Amendment 1 RFP 75N93024R00030.pdf

AMENDMENT #1 RFP No. 75N93024R00030 1

Amendment No. 1 RFP No. 75N93024R00030

“NIAID Virology Quality Assurance”

Solicitation Number: 75N93024R00030

Amendment Number: One (1)

Amendment Issue Date: January 13, 2025

Proposal Due Date/Time: April 8, 2025, at 3:00 PM, EST (Unchanged)

Issued By: Ashley Kinderdine

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY shawnice.williams@nih.gov Shawnice Williams, Contract Specialist Phone: 301-761-5431

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment is to add Attachment 1 through Attachment 7 to the solicitation.

1. Section J – List of Documents, Exhibits and Other Attachments, is updated to include the referenced Attachments 1 through 7 for RFP No: 75N93024R00030, 35 pages.

END OF AMENDMENT NO. 1, RFP No. 75N93024R00030 mailto:shawnice.williams@nih.gov

Attachment 1- Packaging and Delivery of Proposal

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with

FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

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. Create one PDF file of your Business Proposal, including all attachments:

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, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel

Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of

Proposed Estimated Costs (plus Fee) with Excel Spreadsheet”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

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

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto 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 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

Attachment 1- Packaging and Delivery of Proposal

5. 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).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Font size must be 10 to 12 points.

4. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

5. Margins must be at least one-inch on all sides.

6. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 200 pages.

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section

3. Each Curriculum Vitae (CV) shall not exceed 3pages.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

Attachment 3 – Statement of Work – November 21, 2024 Page 1 of 14

RFP # 75N93024R00030

ATTACHMENT 3: STATEMENT OF WORK

NIAID Virology Quality Assurance (VQA)

RFP #75N93024R00030

1) BACKGROUND and INTRODUCTION

The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions. High quality test results support the safety of study participants and the reliability of study results. DAIDS employs a variety of Laboratory Quality Assurance contractual resources to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing (https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures).

The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV and other viral pathogens (including emerging pathogens and pandemic response) performed on samples collected from participants enrolled in NIAID-sponsored and collaborative multisite clinical studies. The goal of the VQA program is to ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data by providing laboratories with proficiency testing (PT) panels and real-time assay run controls, and analyzing PT panel and assay run data within and across each laboratory participating in the program. The VQA program implements standards of performance for new and existing state-of-the-art virologic assays, develops and employs biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials (QCMs) and reagents. The VQA program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, pathogenesis, drug resistance, and cure, including the assessment of vaccine and treatment efficacy, post-exposure prophylaxis (PrEP), other preventive measures, and response to emerging viral pathogens of pandemic potential.

The VQA has been in operation since 1988 and has developed and standardized quality control procedures for numerous virologic assays in support of NIAID-sponsored and collaborative clinical trials.

The VQA will continue to serve current and future NIAID-sponsored clinical trial networks, cohorts, and collaborating study groups (User Groups), as well as individual grantees conducting clinical research.

The current contract is held by Duke University, Durham, North Carolina, under contract number 75N93019C00015. The period of performance of the current contract is June 21, 2019, through June 20, 2026.

2) SCOPE

The Contractor shall provide laboratories (Labs) performing virologic testing for NIAID-sponsored and collaborative clinical trials and Labs from health agencies partnering with NIAID, with a comprehensive https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures

Attachment 3 – Statement of Work – November 21, 2024 Page 2 of 14 quality assessment program and real-time assay validation for virologic assays for HIV and other viral pathogens. The contract also provides for the planning and execution of single and multi-laboratory studies for the evaluation and development of new and existing virologic assays and supporting statistical methodologies. QCMs necessary for this work will be acquired, characterized, stored, catalogued, and dispensed as necessary. This contract also includes Options to increase level of effort in support of: (1) unanticipated increases in demand related to support of additional Labs; (2) performance of late-stage assay validation and/or testing of clinical samples in a CLIA-certified laboratory; and (3) response to emerging viral pathogens and other public health emergency needs.

3) TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall 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 below.

Specifically, the Contractor shall perform the following tasks:

A. IMPLEMENT LAB PERFORMANCE STANDARDS AND ASSESS LAB PERFORMANCE

1. International Organization for Standardization and International Electrotechnical

Commission (ISO/IEC) 17043 Certification for PT (Proficiency Testing) Providers

Within one year of the contract, the Contractor shall obtain ISO/IEC certification for PT providers and maintain the certification throughout the life of the contract.

2. PT of Virologic Assays

This Contract shall serve “User Groups” which consist of current and future NIAID-sponsored clinical trial networks and collaborating study groups as well as NIAID-supported non-network clinical trials and partnering health institutes/agencies. When Labs are chosen by User Groups to participate in a clinical trial, it is critical to evaluate, both initially and on an on-going basis, the ability of Labs to perform protocol-specified tests correctly and reliably. Labs are required to be assessed for proficiency in performing virologic assays for HIV and related coinfections, and antiviral drug resistance. The Contractor will determine test proficiency through evaluation of results obtained using panels of coded (unknown to Labs) QCMs. Panels of QCMs are tested by the Labs on a regular basis. Section C below, provides further information on QCMs.

For each assay specified by the COR, the Contractor shall perform the following tasks:

a) Prepare and provide participating Labs with PT panels of coded QCMs, at intervals specified by the COR. Panels must include QCMs that correspond to the clinical samples used in each assay (i.e. whole blood, plasma, serum, Peripheral Blood Mononuclear Cells (PBMC), dried-blood spots (DBS), etc.).

b) Design new or implement currently available tools to capture PT panel assay results and information related to test methodology and instrumentation used at the Labs. Where possible, the Contractor shall provide electronic means for retrieval of results.

Attachment 3 – Statement of Work – November 21, 2024 Page 3 of 14

c) Provide methodology for retrieval of PT results from Labs after completion of each round of testing.

d) Verify the accuracy and completeness of data received from Labs.

e) Monitor the Labs’ performance in analyzing PT panels based on criteria formulated by the Contractor, relevant User Groups, and the COR. Evaluation factors may include statistical parameters such as goodness of fit, deviation around a mean, coefficient of variation, and other factors as applicable to the specified assays.

f) Release Lab-specific preliminary reports to each Lab (provisional performance status), within five business days following receipt of PT results from all participating Labs. The Contractor shall review PT results for accuracy and completeness and discuss the PT results with the COR, and others designated by the COR, in conference calls.

g) Within 30 business days of receipt of data from all participating Labs, a Final PT Report shall be submitted to each Lab, the COR, and others as requested by the COR.

h) PT panels may be created by the Contractor or acquired, if available, from other providers [e.g., the College of American Pathologists (CAP)], and shipped to Labs at regular intervals.

i) When PT panels are not created by the VQA, the contractor shall:

i. Identify providers of PT panels and assess their suitability considering appropriateness of the materials used to compose the PT panel, frequency of panel shipments to Labs, performance grading schemes, and ease of obtaining Lab proficiency data from PT panel providers.

ii. Facilitate the enrollment of Labs identified by the COR into the PT Program, and, when directed by the COR, pay for the PT panels and their shipment to Labs.

iii. Receive and review Lab-specific performance reports produced by the PT provider after each PT round.

iv. Monitor laboratory performance and provide guidance to laboratory to address related Corrective and Preventive Actions (CAPA)

j) When performance failure is identified, the Contractor shall:

i. Send the Lab an Investigation Report Form to initiate investigation of the root causes of the failure and to indicate steps to prevent such failures from re-occurring.

ii. Provide guidance, assistance, and training to Labs in areas needing improvement.

iii. At the direction of the COR, provide Labs with additional QCMs to facilitate investigation of poor performance and/or to verify successful implementation of corrective measures at the Lab.

iv. Keep the COR and User Groups indicated by the COR informed of activities provided by the VQA in efforts to address and improve Labs’ poor performance.

Attachment 3 – Statement of Work – November 21, 2024 Page 4 of 14

v. Provide a summary of lab-specific performance issues in the semi-annual report.

3. Real-Time Assay Validation

To ensure assay validity, the Contractor shall provide Labs with QCMs for use as external controls in each assay run. QCM assay results falling outside predetermined ranges indicate an invalid assay. As directed by the COR, the Contractor shall:

a) Determine acceptable ranges for validity of QCM assays based on recommendations from assay manufacturers and/or User groups.

b) Provide Labs with known QCM to be used for each virologic assay type that requires real-time validation.

c) Provide Labs with instructions regarding the proper use of QCMs in assays and storage of QCMs at the Lab.

d) Instruct Labs to maintain internal reagent inventories for real-time assay validation and communicate needs to Contractor.

4. Verification of Assay Performance Specifications

Labs are required to verify the performance specifications for virologic assays used as endpoints for clinical trials or used for trial participant management. Verification is determined through evaluation of results obtained with panels of QCMs and local clinical samples. For each assay specified by the COR, the Contractor shall perform the following tasks:

a) Provide participating Labs with verification plans and QCM panels for verification. Each Lab is responsible for obtaining local clinical samples for verification.

b) Analyze verification performance results from the Labs and provide Labs, and others as specified by the COR, with a detailed report of the results within 30 business days of submission of results to the Contractor by the Lab. Evaluation factors may include statistical parameters such as goodness of fit, deviation around a mean, coefficient of variation, and other factors as applicable to the specified assay. While the Contractor is responsible for reviewing and indicating acceptability of the verification results, the Contractor is not responsible for approval of the verification results. Approval for verification of the results is the responsibility of the Laboratory Director at each Lab that produces a report.

5. Lab Training and Assistance

a) Training for commercially available assays is generally provided by the manufacturer. Where training is not provided by a manufacturer, the Contractor shall assist in training Lab personnel.

Specifically, the Contractor shall perform the following:

Attachment 3 – Statement of Work – November 21, 2024 Page 5 of 14

i. Provide Labs with standard operating procedures (SOPs), electronic or hard copy, for performing virologic assays at the time of enrollment and whenever procedures/SOPs are updated by the Contractor, manufacturers, or User Groups.

ii. As new assays are developed, the Contractor will:

a. Prepare training materials for the new assays (e.g. assay procedures/SOPs, instructional videos, diagrams, and pictures).

b. Make training materials available to Labs through the VQA document repository.

b) The Contractor shall assist the Labs to improve assay performance when results deviate from accepted values agreed upon by the Contractor, User Groups and the COR. Specifically, the Contractor shall perform the following:

i. Identify and quantify sources of variability and/or other reasons for such performance by direct inquiry or by survey, and provide Labs with additional written, telephonic, or electronic instruction.

ii. Review corrective action plans from the Labs and assist with implementation of the plans.

iii. Provide Labs with additional QCM panels for re-testing after implementation of corrective measures; analyze data from the additional panels and report results to Labs and to the COR.

iv. At the request of the COR, coordinate visits for lab personnel to the Contractor’s Lab for the purpose of training.

v. At the request of the COR, travel to Labs to investigate results that deviate from accepted values and assist with implementation of corrective action.

B. EVALUATION, STANDARDIZATION AND APPLICATION OF VIROLOGIC AND BIOSTATISTICAL

ANALYTICAL METHODOLOGIES

To support the continued development and harmonization of virologic assays for HIV and other viral pathogens, including low-cost simple technologies and laboratory developed tests (LDTs), and their application to vaccine, prevention and therapeutic studies, the Contractor shall conduct studies to optimize new or existing virologic methodologies, and investigate and integrate biostatistical methodologies for the evaluation and interpretation of laboratory data. The VQA will also provide support to testing Labs for the standardization and validation of study-specified LDTs designed to contribute to clinically useful information and enable sound product development decisions.

1. Evaluation and Comparison of Virologic Assay Methodologies

The Contractor shall conduct preliminary studies in-house (at Contractor’s laboratory) and subsequently single- and multi-Lab studies with the following aims:

a) Evaluate and compare existing and newly developed commercial and lab-based “in-house” virologic assays and reagents. For each evaluation, the Contractor shall provide selected Labs with assay-appropriate coded QCMs. Labs shall be selected by the Contractor and approved by the COR.

Attachment 3 – Statement of Work – November 21, 2024 Page 6 of 14

b) Evaluate and compare specimen handling, processing, and storage procedures. For each study, the Contractor shall provide selected Labs with appropriate known standards and coded QCMs.

Labs shall be selected by the Contractor and approved by the COR.

c) Assemble and statistically analyze data from the above-mentioned studies and forward results to the COR and User Group(s) as directed by the COR.

d) For each evaluation (in-house, single-Lab, or multiple-Labs):

i. Draft an evaluation protocol for review by the COR, Study Groups and statisticians, incorporate suggestions, and produce a final evaluation protocol.

ii. Acquire and characterize appropriate QCMs; provide QCMs to selected Lab(s) participating in the evaluation.

iii. In collaboration with participating Lab(s) and statisticians, design data collection tools to capture evaluation results and related information about methodology and instrumentation at the Lab(s).

iv. Provide Lab(s) with instructions regarding proper use of QCMs in assays, storage of QCMs, format and deadlines for reporting test results.

v. Receive evaluation results and related information from the Lab(s) and check for accuracy and completeness.

vi. Within 15 calendar days of the conclusion of each evaluation, prepare a comprehensive Evaluation Report. The report shall include the purpose and design of the evaluation, information on participating Lab(s) and collaborators, complete information on QCM acquisition and characterization, and evaluation results. Distribute reports to the COR, User Groups and participating Labs.

2. Assay Characterization, Qualification and Validation

The Contractor shall provide support to Labs planning to perform study-specified LDTs to achieve the needed level of compliance with evolving requirements of regulatory entities, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on study design and purpose.

Related NIAID guidance is available https://www.niaid.nih.gov/research/daids-clinical-research-laboratory-specimens-management. Specifically, the Contractor shall:

a) Provide the required/appropriate level of characterization of study-specified assays based on the design and intended purpose of the study to the COR and others indicated by the COR.

b) Review and determine adequacy of assay protocols and assay characterization SOPs received from testing Labs; provide guidance to Labs and examples of SOPs as needed.

c) Receive assay characterization data from Labs, assess data adequacy and provide guidance to Labs when gaps are identified.

d) As needed, and at the direction of the COR, provide reagents to support assay characterization at a Lab.

https://www.niaid.nih.gov/research/daids-clinical-research-laboratory-specimens-management https://www.niaid.nih.gov/research/daids-clinical-research-laboratory-specimens-management

Attachment 3 – Statement of Work – November 21, 2024 Page 7 of 14

e) Within 30 business days after receiving final assay characterization data from the Lab(s), summarize data in a “fit-for-purpose” report, and provide the report to the COR and others designated by the COR.

3. Analytical and Biostatistical Methodologies

As directed by the COR, the Contractor will collaborate with User Groups and statisticians to evaluate and apply existing or novel statistical models for assessment, interpretation, and validation of virologic assay test results. The Contractor shall perform the following tasks:

a) Develop, with User Groups, quality control parameters for new assays as they are implemented in clinical studies.

b) Develop approaches to statistical analysis and interpretation of data from virologic assays. This must include at a minimum, methods for determination of detection limits or cut-off values;

methods to evaluate precision, accuracy and linearity of quantitative assays; methods to evaluate and compare intra-and inter- Lab variation, and methods to measure the effects of possible variation of assay parameters on precision, accuracy and linearity.

c) Develop plans for on-site verification of assay performance specifications as designated by the

COR. For unmodified FDA-approved quantitative assays the verification must include analyses of accuracy, precision and linearity. For modified FDA-approved or non-FDA-approved assays, verification must also include analytical sensitivity and analytical specificity.

C. QUALITY CONTROL MATERIALS (QCMS) AND REAGENTS

The Contractor shall create or procure materials and reagents necessary for production of QCMs and prepare and characterize the QCMs and materials and reagents needed to support work outlined in Sections 3.2 and 3.4, above. Materials and reagents will include biohazardous materials (i.e. blood borne pathogens including HIV, and other viral pathogens).

1. Donor Program

The Contractor shall develop and maintain a donor program for obtaining appropriate materials from well-characterized (e.g., with known CD4 and CD8 cell counts, HIV and/or HCV RNA levels, CBC) people living with and without HIV. The donor pool must allow for the acquisition of materials from volunteers with HIV subtype B as well as non-B subtypes of HIV and relevant types and subtypes of other viruses.

The donor pool should include individuals with characterized antiretroviral resistance patterns during viremia and other antiviral resistance (e.g., to Direct-acting antivirals in HCV). The Contractor must collaborate or subcontract with at least one non-US institution for the collection of samples containing non-B subtypes of HIV, with and without characterized antiretroviral resistance.

2. QCMs

QCMs for use in the work outlined in Sections 3.2 – 3.4 above can be produced from clinical samples obtained from the donor program, from cultured viruses and cells, infectious molecular clones (in the

Attachment 3 – Statement of Work – November 21, 2024 Page 8 of 14 case of drug resistance mutations), or from other commercial sources. As directed by the COR, the Contractor shall collect QCMs including the following:

a) Serum and plasma samples (from HIV-positive donors and/or HIV-spiked normal plasma/serum) containing known numbers of HIV RNA copies/ml for RNA quantification

b) Whole blood from well-characterized donors, including HIV-positive (subtype B and non-B subtypes) and HIV-negative donors, for HIV DNA or TNA PCR assays.

c) Cell pellets with known DNA copy numbers for use in HIV DNA or TNA PCR assays.

d) Whole blood/serum/plasma samples from HIV-positive donors (subtype B and non-B subtypes) containing drug resistance mutations for HIV drug resistance assays.

e) Plasma and viable PBMC aliquots from antiretroviral-treated and virologically suppressed people with HIV (subtype B as well as non-B subtypes) for use in assays measuring HIV reservoirs.

3. Additional QCMs and Reagents

Additional QCMs and reagents relevant to viral pathogens other than HIV and future virologic assays may also be required. The Contractor shall produce or obtain additional reagents as needed for QCMs (e.g.

infected cell lines, viral lysates, viral stocks, enzymes). These shall be obtained from research institutions or commercial sources, domestic or international.

4. Characterization of QCMs

Prior to use in laboratory performance or in assay or kit evaluation studies, the Contractor shall determine QCM and reagent characteristics, including conducting stability testing studies to assess optimal use and storage conditions. Examples include the following:

a) Concentration of HIV-infected cells in frozen cell pellets

b) HIV RNA or other viral nucleic acid levels in spiked plasma or other samples

c) Drug resistance mutations in HIV-infected blood samples used for drug resistance PT (e.g. Sanger and NGS methods)

d) HIV p24 antigen levels in, plasma, serum, and culture medium

e) HIV reservoir measurements (e.g. Infectious units per million resting CD4 cells or per million

PBMCs)

f) Cell-associated RNA and DNA levels in cell samples from treated individuals

g) Reagent handling conditions (e.g. length of storage, storage temperature and shipping temperature and time) and potential impact on stability and activity

5. Storage of QCMS and Reagents

The Contractor shall inventory and store aliquots of characterized QCMs and reagents under conditions that ensure continued activity and viability. As relevant, retain available aliquots from old lots for comparison to new lots.

Attachment 3 – Statement of Work – November 21, 2024 Page 9 of 14

6. QCM and Reagent Shipping

Upon COR approval, the Contractor shall ship QCMs and reagents to specified domestic and international destinations under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO dangerous goods shipping regulations and other relevant shipping regulations https://www.iata.org/en/publications/dgr/.

In addition, the Contractor shall perform the following:

a) Execute agreements with receiving institutions regarding relevant standards for safe handling and authorized use of QCMs and reagents.

b) Obtain the appropriate interstate, intrastate and foreign shipping licenses and permits for transporting biohazard materials.

c) Coordinate the shipments of QCMs and reagents to the Labs, including prior notice of upcoming shipments.

d) With each shipment of QCMs, provide the Labs with procedures/SOPs (written and/or via electronic mail) regarding the following:

1. Use of QCMs in assays

2. Storage of QCMs at the Lab

3. Deadlines for, and method of reporting results of QCM testing

D. PROGRAM MANAGEMENT

1. Program Coordination

a) Provide for the overall management, integration, and coordination of all contract activities including study protocol development, selection of assays and samples, and defining timelines for studies and delivery of results. Provide for communications, tracking, monitoring, and reporting on project status and progress, and recommend modifications to project requirements and timelines.

b) Ensure that all personnel, equipment, and facilities are compliant with applicableregulatory requirements in effect throughout the contract period of performance.

c) Provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all projects carried out under this contract and effective communications with the COR and the Contracting Officer (CO).

2. Meetings and Teleconferences

The Contractor shall be responsible for the following:

a) Contract Initiation Meeting Within 30 calendar days after the effective date of the contract, participate in a one-day Contract Initiation Meeting with the COR, the CO and other NIAID personnel designated by the COR, to be held at the Contractor’s site. The purpose of the Contract Initiation Meeting is to orient the Contractor to NIAID contract procedures. Contractor staff such as the PI, project manager, laboratory director, scientific consultants, agency grants managers and accountants may be requested to participate.

https://www.iata.org/en/publications/dgr/

Attachment 3 – Statement of Work – November 21, 2024 Page 10 of 14

b) Annual Site Visits Arrange for and conduct annual site visits at the Contractor’s facility for the COR and other NIAID staff to review and discuss project progress; approaches to overcoming identified problems/obstacles; make recommendations for modifications in project timelines, objectives, and research methodologies based on outcomes to date; and discuss future plans. These site visits shall be attended by the Principal Investigator, the Contractor’s business representative, and all key personnel.

1. Plan and submit the agenda to the COR for approval at least seven (7) business days before the site visit.

2. Develop written and oral presentation materials.

3. As directed by the COR, manage the logistics associated with the site visits; and travel including costs for all non-Government site visit attendees.

4. Prepare and submit a detailed summary report of the Annual Site Visit to the COR and CO within ten (10) business days of completion of each annual site visit.

c) Teleconferences

Plan and conduct monthly and ad-hoc teleconference calls and meetings with the Contractor’s key personnel, the COR, and other contractor personnel specified by the Contractor or the COR to review overall progress. Prepare the agenda and meeting/teleconference materials and distribute to all participants at least 1 day prior to the teleconference. Record meeting notes and distribute to COR, CO, and contractor staff within three days of the meeting. Provide a summary of all meetings and teleconferences in the Semi-Annual Progress Reports.

Plan and conduct meetings of the Contractor’s key personnel and specific Lab investigators as necessary via teleconference, to review Lab-specific problems and resolutions and to review progress on assay development studies. Provide a summary of all meetings and teleconferences in the Semi-Annual Progress Reports.

3. Budget Reports

The Contractor shall prepare and provide quarterly budget reports to the COR and CO that indicate the current budget, estimated cost projections for each study, including spent, but not yet invoiced funds, and funds remaining.

4. Dissemination of Virology Quality Assessment Technical and Scientific Data

The Contractor shall, upon approval of the COR, disseminate technical and scientific data that result from activities conducted under this contract through publication and presentation of data and through conference calls and meetings with relevant parties. All electronic documents shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Helpful Resources."

Specifically, the Contractor shall perform the following tasks:

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

Attachment 3 – Statement of Work – November 21, 2024 Page 11 of 14

a) Within 3 months of final data analysis, prepare materials to support preparation of scientific manuscripts for publication in peer reviewed journals and submit these materials to the COR for review and approval prior to publication.

b) Participate in annual meetings of the NIAID HIV clinical trial networks designated by the COR to meet with Contract users and provide assistance and technical advice regarding virology testing and Contract activities. Materials submitted for presentation and final presentations must be submitted to the COR at least 3 business days prior to the date of submission or presentation.

c) Post quality assessment technical and scientific data on a NIAID SharePoint or other approved document library accessible to User Groups.

d) Submit abstracts and requests to present data at research conferences relevant to the VQA to the COR within three business days prior to submission. Participate in relevant conferences with the appropriate contract staff as deemed appropriate by the COR.

E. AUDITS

NIAID may authorize, at any time during the contract period of performance, independent audits of Contractor performance with respect to the functions specified in the Statement of Work, including review of Contractor processes, procedures and operations at the Contractor’s site. NIAID shall notify the Contractor of plans for independent audits 10 business days in advance of the scheduled audit. For audits conducted at Contractor facilities, the Contractor shall ensure that appropriate staff and all necessary information and documentation are available. For-cause audits may be performed at any time and without advance notice to the Contractor in instances of suspected non-performance and/or non-compliance with Federal and/or country-specific regulatory requirements.

F. DOCUMENTATION AND DATA MANAGEMENT

The Contractor shall track and make available documents in support of activities performed under the contract. The Contractor shall:

a) Store, organize, track, retrieve documents and reports on Lab-specific information and activities.

All publicly accessible documents shall comply with Section 508 and meet the Section 508 accessibility standards.

b) Maintain and update Lab-specific documents such as Lab contact information, proficiency testing performance records, assay development and validation reports, and reports of VQA communications with Labs.

c) Provide security measures for Lab-specific PT data accessible only to Lab staff and to individuals identified by the COR.

d) Maintain and update information related to QC samples, and reagents, including source, type, amounts, characteristics and lot numbers, shipping dates to Labs, stability data, and storage.

Attachment 3 – Statement of Work – November 21, 2024 Page 12 of 14

e) Maintain and update a public document library for Labs and User Groups, which contains Contractor’s presentations, policies, news releases, and guidance materials and resources organized by categories. The searchable library shall comply with Section 508 and meet the Section 508 accessibility standards.

f) Provide tracking information for stored documents that includes name and/or type of document, description, author and/or origin, date received, and date stored by the Contractor.

g) Perform an information systems security audit that conforms to standards for federal information systems and as relevant to the design, the platform shall comply with FISMA and/or FedRAMP requirements (see https://www.dhs.gov/fisma and http://www.fedramp.gov).

G. INITIAL AND FINAL TRANSITION

1. Initial Transition

As directed by the CO, in the event of transition to a new contractor, the Contractor shall ensure an orderly, secure, and efficient transition of activities from the previous contractor, as follows:

a) Within 10 business days of the effective date of the contract, the COR will provide the new Contractor with a copy of the incumbent contractor’s Final Transition Plan, which will specify transition requirements and processes. The transition will require the transfer of contract-related materials and data that include but are not limited to the following:

i. Stored QCMS, reagents, biological samples, cell lines and tissues.

ii. Communication and correspondence files, all computerized data files and any documentation and specifications related to software systems used in performance of the contract, including proficiency testing and real-time assay validation files, assay development research data files, inventory files, and statistical analysis data files including PT and Real-Time Assay Validation Data, Assay Research and Development, QCM Data.

iii. Government Furnished Property (GFP) in possession of the incumbent contractor, such as instruments, analytical equipment, computers, software, freezers, etc. and any active maintenance agreements and active warranties.

iv. Verification of equipment performance standards shall take place prior to and after the transfer.

b) Within 14 business days of the effective date of the contract, the Contractor shall submit to the

COR and CO for approval, an Initial Transition Plan and timeline for the transition of activities and contract-related materials from the current contractor. The Plan shall include coordination with the Labs to ensure an orderly transition.

c) Upon COR and CO approval of the Initial Transition Plan, implement and complete the transition within the first 20 calendar days following the effective date of the contract.

https://www.dhs.gov/fisma http://www.fedramp.gov/

Attachment 3 – Statement of Work – November 21, 2024 Page 13 of 14

2. Final Transition

As directed by the CO, provide a Final Transition Plan for the orderly, secure and efficient transition of contract-related materials, data, and activities, to a successor contractor or the Government, if other than the incumbent is awarded a follow-up contract. This plan shall be subject to written approval by the COR and CO.

a) The Draft Final Transition Plan shall be submitted to the COR and CO 6 months prior to the expiration date of the contract for review and comment. Upon receipt of the COR’s and CO’s comments, the Contractor shall revise the Draft Final Transition Plan as necessary.

b) The Final Transition Plan shall be submitted for written approval to the COR and CO 3 months prior to the expiration date of the contract. The Contractor shall implement and complete the Transition Plan by the completion date of the contract.

c) The transition process will require the transfer of contract-related material to include:

i. Stored QCMs, reagents, biological samples, tissues, to include biohazardous materials

ii. Communication and correspondence files, all computerized data files and any documentation and specifications related to software systems used in performance of the contract, including proficiency testing and real-time assay validation files, assay development research data files, inventory files, and statistical analysis data files

iii. Scientific data, QA data, reports, and procedures/SOPs

iv. Government-furnished property such as instruments, computers, software, freezers, etc.

H. OPTIONS

In addition to the functions and services to be provided for in the Base period, the Government may exercise, at its discretion, Options as follows:

a. Options 1 through 6, Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the base period annually for a total contract period of up to 7 years.

b. Options 7 through 38, Increase Level of Effort: The Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include the following:

a) Options 7-26: Increased Level of Effort for Additional Labs

During the contract, it may be necessary to incorporate additional Labs to support new NIAID-sponsored and collaborative clinical trials. Such an addition would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each option of this type will implement work commensurate with the addition of 5 Labs. These options may be exercised during Years 2 through 7. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated

Attachment 3 – Statement of Work – November 21, 2024 Page 14 of 14 increase in work volume by 0.25 FTE, including consultant and subcontractor effort, to accommodate these additional Labs during the first and each subsequent year of activation.

The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Option year in which the Option is exercised.

b) Options 27-32: Increased Level of Effort for Additional Expertise

During the contract, it may be necessary to develop a quality assessment program for assays associated with HIV-related viruses and/or emerging pathogens that would directly support high priority NIAID research programs. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.30 FTE, including consultant and subcontractor effort, for each option exercised.

The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Option year in which the Option is exercised.

c) Options 33-38: Increased Level of Effort for the Addition of CLIA Certified Labs During the contract, it may become necessary to use new and novel virologic assays in clinical trials where results will be used for clinical decisions within the trial. This will necessitate the use of a CLIA certified laboratory for late-stage validation of the assay and for clinical testing. If necessary, this will be provided through the exercise of options to this contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE, including consultant and subcontractor effort, for each option exercised. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Option year in which the Option is exercised.

Attachment 4: Technical Proposal Instructions RFP # 75N93024R00030 Page 1 of 5

ATTACHMENT 4: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

NIAID Virology Quality Assurance

It is strongly recommended that offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the solicitation and provide specific instructions and formatting for the Technical Proposal.

While Section L of the solicitation provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Statement of Work, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the solicitation as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

SECTION 1:

1) PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, and identify if the proposal is an original or a copy. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government

RFP # 75N93024R00030 Page 2 of 5 except for evaluation purposes, shall also include the legend regarding Restriction on Disclosure and Use of Data prescribed by FAR 52.215-1(e)]

2) TABLE OF CONTENTS

SECTION 2: TECHNICAL PROPOSAL OVERVIEW (suggested 3-page maximum)

Provide a brief overview of the Technical Proposal, including:

1) A brief description of the activities proposed by the offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key personnel for the offeror and the proposed subcontractors with degrees, titles and role in the project.

2) By area of expertise, provide the total number of staff, the number available to be assigned to the contract for the offeror and all proposed subcontractors, and total number of additional staff to be hired and trained.

3) A brief description of the facilities and equipment to be made available by the offeror and all proposed subcontractors.

SECTION 3: TECHNICAL PLAN/APPROACH

A. IMPLEMENTATION OF LAB PERFORMANCE STANDARDS AND LAB ASSESSMENT

Discuss your experience, approach and plans for proficiency testing programs, real-time assay validation, and assay verification programs. Include plans for providing Labs with panels for testing, transmission of data and results, data analysis and reporting. Discuss plans for providing assistance to Labs whose results deviate from accepted values. Include any plans for travel to labs to provide assistance.

B. EVALUATION, STANDARDIZATION AND APPLICATION OF VIROLOGIC AND BIOSTATISTICAL

ANALYTICAL METHODOLOGIES

Discuss your experience, approach, and plans for conducting single- and multi-Lab evaluations of new and existing virologic assays and/or comparative studies of existing or novel assays, assay kits, including study design, provision of appropriate QCMs, data collection, statistical analysis, interpretation, and validation of virologic assay test results.

C. PROVISION OF QUALITY CONTROL MATERIALS AND REAGENTS

1. DONOR PROGRAM

Discuss plans to establish and maintain a donor program for obtaining materials from well-characterized human subjects. Discuss access to populations of infected donors and discuss plans for acquisition of materials from volunteer donors infected with different subtypes of HIV and relevant subtypes of other viruses. Include plans for compliance with applicable domestic and international regulations on the use of human subjects (including, for example but not limited to IRB submission and approval plans, consent procedures, etc.) and with HIPAA and Privacy Act requirements.

https://www.acquisition.gov/far/part-52#FAR_52_215_1

RFP # 75N93024R00030 Page 3 of 5

2. QCMs

Discuss your experience, approach, and plans for the acquisition of QCMs and reagents specified in the Statement of Work, including QCM acquisition,…