RFP 75N95020R00018.pdf

OMB #0990-0115

NATIONAL INSTITUTE ON DRUG ABUSE

REQUEST FOR PROPOSAL (RFP) No. RFP Number : 75N95020R00018

“NIDA Developmental Studies Biorepository and Analysis Center”

Issued by:

Andrew R. Hotaling, Contracting Officer NIDA Section, Contracts Management Branch Blue Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892-6012

Point of Contact: Josh Lazarus, Contract Specialist E-Mail: josh.lazarus@nih.gov Phone: 301.443.6677

DATE ISSUED: February 25, 2020

PROPOSAL DUE: April 9, 2020, 3:00 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. 75N95020R00018 for the “NIDA Developmental Studies Biorepository and Analysis Center.”

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 $300,000 and a maximum quantity of $47,000,000.

It is anticipated that the performance period of the contract will be from September 17, 2020 through September 16, 2025. 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 4:00 p.m. on Tuesday, March 10, 2020. 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 4:00 p.m. on Tuesday, March 10, 2020. RFIs may be submitted by e-mail to josh.lazarus@nih.gov and andrew.hotaling@nih.gov with the subject line “RFI – RFP 75N95020R00018.”

NIDA may conduct site visits after the submission of proposal and prior to award.

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.

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 Cost Information, Attachment 11. Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A hard copy of the spreadsheet must be included in the Business Proposal. Additionally, an electronic copy may be provided utilizing NIH’s Secure File Transfer program at https://secureemail.nih.gov.

Do not send encrypted files.

Also include with your business proposal:

• Separate cost/prices for the task order listed in the Statement of Work (SOW) in Part E. Tasks for Price Proposal Evaluation (also see Attachment 11); and

• Your proposed prices in the Schedule of Contract Prices (Attachment 19).

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.

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than April 9, 2020, 3:00 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 the Government Point of Entry (GPE) (https://beta.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 the GPE

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 Josh Lazarus, or the undersigned, at the NIDA Section, Contracts Management Branch Blue. 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 Blue should not occur.

Sincerely, Andrew R. Hotaling, 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:

75N95020R00018

3. Issue Date:

February 25, 2020

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : NIDA Developmental Studies Biorepository and Analysis Center

6. ISSUED BY:

NIDA Section Contracts Management Branch Blue Office of Acquisition National Institute on Drug Abuse National Institutes of Health 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 3:00 p.m. local time on April 9, 2020. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, " Proposal Summary and Data Record, NIH 2043."

9. This solicitation requires delivery of proposals 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 (S AM) prior to award of a contract. Offerors must access The System for Award Management (SAM) at http://www.sam.gov.

11. FOR INFORMATION CALL: Josh Lazarus, Contracting Officer

PHONE: 410-443-6677

e- MAIL: josh.lazarus@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Andrew R. Hotaling, Contracting Officer Office of Acquisition, NIDA NIDA Section Contracts Management Branch Blue http://www.sam.gov

RFP Number : 75N95020R00018

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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

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

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

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

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. 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. 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. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION FACTORS

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 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 objective of this contract is to establish and maintain the Adolescent Brain Cognitive Development (ABCD) Study and the HEALthy Brain and Child Development (HBCD) Study Biorepository and Analysis Center, which shall:

• Provide a biorepository capable of storing over 2,000,000 samples in a secured, humidity and temperature-controlled facility at each samples’ required storage conditions in accordance with current Best Practices for Repositories, Biospecimen Resources, Clinical and Laboratory Standards, and Good Laboratory Practice (GLP; 21 CFR 58). The College of American Pathologist’s (CAP) Biorepository Accreditation is preferred;

• Provide Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for performing metabolic, hematologic, and other assays, and cutting-edge, high-throughput genotyping, sequencing, and gene-expression capabilities;

• Develop strong cooperative relationships with the ABCD and HBCD Data Centers and study experts in genetics and biospecimens. The Government may execute task orders or modifications to task orders for changes to the protocols, data structure, or type of services that may be required as the studies mature (see Sample Task Orders for reference);

• Provide or develop an Application Programming Interface (API) for the transmission of data to the ABCD and HBCD Data Centers and a cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources; and

• Create and maintain a data management system including a technical and administrative infrastructure to ensure efficient planning, initiation, implementation, documentation and management of all contract activities. This includes Standard Operating Procedures (SOPs) for tasks such as sample receipt, storage, processing, quality control, and distribution procedures.

ARTICLE B.2. PRICES/COSTS

1. 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 $300,000 (minimum) nor more than a total of $47,000,000 (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).

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2. The prices set forth in this ARTICLE will cover the contract period September 17, 2020 through September 16, 2025.

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

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

5. 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 19).

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.

To ensure that the Contractor is aware of the criticality of beginning contract close out process immediately following contract expiration, the Contractor shall include an Advance Understandings provision identifying the requirement to submit certain close out documents at the time of delivery of the final report under the contract, and is advised that quick close out procedures in accordance with FAR 42.7 shall be used by the Government to the maximum extent possible to expedite the administrative close of the contract or task order.

[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 09-25-0200 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 formatas 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 Reports

1. Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. NOTE: The Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

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

a. Monthly Progress Report:

On or before the 15th calendar day of each calendar month, 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.

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

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3) 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.

4) The Contractor shall coordinate with the COR and the Data Centers regarding the frequency, content, format, and method of delivery for genetic, metabolic, and other data transfers.

5) The Contractor shall create and maintain a separate spreadsheet for each Study and for each subcomponent as identified by the COR, to track the progress of work when processing, genotyping or sequencing samples. The spreadsheet shall report:

a. The date of receipt of biological samples,

b. The date for beginning and completion of QC for the samples,

c. The date for beginning and completion of genotyping or analysis,

d. The date(s) when data and clinical reports were sent to the Data Centers, the file names, and a description of the content of the files.

The Contractor shall update the spreadsheet 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.

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. An annual report will not be required for the period when the Final Report is due. A Monthly Report shall not be submitted when an Annual Report is due.

The Annual Report shall be due within 15 calendar days after the Anniversary Date of the Contract.

Thereafter, reports shall be due on or before 15 calendar days following the reporting period.

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 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

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1. Reporting of Financial Conflict of Interest (FCOI)

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

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

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

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

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

2. Annual Data Delivery Deadlines for the Data Centers

The Contractor shall provide one report annually, as directed by the COR samples collected by the data lock deadline which shall be genotyped/analyzed and data and clinical reports sent to the respective Data Centers by the end of the Study quality control (QC) window for the annual curated release.

3. Training Materials

The Contractor shall coordinate with the Data Centers regarding the frequency, content, format, and method of delivery for genetic, metabolic, and other data transfers.

a. Annual Meeting:

The Contractor shall prepare a presentation for both the ABCD and HBCD annual meeting, At the annual meeting, Contractor shall meet with the ( s) and members of the study team to procedures and answer questions from study participants. The Contractor shall prepare 2 seperate presentations and deliver the final presentations to the COR 15 calendar days prior to each of the annual meetings.

b. Training Semi- annual:

The Contractor shall prepare a presentation( s) highlighting its standard operating procedures for collecting biospecimens, short- term storage conditions, shipping logistics, sample processing, tracking, ordering additional collection supplies, sample distributions and ultimate long- term storage. In addition to presentations, Contractor shall provide Principal Investigators ( PIs) and their representatives access to biospecimen collection kits as well as hands- on detailed instruction on the biospecimen collection process. The Contractor shall prepare 2 seperate presentations and deliver the final presentations to the COR 15 calendar days prior to each of the semi- annual meetings.

c. Training M anagement Information Ongoing:

The Contractor shall provide site coordinators and research staff with training materials for collecting samples and interfacing with the Contractor's data systems ( i.e., the Laboratory Information Management System (LIMS)) in an online training course format. Contractor will collaborate with Study training coordinators to arrange access to the online training, and will provide a record of which individuals have completed training and had an account created and the related dates to Study training coordinators and the COR. Upon completion of the training and activation of each account, the Contractor shall include in the monthly report, a list of those individuals who have completed the training to receive a certificate and who have activated their account.

4. 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.

a. Upon contract completion the Contractor shall deliver all data sets, files, records, electronic programs and records generated under this contract.

b. Upon contract completion the Contractor shall deliver all copies of licenses, copyrighted instruments, and CRF agreements generated under this contract.

5. Contract Closeout Deliverable Package In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for providing the following items (as applicable): Indirect cost rate proposals for all years (in which a proposal was not previously submitted); final property inventory (excluding intellectual property); standard forms SF1428 and SF1429 (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).

6. 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.

c. Information Security and/or Physical Access Security Deliverables

1. BASELINE SECURITY REQUIREMENTS

a. Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor.

Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

b. Standard for Encryption- The Contractor (and/or any subcontractor) shall:

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1. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

2. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

3. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption standard requirements.

Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including

PII).

4. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative within 15 calendar days of the validation.

5. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/ decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

c. 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.

d. 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.

2. TRAINING

a. Mandatory Training for All Contractor Staff- All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training Policies.

http://irtsectraining.nih.gov/

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b. Role-based Training- All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/ Pages/rolebasedtraining.aspx.

c. Training Records- The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 calendar days after contract award and annually thereafter or upon request.

3. RULES OF BEHAVIOR

a. The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior https://ocio.nih.gov/InfoSecurity/training/Pages/ nihitrob.aspx, which are contained in the NIH Information Security Awareness Training Course http:// irtsectraining.nih.gov.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual NIH Information Security Awareness Training. If the training is provided by the contractor, the signed Rules of Behavior must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. BASELINE SECURITY REQUIREMENTS

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.

1. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 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 30 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 https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

- 12 -bid or proposal that resulted in the award of this contract. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

• Assessment Plan / Report (SAP/SAR) - due 30 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 30 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 POA&M weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

• Contingency Plan and Contingency Plan Test - due 60 calendar days after contract award.

The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies.

Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

• E-Authentication Questionnaire - The Contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary.

System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines. Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

5. CLOUD SERVICES

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a. HHS FedRAMP PRIVACY AND SECURITY REQUIREMENTS The Contractor (and/or any subcontractor) shall be responsible for the following privacy and security requirements:

1. FedRAMP Compliant ATO. Comply with FedRAMP Security Assessment and Authorization (SA&A) requirements and ensure the information system/service under this contract has a valid FedRAMP compliant (approved) authority to operate (ATO) in accordance with Federal Information Processing Standard (FIPS) Publication 199 defined security categorization. If a FedRAMP compliant ATO has not been granted, the Contractor shall submit a plan to obtain a FedRAMP compliant ATO by 30 calendar days of the contract award.

a. A security control assessment must be conducted by a FedRAMP third-party assessment organization (3PAO) for the initial ATO and annually thereafter or whenever there is a significant change to the system's security posture in accordance with the FedRAMP Continuous Monitoring Plan.

6. PROTECTION OF INFORMATION IN A CLOUD ENVIRONMENT

a. If contractor (and/or any subcontractor) personnel must remove any information from the primary work area, they shall protect it to the same extent they would the proprietary data and/or company trade secrets and in accordance with HHS/NIH policies.

b. HHS will retain unrestricted rights to federal data handled under this contract. Specifically, HHS retains ownership of any user created/loaded data and applications collected, maintained, used, or operated on behalf of HHS and hosted on contractor's infrastructure, as well as maintains the right to request full copies of these at any time. If requested, data must be available to HHS within one (1) business day from request date or within the timeframe specified otherwise. In addition, the data shall be provided at no additional cost to HHS.

c. The Contractor (and/or any subcontractor) shall ensure that the facilities that house the network infrastructure are physically and logically secure in accordance with FedRAMP requirements and HHS policies.

d. The contractor shall support a system of records in accordance with NARA-approved records schedule(s) and protection requirements for federal agencies to manage their electronic records in accordance with 36 CFR § 1236.20 & 1236.22 (ref. a), including but not limited to the following:

1. Maintenance of links between records and metadata, and

2. Categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

e. The disposition of all HHS data shall be at the written direction of HHS/NIH. This may include documents returned to HHS control; destroyed; or held as specified until otherwise directed. Items returned to the Government shall be hand carried or sent by certified mail to the COR.

f. If the system involves the design, development, or operation of a system of records on individuals, the Contractor shall comply with the Privacy Act requirements.

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7. SECURITY ASSESSMENT AND AUTHORIZATION (SA&A) PROCESS

a. The Contractor (and/or any subcontractor) shall comply with HHS and FedRAMP requirements as mandated by federal laws, regulations, and HHS policies, including making available any documentation, physical access, and logical access needed to support the SA&A requirement. The level of effort for the SA&A is based on the system's FIPS 199 security categorization and HHS/NIH security policies.

1. In addition to the FedRAMP compliant ATO, the contractor shall complete and maintain an agency SA&A package to obtain agency ATO prior to system deployment/service implementation. The agency ATO must be approved by the NIH authorizing official (AO) prior to implementation of system and/or service being acquired.

2. CSP systems categorized as Federal Information Processing Standards (FIPS) 199 high must leverage a FedRAMP accredited third-party assessment organization (3PAO); moderate impact CSP systems must make a best effort to use a FedRAMP accredited 3PAO. CSP systems categorized as FIPS 199 low impact may leverage a non-accredited, independent assessor.

3. For all acquired cloud services, the SA&A package must contain the following documentation: SSP, SAR, POA&M, Authorization Letter, CP and CPT report, E-Authorization (if applicable), PTA/PIA (if applicable), Interconnection/Data Use Agreements (if applicable), Authorization Letter, Configuration Management Plan (if applicable), Configuration Baseline, Following the initial ATO, the Contractor must review and maintain the ATO in accordance with HHS/NIH policies.

b. HHS reserves the right to perform penetration testing (pen testing) on all systems operated on behalf of agency. If HHS exercises this right, the Contractor (and/or any subcontractor) shall allow HHS employees (and/or designated third parties) to conduct Security Assessment activities to include control reviews in accordance with HHS requirements. Review activities include, but are not limited to, scanning operating systems, web applications, wireless scanning; network device scanning to include routers, switches, and firewall, and IDS/IPS; databases and other applicable systems, including general support structure, that support the processing, transportation, storage, or security of Government information for…