Sol_75N95024R00054.pdf

75N95024R00054

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 144

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

04/30/2024 X

NIDA-EXEC

National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

1630 ED 05/30/2024

EVAN C FEELY +13 01

evan.feely@nih.gov

018-2753

X

X

X

X

X

X

X

X

X

X

X

X

PAGE(S)

RIEKA N. PLUGGE

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 144

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N95024R00054

(A) (B) (C) (D) (E) (F)

Period of Performance: 09/01/2024 to 08/31/2029

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. OPTION PRICES

4. PROVISIONS APPLICABLE TO DIRECT COSTS

5. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications

1. REPORTING REQUIREMENTS

2. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging and Marking

SECTION E - Inspection and Acceptance

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

F.4. FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. TASK ORDER PROCEDURE

3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

4. INDIRECT COST RATES

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. GOVERNMENT PROPERTY

G.7. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023)34

G.8. HHSAR 352.237-75 Key Personnel. (DEC 2015)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. RESEARCH AND DEVELOPMENT DATA IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM

3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

4. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

5. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-

FUNDED RESEARCH

6. ACKNOWLEDGEMENT OF FEDERAL FUNDING

7. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES

8. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

9. ANIMAL WELFARE

10. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

11. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

12. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

13. GUN CONTROL

14. OPTION PROVISION

15. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

16. CONFIDENTIALITY OF INFORMATION

17. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

18. PUBLICATION AND PUBLICITY

19. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

20. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

21. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

22. SHARING RESEARCH DATA

23. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

24. CONSTITUTION DAY

H.25. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015) ...69

SECTION I - Contract Clauses

I.1. GENERAL CLAUSES

I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

I.3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

I.4. SMALL BUSINESS ADMINISTRATION - 8(a) PROGRAM CLAUSES

I.5. SERVICE CONTRACT LABOR STANDARDS

SECTION J - List of Documents, Exhibits and Other Attachments

SECTION K - Representations, Certifications, and Other Statements of Bidders

K.1. FAR 52.209-12 Certification Regarding Tax Matters. (OCT 2020)

SECTION L - Instructions, Conditions, and Notices to Bidders

L.1. FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. (JAN 2017)

L.4. FAR 52.215-1 Instructions to Offerors - Competitive Acquisition. (NOV 2021)

L.5. FAR 52.215-1 Instructions to Offerors - Competitive Acquisition. (NOV 2021) - Alternate I (OCT 1997)

L.8. FAR 52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than Cost or Pricing Data. (NOV 2021)

L.11. FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer. (JUL 2013) ...136

L.12. FAR 52.233-2 Service of Protest. (SEP 2006)

L.14. FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998)

L.15. HHSAR 352.219-70 Mentor-Protege Program. (DEC 2015)

L.16. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015) ..138

SECTION M - Evaluation Factors for Award

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institutes of Neurological Disorders and Stroke (NINDS) established 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 continue to 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.

2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $ 10,0000.00 (minimum) nor more than a total of $ 80,000,000.00 (maximum) for successful performance of this contract.

b. This Indefinite Delivery, Indefinite Quantity (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 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 Section I 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 of 09/01/2024 through 08/31/2029.

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.

3. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.26., 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 Contract SECTION I - CONTRACT CLAUSES, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in a resultant Task Order. If the Government exercises this/these option(s), notice must be given 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.

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.

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.

a. Personal Services and Inherently Government Functions Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's

Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor.

If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

b. Site Visits The NINDS anticipates making visits to the Contractor facility, as needed. Contractor shall be responsible for making the facility available for a visit and arranging meetings with appropriate personnel.

c. Human Materials Any acquisition and/or supply of human specimen materials, requires advance written approval from the Contracting Officer.

d. The following research is not anticipated to take place under this contract:

-Human fetal tissue;

-Human Stem Cell Research;

-Recombinant or Synthetic Nucleic Acid Molecules -Large-scale Human or Non-Human Genomic Data -HeLa Cell Whole Genome Sequence Data -Agent or Toxin that is Listed in the U.S. Government Policy for Oversight of Life Sciences Dual Use Research of Concern (DURC) -Highly Pathogenic Agent

e. Manuscripts and press releases

Manuscripts for scientific publications and press releases shall be considered to include the public release of information to any medium. The Contractor shall not submit a final manuscript or publish a press release related to this contract without receiving prior concurrence from the Contracting Officer's Representative (COR). The Contractor shall submit an advance copy of the document to the Contracting Officer and COR. Upon acknowledgment of receipt, the COR will have ten (10) working days to respond with concurrence or comments. In the event that the COR does not communicate concurrence or comments to the Contractor within ten (10) working days following acknowledgement of receipt of the advance copy, concurrence may be presumed.

f. Informed Consents All informed consents related to human research materials shall be approved in writing and in advance by the COR.

SECTION C - Description/Specifications

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 02/08/2024 , attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the [Description/Specification/Work Statement/Statement of Work] , dated [ ] , set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.

1. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

These reports 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: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

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 in addition to the required electronic version(s) hard copies 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

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

2. Summary of Salient Results The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. 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 Report 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 Report 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 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.

5. Other Reports/Deliverables

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: https://www.ecfr.gov/current/title-45/part-94. See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

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

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

a. 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

b. 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]

3. Invention Reporting In accordance with contract Article C.2. "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.

4. Service Contract Annual Report In accordance with FAR 52.204-15 "Service Contract Reporting Requirements for Indefinite- Delivery Contracts," the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September 30) under this contract for orders that exceed the thresholds established in 4.1703(a)(2), the following information to http://www.sam.gov, with an electronic copy to the Contracting Officer:

1) Contract number and 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 52.204-15, "Service Contract Reporting Requirements for Indefinite- Delivery Contracts" at https://www.acquisition.gov/).

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

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

C. System Security Plan (SSP) - due within 30 days after contract award. The SSP must 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 must 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 must 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 must update the SSP at least annually thereafter.

D. Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment must 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 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.

E. Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) must have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party must 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 must 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).

F. Plan of Actions and Milestones (POA&M) - due 30 days after contract award. The POA&M must be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All findings/weaknesses must be documented in the POA&M and remediated/mitigated from the date the weaknesses are formally identified and documented by the timelines below:

• Critical within 30 days;

• High within 60 days;

• Medium within 1 year; and

• Low within 1 year.

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, must 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 must be updated at least quarterly.

G. 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, must 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 must update and test the Contingency Plan at least annually.

H. E-Authentication Questionnaire - The contractor (and/or any subcontractor) must 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 must 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.

I. 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). To determine the designation, the Position Designation Tool (PDT) discussion is found at:

https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx and the link to access the tool is found at: https://pdt.nbis.mil/ .

The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and 'Q' access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and 'L' access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[X] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

J. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

The Contractor (and/or any subcontractor) must 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 must 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 must 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://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

a. If the Contractor is filling a new position, the Contractor must 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.

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

c. The Contractor must 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.

d. All contractor and subcontractor employees must 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.

e. 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 must ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

f. 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).

g. The Contractor must 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).

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

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

K. CONTRACT INITIATION AND EXPIRATION

a. General Security Requirements - The Contractor (and/or any subcontractor) must 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 must follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Directive (2018) located at:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive- 2018.pdf . HHS EA requirements located at: https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf and NIH EA requirements are located at:

https://ocio.nih.gov/PM/Pages/EPLC.aspx .

b. System Documentation - Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals ( specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information - As part of contract closeout and at expiration of the contract, the Contractor ( and/ or any subcontractor) must 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.

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

e. Contractor Responsibilities Upon Physical Completion of the Contract- The Contractor (and/ or any subcontractors) must 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 must 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.

f. The Contractor ( and/or any subcontractor) must 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 must be made available to the CO and/ or COR upon request.

g. 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 must be submitted to the Contracting Officer ( CO) and/ or CO Representative ( COR) prior to performing any work under this acquisition.

h. Vulnerability Scanning Reports - The Contractor must 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 must be submitted under a separate cover on monthly basis.

i. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must 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:

i. 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.

ii. 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 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.

iii. 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.

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

c. Section 508 Annual Report

The Contractor must 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:

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual _report.doc.

8. Reports must be sent to the following addresses as specified: Please see Article F.2. Deliveries

2. 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:

rieka.plugge@nih.gov

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 email 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.

SECTION D - Packaging and Marking

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.

1. For the purpose of this SECTION, the Contracting Officer's Representative (COR) 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.

2. 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 52.246-8 Inspection of Research and Development - Cost-Reimbursement. (MAY 2001)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

The estimated ordering period of this contract shall be from 09/01/2024 through 08/31/2029. The period of performance shall be specified for any individual resultant task orders issued.

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 [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Quantity Delivery Schedule A: Technical Deliverables

(1)

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

1 e-copy 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 e-copy to COR

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

(3)

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

1 e-copy to COR

After…