RFP_75N95023R00034.pdf

National Institute on Drug Abuse Request for Proposal (RFP) No. 75N95023R00034

“National Addiction and HIV Data Archive Program”

Issued by:

Josh Lazarus, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisitions, National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

Point of Contact: Scott Duernberger, Contract Specialist E-Mail: scott.duernberger@nih.gov Phone: 301.594.0670

DATE ISSUED: Wednesday, August 16, 2023

PROPOSAL DUE DATE: Friday, September 29, 2023, 12:00 P.M. Eastern Time

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95023R00034 titled “National Addiction and HIV Data Archive Program”.

This RFP is prepared in accordance with the Uniform Contract Format (UCF) prescribed for Government wide application by the Federal Acquisition Regulation (FAR). The UCF is both an RFP and contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

The Government anticipates to award a single cost reimbursement type contract with a base period of 1 year with the potential for four 1-year option years and additional options for increased quantities. The Government may fund options dependent on the previous year's performance and the availability of funds. The estimated base performance period of the contract will be from April 1, 2024 to March 31, 2025. Offerors must respond with separate technical and pricing proposals for the entire project and total period of performance, including separately priced option years and options for increased quantities.

All offerors must be REGISTERED and have an ACTIVE System for Award Management http://www.sam.gov/ (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management http://www.sam.gov/(www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance and FAR 52.207-7 System for Award Management to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

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 scott.duernberger@nih.gov by August 30, 2023. 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.

Furnish in writing (e-mail is acceptable) to the Contracting Officer any areas of uncertainty, which, in your opinion, require clarification or correction. You must submit your questions in sufficient time for receipt by the Contracting Officer and Contract Specialist on or before August 30, 2023. Mark the e-mail, "Offeror's Questions, RFP No. 75N95023R00034."

The Business Proposal

The Business Proposal must contain a detailed breakdown of costs by task, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. Please utilize the Breakdown of Proposed Estimated Costs and Excel spreadsheet contained in Attachment 10.

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.

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.

The Technical Proposal

Offerors shall complete and attach a Technical Proposal Cover Sheet to their technical proposal. Be sure to list all professional personnel and organizations named in the proposal who have any role in the proposed work including staff, subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be shown for each person named. If needed, additional sheets may be included using the same format. This information is vital to ensure that no conflicts of interest exist with the review committee members.

Format and content requirements for the 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 Friday, September 29, 2023, 12:00 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/home/howto and in Attachment 01.

All notices related to this solicitation will be posted on SAM.gov (http://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.gov

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 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 Scott Duernberger, at the NIDA Section, Contracts Management Branch Red, who may be reached at scott.duernberger@nih.gov or (301) 594-0670; 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 NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA/NIH

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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:

75N95023R00034

3. Issue Date:

August 16, 2023

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : National Addiction and HIV Data Archive Program

6. ISSUED BY:

NIDA Section Contracts Management Branch, Red Office of Acquisition, National Institute on Drug Abuse C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive - Dock 11 Gaithersburg, MD 20877

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 12:00 p.m. Eastern Standard Time on September 29, 2023. Offers will be valid for 180 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 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 System for Award Management (SAM) prior to award of a contract. Offerors must access the The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Scott Duernberger, Contract Specialist

PHONE: 301-594-0670

e-MAIL: scott.duernberger@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

http://www.sam.gov

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

Joshua T. Lazarus Contracting Officer, NIDA Section Contracts Management Branch, Red Office of Acquisition, NIDA

RFP Number : 75N95023R00034

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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

a. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

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10. Specific Copyright Provisions Applicable to Software Development and/or Enhancement(s)

11. Privacy Act - Treatment of Proposal Information

12. Selection of Offerors

13. Institutional Responsibility Regarding Investigator Conflicts of Interest

14. ROTC Access and Federal Military Recruiting on Campus

15. Past Performance Information

16. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT

PROCUREMENTS

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

18. 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

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. 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. EVALUATION OF OPTIONS

4. EVALUATION OF DATA SHARING PLAN

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objectives of this contract are to continue a data archive of drug addiction and HIV research data, primarily archiving social and behavioral science data, though other data could be included. The vendor shall:

1. Develop, maintain, and expand data infrastructure and data archive access that complies with federal security requirements and provide tiered level of controlled data access;

2. Expand the holdings of NAHDAP by recruiting drug addiction and HIV social science and/or transdisciplinary researchers to deposit their data by actively working with the drug addiction and HIV research fields;

3. Ensure that deposited data get maximum use, in part by devising and implementing outreach and marketing strategies to ensure the drug addiction and HIV research fields are aware of the special topic archive and of what datasets are available for secondary analysis and by displaying the utility of this approach for addressing new research questions;

4. Monitor and track data use statistics and citations resulting from data archived in NAHDAP;

5. Provide technical assistance support to data producers and data depositors to assist in preparing their data for archiving and planning for the data deposition process;

6. Provide technical assistance support to data users, including organized workshops and trainings;

7. Develop a system to prioritize datasets and apply the appropriate level of curation to high priority datasets while making others available with less curation and cost;

8. Stay abreast of advances in the field of data archiving and integrating cutting edge strategies into the archive and implementing them when directed by the COR.

ARTICLE B.2. ESTIMATED COST - OPTION

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

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

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

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. 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 represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

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Period of Performance Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee ($)

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 Period(s)

ARTICLE B.3. OPTION PRICES

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

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

b. Pursuant to FAR Clause 52.217-7 set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Quantity Task(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract.

The estimated cost plus fixed fee of this contract will be increased as set forth in paragraph c., below. Option Quantity Task A may be exercised once during the Base Period of the contract and once during the final contract year. Option Quantity Task B, may be exercised up to (10) times, and Option Quantity Task C, may be exercised up to (15) times during each year of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract.

c. Upon the delivery and acceptance of the Option Item described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the amount set forth below:

Option Quantity Task Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Option Quantity Task A, Base Period

Option Quantity Task A, Final Contract Year

Option Quantity Task B, Option Quantity Task C,

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Option Quantity Task Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award. NIDA reserves the right to have the contracted services in this contract benefit NIDA and other components of NIH.

[Remainder of Page Intentionally Left Blank]

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, 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 as specified in the ARTICLE F DELIVERIES of the

RFP.

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

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. 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 purposes, electronic version(s) of the following reports will be required:

a. Project Management Plan (PMP): The Contractor shall submit a revised Project Management Plan (PMP) to the COR that documents the plans for managing all project tasks to help ensure project objectives are met.

b. Addendum Update of the Project Management Plan: In the subsequent option periods, the Contractor shall submit an addendum update of the respective PMP to the COR in accordance with the SOW. The purpose of the addendum is to summarize and highlight key changes in the PMP resulting from the execution of the NAHDAP requirements, as the final reference and resource.

c. Monthly Meeting Agenda: The Contractor shall develop and submit a meeting agenda to the COR, in a format approved by the COR, in accordance with the SOW. The Contractor shall attach to the meeting invite the meeting agenda and minutes from the previous meeting.

d. Monthly Meeting Minutes: The Contractor shall develop and submit a meeting agenda to the COR, in a format approved by the COR, in accordance with the SOW. The Contractor shall attach to the meeting invite the meeting agenda and minutes from the previous meeting.

http://www.hhs.gov/web/508/index.html

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f. Semi-annual Report: At the request of the COR the contractor will provide semi-annual reports.

This report shall contain an outline and summary of notable achievements, methods followed, results obtained, and problems encountered and their solutions during the last six months of the contract.

This report shall be due within 15 calendar days following the six month period being reported on. The monthly report is not required when semi-annual report is submitted.

g. Annual Report: This report shall include a summation of results of the entire contract work for the period covered (monthly and semi-annual reports are not required when they coincide with the annual report).

h. Monthly Budget Report: These reports shall detail expenditures and projected expenses by task on a monthly basis. The report must include a summary of personnel time in hours for the last month, by task (or major subtask, when appropriate); estimated percent of total time expended; and a chart of costs, by task (or major subtask when appropriate), for the month and cumulative total in a format approved by the COR. The report must comment on the expenditure of funds in any month that deviates from the expected expenditure.

i. Inventory of Potentially Upcoming Datasets: The Contractor shall identify potential datasets for deposit. The inventory matrix must be searchable and sortable and must contain, at a minimum, details on the name of the study, populations and topics covered, the sponsor and/or PI, the organization that conducted the study, whether the data are available through alternate sources, whether a disclosure analysis was or will be needed, and confidentiality assurances provided to respondents.

j. Data Archive Access Plan: The Contractor shall submit to the COR the Data Archive Access Plan in accordance with the SOW and implement this plan upon COR’s approval.

k. Addendum Update of the Data Archive Access Plan: In the subsequent option periods, the Contractor shall submit to the COR the Addendum Update of the Data Archive Access Plan as an addendum for the sole purpose of documenting key changes in accordance with the SOW.

l. Disaster Recovery Plan: the Contractor shall develop a disaster recovery plan to cover both man-made and natural disasters. The plan must include, but not be limited to, the following features: a) maintain at least one complete copy of all data files (both public-use and original source data) in a secure off-site storage facility; b) a back-up equipment plan; and c) a timeline and a list of resources required to perform a full disaster recovery. The Contractor shall submit the disaster recovery plan to the COR in accordance with the SOW.

m. Outreach, Expansion, and Tracking Plan: The Contractor shall submit to the COR the Outreach, Expansion, and Tracking Plan in the base year in accordance with the SOW and implement this plan upon COR’s approval.

n. Addendum Update of the Outreach, Expansion, and Tracking Plan: In the subsequent option periods, the Contractor shall submit to the COR the Addendum Update of the Outreach, Expansion, and Tracking Plan as an addendum for the sole purpose of documenting key changes in accordance with the SOW.

o. Data Deposition and Dissemination Plan: The Contractor shall submit to the COR the Data Deposition and Dissemination Plan in the base year in accordance with the SOW and implement this plan upon COR’s approval.

p. Addendum Update of the Data Deposition and Dissemination Plan: In the subsequent option periods, the Contractor shall submit to the COR the Addendum Update of the Data Deposition and Dissemination Plan as an addendum to attach for the sole purpose of documenting key changes in accordance with the SOW.

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q. Data Producer and Depositor Technical Assistance (TA) Plan: The Contractor shall submit to the COR the Data Producer and Depositor TA Plan in the base year in accordance with the SOW and implement this plan upon COR’s approval.

r. Addendum Update of the Data Producer and Depositor Technical Assistance (TA) Plan: In the subsequent option periods, the Contractor shall submit to the COR the Addendum Update of the Data Producer and Depositor TA Plan as an addendum to attach for the sole purpose of documenting key changes in accordance with the SOW.

s. Data User TA Plan: The Contractor shall submit to the COR the Data User TA Plan in the base year in accordance with the SOW and implement this plan upon COR’s approval.

t. Addendum Update of the Data User TA Plan: In the subsequent option periods, the Contractor shall submit to the COR the Addendum Update of the Data User TA Plan as an addendum for the sole purpose of documenting key changes in accordance with the SOW.

u. Revised Transition Plan: The Contractor shall update and submit a revised Transition Plan to the COR in accordance with the SOW.

v. Special Project Plan: The Contractor shall submit a Special Project Plan in accordance with the SOW that details how the Contractor plans to accomplish the requirements, including the proposed timeline, resources, and how the progress will be monitored and communicated to the COR.

w. Special Project Plan: At the completion of the special project, the Contractor shall submit a Special Project Report in accordance with the SOW to describe what has been accomplished, timeline undertaken, evaluation of the effectiveness of the special project as applicable, and recommendations and next steps. The content of the report will be developed in consultation with the

COR.

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: http://www.ecfr.gov/cgi-bin/text-idx?

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

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

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

2. Source Code and Object Code http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

3. Information and/or Physical Security The Contractor shall submit reports as required and described by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H.13 and listed in F.2 of this contract.

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

5. Disaster Recovery Plan The Contractor shall submit a Disaster Recovery Plan in accordance with Task 2, #4 of the Statement of Work.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

The first annual utilization report shall be submitted in accordance with the DELIVERIES Article is SECTION F of this RFP. 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 electronically to the Contracting Officer and the Contracting Officer's Representative.

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

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

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

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract 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 the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, (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 Division of Epidemiology Service and Prevention Research NIDA 3WFN MSC 6023 - 16071 Industrial Drive - Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

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).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from April 1, 2024 through March 31, 2025.

a. 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 Quanitiy A (if exercised) January 1, 2024 – March 31, 2024 Option Year 1, Contract Year 2 April 1, 2025 - March 31, 2026 Option Year 2, Contract Year 3 April 1, 2026 - March 31, 2027 Option Year 3, Contract Year 4 April 1, 2027 - March 31, 2028 Option Year 4, Contract Year 5 April 1, 2028 - March 31, 2029

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Task Name Date Due (1a) Task 1. Project Management Revised Project Management

Plan Thirty (30) days after CED

(1b) Task 1. Project Management Addendum Updated of the Project Management Plan

Thirty (30) days after beginning of the option period

(2a) Task 1. Project Management Monthly Meeting Agenda Seven (7) days prior to the meeting

(2b) Task 1. Project Management Monthly Meeting Minutes Seven (7) days after completion of the meeting

(3) Task 1. Project Management Semi-Annual Report and Annual Report

Fifteen (15) days following six-month period unless otherwise specified by the COR; Annual report at the end of the POP

(4) Task 1. Project Management Monthly Budget Report Fifteen (15) days after each month

(5) Task 1. Project Management Inventory of Potentially Upcoming Datasets

Fifteen (15) days after each quarter

(6a) Task 2. Data Archive Access Data Archive Access Plan Thirty (30) days after CED (6b) Task 2. Data Archive Access Addendum Update of the

Data Archive Access Plan Thirty (30) days after beginning of the option period

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Item Task Name Date Due

(7) Task 2. Data Archive Access Disaster Recovery Plan Ninety (90) days after CED and ninety (90) days after a disaster

(8a) Task 3. Outreach, Expansion, and Tracking

Outreach, Expansion, and Tracking Plan

Thirty (30) days after CED

(8b) Task 3. Outreach, Expansion, and Tracking

Addendum Update of the Outreach, Expansion, and Tracking Plan

Thirty (30) days after beginning of the option period

(9a) Task 4. Data Deposition and Dissemination

Data Deposition and Dissemination Plan

Thirty (30) days after CED

(9b) Task 4. Data Deposition and Dissemination

Addendum Update of the Data Deposition and Dissemination Plan

Thirty (30) days after beginning of the option period

(10a) Task 5. Technical Assistance to Data Producers and Depositors

Data Producer and Depositor TA Plan

Thirty (30) days after CED

(10b) Task 5. Technical Assistance to Data Producers and Depositors

Addendum Update of the Data Producer and Depositor TA Plan

Thirty (30) days after beginning of the option period

(11a) Task 6. Technical Assistance to Data Users

Data User TA Plan Thirty (30) days after CED

(11b) Task 6. Technical Assistance to Data Users

Addendum Update of the Data User TA Plan

Thirty (30) days after beginning of the option period

(12) Option Quantity Task A.

Transition Services

Revised Transition Plan Thirty (30) days after CED

(13) Option Quantity Task B.

Special Projects

Special Project Plan To be determined by the

COR

(14) Option Quantity Task B. Special Projects

Special Project Plan To be determined by the

COR

(15) Information and System Security

System Security Plan (SSP) Within 90 calendar days of contract award and updated annually from contract award, if options are exercised

(16) Information and System Security

Penetration Testing Plan & Test Results

Within 90 calendar days of contract award

(17) Information and System Security

Security Assessment Plan/ Report (SAP/SAR)

Within 90 calendar days of contract award

(18) Information and System Security

Vulnerability Management Plan

Within 90 calendar days of contract award

(19) Information and System Security

Plan of Actions and Milestones (POA&M)

Within 90 calendar days of contract award

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Item Task Name Date Due

(20) Information and System

Security Contingency Plan (CP) and Contingency Plan Test (CPT) Report

Within 90 calendar days of contract award

(21) Information and System Security

Configuration Baseline & Configuration Management Plan (CMP)

Within 90 calendar days of contract award and updated annually from contract award, if options are exercised

(22) Information and System Security

Interconnection Security Agreement / Data Use Agreements (if applicable)

Within 90 calendar days of contract award

(23) Information and System Security

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

Within 90 calendar days of the PTA and updated annually from contract award, if options are exercised

(22) Information and System Security

FIPS 199 Assessment Within 90 calendar days of contract award

(23) Information and System Security

Incident and Breach Response Plan

Within 90 calendar days of contract award

(24) Information and System Security

E-Authentication Threshold Analysis (ETA) / E- Authentication Risk Assessment (ERA)

Within 90 calendar days of contract award

(25) Information and System Security

Authorization To Operate / Recommendation to Operate Letter

Within 90 calendar days of contract award

(26) Information and System Security

Incident Response Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery.

Incident Reporting outlined within Incident Response Plan.

(27) Information and System Security

Operating system, database, Web application, and network vulnerability scan results

Due 60 days after contract award, and then Monthly or as requested by NIDA. Scan results must include Asset Name, IP address, vulnerability, and scan result and formatted & sorted as requested by NIDA.

(28) Information and System Security

POA&M updates Due 60 days after contract award, and then Monthly or as requested by NIDA. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented

(29) Information and System Security

Updated/revised A&A authorization package documentation.

Due 60 days after contract award, and then Monthly or as requested by NIDA.

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Item Task Name Date Due

(30) Information and System

Security Any configuration changes to the system and/or system components or CSP’s cloud environment, that may impact HHS/NIH/NIDA’s security posture.

Due 60 days after contract award, and then Monthly or as requested by NIDA.

(31) Information and System Security

Roster of Employees Requiring Suitability Investigations

Within 30 calendar days of contract award

(32) Information and System Security

Report of New and Departing Employees

Within 5 days of relevant staff changes

(33) Information and System Security

Non-Disclosure Agreements Prior to performance of any work under this contract

(34) Information and System Security

Encryption Validation Within 15 days of validation.

Verification that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2

(35) Information and System Security

Training Records. Copy of training records for all mandatory training. In conjunction with contract award and annually thereafter or upon request. No later than 30 days after contract award.

(36) Information and System Security

Rules of Behavior Initiation of contract and at least annually thereafter. NIH Rules of Behavior found within the NIH Annual Information Security Training Course. If additional Rules of Behavior apply for NIDA, they will be provided.

(37) Information and System Security

List of Personnel with defined roles and responsibilities

Within 30 Days of the effective date of this contract or before an employee begins working on this contract.

(38) Information and System Security

Onboarding documentation when beginning contract

Prior to performing any work on behalf of HHS. Contract employees will receive further instructions via email from the NIH Division of Personnel Security and Access Control

(DPSAC).

(39) Information and System Security

Off-boarding documentation, equipment and badge when leaving contract

Within 3 days after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

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Item Task Name Date Due

(40) Information and System

Security Certification of Sanitization of Government Files and Information

2 weeks prior to contract expiration or as directed by the NIDA. See Appendix G of NIST SP 800-88 for sample form.

(41) Information and System Security

If the procurement involves a system or cloud service, additional documentation will be required, such as a Disposition/ Decommission Plan.

At least 2 weeks prior to contract expiration, or as directed by the NIDA.

(42) Information and System Security

Asset Inventory/Management Report

A SCAP-compliant tool generated inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. Due within 90 days after contract award.

(43) Information and System Security

Section 508 Annual Report Within 15 calendar days following the end of each contract year, if options are exercised

(44) Information and System Security

Disaster Recovery Plan Within 30 calendar days of contract award and updated annually from contract award, if options are exercised

(45) n/a Annual Utilization Report Within 15 calendar days following the end of each contract year, if options are exercised

(46) n/a Final Invention Statement on or before contract expiration

b. 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. LEVEL OF EFFORT

a. During the Base Period of performance of this contract, the Contractor shall provide (TBD) direct labor hours.

If all Option Periods of this contract are exercised, the Contractor shall provide (TBD) labor hours. Additionally, labor hours for Option Quantities are as specified below. The labor hours exclude vacation, holiday, and sick leave. These labor hours exclude subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

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Labor Category

Base Period (Year 1)

Option Period 1 (Year 2)

Option Period 2 (Year 3)

Option Period 3 (Year 4)

Option Period 4 (Year 5)

Total

Total (Base and Option Periods) Option Quantity A Option Quantity B Option Quantity C Option Quantity Subtotal

Total

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer Hours than the minimum specified number of direct labor Hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of Hours by which the number of direct labor Hours furnished is less than the number of direct labor Hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

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

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

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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:

(To be specified prior to award.)

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

The Alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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

The Government may unilaterally change its COR designation.

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

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual.