacco retailers located in the subject jurisdiction(s) which will be provided to the contractor upon award. 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), and unique ID number (assigned by FDA when added to

TIMS). The Contractor is responsible for making changes to their retail outlet list contained in the TIMS system, according to FDA guidance.

2. Entities Not Included on Retail Outlet Lists

The Contractor shall be responsible for adding new establishments to TIMS, after verifying that the retail establishment is not already in TIMS. The Contractor shall contact FDA to coordinate the upload of a large list of establishments once a quarter, if needed. See

Attachment 2 for the current required format for the retail outlet list. The format is subject to change based on program needs.

Entities discovered to sell regulated tobacco products but are not in the TIMS database shall be added to TIMS. Before the entity is added, the PC shall verify that the entity:

• Sells regulated tobacco products;

• Is not already in the TIMS database; and

• Is open for business.

3. Selection of Retailer Undercover Buy (UB) Inspections

Contractor shall utilize FDA TIMS system to issue Inspection assignments. FDA will request that certain retail outlets or areas be inspected. The Contractor may determine the date of assignment, retailer location (selected from the retailer list), and timeframe for completion of retailer inspections. However, the Contractor’s assignment discretion is subject to the following contractual requirements:

1. The Contractor shall not assign the UB inspections at a retailer location where a retailer inspection has been completed within a year from the prior inspection unless otherwise directed by FDA. FDA may specify the number and location of retailer inspections to be completed during a contract period, and the Contractor shall comply with these requirements.

2. For inspections where FDA requests that certain retail outlets or geographic areas be inspected, the Contractor shall assign or conduct UB inspections only within the area or areas specifically designated by FDA. FDA will notify the Contractor in writing of the scope of said areas. FDA retains the sole right to define what constitutes an area.

FDA retains the sole right to expand or narrow, at any time, any area or areas within the jurisdiction.

3. The UB inspections shall be completed within 90 calendar days of assignment.

4. Alternatively, the Contractor may be responsible for identifying retailers to inspect in each jurisdiction. In identifying which retailers to inspect in each jurisdiction, the

Contractor shall prioritize geographic areas with a higher risk for regulatory violations, such as: (1) areas with high rates of youth tobacco use, (2) areas where youth report easy access to tobacco products, (3) areas located in close proximity to middle and high schools, and (4) regions with lower socioeconomic populations

(historically associated with market targeting).

For FDA Directed UB Inspections, the Contractor shall focus on inspecting areas that have not been inspected in prior years before returning to retailers that have been inspected under this contract.

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

The Contractor shall also provide the FDA 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).

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

FDA’s Tobacco Inspection Management System (TIMS) works in conjunction with a specific handheld device provided by FDA and allows for the electronic transmission of information. FDA will not consider contractor provided devices. The TIMS application provides FDA and Contractors with a front-end web interface for accessing and managing

FDA tobacco inspection assignment information and related processes. The handheld devices currently provided to Inspectors by FDA is an iPhone. FDA will provide the service plans for these devices.

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

Additionally, the Contractor is required to ensure all Inspectors’ handheld devices are operating the most current version of software, as designated by FDA. Failure to utilize the most current version of the software is prohibited.

The Contractor is responsible for ensuring that Inspectors submit data to FDA as defined in C.1.6 through C.1.7, below.

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, 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 prior to beginning work on the contract.

C.1.6. 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 B.1.C.). Generally, the

Contractor shall carry out two (2) types of tobacco compliance check inspection assignments:

(1) Undercover Buy (UB) assignments, to determine a retailer’s compliance with age and photo identification requirements; and (2) Advertising and Labeling (A&L), to cover other provisions of the FD&C Act as amended by 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 or areas to Inspectors via TIMS. FDA will request that certain retail outlets or areas be inspected. FDA will request that a specific type of regulated product be purchased during an inspection.