Attachments_-_all_RFP.pdf

Section J – List of Documents, Exhibits and Other Attachments

1. Packaging and Delivery of Proposals

2. Statement of Work – Task Areas A and B

3. Statement of Work – Task Area A and Contractor’s Report of Task Order (TO) Completion

4. Statement of Work – Task Area B and Contractor’s Report of Task Order (TO) Completion

5. Annual Representations and Certifications

6. Task Order (TO) Request for Proposal for Task Area A

7. Task Order (TO) Request for Proposal for Task Area B

8. Additional Technical Proposal Instructions

9. Additional Business Proposal Instructions

10. Technical Proposal Cost Summary

11. Summary of Related Activities

12. Proposal Intent Response Form

13. Proposal Summary NIH-2043

14. HHS Subcontracting Plan Template

Access the SBCX Guide at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workforminformation/attachment-files-section-j.

15. Breakdown of Proposed Costs

16. Offeror Point of Contact

17. Certificate of Current Cost and Pricing Data

18. Disclosure of Lobbying Activities, SF-LLL

Also located at: https://www.gsa.gov/formslibrary/disclosure-lobbying-activities.

19. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-

Reimbursement Contracts, NIH(RC)-4

20. Invoicing Instructions with IPP - Invoice and Payment Provisions (Vendor has transitioned to

IPP)

21. Roster of Employees Requiring Suitability Investigations

Excel file located at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachmentfiles-section-j.

22. Employee Separation Checklist Fillable PDF format located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf.

23. HHSAR Deviation Clauses https://oamp.od.nih.gov/nih-document-generation-system/dgs-workforminformation/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workforminformation/attachment-files-section-j https://www.gsa.gov/formslibrary/disclosure-lobbying-activities https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachmentfiles-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachmentfiles-section-j https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

Packaging and Delivery of Proposals

I. DUE DATE: 3:00 PM EST Eastern time on January 10, 2025

Proposals not received at the place and time specified in the solicitation will be considered late and will be handled in accordance with and HHSAR 352.215-70. Your proposal shall be organized as specified in SECTION L, General Instructions

II. PROPOSAL SUBMISSION

A. Email proposal submission

1. Proposals must be submitted via email ONLY to the below email addresses:

Ethan J. Mueller – Contracting Officer – Email Address - Ethan.Mueller@nih.gov

Stacy C. Turner – Contract Specialist – Email Address - Stacy.Turner@nih.gov

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. The Business Proposal must be comprised of the following files:

a. The first file must be a PDF of your Business Proposal, with all attachments, including the Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet.” The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s)may be scanned and merged into the Business Proposal PDF file.

b. The remaining file(s) must be the “Breakdown of Proposed Estimated Costs(plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF.

Multiple Excel files may be included, as necessary. The excel template is located here: (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx)

3. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

4. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

The National Gene Vector Biorepository (NGVB) Statement of Work (SOW) for Task Areas A & B

October 10, 2024

1.0 INTRODUCTION

1.1 BACKGROUND

This initiative is to continue the National Gene Vector Biorepository (NGVB), which is an integral component of the National Heart, Lung and Blood Institute (NHLBI) gene therapy resource portfolio.

The objective of the National Gene Vector Biorepository (NGVB) is to provide critical resources and services to NHLBI investigators performing preclinical and clinical gene therapy research. This is accomplished by offering of support in three main areas: (1) Making available over 70 reagents (AAV and lentiviral plasmids, certified cell lines and retroviral packaging cell lines) for constructing and evaluating gene therapy vectors; (2) Providing GLP specimen archiving and storage of samples derived from preclinical pharmacology and toxicology studies, thereby enabling investigators to remain in compliance with FDA regulations; and (3) Performing testing services -- including replication competent retrovirus (RCR) and lentivirus (RCL) assays, and insertion-site analyses for mutagenic events -- that assist with meeting FDA requirements for GMP production and monitoring of gene therapy clinical trials.

The NGVB must have the capability to store biospecimens under the specialized requirements of Good Laboratory Practices (GLP) standards needed for IND-enabling work. Currently, there are over 20,000 irreplaceable tissue and blood specimens that have been archived, and the NGVB contractor will need the capability to store and maintain these and future specimens. Additionally, the NGVB performs assay development and testing for the clinical specimens under College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) certifications and/or Good Manufacturing Practices (GMP) standards, as may be required.

1.2 SCOPE

The NHLBI requires the NGVB to support translational gene therapy research by providing resources and services, including those that allow investigators to meet the unique FDA requirements associated with gene therapy. The work is focused in the following four main areas:

1.) Reagent Repository, 2.) Pharmacology and Toxicology Resources, 3.) Clinical trial and pharmacology study biospecimen archiving under Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) conditions, and 4.) Research and Development of qualified assays for Insertional Site Analysis. The NGVB also will create and maintain a website that describes the resources it makes available to researchers, including interactive tools such as those available at the current website: https://ngvbcc.org/Home.action.

1.3 OBJECTIVE

The objective of the NGVB contract is to continue supporting gene therapy research, particularly clinical applications in the areas of heart, lung, and blood diseases. Under this contract, the NGVB https://ngvbcc.org/Home.action https://ngvbcc.org/Home.action will continue to provide resources and support services to gene therapy investigators for both pre-clinical studies and clinical trials.

2.0 TASK AREAS AND TECHNICAL REQUIREMENTS

2.1 Task Area A: Core Administrative Tasks

The Contractor shall perform all administrative tasks required to maintain this award.

The main purpose of this task area is to provide administrative services as needed to manage the contract program. The services to be provided may include, but are not limited to, the following:

A. Transition-in Services

Not applicable to the incumbent.

The non-incumbent shall submit a schedule and budget for:

• Transfer of knowhow, manual of procedures, records and SOPs from incumbent to non-incumbent staff.

• Physical transfer of 70-80 reagents (AAV and lentiviral plasmids, certified cell lines and retroviral packaging cell lines) and approximately 20,000 archived biospecimen samples from their current location in Indianapolis, Indiana to its facility. This plan should include a description of measures that will be undertaken to mitigate risks of sample loss and ensure maintenance of accurate sample labeling.

• Migration of the current NGVB website from the incumbent’s web-hosting platform to one owned and operated by the new awardee.

B. Manual of Procedures

The contractor shall create, and regularly maintain for the life of the contract, a Manual of Procedures (MOP):

1. Describe the administrative structure of the NGVB.

2. Describe how electronic databases will be updated and maintained securely and confidentially.

3. Describe how specimens will be submitted/received, tracked, stored and maintained.

4. Describe how requests for services will be submitted/received, tracked, managed and responded.

C. Other Administrative Tasks

The contractor shall:

1. Provide dedicated personnel to serve as point-of-contact for all inquiries related to each scientific work request.

2. Develop and manage a submission process for NIH-supported investigators to submit a request for services to the NGVB. The request for services should describe the NIH Institute or Center that is funding the parent research project. The contractor shall manage a submission receipt process/workflow to include (i) rolling (continuous) electronic submission via web-based forms; (ii) data checks for completeness and consistency; (iii) submission tracking and processing through various stages of handling.

3. Establish an External Advisory Board (EAB) composed of three (3) or four (4) experts in the gene therapy field and ex-officio government representatives from the NIH and FDA. The EAB should meet at least once yearly, in person if possible. The annual EAB meeting may be held in conjunction with the annual meeting of the American Society of Gene and Cell Therapy (ASGCT), if desired. Additionally, teleconferences and email communications with the EAB can be conducted as needed during the year. Honoraria may be provided to the non-government EAB members.

4. The PI of the NGVB, and up to one Co-PI or other Senior Key Personnel, shall attend and participate in NHLBI Gene Therapy Resource Program meetings, such as the

Steering Committee meetings or other program meetings, as appropriate.

5. Develop and maintain a public-facing website to communicate information about the NGVB including but not limited to the mission and features of the program and the process for applying for services. The code for the website shall be open source, Section 508 compliant, compliant with all NIH/HHS/Federal security policies, and made available at the discretion of the COR. Compliance with the following "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports shall be adhered to:

https://www.access-board.gov/ict/

• Chapter 3: Functional Performance Criteria

• Chapter 4: Hardware

• Chapter 5: Software

• Chapter 6: Support Documentation and Services

• Chapter 7: Referenced Standards

Awardee should engage with the NHLBI 508 Program Manager early in the life cycle to ensure that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports that are required in this Statement of Work are all 508 conformant. In doing so, please also follow the HHS Accessibility Conformance Checklists as well as the Attached NHLBI Section 508 Accessibility Determination Form.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fweb%2Fsection-508%2Faccessibility-checklists%2Findex.html&data=05%7C02%7Cethan.mueller%40nih.gov%7Cff78b7c4ffe7432a416008dcfd9e7a08%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638664104312755357%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2FO2EFiCbbyj86iB%2B72ekv5dIF2RxY%2FrEuV9vV1pXWec%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fweb%2Fsection-508%2Faccessibility-checklists%2Findex.html&data=05%7C02%7Cethan.mueller%40nih.gov%7Cff78b7c4ffe7432a416008dcfd9e7a08%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638664104312755357%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2FO2EFiCbbyj86iB%2B72ekv5dIF2RxY%2FrEuV9vV1pXWec%3D&reserved=0

6. Develop and maintain an internal database for tracking and managing requests for services and funded projects. This database shall be accessible to COR and Contracting officer.

7. Make all reports and supporting documents and data available for review by NHLBI or

Federal oversight representatives if a site visit or audit is requested. Prepare materials for, and participate in, any planned site visits by NHLBI or other federal staff and outside experts to the contractor’s facilities. Ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits.

8. Participate, as necessary, in teleconference and meetings with the requesting investigator, NHLBI staff, and other federal agency staff members (e.g., staff from other NIH ICs) as applicable.

9. Maintain a listing of publications and presentations that were supported by work performed by the NGVB and make this available to the NHLBI GTG upon request.

10. Provide online tutorials or educational materials on the resources and services offered by the NGVB.

11. If appropriate, host an exhibit booth at the annual ASGCT meeting to showcase the services offered by the NGVB.

12. Perform small-scale research and/or development projects as needed to answer scientific questions as they arise and/or to meet the objectives of the NGVB.

D. Contract Expiration:

The Contractor, Only if requested by the COR, shall submit a transition plan that identifies a delivery schedule for transferring all the materials identified to the successor contractor.

The transition plan shall be submitted at least two (2) months prior to the expiration date of the task order/contract, or earlier. The Contractor, Only if requested by the COR, shall perform the following activities beginning at least 90 days prior to task order/contract expiration, or earlier:

1. The Contractor shall cooperate fully with the successor Contractor.

2. The Contractor shall participate in meetings and telephone conversations with the

COR and the successor Contractor in which current procedures and activities are discussed in detail.

3. The Contractor shall provide a detailed list of all tasks currently in progress.

4. Prior to the end of the task order/contract, the Contractor shall determine the disposition (e.g., maintain, return to sender, destroy) of the specimens, contacting submitters as necessary. By 2 months prior to the task order/contact end, the Contractor will have determined which specimens need to be maintained and transferred to the next Contractor.

5. The Contractor shall deliver in clearly labeled packaging to the successor Contractor the following in accordance with the delivery schedule provided in the approved transition plan, including: all Government-furnished property; electronic versions of documents developed under this contract; Web-related files; mailing lists; and all related materials developed under this contract.

6. The contractor will coordinate the preparation, packing, and shipping of those specimens that are to be maintained and will work with the incoming contractor to ensure specimens are safely and securely transferred.

7. The Contractor shall also deliver to the successor Contractor all software programs, all source code documentation and data developed or altered in the performance of this contract and for which contract funds were expended, including the laboratory information system and sample tracking system. These shall be provided in an appropriate form, such as duplicate copies of electronically stored records and web content, and images of stored media. The Contractor shall also provide full documentation pertaining to the programs.

8. The Contractor shall pack all items and equipment in a safe and appropriate manner to ensure that equipment is not damaged and adherence to warranty conditions and service agreements is maintained.

9. The Contractor shall be responsible for transportation of equipment and materials and other costs required for the transition. The Contractor shall prepare an estimate for the costs related to the transfer of specimens, equipment, and materials no later than 2 months prior to the task order/contract end and submit this to the COR and Contracting Officer.

2.2 Task Area B – Core Laboratory Activities

1. Serve as a biologic specimen and data archiving service for animal studies performed in support of an IND and human studies/clinical gene therapy trials performed under an IND.

2. Serve as a biologic specimen service for samples derived from human clinical trials in compliance with Good Clinical Practice guidelines.

3. Develop assays and perform testing on clinical specimens as required by the FDA for gene therapy clinical trials. This includes testing for replication competent virus (RCV) and insertional site analyses to look for potential malignant transformation of the transduced cells on clinical specimens from gene therapy clinical trials supported by the NIH, as required by the FDA.

4. Develop assays for clinical specimen testing and perform testing under the College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) certifications and/or Good Manufacturing Practices (GMP) standards and Standard Operating Procedures, as the case requires.

5. Archive current and future animal-derived specimens from Pharmacology/Toxicology studies under GLP conditions.

6. Maintain the current gene therapy reagent repository and sharing service with a web-based catalogue of gene therapy reagents, including plasmids, cell lines, and vectors. Also, supply certified and research-grade cell lines for vector production, key adeno-associated virus (AAV), and adenoviral, retroviral, lentiviral, DNA, and herpes simplex virus (HSV) vector reagents.

7. Maintain a web-based database of completed gene therapy biodistribution and toxicity studies (pharmacology/toxicology database).

8. As appropriate and mutually agreed upon, provide DNA support services including but not limited to the use of retroviruses, design, construction of vector genomes for overexpression of therapeutic genes, gene silencing using siRNA/miRNA strategies and in vivo gene editing using CRISPR/Cas9 or other system, optimization of transgene cassettes and codon optimization of genes of interest, structure and sequence analysis and next generation sequencing (NGS) to identify CRISPR-Cas9 induced mutations.

9. Perform small-scale research and/or development projects as needed to answer scientific questions as they arise and/or to meet the objectives of the NGVB.

3.0 Reporting Requirements and Deliverables

Item Description Task Areas Quantity Delivery Schedule

Manual of Procedures

(MOP)

A 1

Due within 30 days months of the issuance of the task order/contract.

Updated continuously and available upon request.

Request for service process and implementation

A 1

Due within 6 months of the issuance of task order/contract. Maintained with periodic updates after that.

3 Monthly invoices A & B 1 Monthly

4 Monthly technical narrative

A & B 1 Monthly (with invoice)

Semi-annual Technical Progress Report

A & B 1 Within 30 days of each 6-month period

6 Final Technical Report A & B 1

First draft within 90 days of task order/contract expiration; Final version due 30 days before task order/contract expiration date.

Contractor’s Report of Task Order Completion

A & B 1 Within 30 days of each task order expiration

Summary of salient results

A &B 1 Include with Final Technical Report

Subcontracting Reports

A & B 1 On April 30 and October 30 and subcontract expiration.

Invention reporting requirement and Annual Invention Report

A & B 1 Annually

11 Section 508 Annual Report

A & B 1 Annually

Multiple principal investigator leadership plan (If applicable)

A 1 Annually, if applicable

Technical and business transition-out plan

A 1

Only if requested by the COR:

(1) Begin developing 90 days prior to the task order/contract expiration;

(2) Submit a draft 30 days prior to the task order /contract expiration.

14 Final Report A & B 1

Submit a final report upon the task order/contract’s expiration date or Upon written request from the COR.

The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity

Ray Ebert, COR Ray.ebert@nih.gov

1-14 1 electronic copy

Stacy C. Turner, Contract Specialist turners@nhlbi.nih.gov

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

Examples:

Technical Proposal: XYZ Company_75N92025R00003_Technical.pdf Business Proposal: XYZ Company_75N92025R00003_Business.pdf Excel Workbook: XYZ Company_75N92025R00003_Business.xlsx

Statement of Work (SOW) for the Task Area A Task Order

(Twelve (12) Month Base Period and Four (4) Twelve (12) Month Option Periods

2.1 Task Area A: Core Administrative Tasks

The Contractor shall perform all administrative tasks required to maintain this award.

The main purpose of this task area is to provide administrative services as needed to manage the contract program. The services to be provided may include, but are not limited to, the following:

A. Transition-in Services

Not applicable to the incumbent.

The non-incumbent under the Twelve (12) Month Base Period Only shall submit a SEPARATE BREAKOUT schedule and budget for:

• Transfer of knowhow, manual of procedures, records and SOPs from incumbent to non-incumbent staff.

• Physical transfer of 70-80 reagents (AAV and lentiviral plasmids, certified cell lines and retroviral packaging cell lines) and approximately 20,000 archived biospecimen samples from their current location in Indianapolis, Indiana to its facility. This plan should include a description of measures that will be undertaken to mitigate risks of sample loss and ensure maintenance of accurate sample labeling.

• Migration of the current NGVB website from the incumbent’s web-hosting platform to one owned and operated by the new awardee.

B. Manual of Procedures

The contractor shall create, and regularly maintain for the life of the contract, a Manual of Procedures (MOP):

1. Describe the administrative structure of the NGVB.

2. Describe how electronic databases will be updated and maintained securely and confidentially.

3. Describe how specimens will be submitted/received, tracked, stored and maintained.

4. Describe how requests for services will be submitted/received, tracked, managed and responded.

C. Other Administrative Tasks

The contractor shall:

1. Provide dedicated personnel to serve as point-of-contact for all inquiries related to each scientific work request.

2. Develop and manage a submission process for NIH-supported investigators to submit a request for services to the NGVB. The request for services should describe the NIH Institute or Center that is funding the parent research project. The contractor shall manage a submission receipt process/workflow to include (i) rolling (continuous) electronic submission via web-based forms; (ii) data checks for completeness and consistency; (iii) submission tracking and processing through various stages of handling.

3. Establish an External Advisory Board (EAB) composed of three (3) or four (4) experts in the gene therapy field and ex-officio government representatives from the NIH and FDA. The EAB should meet at least once yearly, in person if possible. The annual EAB meeting may be held in conjunction with the annual meeting of the American Society of Gene and Cell Therapy (ASGCT), if desired. Additionally, teleconferences and email communications with the EAB can be conducted as needed during the year. Honoraria may be provided to the non-government EAB members.

4. The PI of the NGVB, and up to one Co-PI or other Senior Key Personnel, shall attend and participate in NHLBI Gene Therapy Resource Program meetings, such as the

Steering Committee meetings or other program meetings, as appropriate.

5. Develop and maintain a public-facing website to communicate information about the NGVB including but not limited to the mission and features of the program and the process for applying for services. The code for the website shall be open source, Section 508 compliant, compliant with all NIH/HHS/Federal security policies, and made available at the discretion of the COR. Compliance with the following "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports shall be adhered to:

• Chapter 4: Hardware

• Chapter 5: Software developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports that are required in this Statement of Work are all 508 conformant. In doing so, please also follow the HHS https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fweb%2Fsection-508%2Faccessibility-checklists%2Findex.html&data=05%7C02%7Cethan.mueller%40nih.gov%7Cff78b7c4ffe7432a416008dcfd9e7a08%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638664104312755357%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2FO2EFiCbbyj86iB%2B72ekv5dIF2RxY%2FrEuV9vV1pXWec%3D&reserved=0

6. Develop and maintain an internal database for tracking and managing requests for services and funded projects. This database shall be accessible to COR and Contracting officer.

7. Make all reports and supporting documents and data available for review by NHLBI or Federal oversight representatives if a site visit or audit is requested. Prepare materials for, and participate in, any planned site visits by NHLBI or other federal staff and outside experts to the contractor’s facilities. Ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits.

8. Participate, as necessary, in teleconference and meetings with the requesting investigator, NHLBI staff, and other federal agency staff members (e.g., staff from other NIH ICs) as applicable.

9. Maintain a listing of publications and presentations that were supported by work performed by the NGVB and make this available to the NHLBI GTG upon request.

10. Provide online tutorials or educational materials on the resources and services offered by the NGVB.

11. If appropriate, host an exhibit booth at the annual ASGCT meeting to showcase the services offered by the NGVB.

12. Perform small-scale research and/or development projects as needed to answer scientific questions as they arise and/or to meet the objectives of the NGVB.

D. Contract Expiration: Offeror will provide a separate line item breakout budget for these Tasks that is separate from ALL other Items that are contained in the SOW.

The Contractor, Only if added to the Task Order via a funded and executed Task Order modification signed by the Contracting Officer and then requested by the COR and, shall submit a transition plan that identifies a delivery schedule for transferring all the materials identified to the successor contractor. The transition plan shall be submitted at least two (2) months prior to the expiration date of the task order, or earlier. The Contractor, Only if added to the Task Order via a funded and executed Task Order modification signed by the Contracting Officer and then requested by the COR, shall perform the following activities beginning at least 90 days prior to task order expiration, or earlier:

1. The Contractor shall cooperate fully with the successor Contractor.

2. The Contractor shall participate in meetings and telephone conversations with the COR and the successor Contractor in which current procedures and activities are discussed in detail.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fweb%2Fsection-508%2Faccessibility-checklists%2Findex.html&data=05%7C02%7Cethan.mueller%40nih.gov%7Cff78b7c4ffe7432a416008dcfd9e7a08%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638664104312755357%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2FO2EFiCbbyj86iB%2B72ekv5dIF2RxY%2FrEuV9vV1pXWec%3D&reserved=0

3. The Contractor shall provide a detailed list of all tasks currently in progress.

4. Prior to the end of the task order, the Contractor shall determine the disposition (e.g., maintain, return to sender, destroy) of the specimens, contacting submitters as necessary.

By 2 months prior to the task order end, the Contractor will have determined which specimens need to be maintained and transferred to the next Contractor.

5. The Contractor shall deliver in clearly labeled packaging to the successor Contractor the following in accordance with the delivery schedule provided in the approved transition plan, including: all Government-furnished property; electronic versions of documents developed under this contract; Web-related files; mailing lists; and all related materials developed under this contract.

6. The contractor will coordinate the preparation, packing, and shipping of those specimens that are to be maintained and will work with the incoming contractor to ensure specimens are safely and securely transferred.

7. The Contractor shall also deliver to the successor Contractor all software programs, all source code documentation and data developed or altered in the performance of this contract and for which contract funds were expended, including the laboratory information system and sample tracking system. These shall be provided in an appropriate form, such as duplicate copies of electronically stored records and web content, and images of stored media. The Contractor shall also provide full documentation pertaining to the programs.

8. The Contractor shall pack all items and equipment in a safe and appropriate manner to ensure that equipment is not damaged and adherence to warranty conditions and service agreements is maintained.

9. The Contractor shall be responsible for transportation of equipment and materials and other costs required for the transition. The Contractor shall prepare an estimate for the costs related to the transfer of specimens, equipment, and materials no later than 2 months prior to the task order end and submit this to the COR and Contracting Officer.

Item Description Quantity Delivery Schedule

1 Manual of Procedures (MOP) 1

Due within 30 days months of the issuance of the task order/contract.

Updated continuously and available upon request.

Request for service process and implementation

Due within 6 months of the issuance of task order/contract. Maintained with periodic updates after that.

3 Monthly invoices 1 Monthly

4 Monthly technical narrative 1 Monthly (with invoice)

Semi-annual Technical Progress Report

Within 30 days of each 6-month period

6 Final Technical Report 1

First draft within 90 days of task order/contract expiration; Final version due 30 days before task order/contract expiration date.

Contractor’s Report of Task Order Completion

Within 30 days of each task order expiration

8 Summary of salient results 1 Include with Final Technical Report

Subcontracting Reports (If applicable)

On April 30 and October 30 and subcontract expiration only within Task Order period of performance.

Invention reporting requirement and Annual Invention Report

1 Annually

11 Section 508 Annual Report 1 Annually

Multiple principal investigator leadership plan (If applicable)

1 Annually, if applicable

Technical and business transition-out plan

Only if added to the Task Order via a funded and executed Task Order modification signed by the Contracting Officer

Only if requested by the COR:

(1) Begin developing 90 days prior to the task order/contract expiration;

(2) Submit a draft 30 days prior to the task order /contract expiration.

14 Final Report 1 Submit a final report upon the task order/contract’s expiration date or Upon written request from the COR.

The following below from the parent contract are referenced regarding the Twelve (12) Month Base Period and the Four (4) Twelve (12) Month Option Periods of this Task Order SOW.

352.204-72 RECORDS MANAGEMENT (FEB 2024) (DEVIATION)

(a) Applicability. This clause applies to contracts that include Federal records, as defined in paragraph (b).

(b) Definition. As used in this clause—

Federal record means all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. See 44 U.S.C. 3301.

(1) The term Federal record—

(i) Includes HHS records;

(ii) Does not include personal materials;

(iii) Applies to records created, received, or maintained by

Contractors pursuant to their contract; and

(iv) May include deliverables and documentation associated with deliverables.

(2) Recorded information means all traditional forms of records, regardless of physical form or characteristics, including information created, manipulated, communicated, or stored in digital or electronic form. (See 44 U.S.C. 3301.)

(3) Personal materials means documentary materials belonging to an individual that are not used to conduct agency business. Personal files are excluded from the definition of Federal records and are not owned by the Government. (See 36 CFR 1220.18.)

(c) Requirements.

(1) The Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapters 21, 29, 31, 33), NARA regulations at 36 CFR chapter XII subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all Federal records, regardless of form or characteristics, mode of transmission, or state of completion.

(2) In accordance with 36 CFR 1222.32, all data created for

Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), and the Privacy Act of 1974 (5 U.S.C. 552a), and must be managed and scheduled for disposition only as permitted by statute or regulation.

(3) In accordance with 36 CFR 1222.32, the Contractor shall maintain all Federal records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

(4) The Contractor is responsible for preventing the alienation or unauthorized destruction of Federal records, including all forms of mutilation.

Federal records may not be removed from the legal custody of HHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Contracting Officer. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. The Contractor shall report to the

Contracting Officer any unlawful or accidental removal, defacing, alteration, or destruction of Federal records.

(5) The Contractor shall immediately notify the Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that appropriate personnel are trained to adhere to these contract requirements, and that applicable, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of information, data, documentary material, Federal records and/or equipment is properly protected. The Contractor shall not remove Federal Records from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Contracting Officer. When information, data, documentary material, Federal records and/or equipment are no longer required, it shall be returned to HHS control or the Contractor must hold it until otherwise directed.

Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or as otherwise directed by the Contracting Officer. Destruction of Federal records is expressly prohibited unless in accordance with paragraph (c)(4).

(6) The Contractor shall only use Government information technology equipment for purposes specifically authorized by the contract and in accordance with HHS policy.

(7) The Contractor shall not create or maintain any Federal records containing any non-public HHS information that are not specifically authorized by the contract.

(8) The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

(9) All Contractor employees assigned to this contract handle Federal records are required to take HHS-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

(d) Subcontract flowdown. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract.

(End of clause)

352.224-70 NOTIFICATION OF SYSTEM OF RECORDS NOTICE (FEB 2024) (DEVIATION)

(a) This contract provides for the design, development, or operation of a system of records about individuals from which information about an individual is retrieved by the individual’s name or by some other identifying particular assigned to the individual.

(b) The System of Records Notice(s) (SORN(s)) that is applicable to this contract is/are: 9-25-0200 Clinical, Basic and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.

(c) The System of Records design, development, or operation work the Contractor is to perform is: Management of a biorepository that includes clinical specimens.

(d) The disposition to be made of the Privacy Act records upon completion of contract performance is as follows: The solicitation and award will state that, at the end of contract performance, HHS will provide disposition instructions to the contractor for securely transferring or destroying (in accordance with NIST SP 800-88) any agency records that are in the contractor’s (or any subcontractor’s) custody or control.

(e) Subcontract flow down. The Contractor is required to include this clause in all subcontracts at any tier performing work under the prime contract involving design, development, or operation work involving a System of Records.

352.224-71 CONFIDENTIAL INFORMATION (FEB 2024) (DEVIATION)

(a) Definition. As used in this clause—

Confidential information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Identification of information. Specific confidential information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, is identified in this contract.

(c) Disclosure. The Contractor shall not disclose confidential information or records until written notice is provided to the Contracting Officer at least 45 days in advance of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency. The Contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Government furnished or provided information: For information provided by or on behalf of the government—

(1) The publication or dissemination of the following types of information are restricted under this contract: clinical biospecimens with PII.

(2) The reason(s) for restricting the types of information identified in subparagraph (d)(1) is/are: privacy act records.

(e) The Contractor shall consult with the Contracting Officer when there is uncertainty with regard to the confidentiality of, or a property interest in, information under this contract prior to the release, disclosure, dissemination, or publication of such information.

352.239-75 SECURITY CONTROLS COMPLIANCE TESTING (FEB 2024) (DEVIATION)

On a periodic basis, HHS, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy controls implemented by the Contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the Contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein HHS information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of HHS, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice, to include unannounced assessments, as determined by HHS in the event of an incident or a breach, or at any other time.

352.239-76 SECURITY REQUIREMENTS FOR GOVERNMENT-OWNED CONTRACTOR-OPERATED AND

CONTRACTOR-OWNED CONTRACTOR-OPERATED RESOURCES (FEB 2024) (DEVIATION)

(a) Federal policies. The Contractor shall comply with applicable federal laws, regulations, and HHS policies that include, but are not limited to—

(1) HHS Policy for Information Security and Privacy Protection (IS2P);

(2) Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101);

(3) National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, latest revision, Security and Privacy Controls for Information Systems and Organizations;

(4) Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and

(5) Any other applicable federal laws, regulations, NIST guidance, and local HHS policies.

(b) Assessment and Authorization (A&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 shall work with the agency and supply the deliverables required to complete the ATO within 90 days after contract award.

The Contractor must conduct the A&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800- 53 Rev. 5. NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

(1) A&A package deliverables. The Contractor shall provide an A&A package within 30 days of contract award to the Contracting Officer and/or the Contracting Officer’s Representative (COR). The following A&A deliverables are required to complete the A&A package.

(ii) A System Security Plan (SSP) is 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 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 policies and other guidance. The SSP must 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 must provide an overview of the system environment and security requirements to protect the information system (see HHSAR 302.101, Definitions) 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 review and update the SSP at least annually thereafter and if requested, provide a copy of the updated SSP to the COR.

(iii) A Security Assessment Plan/Report (SAP/SAR) is due within

30 days after contract award. The security assessment must be conducted by an independent assessor and be consistent with NIST SP 800-53 Rev. 5, NIST SP 800- 30, and HHS policies. The assessor will document the assessment results in the SAR. Thereafter, the Contractor, in coordination with the COR shall conduct, or as directed, in the assessment of the security controls and update the SAR at least annually. A copy of the updated SAR shall be provided to the COR, if requested.

(iv) All systems shall have a completed privacy threshold analysis

(PTA). If the PTA results determines the system contains personally identifiable information, a privacy impact assessment, approved by the HHS SAOP, is required.

(v) System Privacy Plan and Privacy Control Assessment. As required in OMB Circular A-130, a System Privacy Plan and Privacy Control Assessment shall be included in A&A. The plan and assessment may be included in the Security System Plan, or a separate report in the A&A, as determined by the COR.

(vi) An Independent Assessment is due 90 days after the contract award. The Contractor shall have an independent third-party validate the security and privacy controls in place for the system(s) commensurate with the risk levels per NIST SP 800-53B. 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 and document all remaining deficiencies in a system Plan of Actions and Milestones (POA&M).

(vii) The POA&M is due as follows—

(A) All findings/weaknesses must be documented in the

POA&M and remediated/mitigated from the date the weaknesses are formally identified and documented;

(B) Critical-risk weaknesses must be mitigated within 30 days from the date the weaknesses are formally identified and documented;

(C) High-risk weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented;

(D) Medium weaknesses must be mitigated within 1 year from the date the weaknesses are formally identified and documented; and

(E) Low weaknesses must be mitigated within 1 year from the date the weaknesses are formally identified and documented.

(2) HHS will determine the risk rating of all vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, flaws and security defect in a system (that require to create a patch for remediation), 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 https://www.cio.gov/policies-and-priorities/circular-a-130/ document consistent with the HHS Standard for Plan of Action and Milestones policies. Depending on the severity of the risks, HHS may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, continue to remediate weaknesses throughout the contract. The POA&M document shall be updated at least quarterly.

(3) A Contingency Plan and Contingency Plan Test are due 60 days after contract award. The Contingency Plan shall be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with…