Amend0001_pages.pdf

Solicitation 75F40125R00034

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Amendment 0001 (8/21/2025) from CO/Contract Specialist (CS). All documentation including the approval must be provided to FDA when invoicing.

B.3 COST

1. INSPECTIONS (CLIN 1)

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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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”

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”

2. NON-INSPECTION TRAVEL (CLIN 2)

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) (CLIN 3)

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 F – DELIVERABLES OR PERFORMANCE

F.1 PERIOD OF PERFORMANCE

The Period of Performance for this IDIQ Contract shall be five (5) years/sixty months. The first task order will be for 8 months however all subsequent task orders may have varying periods of performances.

F.2 DELIVERABLES

Below is a list of deliverables to be completed in each task order. All deliverables required by this Contract shall be delivered via e-mail to the COR except when indicated below that the CS and the COR receive copies. All deliverables shall be subject to the inspection and acceptance of the COR. Any deviations from this list, or additional deliverables may be delineated at the task order level.

REFERENCE # DELIVERABLES TIMELINE/DUE DATE

C.1.1. I Names, current employer, job title, of individuals for commissioning, security contact information and any other documentation FDA deems necessary for commissioning

Two days prior to performing any work on behalf of HHS/FDA via email to COR

C.1.1. II Certification of commissionable personnel

Two days prior to each Inspector performing any work on behalf of HHS/FDA via email to COR

C.1.1. V Underage Purchaser information updated in TIMS

Fourteen (14) calendar days before the Underage Purchaser begins inspecting

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C.1.1. IV Verify current contact information for all Inspectors

Annually, within two (2) business days of request from FDA; and at the end of the contract period

C.1.1. II Notification of changes to commissioning/background information for PC, BPC, Inspectors, to CO/CS and COR

Within two (2) business days of contractor’s notification via email to CO/CS and COR

C.1.1. II Notify the FDA COR of any changes of employment status of a commissioned employee

Within one (1) business day of notice given by or to the commissioned employee via email to COR

C.2.2.III Quality Control Plan to CO/CS and

COR

Within ten (10) business days of award and at least thirty (30) calendar days prior to any changes via email to CO/CS and COR

C.2.2(f) Inventory of FDA Equipment to CO/CS and COR

Provide updates quarterly via email to CO/CS and COR

C.2.4 Retail outlet list or updates to list Provide updates quarterly via email to

COR

C.2.6.I Contractor’s Commitment to Protect Non-Public Information to CO/CS and COR

Provide to CO/CS and COR via email two days prior to each staff member performing work on this contract

C.2.6 A&L inspection results (recorded findings and photographs)

75% of inspections shall be completed within ninety (90) calendar days of assignment. 15% shall be completed within fifteen (15) calendar days of assignment, and 15% shall be completed within five (5) calendar days of assignment

C.2.6 UB inspection results (recorded findings and photographs)

Up to 10% within five (5) calendar days and the remainder within ninety

(90) calendar days of assignment

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SECTION J - LIST OF ATTACHMENTS

The following are attachments for this solicitation:

Attachment 1: List of Materials

Attachment 2: Retail Outlet List Template and Instructions

Attachment 3: Form FDA 3398 –Commitment to Protect Non-Public Information (NPI) Agreement

Attachment 4: Cost Estimate Pricing Format

Attachment 5: SF LLL Disclosure of Lobbying Activities

Attachment 6: FDA Tobacco Invoice Form

Attachment 7: Monthly Report Template

Attachment 8: Appendix Q HHS Contracting Guide for Contract of Government property

Attachment 9: Whistleblower protections for Contractors.

Attachment 10: SBCX Industry Subcontracting Guide

Attachment 11: Certificate of Current Cost or Pricing Data

Attachment 12: Form FDA 482 Notice of Inspections

Attachment 13: HHS Subcontracting Plan Template

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c) The Offeror must complete Section K of the RFP, Representations, Certifications,

d) and other Statement of Offerors. One originally signed copy of Section K must be included with the original business proposal. Disclosure and Use of Lobbying Activities - Standard Form LLL, "Disclosure of Lobbying Activities" has been included in the Section J, Attachment 5 for use in accordance with FAR 52.203- 11- Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (APR l991) and is accessible at http://www.gsa.forms. If the Offeror has activity to report, it shall complete SF- LLL “Disclosure of Lobbying Activities” and shall include one originally signed copy with the business proposal.

e) If the offeror is proposing subcontracting cost, the offeror must provide the breakdown of the subcontracting costs including, direct labor, fringe benefit, materials, travel, and indirect rate for the subcontractor. Offeror must submit signed offer from proposed subcontractor with all associated cost with their business proposal.

f) If subcontracting cost is proposed, the offeror must include information on how they are going to staff for the contract; provide all upfront cost and identify all fees being proposed.

If fringe benefit and overhead cost are included in your proposal the offeror must include a rate agreement letter signed by the offeror’s cognizant federal agency or financial officer confirming the fringe benefit and overhead rate for that company. If burden rates have been approved by a cognizant federal agency, the offer must provide detailed projected estimates of the various items which are included in the total fringe benefits and overhead pools.

3. VOLUME III - SUBCONTRACTING PLAN EMAIL NOTIFICATION

In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the proposal submission process for all states/territories and must be submitted separately from the technical and cost proposals.

The state’s subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award. Submission of the subcontracting plan is a two step process. Step 1:

The state/territory must submit their respective completed subcontracting plan template (Attachment 13) at time of proposal submission.

Step 2: Upon approval of the completed subcontracting plan template by the contracting officer during the evaluation phase, the respective state will receive a notification from HHS (or contracting officer) to submit the plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov. The state shall follow the instructions outlined in the Attachment 10 - SBCX Industry Subcontracting Guide to successfully submit their subcontracting plan by the proposal submission deadline.

Any technical questions regarding the use of the SBCX system may be submitted via email to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday – Friday, 6:00 a.m. – 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and a representative will respond within the

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New Jersey Michele Jackson Michele.Jackson@fda.hhs.gov

Pennsylvania Pamela Lee Pamela.Lee@fda.hhs.gov

Washington Brandon Rufus Brandon.Rafus@fda.hhs.gov

Wisconsin Brandon Rufus Brandon.Rafus@fda.hhs.gov

Commonwealth of the Northern Mariana Islands

Janice Heard Janice.Heard@fda.hhs.gov

L.8 PRE-PROPOSAL CONFERENCE

Interested parties must submit the information below via email to Pamela.Lee@fda.hhs.gov no later than August 13, 2025, at 9:00 AM ET for inclusion in the pre-proposal conference meeting. No more than four (4) individuals will be accepted per State for inclusion in the pre-proposal conference. One (1) of the participants to the pre-solicitation conference must be someone for your jurisdiction’s contracting or finance office. No questions will be addressed during the Pre-Proposal Conference. Any questions after the Pre-Proposal Conference should be submitted to Pamela.Lee@fda.hhs.gov by COB on August 20, 2025 @ 10:00 AM ET.

Please include the solicitation number, the State of XXX, in the subject line when submitting questions.

L.9 PROPOSAL SUBMISSION DUE DATE

Offerors who are interested in this RFP must submit their proposal by NO LATER THAN 10:00 AM ET August 27, 2025. Offerors shall submit one (1) electronic copy of Volumes II to Pamela.Lee@fda.hhs.gov. All electronic submissions must contain the RFP solicitation number and title in the subject of the electronic submission email.

L.10 MACROS

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.