75F40125R00034 Released.pdf

75F40125R00034

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

1 114

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

08/08/2025 X

DAP

DHHS/FDA/OAGS/DAP

ATTN: Pamela Lee 11601 Lansdown Street 3WFN/13th Floor North Bethesda MD 20852

1000 ET 08/22/2025

Pamela T Lee Pamela.Lee@fda.hhs.gov

X

X

X

X

X

X

X

X

X

X

X

X

X

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 - 5 6 - 14

15 - 33 35 - 36 37 - 39 40 - 46 47 - 70

71 - 86

88 - 99

100-112

113-114

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

Solicitation 75F40125R00034

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Table of Contents

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BACKGROUND/OBJECTIVES

1. BACKGROUND

2. OBJECTIVES

3. APPLICABLE LAWS AND REGULATIONS

B.2 CONTRACT TYPE AND PRICE SCHEDULE

B.3 COST

1. INSPECTIONS

2. NON-INSPECTION TRAVEL

3. OTHER DIRECT COSTS (ODC)

4. UNALLOWABLE COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 SCOPE OF WORK

C.2 TECHNICAL REQUIREMENTS

1. TOBACCO RETAIL COMPLIANCE CHECK INSPECTION PROGRAM PARTICIPANTS

AND RESPONSIBILITIES

I. Contractor II. Background Investigations/Commissioning Process III. Key Personnel: Program Coordinator (PC)/Backup Program Coordinator (BPC) IV. Inspectors V. Information Regarding Underage Purchasers VI. Conflict of Interest

2. PROGRAM MANAGEMENT TASKS

I. Communication and Data Transmission II. Site Visit III. Quality Control Plan

3. TOBACCO RETAIL INSPECTION PROGRAM TRAINING

I. Training for Contractors and Subcontractors II. Training for Underage Purchasers III. Key Personnel Orientation

4. IDENTIFICATION OF RETAILERS

5. FDA’S TOBACCO INSPECTION MANAGEMENT SYSTEM (TIMS)

6. COMPLIANCE CHECK INSPECTIONS

7. REVIEWING COMPLIANCE CHECK INSPECTION RESULTS AND ASSISTING WITH

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ENFORCEMENT ACTIONS

I. Compliance Check Inspection Inquiries II. FDA Enforcement Actions

8. CONTRACT KICKOFF/TRANSITIONING OUT

I. Kickoff Meeting II. Transition-Out

9. MONTHLY REPORT/MONTHLY STATUS MEETINGS

I. Monthly Report II. Monthly Status Meetings

SECTION D – PACKAGING AND MARKING

D.1 PACKAGING

D.2 MARKING

SECTION E - INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE

E.2 INSPECTION ACCEPTABILITY CRITERIA

SECTION F – DELIVERABLES OR PERFORMANCE

F.1 PERIOD OF PERFORMANCE

F.2 DELIVERABLES

F.3 PLACE OF DELIVERY

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 AUTHORITIES OF GOVERNMENT PERSONNEL

G.2 HHSAR 352.237-75 KEY PERSONNEL (Dec 2015)

G.3 FDA ELECTRONIC INVOICING AND PAYMENT REQUIREMENTS - INVOICE PROCESSING

PLATFORM (IPP) (JAN 2022)

G.4 GOVERNMENT FURNISHED PROPERTY (GFP)

G.5 CONTROL OF PROPERTY

G.6 REPORT ON ACCESS TO GOVERNMENT PROPERTY

G.7 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 PROCUREMENT REQUIRING INFORMATION SECURITY AND/OR PHYSICAL ACCESS

SECURITY

H.2 COMMISSIONING OF INSPECTORS

H.3 CONTRACTOR PERSONNEL SECURITY CLEARANCE STANDARDS AND RESIDENCY

REQUIREMENTS

H.4 PROCUREMENTS INVOLVING GOVERNMENT INFORMATION PROCESSED ON GOCO OR

COCO SYSTEM

H.5 ORGANIZATIONAL CONFLICTS OF INTEREST

H.6 TASK ORDERS

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I. Procedures for Issuing Task Orders

SECTION I - CONTRACT CLAUSES

I.2 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR) (48 CFR CHAPTER 3) CONTRACT CLAUSES

I.3 FAR CLAUSES IN FULL TEXT

1. FAR 52.216-18 – ORDERING (AUG 2020)

2. FAR 52.216-19 – ORDER LIMITATIONS (OCT 1995)

3. FAR 52.216-22 – INDEFINTE QUANTITY (OCT 1995)

4. FAR 52.217-8 OPTION TO EXTEND SERVICES (Nov 1999)

5. FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (Mar 2000) [for Task Orders]

6. FAR 52.232-20 LIMITATION OF COST (Apr 1984)

7. 52.232-22 LIMITATION OF FUNDS (APR 1984)

8. 52.244-2 SUBCONTRACTS (JUN 2020)

SECTION J - LIST OF ATTACHMENTS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

K.1 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (Jan 2025)

K.2 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS –

REPRESENTATION AND DISCLOSURES (DEC 2023)

K.4 352.239-78 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE

(FEB 2024) (DEVIATION)

L.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) 100

L.2 FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

L.3 GENERAL INFORMATION

L.4 FAR 52.233-2 SERVICE OF PROTEST (SEPT 2006)

L.5 GENERAL PROPOSAL INSTRUCTIONS

1. VOLUME I – ORAL TECHNICAL PROPOSAL INSTRUCTIONS

2. VOLUME II – BUSINESS PROPOSAL INSTRUCTIONS

I. COST OR PRICING DATA

II. DIRECT LABOR

III. OVERHEAD

IV. DIRECT LABOR/STAFFING NARRATIVE

V. TRAVEL EXPENSE

VI. CONSULTANT SERVICES (If Applicable)

VII. OTHER DIRECT COSTS

VIII. EXAMPLE COST FORMAT

IX. ADDITIONAL DOCUMENTS TO BE SUBMITTED WITH BUSINESS PROPOSAL

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3. VOLUME III - SUBCONTRACTING PLAN EMAIL NOTIFICATION

L.6 PAST PERFORMANCE

L.7 RFP INQUIRIES AND QUESTIONS DUE DATE

L.8 PRE-PROPOSAL CONFERENCE

L.9 PROPOSAL SUBMISSION DUE DATE

L.10 MACROS

L.11 FILE SIZE LIMITATIONS

SECTION M - EVALUATION FACTOR FOR AWARD

M.1 BASIS FOR AWARD

M.2 ORAL PRESENTATION EVALUATION

M.3 PAST PERFORMANCE EVALUATION

M.4 SUBCONTRACTING EVALUATION

M.5 COST METHODOLOGY

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BACKGROUND/OBJECTIVES

1. 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 Food and Drug Administration (FDA) authority to regulate the manufacture, marketing, sale, and distribution of tobacco products to protect public health, generally, and to reduce tobacco use by youth. FDA conducts compliance check inspections of tobacco retail establishments to help determine a retailer's compliance with federal laws and regulations, including the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, and associated regulations.

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

2. OBJECTIVES

The purpose of this IDIQ contract is to:

1. Enforce the provisions cited herein Section C, Description/Specifications/Statement of Work, 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 herein Section C, Description/Specifications/Statement of Work 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 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.

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3. 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.

On April 14, 2022, the definition of tobacco product in the FD&C Act was amended to include tobacco products containing nicotine from any source, including synthetic nicotine. It is illegal for a retailer to sell any tobacco product containing nicotine from any source – including cigarettes, smokeless tobacco, and e-cigarettes – to anyone under 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:

I. Age and Photo Identification Restrictions – Retailers:

a) May not sell regulated tobacco products to anyone younger than 21 years of age.

b) Must verify the age of any person under age 30 purchasing regulated tobacco products by means of photo identification containing the bearer’s date of birth.

II. Advertising and Labeling Restrictions – Retailers:

a) May not sell regulated tobacco products using vending machines (except in facilities where the retailer ensures no person younger than 21 is permitted to enter).

b)May not sell cigarettes, cigarette tobacco, or smokeless tobacco using self- service displays (except in facilities where the retailer ensures no person younger than 21 is permitted to enter).

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

d)May not sell cigarette packages containing fewer than 20 cigarettes.

e) 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.

f) 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

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g)May not sell flavored cigarettes.

h)May not sell or distribute “new” tobacco products that lack the required marketing authorization.

III. Synar Regulation In addition to the Tobacco Control Act, the Department of Health and Human Services (HHS) 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

1. The Contract Type is IDIQ. All Task Orders issued will be cost reimbursement orders. The Contractor shall provide the services described in Section C, Description/Specifications/Work Statement. Except as otherwise specified in the Contract, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise to do all things necessary for, or incident to, the performance of the work set forth herein. The Contractor shall be reimbursed for allowable, allocable, and reasonable costs for performance of these services.

2. In order to constitute a legally binding agreement, the guaranteed minimum will be satisfied with the issuance of base period of the first task order for each jurisdiction, which will be awarded simultaneously with the award of the IDIQ contract.

3. The contract maximum value(s) five (5 year) for the contracts are shown in the individual state tables in Section B.3 below:

Jurisdiction Contract Minimum Maximum Contract Value 5 years

American Samoa $38,247.00 $1,242,413.00

California $159,567.00 $17,270,436.00

Illinois $64,471.00 $4,716,000.00

Michigan $130,023.00 $13,398,834.00

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Minnesota $80,266.00 $6,794,413.00

New Jersey $118,338.00 $11,850,971.00

Pennsylvania $101,909.00 $9,412,655.00

Washington $204,409.00 $14,855,217.00

Wisconsin $73,461.00 $5,713,624.00

Commonwealth of the Northern

Mariana Islands

$52,483.00 $3,128,096.00

4. The contract ceiling amount of all Task Orders shall not exceed the contract maximum value listed above in Section B.2.3.

5. All Task Orders within each jurisdiction are non-competitive. The Task Orders will be issued directly to the agency indicated by the Jurisdiction.

6. The initial task order will be issued with the funding at the time of award of the IDIQ contract.

7. 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.

8. Task orders shall be issued with cost ceilings based on the pricing as described in Section B.3 Cost listed below. It is anticipated the period of performance for the first task order will be 8 months and subsequent task orders may have variable period of performances. The period of performance (POP) of this entire IDIQ contract will be 5 years.

9. 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.

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

11. Any Other Direct Costs (ODCs) not directly related to conducting inspections is Not-to- Exceed (NTE): $20,000 per year. Prior approval of purchases must be received

10 | P a g e from CO/Contract Specialist (CS). All documentation including the approval must be provided to FDA when invoicing.

B.3 COST

1. INSPECTIONS

Inspections shall include all costs necessary to conduct the stated number of Undercover Buys (UB) and Advertising & Labeling (A&L) inspections and enforcement. Examples of costs included are all labor and materials related to inspection travel, tobacco purchases, program management, training, evidence collection, shipping, background checks for Underage Purchasers, locating Underage Purchasers and Inspectors that have left the program, witness testimony, and associated indirect costs including subcontractor costs.

Task orders will indicate the number of inspections to be performed. The Task orders may be issued in period of performance increments up to the maximum UB/A&L inspections and each task order will be based on the pricing set below for each year of this IDIQ contract (See Attachment 4).

Note: CLIN 1 is intended to encompass costs for the specified number of inspections for a full year of conducting inspections within a jurisdiction. CLIN 1 should not include estimated or anticipated staffing costs beyond what would be required for the specified number of inspections listed.

American Samoa

Cost for 1000 UBs and 150 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

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California

Cost for 15000 UBs and 5000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

Illinois

Cost for 25000 UBs and 5000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

Michigan

Cost for 12000 UBs and 5000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

Minnesota

Cost for 25000 UBs and 6000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award”

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New Jersey

Cost for 27500 UBs and 5000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

Pennsylvania

Cost for 17500 UBs and 2500 A&L inspections

POP 1

POP 2

POP 3

POP 4

POP 5

Washington

Cost for 17500 UBs and 5000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award”

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Wisconsin

Cost for 15000 UBs and 3000 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

Commonwealth of the Northern Mariana Islands

Cost for 500 UBs and 125 A&L inspections

POP 1 “Completed at award” POP 2 “Completed at award” POP 3 “Completed at award” POP 4 “Completed at award” POP 5 “Completed at award”

2. NON-INSPECTION TRAVEL

Non-inspection travel shall include costs for travel for the Program Coordinator (PC) and Backup Program Coordinator (BPC) to FDA offices to receive equipment, background checks, security clearance/badging costs only. Non-inspection travel costs shall only be included in task orders where this travel is anticipated. Prior approval of travel must be received from the Contracting Officer/Contract Specialist. All documentation including the approval must be provided to FDA when invoicing.

Non- Inspection Travel (Not to Exceed -

NTE)

Year 1 NTE $10,000 Year 2 NTE $10,000 Year 3 NTE $10,000 Year 4 NTE $10,000 Year 5 NTE $10,000

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3. OTHER DIRECT COSTS (ODC)

ODC shall include other allowable costs not included in 1. Inspections, and that are related to other activities associated with conducting inspections. These costs include supply purchases, (for example, file cabinets, secure evidence storage, Wi-Fi, postage, hardware, and connectivity), necessary to perform this requirement. ODC will be determined at the time of task order award but will not exceed the yearly amounts listed below. Prior approval of purchases must be received from the Contracting Officer/Contract Specialist. All documentation including the approval must be provided to FDA when invoicing.

Other Direct Costs (Not to Exceed - NTE)

Year 1 NTE $20,000 Year 2 NTE $20,000 Year 3 NTE $20,000 Year 4 NTE $20,000 Year 5 NTE $20,000

4. 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:

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

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

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

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

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SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

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, List of Materials, contains a list of materials necessary and/or required for conducting FDA tobacco compliance check inspections.

The estimated number of inspections per period of performance will be provided in each task order for the respective jurisdiction. The actual number of retailers in each jurisdiction varies.

C.2 TECHNICAL REQUIREMENTS

1. TOBACCO RETAIL COMPLIANCE CHECK INSPECTION PROGRAM

PARTICIPANTS AND RESPONSIBILITIES

I. 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. Any person employed under this contract serving as Inspectors, including, as applicable, the Contractor, its employees, and any subcontractor, will be required to undergo the commissioning process described below.

II. Background Investigations/Commissioning Process

Prior to carrying out compliance check inspection activities, all inspectors must be commissioned by FDA. The Contractor shall provide the information for the available employees and subcontractors to be commissioned/receive background investigations, and 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. The Contractor shall provide the COR with all necessary information for Commissioning, including a list that contains the following information for each potential Commissioned Officer: Full Legal Name, current employer, current job title, expected role in the program, full physical work address (PO Box will not be accepted), work number, cell number, and email address. The Contractor shall notify the FDA COR of any changes of employment status within two (2) business days and return the Commissioned Officers credentials within five (5) business days of the Officer no longer working under this Contract.

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All other employees under this contract, or under any subcontractor, who will not be an Inspector will be subject to a background investigation and will be required to sign a Commitment to Protect Non-Public Information Agreement, Form FDA 3398, Attachment 3.

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 the employee(s) contact information to the person(s) or entity most familiar with their organization’s background investigation procedures (the security contact). If applicable, the Contractor must also provide to the security contact information for individuals that the Contractor intends to subcontract.

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 Tier 2 - Federal Level 5 Moderate Risk Public Trust Background Investigation. 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). 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.

Candidates that do not complete and submit the required paperwork within sixty (60) calendar days of receipt from OSO will be removed from the commissioning process.

FDA will not consider resubmission of candidates who are removed from the commissioning process.

Receiving a commission signifies that the employee has accepted a position of public trust and must comply with all applicable federal laws and ethical standards. Each FDA commission is issued for a period of five years.

The 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:

a) The abuse or misuse of the commission.

b) The transmittal of confidential information from a commissioned officer to individuals who are not employees or commissioned officers of HHS.

c) A conflict of interest.

d) Change in criminal or credit history.

e) Substance abuse.

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f) Failure to notify FDA regarding any event or occurrence that could affect.

or change their status, such as a change in job title; or

g) Behavior that may discredit FDA.

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

a) 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

b) the commissioning credentials and all equipment are returned to the FDA within five (5) business days as instructed by the COR.

Any employees of the subcontractor serving as Inspectors will be required to undergo the commissioning process described above. Non-commissioned Contractor personnel shall assume only administrative, planning, and logistical functions that may be performed. This encompasses all functions except performing inspections.

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

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

The PC shall be responsible for overall coordination, gathering information and evidence, and communicating with FDA. The PC shall be responsible for all aspects of the program management work described in Section C.2.2. (Program Management Tasks)

The PC shall be the main point of contact (POC) for FDA. The Contractor may also designate a BPC as an alternate POC to allow the Government consistent communication in the PC’s absence. 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 Contractor. The PC, BPC or designated alternate POC 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 Program Coordinator, Backup Program Coordinator, or Inspectors (e.g., phone number, e-mail address, status, change of personnel, etc.) within two (2) business days.

IV. 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 (FDA), 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 or employee of the State, Territory, or political subdivision thereof. The Contractor shall certify that the

18 | P a g e persons it submits for commissioning meet this commissioning criteria. Due to logistics and associated expenses, the contractor shall, use no more than thirty (30) Inspectors.

Inspectors must maintain regular performance of inspections to remain active on this contract. Inspectors that do not perform a minimum of ten (10) inspections each month may 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 Purchasers currently employed by the Contractor (e.g., phone number and email address).

The Contractor shall annually verify current contact information for all Inspectors and Underage Purchasers who were employed within the past five (5) years but are no longer employed by the Contractor, and the most recent contact information for such Inspectors and Underage 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 that have left the program. The Contractor shall provide the requested information to FDA within two (2) business days of the request.

V. Information Regarding Underage Purchasers

Underage Purchasers are integral to conducting compliance check inspections. The Contractor, rather than FDA, has the oversight responsibility for Underage Purchasers involved in the Program. 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 Purchasers who are 16 or 17 years-old are also minors, and as such, have special protections that are discussed below. The Contractor shall conduct background checks on all Underage Purchasers ages 18 – 20, prior to working on the program.

The Contractor shall keep at least one photo on file of each Underage Purchaser involved in the Program and a valid photo ID. FDA protocol does not require Underage Purchasers to carry photo identification for the undercover buy assignments.

However, the Contractor may determine that Underage 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 Purchasers follow the chosen protocol consistently.

The Contractor shall ensure that the Underage 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.

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Identities of Underage Purchasers are to remain as confidential as possible. The Contractor must inform the Underage Purchasers (and, if the Underage Purchaser is a minor, their parents/legal guardians) that the Underage 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 Purchaser is a minor). The PC shall maintain current contact information on all Underage Purchasers who are currently employed by the Contractor or leave the program and this information shall be turned over to the Government annually.

All participating minors shall have a Medical Release signed by a parent or legal guardian authorizing emergency medical treatment while under the supervision of a commissioned officer or chaperone, as required by the laws within the jurisdiction.

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 Purchasers to conduct undercover buy assignments or where a purchaser’s possession of tobacco products is illegal prior to using Underage Purchasers in those jurisdictions. The proper authorities would be those authorities that may grant immunity to Underage 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 Purchasers are insured against accidents or other injuries. If the Underage 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 Purchasers. Proof of insurance, including automobile liability coverage for commissioned officers and chaperones transporting Underage Purchasers, shall be maintained by the Contractor, and made available to FDA upon request.

A unique identification number shall be generated by the Contractor to protect the identity of the Underage Purchasers. The Contractor shall maintain information cross-referencing each unique identification number to a specific Underage Purchaser. The Contractor shall input each Underage Purchaser’s unique identification number into FDA’s Tobacco Inspection Management System (TIMS) once the Contractor receives access. For Underage Purchasers ages 18- 20, the Contractor shall update TIMS with confirmation of completion of required background check.

VI. Conflict of Interest

The PC, BPC, and individuals participating in 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

20 | P a g e 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 any manufacturer, distributor, or importer of tobacco products.

Examples of significant financial interests include:

a) 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.

b) 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/BPCs or Commissioned Officers by any applicable federal law or ethical standard.

2. PROGRAM MANAGEMENT TASKS

The Contractor shall provide program management services to ensure the quality, timeliness, and accuracy of its work under this contract and the applicable task order/s. The Contractor shall conduct all program management tasks through its key personnel, the PC and BPC, or designated administrative personnel in the absence of the PC and BPC. The key personnel shall serve as the primary POC with FDA. These tasks include, the following areas as described in detail elsewhere in the statement of work:

(a) Recruiting, hiring, and training all contractor(s) and subcontractor(s) employees involved with conducting tobacco retail compliance check

21 | P a g e inspections.

(b) 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) Securing and maintaining all required information and documents pertaining to Inspectors, and Underage Purchasers, including maintaining current contact information for currently employed and former Inspectors, and Underage Purchasers who participated in inspections within the past five years.

(d) Securing and maintaining a grant of immunity for Underage Purchasers from the proper authorities, as appropriate.

(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.

(f) Ensuring all contractual requirements for inspection procedures are communicated, implemented, and followed by all Contractor and subcontractor employees; Ensuring that an inventory of all FDA-issued equipment assigned to the Contractor (including mobile devices) is completed and submitted to FDA annually and within ten (10) business days of FDA’s request. Ensuring that inventory of credentials is submitted to FDA annually. 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.

(g) Coordinate with FDA on responses to press inquiries and press announcements on the FDA Tobacco Compliance Check Inspection Program and its results, Facilitating timely completion of all training requirements for all employees or subcontractor employees under this Contract.

(h) 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.

(i) Storing and maintaining chain of custody of evidence according to FDA guidelines, and otherwise facilitating inspections.

(j) Reviewing inspection results submitted by inspectors and reports provided by FDA to monitor inspection quality and ensure conformity with acceptability requirements in the contract.

(k) Securing current and former Inspectors as witnesses, where necessary.

(l) Proactively informing FDA of any issues and problems that should be addressed in order for the overall effective accomplishment of task order goals.

(m) Corrective actions that need to be taken by the Contractor shall be clearly defined and communicated to FDA and have identified dates for completion.

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(n) Assisting FDA with post-inspection follow-up, if required.

(o) Submitting timely monthly reports and invoices.

I. Communication and Data Transmission

FDA will supply government furnished equipment only (up to two laptops) to the Key Personnel (PC and BPC) identified in this Contract. All communication from FDA will be sent to the government furnished property provided to the PC and BPC. Key Personnel shall use the government furnished equipment to maintain program files, communicate with FDA, and manage the FDA program.

FDA will supply handheld devices (iPhone) to Inspectors. The Contractor must ensure Inspectors use government furnished handheld devices to record compliance check inspection data and manage compliance check inspection work, including proper use by Underage Purchasers. The Contractor is responsible for ensuring that all FDA required training is completed in accordance with the specified timeframes. The Contractor is responsible for ensuring that all personnel issued government furnished equipment follows all FDA protocol regarding proper use and handling of such equipment. Failure to follow protocol may result in removal from the FDA program. The Contractor shall ensure that FDA-issued equipment is never taken out of the country.

The Contractor shall respond to all inquiries from FDA within two (2) business days.

II. Site Visit

FDA anticipates conducting site visits to review all aspects of the compliance check inspection program and ensure compliance with the contract during the period of performance of this contract. FDA shall provide the contractor with a minimum of thirty

(30) calendar day notice prior to any planned visit. All documents and logs will be reviewed. PC and BPC must be present during a planned site visit.

III. 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:

a) FDA funds under this contract are only used for FDA tobacco enforcement activities. The plan shall include, but is not limited to describing how:

b) Time dedicated to contract work is recorded.

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

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

e) The number of errors in submissions and/or evidence documentation is minimized. The plan shall include but is not limited to describing how areas needing improvement will be identified and remedied.

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

g) 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.

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

i) 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.

j) All Program employees:

1) Have documented all required trainings (including Underage

Purchasers).

2) Remain knowledgeable about current procedures; and

3) 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, compliance check inspection procedures, evidence collection, training, report submissions, and IT system improvements (e.g., updating software applications).

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3. TOBACCO RETAIL INSPECTION PROGRAM TRAINING

I. 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 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 task order.

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.

FDA will notify the Contractor of Inspectors that make multiple and/or repeated errors.

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.

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.

II. Training for Underage Purchasers

The Contractor shall train Underage Purchasers using its own instituted training methods, in addition to ensuring that each Underage Purchaser completes the required FDA training.

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

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Each Underage Purchaser must successfully complete the required FDA training prior to conducting any inspections.

III. Key Personnel…