RFP_75N95022R00009.pdf

OMB #0990-0115

NATIONAL INSTITUTE ON DRUG ABUSE

REQUEST FOR PROPOSAL (RFP) No. 75N95022R00009

“Clinical Trial Networks Data, Statistics, and Clinical Trial Support Center (DSC6)”

Issued by:

Khurram M. Shaikh, Contracting Officer NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

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

DATE ISSUED:

PROPOSAL DUE:

December 23rd, 2021

February 7th, 2022, 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. 75N95022R00009 for the Clinical Trial Networks (CTN) Data, Statistics, and Clinical Trial Support Center (DSC6).”

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

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

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years. NIDA intends to award cost reimbursement task orders under this contract. These individual task orders may include options periods and/or options quantities. If options are utilized for an individual task order they will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. Options for Increased Quantity will be priced and evaluated prior to award and shall be established at the contract level. All funding will be made through the issuance of task orders and will be dependent on program needs and availability of funds. Various task orders will be issued to support distinct tasks and studies which will separately support the CTN and the National Institutes of Health (NIH) launched HEAL (Helping to End Addiction Long-term) Initiative.

The contract will contain a guaranteed minimum of $100,000 and an estimated maximum quantity of $31,154,646 for the ordering period. NIDA anticipates that the ordering period of the contract will be from July 1, 2022 through June 30, 2027.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L. Please include separate pricing for each individual sample task order and option quantity.

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 3:00 p.m. on Wednesday, January 12th, 2022. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Requests for Information (RFIs)

Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. RFIs must be submitted on or before 3:00 p.m. Wednesday, January 12th, 2022. RFIs may be submitted by e-mail to josh.lazarus@nih.gov with the subject line “RFI – RFP 75N95022R00009.”

NOTE: Site visits will not be provided.

The Technical Proposal

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

It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. NIDA 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

Offerors must have an authorized organizational official sign the Business Proposal. It must contain a detailed breakdown of costs for each of the sample task orders and option quantities. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. NIDA directs special attention to Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 9. Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment 7) 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 February 7th, 2022, 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 submitting a proposal via eCPS can be found at https://ecps.nih.gov/home/howto and in Attachment 1.

All notices related to this solicitation will be posted on www.SAM.go (https://www.sam.gov) as well as the NIDA Contracts Home Page (https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). If you would like to receive e-mail notifications of updates to this solicitation, please register with

SAM.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or 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 Red. We may be reached at (301) 443-6677;

collect calls will not be accepted. Discussions with any other individual outside the NIDA Section, Contracts Management Branch Red should not occur.

Sincerely, Khurram M. Shaikh, Contracting Officer National Institutes of Health, Office of Acquisition, NIDA

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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:

75N95022R00009

3. Issue Date:

December 23, 2021

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : CTN Data, Statistics, and Clinical Trial Support Center (DSC6)

6. ISSUED BY:

NIDA Section Contracts Management Branch Red 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 Ferbuary 7, 2022. 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 PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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 CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Josh Lazarus, Contract Specialist

PHONE: 301-443-6677

e-MAIL: josh.lazarus@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Khurram M. Shaikh Contracting Officer Office of Acquisitions NIDA Section, Contracts Management Branch, Red http://www.sam.gov

RFP Number : 75N95022R00009

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE 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. Certification of Filing and Payment of Taxes

15. Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements. . . 73

16. Past Performance Information

17. HHS Security and Privacy Language for Information and IT Procurements

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

19. 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. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. 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. TECHNICAL EVALUATION FACTORS

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. 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 negotiations are conducted) AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) facilitates collaboration between NIDA, research scientists at universities, and treatment providers in the community with the aim of developing, testing, and implementing new addiction treatments. The network has contributed to broad reaching changes in medical practice, including the development of the opioid treatment medication buprenorphine.

The CTN conducts single and multi-site clinical trials through grants, contracts and cooperative agreements in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. In support of efforts to address the national opioid public health crisis, the CTN plans a significant expansion of its opioid research portfolio. Development and implementation of studies to improve access to high-quality addiction treatment, for example, by facilitating delivery of opioid use disorder treatment in general medical settings is expected. These studies could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry type trials or surveys.

NIDA requires a data and clinical research organization to support and provide resources in managing and carrying out multiple trials in drug abuse research. NIDA requires a Contractor to provide support for systems, procedures, and expertise in data management, statistical support, and information support and services. The systems will be used to support data collection, data analysis, document management, information exchange, scientific discovery efforts and clinical evaluation of promising new anti-addiction therapies and companion behavioral interventions in order to further NIDA's mission.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Delivery, Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $100,000 (minimum) nor more than a total of $31,154,646 (maximum) for successful performance of this contract.

b. For cost reimbursement task orders, the fixed fee for individual task orders will be negotiated by task order. The fixed fee shall be paid in installments as negotiated (based on percentage of completion of work or the percent of total effort expended), as determined by the Contracting Officer, and shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General

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Clause Listing in Part II, ARTICLE I.1 of this contract. Payment of fixed fee shall not be made in less than monthly increments.

c. The costs set forth in this ARTICLE will cover the estimated ordering period from July 1, 2022 through June 30, 2027.

d. The Government will issue Task Orders based on the work described in SECTION C of this contract.

e. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G of this contract.

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, Option for Increased Quantity- Separately Priced Line Item, set forth in ARTICLE I.3. and ARTICLE I.4. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Quantities 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 15 calendar days before the expiration date 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. The price of the task order will be increased as set forth in paragraph c., below.

c. Upon the delivery and acceptance of the Option Service described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below:

Description of Option Item(s) -or- Option Service(s)

Quantity (Units) -or- Minimum & Maximum

Unit Price Total Price of Option -or- Minimum

& Maximum Option Quantity Task A

- Administrative & Concept Support Services Option Quantity Task B - Research Protocol Development and Support

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.

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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.

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.

The Contractor shall meet (by conference call or face-to-face) with NIDA's COR and designee(s) once per week during the first year of the contract, and at least once every two weeks thereafter. The Contractor shall deliver a project plan to identify the tasks, schedules, and milestones. In addition to the reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports:

a. Project Plan:

The Contractor shall provide the COR a Project Plan within 2 weeks of each Task Order Award. The Project plan will describe the tasks to be performed within each task order, detail the schedule and timeline as well as identify the project milestones.

b. Quarterly Progress Report:

Quarterly Progress Reports shall be brief reports that include the following elements separated by each task order:

● work accomplished during the period;

● progress on all trials/ projects

● planned activities for the upcoming period; and

● a description of any problems experienced during the period or anticipated in the upcoming period.

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One (1) copy of the Quarterly Progress Report shall go to the COR within ten (10) calendar days following the end of each contract quarter. The first reporting period consists of the first full three months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each three-month quarter.

c. Annual Progress Report:

The Annual Progress Report shall include a summation of the work accomplished under the contract for the period covered. An Annual Progress Report will not be required for the period when the Final Report is due. A Quarterly Progress Report shall not be submitted when an Annual Progress Report is due.

d. Task Order Final Report:

The Task Order Report shall include a summation of the work accomplished under issued task orders. This shall cover the entire period of performance for that task order. It should include highlights, issues and their resolution, recommendations or lessons learned, etc.

e. Final Report:

The Final Report shall include a summation of the work performed for the entire contract period of performance. The Final Report shall be submitted in accordance with the deliveries of this contract. An Annual Progress Report will not be required for the period when the Final Report is due.

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

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

45 CFR Part 94 is available at: 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

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.

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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3. HHS Security and Privacy Language For Information and IT Procurements

INFORMATION AND/OR PHYSICAL SECURITY

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.

B. 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 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.

● Security 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. 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 calendar days and all medium weaknesses must

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

C. 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.

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

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

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

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

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

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

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

4. Comply with the Privacy Act requirements.

mailto:fisma@hhs.gov

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

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

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

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

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

F. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/ or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/ Documents/SuitabilityRoster_10-15-12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

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

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

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

- 11 -additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor.

However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

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

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

G. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012). HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html.

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3. Sanitization of Government Files and Information - As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4. Notification- The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 15 calendar days before an employee stops working under this contract.

5. Contractor Responsibilities Upon Physical Completion of the Contract- The Contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

https://www.hhs.gov/ocio/ea/documents/proplans.html

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6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 calendar days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

H. 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.

I. Vulnerability Scanning Reports – The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under a separate cover on monthly basis.

J. Government Access for Security Assessment In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

1. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract. The Government includes but is not limited to the U.S.

Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

2. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

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3. Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited.

Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

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

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

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be shall be submitted electronically to the Contracting Officer at the following address:

To Be Determined

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.