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Evaluation, Development and Utilization of Statistical and Mathematical Methods Federal contract opportunity
Solicitation number
FDA-RFP-1142919
Issued by
Department of Health and Human Services Food and Drug Administration

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FDA-RFP-1142919

PART I-THE SCHEDULE

SECTION 1: DESCRIPTION

Solicitation number FDA-RFP-1142919 is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 15 and included in this notice. This announcement constitutes the only full and open competition solicitation. The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-78. The North American Industrial Classification System (NAICS) code for this procurement is 541990- All Other Professional, Scientific, and Technical Services or 541690-Other Scientific and Technical Consulting Services.

SECTION 2: SUPPLIES OR SERVICES AND PRICES/COSTS

2.1 CONTRACT TYPE

The government anticipates an Indefinite Delivery/ Indefinite Quantity Contract with Firm-Fixed Price and Labor Hour task orders for the Evaluation, Development, and Utilization of Statistical and Mathematical Methods.

2.2 PRICING

Labor Category
Estimated Hours-Base Year
Base

Year Hourly Rates

Estimated Hours Per Year for Option Years 1-4
Option

Year 1 Option

Year 2 Option

Year 3 Option

Year 4

Statistician
2000
$
4000
$
$
$
$
Mathematician
2000
$
4000
$
$
$
$
Computer Scientist
1500
$
4000
$
$
$
$
Informatic Scientist
1500
$
1500
$
$
$
$
Project Manager
500
$
600
$
$
$
$

Travel-Base Year

Total
$
$
$
$
$

SECTION 3: DESCRIPTION/SPECIFICATIONS

3.1 BACKGROUND

Tobacco use is a leading cause of preventable illness in the United States and is responsible for approximately 443,000 deaths annually. The mission of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is to protect the public health by issuing and enforcing tobacco product regulations and educating the public about the dangers of tobacco use. On June 22, 2009 the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was signed into law.

The Tobacco Control Act authorizes FDA to require disclosure of any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives. (2) Any or all documents related to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer. (3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors. Additionally, the Tobacco Control Act provides FDA with the authority to regulate tobacco products, retailers, distributors, and manufacturers and requires FDA to contract, where possible, with states and territories to conduct inspections of tobacco retailers.

Understanding the harms and risks of the usage of tobacco products at both the individual and population level is an integral part of CTP’s mission. CTP oversees the implementation of the Tobacco Control Act. More specifically, CTP Office of Science (OS) is responsible for establishing the scientific basis for enabling regulations under the Tobacco Control Act while the CTP Office of Compliance and Enforcement (OCE) is responsible for enforcing the regulations under the Tobacco Control Act.

This project has two main objectives. The first objective is to enable CTP to develop a thorough understanding of the mathematical and statistical properties and behavior of several computer-based, mathematical, and statistical models—specifically, bioinformatics methods for text analytics and topic models, system dynamics models, and agent-based models—through an independent rigorous scientific review and evaluation of these models. Additionally, this IDIQ includes the development of text analytics and topic models, system dynamics models, and agent-based models to aid CTP in the implementation of the Tobacco Control Act. Secondly, this project requires timely and comprehensive validation of algorithms developed to monitor enforcement activities, expert assessment of the overlap of data collection procedures and statistical analysis requirements, analysis and graphical display of geocoded data, and data quality validation and statistical analyses of data resulting from CTP’s enforcement activities. The outcomes of this IDIQ will provide CTP the level of scientific rigor needed to inform regulatory science and to support the regulatory decision-making and enforcement processes.

3.2 PROJECT PURPOSE/ OBJECTIVES

The objective of this contract is to set up a flexible ordering instrument with possible multiple contractors under which FDA can place orders for the contractor to conduct a thorough scientific analysis of mathematical and statistical methods and algorithms (e.g. system dynamics models, agent-based models, and bioinformatics methods for text analytics and topic modeling), validate existing and develop new mathematical and statistical methods and algorithms, assess the overlap of data collection procedures and statistical analysis requirements, and data quality validation and statistical analyses of data resulting from CTP’s enforcement activities. The fulfillment of the objectives of this contract will aid CTP in the implementation of the Tobacco Control Act.

Contract Type-Indefinite Delivery Indefinite Quantities (IDIQ).

3.3 SCOPE OF WORK

The scope of this contract includes consulting in the following areas:

· Literature reviews of statistical and mathematical methods identified by CTP

· Mathematical and statistical experimental evaluations of methods and algorithms identified by CTP

· Recommendations regarding the applicability and efficacy of methods and algorithms identified by CTP under various constraints and scope conditions

· The extension or development of statistical or mathematical methods identified by CTP

· Data quality validation and statistical analysis of tobacco enforcement activity data.

· Reports that highlight findings from the statistical analysis of tobacco enforcement activity data

· Analysis and display of information using geocoded data

· Evaluation of approaches and techniques used to gather tobacco enforcement activity data

Specific task areas and activities are described in Section 3.4. These descriptions represent broad categories of services; however the intent of this contract is to obtain all types of services necessary to accomplish the stated objective. A separate statement of work will be issued for each task order with specific aims and objectives for the contractor by FDA.

3.4 TECHNICAL REQUIREMENTS

Task Areas

3.4.1 Literature reviews

The contractor shall provide thorough literature reviews of current and existing research that focus on the mathematical and statistical characterization of existing methods of system dynamics models, agent-based models, and bioinformatics methods for text analytics and topic modeling. As this project includes a number of distinct algorithms and models, the models or algorithms to be assessed in each literature review will be identified by CTP scientists. The literature review should include a thorough and in-depth discussion of the selection criteria for the documents included in the review, the theoretical development of the model or algorithm, extensions and modifications to the model or algorithm, and applications or conditions in which the model or algorithm performs optimally or sub-optimally.

3.4.2 Experimental evaluation

The contractor shall conduct a thorough experimental evaluation in which they compare a group of methods and algorithms identified by CTP. The experimental evaluation should include a discussion of the suitability, reliability, robustness, and computational efficiency of each method under various conditions. Additionally, it should evaluate the performance of the models or algorithms relative to the other included models or algorithms.

3.4.3 Recommendations

The contractor, based upon the literature reviews and experimental evaluations, shall provide written recommendations to CTP regarding which models or algorithms are more or less suitable in various conditions or under specific scope conditions and may be a required to implement the recommendations.

3.4.4 Extension of current or development of new models

The contractor—based upon the literature reviews, experimental evaluations, and recommendations—shall develop or extend current mathematical and statistical methods to aid CTP in the implementation of the Tobacco Control Act. Also, a thorough comparison of the developed methods to the available methods, using the framework noted above (4.2 Experimental Evaluation) should be conducted.

3.4.5 Statistical analysis of enforcement activity data and model and data validation

The contractor shall conduct a quality assurance review of collected tobacco enforcement data and conduct statistical analyses of the tobacco enforcement data. The findings from the quality assurance review and the statistical analyses shall be regularly conveyed to CTP in a report. Additionally, the contractor shall conduct statistical validations of the algorithms and statistical models developed to aid in the enforcement of the Tobacco Control Act.

3.4.6 Analysis and display of information using geocoded data

The contractor shall evaluate geocoded datasets provided by CTP to compare data collected during enforcement activities with standard datasets, such as school and census data. Contractor shall also display geocoded data to provide visual presentations of information, as well as, display inspection related data on regional and national maps.

3.4.7 Evaluation of, reporting on and future directions of data collection techniques and analyses

The contractor shall evaluate the data collection techniques and procedures utilized by CTP and assess the extent to which the data collection efforts are consistent with OCE’s ability to enforce the Tobacco Control Act. The contractor shall provide a report that highlights the finding from assessment, detailing how the data collection efforts can be adjusted to better aligned with OCE’s ability to enforce the Tobacco Control Act.

3.5 REPORTS AND DELIVERABLES

All reports required under this contract shall be submitted electronically to the COR in the following way:

Reports: Microsoft Word® or Portable Document Format (PDF)

Spreadsheets: Microsoft Excel® or Microsoft Access®

Presentations: Microsoft PowerPoint® or PDF

Computer Code: Plain text, software independent format If it is not possible to include graphics and images (for example, for figures and illustrations) in the same electronic file, FDA will accept text in one of the above formats and the graphics and images as separate files. Examples of acceptable graphics and image file formats are: JPEG, PNG, Postscript (PS/EPS) and VSD.

All deliverables shall be compliant with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR Part 1194).

All other reports and deliverables shall be specified on each task order.

Deliverable
Delivery Date
Content of the Deliverable
Project Plan
10 days after task order award
Details the Contractor’s performance plan for each task order, including a timeline with major and minor milestones, to actuate the specific task order.
Monthly Progress Reports
The Contractor shall electronically submit to the COR by the 10th of each month for each thirty day period of the task order
Describe the methods, scientific approaches, or enforcement data being evaluated, compared, and/or developed, and subsequent steps in the research.
Technical Report-Evaluation of current methods
As specified in each individual task order
Report shall provide a thorough description of the models, methods, or data to be review or analyzed, as specified in each task order. Technical reports shall also be provided for the evaluation and comparison of these models, methods, or data as specified in each task order. These reports shall include recommendations for appropriate methods, models, or data collection. The reports should also include the computer code used in the evaluation and comparison of methods, as specified in each task order. The computer code shall be in a plain text data format that is not software dependent.
Technical Report- Comparison of Existing Methods and Developed Methods
As specified in Each Task Order
The development of methods and procedures done in task orders shall be thoroughly described in a self-contained technical report. The technical report shall include the computer code used in the evaluation and comparison of the methods/models, as specified in each task order. The computer code shall be well-annotated and documented to facilitate the implementation of the developed methods. The computer code used in the evaluation and comparison of methods shall be in a plain text data format that is not software dependent.
Other task specific deliverables
As specified in the Individual Task Order
As specified in the Individual Task Order.

SECTION 4: PACKAGING and MARKING For electronic deliverables, the title of the document and contract number shall be identified in the subject line of the email.

SECTION 5: INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of deliverables to be provided.

For the purpose of this PART, (Determined at time of Award) is the authorized representative of the Contracting Officer.

Inspection and acceptance will be performed at:

FDA

Center for Tobacco Products

Food and Drug Administration

10903 New Hampshire Ave

Building 75

Silver Spring, MD 20993

Acceptance may be presumed unless otherwise indicated in writing by the COR.

SECTION 6: DELIVERY OR PERFORMANCE

6.1

PERIOD OF PERFORMANCE

Base Year:

March 23, 2015 through March 22, 2016 Option Year One:

March 23, 2016 through March 22, 2017 Option Year Two:

March 23, 2017 through March 22, 2018 Option Year Three:

March 23, 2018 through March 22, 2019 Option Year Four:

March 23, 2019 through March 22, 2020 6.2

PLACE OF PERFORMANCE

Contractor’s Facility or an offsite appropriate facility will be the place of performance. Any in person meetings will occur at White Oak Campus, 10903 New Hampshire Ave, Bldg. 75, Silver Spring, MD facilities.

SECTION 7: CONTRACT ADMINISTRATION

Contracting Officers Representative (COR)

7.1 The following COR will represent the Government for the purpose of this contract: (Determined at time of Award)

7.1.1The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

7.1.2 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFP; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

Contracting OFFICER (CO) and Contract Specialist (CS) 7.2 Contact information for the Contracting Officer:

James Chestnut James.Chestnut@fda.hhs.gov 240-402-7570

7.3 Contact information for the Contract Specialist:

Juana Quinteros

Juana.Quinteros@fda.hhs.gov

240-402-7624

7.5 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

7.6 ORDERING PROCESSES AND PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Section I entitled “Ordering.” The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

Task Order Procedures – When a need for services within scope of this contract arises, the FDA will issue a Request for Task Order Proposal (RTOP). The task order will be competed amongst awardees (if multiple award). The process for awarding tasks orders will be as follows:

1. FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RTOP via email. The RTOP will include at a minimum a SOW, the period of performance, reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

2. The Contractor(s) shall prepare and submit a task proposal addressing all areas of the requirement. The contractor shall adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

3. Within ten (10) business days (unless another time frame is specified in writing), the contractor(s) will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling.

4.

FDA will evaluate the task order proposal(s) for technical acceptability and price reasonableness. FDA will consider the following technical factors in order of importance: technical approach, whether the labor mix is appropriate; and whether the level of effort is sufficient. If all factors are found equal the determining factor will be price. If the FDA has questions or concerns the Contracting Officer will contact the contractor, and may ask for a revised proposal.

5.

Once the proposal is acceptable, the Contracting Office will issue the task order.

6.

Orders will include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. SOW

e. Price/Ceiling

f. Period of Performance

g. Any terms, conditions, or instructions unique to the order

h. A Conflict of Interest Statement signed by all employees

7. The offeror shall use their fully burdened labor rates to propose on all task orders.

8. A fair opportunity will be given to all awardees (if multiple awards are made).

9. The Contractor is encouraged to offer any and all discounts for goods and services provided under future task orders. The type or amount of discount may vary based on the circumstances of each particular task order and should be proposed in accordance with the Contractor’s pricing policies.

7.7 GOVERNMENT FURNISHED PROPERTY (GFP) AND GOVERNMENT FURNISHED INFORMATION (GFI)

The Contractor will be provided FDA laptops to store and perform secure analysis. All analysis shall be completed using FDA approved applications, which currently include SPSS, Stata, and ArcGIS software. All contractor personnel utilizing FDA equipment shall complete the equip85, eArrive, and HHS 745 forms in order to be badged and gain systems access. This process takes 10-14 business days, which the Contractor shall reflect in the project timeline in areas requiring FDA systems access by Contractor personnel who do not have systems access.

All models, algorithms, and data provided to the Contractor during the course of performance are strictly confidential and shall not be disclosed. The Contractor shall submit signed Contractor’s Commitment to Prevent the Disclosure of Non-Public Information forms within five business days after award and prior to commencing any work involving government data.

7.8 TRAVEL

Travel is anticipated as part of this IDIQ. Specifically, it is anticipate that the Contractor will travel once yearly to attend face to face meetings in the Washington D.C. metropolitan area at which the contractor and the FDA staff can discuss current and proposed scientific, methodological, technical issues and approaches, as well as project progress. All travel must comply with Federal Travel Regulations, as meetings are expected to take place at the Center for Tobacco Products offices in the Washington D.C. metropolitan area. Meetings will be held separately with each Contractor unless otherwise indicated.

SECTION 8: SPECIAL CONTRACT REQUIREMENTS

8.1 INVOICING INSTRUCTIONS

FDA TWO-WAY-Matching Invoice Clause

A.

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

(I) One original and one copy to the approving official:

U.S. Food And Drug Administration

Office Of Acquisitions And Grants Services

ATTN: Juana Quinteros/ CS

5630 Fishers Lane

Room 2122, HFA-500

Rockville, Maryland 20857

E-mail: Juana.Quinteros@FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery, and e-mail

(II) One copy to the contracting officer representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food And Drug Administration

Office Of Program Operations

ATTN: [INSERT NAME], COR

White Oak Campus

10903 New Hampshire Avenue

Room XXXX

Silver Spring, Maryland 20993

E-mail: xxxx.xxxx@FDA.HHS.GOV

*** Acceptable methods of delivery include: mail, hand delivery, or e-mail

B.

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 – www.SAM.gov) 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:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) 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;

(ix) taxpayer identification number (TIN);

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

(xi) name and telephone number of the FDA contracting officer technical representative (cotr) 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 ■ 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:

(a) List Of All Invoices Submitted To Date Under The Subject Award, Including The Following:

(1) Invoice Number, Amount, & Date Submitted

(2) Corresonding Payment Amount & Date Received

(B) Total Amount Of All Payments Received To Date Under The Subject Contract Or Order

(C) And, For Definitized Contracts Or Orders Only, Total Estimated Amounts Yet To Be Invoiced For The Current, Active Period Of Performance

C.

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.

D.

Questions regarding invoice payments should be directed to the FDA payment office at:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

8.2 ORGANIZATIONAL CONFLICT OF INTERESTS

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

The contractor must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions. Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found acceptable by the Government and enforced.

8.3 508 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 The contractor is expected to use the existing FDA environment and tools which are already in compliance with 508 standard requirements.

8.4 ACCESS TO NON PUBLIC INFORMATON

All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as an attachment (3) to this contract. 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 FDA Project Officer and the Contracting Officer. Any new contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand-deliver it to the Contracting Officer ten (10) days prior to said new employee's commencement of work on this contract.

The prime contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

This clause applies to the contractor, any subcontractors, and any consultants. Non-public information will be released to only those persons who will be using the contractor's approved facility unless the off-site facility has been reviewed by the FDA Physical Security Staff and approved in writing by the FDA Physical Security Office.

Non-public information will not be released to the contractor unless all required security precautions have been met [as demonstrated during an inspection by the Food and Drug Administration (FDA) Physical Security Staff], and written procedures for enforcing them have been provided by the contractor and approved in writing by the Physical Security Staff. The FDA Physical Security Office will notify the contractor of the approval.

8.5 SUBCONTRACTING PROVISIONS

a.

Small Business Subcontracting Plan

The Small Business Subcontracting Plan is attached hereto and made a part of this contract per FAR 19.708 (b).

b.

Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1.

Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th

October 30th

Expiration Date of Contract

2.

Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer and Contract Specialist shall be included as a contact for notification purposes at the following e-mail address:

Juana Quinteros

Contract Specialist

Juana.Quinteros@fda.hhs.gov

PART II-CONTRACT CLAUSES

SECTION 9: CLAUSES and PROVISIONS

9.1 FAR Clauses:

9.1.1 FAR Clause 52.252-2: Clauses Incorporated by Reference (FEB 1998):

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far/index.html.

· FAR 52.203-3: Gratuities (APR 1984)

· FAR 52.203-5: Covenant Against Contingent Fees (MAY 2014)

· FAR 52.203-7: Anti-Kickback Procedures (MAY 2014)

· FAR 52.212-4: Contract Terms and Conditions—Commercial Items (DEC 2014)

· FAR 52.212-4 Alt 1

· FAR 52.217-5: Evaluation of Options (JUL 1990)

· FAR 52.227-14: Rights in Data (MAY 2014)

· FAR 52.246-4: Inspection of Services-Fixed Price Clause (AUG 1996)

9.1.2 FULL TEXT:

FAR 52.212-5: Contract Terms and Conditions Required Implementing Statutes or Executive Orders—Commercial Items (DEC 2014):

(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 (Dec 2014)

(2) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

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

(4) 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:

_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 (Apr 2010) (41 U.S.C. 3509).

___ (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 (Jul 2013) (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).

___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

___ (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.

__x_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (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 2014) (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 2014) of 52.219-9.

_x__ (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).

___ (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).

___ (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 (Feb 1999).

_x__ (28) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

__x_ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (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 (Jul 2014) (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).

___ (33) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 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.)

___ (34) (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.)

___ (35) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Jun 2014) of 52.223-13.

___ (36) (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.

___ (37) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (38) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).

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

_x__ (39) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (40) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (41) (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.

___ (42) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__x_ (43) 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).

___ (44) 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).

___ (45) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (46) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (47) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (48) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_x__ (49) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (50) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (51) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (52) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (53) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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:

__x_ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

__x_ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__x_ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).

___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

___ (10) 52.222-55, Minimum Wages Under Executive Order 13658 Dec 2014)(Executive Order 13658).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

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

(vii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

(viii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(ix) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(x) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(xi) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xiii) 52.222-54, Employment Eligibility Verification (Aug 2013).

(xiv) 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).

(xv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xvi) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014)(Executive Order 13658).

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

· FAR 52.216-18: Ordering (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from March 23, 2015 through March 22, 2020.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

· 52.216-19: Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1000 the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor --

(1) Any order for a single item in excess of $2.4 million;

(2) Any order for a combination of items in excess of $___ million; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 30 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

· 52.216-22: Indefinite Quantity (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause.

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