Draft Statement of Work.docx

Food and Drug Administration (FDA)

Center for Tobacco Product

Office of Compliance and Enforcement

CTP IDIQ

This Indefinite Delivery / Indefinite Quantity (IDIQ) Contract is anticipated to be a Time and material cost contract with a minimum of $100,000.00 and a contract maximum of $65,000,000.00. The associated North American Industrial Classification System (NAICS) code for this procurement is 541611. Its associated Small Business Size Standard is $15 Million.

1. BACKGROUND

The FDA Center for Tobacco Product’s (CTP), Office of Compliance and Enforcement (OCE) has the authority to regulate tobacco products, manufacturers, and retailers. OCE regulates tobacco products, manufacturers, and retailers through a variety of enforcement methods. These methods include inspections of manufacturers and retailers, reviewing product regulatory submissions and notifications, and finding and analyzing print and electronic advertising, labeling, and promotions.

OCE is seeking data collection, review, compiling, and analysis services to enable OCE staff to effectively focus attention on the decisions and actions required to enforce tobacco regulations.

2. BUSINESS AND TECHNICAL ENVIRONMENT

In performing these services, the contractor shall be required to review and understand FDA guidance regarding the Tobacco Control Act and apply that understanding in the analysis of compliance records.

All services tasked through this IDIQ shall be performed at the contractor’s facilities. On a task by task basis, the FDA will provide access to Government databases and systems. The majority of the work will be performed electronically. There is no need for the storage of a large volume of paper files. In providing services, the Contractor shall follow FDA/CTP-provided Standard Operating Procedures which are regularly reviewed and updated.

3. BUSINESS OBJECTIVES

Through this IDIQ, the Government seeks to achieve the following objectives:

· Consolidate interrelated tasks to improve the efficiency and effectiveness of the FDA/CTP enforcement mission

· Create infrastructure to manage the growth in enforcement related activities anticipated by CTP over the next five years

4. SCOPE OF WORK

This scope of work encompasses the following task areas:

· Transition-In

· Program and Project Management

· Receipt, Review, and Processing of Retailer Compliance Check Inspection Data and Associated Documents

· Transition-Out

5. TASKS

In performing services, the contractor shall review and understand FDA guidance regarding the Tobacco Control Act and apply that understanding in the analysis of compliance records. In performing services, the Contractor shall abide by Program changes needed to maintain efficiency of Program operations and accuracy of compliance check inspection data and evidence. Such changes may include, but are not limited to, template updates, order of procedures, and IT system improvements. The Government will issue tasks under this IDIQ to provide the following types of services:

5.1. TRANSITION-IN

Transition-In services provides orderly transition from the incumbent Contractor to the successor Contractor. The successor Contractor shall work toward the Government’s goal of ensuring minimal disruption to the current operational activities.

The Contractor shall provide Transition-In support during the transition period. Upon completion of transition in period, the Contractor shall assume full operating accountability and responsibility for all tasks. Specifics related to the transition-in tasks and timeline will be detailed at the Task Order level. Representative transition activities under this task area include but are not limited to:

· Develop a Transition-In Plan to ensure full operating accountability and responsibility of the task order

· Conduct and coordinate all on-boarding activities and obtain secure badging for all Contractor personnel

· Engage in regularly scheduled meetings

· Participate in Transition-In meetings

· Participate in knowledge transfer activities such as “shadowing”

· Ensure contractor key personnel are available to work immediately after IDIQ Task Order awards

5.2. PROGRAM AND PROJECT MANAGEMENT

Program management services provide overall management of the Task issued under this IDIQ, including the coordination and response to Task requests. Project management services address the management of each individual Task to ensure the appropriate execution of technical and management activities. Project Management also includes budget, schedule, and quality management of the Task.

Representative activities include:

· Develop, maintain, and implement an approved quality assurance plan (QAP) for each task order. The QAP shall include quality assurance and quality control activities.

· The Contractor shall provide reports on progress as specified under the individual task order

The contractor shall perform project and program management activities for the collection, review, and analysis of relevant data for compliance reports and regulatory submissions. These management activities shall establish control, management, monitoring, and notification mechanisms and shall include working with and reporting to the COR and COR designees to ensure that tasks are executed.

Representative activities include but are not limited to:

· Prepare a Contract Management Plan and Task Order Management Plan for each task order describing the technical approach, communication mechanisms, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout task order duration

· Manage and coordinate requirements and requirements execution across all tasks

· Plan, organize, secure, and manage resources with appropriate knowledge and skills

· Maintain quality control through repeatable, managed processes

· Collect system and performance metrics associated with each task area, as will be defined in each Task Order

· Track and manage cost

· Proactively inform the designated COR and COR designee of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA or other contractors, shall be clearly defined and communicated to the COR or COR designee and have identified dates for completion

· Provide monthly status reports to the COR and COR designee. Within the first thirty (30) days after task order award, the Contractor shall design, and the COR will approve a standard reporting format that includes the following types of information at a minimum:

· Status and progress of tasks by task order

· Cost and schedule variances against agreed-upon baselines

· Significant risks to scheduled deliverables and plans to mitigate them

· Issues, recommendations and escalation

· Progress against task order service level metrics

· Recommendations for changes or additional activities to ensure that the tasks support progress on the overall objectives in section 3

· Specific metrics as described in a Plan of Action and Milestones (POAM), if associated with a specific Task Order

· Prepare materials for and participate in meetings including but not limited to:

· Project reviews, management briefings, stakeholder presentations, cross-agency information exchanges and other similar meetings

· Disclosures as required by the conflicts of interest clause regarding financial relationships, plans to mitigate potential conflicts of interest, and any updates to organizational conflict of interest policies and procedures related to this requirement

5.3. RECEIPT, REVIEW, AND PROCESSING OF RETAILER COMPLIANCE CHECK INSPECTION DATA AND ASSOCIATED DOCUMENTS

The Tobacco Control Act requires FDA to contract, where feasible, with states and U.S. territories to inspect tobacco retailers. CTP receives and reviews inspection results from these programs to determine if administrative or enforcement action is necessary. As tasked, the Contractor shall provide services supporting the reception and review of inspection results to recommend administrative or enforcement action as necessary. Representative activities include:

· Shipping, receipt, data entry, review, compilation, and processing of documents associated with the Tobacco Retailer Compliance Check Inspection Program including inspection data.

· Review activities may include compiling information into templates provided by FDA, and research or verification of provided data via internet, mail, e-mail, or telephone

· Processing documents may include, data entry, uploading documents and creating cases in databases identified by the FDA. Documents associated with the Tobacco Retailer Compliance Check Inspection Program include, but are not limited to: inspection reports, administrative or enforcement notices and follow-ups, and details regarding tobacco retail establishments. These documents vary in length; however, the typical range is from one (1) page to twenty-five (25) pages

· Receiving documents from Retailers may include generating, scanning, uploading, or compiling documents, and tracking delivery of mailings

Certain tasks under Task 5.3 will require delivery of documents to FDA’s White Oak campus in Silver Spring, Maryland, once a week. Couriered documents must be delivered to the contractor’s physical location so that they are processed the same day.

5.4. TRANSITION-OUT

Services to facilitate the transition of contracted activities and services to the Federal Government or to a follow-on Contractor at the end of the contract period of performance.

The Contractor shall provide transition out activities, to include, but not be limited to, a transition out plan, leading Technical Exchange Meetings (TEMs) with the successor to impart knowledge of all processes, systems, applications, and databases. During this period, the Contractor shall ensure no degradation in support provided under the task order. Between the COR designated turnover date and the end of the contract period of performance, the outgoing Contractor shall ensure all task order activities are closed out and provide sustainment support to complete the transition.

Representative activities under this task area include but are not limited to:

· Providing FDA with current versions of all documentation developed, maintained, or updated under this contract, to include the native format for attachments and diagrams (e.g., Visio), with applicable configuration management information

· Providing FDA with all licensing and renewal information, asset management records, software documentation, and training materials

· Providing FDA with a current inventory of all Government-owned assets used by the Contractor along with full support in the reconciliation of this inventory

· Providing the successor with the ability to “shadow” and participate in knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor

6. PLACE OF PERFORMANCE

The place of performance will be specified at the task order level.

7. PERIOD OF PERFORMANCE

The period of performance is five (5) years.

Each task order will have its own individual period of performance.

8. GOVERNMENT POINTS OF CONTACT

Contract Specialist (CS) Noah Wills 240-402-5220 Noah.Wills@fda.hhs.gov

Contracting Officer (CO)

TBD

IDIQ Contracting Officer’s Representative (COR)

TBD

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