FINAL_RFP_-_CTP_OCE_IDIQ.pdf

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FACILITYCODE

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OFFEROR

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ROOM 2129, HFA-500

5630 FISHERS LANE

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541611

SIZE STANDARD:

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RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

01/14/2015 1400 ET

12/17/2015

240-402-7600ELIZABETH KENNEDY

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INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

16-223-SOL-00002

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 69 1159335OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

ROCKVILLE MD 20857

TELEPHONE NO.

17a. CONTRACTOR/

Silver Spring MD 20993 Building 75 10903 New Hampshire Avenue The US Food and Drug Administration

WHITE OAK CAMPUS, BUILDING 75

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ROCKVILLE MD 20857

ROOM 2129, HFA-500

5630 FISHERS LANE

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VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DCSC

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

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ITEM NO.

This is a Request for Proposal for the Food and Drug Administration Center for Tobacco Products Office of Compliance and Enforcement for support services.

The period of performance shall be one year from date of award plus four one-year option periods to be exercised at the discretion of the Government.

Please see attached.

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HEREIN, IS ACCEPTED AS TO ITEMS:

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DATED

GARY KLAFF

. YOUR OFFER ON SOLICITATION (BLOCK 5),

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OFFER

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41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

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ITEM NO.

1 Per OAGS request a requisition is being submitted to provide base funding for OCE's IDIQ Contract

This requisition will replace unfunded requisition 1144645 which was submitted February

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

69 2 of

Food and Drug Administration (FDA)

Center for Tobacco Product

Office of Compliance and Enforcement

Request for Proposal #: FDA-SOL-16-1144645

Table of Contents

1. Background

2. Business and Technical Environment

3. Business Objectives

4. Scope of Work

5. Tasks

5.1. Transition-In

5.2. Program and Project Management

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

5.4. Analysis and Compilation of Data for Tobacco Product Review Program

5.5. Surveillance, Review, and Notification of Online and Print Sale and Promotional Activities of Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers

5.6. Analysis and Compilation of Data for Promotion, Advertising, and Labeling Review Program . 10

5.7. Surveillance of Sale to Minors by Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers

5.8. Transition-Out

6. Place of Performance

7. Period of Performance

8. Government Points of Contact

8.1. Contracting Officer’s Authority

8.2. Contracting Officer’s Representative

9. Government Furnished Property

10. Travel Administration

11. Key Personnel

12. Security

13. Organizational Conflict of Interest

14. Do Not Compete

15. Non-Personal Services

16. Personnel Security Clearance requirements

17. 508 Standard Requirements

18. Inspection and Acceptance

19. General Invoicing Instructions

20. Federal Acquisition Regulation (FAR) Clauses

21. Health and Human Services Acquisition Regulation (HHSAR) Clauses

22. Quotation Preparation Instructions:

23. Basis of Award and Evaluation Criteria

This Request for Proposal (RFP) announcement constitutes the only solicitation that will be issued;

proposals are being requested and a written solicitation will not be issued. This requirement is being solicited as a competetive 8(a) small business set aside, and the Government contemplates a single award, hybrid Labor Hour/Firm-Fixed Price, ID/IQ contract will result from this solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 541611. Its associated Small Business Size Standard is 500 employees

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 will 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 will 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

• Analysis and Compilation of Data for Tobacco Product Review Program

• Surveillance, Review, and Notification of Online and Print Sale and Promotional Activities of Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers

• Analysis and Compilation of Data for Promotion, Advertising, and Labeling Review

Program

• Surveillance of Sale to Minors by Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers

• 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 Tasks 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 Contractor-awarded tasks are executed.

Representative activities include but are not limited to:

• Prepare a Contract Management Plan across all task orders 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 30 days after contract award, the Contractor shall design and the COR will approve a standard reporting format that includes the following types of information at a minimum:

o Status and progress of tasks by task order o Cost and schedule variances against agreed-upon baselines;

o Significant risks to scheduled deliverables and plans to mitigate them;

o Issues, recommendations and escalation o Progress against task order service level metrics;

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

o 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:

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

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.

o 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.

o 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 1 page to 25 pages.

o 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, twice daily. Couriered documents must be delivered to the contractor’s physical location so that they are processed the same day.

5.4. ANALYSIS AND COMPILATION OF DATA FOR TOBACCO PRODUCT REVIEW PROGRAM

Tobacco manufacturers are required to submit marketing applications for approval in order to market or continue to market new, modified, or grandfathered tobacco products. As tasked, the Contractor shall provide services to analyze and compile marketing applications for the Tobacco Product Review Program. Representative activities include:

• Analyze, compile, upload, and track industry submissions and notifications. These submissions and notifications include but are not limited to electronic and paper documents.

• Process documents in compliance with CTP instructions and perform related administrative duties to support the tobacco product review program.

• Send electronic or paper files to FDA offices or uploading electronic files into databases, as directed by the Contracting Officer’s Representative (COR).

• Send, receive, tracking, perform, uploading, quality assurance, review and control, scanning of documents, and other aspects of data management associated with the review.

• Provide written reports on progress under the task order.

5.5. SURVEILLANCE, REVIEW, AND NOTIFICATION OF ONLINE AND PRINT SALE AND

PROMOTIONAL ACTIVITIES OF REGULATED TOBACCO PRODUCT MANUFACTURERS,

DISTRIBUTORS, IMPORTERS, AND RETAILERS

FDA conducts routine surveillance of online and print tobacco sale and promotional activities of regulated tobacco product manufacturers, distributors, importers, and retailers to ensure compliance with the FD&C Act and its implementing regulations. FDA reviews results from this routine surveillance to determine if administrative or enforcement action is necessary. As tasked, the Contractor shall provide services to assist the FDA in surveillance of online and print tobacco sale promotional activities of regulated tobacco product manufacturers, distributors, importers, and retailers. Representative activities include:

• Search for, compile, record, review, analyze, and track information as identified and/or requested by FDA for online, print and other promotional material.

• Provide data and reports containing the information obtained from this activity to the

COR.

• Draft notifications associated with this activity and provide associated data entry, review, compilation, and processing of notifications.

5.6. ANALYSIS AND COMPILATION OF DATA FOR PROMOTION, ADVERTISING, AND

LABELING REVIEW PROGRAM

FDA reviews tobacco industry submissions and notifications containing information that relates to the labeling, advertising, or promotion of regulated tobacco products to ensure compliance with the Tobacco Control Act. FDA also reviews labeling and advertising or other promotional activities that may be identified through various methods such as research and surveillance, inspections, investigations, or consumer complaints. As tasked, the Contractor shall provide services to perform analysis and compile data for the Promotion, Advertising, and Labeling Review Program for tobacco industry submissions and notifications.

• Compile, record, review, analyze, and track information contained in industry submissions and notifications.

• Conduct routine searches (as specified in 5.6) to identify possible promotional events or activities where free samples of tobacco products may be distributed.

• Send, receive, tracking, uploading, quality assurance review and control, scanning of documents, and other aspects of data management associated with the review program.

5.7. SURVEILLANCE OF SALE TO MINORS BY REGULATED TOBACCO PRODUCT

MANUFACTURERS, DISTRIBUTORS, IMPORTERS, AND RETAILERS

FDA conducts routine surveillance of internet tobacco retailers that sell regulated tobacco products to consumers in the United States. In particular, FDA conducts routine surveillance of sale of regulated tobacco products to minors by tobacco product manufacturers, distributors, importers, and online retailers to ensure compliance with the FD&C Act and its implementing regulations. FDA reviews results from this routine surveillance to determine if administrative or enforcement action is necessary. As tasked, the Contractor shall have a minor attempt to purchase regulated tobacco products from internet tobacco retailers provided to it by FDA. The Contractor shall also search for, compile, record, review, analyze, and track online and other information associated with routine surveillance of the sale of regulated tobacco products to minors.

• recruit minors (the contractor, rather than FDA, has the oversight responsibility for minors) to conduct online purchases of regulated tobacco products that are within the required age range (16 or 17 year olds)

• obtaining a copy of minors birth certificate and identification (if available) and an original parental/legal guardian consent form.

• Assume responsibility for protecting minors and their personal information and ensure that all Minors are insured against accidents or other injuries. Proof of insurance shall be maintained by the Contractor and available to FDA upon request.

• Facilitate, complete, and document purchases including payment and shipment.

• Secure a grant of immunity from the proper authorities prior to using Minors in any jurisdiction where it would be illegal to use Minors to conduct online undercover buy assignments or where a minor’s possession of tobacco products is illegal and provide proof of such immunity upon request from FDA.

• Sending, receipt, tracking, analysis, compilation, preparation, processing, and other aspects of management, of information, documents, and other materials associated with this activity.

• In compliance with federal and local laws, the Contractor shall be required to perform task 5.7 - Surveillance of Sale to Minors by Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers - within the Commonwealth of Virginia. Certain tasks will also require delivery of documents to FDA’s White Oak Campus is Silver Spring, Maryland on a daily basis. However, an Offeror need not be based or headquartered in the Commonwealth of Virginia.

5.8. 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

In compliance with federal and local laws, the Contractor shall be required to perform task 5.7 - Surveillance of Sale to Minors by Regulated Tobacco Product Manufacturers, Distributors, Importers, and Retailers - within the Commonwealth of Virginia.

The place of performance for all other work will be specified at the task order level.

7. PERIOD OF PERFORMANCE

The period of performance is a base period of one year plus four one-year option periods from the date of award.

Each Task Order will have its own individual period of performance.

8. GOVERNMENT POINTS OF CONTACT

Contract Specialist

Elyse Kennedy 5630 Fishers Lane Rockville, Maryland 20857 Voice: (240) 402-7600 Elizabeth.Kennedy@fda.hhs.gov

Contracting Officer Gary Klaff 5630 Fishers Lane Rockville, Maryland 20857 Voice: (240) 402-7555 Gary.Klaff@fda.hhs.gov

IDIQ Contracting Officer’s Representative (COR)

TBD

8.1. CONTRACTING OFFICER’S AUTHORITY

a. The Contracting Officer (CO) has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this IDIQ and is the only person authorized to approve changes to any of the requirements under this IDIQ and resulting orders, and notwithstanding any provision contained elsewhere in this IDIQ, this authority remains solely with the CO.

b. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this IDIQ. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the IDIQ. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the IDIQ.

8.2. CONTRACTING OFFICER’S REPRESENTATIVE

The Contracting Officer (CO) may designate other Government personnel (known as the Contracting Officer’s Representative) to act as their authorized technical representative for IDIQ administration functions which do not involve changes to the anything within the IDIQ SOW, scope, price, schedule, or terms and conditions of the IDIQ. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the contract.

mailto:Elizabeth.Kennedy@fda.hhs.gov mailto:Gary.Klaff@fda.hhs.gov

The responsibilities and limitations of the COR are as follows:

1. The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and other responsibilities, which may or may not be specified in the

IDIQ.

2. The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the IDIQ pricing, terms or conditions. Any Contractor request for changes shall be referred to the CO directly or through the COR. No such changes shall be made without the expressed prior authorization of the CO. The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.

The Contractor shall immediately contact the CO if there is any question regarding the authority of an individual to act on behalf of the CO under this IDIQ.

9. GOVERNMENT FURNISHED PROPERTY

All Government Furnished Property (GFP), to include information, material, and equipment, will be specified within the individual Task Orders. All GFP is the property of the Government and will not be transferred to any individual or agency, public or private, without the express written approval of the Contracting Officer, except as required for the specific performance of the Task Orders.

Each Task Order will identify Government Furnished Equipment and Government Furnished Information.

10. TRAVEL ADMINISTRATION

No travel is anticipated under this IDIQ. However, any travel costs incurred by the contractor within the Washington/Baltimore Metro area is considered local travel and will not be reimbursed. If travel is required, all requests for travel shall be submitted to the CTP COR and CO and must be approved in advance. All costs shall be in accordance with the Federal Travel Regulations and the Contractor will be reimbursed based on number of trips, number of persons traveling, lodging, per diem, air/rail, / car transportation. No Contractor travel expenses shall be reimbursed for ordinary, day-to-day performance under this contract.

Federal Travel Regulation: http://www.gsa.gov/portal/content/104790 http://www.gsa.gov/portal/content/104790

11. KEY PERSONNEL

The contract Program Manager is considered Key Personnel.

Additional requirements for Key Personnel will be specified in the individual Task Orders pursuant to Health and Human Services Acquisition Regulation (HHSAR) Clause 352.237-75, Key Personnel.

12. SECURITY

During the course of performance FDA will provide the contractor with data that is strictly confidential and shall not be disclosed to other than authorized individuals and organizations.

Contractor personnel shall sign the provided FDA Form 3398 - Commitment to Protect Non-Public Information within five days of receiving the form and prior to commencing any work involving information under issued tasks. The Form will specify all information designated as non-public.

Where task orders require Contractor access to FDA systems using FDA provided laptops or access to FDA Document Control Centers and Mailrooms, all contractor personnel utilizing those systems shall complete and sign the equip85, eArrive, and HHS 745 forms in order to be badged and gain systems access. The Contractor shall ensure the completion of these forms. Badging may take 21-31 business days and the Contractor shall reflect that in the timeline for a task order.

The contractor shall ensure compliance with IT security requirements, including the following:

DHHS Information Security and Privacy Program http://www.hhs.gov/ocio/securityprivacy/index.html

Federal Information Security Management Act (FISMA) http://www.whitehouse.gov/sites/default/files/omb/memoranda/m03-19.pdf

National Institute of Standards and Technology (NIST) SP800-53 http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05- 01-2010.pdf

FDA Security Authorization process, which closely resembles NIST SP800-37 http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf

Format and Media: The Contractor shall furnish deliverables in a manner consistent with the FISMA and NIST security requirements of the information provided. For example, the contractor shall not send Sensitive Personal Identifying Information via e-mail across the internet.

13. ORGANIZATIONAL CONFLICT OF INTEREST

http://www.hhs.gov/ocio/securityprivacy/index.html http://www.whitehouse.gov/sites/default/files/omb/memoranda/m03-19.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-01-2010.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-01-2010.pdf http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict.

The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities: The Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(End of clause)

14. DO NOT COMPETE

The contractor and all of its present and future affiliates and subsidiaries agree to:

1) Not compete nor assist anyone in competing for any competitive acquisition of the requirements or services described in the documents which the contractor has been provided access to or delivers under this contract and task orders thereof.

2) Not furnish either as a prime contractor or subcontractor the requirements or services described in paragraph a.1) above.

The above prohibitions shall also apply to the contractor's employees, subcontractors, consultants or any other person who participates in the performance of this contract. The contractor shall require such persons to sign the Organizational Conflict of Interest Statement agreeing to the above restrictions. An executed Organizational Conflict of Interest Statement shall be provided to the Contracting Officer, prior to a person beginning work under this contract/order.

Noncompliance with the above restrictions and conditions shall be a cause for: termination of this contract for default; and/or, disqualification of any proposal submitted for a competition.

15. NON-PERSONAL SERVICES

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor.

The Contractor and the Contractor’s employees are not employees of the federal Government and are not eligible for entitlement and benefits given federal employees.

Contractor personnel under this contract shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal

Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

• Be placed in a position of command, supervision, administration or control over personnel or personnel of other Government contractors, or become a part of the

Government organization.

• Be used in administration or supervision of procurement activities.

16. PERSONNEL SECURITY CLEARANCE REQUIREMENTS

Risk level will be determined at the task order level. The contractor shall comply with FDA Personnel Security Requirements provided in Attachment A.

17. 508 STANDARD REQUIREMENTS

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm. This requirement is shall comply with the following standards:

1194.22 – Web based intranet and internet information and applications

1194.31 – Functional performance criteria

1194.41 – Information, documentation, and support All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.accessboard.gov/sec508/508standards.htm - Part 1194.

18. INSPECTION AND ACCEPTANCE

In accordance with the inspection and acceptance clause, all work under this contract is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the government. The Government’s Contracting Officer’s Representative (COR) is a duly authorized representative of the government and is responsible for inspection and acceptance of all items to be delivered under this contract. Unless otherwise specified by the COR, the general quality measures, as set forth below, will be applied to each work product received from the contractor under this IDIQ.

• Accuracy: Work products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity: Work products shall be clear and concise. Diagrams shall be easy to understand and be relevant to the supporting narrative.

• Consistency to Requirements: All work products must satisfy the requirements of this statement of objective.

http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm

• Timeliness: Work products shall be submitted by the due date specified in this statement of work or submitted in accordance with a later scheduled date determined by the Government.

• File Editing: All text and diagrammatic files shall be editable by the Government.

• Format: Work products shall be submitted in hard copy (where applicable) and in media mutually agreed upon prior to submission.

19. GENERAL INVOICING INSTRUCTIONS

*Specific invoice instructions will be provided at the Task Order level.

The contractor shall submit all invoices to all addresses in the manner specified below:

1. One original and one copy to the approving official:

TBD

2. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked “Courtesy Copy Only”:

TBD

Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the Contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed, including:

• Period of performance for which costs are claimed;

• Itemized travel costs, including origin and destination;

• Any other supporting information necessary to clarify questionable expenditures

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(xi)Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order;

(xii) Any other information or documentation required by the purchase order/award.

(xiii) Contractor is not required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

• List of all invoices submitted to date under the subject award, including the following:

o Invoice number, amount, and date submitted o Corresponding payment amount and date received

• Total amount of all payments received to date under the subject contract or order

• And, for definitzed contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

Questions regarding invoice payments should be directed to the FDA Payment Office at:

Division of Payment Services Food and Drug Administration

8455 Colesville Road 8th Floor

MAIL HUB 2145

Silver Spring, MD 20903 Attn: Vendor Payments

20. FEDERAL ACQUISITION REGULATION (FAR) CLAUSES

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Dec 2015)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

_X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

_X__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

__X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (Pub.

L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved] __X_ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

_X__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

__X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved] __X_ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

__X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (Oct 2015) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__X_ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

__X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

__X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

__X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

__X_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

__X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

__X_ (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

__X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O.

13627).

___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

__X_ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Oct 2015) of 52.223-13.

__X_ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

__X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513).

___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C.

chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112- 43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

__X_ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__X_ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov…