Sol_75F40125R00018- Final.pdf

75F40125R00018

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

1 128

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

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G

F

E

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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

12/19/2024 X

DAP

DHHS/FDA/OAGS/DAP

ATTN: JANICE HEARD

10903 New Hampshire Ave.

WO2/3rd Floor Silver Spring MD 20903

1700 ET 01/21/2025

JANICE S HEARD 215

JANICE.HEARD@FDA.HHS.GOV

717-3093

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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 3-10

11-31 31-32 32-33 33-36 37-41 41-79

79-97

98-106

107-120

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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

2 128

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75F40125R00018

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

1 Third Party Tobacco Retail Compliance Check

Inspection Program IDIQ - REGION 1, 2, 3 & 5

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

Solicitation 75F40125R00018

FDA Tobacco Retailer Inspection Services (FY25 IDIQ) THIRD PARTY

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 the Food and Drug Administration (FDA) authority to regulate the manufacture, marketing, sale, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. FDA conducts compliance check inspections of tobacco retail establishment 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 a state or territory to conduct compliance check inspections of tobacco retailers, as required under 21 U.S.C. 372(a)(l)(B)(i). FDA issues contracts with a state or territory to assist with compliance check inspections of retail establishments. FDA has a goal of establishing a contract, where feasible, with every U.S.

state and territory. When FDA could not contract with states and territories, FDA has awarded contracts to third-party entities that are able to hire commissionable inspectors to do compliance check inspections of tobacco retailers in those jurisdictions. FDA currently requires third-party, tobacco retailer inspection services. Task orders will be issued under this required Indefinite Delivery Indefinite Quantity (IDIQ) Contract to perform the requirements identified in this Statement of Work.

2. OBJECTIVES

The purpose of this IDIQ contract is to:

1. 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.

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

3. 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.

4. 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 IDIQ.

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.

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 IDIQ 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 the age of any person under age 27 purchasing regulated tobacco products 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.

o May not sell cigarettes, cigarette tobacco, or smokeless tobacco using self-service displays.

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 advertisement for cigarettes 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.

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

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 all applicable regions.

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 IDIQ, 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.

A. The Contract Type is Indefinite Delivery/Indefinite Quantity (IDIQ) with Task Orders (TO) that can be any combination of Firm Fixed Price (FFP, Labor Hour (LH), Time and Material (T&M), and Cost Reimbursement (CR). Permissible TO Contract types include FAR 16.2 Fixed-Price and FAR 16.3 Cost- Reimbursement. These Contract types can be used individually or in combination within a single task order comprising multiple CLINs.

B. The Contractor guaranteed minimum is anticipated to be satisfied upon IDIQ contract award for each corresponding region. For each region, the guaranteed minimum of $10,000 will be met by the issuance of Task Order 0001.

C. The contract minimum and maximum value(s) over five (5) years and awarded under this contract is shown below:

Region Contract Minimum (Task Order 0001 value)

Maximum Contract Value over 5 years

REGION 1

Connecticut, Delaware, Maine, $10,000 $27,000,000.00

Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont

REGION 2

Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin

$10,000 $31,000,000.00

REGION 3

Alabama, Arkansas, District of Columbia, Georgia, Florida, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, US Virgin Islands, Virginia, West Virginia

$10,000 $68,000,000.00

REGION 5

Puerto Rico

$10,000 $5,000,000.00

D. The Contractor shall be paid a firm fixed price per inspection type. Price per inspections price shall include cost necessary to perform inspections, including inspection related travel. The Fixed Price (FP) Labor Rates proposed represent the Offeror’s fully-burdened FP hourly labor rates per inspection type. Rates provided in the pricing template will be used as ceiling labor rates for pricing of all labor proposed under future fixed priced tasks issued under this IDIQ Contract. At time of award, the Contractor’s FP ceiling labor rates for each inspection type will be incorporated into the contract.

E. 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.

F. The contract ceiling amount of all Task Orders shall not exceed the contract maximum value listed above in Section B.2.C.

G. Contractor personnel may be required to travel to support the requirements of this contract as stated in individual task orders. For those task orders requiring travel, the specific travel requirements will be included in the order’s request for proposal. Travel shall not commence without prior written consent in accordance with instructions in the task orders.

If authorized in the task order, travel will be reimbursed at actual cost in accordance with the limitations set forth in FAR Subpart 31.205-46, Travel Costs. Profit shall not be applied to travel costs. To the extent authorized by the task order, Contractors may apply indirect costs to travel in accordance with the Contractor’s usual accounting practices consistent with FAR 31.2.

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

I. All program management labor will be paid a labor hour rate. Loaded Hourly Rates - Documentation of actual program management hours shall be submitted when invoicing. Documentation must be acceptable to FDA (See clauses G.2 and G.3)

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

FIRM FIXED PRICED CONTRACT LINE ITEM ( (PER REGION)

1.Conducting retail inspections and providing related support services

The Contractor shall include all costs except program management activities necessary to conduct the stated number of Undercover Buy (UB) and Advertising & Labeling (A&L) inspections and enforcement. Examples of costs include labor and materials related to inspection travel, tobacco purchases, Inspector and Underage Purchaser training, evidence collection, shipping, background checks and all associated indirect costs including subcontractor costs. Task orders will indicate the number of inspections to be performed.

Inspection Type Firm Fixed Price per Inspection Year 1

Firm Fixed Price per Inspection Year 2

Firm Fixed Price per Inspection Year 3

Firm Fixed Price per Inspection Year 4

Firm Fixed Price per Inspection Year 5

Undercover Buy Advertising and Labeling

LABOR HOUR (CLIN)

Program Management/ (PER REGION)

Year 1 Hourly Rate

Year 2 Hourly Rate

Year 3 Hourly Rate

Year 4 Hourly Rate

Year 5 Hourly Rate

Program Coordinator (PC) Backup Program Coordinator (BPC)

Program Management - Program Management cost is the labor rate for each labor category. Examples of cost are fully loaded labor rates for the Program Coordinator (PC), Backup Program Coordinator (BPC) and costs related to locating Underage Purchasers and inspectors that have left the program.

COST REIMBURSEMENT (CLIN's)The Contractor shall only be reimbursed for allowable, allocable, and reasonable costs for performance of non-inspection related travel.

Non- Inspection Travel The Contractor shall include costs for the PC and BPC to travel to the closest FDA offices to receive equipment, background checks, and security clearances/badges. Non-inspection travel costs shall only be included in task orders where this travel is anticipated.

Not-to- Exceed Year

Not-to- Exceed Year 2

Not-to- Exceed Year

Not-to- Exceed Year 4

Not-to- Exceed Year

*Non-Inspection Travel

$10,000 $10,000 $10,000 $10,000 $ I 0,000

Other Direct Cost (ODC)

Other Direct Cost

(ODC)

Not-to- Exceed Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year 5

REGION 1 $100,000 $100,000 $100,000 $100,000 $100,000

REGION 2 $100,000 $100,000 $100,000 $100,000 $100,000

REGION 3 $100,000 $100,000 $100,000 $100,000 $100,000

REGION 5 $6,000 $6,000 $6,000 $6,000 $6,000

ODC shall include other allowable costs not included in the fixed price per inspection.

ODCs include supply purchases, (for example, file cabinets, secure evidence storage, Wi-Fi, postage, hardware, and connectivity), necessary to perform this requirement. The ODC ceiling will be listed as Not-To-Exceed (NTE) $100,000 dollars per year for Regions 1-4 and $6000 per year$ dollars per year on each task order awarded. Prior approval for ODC purchases shall be obtained from the CO and COR. All documentation including the approval must be provided to FDA when invoicing.

Purchases that are not approved by the COR and CO will not be reimbursed.

Witness Testimony Compensation

Compensation for Witness Testimony

Not-to- Exceed Year 1

Not-to- Exceed Year 2

Not-to- Exceed Year 3

Not-to- Exceed Year 4

Not-to- Exceed Year 5

REGION 1 $10,000 $10,000 $10,000 $10,000 $10,000

REGION 2 $10,000 $10,000 $10,000 $10,000 $10,000

REGION 3 $10,000 $10,000 $10,000 $10,000 $10,000

REGION 5 $10,000 $10,000 $10,000 $10,000 $10,000

Witness testimony cost for Inspectors and Underage Purchasers shall not exceed $50,000 for the life of the IDIQ. Compensation for witness testimony costs will be reimbursed based on inspection rates. Compensation is based on the amount of time testifying. Typically, witness testimony will be conducted via teleconference during normal business hours.

The time required to testify as a witness and provide oral testimony may be up to five (5) hours per enforcement action that may require witness testimony.

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.

SECTION C- DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C. 1 SCOPE OF WORK

Independently, and not as an agent of the Federal Government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. The Contractor shall coordinate the work under this contract with other tobacco enforcement activities as requested. All work will be performed in accordance with the terms of this contract and any Task Order issued hereunder. Attachment 1 - Material List contains a list of materials necessary for conducting FDA tobacco compliance check inspections. FDA is anticipating inspection services in the regions listed in the table below. 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.

*Region List of jurisdictions in the region 1 Connecticut, Delaware, Maine, Massachusetts, New Hampshire, New

Jersey, New York, Pennsylvania, Rhode Island, Vermont

2 Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin

3 Alabama, Arkansas, District of Columbia, Georgia, Florida, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, US Virgin Islands, Virginia, West Virginia

5 Puerto Rico

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

A separate IDIQ contract award is anticipated for each region. A single Contractor may receive awards for multiple regions; however, each region will be awarded separately

Region* Inspections

UB A&L

Region 1

Region 2 Region 3 Region 5

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

Number of undercover buys and Advertising and Labeling is based off of Sample Task Orders.

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

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

B. BACKGROUND INVESTIGATIONS/COMMISSIONING PROCESS

Prior to carrying out compliance check inspection activities, all Inspectors must be commissioned by FDA. 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.

All other employees under this contract, or under any subcontract, 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.

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 applicable, the Contractor must also provide security contact information for individuals that the Contractor intends to subcontract. FDA's Office of Security Operations (OSO) conducts a Tier 2 - Federal Level 5 Moderate Risk 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.

Candidates that do not complete and submit the required paperwork within 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 Contractor is responsible for immediately notifying the COR of any event or occurrence that could affect or change an employee or subcontractor commissioning status, including but not limited to the reasons for revocation outlined below.

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

• Repeated failure to follow FDA procedures.

• 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; 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 two (2) business days of notice given by or to the commissioned employee, including the reason for the separation: and the commissioning credentials and all government furnished equipment (GFE) shall be returned to the

FDA within five (5) business days as instructed by the COR.

C. KEY PERSONNEL FOR EACH TASK ORDER: PROGRAM COORDINATOR/BACKUP

PROGRAM COORDINATOR

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 PC shall be responsible for all aspects of the program management work described here in section C.1.2.

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 with the BPC when the PC is unavailable. The PC and BPC together shall equal one (I) Full Time Equivalent (FTE).

Other Program management hours shall not exceed 500 hours. The PC shall account for at least 51% of the program management effort than the BPC. For the purposes of this contract, an FTE is equal to 2080 hours. The PC, BPC 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, Inspectors, or Underage Purchasers (e.g., phone number, e-mail address, status, change of personnel, etc.).

D. INSPECTORS

The Contractor shall conduct compliance check inspections through persons who are United States citizens and who are also 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)(l)(A) of the FD&C Act (21 U.S.C. § 372(a)(l )(A)), which includes any health, food, or drug officer or employee of the State, Territory, or political subdivision thereof.

Due to logistics and associated expenses, the Contractor shall have no more than thirty (30) Inspectors. Inspectors must maintain regular performance of inspections to remain active on a task order within this contract. Inspectors that do not perform a minimum of l 0 inspections per month in their respective jurisdictions 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 years but are no longer employed by the Contractor, and the most recent contact information for such inspectors and Underage Purchaser shall be provided to FDA. Additionally, FDA may request individual contact information for inspectors who have left the program that shall be provided within two (2) business days of the request.

E. 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 (1) photo on file for each Underage Purchase involved in the Program and a copy of a valid photo identification (ID) card. FDA protocol does not require Underage Purchasers to carry photo identification for the undercover buy assignments. However, the Contractor may determine that Underage Purchaser should carry valid photo identification and present identification if requested. Such decisions are left to the discretion of the Contractor. The Contractor shall ensure that all Underage Purchaser 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 certificates 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 Purchasers are to remain as confidential as possible. The Contractor shall inform the Underage Purchaser (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 Contractor 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 form 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 for minors 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 any 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 Purchaser 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 Purchaser, 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 Purchaser. 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. The Contractor shall update TIMS with each Underage Purchaser’s unique identification number, gender, and date of birth at least fourteen (14) calendar days prior to the Underage Purchaser beginning work. For Underage Purchasers ages 18-20, the Contractor shall update TIMS with confirmation of completion of required background check.

F. CONFLICTS 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 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) 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 i ts PCs, or Commissioned Officers by any applicable federal law or ethical standard.

C.1.2 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 point of contact 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 and subcontractor employees involved with conducting tobacco retail compliance check inspections.

b. Facilitating the 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).

c. 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).

d. 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 (5) years (C.1.1.D).

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

f. 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).

g. Facilitating timely completion of all training requirements for all employees or subcontractor employees under this Contract (C.1.3).

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

i. 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 shall include who is assigned the equipment. FDA must be alerted within one

(1) business day if FDA-issued equipment protocol is not followed or if FDA-issued equipment is lost or stolen (C.1.2).

j. Storing and maintaining chain of custody of evidence according to FDA guidelines, and otherwise facilitating inspections (C.1.6).

k. 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).

l. Reviewing inspection results submitted by inspectors and reports provided by FDA to monitor inspection quality and ensure conformity with acceptability requirements in the contract (C.1.7).

m. Proactively informing FDA of any issues and problems that should be addressed in order for the overall effective accomplishment of task order goals. Corrective actions that need to be taken by the Contractor shall be clearly defined and communicated to FDA and have identified dates for completion.

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

o. Securing current and former inspectors as witnesses, where necessary (C.1.7).

p. Submitting monthly reports and invoices (C.1.9).

1. LOCATING INSPECTORS AND UNDERAGE PURCHASERS

The Contractor shall obtain and verify current contact information for Inspectors and Underage Purchasers, previously affiliated with FDA's inspection program, who are no longer affiliated with the program. The Contractor shall contact and coordinate with former inspectors and Underage Purchasers to be available to provide FDA specific knowledge related to inspections conducted by the inspector and serve as witnesses in litigation or other actions regarding past inspections.

a. FDA will initiate the request to locate former CTP inspectors by providing the Contractor at minimum a full name and the state or territory where the former staff member worked.

b. The Contractor shall contact any potential matches to verify that they have found the correct person.

c. The Contractor shall provide to the FDA all available contact information for the staff member to include work address, home address, email address, work phone number, home phone number, cell phone number, and name of current employer.

d. At a minimum, the Contractor shall provide a valid phone number at which FDA can contact the former staff member.

e. The Contractor shall provide the contact information within 10 business days of FDA's request.

f If the Contractor cannot locate the former staff member, the Contractor shall document the steps taken to attempt to locate the former staff member within 10 business days of FDA’s request.

g. The Contractor shall coordinate meetings and information collection between FDA and former inspectors and Underage Purchasers.

h. The Contractor shall compensate the designated individuals for the time these individuals spend assisting FDA which will be specified at the individual task level.

The FDA does not expect more than a reasonable effort to locate inspectors and Underage Purchasers. Reasonable effort shall be defined as internet research and direct contact through telephone and/or email.

2. COMMUNICATION AND DATA TRANSMISSION

FDA will supply government furnished equipment (two laptops) to the Key Personnel (PC and BPC) identified in this Contract. All communication from FDA will be sent to the government furnished equipment 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 iPhones to Inspectors. The Contractor shall ensure Inspectors use the iPhones to record compliance check inspection data and manage compliance check inspection work, including proper use of handheld devices by Underage Purchasers. Government issued iPhones shall only be used to perform the necessary work related to the contract requirements. Devices shall not be used for any personal activities. 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.

3. SITE VISIT:

FDA anticipates conducting site visits at the Contractor's facility to review all aspects of the compliance check inspection program and ensure compliance with the contract during the period of performance of this contract. FDA shall provide the contractor with a minimum of 30 calendar day notice prior to any planned visit. All documents and logs will be reviewed. The PC and BPC shall be present during a planned site visit.

4. 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:

• Time dedicated to contract work is recorded.

• 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 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:

• Have documented all required trainings (including Underage Purchasers);

• Remain knowledgeable about current procedures; and

• 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 shall 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).

C.1.3 TOBACCO RETAIL INSPECTION PROGRAM TRAINING ·

A. TRAINING FOR PROGRAM COORDINATOR, BACK-UP PROGRAM

COORDINATOR AND INSPECTORS

The COR will provide information regarding the FDA Tobacco Compliance Check Inspection Program 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 shall 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 sessions will be conducted via teleconference or webinars. FDA will provide up to 24 hours of training during each period of performance of each task order.

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

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

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

C. Key Personnel Orientation

Key Personnel shall undergo FDA Administrative orientation prior to beginning work on the Contract.

C.1.4. IDENTIFICATION OF RETAILERS

A. RETAIL OUTLET LIST

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