OH_Task_Order.pdf

TASK ORDER 1 (REGION 2)

Jurisdiction: OHIO

Period of Performance:

September 30, 2019 –September 29, 2020

TOTAL FIXED PRICE: $ _____________

Task 1 - Conducting retail inspections and providing related support services

Number of

Inspections Firm Fixed price per Inspection

Total Price

Inspection Type Contractor Directed Contractor-Directed Undercover Buy

6000 $ $

FDA-Directed Inspections $ $ Undercover Buy 3000 $ $

Advertising & Labeling 3000 $ $

Program Management/Non-Inspection Travel

Task NTE Price

Program Management Costs

$TBD

* Non-inspection Related Travel (Not to exceed value)

$10,000

Program Management – Program Management is: Labor Hour Loaded Hourly Rates – If proposed, the fixed hourly rate listed is "loaded" and shall only include the following: Salary cost or consulting fee of the individual providing the services; Payroll costs (fringe benefits, FICA, etc.); Indirect costs applicable to labor; and Profit or fee, if any;

Non-Inspection Travel – Travel is cost-reimbursement and shall not exceed $10,000 per year.

All travel must be approved by Contracting Officer’s Representative (COR) prior to travel.

Travel will be reimbursed according the Federal Travel Regulations (FTR).

Other Direct Cost

Not-To-Exceed Price

Other Direct Costs

(ODC)

$6,000

Task 2 - Locating Inspectors and Minors

Locating Witnesses $15,000

Compensation for locating witnesses will be reimbursed based on actual expenses.

Documentation must be submitted to Contracting Officer’s Representative (COR) for reimbursement along with invoice for reimbursement.

Compensation for Witness Testimony

$10,000

Compensation for witness testimony will be reimbursed based on actual expenses incurred.

Compensation is based on the amount of time testifying. Typically, witness testimony will be conducted via teleconference during normal business hours. Any travel related expenses for testimony must be submitted to COR for approval and will be reimbursed according to Federal Travel Regulation (FTR).

PROGRAM COORDINATOR/BACKUP PROGRAM COORDINATOR

The Contractor shall designate a Program Coordinator (PC) who shall be responsible for overall coordination, gathering information and evidence, and communicating with FDA for the jurisdiction. The PC shall be responsible for all aspects of the program management work described in the IDIQ. This position should be the main point of contact for FDA for the jurisdiction. The Contractor shall also designate a Backup Program Coordinator (BPC) so the Government will always have a point of contact. In the event that the PC and BPC are not available, the Contractor shall designate and notify the COR of a point of contact with authority to make decisions on behalf of the PC/BPC. The PC and backup/alternate PC together shall equal at least one (1) Full-Time Equivalent (FTE) per task. The PC must account for the majority percentage of the FTE. For the purposes of this contract an FTE is equal to 2080 hours. The Program Coordinator, Backup Program Coordinator or designated alternate shall be available at all times during business hours to communicate with the FDA.

The Contractor shall inform the COR when there are any changes to the information for Program Coordinator, Backup Program Coordinator, Commissioned Officers, Administrative Assistants, Chaperones, or Minors (e.g., phone number, e-mail address, status, change of personnel, etc.).

INSPECTION ACCEPTABILITY CRITERIA

Acceptable inspection result deliverables require that an inspection team visits a retail establishment to conduct a compliance check inspection, observe and document the retailer’s operational status and compliance with the requirements of the Tobacco Control Act, and submit the required findings to FDA within the required timeframe. Additionally, the following inspection acceptability criteria must be met:

A. Undercover Buy Assignments

1. The minor must be 16 or 17 years of age at the time the inspection is conducted.

2. Each inspection must be completed before the inspector starts a new inspection; this includes completion of all required documentation.

3. All inspections must include at least one (1) on-site photograph of the establishment that provides a clear representation of the establishment, including signage, street number if available, or an explanation as to why a representative photograph(s) could not be taken.

B. Advertising and Labeling Assignments

1. The inspection record for every completed assignment must include a photograph of a properly issued and signed Form FDA 482 or an explanation within the inspection assignment record explaining the absence of the FDA 482.

2. Each inspection must be completed before the inspector starts a new inspection; this includes completion of all required documentation.

3. If there are any potentially violative items, the inspector must take at least one (1) photograph of the violative item that establishes where it is in the establishment or explain within the inspection assignment record why such a photograph could not be taken.

4. All inspections must include at least one (1) on-site photograph of the establishment that provides a clear representation of the establishment, including signage, street number if available, a clear representation of the establishment’s operational status, or an explanation as to why a representative photograph(s) could not be taken.

It is the Contractor’s responsibility to confirm that all inspections submitted to FDA meet the criteria described in this section.

MONTHLY REPORTS

The Contractor shall submit a Monthly Report to the FDA COR by the 10th business day of the following month. A Monthly Report is a quantitative description of overall progress and applicable supporting data in sufficient detail to comprehensively explain progress to date.

Appropriate format and topics include:

1. Cover page

2. Contract Number and Title

3. Type of report, sequence number and period being covered

4. Contractor’s Name and Address

5. Author

6. Date

7. Total number of inspections performed for monthly performance period, and total number of inspections performed to date.

8. Updates to the retail outlet list or certification that the current outlet list is the most up to date list, and all corrections have been previously inputted into TIMS.

9. Number of retail outlets that were eliminated by prescreening, both cumulative and in this month.

10. Number of follow-up FDA questions answered concerning compliance check inspections, and number pending and reasons why.

11. List of new employees and employees who have left the program.

12. Media coverage, contact, and/or inquiries, if any.

13. Dates on which Inspectors received FDA training and updates.

14. Description of the jurisdiction’s Synar program and how it is coordinated with work under this Contract per month, if at all.

15. Description of any non-FDA tobacco control programs in the

Contractor’s Jurisdiction and how they are coordinated with work under this Contract if at all.

16. Description of retail outlet inspectional coverage plan.

17. Description of retail outlet inspectional coverage plan for the next month.

18. Total number (and percentage) of retail outlets inspected in racial and ethnic minority communities for the current period and to date

19. Description of how retail outlets in racial and ethnic minority communities will be covered in the next month.

20. Total number (and percentage) of retail outlets inspected in areas that are in close proximity to where there is a high concentration of youth (e.g., schools, recreation centers, etc.).

21. Description of retail outlet inspectional coverage plan in areas that are in close proximity to where there is a high concentration of youth (e.g., schools, recreational centers, etc.

22. Description of Contractor’s program for the protection, preservation and maintenance of all Government property, recent procedures to educate their employees concerning individual responsibilities for Government property, and recent efforts to monitor and assess the Contractor’s property control system.

23. Feedback regarding the use of handheld devices and other hardware, TIMS, and the online compliance check inspection process.

24. Feedback regarding the FDA program in general, including issues or concerns.

CONTRACT ADMINISTRATION DATA

AUTHORITIES OF GOVERNMENT PERSONNEL

The Contractor shall share sufficient information throughout the life of the contract and resulting Task Order(s) that the FDA maintains oversight and control of all inspection activities, and that the FDA may redirect the Contractor’s activities, as deemed necessary or otherwise in the best interests of the FDA. The following individuals shall be the Government's points of contact during performance of the Contract:

CONTRACT SPECIALIST

All communications pertaining to contractual and/or administrative matters under the Contract should be addressed to the Contract Specialist. The Contract Specialist assigned to this Contract is (*TBD). All contract administration shall be performed by the Contract Specialist, (*TBD), FDA/OC/OAGS, 4041 Powder Mill Rd, Beltsville MD 20705. (*TBD) can be reached at TBD or electronically at TBD @fda.hhs.gov.

COR APPOINTMENT AND AUTHORITY

1. The COR assigned to this Contract is: *TBD.

2. Performance of work under this Contract must be subject to the technical direction of the COR identified above, or a representative designated in writing. The term “technical direction” includes, without limitation, direction to the Contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

3. Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have authority to issue technical direction that:

• Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

• Constitutes a change as defined in the clause entitled “Changes”;

• In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

• Changes any of the terms, conditions, or specification(s)/work statement of the Contract;

• Interferes with the Contractor's right to perform under the terms and conditions of the Contract; or

• Directs, supervises or otherwise controls the actions of the Contractor's employees.

4. Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within five (5) business days, with a copy to the Contracting Officer.

5. The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his/her designee, does not fall within the scope of his/her authority, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government business day.

6. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the Contract shall be subject to the terms of the FAR Clause 52.233-1, Disputes. The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the Contract, and to notify both the Contractor and the Contracting Officer of any deficiencies observed. A letter of designation shall be issued to both the COR and the Contractor at the time of the Contract award setting forth in full the responsibilities and limitations of the COR.

7. The Contractor must receive Contracting Officer’s Authorization (COA) prior to assigning the Program Coordinator (PC) and Backup Program Coordinator (BPC) to this Contract.

8. The individuals cited below are key personnel:

Program Coordinator (PC)

Name: *shall be identified at contract award.

Title: Program Coordinator (PC) Email Address: ________________ Telephone: ___________________ Mailing Address: _______________

Backup/Alternate Program Coordinator (BPC) Name: *shall be identified at contract award.

Title: Backup/Alternate Program Coordinator (BPC) Email Address: ______________________ Telephone: __________________________ Mailing Address: