RFP-NIAID-DMID-NIHAI201800005_Solicitation.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Purchase Authority: P.L. 81-692, as amended.

2. Request for Proposal (RFP) Number:

NIHAI201800005

3. Issue Date:

October 11, 2018

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Bioinformatics Resource Centers for Infectious Diseases

6. ISSUED BY:

Brian Madgey, Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane Room 3D47, MSC 9821 Bethesda, MD 20892-9821 (For express delivery services use: Rockville 20852)

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," 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 Proposal," until 3:00 PM local time on January 10, 2019. 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: Brian Madgey, Contracting Officer

PHONE: 240-627-3712

e-MAIL: brian.madgey@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Brian Madgey Contracting Officer, MID RCB-A, OA

NIAID

National Institutes of Health http://www.sam.gov

RFP Number : NIHAI201800005

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - 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

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. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

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

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. Certification of Filing and Payment of Taxes

15. 52.203-98 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality

16. Past Performance Information

17. Prohibition on Contractor Involvement with Terrorist Activities

18. HHS Security and Privacy Language

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

20. 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

15. Certification of Visas for Non-U.S. Citizens

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

8. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES

The Contractor shall provide bioinformatics resources and services for the infectious disease community.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. ESTIMATED COST - OPTION

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

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

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

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

d. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Schedule Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period: September 1, 2019 - August 31, Base Period: Optional Quantity*

Option Period One: September 1, 2020 - August 31, 2021

Option Period One: Optional Quantity*

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Schedule Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period Two: September 1, 2021 - August 31, 2022

Option Period Two: Optional Quantity*

Option Period Three: September 1, 2022 - August 31, 2023

Option Period Three: Optional Quantity*

Option Period Four: September 1, 2023 - August 31, 2024

Option Period Four: Optional Quantity*

Total [Base Period and all Option(s)]

* Quantity Options may be exercised up to nine

(9) times at the discretion of the Government.

Note: Please refer to Section L (Instructions, Conditions, and Notices to Offerors) for the level of effort (i.e., direct labor hours) associated with the schedule.

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.

The below Advance Understandings are applicable to this solicitation.

Data Transfer Agreement

In the event of an investigator-initiated submission of proprietary data to the Bioinformatics Resource Centers (BRC) data, and as requested by the data owner or by the Contracting Officer's Representative (COR), the Contractor agrees to generate a Data Transfer Agreement to be approved by the COR and accepted by all the parties involved prior to the submission of the data. The Contractor shall maintain a filing record of these agreements.

Unless requested by the data provider, transfer agreements are not required for the transfer of data from existing publicly accessible databases or studies reported in the literature.

Data Access Agreement

Although the BRCs are publicly accessible resources that support a variety of data types, some of the BRCs information may be of a sensitive nature, such as the phenotypic information associated to clinical isolates. As

- 6 -required by the data owner and/or requested by the COR, Contractor agrees to generate a Data Access Agreement to be approved by the COR and accepted by the prospective users of such sensitive data prior to enabling access/use.

Usage of Third Party's Data and Confidential Information

The Contractor agrees that the use of data provided to the Contractor by third parties or by the Government for activities performed under this contract, shall be restricted to projects within the scope of the contract and shall not be released (except by the publication provisions of this contract) to any other party without approval of the COR. If the Government determines that some information/data that the Contractor will be provided by a third party or the Government during the performance of the contract is of a sensitive/proprietary nature, the Contractor shall guarantee strict confidentiality of such information/data during the performance of the contract. This restriction applies until the data and information are publicly released to the scientific community, in accordance with the publication provisions of this contract. Contractor agrees to acquire any and all necessary rights and permissions from third parties to third party information/data for use by and on behalf of the Government, including but not limited to the public access, use and dissemination of such third-party data, and any other activity as required by the Government in the performance of this contract.

Sensitive/Proprietary Information

It refers to data/information of any kind which is disclosed by the Government or a third party to the Contractor, or that is generated at the request of the Government with the consent of the Contractor and deemed by the Government to be "Sensitive/Proprietary Information". Such data shall be treated as "Confidential" and will be identified with the appropriate marking. The Government shall identify, in advance of the initiation of the requested activity, the data types and datasets that would be considered to be Sensitive/Proprietary Information. In the event that sensitive/ proprietary information is provided visually or orally, obligations of confidentiality shall attach only to that information which is identified as "Confidential" at the time of disclosure.

Intellectual Property

All data, documentation and software delivered under any resulting contract will be delivered with unlimited rights as set forth in FAR 52.227-14 for the Government. All software developed under this solicitation must be released under an approved non-viral open source license as set forth in FAR 52.227-17. To clarify, the software must be released by the Contractor under an Open Source Initiative-approved, non-viral, open source license. See http://opensource.org/ licenses.

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, dated October 3, 2018, 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.

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

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that the following reports will be required in electronic format:

i. Monthly Progress Report

a. This report shall include a brief description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. This report is due within 10 calendar days following each reporting period.

b. The Monthly Progress Report shall include the following information:

1. The status of activities in the project plan for the period and milestones completed.

2. Help desk activities and bioinformatic services provided.

3. Workshop, training, conference presentations, and materials conducted/made available.

4. Meetings held with community users, NIAID programs, and staff.

5. Planned manuscripts as well as those published, if any.

6. Project challenges and risks/issues.

7. When applicable, updates to previously submitted deliverables. Updated deliverables shall be submitted with Monthly Progress Report under a separate cover.

c. A Monthly Progress Report shall not be required for the period when an Annual Progress Report is due.

ii. Annual Progress Report

a. The first report shall cover the entire base period of this contract and shall be due on the last day of the base contract period. Thereafter, reports shall be due on the last day of the contract period for each option period, if exercised.

b. The Annual Progress Report shall include the following information:

1. A summation of the work performed in the contract period.

2. An assessment of operational costs to provide access to data, tools, and associated services.

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

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3. Any noteworthy scientific success stories of the community having benefited and/ or impacted from the BRC resources and services that would have otherwise been scientifically challenging, cost prohibitive, and/or not possible at all.

c. An Annual Progress Report shall not be required for the period when the Final Report is due.

iii. Final Report

a. This report shall consist of the work performed and results obtained for the entire contract period of performance as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted on or before the last day of the contract performance period.

b. The Contractor shall provide the Contracting Officer's Representative (COR) and Contracting Officer (CO) with one electronic copy of the Final Report in draft form 60 calendar days prior to the completion date of this contract. The COR will review the draft report and provide the CO with comments within 30 calendar days after receipt. The Final Report shall be corrected by the Contractor, if necessary, and the final version delivered as specified in the above paragraph.

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. HHS Enterprise Life Cycle (EPLC) Reporting Requirements

a. The Contractor shall submit the following deliverables. The Government will provide reporting templates at time of contract award.

i. Requirements Document: Document shall cover the requirements planned in the base year of the contract. Initial document shall be delivered within 30 calendar days after contract award. Updates to the document shall occur annually, covering the requirements for that contract period, and shall be submitted within 30 calendar days after the effective date of each option period, if exercised.

ii. Design Plan: Plan shall describe the architecture, hardware, software, and technologies leveraged of the systems and services. The document shall be updated and approved by the COR and CO prior to any planned system changes. Initial plan shall be delivered within 30 calendar days after contract award. Updates to the plan shall be submitted under a separate cover with the Monthly Progress Report.

iii. Project Management Plan: The Project Management Plan, included as part of the technical proposal, shall be updated to include collaborative transition activities and tasks required to develop a single BRC website in collaboration with the other BRC contractor.

Initial update shall be delivered within 30 calendar days after contract award. Updates to the plan shall occur annually and/or when there are significant changes and shall be submitted under a separate cover with the Monthly Progress Report.

iv. Test Plan: Plan shall include unit, regression, and user testing to be performed of the system. The test plan shall be delivered with each public BRC release under a separate cover with the Monthly Progress Report.

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v. Test Report: The report shall include results of unit, regression, and user testing and plan of action to remedy tests that either fail or do not meet the benchmarks. The Test Report shall be delivered with each public BRC release under a separate cover with the Monthly Progress Report.

vi. Performance Metrics Plan: The plan shall include the description of operational metrics planned such as query performance, uptime, and other relevant metrics in accordance with the Statement of Work. The Plan shall be delivered within 30 calendar days after completion of transition activities.

vii. Usage Metrics Plan: The plan shall include the description of metrics that will be collected during the operations for tracking usage, help desk activities, and other relevant metrics in accordance with the Statement of Work. The Plan shall be delivered within 30 calendar days after completion of transition activities.

viii. Monthly Systems Performance Metrics Report: The Contractor shall provide reports of the metrics collected in accordance with the approved Performance Metrics Plan. The reports shall be delivered under separate cover with the Monthly Progress Report and openly published online.

ix. Monthly Usage Metrics Report: The Contractor shall provide reports of the usage in accordance with the approved Usage Metrics Plan. The Reports shall be delivered under a separate cover with the Monthly Progress Report and openly published online.

x. User Documentation: In addition to the hosted/provided resources, the Contractor shall deliver sufficient documentation for the resources and service offerings to support end-users and administrators. The Contractor shall deliver initial document with first release in the Base Period under a separate cover with the Monthly Progress Report and make the document available online for users. Updates shall be submitted under separate cover with the Monthly Progress Report in time for each release and openly published online.

2. 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.)

3. 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.

4. Information and/or Physical Security Reporting 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 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

- 10 -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) below. 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, the Contracting Officer's 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.

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 a SA&A package within 180 days of contract award to the CO and COR. The following SA&A deliverables are required to complete the SA&A package.

• FIPS 199 Standards for Security Categorization - due within 30 days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard. After resolution of any comments by the Government on the draft FIPS 199 Assessment, the Contracting Officer shall accept the FIPS 199 Assessment and incorporate the Contractor's final version into the contract.

• E-Authentication Questionnaire - due within 30 days after contract award. 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

• Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) - due within 30 days after contract award. Please refer to Article H.14.1.A.12 for additional information.

• System Security Plan (SSP) - due within 180 days of 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 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 within 180 days of 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 control baseline shall be in accordance with the Information Security Categorization in ARTICLE H.12.1.A.3 of the solicitation. Assessments of controls shall be performed by an independent third party. 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 within 180 days of 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

- 11 -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 within 180 days of 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 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 within 180 days of 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.

C. 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).

[X] 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).

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

1. 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 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 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 days of the notification.

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

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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 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.

D. 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, and 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 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, COR and Information Systems Security Officer (ISSO) within fifteen 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 COR. Additionally, the Contractor shall provide a certification that all government information https://www.hhs.gov/ocio/ea/documents/proplans.html

- 13 -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.

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 days of the employee's exit from the contract. All documentation shall be made available to the CO and COR upon request.

E. 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 CO and COR prior to performing any work under this acquisition.

F. 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. This report shall be submitted on a monthly basis under a separate cover with the Monthly Progress Report.

G. 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:

a. 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.

b. 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.

c. 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.

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

5. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. 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."

6. Final Transition Plan

The Contractor shall submit a Draft Transition Plan within six (6) months after contract award. The Final Transition Plan (approved by the COR and CO) shall be submitted six (6) months prior to the expiration date of the contract.

7. Monthly Meeting Agenda & Minutes

The Contractor shall organize and conduct a monthly meeting among the Principal Investigator (PI), relevant team members, the COR, and CO(s). The meeting shall be scheduled in coordination with the COR and CO(s). The Contractor shall prepare and circulate the agenda to attendees no less than two (2) calendar days in advance of the monthly meeting and submit meeting minutes and action items within seven (7) calendar days after the meeting.

8. 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.

REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein shall be submitted in electronic format. All electronic contract deliverables shall be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website:

https://erds.niaid.nih.gov/. 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."

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.

Annual utilization reports shall be due each year on or before the anniversary date of the contract's effective date. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer - "To be specified prior to award" http://www.hhs.gov/web/508/contracting/technology/vendors.html

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Email - "To be specified prior to award"

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

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

SECTION D - PACKAGING, MARKING AND SHIPPING

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

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, MSC 9821 Bethesda, MD 20892-9821

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

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

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

Alternate I (April 1984) is not applicable to this contract.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from September 1, 2019 through August 31, 2020.

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

Option Option Period Option Period One September 1, 2020 through August 31, 2021 http://www.iedison.gov

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Option Option Period Option Period Two September 1, 2021 through August 31, 2022 Option Period Three September 1, 2022 through August 31, 2023 Option Period Four September 1, 2023 through August 31, 2024

ARTICLE F.2. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide direct labor hours. The labor hours include vacation, holiday, and sick leave. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

Labor Category Base Period Option Period One

Option Period Two

Option Period Three

Option Period Four

Professional

Other Professional

Support

Totals

Quantity Option(s): If the Government exercises an Option Quantity pursuant to the OPTION PROVISION Article in SECTION H of this contract, it is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

Labor Category Base Period, Optional Quantity

Option Period One, Optional

Quantity

Option Period Two, Optional

Quantity

Option Period Three, Optional

Quantity

Option Period Four, Optional

Quantity

Professional

Other Professional

Support

Totals

Be advised that each Quantity Option may be exercised up to nine (9) times in the period of performance for which the option is negotiated. There is no obligation on the part of the Government to exercise any Quantity Option in any given period of performance.

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor Hours specified herein are furnished.