RFP_75N95022R00097.pdf

OMB #0990-0115

NATIONAL INSTITUTE ON DRUG ABUSE

REQUEST FOR PROPOSAL (RFP) No. 75N95022R00097

“NIDA Center for Genetics Studies”

Issued by:

Joshua T. Lazarus, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892-6012

Point of Contact: Polina Klimenkova, Contract Specialist E-Mail: polina.klimenkova@nih.gov Phone: 301.443.6677

DATE ISSUED: September 14, 2022

PROPOSAL DUE: October 14, 4:00 P.M. (Eastern Time)

The National Institute on Drug Abuse (NIDA) invites you to submit a proposal responding to the requirements of this RFP No. 75N95022R00097 for the “NIDA Center for Genetics Studies.”

This Request for Proposal is released under FULL AND OPEN Competition Procedures.

NIDA prepared this Request for Proposal 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.

NIDA anticipates the award of one indefinite delivery, indefinite quantity (IDIQ), contract for fixed price task orders. NIDA expects to award at least one task order to a single contractor at award. Future funding will be made through issuance of task orders and will be dependent on program needs and funding availability. The contract will contain a guaranteed minimum of $100,000 and a maximum quantity of $15,000,000.

It is anticipated that the ordering period of the contract will be from March 14, 2023 through March 13, 2028.

Offerors shall respond with technical and cost/price proposals based on the assumptions provided in Sections C and L.

General

Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 2 is a "Proposal Intent Response Sheet." Please complete this form and return it to the below address on or before 8:00 p.m. on September 30, 2022. 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.

Requests for Information (RFIs)

Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. RFIs must be submitted on or before 8:00 p.m. on September 29, 2022. RFIs may be submitted by e-mail to josh.lazarus@nih.gov and polina.klimenkova@nih.gov with the subject line “RFI – RFP 75N95022R00097.”

The Business Proposal

You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of prices/costs by sample task order, for each cost category/element, an explanation of the basis for all prices/costs, and provide documentation to support these prices/costs. We direct special attention to Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet contained in the Business Proposal Attachments.

Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A copy of the spreadsheet must be included in the Business Proposal.

Also include with your business proposal:

• Separate cost/prices for the task order listed in the Statement of Work (SOW). Tasks for Price Proposal Evaluation (also see Attachment 12); and

• Your proposed prices in the Schedule of Contract Prices (Attachment 22).

A completed Form NIH-2043, “Proposal Summary and Data Record” 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 Small Business Subcontracting Plan, Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. See Section L.2.c. for additional detail.

The Technical Proposal

Offerors shall complete and attach the “Technical Proposal Cover Sheet” for each copy of their technical proposal.

It is important that you list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes your staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. We will use this information to ensure that no conflicts of interest exist with the selected review committee members.

Technical Proposal are detailed in Section L.2.b.

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than October 14, 2022, 4:00 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 how to submit a proposal via eCPS can be found at https://ecps.nih.gov/HowToSubmit and in Attachment 01.

All notices related to this solicitation will be posted on https://www.sam.gov as well as the NIDA Contracts Home Page (https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). 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 mailto:josh.lazarus@nih.gov mailto:polina.klimenkova@nih.gov http://rcb.cancer.gov/rcb-internet/forms/2043.pdf http://ocm.od.nih.gov/contracts/rfps/TechCov.htm https://ecps.nih.gov/ https://ecps.nih.gov/HowToSubmit https://www.sam.gov/ https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps 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 legally can 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 National Institute on Drug Abuse 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 Polina Klimenkova and Josh Lazarus, or the undersigned, at the NIDA Section, Contracts Management Branch Red. We may be reached at

(301) 443-6677; collect calls will not be accepted. Discussions with any other individual outside the NIDA Section, Contracts Management Branch Red should not occur.

Sincerely, Josh Lazarus, Contracting Officer National Institutes of Health, Office of Acquisitions, NIDA

Enclosure

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102-321 as amended

2. Request for Proposal (RFP) Number:

75N95022R00097

3. Issue Date:

September 14, 2022

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : NIDA Center for Genetic Studies

6. ISSUED BY:

NIDA Section Office of Acquisition National Institute on Drug Abuse c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 4:00 p.m. local time on October 14 2022. Offers will be valid for 150 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the eCPS Website.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS/HER DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov.

11. FOR INFORMATION CALL: Polina Klimenkova, Contract Specialist

PHONE: 301-443-6677

e-MAIL: polina.klimenkova@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Josh Lazarus Contracting Officer NIDA Section Contracts Management Branch Red, NIDA http://www.sam.gov

RFP Number : 75N95022R00097

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

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10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

5. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. TECHNICAL EVALUATION CRITERIA

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

7. EXTENT OF SMALL BUSINESS PARTICIPATION

8. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified and capable offerors to maintain and expand the NIDA Center for Genetic Studies (NCGS) as a repository to:

1. Receive de-identified clinical, diagnostic, pedigree structure, environmental exposure information and other phenotypic data along with blood samples or other biospecimens (e.g. blood, cell lines, skin fibroblasts, DNA, RNA, serum, saliva, hair, urine, fecal matter) from funded grants and/or contracts supporting research on the genetics of addiction and addiction vulnerability;

2. Process these data and materials to create databases, serum, DNA, RNA, and cell lines;

Widely distribute all data and materials in the NIDA Human Genetics Initiative to qualified investigators in the scientific community in a cost-effective manner;

3. Maintain storage of data and biospecimens;

4. As stipulated by NIDA staff, perform microarray typing on pre-existing and/or new de-identified biospecimens;

5. As stipulated by NIDA staff, perform state-of-the-art* sequencing on pre-existing and/or new de-identified biospecimens for genomic and/or epigenomic analyses in bulk tissue and single cells;

6. As stipulated by NIDA staff, perform state-of-the-art* sequencing on pre-existing and/or new de-identified biospecimens for RNA transcriptome analyses in bulk tissue or single cells;

7. As stipulated by NIDA staff perform state-of-the-art* chromatin capture, chip-seq, as cut and run sequencing.

8. Support the creation of reprogrammed cellular derivatives, such as induced pluripotent stem cells (iPSCs) to facilitate the molecular and cellular study of brain development and addiction processes;

9. Create a cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources as well as research summaries and outbound links for all addiction related studies available through the NIH database of Genotype and Phenotype (dbGaP) system; Develop advanced encryption methods that allowing linking of data in the repository to other types of data.

10. Facilitate NIDA genetic studies data (both genotype and phenotype) being uploaded into NIH databases such as BioSample, and the dbGaP systems.

*For proposal purposes, please note that the state-of-the-art technologies may change as technologies change which will drive down costs - Offerors should identify what state of the art technologies are.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Delivery 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 $100,000 (minimum) nor more than a

- 5 -total of $15,000,000 (maximum) for successful performance of this contract. The minimum amount is inclusive of all task orders issued under this contract. Total compensation will be based on the combined negotiated task orders (fixed price).

b. The prices set forth in this ARTICLE will cover the contract ordering period March 14, 2023 through March 13, 2028.

c. The Government will negotiate and award fixed price Task Orders based on the work described in SECTION C of this contract.

d. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

e. Under issued Task Orders, and upon delivery and acceptance of the item(s) described in SECTION C of this RFP and identified in the schedule of contract prices (see Attachment, Section J).

ARTICLE B.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.

ARTICLE B.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. NIDA reserves the right to have the contracted services provided to benefit NIDA and any other component of NIH.

Research under this contract shall not involve human fetal tissue or stem cell research.

[Remainder of Page Intentionally Left Blank]

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK (SOW)

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. 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's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format specified in the ARTICLE F DELIVERIES of the RFP. There are two main components to the Statement of Work (SOW), Component A is biospecimen processing and Component B is data management. Components A and B are fully described in SOW.

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

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in 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: The Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

a. Monthly Progress Report:

The Contractor shall submit the monthly report to the NIDA Contracting Officer's Representative (COR). In this report the Contractor shall include the following:

1) Number of biospecimens and samples received and transformed from each research project during the month and a cumulative total to date for the contract.

2) Subject, site, and cell repository identification (ID) numbers for each subject on whom a cell line was successfully established during the month.

3) Clear documentation of the success rate for cell line transformation during the month and for the contract to date. This shall be calculated as the number of subjects for which a cell line was successfully created, divided by the total number of subjects on whom a blood sample was received for cell line transformation.

4) Clear documentation of all unsuccessful attempts at cell line transformation during the month and for the contract to date, including corrective action taken. Requests for blood re-draws during the month shall be clearly documented.

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5) Number of subjects on whom a blood sample was submitted, for whom comprehensive clinical information obtained from a structured psychiatric diagnostic interview was received (for current month and cumulative to date).

6) Number of subjects on whom a blood sample was submitted, for whom final best estimate diagnostic information was received (for current month and cumulative to date).

7) Number of subjects on whom a blood sample was submitted, for whom environmental exposure information was received (for current month and cumulative to date).

8) Descriptive information regarding genotypic data (e.g., number of genotypes per disorder) received during the month and cumulative to date.

9) Summary of sales of data and biological materials and reimbursements during the month and cumulative amount to date. Monthly total should be the same as the offset recorded on monthly voucher.

10) Summary of remaining funds and provide an accurate accounting of costs incurred to date but not invoiced. In addition, an estimate of DNA/biological samples that would be allowed under the remaining years' current budget.

11) The Contractor shall create and maintain a Gantt chart to track the progress of work when genotyping or sequencing samples. The Gantt chart shall report:

a. The receipt of approval by COR for samples to be genotyped,

b. The date of receipt of sample manifest,

c. The date of receipt of biological samples,

d. The date for beginning and completion of genotyping or sequencing Quality Control (QC) for the samples,

e. The date for beginning and completion of genotyping,

f. The date of receipt of data and receipt of data dictionary,

g. The date when data cleaning began and when data cleaning was completed,

h. The date of submission of genotype and phenotypic data to dbGaP,

i. The date of query from dbGAP requesting clarification or amending the submission to dbGaP,

j. The date when dbGAP accepts of genotype and phenotypic data,

k. The date when dbGAP publishes the study.

The Contractor shall update the Gantt chart monthly and provide this deliverable with the administrative report.

The first reporting period consists of the first full month of performance plus any functional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. The Monthly Progress Report shall be due on or before the 5th day of the month.

b. Annual Report:

The Contractor shall submit the annual report on activities during the year. In the Annual Report the Contractor shall (1) summarize all of the activities conducted under the contract during the period covered, and (2) include an executive summary. NIDA will not require the Contractor to submit a monthly report when an annual report is due. The Annual Report is due within the first 15 calendar days after the first contract year.

c. Task Order Final Report:

When the Contractor completes a Task Order, the Contractor shall submit a Task Order Final Report to NIDA by the expiration date of the Task Order. The Contractor shall include in each Task Order Final Report a summation of the work performed and results obtained during the performance of the

- 8 -specific Task Order. This report shall be in sufficient detail to describe comprehensively the results achieved. The Contractor shall submit to NIDA the Task Order Final Report in accordance with ARTICLE F DELIVERIES of the RFP.

d. Final Report:

In the Final Report the Contractor shall include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Contractor shall submit to NIDA the Final Report in accordance with ARTICLE F DELIVERIES of the RFP. NIDA will not require an Annual Report or Monthly Report when the Final Report is due.

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.

b. 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/subtitle-A/subchapter-A/part-94.

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

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

2. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION SECURITY AND/ OR PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.

a. Security Assessment and Authorization (SA&A)

A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

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

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

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b. SA&A Package Deliverables

The Contractor (and/or any subcontractor) shall provide an SA&A package within 90 calendar days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

• System Security Plan (SSP) - due within 90 calendar days after contract award. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements and should include a network diagram. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

• Assessment Plan / Report (SAP/SAR) - due 90 calendar days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies.

The assessor will document the assessment results in the SAR. The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment.

Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below. Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

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

• POA&M - due 90 calendar days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 calendar days from the date the weaknesses are formally identified and documented. The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated

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POA&M weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

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

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

c. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)

The Contractor shall assist the NIH Office of the Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed. The NIH PIA guide is located at https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/ NIH%20PIA%20Guide.pdf.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the OpDiv SOP or designee with completing a PIA for the system or information within 60 calendar days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the NIH Office of the SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

The Contractor shall update the PTA/PIA on an annual basis.

d. FIPS 199 Assessment

In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability , which means ensuring timely and reliable access to and use of information.

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b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements.

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) calendar days after contract award and then annually within thirty (30) calendar days of the contract anniversary. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

e. Position Sensitivity Designations

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

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

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

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

f. Contractor Non-Disclosure Agreement (NDA)

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

3. Section 508 Annual Report

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

4. Multiple Principal Investigators Leadership Plan The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

The 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 Contracting Officer and the Contract Specialist electronically.

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 encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

[Remainder of the Page Left Intentionally Blank]

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SECTION D - PACKAGING, MARKING AND SHIPPING

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

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer, or his/her 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 (See Article G.1) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse c/o 3WFN MSC 6012 301 North Stonestreet Ave Bethesda, Maryland 20892

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

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

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

FAR Clause 52.246-16, Responsibility for Supplies (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The ordering period for this contract shall be from March 14, 2023 through March 13, 2028. The period of performance for each task order shall be specified in the respective task order.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the SOW (see Attachment 3) of this contract (as issued under specific task orders) 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 and anyway else in this contract will be required to be delivered electronically and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule

(1) Monthly Progress Report 1 electronic copy to COR On or before the 5th calendar day of each month

(2) Annual Progress Report 1 electronic copy to COR

& CO

Within 15 calendar days after the first contract year.

(3) Task Order Final Report 1 electronic copy to COR &

CO

On or before task order expiration

(4) Final Report 1 electronic copy to COR &

CO

On or before contract expiration

(5) Individual Subcontract Report 1 electronic submitted to eSRS

Semi-Annually on April 30th and October 30th

(6) Summary Subcontract Report 1 electronic submitted to eSRS

Annually on October 30th

(7) Section 508 Annual Report 1 electronic copy to CO Within 15 business days of end of each contract year

(8) Annual Utilization Report 1 electronic copy to CO Within 15 business days of end of each contract year

(9) Final Invention Statement 1 electronic copy to CO On or before contract expiration

(10) Roster of Employees Requiring

Suitability Investigations 1 electronic copy to COR &

CO

Within 14 calendar days of contract effective date and updated as necessary upon changes in staff

(11) Report of New and Departing Employees

1 electronic copy to COR &

CO

Within 7 business days of any staff changes

(12) Contractor Non-Disclosure Agreement

1 electronic copy to COR &

CO

Within 5 business days of any staff changes

(13) Reporting of Financial Conflict of Interest (FCOI) electronic copy to CO See Article C.2(b)(1) for details.

(14) Summary of Salient Results 1 electronic copy to COR and the CO

On or before contract expiration

(15) System Security Plan (SSP) 1 electronic copy to COR & CO and ISSO

Within 90 calendar days of contract award and updated annually

(16) E-Authentication Questionnaire 1 electronic copy to COR & CO and ISSO

Within 90 calendar days of contract award and updated annually

(17) Security Assessment Plan (SAP) & Security Assessment Report (SAR)

1 electronic copy to COR & CO and ISSO

Within 90 calendar days of contract award and updated annually on the contract anniversary date.

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Item Description Quantity Delivery Schedule

(18) FIPS 199 System

Categorization 1 electronic copy to COR &

CO

Within 30 calendar days of contract award and updated annually

(19) Plan of Actions & Milestones

(POA&M)

1 electronic copy to COR & CO and ISSO

Within 90 calendar days of contract award and updated annually

(20) Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

1 electronic copy to COR & CO and ISSO

Within 90 calendar days after completion of the PTA and updated annually

(21) Revised/Updated Multiple Principal Investigators Leadership Plan

1 electronic copy to COR and the CO

Prior to any change in Principal Investigators named in ARTICLE G.2.

KEY PERSONNEL

In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for providing the following items: Indirect cost rate proposals for all years (in which a proposal was not previously submitted); final property inventory (excluding intellectual property); standard forms 1428 and 1429 (if applicable);

settling all subcontract costs and any issues thereunder; subcontracting compliance reports for all years to the eSRS;

final patent and royalty reports; Contractor's release of claims, i.e. Contractor's closing statement; the Contractor's Assignment of Refunds, Rebates and Credits; and a final invoice or completion voucher (marked final).

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

TBD

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.

The Government may unilaterally change its COR designation, at any time during the performance of the contract.

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

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

(End of Clause)

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

Name Title

To Be Named

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to…