RFP-NIH-NINDS-17-03_including_all_Attachments.pdf

REQUEST FOR PROPOSALS (RFP) No. NIH-NINDS-17-03

Project Title: “NINDS Center for Clinical Research Resources”

ISSUE DATE: March 1, 2017

DATE DUE: May 3, 2017

Ladies and Gentlemen:

The National Institute of Neurological Disorders and Stroke (NINDS), NIH, invites you to submit a proposal in response to the requirements of the enclosed RFP No. NIH-

NINDS-17-03.

The NINDS seeks to award a contract to an organization with the requisite qualifications and capabilities to provide scientific and technical clinical research support services in the area of Quality Control/Quality Assurance clinical trial monitoring, statistical and methodological support, clinical data acquisition and archiving support and common data element (CDE) development support.

The envisioned contract award is a follow-on requirement to the current National Institute of Neurological Disorders and Stroke (NINDS) Center for Clinical Trial Resources requirement currently being performed under NINDS contract HHSN271201200034C by the EMMES Corporation.

THIS ACQUISITION IS ISSUED ON A WOMAN-OWNED SMALL BUSINESS SET-ASIDE

BASIS whereby only woman-owned small businesses will be eligible for contract award.

Please reference Article I.3., FAR Clause 52.219-30, “Notice of Set-Aside for, or Sole Source Award to, Woman-Owned Small Business Concerns Eligible Under the Woman- Owned Small Business Program (December 2015)” for further details.

The North American Industry Classification System (NAICS) code for this this requirement is 541712. The small business size standard is 1,000 employees.

If your organization is a Woman-Owned Small Business, please complete Attachment 4, listed in Section J, entitled “SBA Form 2413 – Woman Owned Small Business (WOSB) Program Certification – WOSBs” and upload to the WOSB Program Repository along with all other required documents as outlined in the Compliance Guide for WOSB Program (www.sba.gov/wosb) prior to submitting an offer.

Offerors are advised to pay particular attention to Section L entitled “Instructions, Conditions, and Notices to Offerors” and Section C entitled “Description/Specification/Work Statement.” Proposals will be evaluated pursuant to Section M entitled “Evaluation Factors for Award.”

http://www.sba.gov/wosb

Additionally, offerors are advised to review the list of attachments in Section J entitled “List of Attachments.” This list provides information as to which attachments need to be completed and submitted with your proposal (and which attachments are included for informational purposes only). Some of the attachments listed in Section J supplement the Instructions in Section L of the main RFP document, so it is important to refer to both Section L and the applicable attachments in Section J when preparing your proposal. The list of attachments in Section J also provides links to fillable forms for many of the attachments that need to be completed and submitted with your proposal.

Your attention is further directed to Attachment 2, "Proposal Intent Response Sheet.” If you intend to submit a proposal in response to this solicitation, we ask that you send a copy of the Proposal Intent Response Sheet via e-mail it to Jason Williams at willjas@nida.nih.gov.

It is your responsibility to monitor the web page at http://www.FedBizOpps.gov/ for any amendments that might be issued under this RFP. A separate notice of RFP amendments, if any, to individual sources, will not be made.

Proposals are to be delivered electronically via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Please reference Attachment 1, listed in Section J, entitled “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website” for instructions and further details. Please note that you must create an account in the NIH electronic Contract Proposal Submission (eCPS) system/website in order to submit a proposal and it may take up to there (3) business days to establish a new account. Please apply for a new account early to allow enough time for the registration process.

Your attention is directed to the RFP provision entitled “LATE PROPOSALS AND REVISIONS” set forth in Section L, paragraph 1, (j) of this RFP, implemented by HHSAR 352.215-70. Please review these provisions so that you will be fully aware of the time requirements for submitting your proposal. It is your responsibility to ensure that your proposal is delivered by the due date and time to the NIH electronic Contract Proposal Submission (eCPS) website as required in the RFP.

Your proposal must be prepared in the format prescribed in the RFP. Please be sure that all documents which you are required to complete and sign (e.g., Representations and Certifications, NIH Form 2043 “Proposal Summary and Data Record”, NIH Section 508 Product Assessment Template etc.) are submitted with your proposal (again, please review the list of attachments included in Section J which will indicate which attachments need to be completed and submitted with your proposal [and whether to include with your Technical Proposal or Business Proposal]).

Your proposal must provide a contact name and telephone number, your company name and complete mailing address. Furthermore, FAR Provision 52.204-7, System for Award Management (SAM), which is applicable to this solicitation, requires that a prospective mailto:willjas@nida.nih.gov http://www.fedbizopps.gov/ https://ecps.nih.gov/ awardee be registered in the SAM database prior to award, during performance, and through final payment of any contract resulting from this solicitation. In addition, your organization’s Tax Identification Number (TIN) and Dun & Bradstreet Number must be provided. Additionally, please note that FAR Provision 52.204-6, Data Universal Numbering System (DUNS) Number, requires you to submit a DUNS number for your company along with your offer. Contact information for Dun and Bradstreet is provided in the FAR provision at 52.204-6. Please include this information on the first page of your business proposal.

The RFP does not commit the Government to pay the costs for the preparation and submission of a proposal.

It also is brought to your attention that the Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

Any and all questions concerning this RFP should be directed to Jason Williams, Contracting Officer, NINDS R&D CMB, NIDA, in writing to willjas@nida.nih.gov. In my absence inquires or questions can be directed to Mr. Kirkland L. Davis, Chief, NINDS R&D Contracts Management Branch, NIDA, NIH at kd17c@nih.gov or at (301) 496-1813.

Sincerely yours, Jason S. Williams Contracting Officer NINDS R&D Contracts Management

Branch, NIDA, NIH mailto:willjas@nida.nih.gov mailto:kd17c@nih.gov

RFP-NIH-NINDS-17-03

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: 42 U.S.C. 285(j)

2. Request for Proposal (RFP) Number:

RFP-NIH-NINDS-17-03

3. Issue Date:

March 1, 2017

4. Set Aside: Woman-Owned Small Business Set- Aside NAICS 541712 [ ] No Size Standard 1,000 employees [X] Yes See Article I.3., FAR Clause 52.219-30

5. Title : NINDS Center for Clinical Research Resources

6. ISSUED BY:

National Institutes of Health, DHHS Office of Acquisitions, Neurosciences

NINDS R&D CMB, NIDA

6001 Executive Blvd, Suite 3287 Bethesda, MD 20892-9531

7. SUBMIT OFFERS TO:

See Part III, Section J, ATTACHMENT 1 of this Solicitation.

Offers are to be submitted electronically via the NIH electronic Contract Proposal Submission (eCPS) website.

https://ecps.nih.gov

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal (eCPS) Website," until 4:30 PM Eastern Standard Time on May 3, 2017. Offers will be valid for 150 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal (eCPS) Website.” Proposals must be submitted electronically via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

IF YOUR PROPOSAL IS NOT RECEIVED AT THE PLACE [eCPS website] AND TIME SPECIFIED IN

BLOCK 8. ABOVE, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH

HHSAR Clause 352.215-70, "Late Proposals and Revisions" LOCATED IN SECTION L.1. OF THIS

SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract at https://www.sam.gov

11. FOR INFORMATION CONTACT: Jason Williams, Contracting Officer

PHONE: 301-496-5985

e-MAIL: willjas@nida.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Jason Williams Contracting Officer Office of Acquisitions NINDS R&D Contracts Management Branch, NIDA https://ecps.nih.gov/ https://ecps.nih.gov/ https://www.sam.gov/

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES (Articles I.1. through I.3.)…………………………………………………………..42

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Institutional Responsibility Regarding Investigator Conflicts of Interest

11. Certification of Filing and Payment of Taxes

12. Past Performance Information

13. Information and Physical Access Security

14. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Sharing Research Data

5. Section 508 accessibility standards for HHS Web Site Content and Communications Materials

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Data Other than Certified Cost or Pricing Data

4. Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (October 2010)

5. Salary Rate Limitation

6. Total Compensation Plan

7. Other Administrative Data

8. Qualifications of the Offeror

9. Subcontractors

10 Proposer's Annual Financial Report

11. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

PART I - 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 NINDS Division of Clinical Research (DCR) is charged with ensuring the highest quality of each NINDS-funded clinical research project in terms of both conduct and the integrity of resultant data and ensuring compliance with DHHS/NIH/NINDS regulations regarding human subject protection and safety monitoring. To ensure the highest quality product and most efficient use of resources, DCR has established a programmatic requirement for clinical research-related scientific and technical support for NINDS-sponsored clinical research in the form of an NINDS Center for Clinical Research Resources.

The Contractor shall provide scientific and technical support toward the conduct of NINDS-sponsored clinical research in the areas of Quality Control/Quality Assurance clinical trial monitoring, statistical and methodological support, clinical data acquisition and archiving support and common data element development support.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

Basic Requirement

The basic requirement, which consists of the four performance areas contained in the Statement of Work (Quality Assurance/Quality Control clinical trial monitoring, statistical and methodological support, clinical data acquisition and archiving and common data element development support) will be funded on cost reimbursement, term, level-of-effort basis and will consist of a base 12-month (1 year) period of performance with four successive 12-month Term Options for a total potential performance period of 5 years.

Quantity Options

The Common Data Element performance area under this contract will contain up to 10 separately-priced Quantity Options for: 1) the development of new disease-specific Common Data Elements, if and when identified, such that they may be added to the NINDS Common Data Element website disease-specific-library; and 2) development and implementation of web-based training modules, if and when the need is identified, to assist website users in navigating and utilizing the NINDS Common Data Elements website from both a general framework standpoint and more specific training modules related to particular disease-specific Common Data Elements contained on the website.

Quantity Options, if exercised, will be funded on a cost reimbursement, completion basis (completion for the New Disease-Specific CDE Development Options being final acceptance and upload of the new disease data to the NINDS Common Data Elements website; completion of the Web-Based CDE

Training Module Options being the final acceptance and upload of the training module to the NINDS Common Data Elements website).

Though these Quantity Options may be exercised at any time during the performance period of the contract, It is estimated that one (1) New Disease-Specific CDE Development Option and one (1) Web- Based CDE Training Module Option will be exercised each year.

NOTE: Exercise of any Term Option (Basic Requirement) or Quantity Option (New Disease-Specific CDE Development Option and/or Web-Based CDE Training Module Option) is subject to continued Institute need for such services and availability of funds in the Fiscal Year in which said options would be exercised.

ARTICLE B.3. ESTIMATED COST AND FIXED FEE – BASIC REQUIREMENT PLUS BASIC REQUIREMENT

TERM OPTIONS

The basic contract requirement represents a cost plus fixed fee level of effort contract (i.e., severable services) with a one-year base period and four successive one-year Option periods of performance.

The level of effort requirements of the base contract represent severable services that are continuing and recurring in nature. Despite the extensive performance history of this contract, the NINDS still have no way of knowing, even within a reasonable range of estimation, the exact course of action that will need to be taken in order to perform the four Performance Area support functions contained in the Statement of Work (Monitor Quality Assurance/Quality Control in Clinical Research; Statistical and Methodological Support; Clinical Data Acquisition and Archiving; and Common Data Element support) in any given year. Therefore, the most that the NINDS can fairly bargain for is that the Contractor have available and provide a cadre of personnel to be able to devote to the specific performance requirements as they are identified. Thereby, the Contractor’s performance obligation and the Government’s need can only be defined in terms of the expected level of effort that can be provided on an annual basis, for each 12 month period, as a means of defining the Contractors performance obligation and the Government’s need for the basic requirement. The clause at FAR 52.232-20, Limitation of Cost, is included and is made a part of this contract and applies to the base contract and each successive option period so exercised.

a. The estimated cost of the Base contract is $TBD (estimated 12,500 hours/ level-of-effort).

b. The fixed fee for the Base contract is $TBD. The fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1 of this contract.

c. The total estimated amount of the base contract, represented by the sum of the estimated cost plus the fixed fee, is $TBD.

d. If the Government exercises its Basic Requirement Options to extend the period of performance for out years two through five pursuant to the OPTION PROVISION Article in SECTION H of this contract, the following represents the cost and fee for each of the Basic Requirement term options:

Level-of- Effort Hours

Performance Period Cost Fee Total Contract Amount

Option 1 – Basic Requirement

12,500 (Estimate)

09/30/18 – 09/29/2019

$TBD $TBD $TBD

Option 2 – Basic Requirement

12,500 (Estimate)

09/30/19 – 09/29/2020

$TBD $TBD $TBD

Option 3 – Basic Requirement

12,500 (Estimate)

09/30/20 – 09/29/2021

$TBD $TBD $TBD

Option 4 – Basic Requirement

12,500 (Estimate)

09/30/21 – 09/29/2022

$TBD $TBD $TBD

e. If the Government intends to NOT exercise a subsequent Basic Requirement Option, as contained in paragraph (d), the Contractor will be informed 60 days prior to contract expiration in order to allow for any final deliverables, including but not limited to, the Final Report. Otherwise, the Government shall notify the contractor in writing at least 30 days in advance of its intent to exercise any subsequent Basic Requirement Option listed in paragraph d) above. See ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, FAR 52.217-9, Option to Extend the Term of the Contract, for full details.

ARTICLE B.4. OPTIONS FOR INCREASED QUANTITY – SEPARATELY PRICED LINE ITEMS

In addition to the basic contract requirement, as addressed in Article B.2., the Government will also have the right to exercise a variety of quantity options during the performance period of this contract (estimated to be five years, assuming all of the Basic Requirement Term Options are exercised). Each Quantity Option contained in this Article will represent a separately priced line-item inclusive of cost plus fixed fee and each Quantity Option represents a non-severable requirement to be fully funded at the time the Option is exercised. The Quantity Options, as described in the Statement of Work (Article C.1), are listed below:

Up to five (5) New Disease-Specific Common Data Element Development Options Up to five (5) Common Data Element Web-Based Training Module Options

QUANTITY OPTIONS (Separately Priced Line Items)

Option Item Option(s) Exercised 09/30/17 – 09/29/18

Option(s) Exercised 09/30/18 – 09/29/19

Option(s) Exercised 09/30/19 – 09/29/20

Option(s) Exercised 09/30/20 – 09/29/21

Option(s) Exercised 09/30/21 – 09/29/22

New CDE Development – Price Per Option

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

CDE Web-Based Training Module – Price Per Option

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

Cost: $TBD Fee: $TBD Total: $TBD

a. Unless the Government exercises its option(s) pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Basic Contract Requirement specified in the Statement of Work as Defined in SECTIONS C and F.

b. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity – Separately Priced Line Items set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the options as described above and as specified in SECTIONS C and F of this contract. If the Government exercises these options, notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract.

c. Payment of fee for each option shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. The fee for each option shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer.

ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property;

12) Printing costs; and 13) Research Funding.

ARTICLE B.6. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated December 7, 2016, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments -- ATTACHMENT No. 3).

ARTICLE C.2. TECHNICAL REPORTING REQUIREMENTS AND DELIVERABLES

A description of the Technical, Administrative and IT-Security related deliverables is contained in the Statement of Work, attached hereto and made a part of this Solicitation (See SECTION J – List of Attachments – ATTACHMENT No. 3).

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before 09/29/2018. Thereafter, reports shall be due annually on or before 09/29 of each subsequent year of contract performance (if Term Options are exercised). The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Jason Williams, Contracting Officer National Institutes of Health NINDS R&D Contracts Management Branch, NIDA 6001 Executive Blvd., Suite 3287 Bethesda, MD 20892-9531 (FedEx/courier use: Rockville, MD 20852 in lieu of Bethesda address)

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov/

SECTION D - PACKAGING, MARKING AND 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, TBD is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard Rockville, MD 20852

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

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

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from September 30, 2017 through September 29, 2018.

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 Option Period

Term Option 1 – Basic Requirement 09/30/2018 – 09/29/2019

Term Option 2 – Basic Requirement 09/30/2019 - 09/29/2020

Term Option 3 – Basic Requirement 09/30/2020 – 09/29/2021

Term Option 4 – Basic Requirement 09/30/2021 – 09/29/2022

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final 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 Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS section of the Statement of Work (Article C.1 of this contract) will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Description Quantity Due Date

TECHNICAL DELIVERABLES

Quarterly Progress Reports 1 e-copy to the CO; 1 e-copy to the

COR

January 15, April 15, and June 15 of each year of contract performance period

(base period and basic requirement term options) Annual Progress Reports 1 e-copy to the CO and

COR

On or before final day of each one-year basic requirement contract performance period (Annually on Sept 29) Quarterly List/Inventory of Archived Data Sets and Materials

1 e-copy to the CO, COR and NINDS

Data

Archiving

Liaison

January 15, April 15, June 15 and

September 29 annually (same due dates as corresponding contract Quarterly and

Annual Progress Reports)

Special Project Reports (Statistical and Methodological Performance Area)

1 e-copy to the CO and

COR

Within 30 days of completion of project

Data Audit and Site Visit Reports

1 e-copy to

CO, COR, site

PI; and for

Extramural

Monitoring visits [only] 1 e-copy to applicable

NINDS

Program

Manager

Draft report(s) due one week from completion of site visit; Final report(s) due 15 business days from receipt of comments on Draft report(s) from NINDS

COR

Archived Data Sets and

Materials

ALL

COLLECTED

Delivery location TBD

15 days prior to expiration of contract

Common Data Elements data and materials (see

Article C.2.e. contained in

Statement of Work)

ALL

COLLECTED

Delivery location TBD

30 days prior to expiration of contract

Source Code & Object Code

(see Article C.2.g. in SOW)

Upon expiration of contract

ADMINISTRATIVE AND

REGULATORY

DELIVERABLES

Section 508 Annual Report -

Electronic and Information

Technology Accessibility –

(see “Electronic and

Information Technology

Accessibility” Article in

Section H of contract)

1 e-copy to

CO and COR

Annually, on or before August 30.

Service Contract Annual

Report

Electronic submission to www.sam.go v with e-copy to CO

October 31st of each contract year in accordance with FAR 52.204-14, “Service

Contract Reporting Requirements” contained in full text in Article I.4.

http://www.sam.gov/ http://www.sam.gov/

Annual Invention Utilization

Report (see Article C.3.)

1 e-copy to the CO

On or before the anniversary date of contract award.

Final Invention Statement

(see Article C.3.)

1 e-copy to the CO

On or before the expiration/ termination date of the contract.

Reporting of Financial

Conflict of Interest (FCOI)

(see “Institutional

Responsibility Regarding

Investigator Financial

Conflicts of Interest” Article in Section H of contract

1 e-copy to

CO

As applicable, per “Institutional

Responsibility Regarding Investigator

Financial Conflicts of Interest” Article in

Section H of contract; in accordance with

45 CFR Part 94.

INFORMATION AND

PHYSICAL ACCESS SECURITY

DELIVERABLES (see

“Information and Physical

Access Security Article in

Section H of contract for full details)

Contractor-Employee Non-

Disclosure Agreement(s)

1 e-copy to the COR and

COR

Prior to any employee working under the contract who may have access to non-public Department Information.

Roster of Employees

Requiring Suitability

Investigations

1 e-copy to the CO and

COR

Initial report due 14 days after contract award and thereafter written notice of updates to NINDS CO and COR, within 5 working days before a new employee assumes a position that requires access to HHS information systems or data;

upon departure for departing personnel with such access.

IT Security Plan 1 e-copy to the CO and

COR

Due within 30 days after contract award and updated annually thereafter

IT Risk Assessment 1 e-copy to the CO and

COR

Due within 30 days after contract award and annually thereafter

FIPS 199 1 e-copy to the CO and

COR

Due within 30 days after contract award

Interconnection Security

Agreement (ISA) – see

Article C.2.I. of Statement of

1 e-copy to

CO and COR

Due within 30 days after contract award

Work

IT SC&A 1 e-copy to the CO and

COR

Due three (3) months after contract award and annually thereafter.

Reporting of New and

Departing Employees

1 e-copy to the CO and

COR

Within 5 working days of staffing changes that require Information

Security access/suitability determinations.

Vulnerability Scanning

Reports

1 e-copy to the CO and

COR

1st report due 40 days after contract award. Monthly reports thereafter due

10 calendar days after end of each monthly reporting period.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973.

All paper/hardcopy documents/reports submitted under this contract, if these should prove necessary in the performance of this contract, shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

The e-mail and mailing addresses for the Contracting Officer and Contracting Officer’s Representative (COR) are as follows:

Contracting Officer COR

Jason Williams TBD National Institutes of Health National Institutes of Health NINDS R&D CMB, NIDA NINDS Division of Clinical Research 6001 Executive Blvd., Suite 3287 6001 Executive Blvd., Rm [TBD]

Bethesda, MD 20892-9531 Bethesda, MD 20892-9527

(For FedEx/courier delivery use “Rockville, MD 20852” for both of the above addresses)

E-mail: willjas@mail.nih.gov E-mail: TBD

NINDS Data Archiving Liaison

TBD

National Institutes of Health NINDS Data Archiving Liaison Division of Clinical Research 6001 Executive Blvd., Rm TBD Bethesda, MD 20892-9525 (FedEx/courier use: Rockville, MD 20852)

E-mail: TBD mailto:willjas@mail.nih.gov

Separately Priced Line Item Option Deliverables:

New Disease-Specific Common Data Element Development Options:

Item Description Due Date

(1) All hard copy and electronic documents developed, inclusive of Stakeholder consensus meeting materials and minutes leading to the initial posting of the new disease-specific CDE to the NINDS Common Data Elements website. A complete and comprehensive report, inclusive of all related materials/information shall be delivered.

Upon completion of Option requirement

(2) The electronic module, in COR-prescribed format, posted to the NINDS Common Data Elements website in a user-friendly turn-key operation format

Upon completion of Option requirement

Delivery Location: NINDS location as specified by the COR.

Web-Based Common Data Element Training Module Options:

Item Description Due Date

(1) Web-based training module in COR-prescribed format, posted to the NINDS Common Data Elements website in a user-friendly turn-key operation format

Upon completion of Option requirement

Delivery Location: NINDS location as specified by the COR.

ARTICLE F.3. LEVEL OF EFFORT – BASIC REQUIREMENT AND BASIC REQUIREMENT TERM OPTIONS

a. In accomplishing the work set forth herein, the Contractor shall provide the direct labor effort as set forth below during the period of performance of this contract. The labor effort includes absences for vacation, holiday, and sick leave. It is estimated that the percent labor effort is constituted as specified below and will be expended approximately as follows:

DIRECT LABOR HOURS

Labor Category Base Contract

09/30/17 – 09/29/18

Option 1 – Basic

Requirement 09/30/18 – 09/29/19

Option 2 – Basic

Requirement 09/30/19 – 09/29/20

Option 3 – Basic

Requirement 09/30/20 – 09/29/21

Option 4 – Basic

Requirement 09/30/21 – 09/29/22

Principal Investigator

200 hours 200 hours 200 hours 200 hours 200 hours

Project Manager 700 hours 700 hours 700 hours 700 hours 700 hours

Other Professional 11,600 hours 11,600 hours 11,600 hours 11,600 hours 11,600 hours

Labor Category Base Contract

09/30/17 – 09/29/18

Option 1 – Basic

Requirement 09/30/18 – 09/29/19

Option 2 – Basic

Requirement 09/30/19 – 09/29/20

Option 3 – Basic

Requirement 09/30/20 – 09/29/21

Option 4 – Basic

Requirement 09/30/21 – 09/29/22

Totals 12,500 hours 12,500 hours 12,500 hours 12,500 hours 12,500 hours

PROSPECTIVE OFFERORS ARE ADVISED THAT THE ABOVE ESTIMATES ARE FURNISHED FOR

YOUR INFORMATION ONLY AND ARE NOT TO BE CONSIDERED RESTRICTIVE FOR PROPOSAL

PURPOSES. OFFERORS ARE REQUESTED TO FURNISH ESTIMATES OF PERSONNEL AND EFFORT

BASED UPON THE REQUIREMENTS OF THE SOW AND THE PROPOSED APPROACH OFFERED

FOR ACHIEVING THE STATED OBJECTIVES.

Please refer to Attachment No. 3, “Statement of Work”, Attachment No. 10, “Budget Assumptions for Business Proposal Preparation”, Attachment No. 11, “Breakdown of Proposed Estimated Costs (plus fee) with Excel Spreadsheet”, and Attachment No. 12, “Business Proposal Budget Template” for full details on how to prepare and submit your budget in response to this Request for Proposals [Attachments Nos. 10 and 12 are informational attachments only -- please utilize Excel Spreadsheet in Attachment No. 11 to submit budget].

b. The Contractor shall have satisfied the requirement herein if not less than 90% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. 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: https://www.acquisition.gov/?q=browsefar .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

https://www.acquisition.gov/?q=browsefar%20

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 specified prior to 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 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 this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer.

The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD Principal Investigator

TBD Project Manager

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts 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.

1. 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.

a. The original hard copy invoice less supporting documentation shall be submitted to the following designated billing office :

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One electronic copy of the invoice including all supporting documentation shall be submitted to the following approving official :

Jason S. Williams, Contracting Officer NINDS Contracts Management Branch, NIDA

E-mail: willjas@nida.nih.gov

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: MSWord, 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. [Note: 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."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is Office of Acquisitions, Neurosciences (OAN)

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: NINDS Center for Clinical Research Resources

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496- 6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

d. The Contractor agrees to provide with each monthly contract financing request a detailed breakdown of the direct labor/personnel charges claimed, to include: (1) a list of individuals by name; (2) their title/position under the contract; (3) their hourly/annual salary rate; (4) percent of effort charged; and (5) amount claimed for each.

e. The Contractor shall track, record, and report costs incurred separately for the base contract and for each successive Basic Requirement Option so exercised as set forth in Article B.2.(d).

The performance period associated with the base contract and each successive basic requirement option as itemized in Article B.3 (d) represent separate and distinct 12-month periods for each.

In order to be in compliance with obligation and disbursement regulations and associated Appropriations Law, all invoices must reflect the performance period for each, i.e., for the Base Contract Period and each successive Basic Requirement Option so exercised, respectively, costs were incurred under. Some invoices may have costs associated with more than one of the five 12-month performance periods outlined in Article B.3.(d). If an invoice contains costs for work incurred under multiple performance periods, the Contractor shall report these costs (both direct and indirect) separately by the applicable Base Contract Period/Option.

The Contractor shall also track, record and report costs incurred separately for each Quantity Option contained in Article B.4.in the same manner described above.

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.6. 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: http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf .

ARTICLE G.7. 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 42.15.