RFP_NIH-NINDS-75N95019R00027.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 99-158 as amended

2. Request for Proposal (RFP) Number:

NIH-NINDS-75N95019R00027

3. Issue Date:

03/27/2019

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Screening of Investigational Agents through the “NINDS Preclinical Screening Platform for Pain” (PSPP)

6. ISSUED BY:

National Institute of Neurological Disorders and Stroke (NINDS) Section Contracts Management Branch (CMB), Red Office of Acquisitions (OA) National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH) 6001 Executive Blvd., Bldg. NSC / Rm. 3172 Rockville, MD 20892-9661

7. SUBMIT OFFERS TO:

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https:// ecps.nih.gov. See Part III, Section J, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," Attachment 1 of this Solicitation.

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 the Proposal for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 05:00 P.M., Eastern Standard Time on 05/10/2019. Offers will be valid for 120 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 to be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov as stated in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." Proposals submitted by facsimile or e-mail will not be accepted.

IF YOUR PROPOSAL IS NOT RECEIVED VIA THE ELECTRONIC CONTRACT PROPOSAL SUBMISSION

(ECPS) WEBSITE BY THE DATE AND TIME OF PROPOSAL SUBMISSION, THEN IT WILL BE

CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal, and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation.

Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov.

11. FOR INFORMATION CALL: Rieka Plugge, Contract Specialist

PHONE: (301) 827-7515

e-MAIL: rieka.plugge@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. Offeror questions must be submitted on or before 5:00 P.M., EST, on 04/10/2019. Offeror questions must be submitted by e-mail to rieka.plugge@nih.gov with the subject line: "RFI - RFP 75N95019R00027"

Nancy Lamon-Kritikos Contracting Officer, NINDS Section Contracts Management Branch Red Office of Acquisitions, NIDA https://ecps.nih.gov https://ecps.nih.gov https://ecps.nih.gov https://www.sam.gov http://www.sam.gov

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RFP Number : NIH-NINDS-75N95019R00027

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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

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. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

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. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

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

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. LIVE VERTEBRATE ANIMALS EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. TECHNICAL EVALUATION FACTORS

8. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

9. PAST PERFORMANCE FACTOR

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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, IF NECESSARY, 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 National Institutes of Neurological Disorders and Stroke (NINDS) is establishing the Preclinical Screening Platform for Pain (PSPP) in response to the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) initiative. The HEAL initiative (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative) is a trans-NIH effort to fast-track basic, translational, and clinical research in the field of addiction and pain to address the national opioid crisis. The goal of the PSPP is to foster the development of opioid alternatives to treat all types of pain conditions.

As part of this HEAL Initiative, the PSPP will provide pain researchers from the academic and industry community with a centralized resource for testing compounds, biologics, natural products, and devices for their potential as opioid alternatives. Contributors with a promising non-addictive therapeutic for pain (Contributors) will be invited to submit bioactive investigational agents to the PSPP for testing. These investigational agents will be evaluated to determine if they are non-opiate, metabolically stable compounds that show promise in established and newly developed models of pain.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract as contemplated by FAR 16.504. Any resultant IDIQ contract award will contain a guaranteed minimum of $30,000 and the estimated maximum amount will be $49,900,000 during the five (5) year ordering period of this contract.

b. This IDIQ contract has a total ordering period of five (5) years. As necessary, NINDS will issue Task Orders for the Contractor to perform any or all of the Performance Activities in the Statement of Work (SOW). It is anticipated that these task orders will be cost reimbursement level-of-effort or completion type task orders and the fixed fee for individual task orders will be negotiated by task order. The IDIQ Contract shall allow for the issuance of level-of-effort (LOE) task orders where the resultant contractor is required to incur a specified number of labor hours in categories of labor applicable to key personnel, to be performed in a specific period of time. Payment for a LOE task order shall be based upon effort, not results, as compounds may not be found viable during the pre-clinical screening process. To monitor the progress of any resultant LOE task order the contractor shall submit a report showing the results achieved through application of the required level of effort.

The issuance of completion type task orders shall also be allowed should more well-defined tasks for known viable compounds be required to complete the entire screening process from the beginning to the end testing stages. The fixed fee shall be paid in installments as negotiated (based on percentage of completion of work

- 6 -or the percent of total effort expended), as determined by the Contracting Officer, and 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 the contract. Payment for fixed fee shall not be made in less than monthly increments.

c. The costs set forth in this ARTICLE will cover the estimated contract period 09/30/2019 through 09/29/2024 (5-year ordering period).

d. The Government will issue Task Orders based on the work described in SECTION C of this contract.

e. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.3. OPTION PRICES

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

ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

b. Pursuant to FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item, FAR Clause 52.217-8 Option to Extend Services, and FAR Clause 52.217-9 Option to Extend the Term of the Contract set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES and ARTICLE I.4. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform Option Period(s) specified in a resultant Task Order. If the Government exercises these options, notice must be before the expiration date of the contract / task order. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract.

ARTICLE B.4. 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.5. 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.

Confidential Treatment of Sensitive Information

The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

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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 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 01/04/2019, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format as specified in ARTICLE F DELIVERIES of the RFP.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

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: https://www.hhs.gov/ web/section-508/contracting/technology-products/product-accessiblity-template/index.html under "Vendor Information and Documents."

Additionally, when submitting electronic reports and forms the offeror shall ensure they fully conforms to the applicable Revised 508 Standards prior to delivery and before final acceptance.

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 any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during 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. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that the required electronic version(s) of these reports will be required as follows:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract / task order [ ] Final - Upon final completion of the contract / task order (with a requirement for a Draft Final Report)

2. Summary of Salient Results http://www.hhs.gov/web/508/index.html https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/index.html https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/index.html

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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. This report will be required on or before the expiration date of the contract.

3. Protocol Manual (established and validated in-vivo pain models in any animal species)

Describing established and validated in-vivo pain models in any animal species. This shall be due within 60 calendar days after contract award in an electronic format.

4. Protocol Manual (in-vitro and or in-vivo methods, test preparations, relevant mathematical calculations and formula derivations)

Describing in-vitro and or in-vivo methods, test preparations, relevant mathematical calculations and formula derivations. This shall be due within 60 calendar days after contract award in an electronic table format.

5. Protocol Manual (newly established and validated in-vivo pain models in any animal species)

Describing newly established and validated in-vivo pain models in any animal species. This shall be due within 30 calendar days after completion of the validation of the experimental study according to the COR specifications.

6. Preliminary Data Reports

After completion of the in-life portion of the study, the Contractor shall prepare a preliminary data report, to be submitted within 5 calendar days from the end of in-life portion of the study. Within 10 calendar days of submission of the data report, the Contractor shall submit a full draft report for review and comment by the COR. After receipt of COR comments, raw data and a final study report shall be delivered and /or transferred to a specified NINDS-Data base.

7. Final Data Reports

The Contractor in coordination with the NINDS data management representative shall coordinate a seamless transfer of raw and analyzed data, statistical and method(s) of analysis into the NINDS database within 1 week of finalization on study reports.

8. Comprehensive Summary Reports

As directed by the NINDS COR, a comprehensive report of all PSPP studies shall be completed within 45 calendar days after final test results are submitted for each investigational Agent. Other less comprehensive summaries for "pilot studies and special projects" shall have a 30 calendar day completion requirement for each separate candidate selected.

9. Quarterly Progress Reports

Quarterly Progress Reports for all testing summaries shall be provided in an approved electronic format to the COR. Quarterly Reports shall comprise of: a) a summary of all testing performed in the performance period; b) status of all projects under development (i.e. new model development, pilot studies), problem areas and any performance delays encountered or that may impede future performance; c) list of comprehensive summary reports in preparation or completed during the reporting period and d) Solutions to identified problems encountered during the reporting period if any. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. Reports shall be due on or before the 10th calendar day following each reporting period.

The Contractor shall send two copies of the Quarterly Progress Reports, one to the COR and one copy to the Contracting Officer, NINDS.

10. Conference Call Summaries

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The Contractor shall be required to generate and deliver summaries of all conference calls conducted in performance of work under the contract. The summary shall consist of a bulleted list of decisions made and action items identified on the call. These summaries shall be sent via e-mail to all participants within 48 hours of each call. The exact number and timing for such calls will depend on the specifics and circumstances surrounding each individual project.3. Protocol Manual

11. Subcontracting Reports

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

1. Individual Subcontract Reports (ISR)

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

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

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

October 30th

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

Contracting Officer e-mail: [To be specified prior to award]

12. Invention Reporting

In accordance with contract Article C.3. "Invention Reporting Requirement", an Annual Invention Utilization Report shall be due on or before the anniversary date of the contract award and a Final Invention Statement will be due on or before the expiration date of the contract. Note: The same form is used for both the annual and the final report.

13. Service Contract Annual Report

In accordance with FAR 52.204-14, "Service Contract Reporting Requirements", contained in full text in Article I.6. of the contract, the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September

30) the following information to http://www.sam.gov, with an electronic copy to the Contracting Officer:

1) Contract number and, as applicable, order number.

2) The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract.

3) The number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

4) Data reported by subcontractors [if applicable] under paragraph (f) of the subject clause (see full text of clause FAR 52.204-14, "Service Contract Reporting Requirements" in Article I.6. of the contract).

b. Other Reports/Deliverables http://www.esrs.gov

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1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

INFORMATION AND/OR PHYSICAL SECURITY

A. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three

(3) months after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

B. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

• System Security Plan (SSP) - due within 30 days after contract award. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

• Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

- 11 -by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

• Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

• POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented. The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued.

Thereafter, the POA&M shall be updated at least quarterly.

C. Contingency Plan and Contingency Plan Test - due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed.

Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

• E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

D. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[X] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

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Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change.

The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

E. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://www.hhs.gov/ocio/ea/documents/proplans.html

- 13 -provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4. Notification- The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within fifteen days before an employee stops working under this contract.

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

F. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

G. Vulnerability Scanning Reports The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under a separate cover on monthly basis.

H. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

a. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

b. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in

- 14 -applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

c. Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

d. Cooperate with inspections, audits, investigations, and reviews.

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

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 annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. 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 e-mail address(s):

Contracting Officer:

[To be specified at time of award]

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.

[Remainder of Page Intentionally Left Blank] http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.iedison.gov

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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 / task order number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

[Remainder of Page Intentionally Left Blank]

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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, the Contracting Officer's Representative (COR) (Refer to Article G.1.) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health 6001 Executive Boulevard Rockville, MD 20892

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. This clause will be applicable to most contracts resulting from this RFP. However, the organizational structure of the successful offeror will determine the specific clause to be contained in the contract awarded from this RFP.

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

Alternate I (April 1984) is not applicable to this contract.

- 17 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The estimated 5-year ordering period of performance of this contract shall be from 09/30/2019 through 09/29/2024.

The period of performance shall be specified for any individual resultant task orders issued.

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 Article in SECTION C 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:

Item Description Quantity Delivery Schedule

(1) Protocol Manuals

(established and validated in-vivo pain models in any animal species)

1 to COR 60 calendar days after contract/task order award

(2) Protocol Manuals (in-vitro and or in-vivo methods, test preparations, relevant mathematical calculations and formula derivations)

1 to COR 60 calendar days after contract/task order award

(3) Protocol Manuals (newly established and validated in-vivo pain models in any animal species)

1 to COR 30 calendar days after completion of the validation of the experimental study according to the COR specifications

(4) Preliminary Data Reports 1 to COR After completion of an in-life portion of the study for any resultant task order

(5) Final Data Reports 1 to COR Within 1 week of finalization on study reports for any resultant task order

(6) Comprehensive Summary Reports

1 to COR Within 45 calendar days after final test results are submitted for each investigational Agent for any resultant task order

(7) Quarterly Progress Reports 1 to COR Within 10 calendar days following the reporting period for contract/ task order

(8) Conference Call Summaries 1 to COR; 1 to CO Within 48 hours of each call

(9) Final Technical Report &

Summary of Salient Results 1 to COR; 1 to CO Upon final completion date of the contract/task order

(10) Individual Subcontract

Reports (ISR) Electronic Submission (external)

April 30 th;

October 30 th;

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Item Description Quantity Delivery Schedule Expiration Date of Contract for the entire life of this contract

(11) Summary Subcontract Report (SSR)

Electronic Submission (external)

Annually on the following date for the entire life of this contract: October 30 th

(12) Service Contract Annual Report

Electronic Submission (external)

Annually by October 31 st for the entire life of this contract

(13) Reporting of Financial Conflict of Interest

(FCOI)

1 to CO See Article C.2(b)(1) for details.

(14) Security Assessment and Authorization (SA&A) Package Deliverables

1 to COR; 1 to CO Within 30 calendar days of contract award

(15) System Security Plan (SSP) 1 to COR; 1 to CO Within 30 calendar days of contract award

(16) Security Assessment Plan/ Report (SAP/SAR)

1 to COR; 1 to CO 30…