Sol_75N95024R00124_Amendment1_0001.pdf

AMENDMENT #1:

NIH NeuroBioBank Brain and Tissue Repository

75N95024R00124

The purpose of this Amendment is to:

(1) Inform vendors that the following documents are hereby redacted and replaced in full and supersede the original versions posted on SAM.gov on October 15, 2024.

Attachment Number 4 – Statement of Work AMENDMENT 1

Attachment Number 5 – Additional Technical and Business Proposal Instructions AMENDMENT 1

(2) Inform vendors that the following document is hereby revised and supersedes the original version posted on SAM.gov on October 15, 2024 (text revisions within this document have strikethroughs or are highlighted as necessary to revise the text):

Solicitation Amendment 1, See specifically Section J, page 98 and Section L page 104

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health

National Institute on Drug Abuse

Bethesda, Maryland 20892

NATIONAL INSTITUTE OF MENTAL HEALTH

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95024R00124

PROJECT TITLE: NIH NEUROBIOBANK BRAIN AND TISSUE REPOSITORY

ISSUED BY:

Robin Knightly Contract Specialist NIMH Section Contracts Management Branch, Red Office of Acquisition, NIDA

Email: robin.knightly@nih.gov Phone: (301) 827-5302

Rieka Plugge Supervisory Contracting Officer Branch Chief Contracts Management Branch, Red Office of Acquisition, NIDA

Email: rieka.plugge@nih.gov Phone: (301) 827-7515

DATE ISSUED: October 15, 2024

PROPOSAL DUE: November 14, 2024, 5:00 P.M. (Eastern Standard Time)

The National Institute of Mental Health (NIMH) invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00124 titled NIH NeuroBioBank Brain and Tissue Repository.

NIMH prepared this Request for Proposal (RFP) in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, and III of the Uniform Contract Format.

All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

NIMH expects to award multiple cost reimbursement, term (level of effort) type contracts with a 1-year base period, 4 option years, ad option quantities. Future funding will be dependent on the previous year’s performance and the availability of funds. The initial period of performance will start on or around May 2025. You should respond with technical and cost/price proposals based on the assumptions provided in Sections C and L. Please include separate cost/prices for each individual option.

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 3 is a "Proposal Intent Response Sheet." Please complete this form and return it to the below address on or before 5:00 P.M. Eastern Time, on October 24, 2024. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Offeror Questions 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., on October 24, 2024. Offeror questions may be submitted by e-mail to robin.knightly@nih.gov and rieka.plugge@nih.gov with the subject line:

“RFI – RFP 75N95024R00124”

NOTE: Site visits will not be provided.

The Technical Proposal It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed. NIMH will use this information to ensure that no conflicts of interest exist with the selected review committee members. Technical Proposal Instructions are detailed in Section L.2.b.

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal. It must contain a detailed breakdown of costs for each of the sample task orders and option quantities.

For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. NIMH directs special attention to Breakdown of Proposed Estimated Costs w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 10. Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment 9) must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. See Section L.2.c. for additional detail.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than November 14, 2024, 5:00 P.M., Eastern Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly.

Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/HowToSubmit and in Attachment 2.

All notices related to this solicitation will be posted on SAM (https://www.sam.gov). If you would like to receive e-mail notifications of updates to this solicitation, please register with

SAM.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The RFP shall take precedence if any of the content in this letter is contradictory.

The NIMH appreciates your interest in this RFP and looks forward to receipt of your proposal.

Requests for any information concerning this RFP should be directed to the undersigned or Robin Knightly at robin.knightly@nih.gov or (301) 827-5302. Discussions with any other individuals should not occur.

Sincerely, Rieka Plugge Supervisory Contracting Officer Branch Chief Contracts Management Branch, Red Office of Acquisition, NIDA

Email: rieka.plugge@nih.gov Phone: (301) 827-7515

SECTION A - Solicitation/Contract Form SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. ESTIMATED COST - OPTION

3. PROVISIONS APPLICABLE TO DIRECT COSTS

4. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications/Work Statement

1. REPORTING REQUIREMENTS

2. INVENTION REPORTING REQUIREMENT

SECTION D - Packaging, Marking, and Shipping SECTION E - Inspection and Acceptance SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

3. LEVEL OF EFFORT

4. FAR 52.242-15 Stop-Work Order. (AUG 1989)

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

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

3. CONTRACT FINANCIAL REPORT

4. INDIRECT COST RATES

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. GOVERNMENT PROPERTY

7. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023)...32

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

4. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

5. RESEARCH INVOLVING HUMAN FETAL TISSUE

6. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

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

FUNDED RESEARCH

8. ACKNOWLEDGEMENT OF FEDERAL FUNDING

9. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

10. OMB CLEARANCE

11. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

12. GUN CONTROL

13. OPTION PROVISION

14. SUBCONTRACTING PROVISIONS

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. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

20. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

21. SHARING RESEARCH DATA

22. CONSTITUTION DAY

23. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

24. USE OF FUNDS FOR PROMOTIONAL ITEMS

25. HHSAR 352.224-70 Privacy Act. (DEC 2015)

26. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

27. HHSAR 352.270-13 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research. (DEC 2015)

SECTION I - Contract Clauses

1. GENERAL CLAUSES

2. AUTHORIZED SUBSTITUTION OF CLAUSES

3. ADDITIONAL CONTRACT CLAUSES IN FULL TEXT

4. SERVICE CONTRACT LABOR STANDARDS

SECTION J - List of Documents, Exhibits and Other Attachments

1. SECTION J - LIST OF ATTACHMENTS

SECTION K - Representations, Certifications, and Other Statements of Bidders SECTION L - Instructions,Conditions, and Notices to Offerors

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

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

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

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

10. FAR 52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than Cost or Pricing Data. (NOV 2021) - Alternate I (OCT 2010)

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

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

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

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

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

17. HHSAR 352.270-4 a Notice to Offerors, Protection of Human Subjects. (DEC 2015) - Alternate I

(DEC 2015)

SECTION M - Evaluation Factors for Award

SECTION A - Solicitation/Contract Form

PART 1 - THE SCHEDULE

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

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM , ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION

APPLICABLE TO THE CONTRACT AWARD.

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

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - Supplies or Services and Prices/Costs

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objective of this initiative is to increase the availability of human disease and control specimens for research (brain and central nervous system (CNS) tissues) by establishing contract collection site(s) to more efficiently acquire, curate, store, and distribute these specimens to qualified investigators. A broader objective is to increase proactive involvement of the disease advocacy and patient communities, with the ultimate goal of reducing the burden of nervous system disorders. It is anticipated that multiple contract collection sites will be established from this RFP.

The purpose of this contract is to establish collection sites(s) (i.e., the NIH NeuroBioBank Brain and Tissue Repository (NBB)) to provide services that will actively acquire, receive, process, store, curate, preserve, and distribute CNS and related biological specimens to qualified investigators.

2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount will be increased as follows:

Estimated Cost ($)

Base Period Option Period 1 (Contract Year 2) Option Period 2 (Contract Year 3) Option Period 3 (Contract Year 4) Option Period 4 (Contract Year 5) Total [Base Period and Option(s)]

c. If the Government exercises its option for additional quantities of hours under this contract, pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount will be increased as follows:

Period of Performance Option Quantities for Additional

Hours (Estimated Cost) ($) Option Quantity 1

5% effort* Base Period Option Period 1 (Contract Year 2) Option Period 2 (Contract Year 3) Option Period 3 (Contract Year 4) Option Period 4 (Contract Year 5)

Transition Option (Final Year of Contract)** Transition Option (up to 80% effort less any exercised Option Quantities)

TOTAL Base Period & Option(s)

*Note: Options for additional quantities of effort (hours) may be exercised up to 16 times per contract year. **Transition Option can be exercised only during the final year of contract performance. When Transition Option is exercised, the total effort for the Transition Option and any exercised Option Quantities cannot exceed 80% of effort.

3. 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.

4. 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.

SECTION C - Description/Specifications/Work Statement

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 10/10/2024 attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract.

Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer Representative (COR).

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

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

[X] 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)

1. 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.

5. Other Reports/Deliverables

a. 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.)

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.

A. 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.

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 first annual utilization report shall be due on or before 15 calendar days after the end of the base period (if option period is exercised). Thereafter, reports shall be due on or before the 15th Calendar day following the reporting period.

The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer

National Institutes of Health

National Institue on Drug Abuse (NIDA)

Office of Acquisition

C/O NIH Mail Center, 3WFN MSC 6012

16071 Insustrial Dr - Dock 11

Bethesda, Maryland 20877

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.

SECTION D - Packaging, Marking, and Shipping

A. PACKAGING, MARKING, AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. Refer to Attachment 3, Statement of Work for specific packaging, marking and shipping details. 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.

The Contractor shall have the appropriate shipping licenses and permits from local, State, Federal and International authorities for the safe import, storage, and distribution of biological specimens, according to current regulatory guidelines, as applicable.

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) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Mental Health (NIMH) 6001 Executive Blvd.

Bethesda, MD 20892

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.

1. FAR 52.246-9 Inspection of Research and Development (Short Form). (APR 1984)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from May 1, 2025 through April 30, 2026 .

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

Option Option Period Option Period 1 (Contract Year

2) May 1, 2026 through April 30, 2027

Option Period 2 (Contract Year

3) May 1, 2027 through April 30, 2028

Option Period 3 (Contract Year

4) May 1, 2028 through April 30, 2029

Option Period 4 (Contract Year

5) May 1, 2029 through April 30, 2030

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

(1) Level of Effort (Direct Labor Hours) and Report

Electronic

Monthly; provide breakdown of LOE/hours for each named personnel as supporting documentation with monthly invoices and as indicated in the Statement of Work (SOW)

(2) Standard Operating Procedures (SOP) Electronic

Due within thirty (30) days after contract award; in accordance with information provided in the

Statement of Work (SOW)

(3) Quarterly Technical Progress Reports Electronic

Due quarterly, fifteen (15) calendar days following completion of the contract quarter, and with the final due on contract completion date; in accordance with Section C.2 of the contract as specified in the Statement of Work (SOW) (Include donor acquisition reports, specimen integrity evaluations)

(4)Annual Technical Progress Report

Electronic and one

(1) hard copy

Due annually, no later than the 20th calendar day of the month following the end of the contract year in accordance with Section C.

of the contract and as specified in the SOW

(5)Final Tehncial Progress Report

Electronic and one

(1) hard copy

Submit by completion date of the Contract in accordance with Section C of the contract and as specified in the SOW

(6)

Quality Assurance System/Quality Management Program (QMP) Plan

Electronic

Due sixty (60) calendar days following contract award; in accordance with Section C of the contract and SOW; include details of updates/changes made in scheduled Technical Progress Reports

(7)Quality Control Reports

Electronic; with exception of the reports due with the Annual and Final Reports

Quarterly, Annually, and Final with the scheduled Technical Progress Reports, in accordance with Section C of the contract and SOW

(8) Laboratory Information Management System

(LIMS)

Electronic

Due within fourteen (14) business day after contract award; include details of any updates/changes made in scheduled Technical Progress Reports

(9)Transition Plan

Electronic; with the exception of the reports due with the Annual and Final Reports

Due six (6) month after award and thereafter, annually with the Annual Technical Report and with the Final Technical Report; in accordance with Section C of Contract and Attachment 3, SOW.

(10)

Roster of Employees Requiring Suitability Investigations (including status updates on background investigations)

Electronic

Due within fourteen (14) calendar days of contract award and within fourteen (14) calendar days of new Contractor or Subcontractor employees start work date on the contract. In accordance with Section C and H of contract (notification of applicable suitability investigation)

(11)System Security Plan (SSP) Electronic Due within 30 days after contract award

(12) Security Assessment Plan Report (SAP/SAR) Electronic

Due within 30 days after contract award

(13)FIPS 199 Assessment Electronic Due within 30 days after contract award

(14) Independent Assessment and Authorization (A&A)

Electronic Due within three (3) months after contract award

(15)Plan of Actions and Milestones (POA&M) Electronic Due within 30 days after contract award

(16)Contingency Plan and Contingency Plan Test

Electronic Due within 60 days after contract award

(17)

Reporting of New and Departing Employees/Employee Separation Checklist

Electronic Due within five (5) working days for new and departing employee

(18) Contractor - Employee Non-Disclosure Agreements

Electronic

Due to the COR and CO prior to Contractor and/or Subcontractor employees performing work under the contract

(19)Vulnerability Scanning Requirements

Electronic Due monthly

(20) Standard for Security Configurations Memo

Electronic Due within 90 days of award and thereafter annually with the Annual Technical Progress Report

(21) Standard for Encryption Memo

Electronic and one

(1) hard copy with the Annual Technical Report

Due within 90 days of award and thereafter annually with the Annual Technical Progress Report

(22)…