13-223-SOL-00047.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DCGM

ROOM 2130, HFA-500

5630 FISHERS LANE

ATTN: Sean Wybenga

DHHS/FDA/OAGS/DCGM

CODE 16. ADMINISTERED BYCODE

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDCGM

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

07/23/13 4:30 EST301-827-6761SEAN WYBENGA

(No collect calls)

INFORMATION CALL:

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

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

13-223-SOL-00047

5. SOLICITATION NUMBER

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

1 34 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

ROCKVILLE MD 20857

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

ROCKVILLE MD 20857

ROOM 2130, HFA-500

5630 FISHERS LANE

ATTN: Sean Wybenga

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DCGM

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDEND

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

13-223-SOL-00047

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PART I

SECTION 1 - SUPPLIES OR SERVICES AND PRICES/COSTS

1.1 SOLICITATION DESCRIPTION

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “Economic Studies of FDA Regulations.”

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-

STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR

COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL

INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT

CONSTITUTES THE ONLY SOLICITATION; PROPOSALS ARE BEING

REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE

ISSUED.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-66. The associated North American Industrial Classification System (NAICS) code for this procurement is 541690. This requirement is for full and open competition as a result of this combined synopsis/solicitation.

1.2 CONTRACT TYPE

The government intends make award to no more than two (2) awardees as a multiple award, Indefinite Delivery/Indefinite Quantity (IDIQ) type contract with the issuance of firm-fixed price, labor-hour and time and materials task orders. The structure of the contract shall be a base period of one (1) year followed by four (4) separate option periods. The total potential period of performance should all four (4) options be awarded is five (5) years.

1.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount will be $1,000.00 over five (5) years inclusive of options. The contract maximum ceiling amount will be $9,000,000.00 over five (5) years inclusive of options.

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1.4 PRICING

The pricing chart below outlines all of the labor categories that shall be required throughout the life of the contract.

The Contractor shall provide services in accordance with the Statement of Work at fixed hourly rates.

Labor Rate Pricing Chart:

Labor Category* Estimated Annual Hours

Year 1 Hourly Rates (Base)

Year 2 Hourly Rates (Option #1)

Year 3 Hourly Rates (Option #2)

Year 4 Hourly Rates (Option #3)

Year 5 Hourly Rates (Option #4)

Total

Project Director 1,350

Program Manager 1,950

Senior Statistician 1,125

Senior Economist 1,350

Junior Economist 4,950

Senior Programmer

Junior Programmer

Senior Analyst 2,100

Junior Analyst 5,100

Senior Editor 1,350

Junior Editor 2,100 $ $ $ $ $ $

Total (for evaluation purposes only)

The material handling fee applicable to other direct costs is: ________

Note: Reference Section C for a full description of each labor category.

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SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

2.1 BACKGROUND

The Economics Staff of the Food and Drug Administration’s (FDA) Office of Planning (OPl) has a requirement to provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget, the U.S.

Congress, professional economists, and the scientific and medical community. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.

2.2 OBJECTIVE

The objective of this contract is to provide FDA with accurate information, data, and analytical models for use in assessments of the economic impacts of FDA actions or contemplated actions.

2.3 SCOPE OF WORK

Activities under the proposed contract shall include, but are not limited to, the following:

A. Methods - While the economic impact of certain FDA regulatory actions can be analyzed via established methods, other FDA initiatives will require novel analytical approaches to evaluate potential effects. For example, estimating the societal effects of initiatives to modernize FDA’s regulatory oversight of product safety and efficacy may require innovative approaches to collect or generate data, such as Internet panels, laboratory or field experiments, expert elicitations, contingent valuation, and data-based simulations.

B. Baseline Measurement - The FDA needs data on the economic characteristics of regulated industries, so that changes in regulatory policies can be empirically examined. This data will include, for example, the number, size, and location (domestic or foreign) of firms and their employment, sales, and number of stock keeping units (labels). In some instances, industry profile studies require supporting documentation for OMB survey clearance procedures.

C. Estimating Effects of Potential Regulatory Actions. The agency’s planned regulatory agenda includes numerous potential regulations that would have economic consequences. The FDA requires data and models that can be used to estimate the effects likely to be associated with many different policies and provisions that could

Page - 5 - of 35 become regulations. These effects include the distribution of behavioral changes of consumers and producers in response to potential agency actions and the changes in risk that would result.

2.4 STATEMENT OF WORK

A. Analyses and Evaluations to be performed by Contractor:

1. Conduct baseline assessment of industry characteristics, including, but not limited to, estimating employment levels, profits, prices, competitive structure, domestic and foreign location, and industry practices (or performance), including all international effects. The baseline should include projected changes over time.

2. Develop methods and collect data to estimate the economic costs of existing or potential regulatory actions. FDA regulations may alter the expected use of a product, as well as result in higher costs of manufacture or distribution. Each component of these costs shall be identified, defined, and quantified, with all data compiled and sorted to facilitate statistical analyses.

3. Develop methods and collect data to estimate the reduction in risk attributable to existing or potential regulatory actions and assess any potentially offsetting increases in risk.

4. Develop methods and measures of the effects of regulations and other exogenous factors on innovation and productivity. R&D and future innovation may be either encouraged or hindered by regulatory requirements.

5. Develop methods and measures of the effects on the competitive vitality of small business in accordance with requirements of the Regulatory Flexibility Act. Many of the firms FDA regulates are small. Record keeping and reporting requirements, for example, may impose disproportionate effects on smaller businesses, because fixed costs are spread over a smaller sales base. FDA is required by law to take these effects into account and to grant regulatory relief, where possible, to small firms.

6. Develop adaptable methods and databases that can cover various regulatory alternatives. Many new options to meet stated objectives arise during regulation development. A critical task is to develop general methods and databases that can be applied to assess the effects of these options as they are proposed or considered.

B. Anticipated Areas of Analyses for which Task Orders May be Issued to the

Contractor:

The following list illustrates the kind of economic research that will be requested.

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Actual task orders will reflect agency priorities at the time of initiation. The contractor shall demonstrate the ability to conduct analyses for both quick response and long range studies.

1. FDA may implement new initiatives to strengthen the review of medical products throughout their life-cycle, to reduce medical product errors and to further protect the safety or integrity of food, human and veterinary drug products, biological products and medical and radiation emitting devices. Evaluating these actions may require surveying the industry (including domestic and foreign producers) to describe baseline conditions, collecting baseline risk information, assessing the potential of various interventions to reduce risk, and assessing the potential of various interventions to have unintended consequences that increase risks.

2. FDA regulates many retail products. To better assess baseline conditions in the markets for these products, FDA may need data on the number of products in one or more of these categories, including OTC drugs, retail medical devices, and traditional and non-traditional tobacco products.

3. FDA is interested in assessing the validity of the growing number of cost effectiveness analyses prepared by pharmaceutical companies. The contractor would assist in the development of appropriate methodologies.

4. FDA is interested in assessing the effects of requiring informational or warning labels on consumer labeling. The contractor would assess the behavioral responses of consumers and domestic and foreign industry to different proposed labels for the different product categories regulated by FDA.

5. The products and components of many products regulated by FDA are imported.

FDA regulations apply equally to imported and domestically manufactured or processed goods. The behavioral responses of foreign firms to FDA regulations, however, may differ greatly from the responses of domestic firms. The contractor would design a model that would incorporate FDA data on foreign firms while predicting the response of foreign firms and imports to regulations that increase costs of production. The contractor would illustrate and validate the model for an existing FDA-regulated product or products.

6. Medical scientists are developing more sophisticated tools and novel technologies that might be used to produce or evaluate FDA regulated products. Such technologies include using pharmacogenomics in drug discovery and development or using advances in biotechnology to develop medical products.

The contractor would assist in evaluating the costs and risks associated with regulating novel technologies.

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2.5 LABOR CATEGORY DESCRIPTIONS

Project Director

Manages and is responsible for all aspects of a single project, including overseeing quality control. Communicates clearly and articulately in written and oral form.

Assesses complex research questions, applies appropriate economic, statistical and analytic methods, interprets data and presents study results.

The Government has a preference for a Ph.D. in economics or related field, at least ten

(10) years of experience in economic analyses and five (5) years of experience managing research projects involving economic analysis, and quantitative methods for this position.

Program Manager

Leads the analysis team, applies appropriate economic, statistical and analytic methods, interprets data and presents study results.

The Government has a preference for an advanced degree in economics or related field, at least ten (10) years of experience in economic analyses and two (2) years of experience managing research projects involving economic analysis and quantitative methods for this position.

Senior Statistician

Plans data collection and sampling plans; analyzes numerical data from experiments, studies, surveys, and other sources; and applies statistical methodology to provide information for scientific research and statistical analysis. Shall assist in the preparation and presentation of results of statistical analyses in written reports.

The Government has a preference for an advanced degree in statistics or equivalent and extensive professional experience providing statistical analysis support for projects similar to the statement of work with at least seven (7) years of experience in statistics and statistical and analytical methods for this position.

Senior Economist

Plans data collection and work requirements with project director; collects and analyzes qualitative and quantitative economic data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for an advanced degree in economics, statistics or equivalent fields and extensive professional experience providing economic analysis support for projects similar to the statement of work with at least seven (7) years of experience in statistics and statistical and analytical methods for this position.

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Junior Economist

Collects and analyzes qualitative and quantitative economic data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a Bachelor’s degree in economics or related field with some experience in assisting with economic analysis support for projects similar to the statement of work for this position.

Senior Programmer

Plan and organize the computer modeling needs required to complete projects in the statement of work with the Project Director. Write, update and maintain computer programs developed for the economic or other quantitative models required by projects in the statement of work.

The Government has a preference for a Bachelor’s degree in computer science or information technology and professional experience providing IT support for projects similar to the statement of work with at least seven (7) years of experience in IT support.

Junior Programmer

Write, update and maintain computer programs developed for the economic or other quantitative models required by projects in the statement of work.

The Government has a preference for a Bachelor’s degree in computer science or information technology and must have experience with IT support for projects similar to the statement of work for this position.

Senior Analyst

Plans data collection and work requirements with project director; collects and analyzes qualitative and quantitative data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a Bachelor’s degree and extensive professional experience providing analytical support for projects similar to the statement of work with at least seven (7) years of experience in providing analytic support for projects similar to the statement of work for this position.

Junior Analyst

Collects and analyzes qualitative and quantitative data for studies; applies appropriate mathematical and statistical methodology and assists in the preparation and presentation

Page - 9 - of 35 of results and written reports.

The Government has a preference for a Bachelor’s degree in a field related to the statement of work with experience in assisting with economic analysis support for projects similar to the statement of work for this position.

Senior Editor

Prepares reports, presentations, and written deliverables for publication by assuring reports are written clearly, adequately documented, well organized, and logically and grammatically correct.

The Government has a preference for a Bachelor’s degree or equivalent experience in technical report writing and editing with at least five (5) years of experience in editing technical documents that are similar to the requirements of the statement of work for this position.

Junior Editor

Assists with preparing reports, presentations, and written deliverables for publication by assuring reports are written clearly, well organized, and logically and grammatically correct.

The Government has a preference for a Bachelor’s degree or equivalent experience in technical report writing and editing with experience in assisting with reviewing and editing of technical documents for this position.

SECTION 3 - PACKAGING AND MARKING

All deliverables under this contract shall be packed and marked in accordance with best commercial practices to ensure safe and timely delivery.

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to: Food and Drug Administration

10903 New Hampshire

WO32 RM3230 HFP-60

Silver Spring, MD 20993

Mark for: TBD

The Contractor shall mark each shipment with the company name, the contract number, the item identification, quantity of items, and notice of partial or final delivery.

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SECTION 4 - INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials, documents and services to be provided.

For the purpose of this PART, (COR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

SECTION 5 - DELIVERIES OR PERFORMANCE

Deliverables shall be established with the issuance of each task order. All deliverables shall be delivered F.O.B Destination to the COR for acceptance.

52.247-34 F.O.B. DESTINATION (NOV 1991)

5.1 ANTICIPATED DELIVERABLES

Note: Actual deliverables and deliverable schedules shall be established in the issuance of each individual task order.

Periodic Progress Reports - The Contractor shall submit one (1) electronic copy of the Progress Report that includes a status update on deliverables, any problems encountered, and suggestions for addressing problems each period.

Interim Draft Work Product - The Contractor shall submit to the COR an Interim Draft Work Product. Comments on this report will be provided by FDA within fifteen (15) calendar days after receipt. The interim draft work product shall also include:

• A prototype, example, or draft of the work product specified in the task order. The prototype should include preliminary data validation.

• An indication of any current problems which may impede performance and proposed corrective action.

• A description of personnel who have actually worked on this portion of the task and the number of hours worked. Include any current or proposed deviations from the original task proposal and a brief explanation as to why this change is in the best interest of the government.

Draft Final Work Product - The Contractor shall submit to the COR a draft final work product, which will be after the completion and approval of FDA’s review of the interim

Page - 11 - of 35 draft work product. The contractor shall also submit, where applicable, PC-compatible raw data collected, software and computer programs for implementation of models, guidance to data and models, and in some instances a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, complete list of variables, and full details of coding and classifications used. The Contractor shall be prepared to present results to FDA at this point. This draft final work product is subject to the review and approval of FDA. Such approval or disapproval, with any comments, will be provided by FDA within fifteen (15) calendar days after receipt. The draft final work product shall also include:

• An indication of any current problems which may impede performance and proposed corrective action.

• An outline of the work to be accomplished during the reporting period.

• A quantitative description of overall progress and how it relates to earlier work.

• A description of personnel who have actually worked on this portion of the task and the number of hours worked. Include any current or proposed deviations from the original task proposal and a brief explanation as to why this is in the best interest of the government.

Final Work Product - The Contractor shall submit to the COR the final work product which incorporates any recommended revisions and other changes. The Contractor shall also submit, where applicable, PC-compatible raw data, software and computer programs for implementation of economic models, a written guide to data and models, and in some instances a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, complete list of variables, full details of coding and classifications used, and data validation. The final guide shall include tables, graphs, diagrams, curves, sketches, photographs and drawings as necessary and in sufficient detail to comprehensively explain the creation and use of the work product , which can be a database, model, survey, or a written report.

5.2 ORDERING PERIOD

Task Orders may be issued up to the final day of this contract, and the contract shall remain in force to allow for the completion of all task orders issued. However, the Government shall not issue, and the Contractor shall not accept any new task orders issued subsequent to the performance period of this contract.

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5.3 PERIOD OF PERFORMANCE

The period of performance for the base period of the contract shall be one (1) year from the effective date of the contract.

5.4 OPTION PERIODS

The Government may elect to include four option periods as described below (exact dates will be adjusted at award):

Option PERIOD Option Period One (1) 06/26/2014 to 06/25/2015

Option Period Two (2) 06/26/2015 to 06/25/2016

Option Period Three (3) 06/26/2016 to 06/25/2017

Option Period Four (4) 06/26/2017 to 06/25/2018

SECTION 6 - CONTRACT ADMINISTRATION DATA

6.1 ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the 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 PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order.

A task orders shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work. The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

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3. Period and place of performance

4. Reporting requirements and Deliverables

5. Whether the order will be fixed price, labor hour, time and material or a hybrid type task order

b) Requests for Task Order Proposals (RTOPs) shall only be issued by the

Contracting Officer.

c) The Contractor shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor shall submit the task proposal within the time period specified in the RTOP and 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.

The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

6.2 CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

The 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.

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 a task order; (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.

The contact information for the Contracting Officer is:

James Chestnut James.Chestnut@fda.hhs.gov

Tel: (301)827-3366; Fax: (301) 827-7106 mailto:Doreen.Williams@fda.hhs.gov

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The contact information for the Contract Specialist is:

Sean Wybenga

5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov;

Tel: (301) 827-6761; Fax: (301) 827-7106

The contact information for the Ombudsman is:

Glenda Barfell Glenda.Barfell@fda.hhs.gov Tel: (301) 827-7042; Fax: (301) 827-7106

6.3 INVOICE SUBMISSION

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

(I) One original to the Contracting Specialist:

U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: Sean Wybenga, Contracting Specialist 5630 Fishers Lane Room 2130, HFA-500 Rockville, MD 20852

Email: Sean.Wybenga@fda.hhs.gov

****Acceptable methods of delivery include: mail, hand delivery and email*****

(II) One copy to the contracting officer ‘s representative (COR), clearly marked “Courtesy Copy Only”:

U.S. Food and Drug Administration ATTN: (To be determined upon contract award); COR Address:

Email: XXXXX@fda.hhs.gov

*****Acceptable methods of delivery include: mail, hand delivery and email*****

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 – Central Contractor Registration) and/or 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;

mailto:Sean.Wybenga@fda.hhs.gov mailto:Glenda.Barfell@fda.hhs.gov mailto:Sean.Wybenga@fda.hhs.gov mailto:XXXXX@fda.hhs.gov

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(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; and (c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipping, 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 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; and, (XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is 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 and Date Submitted; 2) Corresponding payment amount and 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 W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov mailto:fdavendorpaymentsteam@fda.gov

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Final payments will occur upon verification by FDA COR and the FDA Technical Advisor, noting successful completion of each task.

Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in the Pricing Terms. Payment will be made on a task order basis.

6.4 KEY PERSONNEL

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The Key Personnel under this Contract are:

Name

SECTION 7 - SPECIAL CONTRACT REQUIREMENTS

7.1 CONTRACTOR PERFORMANCE EVALUATION(S)

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

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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.

7.2 ACOUNTABILITY AND SECURITY

All Contractor and subcontractor employees who will have access to Government information and/or sensitive materials must sign a Confidentiality Agreement. It is the responsibility of the Contractor to assure that such Agreements have been signed before access is permitted. Copies of signed agreements should be provided to the Task Order

COR.

7.3 508 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.

http://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm http://www.access-board.gov/sec508/provisions.htm

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7.4 SECURITY AND PRIVACY

Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. Personnel assigned to this contract shall be required to complete and undergo a National Agency Check Inquiry (NACI) before the contractor employee may be issued an identification badge as well as bill to the contract (not prior to assignment). Unfavorable information security check results will be reported to GSA and appropriate action taken.

Because of the sensitivity of much of the FDA data, contractor staff shall also be required to undergo a Level 5 Public Trust security clearance, including finger printing, performed under the auspices of the FDA.

The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval of the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure (e.g. Privacy Act or Data Collected Under an assurance of Confidentiality) may be disclosed to them.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the task order that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the task order. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

HHS policy requires contractors/subcontractors receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The contractor shall ensure that each contractor/subcontractor employee has completed the FDA Computer Security Awareness Training course prior to performing any contract work and thereafter annually during the period of performance of the contract. HHS may change, add or modify Computer Security Awareness training requirements to enhance the HHS computer security program.

Each contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete and submit the FDA Form 3398:

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non- Disclosure agreement shall be submitted to the Project Officer or designee prior to performing any work under the contract. The Project officer or designee will inform the contractor of any additional forms and training that are required.

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7.5 TRAVEL AND PER DIEM

Travel and Per Diem authorized under this contract shall be reimbursed in accordance with the Federal Travel Regulations currently in effect. Per Diem rates shall not exceed the Government approved rates in effect (http://www.gsa.gov/portal/category/21287).

Travel requirements under this contract shall be met using the most economical form of transportation available. If economy class transportation is not available, the request for payment voucher must be submitted with justification for use of higher class travel indicating dates, times, and flight numbers. All travel shall be scheduled sufficiently in advance to take advantage of offered discount rates, unless otherwise directed by the Contracting Officer.

http://www.gsa.gov/portal/category/21287

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SECTION 8 - CONTRACT CLAUSES

8.1 HHSAR CLAUSES INCORPORTATED BY REFERENCE

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:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.201-70, PAPERWORK REDUCTION ACT (JAN 2006)

352.202-1, DEFINITIONS (JAN 2006)

352.203-70, ANTI-LOBBYING (JAN 2006)

352.215-70, LATE PROPOSALS AND REVISIONS (JAN 2006)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (JAN 2010)

352.223-70, SAFETY AND HEALTH (JAN 2006)

352.224-70, PRIVACY ACT (JAN 2006)

352.227-70, PUBLICATIONS AND PUBLICITY (JAN 2006)

352.239-70, ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY

(JAN 2010)

352.242-70 KEY PERSONNEL (JAN 2006)

352.242-71, TOBACCO-FREE FACILITIES (JAN 2006)

352.242-73, WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

352.270-10 ANTI-LOBBYING (JAN 2006)

http://www.hhs.gov/policies/hhsar/subpart301-1.html

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8.2 52.252-2 FAR 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.

52.212-4, CONTRACT TERMS AND CONDITIONS—COMERCIAL ITEMS (FEB

2012) ALTERNATE I (AUG 2012)

52.216-7, ALLOWABLE COST AND PAYMENT (JUN 2011)

52.232-99, PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS (DEVIATION) (AUG 2012)

8.3 FAR CLAUSES BY FULL TEXT

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS.

OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (DEC 2012)

An offeror shall only complete paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLETMENT STATUTES OF EXECUTIVE ORDERS—COMMERCIAL

ITEMS.

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL ITEMS (JAN 2013)

(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) 52.222-50, 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)).

(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) (Pub. L. 108-77, 108-78).

http://www.acquisition.gov/far/index.html http://orca.bpn.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_233_240.html#wp1113344

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(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. 253g and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

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

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Aug 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

__ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

__ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313).

__ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 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).

__ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns

(JAN 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (11) [Reserved] __ (12)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (13)(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.

__ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

_X_ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (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 (Jul 2010) of 52.219-9.

__ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

__ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

_X_ (18) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (19)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business

Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and

Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

https://acquisition.gov/far/current/html/52_200_206.html#wp1137622 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+2+13++%2841%29%20%20AND%20%28%2841%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://acquisition.gov/far/current/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1144881 https://acquisition.gov/far/current/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1144992 https://acquisition.gov/far/current/html/52_207_211.html#wp1140926 https://acquisition.gov/far/current/html/52_207_211.html#wp1145644 https://acquisition.gov/far/current/html/52_207_211.html#wp1146366 https://acquisition.gov/far/current/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 https://acquisition.gov/far/current/html/52_217_221.html#wp1136017 https://acquisition.gov/far/current/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058 https://acquisition.gov/far/current/html/52_217_221.html#wp1136058…