NIH-16-012025_PDTFAB.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 17, 23, 24, & 30

1. REQUISITION NUMBER

Specified prior to award

PAGE 1 OF

2. CONTRACT NO. 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

PDTFAB

6. SOLICITATION ISSUE

DATE

07/07/2016

7. FOR SOLICITATION

INFORMATION CALL:

Lisa - lisa.schaupp@nih.gov

b. TELEPHONE NUMBER (No collect calls)

301-402-0735

8. OFFER DUE DATE/

LOCAL TIME

08/09/2016 10:00 a.m. ET

THIS ACQUISITION IS OR ASIDE:

SMALL BUSINESS WOMEN-OWNED SMALL BUSINESS

HUBZONE SMALL

9. ISSUED BY CODE

National Institutes of Health Clinical Center Two Democracy Plaza, Suite 6707 Democracy MSC 5480 Bethesda, MD 20892-5480 •

% FOR:

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

541512

SIZE STANDARD:

$27.5 million

EDWOSB

(A)

11. DELIVERY FOR FOB DESTINA

TION UNLESS BLOCK IS

MARKED

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

13b. RATING

METHOD OF SOLICITATION

15. DELIVER TO

National Institutes of Health Main Campus Bethesda, MD 20892

CODE 16. ADMINISTERED BY

See Block 9

CODE

17a. CONTRACTOR/

OFFEROR CODE

FACILITY

CODE

PAYMENT WILL B E MADE BY CODE

Office of Financial Management Commercial Accounts

East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

TELEPHONE NO. _

CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK UNLESS BLOCK

ITEM NO.

20.

SCHEDULE OF SUPPLIES /SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

See the following for price quotation.

Attachment 2 - Pricing Table Attachment 3 - Task Order One (1) Request for Quotation

(Use Reverse and/or Attach Additional Sheets as Necessary) AMOU (For Govt. Use Only)

[X] 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA [X]ARE | NOT ATTACHED

| | ARE ARE NOT ATTACHED

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 2

COPIES TO ISSUING OFFICE. CONTRACTOR A G R E E S TO FURNISH AND

DELIVER ALL ITEMS S E T FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

ADDITIONAL S H E E T S SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

29. AWARD OF CONTRACT: R E F . OFFER

. YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

S E T FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR UNITED STATES OF AMERICA (SIGNATURE OF CONTRACT OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED NAME OF CONTRACTING OFFICER (Type

Julius Y.

A fcin A

31c. DATE SIGNED

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

RFP

RFP TABLE OF CONTENTS

- THE SCHEDULE 3

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS " "

PART II - CONTRACT CLAUSES 23

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL

INFORMATIONAL ATTACHMENTS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

GENERAL INFORMATION 25

a. INSTRUCTIONS TO ACQUISITION b CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS e PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD 29

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST " " "

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record

4. Separation of Technical and Business Proposals 32

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

Selection of Offerors

Past Performance Information

12. Solicitation Provisions by Reference

RFP NIH-16-012025_PDTFAB

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical

c. BUSINESS PROPOSAL INSTRUCTIONS.

Basic Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Salary Rate

5. Small Business Subcontracting Plan

6 Mentor Protege Program, HHSAR 352.219-70

7 HUBZone Small Business Concerns

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

Proposer's Annual Financial Report

Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

GENERAL

. . . 46

2. COST/PRICE

3. MANDATORY QUALIFICATION

4. EVALUATION OF OPTIONS

5 TECHNICAL EVALUATION

6 EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

8 SUBCONTRACTING PROGRAM EVALUATION CRITERIA

- 2 -

PART - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The contractor shall proceed with further development of the disability assessment instrument prototype, premised upon Item Response Theory and Computer Adaptive Testing (CAT) technology, called the Work Disability Functional Assessment Battery (WD-FAB). The Contractor will examine and/or enhance the scientific rigor, refine and/or expand the scope of the instrument's item banks, translate the WD-FAB into other languages, while keeping the instrument's scientific integrity, develop and propose work necessary to aid in the development and design of instrument items and/or applications to assess work place functional demands.

ARTICLE B.2. PRICES/COSTS

a This solicitation contemplates the creation of a single award Indefinite Delivery/Indefinite Quantity contract as described in FAR 16.504 . The guaranteed minimum for the contract is $20,000. The awarded value ceiling for the contract shall be $6,250,000 (maximum).

b The offeror's proposed unit pricing will include a month base period and four (4) month option periods and which is anticipated to begin in September and end in August, All unit prices must be fully burdened (including indirect labor rates) to facilitate apples to apples comparison of proposals.

c The Government will issue Task Orders based on the work described in the Statement of Work, SECTION C of this contract, and which shall be quoted based upon the unit prices which the awardee proposes when it completes the pricing table at Attachment 2. See Section J - List of Attachments. To be clear, the unit prices which an offeror proposes shall be the unit prices which apply to orders awarded during contract performance. For example, the first Task Order Request for Quotation, Attachment 3, shall be based on the prices set forth in the offeror's proposal for the base period of the contract. It is the intent of the government to award the first Task Order upon award of the Contract. The exact quantity of tasks per Period of Performance of the contract is unknown.

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

See Attachment 2, Pricing Table, and Attachment 3, Task Order One (1) Request for Quotation.

ARTICLE B.3. OPTION PRICES

Unless the Government exercises its option pursuant to the option clause referenced in of Work as defined in SECTIONS C and F, for the price set forth ARTICLE B.2. of contract.

b Pursuant to FAR Clause 52.217-9 set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this Government may, by unilateral contract modification, require the Contractor to perform

Opt on the Statement of Work as defined in SECTIONS C and F Go this/these option(s), notice must be information regarding the time frame for this notice set forth the OPTION PROVISION The fixed price of contract will be increased as set forth ,n paragraph c , below.

c Upon the delivery and acceptance of the in SECTION C of the the schedule of charges below, the Government shall pay the Contractor the pr,ce(s) set forth below.

See Attachment 2, Pricing Table.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

All labor hourly rates should be included in the offeror's unit prices. G & A rates will be fixed at the rates proposed for each Performance. No upward adjustments will be contemplated as ,s a fixed price effort.

Travel to meetings and conferences is contemplated in the Statement of Work, Attachment Task Area 3:

Travel to ana approved and specified in an issued Task Order prior to the

FAR 31.205-46, relevant portions of the Federal Travel Regulation, applicable law, and the limitation of funds specified in the contract.

RFP Number :

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a Independently and not as an agent of the Government, the Contractor shall be required to all the ' necessary services, qualified personnel, material, equipment, and facilities, not otherwise by he

Government, as needed to perform the Statement of Work provided at Attachment See SECTION J - of attachments.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: under "Making Files Accessible.

a. Technical Progress Reports

1 In addition to the required reports set forth elsewhere in this Schedule, the preparation and ' submission of regularly recurring Technical Progress Reports will be required in contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken durinq the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

For proposal preparation purposes only, it is anticipated that Technical Progress Reports will be required as follows:

[X] (to include minutes from teleconferences)

[ Quarterly

Annually [ ] Annually (with a requirement for a Draft Annual Report) [ 1 Final - Upon final completion of the contract [X] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. report be required on or before the expiration of each Task Order.

b. Other Reports/Deliverables

1. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

- 5 -

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: under "Vendor Information and Documents."

SECTION D - PACKAGING, SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, To be announced at Contract Award is the authorized representative of the

Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health

Bethesda, MD 20892

The Government reserves the right to an Inspection period of days, unless a different period stated when (the Record of Call/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-1, Contractor Inspection Requirements (April

FAR Clause 52.246-2, Inspection of Supplies - Fixed Price (August

FAR Clause Responsibility for Supplies (April

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be for one base year and four option years. The base year likely start in September 2016 and end in August 2017.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Period Estimated Period of Performance

Option Period One (1) September 1, 2017 through August 31, Option Period Two (2) September through August

Option Period Three (3) September 1, 2019 through August 31, 2020

Option Period Four (4) September 1, 2020 through August 31, 2021

ARTICLE F.2. DELIVERIES

a Satisfactory performance of this contract shall be deemed to occur upon performance of the work described ' in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the

Officer, or the duly authorized representative, of the Items specified in the Delivery Schedule wh,ch are described in SECTION C of this contract.

b Deliveries will most likely be entirely electronic reports. In the rare event physical delivery required, deliveries required by the Contractor shall be made F.o.b. destination as set forth FAR Clause 52.247-35, F o b Destination, Within consignees Premises (April [and any specifications stated SECTION D, PACKAGING AND MARKING AND SHIPPING, of this contract] to the address/addressee listed c.

Delivery Address

National Institutes of Health campus

Bethesda, MD

A precise delivery address shall be provide to the awardee.

d Unless otherwise specified, deliveries shall be made to the Delivery Point specified above Mondays through

' Fridays (excluding Federal Holidays) between the hours of 5:30 a.m. and 5:30 p.m. EST only.

ARTICLE F.3. TIME OF DELIVERY

Time of delivery will be determined by issued Task Order. Resulting reports shall be delivered prior to acceptance of final invoice.

ARTICLE F A CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force effect as if it were given Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

Stop Work Order (August

Alternate (April is not applicable to this contract.

52.242-17, Government Delay of Work (April

52.247-35, F.o.b. Destination Within Consignees Premises (April

- 1 0 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

To be announced at time of award National Institutes of Health Bethesda, MD 20892

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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

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 statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. METHOD OF ORDERING

a. Orders issued under this contract may be placed as follows:

[X] in writing

[ ] via telephone

[ ] via facsimile (fax)

[X] via electronic mail (e-mail)

[ ] Oral [Oral Orders will be confirmed in writing within _ days of issuance.

[ ] Other Specify: —

b. The Contracting Officer is authorized to issue orders and provide written confirmation of oral orders, if applicable, under the contract.

ARTICLE G.3. INVOICE SUBMISSION

a Invoice Instructions for Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts

East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

E-mail: schauppll@cc.nih.gov and COR(tbd)

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

ARTICLE G.4. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at:

hhs contracting guide.pdf.

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually within 30 days after to the expiration date of each Period of Performance.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December a The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible The parties hereto agree that the retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered this contract and will discharge its obligations duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c Contractors involving other agencies or institutions in activities considered to be engaged in research involving ' human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP at: http://www.hhs.aov/ohrp/policv/auidanceonalternativetofwa.pdf).

If at any time during the performance of this contract the Contractor is not in compliance with any of the ' requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone confirmation in writing. If the Contractor fails to complete corrective action within the period of designated the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation OHRP, terminate this contract in whole or in part.

e. (End of clause)

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH

PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide ft Grants and Contracts Announcement dated June 5, 2000 at the following website:

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research' (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed (2) above.

requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.3. NEEDLE EXCHANGE, HHSAR (December

The Contractor shall not use any funds obligated under this contract to carry out program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

(End of clause)

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.5. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF

CONTROLLED SUBSTANCES

The Contractor shall not use contract funds to support activities that promote the legalization of any drug or other substance included in schedule of the schedules of controlled substances established under section 202 of the Controlled Substances Act, except for normal and recognized executive-congressional communications. This limitation shall not apply when the Government determines that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.7. OMB CLEARANCE

In accordance with HHSAR Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer's Representative (COR) and the Contracting Officer has issued written approval to proceed.

ARTICLE H.8. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause Option to Extend the Term of the Contract set forth in SECTION of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the price of the contract will be pre-negotiated as set forth in the OPTION PRICES Article in SECTION B of this contract.

RFP PDTFAB

ARTICLE H.9. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause entitled, "Liquidated Damages-Subcontracting Plan."

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

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 Contract Specialist shall be included as a contact for notification purposes at the following e-mail address:

Lisa.Schaupp@nih.gov Contract Specialist

ARTICLE TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR the following individual has been designated as the NIH Ombudsman for task order and delivery order contracts.

[The appropriate individual will be included in the resultant contract as follows:]

For R&D Contracts: For Non R&D Contracts:

Dr. Sherry Mills Dr. Richard G. Wyatt

NIH Competition Advocate Competition Advocate

6705 Rockledge Drive, Suite 305 1 Center Drive, Room 160, MSC

Bethesda, 20892 Bethesda, Phone: (301)435-2687 Phone: (301)496-4920

E-mail: sherry.mills@nih.gov E-mail: WyattRG@mail.nih.qov

ARTICLE REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:

US Department of Health and Human Services Office of Inspector General

ATTN: HOTLINE OPERATIONS

P.O. Box 23489 Washington, 20026

- 1 6 -

RFP Number: NIH-16-012025_PDTFAB

PART II - CONTRACT CLAUSES

SECTION - CONTRACT CLAUSES

THE FOLLOWING ARTICLE GENERAL CLAUSE LISTING(S) WILL BE APPLICABLE TO MOST CONTRACTS

RESULTING FROM THIS RFP. HOWEVER, THE ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL

OFFEROR(S) WILL DETERMINE THE SPECIFIC GENERAL CLAUSE LISTING TO BE CONTAINED IN THE

AWARDED FROM THIS RFP:

The complete listing of these clauses may be accessed at:

ARTICLE GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE SUPPLY CONTRACT

- 1 7 -

ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

Any authorized substitutions and/or modifications other than the General Clauses which will be based on the type of contract/Contractor will be determined during negotiations.

It is expected that the following substitution(s) will be made part of the resultant contract:

a. FAR Clauses Pension Adjustments and Asset Reversions (October Reversion or Adjustment of Plans for Post Retirement Benefits (PRB) Other Than Pensions (July 2005); and, Notification of Ownership Changes (October are deleted in their entirety.

b. Alternate IV (October FAR Clause 52.215-21, Requirements Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data-Modifications (October is added.

c. FAR Clause 52.227-14, Rights in Data-General (May 2014) is deleted in its entirety.

d. FAR Clause 52.229-3, Federal, State and Local Taxes (February is deleted in its entirety, and FAR Clause 52.229-4, Federal, State and Local Taxes (State and Local Adjustments) (February is substituted therefor.

e. FAR Clause Interest (May is applicable to this contract.

f. Alternate. (February 2002), of FAR Clause 52.232-25, Prompt Payment (July is deleted.

g. FAR Clause 52.249-8, Default (Fixed-Price Supply And Service) (April is applicable to this contract.

ARTICLE ADDITIONAL CONTRACT CLAUSES

Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses by reference, (unless otherwise noted), 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.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

1. FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October

2. FAR CLAUSE 52.204-18 Commercial and Government Entity Code Maintenance (July

3. FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations

(November 2015).

4. FAR Clause Option to Extend Services (November

Contracting Officer may exercise the option by written notice to the Contractor within days of the expiration date of the

5. FAR Clause 52.223-3, Hazardous Material Identification and Material Safety Data (January 1997), with Alternate (July 1995).

6. FAR Clause 52.242-3, Penalties for Unallowable Costs (May

7. FAR Clause Limitation of Liability (February

1. HHSAR Clause 352.223-70, Safety and Health (December

RFP PDTFAB

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses in full

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

1. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (July 2013)

As prescribed in insert the following clause:

a. The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management (SAM) database at http://www. gov.

b. As required by section of the Supplemental Appropriations Act, 2010 (Pub. L. all information posted in FAPIIS on or after April except past performance reviews, will be publicly available. FAPIIS consists of two segments-

1. The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by-

i. Government personnel and authorized users performing business on behalf of the Government; or

ii. The Contractor, when viewing data on itself; and

2. The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for-

i. Past performance reviews required by subpart

ii. Information that was entered prior to April or

Hi. Information that is withdrawn during the waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

c. The Contractor will receive notification when the Government posts new information to the Contractor's record.

1. If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite and request removal within 7 calendar days of the posting to FAPIIS.

2. The Contractor will also an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i. e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

- 2 0 -

3. As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April except past performance reviews, will be publicly available.

d. Public requests for system information posted prior to April will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated

E.O.

(End of clause)

Clause 52.216-18, Ordering (October

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 09/01/2016 through 08/31/2017 .

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.

(End of clause)

3. FAR Clause Order Limitations (October

a. Minimum Order. When the Government requires supplies or services covered by this contract in an amount of less than $20,000 [insert dollar figure or quantity], 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-

Any order for a single item in excess of $5,000,000 .

2. Any order for a combination of items in excess of $6,000,000 ; or series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in subparagraph (1 ) or (2) above.

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) above.

d. Notwithstanding paragraphs (b) and (c) above, 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 7 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.

4. FAR Clause 52.216-22, Indefinite Quantity (October

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.

- 2 1 -

RFP Number: PDTFAB

b. Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

c. Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

d. Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same as if the order were completed during the contract's effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after 03/01/2023 .

(End of clause)

FAR Clause Option to Extend the Term of the Contract (March 2000).

a. The Government may extend the term of this contract by written notice to the Contractor within 1 day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended contract shall be considered to include this option clause.

c. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

- 2 2 -

RFP NIH-16-012025 PDTFAB

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are incorporated into this RFP:

SOLICITATION ATTACHMENTS

Attachment No.

Attachment

Attachment 2:

Attachment 3:

Title

Statement of Work

Pricing Table

Task Order One (1) Request for Quotation

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title

Attachment 4: Summary of Related Activities

Attachment 5: HHS Section 508 Product Assessment Template

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title

Attachment 6: Proposal Summary and Data Record, Attachment 7: Small Business Subcontracting Plan

Attachment 8: Disclosure of Lobbying Activities, Form SF-LLL

Location

Location http://oamp.od.nih.gov/sites/default/files/ http://www.hhs.gov/web/508/contracting/ html

Location http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/NIH2043.pdf http://www.hhs.gov/asfr/ogapa/osbdu/ http://www.gsa.gov/portal/forms/

INFORMATIONAL ATTACHMENTS

Attachment No. Title

Attachment 9: Invoice Instructions for NIH Fixed Price Contracts

Attachment 10: NIH Past Performance Questionnaire

Location http://oamp.od.nih.gov/sites/default/files/

- 2 3 -

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST :

Go to the System for Award Management (SAM) and complete the Representations and Certifications. The SAM website may be accessed at: ; and

2 Complete, and INCLUDE as part of your BUSINESS PROPOSAL:

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

which is included as an Attachment in Section J-LIST OF ATTACHMENTS, SOLICITATION ATTACHMENTS of this solicitation.

If you are unable to access this SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.

3. FAR Clause Incorporation by Reference of Representations and Certifications (December

2014).

The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

- 2 4 -

RFP Number: NIH-16-012025 PDTFAB

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS-COMPETITIVE ACQUISITION [FAR Provision 52.215-1 (January 2006)]

a. Definitions. As used in this provision¬ are negotiations that occur after establishment the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal.

"In writing", "writing", or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information.

"Proposal modification" is a change made to a proposal before the solicitation's closing date and time, made in response to an amendment, made to correct a mistake at any time before award.

"Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations.

"Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day.

b. Amendments to solicitations. this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the

c. Submission, modification, revision, and withdrawal of proposals.

a. Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)( 1)(ii) of this provision.

b. The first page of the proposal must show-

i. The solicitation number;

ii. The name, address, and telephone and facsimile of the offeror (and electronic address if available);

Hi. A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item;

iv. Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and

v. Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office.

3. Submission, modification, revision, and withdrawal of proposals.

- 2 5 -

(i) Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due.

(ii) (A) Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and-

(1) it was transmitted through an electronic commerce method authorized by the solicitation, it was received the initial point of entry to the Government infrastructure not later than 5:00 p.

one working day prior to the date specified for receipt of proposals; or

(2) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(3) It is the only proposal received.

(B) However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government, will be considered at any time it is and may be accepted.

(Hi) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(iv) If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(v) Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn in person by an offeror an authorized representative, the identity the person requesting withdrawal is established and the person signs a receipt for the proposal before award.

(4) Unless…