RFP_75N93020R00007 with attachments.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 81-692, as amended

2. Request for Proposal (RFP) Number:

75N93020R00007

3. Issue Date:

April 16, 2020

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Immunology Quality Assessment (IQA) Program

6. ISSUED BY:

Office of Acquisitions (OA) Division of Extramural Activities (DEA) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Department of Health and Human Services (DHHS) 5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

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 July 15, 2020. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE 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: Christopher Weaver, Contracting Officer (CO)

PHONE: 240-627-3219

e-MAIL: christopher.weaver@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

We strongly suggest that any questions regarding the solicitation be submitted by 3:00 PM local time, on June 15, 2020, so that we can provide timely responses before proposals are due.

Secondary Point of Contact:

John R. Manouelian, Contracting Officer E-mail: manouelj@mail.nih.gov Phone: 240-669-5152 http://www.sam.gov

RFP Number : 75N93020R00007

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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

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. REFERENCE MATERIALS

j. PREPARATION COSTS

k. 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. Privacy Act - Treatment of Proposal Information

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10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. ROTC Access and Federal Military Recruiting on Campus

13. Certification of Filing and Payment of Taxes

14. Past Performance Information

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

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Notice to Offerors of Requirements, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Human Stem Cell Research

5. 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. HUMAN SUBJECT EVALUATION

4. EVALUATION OF OPTIONS

5. EVALUATION OF DATA SHARING PLAN

6. TECHNICAL EVALUATION FACTORS

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

8. 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 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 purpose of the Immunology Quality Assessment (IQA) Program contract is to provide a resource to evaluate and enhance the ability of U.S. and non-U.S. laboratories (Labs) to participate in NIAID-funded and collaborative clinical studies by: (1) monitoring the ability of Labs to reliably perform study-specified immunological tests and cryopreserve peripheral blood mononuclear cells (PBMCs) and other human biological samples; (2) facilitating the optimization, standardization and validation of immunological assay methodologies, with focus on laboratory-developed-tests (LDTs) for implementation in NIAID-supported studies; (3) helping Labs meet sponsor and regulatory requirements for good clinical laboratory practices (GCLP) and submission of data to regulatory agencies; and (4) hosting and maintaining an electronic data management system and document library in support of contract activities.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. 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 will be increased as follows:

Estimated Cost ($) Base Period:

Option Period(s):

Total [Base Period and Option(s)]:

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

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

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ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

The following Advanced Understandings will be included in any resultant contract:

a. Protection of Proprietary Data:

All materials, data and other information supplied by third-party providers or laboratories under this Contract or the COR shall be assumed to be confidential unless specifically identified as not confidential in writing by the COR.

b. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

1. The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

a. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

b. Fringe Benefits - Cite rate and amount.

c. Overhead - Cite rate and amount.

d. Materials & Supplies - Include detailed breakdown when total amount is over $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.

e. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

f. Consultant Fees - Identify individuals and amounts.

g. Subcontracts - Attach subcontractor invoice(s).

h. Equipment - Cite Authorization and amount.

i. F&A - Cite rate and amount.

j. Total Cost

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

2. The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) of unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost clauses in the contract.

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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, dated February 25, 2020, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format and shall be submitted through the NIAID Electronic Reports and Deliverables System, available here: 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."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation.

These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [ Note: 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. ]

These reports shall include a cover page prepared in accordance with the following format:

• Contract Number and Project Title

• Period of Performance Being Reported

• Contractor's Name and Address

• Author(s)

• Date of Submission

• Delivery Address

1. Tri-annual Progress Report

This report shall include a 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 four months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of four full calendar months and be due on the 30th of the month following the end of the reporting period, except when the Final Report is due.

https://erds.niaid.nih.gov/%C2%A0 http://www.hhs.gov/web/508/index.html

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The Contractor shall submit the following required information within the Tri-annual Progress Report:

a. summary and highlights of activities related to preparation and distribution of proficiency testing panels to monitor Labs ability to perform immunological assays.

b. summary and highlights of activities related to review of Labs' ability to perform immunological assays and viable PBMC cryopreservation, including the processing of leukopaks; as well as summary of problems, corrective actions and subsequent performance.

c. summary of in-house or multi-Lab evaluation and/or method comparison studies.

d. summary of activities related to IQA support for assay characterization, qualification or validation.

e. summary of activities related to development and application of statistical and bio-analytical methodologies.

f. summary of activities related to acquisition and characterization of quality control materials.

g. summary of activities related to IQA support to Labs in meeting regulatory requirements for good clinical laboratory practices, including review and resolution of laboratory GCLP audit findings.

h. description of activities related to web enhancement and maintenance.

i. summary of subcontract activities, if applicable.

j. summary of meetings, teleconferences and discussions with the COR, Lab personnel, and others regarding issues relevant to the conduct of the contracted work.

k. summary of facilities/equipment issues.

l. personnel report, which shall include the name, title, percent effort and responsibility of individuals working on the contract and a summary of personnel changes occurring during the reporting interval.

A Tri-annual Progress Report shall not be submitted when the Final Report is due.

2. Final Report

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. A Tri-annual Progress Report will not be required for the period when the Final Report is due.

3. 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.

4. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "" PHS Human Subjects and Clinical Trials Information Form/ Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The first report shall be due June 30, 2021. Thereafter, the report shall be due on or before the 30th day following each reporting period. The final report shall be due on or before the expiration date of the contract.

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In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website: http://grants.nih.gov/ grants/funding/women_min/women_min.htm.

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subgroup differences, a brief statement to that effect, indicating the subgroups analyzed, will suffice. The Government strongly encourages inclusion of the results of subgroup analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/ gender, race and/or ethnicity.

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. Human Subjects IRB Annual Report (Form OMB No. 0990-0263-formerly Optional Form 310)

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.

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.

http://grants.nih.gov/grants/funding/women_min/women_min.htm http://grants.nih.gov/grants/funding/women_min/women_min.htm 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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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 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 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 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

• Independent Assessment - due 90 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 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 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 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

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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. 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).

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/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 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.

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.

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E. 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 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/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.

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.

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

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

G. 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.

H. 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.

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

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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. Other Reports and Deliverables Required by the Contract and Statement of Work

Item Deliverables Contract/SOW Reference

Recipient Delivery Schedule

1. Draft Initial Transition Plan

SOW Section 3.I.1.b

1 electronic copy to COR and CO.

Due within 15 calendar days following the effective date of the contract.

2. Initial Transition Plan SOW Section 3.I.1.b

1 electronic copy to COR and CO.

Due within 20 calendar days following the effective date of the contract.

3. Annual Utilization Report Section C, ARTICLE C.3

1 electronic copy to

CO.

Due on/before the 30 th of the month following each anniversary date of the contract.

4. Lab-specific Immunology PT evaluation Report

SOW Section 3.A.1.e

1 electronic copy to COR, to each Lab and to Others specified by the COR.

Due within 5 business days of obtaining performance grading.

5. Immunology PT Cumulative Performance Report

SOW Section 3.A.1.g

1 electronic Copy to COR, and to Others as specified by the

COR.

Due after each PT round.

6. Lab-Specific PBMC Cryopreservation Performance evaluation Report

SOW Section 3.A.2.c

1 electronic copy to each Lab, 1 electronic copy to COR, and 1 electronic copy to Others specified by the COR.

Due prior to receipt of the next round or cryopreservation evaluation.

7. Cryopreservation Cumulative Performance Report

SOW Section 3.A.2.d

1 electronic Copy to COR, and to Others as specified by the

COR.

Due after each round of performance evaluation.

8. Method Evaluation/ comparison Report

SOW Section 3.B.1.c

1 electronic copy to each participating Lab, 1 electronic copy to COR, and 1 electronic copy to Others specified by the COR.

Due within 3 weeks of obtaining evaluation results.

http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html

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Item Deliverables Contract/SOW Reference

Recipient Delivery Schedule

9. Assay Fit-for-Purpose Report

SOW Section 3.B.2.e

1 electronic copy to each participating Lab, 1 electronic copy to COR, and 1 electronic copy to Others specified by the COR.

Due within 4 weeks of obtaining assay characterization data.

10. Lab-specific post audit Action Plan

SOW Section 3.D.2 1 electronic copy to COR and to Others specified by the COR.

Due within 10 business days of receipt of audit report.

11. Lab visit reports

SOW Section 3.E.3 1 electronic copy to COR, to visited Lab and to Others specified by the COR.

Due within 10 business days of visit completion.

12. Draft scientific manuscripts for publication

SOW Section 3.G.2.a

1 electronic copy to COR and to Others specified by the COR.

Due within 3 months of final data analysis of evaluation studies.

13. Presentations and training materials

SOW Section 3.G.2.b

1 electronic copy to COR and to Others specified by the COR.

Due at least 3 business days prior to presentation.

14. Draft Final Transition Plan

SOW Section I.2.a 1 electronic copy to COR and CO.

Due at least 6 months prior to the expiration date of the contract.

15. Final Transition Plan SOW Section I.2.b 1 electronic copy to COR and CO.

Due not later than 4 months prior to the expiration date of the contract.

16. Final Invention Statement

Section C, Article C.3

1 electronic copy to COR and CO.

Due on/before the expiration date of the contract.

17. All reports and documentation including the invention disclosure report, the confirmatory license, and the government support certification

Section C, Article C.3

1 copy to OPERA. As required by FAR Clause 52.227-11.

18. All Contract-Related Materials, Activities, Government-Owned Equipment & Property, etc.

SOW Section I.2 To a successor contractor or to the Government.

As directed by the COR and CO.

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Item Deliverables Contract/SOW Reference

Recipient Delivery Schedule

19. Human Materials Assurance of OHRP Compliance

Section H, Article H.4 Human Materials (Assurance of OHRP Compliance)

1 electronic copy to COR and CO.

Due prior to commencing any work involving human tissue.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

The first annual utilization report shall be due on or before July 14, 2022. Thereafter, reports shall be due on or before the 15th Calendar day following the reporting period. 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 Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

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.

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

The Contractor will be expected to ship Quality Control Materials (QCMs), related to proficiency testing and the evaluation and interpretation of laboratory data, to specified domestic and international destinations under appropriate shipping conditions and in accordance with International Air Transport Association (IATA)/ International Civil Aviation Organization (ICAO) dangerous goods shipping regulations and other relevant shipping regulations ( https://www.iata.org/publications/dgr/Pages/index.aspx ). Specific shipping/packaging requirements are provided in the Statement of Work. 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.

https://www.iata.org/publications/dgr/Pages/index.aspx

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SECTION E - INSPECTION AND ACCEPTANCE

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

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

3. Inspection and acceptance will be performed at:

Drug Development and Clinical Sciences Branch Therapeutics Research Program, Division of AIDS National Institute of Allergy and Infectious Diseases National Institutes of Health, DHHS 5601 Fishers Lane Bethesda, MD 20892-9830

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 applicable to this contract.

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The estimated period of performance of this contract shall be from June 30, 2021 through June 29, 2022.

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 1 (Contract Year 2) June 30, 2022 through June 29, 2023

Option 2 (Contract Year 3) June 30, 2023 through June 29, 2024

Option 3 (Contract Year 4) June 30, 2024 through June 29, 2025

Option 4 (Contract Year 5) June 30, 2025 through June 29, 2026

Option 5 (Contract Year 6) June 30, 2026 through June 29, 2027

Option 6 (Contract Year 7) June 30, 2027 through June 29, 2028

ARTICLE F.2. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide ____ direct labor effort. The direct labor effort includes vacation, holiday, and sick leave. The direct labor effort includes the effort of subcontractors and consultants. It is estimated that the direct labor effort is constituted as specified below and will be expended approximately as follows:

Labor Category

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional

Other Professional

Support

Totals

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

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

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

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

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52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

To be specified prior to award

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

The Contracting Officer is the only person with authority to act as agent of the Government under this contract.