Attachment E - Sample Task Order.docx

Attachment E: Sample Task Order

Note to Offerors: The Offeror shall propose using the following Sample Statement of Work. The sample is expected to realistic approximation of the actual Task Order issued, but is subject to changes within scope.

CTP Tobacco Compliance Check Inspection Program Data Review

1. BACKGROUND

This is a Task Order under contract ……… Receipt, Review, and Processing of Retailer Compliance Check Inspection Data and Associated Documents.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Contract Act) (Public Law 111-13; 123 Stat. 1776) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing the Food and Drug Administration (FDA) with the authority to regulate tobacco products and tobacco retailers. The FDA Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) has the authority to regulate tobacco products, manufacturers, and retailers through a variety of enforcement methods including inspections of retailers. FDA currently contracts with state, territorial, and tribal agencies and private contractors to perform inspections in more than 55 U.S. states, tribes, and territories.

FDA inspectors conduct inspections at tobacco retailers, where inspection data is gathered. The retailer inspection data is submitted to an inspection database (the Tobacco Inspection Management System, or TIMS). CTP receives and reviews inspection results from the inspection database to determine if any administrative or enforcement action is necessary. Each inspection generates data outputs and inputs. Data from each inspection must be treated in a manner that allows for timely recordation, data compilation, and inspection follow up by the Government.

2. OBJECTIVE

CTP is seeking a contractor to perform duties including updating databases, processing inspection results, shipping/receiving documents, processing, uploading and tracking documents, follow-up activities, and quality assurance checks.

3. DEFINITIONS

For purposes of this Task Order, the following definitions shall apply:

Civil Money Penalty (CMP) – A civil money penalty (CMP) is a monetary penalty assessed for a violation of law.

Case Management System (CMS) – MARCS-CMS is an FDA web-based program that holds the complete and final versions of each case file.

Complaint – A legal document that identifies the statutory or regulatory violations FDA is alleging as the basis for seeking a CMP or a No-Tobacco-Sale Order.

Compliance Check Inspection (CCI) Notice – A document mailed to retailers shortly after a completed inspection where a sale to a minor occurred, notifying the retailer that a potential violation was observed.

Cover Letter – The letter sent to a retail establishment with the CMP or NTSO Complaint.

Enterprise Content Management System (ECMS) – A web-based database that holds working documents related to inspections and enforcement actions.

Firm Establishment Identifier (FEI) – Unique 10-digit number used to identify firms associated with FDA regulated products. This number can be used to find an establishment in CMS.

No-Tobacco-Sale Order (NTSO) – An order prohibiting the sale of tobacco products at a retail outlet indefinitely or for a specified period under section 303(f)(8) of the FD&C Act.

Reply Letter (RL) – Correspondence that CTP sends to answer a retailer’s oral or written response to a Warning Letter.

Retail Establishment Identifier (REI) – Unique identifier for each establishment in TIMS. This number links all inspections in TIMS that are conducted at a specific establishment while under the same owner.

Tobacco Inspection Management System (TIMS) – FDA web application that provides an interface for accessing and managing FDA tobacco inspection assignment information and related processes.

Warning Letter (WL) – An advisory action used to notify an establishment of violations reported by an FDA- commissioned inspector that allows for voluntary compliance. Generally, CTP will issue a WL for the first time a violation is reported at a retailer’s establishment.

CTP Case Management System (CCMS) – Web-based program that tracks case deadlines

Departmental Appeals Board (DAB) – Provides impartial review of tobacco cases

REQUIREMENTS/TASKS

The following tasks shall be performed to support compliance and enforcement efforts. It is anticipated that in a 12-month period approximately 200,000 inspections may be performed by OCE in approximately 55 jurisdictions within the United States. Independently, and not as an agent of the Government, the Contractor shall furnish the necessary personnel and services, except as provided in the schedule, and otherwise do all things necessary for or incident to the performance of the work as described below.

Violations of the Tobacco Control Act may lead to actions against retailers including Warning Letters, Civil Money Penalties, and No-Tobacco-Sale Orders.

This requirement encompasses the following task areas:

· Processing Compliance Check Inspection Notices

· Prepare Summary Reports

· Warning Letter Generation and Processing

· Reply Letter Processing

· CMP Complaint Generation and Processing

· No-Tobacco-Sale Order Complaint Generation and Processing

· Create and Update Cases in FDA Databases

· Settlement and Hearing Documents Generation and Processing

· Document Processing, Shipping, Scanning, Tracking, and Uploading

· TIMS Inspection Follow-Up and Close-out

· CMS Case Close-out

· Project Management

· Transition Out

Task 1: Processing Compliance Check Inspection Notices

The Contractor shall access TIMS daily to process Compliance Check Inspection (CCI) Notices where a potential violation of the Tobacco Control Act has occurred. The Contractor shall retrieve a system-generated CCI Notice (a PDF document) from TIMS. The Contractor shall compare the establishment name and address in the system-generated CCI Notice to the inspector’s notes in TIMS and shall ensure that the establishment photo and other information in the CCI Notice accurately reflects the establishment and the inspection details. If necessary, the Contractor shall correct any discrepancies or incorrect establishment images according to CTP guidelines. In some cases, the Contractor may need to redact portions of the photos. The Contractor shall anticipate processing 400 – 600 CCI Notices per week.

Within one (1) business day of retrieving the CCI Notices, the Contractor shall send an email to CTP which includes any edited CCI Notices (along with the associated unedited CCI Notice), as well as the total number of CCI Notices processed that day. The Contractor shall print the final CCI Notices to be mailed, create UPS shipping labels, and place the documents for pick up by the CTP-designated shipper. The Contractor shall perform quality control to ensure mailings are accurate with no errors. The Contractor shall obtain the confirmation of delivery/delivery receipt for each CCI Notice mailed and upload them into the corresponding inspection case file within two (2) business days of delivery to the retailer. If a delivery confirmation cannot be obtained, or the CCI Notice has been returned, the Contractor shall notify CTP, and follow-up and investigate with the CTP-designated shipper regarding the status of the mailing each business day until resolved. For all returned documents that cannot be delivered, the Contractor shall provide the original copy of all returned documents to CTP after copies have been scanned and uploaded to the appropriate inspection case file in TIMS. CTP may send returned or un-delivered CCI Notices back to the Contractor via courier or via e-mail for additional mailing attempts by CTP’s designated shipper. The Contractor shall create shipping labels for these CCI Notices, place the documents for pick-up, and obtain and upload the confirmation of delivery/delivery receipt, as described above for initial CCI Notices.

Task 2: Prepare Summary Reports

The Contractor shall create a summary report for each potentially violative inspection record. CTP estimates an average of 1,435 (fluctuating between 900 and 1870 weekly) to assist the FDA in determining if violations of the FD&C Act occurred. This will require the Contractor to review all inspection records for completeness, consistency, and accuracy. CTP inspection records include inspection forms, Narrative Reports, photographs, and other related documents. During the review of each inspection record, the Contractor shall communicate incomplete and inconsistent data to CTP within 24 hours of discovery. The Contractor shall prepare the summary reports in ascending order starting with the oldest inspection record unless expressly directed otherwise by CTP.

CTP will provide the Contractor with templates of the summary reports that correspond to the type of inspection being reviewed (e.g., WL, CMP, NTSO). The summary report may include checklists and memoranda for CMP and NTSO Complaints, as well as templates for Warning Letters, Reply Letters, and Cover Letters. The Contractor shall complete the relevant summary report for each pertinent inspection record within three (3) business days of being assigned to a reviewer. See the subtasks below for the anticipated volume and requirements for completing each type of summary report.

Task 2.1: Warning Letter / Summary Report Generation and Processing

Some of the inspection records will include a designation assigned by CTP indicating the Contractor will need to generate a summary report for a Warning Letter and the associated document. The Contractor shall anticipate an average of 500 (fluctuating from 400 – 600) inspection records per week to be designated as Warning Letters / Summary Reports.

Warning Letter documents are mailed to retailers per the requirements of Task 5 below.

Task 2.1.a: Reply Letter and Warning Letter Close-Out Procedures

The Contractor shall anticipate on average 300 -600 inspection assignments to be processed as Reply Letters per week. Processing can involve preparing, mailing, and system updating and uploading. For designated cases, the Contractor shall receive an electronic list and an electronic copy (Template) of Reply Letters for processing. The Contractor shall send CTP a weekly electronic list of Reply Letter cases that were processed and mailed. Processing of Reply Letter documents includes correctly entering and updating information in CMS and TIMS and uploading relevant documents into CMS and TIMS. Letters are mailed per the requirements in Task 5 below.

The Contractor shall receive an electronic list of Warning Letter No Response Cases every other week to process within five (5) business days of receipt. Processing can involve updating CMS and/or TIMS with relevant information. The Contractor shall anticipate an average of 200 (fluctuating from 150 – 250) such cases per week. In some instances, the Contractor will be required to reconcile discrepancies at the direction of CTP.

CTP shall send the contractor a list of Warning Letter cases and associated retailer responses on a routine basis. The contractor shall upload the retailer responses in the corresponding CMS and TIMS case files and update the case files with relevant information.

Task 2.2: CMP Generation and Processing

Some of the inspection records will include a designation assigned by CTP indicating that the Contractor will need to generate a Civil Money Penalty (CMP) summary report and complaint templates.

Task 2.2a: CMP Summary Report Generation and Processing

The Contractor shall complete the summary report, including checklist, memoranda, and electronic file creation, for each designated inspection record within three (3) business days of being assigned to a reviewer. The Contractor can anticipate generating an average of 150 (fluctuating from 50 – 300) CMP summary reports weekly.

Task 2.2b: CMP Complaint Generation and Processing

After CTP approves the CMP summary report, the Contractor shall generate a draft Cover Letter and Complaint from a template provided by CTP for each record. The Contractor shall complete the generation of these documents for each inspection record within three (3) business days of being assigned. The Contractor can anticipate generating an average of 125 (fluctuating between 50 – 200) CMP records (CMP Complaint and Cover Letter) weekly.

CMP Complaints are mailed per the requirements of Task 5 below.

Task 2.3: No-Tobacco-Sale Order (NTSO) Complaint Generation and Processing

Some of the inspection records will include a designation assigned by CTP indicating that the Contractor will need to generate No-Tobacco-Sale Order (NTSO) complaint templates. For each record so designated, the Contractor shall generate a draft Cover Letter and Complaint from a template provided by CTP for each record for subsequent review and approval. The Contractor can anticipate an average of 5 (fluctuating between 0 – 10) inspection records per month to require generation of an NTSO Complaint and Cover Letter, and further processing.

NTSO Complaints are mailed to retailers per the requirements of Task 5 below.

Task 3: Create and Update Cases in FDA Web Based Programs

Enterprise Content Management System (ECMS) is an FDA web-based program which holds the working documents for each assignment. Concurrent with the completion of any of the tasks outlined in Task 2, the Contractor shall create a subfolder located in the specified section of ECMS to upload and store documentation relevant to the current inspection. For each inspection in which a summary report is required to be created, the Contractor shall retrieve all relevant information from the FDA inspection databases and web-based programs and import the documents into the case-specific ECMS folder, and then update TIMS to indicate to CTP that the case is ready for review.

FDA will provide the Contractor signed Warning Letters, Reply Letter, and CMP and NTSO Complaints to be mailed per the requirements stated below in Task 5. Each week, the Contractor shall expect to receive an average of 500 (fluctuating between 400-600) Warning Letters, 250-500 Reply Letters, 150 CMP Complaints (fluctuating between 100 – 175), and 5 NTSO Complaints (fluctuating between 0 – 10).

For CMPs, the Contractor shall access CMS and create a new electronic case file when the Complaint and Cover Letter are generated (after submitting the summary report as described in Task 2.2.a). For NTSOs, the Contractor shall access CMS and create a new electronic case file before submitting the summary report to CTP.

The CMS case file shall include the case information, evidence, and documentation obtained from other FDA databases, such as TIMS and ECMS, as well as information collected and stored previously by the Contractor. The Contractor shall ensure that the CMS case contains the case information, evidence, and relevant documentation within two (2) business days of the mailing of the CMP or NTSO Complaint. The Contractor shall ensure that the CMS case file is accurate and complete based on the final CMP or NTSO Complaint issued.

For Warning Letters, the Contractor shall access CMS to create a new electronic CMS case file within two

(2) business days of mailing the documents. The Contractor shall also update the case in TIMS, including verifying that all electronic documents are uploaded; as well as updating and entering additional information within the same timeframe in both CMS and TIMS. Creating a new CMS case file includes updating the case information, evidence, and documentation obtained from other FDA databases, such as TIMS and ECMS, as well as information collected and stored previously by the Contractor. The Contractor shall establish records in CMS by associating them with the Firm Establishment Identifier (FEI) number provided by CTP. The Contractor shall ensure that the CMS case is accurate and complete based on the final Warning Letter issued. Once the WL has been mailed and delivered, the Contractor shall upload the delivery confirmation and then will verify that the delivered address matches the address on the Warning Letter.

Task 4: Settlement and Hearing Documents Generation and Processing

Complaint documents are mailed to retailers per the requirements of Task 5 below. Upon receipt, the retailer may acknowledge the violations and pay the full penalty (if the complaint seeks a CMP), request a settlement conference with CTP, request a hearing with the Administrative Law Judge, or request an extension from the Administrative Law Judge.

Daily, the Contractor shall obtain completed acknowledgment forms from the online portal and retrieve CMP records of payment from the online payment portal and notify CTP within one (1) business day. For each CMP Complaint where there is a completed acknowledgement form and/or a record of payment, the Contractor shall update and close the case file (as appropriate) in electronic databases, including CMS, TIMS, the CTP case management system (“CCMS”), and the litigation electronic filing system, within one

(1) business day of request from CTP. The Contractor shall also update the electronic payment portal website within one (1) business day of receiving the acknowledgment form and/or payment record. The Contractor shall also retrieve other documents from the electronic filing and payment databases, notify CTP, and update informational databases including CMS, TIMS, and CCMS within one (1) business day. On average, 75 acknowledgment forms and records of payment are expected to be processed weekly (fluctuating between 60 and 90), in addition to other documents and payments submitted by retailers.

CTP will also provide an electronic list daily, as needed, with a request to generate and process settlement- related and hearing-related documents, including correspondence, notices, and motions. Access to templates for these documents will be provided by CTP. The Contractor shall generate settlement-related and hearing- related documents and send to CTP for review and approval within one (1) business day of receiving the electronic list. The Contractor shall also take appropriate action to create, update, and close (as appropriate) each case on the daily list provided by CTP in electronic databases, including CMS, TIMS, CCMS, and the litigation electronic filing system, as appropriate, within one (1) business day of request from CTP. The Contractor shall anticipate generating and processing on average 130 settlement-related and hearing-related documents weekly (fluctuating between 100 – 160).

The contractor shall receive DAB notifications and review and email relevant notifications to a prescribed group of individuals by COB same day of receipt. The contractor shall also update CCMS with court-imposed deadlines contained within those notifications by COB same day.

Task 5: Document Processing, Shipping, Scanning, Tracking, and Uploading

The Contractor shall provide for delivery and pickup of documents, via courier, between FDA’s White Oak campus in Silver Spring, Maryland and the Contractor’s facility (off-site), upon request no more than twice per week. CTP will provide the Contractor with approved documents electronically for subsequent printing and mailing. The approved documents may include 400 – 600 Warning Letters, 250-500 Reply Letters, 100

– 175 CMP Complaints, 0 – 10 NTSO Complaints, 100 – 160 settlement-related and hearing-related documents, and other compliance correspondence and related miscellaneous documents weekly. The Contractor shall verify the correct mailing address for each document based on information obtained from FDA databases; review each document for legibility and format errors; generate the case specific hardcopy mailing package, if necessary, and ensure it is complete; and request or generate a corrected replacement, as needed. The Contractor shall date stamp documents with the date the document is mailed. If a carbon copy (cc) is necessary for a document, the Contractor shall create and mail copies for any required carbon copies through CTP’s designated carrier.

CTP will provide a list of documents contained in FDA databases associated with approved Warning Letters, Reply Letters, CMP Complaints, NTSO Complaints, and settlement-related and hearing-related documents. The Contractor shall update each CMS case file with the listed documents prior to mailing the approved Warning Letters, Reply Letters, CMP Complaints, NTSO Complaints, and settlement-related and hearing- related documents.

The Contractor shall mail all documents using a CTP designated shipper. Shipment will be prepaid by CTP. The Contractor shall notify CTP what documents have been mailed on the same day the documents were mailed via a spreadsheet organized by document type and information as specified by CTP via email.

Within (1) business day of receiving confirmation that delivery has occurred or failed to occur, the Contractor shall notify CTP of confirmations and failed deliveries/return of documents; and shall scan and upload to CMS notices of confirmation, notices of failed deliveries, and return receipts of mailed documents. If any delivery confirmation or return receipt cannot be obtained for any documents, the Contractor shall notify CTP and follow-up and investigate the status of the mailing each business day until resolved. The Contractor shall confirm that all scanned images are clear, and all shipping information provided is to a deliverable address. The Contractor shall ensure that all documents have been properly scanned and mailed and that all general elements are displayed in the proper orientation, including but not limited to: placement of letterhead, date stamp, and signature.

The same day a CMP or NTSO complaint is mailed, the Contractor shall update the case in TIMS and CMS, including ensuring that all necessary electronic documents are uploaded, and updating and entering correct information.

Task 6: Quality Control

The Contractor shall incorporate quality control measures to ensure that draft Warning Letters, Reply Letters, Summary Reports, CMP Complaints, NTSO Complaints, and settlement-related and hearing-related documents meet all requirements provided by CTP prior to submission for processing or mailing within the timeframes identified in the tasks.

Within four (4) business days of mailing a CMP or NTSO complaint, the Contractor shall ensure that every relevant CMS case file is accurate and complete in accordance with the list of associated documents provided by CTP. For each CMS case file this will include, but is not limited to, verifying that the required documents are labeled per CTP provided guidance and uploaded to the appropriate area in CMS. On average, the Contractor can expect to quality control check 160 cases per week (fluctuating 100 to 185) in CMS.

Within five (5) business days of the Warning Letter delivery confirmation being received, the Contractor shall ensure that every relevant CMS case file is accurate and complete in accordance with the list of associated documents provided by CTP. For each CMS case file this will include, but is not limited to, verifying that the required documents are labeled per CTP provided guidance and uploaded to the appropriate area in CMS. On average, the Contractor can expect to quality control check 500 cases per week (fluctuating 400 to 600) in CMS.

Task 7: Project Management

The Contractor shall provide project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and milestones and performance measures are met.

a. Kickoff Meeting

The Contractor shall participate in a kickoff meeting with FDA. The kickoff meeting shall be conducted to introduce the Contractor team, discuss roles and responsibilities, task order objectives, and other relevant issues.

b. Monthly Status Reports

The Contractor shall electronically submit a monthly status report (MSR) to the COR on the 10th business day of each month following beginning of the period of performance of the task order. The MSR shall document progress identifying challenges and propose solutions to problems encountered or anticipated. At a minimum, the MSR shall contain the following information:

· Management Plan

· Provide the approach, organization resources, deliverables, documentation, and management controls to be employed to meet the cost, performance, and schedule requirements throughout execution. At a minimum, the Management Plan shall address the following areas: Cost Management, Quality Management, Communications, Staffing (including staffing plans and staff retention), Project Organization, and Performance Metrics.

· Cost overview for the entire period of performance, i.e., contract amount, cost expended and remaining amounts

· Status and progress of the task order for the reporting month

· Production statistics including the number of Warning Letters, Reply Letters, CMP Complaints, NTSO Complaints, Compliance Check Inspection Notices, settlement-related and hearing-related documents, and any other documents generated during the reporting month

· Cost variances against the task order ceiling

· Risks, Issues, and Mitigation Plans

· Including quality control concerns

· Action Items – which include personnel to whom the action items are assigned, date assigned, due date, and status (i.e., open, closed)

· Description of any problems encountered or anticipated that will affect the completion of any work within the agreed upon time and fiscal constraints, together with recommended solution(s) to such problem(s); or a statement that no problems were encountered.

Task 8: 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. The transition in period may be up to 60-90 days. 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

4. DELIVERABLES

of a potentially violative inspection

weekly Within 3 business days of receipt/assignment

Processing

Warning Letter Close- Out Procedures

weekly Within 5 business days after receiving list of Warning Letter No Response cases

Generation and Processing

Processing

Generation and Processing

weekly For WLs, within 2 business days of mailing the documents Or For CMP and NTSO Complaints, within 2 business days of preparing a summary report

Document Generation and Processing

Tracking

weekly Within 4 business days of mailing a CMP or NTSO Complaint

Within 5 business days of receiving the Warning

Letter delivery confirmation.

Within 10 business days of award

of performance of the task order.

5. GOVERNMENT FURNISHED EQUIPMENT/PROPERTY

The Government shall furnish computer hardware for each direct support contractor employee of this task order effort. Each direct support contractor employee shall receive:

· One (1) laptop computer

· One (1) docking station

All equipment provided by the Government (inclusive of equipment/property not named above) for this effort shall be treated IAW FAR clause 52.245-1 and an accounting of GFE/GFP shall be provided to the COR and attached to this order as an addendum.

6. Control of Property

The program office may issue Government Furnished Equipment (GFE) under this call order. GFE includes a networked PC installed with the FDA standard software for all Contractor Personnel performing work on the FDA network or hosted environment in support of this contract.

This equipment is authorized for transaction of official government business only and shall not be used for personal business. Personal long-distance calls are not authorized. Telephones, facsimile machines and computer equipment are subject to communications security monitoring at all times. Contractor may be issued keys (physical and/or electronic). The contractor shall safeguard the keys from loss, theft or destruction, and must display all keys signed for at scheduled or unscheduled key control inspections.

PCs will be shipped to the FDA office closest to the Contractor’s location. Contractor personnel will need an FDA badge to pick up and gain access to the FDA PC. All initial logins must transpire at FDA location where the PC is picked up. At the end of the period of performance, all PCs and badges must be returned to FDA.

The Contractor shall inventory all accountable Government property and submit a list of that property to the Contracting Officer on commencement of the Contract, usually concurrent with transfer of the property, annually on the anniversary of contract award, and within 90 days after completion or termination of the Contract.

The inventory list, reflecting each item of accountable property as a separate line item, should contain the following data elements:

1. Barcode/tag number

2. Item name/description

3. Manufacturer's name

4. Manufacturer's model number

5. Manufacturer's serial number

6. Unit cost

7. Date received/inventoried

8. Contract number

8. PLACE OF PERFORMANCE

Work is to be performed at a location designated by the contractor.

9. TASK ORDER CONTRACT TYPE

This is a Time & Materials Task Order.

10. TASK ORDER PERIOD OF PERFORMANCE

The period of performance of the order shall be 12 months.

11. TRAVEL

There is no additional travel outside of the Washington, DC Metropolitan area anticipated for this effort. Local travel for meeting attendance will not be reimbursed.

12. PERSONNEL REQUIREMENTS

The key personnel for this task order are the Project/Task Manager, and all designated alternates. The Contractor shall provide a Project Manager who shall serve as the single point of contact for the Contracting Officer (CO) and the Contracting Officer’s Representative (COR). The name of the Project Manager, and the name(s) of any alternate(s) who shall act for the Contractor in the absence of the Project Manager, shall be provided to the Government as part of the Contractor’s proposal. During any absence of the Project Manager, only one alternate shall have full authority to act for the Contractor on all matters relating to work performed under this task order.

Project/Task Manager: Responsible for individual projects day-to-day and achieves operational objectives by contributing information and recommendations to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; resolving problems; completing audits; identifying trends; determining system improvements; implementing change. Organizes, supervises and trains project staff. Maintains continuous surveillance of project milestones and ensures budget compliance and compliance with the terms of the task order.

13. PERSONNEL SECURITY REQUIREMENTS

The Security risk level for this task order is 5. The Contractor must comply with the requirements of FDA’s Personnel Security Requirements.

14. ACCESS NON-PUBLIC INFORMATION

All persons authorized by FDA to work under this Contract are required to sign Form FDA 3398

– Contractor’s Commitment to Protect Non-Public Information Agreement. If a person who has signed this Agreement resigns, is dismissed, or is otherwise no longer working on this Contract, the Contractor shall notify the COR and Contracting Officer within ten (10) calendar days. Any new person assigned to this Contract shall sign the Agreement and shall submit it to the Contracting Officer and COR prior to commencement of any work under this Contract. No person working under this Contract shall be provided or possess non-public information in any form unless written approval and a facility clearance have been granted by the Contracting Officer. The disclosure of any confidential information in violation of the Agreement may be subject to civil or criminal sanctions.

Briefings

An FDA representative (typically, the COR) shall conduct an orientation briefing for the Contractor/Contractor employees. The briefing shall stress: (1) the importance of protecting non-public information; (2) specified computer/Automated Data Processing requirements as outlined in the DHHS Automated Information Systems Security Program Handbook (copy of handbook available upon request); and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates shall be conducted annually.

The Contractor shall brief all employees, subcontractors, and consultants regarding the sensitivity of the information to be handled under the Contract and of the responsibility to protect it. The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized source. The Contractor shall conduct an updated briefing annually and shall submit a report to the COR within ten (10) business days after the briefing. This report shall include: an outline of the briefing, a copy of any briefing materials, date briefing was conducted and the names of the attendees.

15. CONTRACT ADMINISTRATION DATA

The following Contracting Specialist/Officer will represent the Government for this task order: TBD

The following Contracting Officer’s Representative will represent the Government for this task order: TBD