RFP 75N95023R00013 - Attachments.pdf

RFP Number : 75N95023R00013

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RFP SECTION J - LIST OF ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

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SECTION J - LIST OF ATTACHMENTS

The following documents are incorporated into this RFP:

SOLICITATION ATTACHMENTS

Attachment No. Title Location

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

Refer to the RFP attachment folder

Attachment 2: Proposal Intent Response Sheet Refer to the RFP attachment folder

Attachment 3: Statement of Work-IDIQ Refer to the RFP attachment folder

Attachment 4: Reporting Requirements and Deliverables-

IDIQ

Refer to the RFP attachment folder

Attachment 5: Additional Technical Proposal Instructions Refer to the RFP attachment folder

Attachment 6: Additional Business Proposal Instructions Refer to the RFP attachment folder

Attachment 7: Statement of Work-Task Order 1 Refer to the RFP attachment folder

Attachment 8: Reporting Requirements and Deliverables- Task Order 1

Refer to the RFP attachment folder

Attachment 9: Section K - Representations, Certifications, and Other Statements of Offerors

Refer to the RFP attachment folder

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 10: Technical Proposal Cost Summary Refer to the RFP attachment folder

Attachment 11: Summary of Related Activities Refer to the RFP attachment folder

Attachment 12: Voluntary Product Accessibility Template

(VPAT)

Use the following link: https:// www.section508.gov/sell/vpat/

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 13: Proposal Summary and Data Record, NIH-2043

Refer to the RFP attachment folder

Attachment 14: Small Business Subcontracting Plan Refer to the RFP attachment folder

Attachment 15: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet

Use the following link: Breakdown of Proposed Estimated Costs (plus fee) w/ Excel Spreadsheet

Attachment 16: Offeror's Points of Contact Refer to the RFP attachment folder

Attachment 17: Certificate of Current Cost or Pricing Data Refer to the RFP attachment folder

Attachment 18: Disclosure of Lobbying Activities, OMB Form SF-LLL

Refer to the RFP attachment folder https://www.section508.gov/sell/vpat/ https://www.section508.gov/sell/vpat/ https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx

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INFORMATIONAL ATTACHMENTS

Attachment No. Title Location

Attachment 19: Invoice/Financing Request Instructions-CR-

NIH(RC)-1

Refer to the RFP attachment folder

Attachment 20: NIDA Supplemental Billing Instructions, Exhibit A to NIH(RC)-1

Refer to the RFP attachment folder

Attachment 21: Financial Report of Individual Project/ Contract NIH 2706

Refer to the RFP attachment folder

Attachment 22: Instructions for Completing Form NIH 2706 Refer to the RFP attachment folder

Attachment 23: Privacy Act System of Records - 09-25-0200

Refer to the RFP attachment folder

Attachment 24: Safety and Health, HHSAR Clause 352.223-70

Refer to the RFP attachment folder

Attachment 25: Commitment to Protect Non-Public Information Contractor Agreement

Refer to the RFP attachment folder

Attachment 26: Roster of Employees Requiring Suitability Investigations

Refer to the RFP attachment folder

Attachment 27: Employee Separation Checklist Refer to the RFP attachment folder

Attachment 28: COVID-19 Return to Work Guidance Refer to the RFP attachment folder

RFP 75N95023R00013 NIA Clinical Research Support Services - CRSS

Packing and Delivery of Proposal Attachment # 01

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-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

Packing and Delivery of Proposal Attachment # 01 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.

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. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

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

6. Margins must be at least one inch on all sides.

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

B. Page limitations – (see Additional Technical Proposal Instructions):

1. The total page count of the Technical Proposal is described in the Additional Technical Proposal Instructions (Attachment # 4).

2. Total page count does not include:

a. Table of Contents; Section Dividers that do not contain information other than title of Section; Demonstration of Compliance with Section 508, Appendices.

b. Curriculum Vitae (CV)/Resumes.

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

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

Attachment # 02

Statement of Work – SOW - IDIQ Attachment # 03 February 2023 Page 1 of 7

STATEMENT OF WORK

Title: National Institute on Aging Clinical Research Support Services (NIA CRSS)

Background:

The National Institute on Aging (NIA) leads the federal government’s research efforts related to the health and well-being of older people. In recent years, NIA’s budget has substantially increased in recognition of growing public interest and urgency surrounding research on aging, particularly around Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD). Through NIA’s extramural research program, the Institute oversees a clinical research portfolio, that includes four divisions (Aging Biology, Behavioral and Social Research, Geriatrics and Clinical Gerontology, and Neuroscience) and multiple disease areas.

Following the enactment of the National Alzheimer’s Project Act (NAPA) in 2011, NIA’s AD/ADRD clinical research portfolio has grown substantially. The NIA portfolio now spans pharmacological, behavioral, and social interventions. In addition, it includes care, caregiving, AD/ADRD prevention. NIA currently holds no Investigational New Drug Application (IND), and clinical research protocols and associated documents are developed by NIA grantees. The grantees are the Sponsors for any clinical trials that require INDs. Despite not holding INDs currently, the NIA needs support to maximize and ensure efficient and proactive oversight of its clinical research portfolio across the Institute.

The Office of Clinical Research (OCR) within the Division of Extramural Activities (DEA) was recently established to effectively manage, support administrative operations, and ensure that NIA is strategically and proactively planning, implementing, and monitoring best practices to comply with federal clinical research regulatory and policy requirements and achieve planned recruitment and inclusion goals.

Specifically, OCR coordinates and develops NIA-wide clinical research operations and procedures, provides regulatory guidance to grantees and program staff, establishes metrics to inform evaluations, and supports key recruitment activities for clinical studies that are of vital importance to the Institute and its many stakeholders, including Congress.

Statement of Need and Purpose:

Given the substantial increase in NIA’s clinical research portfolio, including AD/ADRD research, NIA’s OCR requires centralized support for clinical research management across the institute. The contract will provide a broad range of support services to assist NIA in managing the institute’s current and evolving clinical research portfolio. Support services include but are not limited to participant safety, data integrity and trials progress (including DSMBs/OSMBs, SOs, safety reporting, etc.), regulatory compliance, biostatistics, recruitment support, and training as needed. The contract shall assist with producing centralized procedures for tracking clinical research regulatory compliance and quality assurance/quality control activities. The overarching goal of the contract is to provide centralized, flexible, as-needed, easy-

February 2023 Page 2 of 7 to-access recurring and ad hoc support for clinical research and to serve as a gap-filling mechanism to provide urgent or unanticipated services for emerging or evolving needs including prompt access to subject matter experts, consultants, etc.

Objectives:

The aim of the contract is to provide centralized and integrated administrative, regulatory, logistic, and statistical support for clinical research management across NIA. Support service areas include project management and implementation, regulatory expertise, quality assurance/quality control, promoting participant recruitment, statistical consultation, developing tools, templates, and trainings, and managing participant safety, data integrity, and trial progress.

1. SCOPE

The following distinct performance areas have been identified as follows:

• Work Area 1: Project Management

• Work Area 2: Regulatory Oversight and Support

• Work Area 3: Analytics Monitoring

• Work Area 4: Recruitment and Retention Support

• Work Area 5: Clinical Research Operations Support and Quality Assurance

• Work Area 6: Statistical and Methodological Consultation

• Work Area 7: Training of NIA Staff in Clinical Research Procedures

2. WORK AREAS/SPECIFIC TASKS

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government under the terms and conditions of the contract as needed to perform the work set forth below.

WORK AREA 1 - PROJECT MANAGEMENT

NIA requires project oversight to help ensure successful completion of the Task Orders (TOs) awarded under the contract. The Contractor shall provide a Program Director who shall be responsible for overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out with each TO. The Contractor shall provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all projects carried out under each TO, and effective communications with the Contracting Officer’s Representative (COR). At the direction of the COR, the Contractor shall work with the key subject matter experts in each NIA Division to meet the needs of the Division.

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The Contractor shall:

1. Provide monthly Financial and Cumulative Summary for the entire Contract, including Monthly Itemized Cost Sheet and a monthly Financial and Cumulative Summary for each individual Task Order.

2. Submit an overarching Communication Plan detailing the strategy to keep the NIA COR informed of progress of tasks and items requiring action on a routine basis, including communication frequency, personnel, and mode of communication. Include a plan for alerting the NIA COR about problems or issues that arise. For each awarded Task Order, provide a plan to ensure appropriate communication among COR, Contractor, and TO leads (when applicable). Each Task Order communication plan must include a summary of how the TO communications will be addressed to coordinate with the overarching communication plan.

3. Submit an Annual Performance Plan for overall contract management and covering each awarded TO. The Annual Performance Plan shall address the plan to accomplish the requirements of the contract and focus on quality, timeliness, and cost-control. The Annual Performance Plan must be reviewed and updated as needed, and when a new TO is issued.

4. Submit a Monthly Progress Report for overall contract management and covering each awarded TO which shall provide an accounting of progress of goals within the contract and each TO and the status of work accomplished.

5. Submit an Annual Progress Report for overall contract management and covering each awarded TO describing and summarizing the work performed during the 12-month period of performance and how it met the Annual Performance Plan.

WORK AREA 2 – REGULATORY OVERSIGHT AND SUPPORT

The Contractor shall provide regulatory support and safety monitoring. The regulatory support and oversight tasks shall include assisting in administrative tasks pertaining to Data and Safety Monitoring Boards (DSMB)/Observational Study Monitoring Boards (OSMB)/Safety Officers (SO), providing regulatory information and subject matter expertise on clinical trial-related requirements, and maintaining safety oversight. The Contractor shall ensure it has the most current and accurate information and certifications regarding the required and evolving clinical research regulations, policies, and guidelines (Federal-wide, NIH, and NIA-specific) related to human subject research, clinical trials policy, and Good Clinical Practice

(GCP).

1. Assist with needed DSMB/OSMB-related activities, such as:

a. Assist with the identification of individuals who are eligible to serve on DSMBs/OSMBs with relevant clinical expertise pertaining to specific clinical trials, such as, biostatisticians, February 2023 Page 4 of 7 and investigators knowledgeable about current clinical research conduct and methodology, etc., conduct preliminary review of nominees’ expertise and conflicts of interest, coordinate nominations with NIA POs and grantees, and prepare all documents for nomination, including CVs and COI, for NIA review and approval.

b. Maintain study-specific roster of NIA-appointed DSMB/OSMB members and SOs and the studies for which they provide oversight.

c. Coordinate DSMB/OSMB logistics, including meeting scheduling, preparation, and attendance; facilitating review of relevant study materials and SO meetings with PIs; and summarizing DSMB meetings, including notetaking and dissemination and writing open and closed summary reports, etc.

d. Populate, maintain, and ensure the quality control of an NIA provided database of DSMB-or OSMB-related documents for all NIA-appointed DSMBs/OSMBs.

e. Provide honoraria for DSMB/OSMB/equivalent members.

f. Provide liability insurance coverage for the NIA-appointed DSMBs/OSMBs/SOs.

2. Complete all other DSMB- related tasks, such as ensuring that all Adverse Events (AEs)/Serious

Adverse Events (SAEs) are provided to the DSMB, as needed.

3. Serve as a knowledge base regarding applicable regulations and policies, such as Office of

Extramural Research (OER) policies and other regulations (such as FDA regulations and guidances) for any changes and ensure SOPs are up to date and reflect the latest guidance.

4. Provide consultancy, via the provision of subject matter experts, expert consultants, etc. as requested, for NIA’s clinical regulatory oversight research activities, for interpretation and implementation of quality assurance guidelines, new regulations, safety-related clinical research management, and other regulatory and administrative needs.

5. Provide logistical support for clinical study related advisory panels and monitoring bodies.

WORK AREA 3 – ANALYTICS MONITORING

NIA’s core tool to manage and monitor its clinical research is the Clinical Research Operations and Management System (CROMS). The Contractor shall assist in managing the quality of data and other information (e.g., study protocols, reports) entered into CROMS, and for any other tools that may be developed to assess and report on the performance of the NIA-funded clinical research portfolio. The Contractor will not be responsible for the CROMS technical oversight.

1. Assist with quality review and assurance of data entry in tools that support NIA clinical research, including NIA’s CROMS (e.g., track reporting completeness in CROMS for new and ongoing clinical studies, including timeliness, consistency, and accuracy of study data entry).

https://www.nia.nih.gov/research/grants-funding/nias-clinical-research-operations-management-system-croms

February 2023 Page 5 of 7

2. Support NIA staff in the development of reports, presentations, peer-reviewed manuscripts, white papers, or other materials requiring analyses for clinical research activities and/or using NIA clinical research tools such as CROMS.

3. Assist OCR in conducting communication and outreach with users of NIA clinical research tools (e.g., CROMS) on an ongoing basis.

4. Provide NIA with digital support for clinical research data management, if needed.

WORK AREA 4 – RECRUITMENT AND RETENTION

The Contractor shall assist in coordinating activities that support recruitment and retention activities for NIA-funded studies. These tasks include but are not limited to contributing to the implementation of the NIA National Recruitment Strategy.

1. Use existing data, including from CROMS, to provide support to:

a. Identify grants that are successful at enrolling participants and codifying successful programs.

b. Identify grants that are experiencing challenges in enrollment and working with program staff to provide support to enhance enrollment efforts.

2. Identify and coordinate best practices for clinical research recruitment, particularly for underrepresented populations, based on ongoing activities across NIA. This may include support related to virtual or hybrid clinical research.

WORK AREA 5 – CLINICAL RESEARCH OPERATIONS SUPPORT AND QUALITY ASSURANCE

The overall objective of the Clinical Research Operations Support and Quality Assurance work area is to ensure that the data resulting from NIA studies are of highest quality and are considered valid and credible within the scientific and clinical community. To accomplish this objective, the Contractor shall provide assistance and guidance from experts in clinical research quality assurance. This assistance may include but is not limited to the provision of scientific resources, support for documentation and quality assurance procedures, conducting study risk assessments, and tracking regulatory compliance, Institutional Review Board (IRB) approval, and NIA clinical risk management updates. The Contractor shall also assist in maintaining a database of NIA staff training compliance (e.g., Good Clinical Practice [GCP] certifications).

1. Monitor for changes in regulations, guidelines, and clinical trials enterprise standards to ensure integrity and data quality for NIA-funded clinical research studies.

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2. Assist with the development and maintenance of NIA clinical research SOPs and policies and ensure that these are updated to meet all applicable requirements, including institutional, regulatory and policy requirements.

3. Provide technical and administrative assistance (e.g., updates to the Clinical Research Study Investigator Toolbox), as needed, to facilitate interpretation and implementation of applicable quality assurance guidelines for NIA clinical studies.

4. Assist in the review of study documentation in CROMS, as needed, for quality, internal consistency and compliance with Good Clinical Practice and other Federal, State, and local laws/regulations including FDA, OHRP, HHS, NIH, and NIA.

5. Perform, coordinate, and manage site visits, in-person or virtually, for designated studies as needed by NIA, to monitor data quality and oversee the integrity of study procedures.

6. Assist NIA staff in the identification of events likely to have a negative influence on the clinical study, evaluate the risks, and compile reports for each study detailing findings and recommendations for risk reduction.

7. Assist NIA staff in the assessment of human subject safety and operational concerns and risks.

8. Collaborate, communicate with, and provide administrative regulatory oversight support to NIA staff and external collaborators (e.g., clinical research networks, researchers, etc.) to facilitate the conduct of research. This includes maintaining a portfolio of partnerships and answering external questions regarding recruitment, retention, safety, and regulatory guidelines.

9. Support communication and coordination between NIA staff and NIA-funded investigators with respect to monitoring Adverse Events (AEs)/Serious Adverse Events (SAEs), coordinating AE/SAE review and follow-ups, and reporting and tracking of adverse events and serious adverse events in CROMS.

10. Track regulatory compliance for NIA- funded clinical studies.

11. Track IRB approval across clinical studies and clinical research risk management updates and maintain a centralized database for NIA.

12. Review and process relevant regulatory documents to ensure compliance with all relevant NIA, NIH, HHS and FDA regulations.

13. Provide support as needed for protocol drafting and review.

WORK AREA 6 - STATISTICAL AND METHODOLOGICAL CONSULTATION

The Contractor shall provide support and consultation to the NIA staff in the area of statistics and clinical research methodology. Statistical consultation may be required to evaluate requests to submit applications for large clinical research studies, address methodological issues identified in ongoing clinical research projects, perform additional analysis of existing datasets, and de-identify trial data. Performance of activities under this work area will be conducted on an as-needed basis.

February 2023 Page 7 of 7

1. Review and make recommendations in areas such as study design, sample size calculations, statistical analysis plan, methodology, randomization procedures, and data management consulting.

2. Serve as a resource for NIA staff by providing a list of advantages and disadvantages of the proposed methods when evaluating a request to submit a large clinical research project. Unusual methodology or particularly creative methods may be requested of the contractor.

3. Conduct statistical analyses to support needs of NIA staff, including meta-analysis, power analysis, and futility analysis.

4. Review and make recommendations to ongoing NIA-funded clinical research studies in areas such as statistical analysis plan, power calculations, need for interim analysis, subgroup analysis, outcome measurements, and treatment effect.

5. Assist NIA projects in the de-identification of study datasets in preparation for sharing data with the research community.

WORK AREA 7 - TRAINING OF NIA STAFF IN CLINICAL RESEARCH PROCEDURES

The Contractor shall assist with identifying tools and trainings where they exist, or developing new tools and trainings related to clinical trials policies, standard operating procedures, and management. These tools and trainings will provide support for NIA staff and grantees, throughout the lifecycle of a clinical study. Producing and disseminating these materials ensures the highest standards of regulatory compliance and data management for NIA-funded clinical research.

1. Assist with the development and dissemination of clinical research management tools, trainings, guidelines, templates, etc. that are subject-area specific (e.g., compliance, data quality, and reporting requirements for clinical research activities, administrative and regulatory procedures, etc.).

2. Provide up-to-date commercially available, industry standard trainings and training materials for clinical research (such as Good Clinical Practice, Human subjects Protections, etc.) for both internal and external use, as requested, and provide management of training completion and maintenance.

3. Support the creation of materials that explain clinical research best practices, including materials that are subject-matter specific.

Reporting Requirements and Deliverables - IDIQ Attachment # 04 February 2023 Page 1 of 2

REPORTING REQUIREMENTS/DELIVERABLES

Deliverables for this IDIQ contract include data for all activities supported by the Contract. The delivery as described below and as directed by the Contracting Officer’s Representative (COR).

In addition to the reports required by the other terms of this Contract or as required by individual Task Orders, the Contractor shall prepare and submit the following reports during the period of performance of this Contract:

It is estimated that the required electronic versions of these reports will be required as follows:

1) Monthly Financial and Cumulative Summary for Entire Contract and for awarded individual Task Orders, including Monthly Itemized Cost Sheet.

2) Communication Plan for the entire contract, and for awarded individual task orders.

3) Annual Performance Plan for contract management including for awarded individual task orders.

4) Monthly Progress Report for the entire contract, including for awarded individual task orders.

5) Annual Progress Report for the entire contract, and for awarded individual task orders.

6) Minutes from Meetings.

7) Drafts and various final study materials.

8) Staff Confidentiality Agreements.

9) Roster of Employees.

10) Contract Closeout Plan.

11) Final Technical Report.

Deliverable Recipients Delivery Schedule

1. Monthly Financial and Cumulative Summary for Entire Contract and for each Task Order, including Monthly Itemized Cost Sheet

1 electronic copy to CO, COR

Monthly, no later than the 15th, except when an annual or final report is due.

2. Communication Plan for the entire contract, and for awarded individual task orders

1 electronic copy to CO, COR

Within 10 days of contract award and at the start of each awarded Task Order

3. Annual Performance Plan for contract management including for awarded individual task orders

Within 10 days of contract award, reviewed annually and updated as needed, updated at the award of each new Task Order

4. Monthly Progress Report for the contract, including Task Orders

Monthly, no later than the 15th, except when an annual or final report is due.

Reporting Requirements and Deliverables - IDIQ Attachment # 04 February 2023 Page 2 of 2

5. Annual Progress Report for the entire contract, and for awarded individual task orders

Annually

6. Minutes from Meetings to COR and when applicable, Task Lead

Draft minutes within 2 business days of the meeting to NIA Task Lead; and final minutes within 1 business day of edits from NIA to recipients as directed

7. Drafts and various final study materials to COR

As directed

8. Staff Confidentiality Agreements (NDAs)

Per contract required timelines.

NDAs must be signed prior to beginning any contract related work.

9. Roster of Employees

Initially and annually as well as updates when changes to key personnel are made.

10. Contract Closeout Plan 1 electronic copy to CO, COR

Due 90 days prior to expiration of the Contract.

11. Final Technical Report

Due 30 days prior to expiration of the Contract.

Additional Technical Proposal Instructions - TPI Attachment # 05 February 2023 Page 1 of 4

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

These additional Technical Proposal instructions reflect the requirements of the Request for Proposal (RFP). While Section L. of the RFP provides general Technical Proposal instructions, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used along with Section L. to prepare the Technical Proposal. Offerors are advised to carefully consider the Statement of Work (SOW) including any supplementary material, Technical Evaluation Criteria, and the RFP in the development of their proposals.

The Offeror’s proposal, including appendices, shall include a detailed table of contents, be formatted by sections, and be cross-referenced to the Technical Evaluation Criteria. Refer to the Attachment labeled “Packaging and Delivery of Proposals” for complete instructions on proposal submission.

The Offeror shall submit a detailed plan indicating how each aspect of the SOW is to be accomplished.

• The Technical Proposal shall include information on how the project is to be organized, staffed, and managed.

• Information should be provided to demonstrate the understanding of management of time frames for planning and accomplishing the work.

• The Technical Proposal shall be in as much detail as necessary to explain the proposed methods and rationale and should reflect a clear understanding of the nature of the work as described in the SOW.

• The Technical Proposal shall include unique arrangements, facilities, equipment, or other factors that the Offeror deems advantageous to the project.

SPECIFIC TECHNICAL PROPOSAL EVALUATION CRITERIA INSTRUCTIONS

PAGE LIMIT: Twenty-five (25) pages for the Technical Proposal Part II (excluding Cover page, Executive Summary, Table of Contents, Demonstration of Compliance with Section 508, Appendices, and Curriculum Vitae/Resumes).

The below table shows the page limits to which offerors’ submissions must adhere.

Volume Section Page limit

Part I Proposal Title Page/Transmittal/Cover Letter 2 Executive Summary 2

Part II SECTION 1: Technical Approach and Management SECTION 2: Staffing Plan and Personnel Qualifications SECTION 3: Organizational Experience

Part III Past Performance 5

February 2023 Page 2 of 4

PART I: COVER PAGES AND TABLE OF CONTENTS

PROPOSAL TITLE PAGE/TRANSMITTAL/COVER LETTER.

TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion. Review table above for page limits.

PART II: TECHNICAL EVALUATION CRITERIA

Each Offeror should address the items below in the Technical Proposal. These items are cross-referenced to the appropriate Technical Evaluation Criteria, which should be used as guidance as to how proposals will be evaluated. Review table above for page limits.

SECTION 1: TECHNICAL APPROACH AND MANAGEMENT (See TEC #1)

• Offerors shall demonstrate understanding of the SOW and describe in detail the needs of NIA with respect to the SOW and how the Offeror’s organization would address them. Offerors shall leverage their knowledge from providing solutions for similar requirements, including those with NIH, in demonstrating their technical approach. The proposals that simply parrot back the SOW, without providing sufficient detail and explanation, will not be considered to meet the requirement.

• The Offerors shall provide a sufficient and detailed plan on how they will successfully perform each Work Area in the SOW, including overall strategy, methodologies, analyses, technologies, and services specific to NIH. Proposals that simply parrot back the SOW, without providing sufficient detail and explanation, will not be considered to meet the requirement.

• Provide an example of problem(s) encountered and solutions identified during the management of a contract of similar purpose, scope, size, and complexity.

• As part of your management plan, demonstrate the ability to communicate, coordinate, and function as a coherent team as well as with subcontractors, consultants and in interactions with the Government, other contractors, other researchers, and the public.

• Describe procedures for competition, selection, and oversight of any proposed subcontractors/consultants. Clearly define how any proposed arrangements would meet program needs. Discuss how subcontractor/consultant arrangements will be structured, organized, managed, and monitored.

• Describe the approach to quality control, quality assurance, and review of performance to optimize the delivery of the desired services within the negotiated schedule and budget and minimize performance risk factors.

February 2023 Page 3 of 4

SECTION 2: STAFFING PLAN AND PERSONNEL QUALIFICATIONS (See TEC #2)

• Provide a staffing plan which details the mix of labor and level of effort required to accomplish the work and include an organizational chart indicating clear lines of authority, staff responsibilities, and a plan for organizational backup. The organizational chart should indicate key personnel and job titles for other staff/positions.

• For persons listed in the organizational chart, provide a table that documents individual training, education, experience, qualifications, and/or expertise and indicate which Work Area(s) each person will support.

• Provide a Resume/Curriculum Vitae (no more than 3 pages for each proposed staff) to document relevant training, experience, expertise, and competency including selected references for publications relevant to the scope of the project.

• Describe a recruitment and retention plan for personnel, particularly addressing those designated as key personnel.

• Key Personnel:

• Include the names for the following two key personnel:

• Project Director – Technical

The Project Director should have an advanced degree of at least a Masters, with a doctoral degree preferred, in a scientific field related to the activities described in the SOW or a combination of education and training. The proposed Project Director should have at least five years of relevant experience.

• Project Manager – Administrator The Project Manager should have an advanced degree of at least a Masters in a business profession, or the equivalent of a Project Management certification. The proposed Project Manager should have at least five years of relevant experience.

• For each key personnel:

• Describe the duties and the proposed effort and availability to the project.

• Describe the education, training, qualifications, experience, and prior accomplishments that demonstrate administrative, and management of large projects relevant and similar in scope, successfully completed on-time and within or under budget. The qualifications and experience should be described in terms of experience with clinical research, including any with NIH.

• Demonstrated ability and experience leading a cohesive team of employees, subcontractors, and consultants on projects similar in scope and complexity.

February 2023 Page 4 of 4

SECTION 3: ORGANIZATIONAL EXPERIENCE (See TEC #3)

• Demonstrate understanding, knowledge, and relevant technical experience in support of clinical research portfolios for each specific Work Area described in the SOW. If offerors have relevant experience with NIH requirements, include details on these requirements as well.

• Discuss recent prior experience (within the last five years) in conducting projects that are similar in scope, size, and complexity to the requirements outlined in the Statement of Work. Provide a brief synopsis of each project and explain how it relates to the activities required in the SOW.

Identify areas where there is no work experience.

• Provide a brief synopsis of each project where small business subcontracting participation was utilized. Describe your approach to maximize subcontracting opportunities with small businesses for this SOW.

• Demonstrate experience in the management and execution of clinical research management projects similar in nature, size, and complexity.

Additional Business Proposal Instructions Attachment # 06 February 2023 Page 1 of 3

ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

These additional Business Proposal instructions reflect the requirements of the Request for Proposal (RFP). While Section L. of the RFP provides general Business Proposal instructions, these instructions are tailored to the specific requirements of the RFP and provide uniform cost assumptions and business clarifications.

The business proposal shall be submitted as a separate volume from the technical proposal. The following information should be used to assist offerors in preparing the business proposal.

The Government anticipates awarding one Indefinite Delivery/Indefinite Quantity (ID/IQ) contract with a 5-years ordering period, for this requirement. It is anticipated that multiple cost reimbursement task orders will be issued during the 5-year ordering period.

Offerors shall submit a business proposal which adequately addresses all required aspects of the solicitation. Offerors should note that with award of the ID/IQ contract, the Government intends to concurrently award the Task Order One: OCR Project Management, DSMB and CROMS-related Support, which is associated with the Work Areas No. 1-6 of the IDIQ Statement of Work. The Statement of Work and the Deliverables of the Task Order One are incorporated to this solicitation.

The award of both the ID/IQ contract and the Task Order One will be made using the information provided in response to this solicitation. Cost information shall be provided in accordance with the information below. Separate costing for the ID/IQ is not required.

Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

TASK ORDER ONE: OCR Project Management, DSMB and CROMS-related Support The Offeror shall submit cost information for the Task Order One activities as they are described in the Order SOW. The Task Order One shall be structured as a cost-plus fixed fee and shall consist of one (1) base year plus four (4) optional years to extend the task for a total possible performance period of five (5) years. Provide a detailed breakdown of costs for each year of the task, including a summary chart of all years.

1. COST ASSUMPTIONS

To estimate the total effort and costs for the Task Order One, Offerors are to anticipate a start date of December 8, 2023, and shall use the following information to develop costs for each year of the Task:

a. Labor – The Government's estimate for the work set forth in the Task Order SOW is 104 full time equivalents (FTEs) across five years. The table below provides general guidance to assist offerors

February 2023 Page 2 of 3 in understanding the level of effort anticipated for this Task. The number of FTEs is for informational purposes and is not meant to be restrictive. Offerors may propose a different level of effort and mix of labor than those provided here.

b. Travel, Meetings, and Conferences – travel is not anticipated for the initial Order. However, it is anticipated that travel will be required under Orders when onsite clinical monitoring and/or site visits are needed. Other travel and meeting costs may be proposed based on management of subcontracts and other task activities.

c. Government Furnished Equipment – it is anticipated that the Government will provide a small number of laptops with VPN capability for the Contractor’s use, as needed. All other equipment shall be the responsibility of the Contractor.

Software and licenses: The Government will provide access and licenses to any government-specific software and/or applications that cannot otherwise be obtained commercially. The contractor will be responsible for obtaining and maintaining all necessary licenses and access to commercially available software.

2. BUSINESS PROPOSAL FORMAT

Refer to Business Proposal Instructions, Section L of this solicitation. The Instructions contain the requirements for proper submission of cost/price data which must be adhered to. This format should be used as a guideline. It may require amending to meet the specific requirements of this solicitation.

February 2023 Page 3 of 3

This format must be used to submit the breakdown of all proposed estimated cost elements. List each cost element for direct costs, indirect costs, and fee, if applicable. In addition, provide detailed calculations for all items. For example:

• For all personnel, list the name, title, rate per hour and number of hours proposed. If a pool of personnel is proposed, list the composition of the pool and how the cost proposed was calculated.

List the factor used for prorating Year One and the escalation rate applied between years.

• For all materials, supplies, and other direct costs, list all unit prices, etc., to detail how the calculations were made.

• For all indirect costs, list the rates applied and the base the rate is applied to.

• For any subcontract proposed, submit a separate breakdown format.

• Justification for the need of some cost elements may be listed as an attachment, i.e., special equipment, above average consultant fees, etc.

• If the Government has provided "uniform pricing assumptions" for this solicitation, the offeror should identify each item. If a deviation from the uniform cost assumption is made, identify the deviation, and provide an explanation.

An electronic spreadsheet titled “Breakdown of Proposed Estimated Costs” is available to assist you in the preparation of your business proposal. It is in EXCEL format and has instructions for use and submission.

Use of this spreadsheet is optional but recommended. The electronic version of the spreadsheet can also be found here:

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_Dec2012.xlsx

IMPORTANT NOTE: Save this file on your computer before opening, otherwise, you will be prompted for a username and a password, and you will lose all the data you may have inserted.

Statement of Work – Task Order 1 Attachment # 07 February 2023 Page 1 of 5

TASK ORDER ONE

STATEMENT OF WORK

TASK ORDER 1: OCR Project Management, DSMB and CROMS-related Support

I - Background:

The National Institute on Aging (NIA) leads the federal government’s research efforts related to research on aging, particularly around Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD). Through NIA’s extramural research program, the Institute oversees a clinical research portfolio, that includes four divisions (Aging Biology, Behavioral and Social Research, Geriatrics and Clinical Gerontology, and Neuroscience) and multiple disease areas.

The Office of Clinical Research (OCR) within the Division of Extramural Activities (DEA) was established to effectively manage, support administrative operations, and ensure that NIA is strategically and proactively planning, implementing, and monitoring best practices to comply with federal clinical research regulatory and policy requirements and achieving planned recruitment and inclusion goals. Specifically, OCR coordinates and develops NIA-wide clinical research operations and procedures, provides regulatory guidance to grantees and program staff, establishes metrics to inform evaluations, and supports key recruitment activities for clinical studies that are of vital importance to the Institute and its many stakeholders, including Congress.

II - Scope

The purpose of this task order is to provide administrative and project management as well as technical support activities to the Office of Clinical Research and other NIA divisions. Under this task, the Contractor shall provide support services associated with the Work Areas 1-6 as described herein.

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 (SOW) below.

III – Technical Requirements

The Contractor shall complete all administrative and management activities related to the NIA Clinical Research Support Services contract. Under this task, the Contractor shall provide project administration, management and support to the work provided under other Task Orders in this contract.

February 2023 Page 2 of 5

The Contractor shall provide the deliverables as described in the IDIQ (Work Area 1): Project Management:

The Contractor shall support manager the Task Order(s), including but not limited to 1) allocation and monitoring of appropriate staff and other supporting resources; 2) monitoring of adherence to scope, budget, and timeline; 3) supervising the contractor team and any subcontracts to ensure quality performance and deliverables; and, 4) assisting the COR with any SOW-related administrative items and meeting support.

The Contractor shall provide the deliverables as described in the IDIQ Work Area 2: Regulatory Oversight and Support:

The Contractor shall provide regulatory and safety monitoring support. The regulatory support and oversight tasks shall include assisting in administrative tasks pertaining to Data and Safety Monitoring Boards (DSMB)/Observational Study Monitoring Boards (OSMB)/Safety Officers (SO), providing regulatory information and subject matter expertise on clinical trial-related requirements, and assisting NIA with maintaining safety oversight. The estimated number of studies requiring a DSMB are: ~150 with 2 meetings/year for each DSMB and estimated number of studies requiring a safety officer are: ~200. The Contractor shall ensure that their staff have the most current and accurate information and appropriate trainings regarding the required and evolving clinical research regulations, policies, and guidelines (Federal-wide, NIH, and NIA-specific) related to human subject research, clinical trials policy, and Good Clinical Practice (GCP), etc.

Data and Safety Monitoring Board/Observational Study Monitoring Boards (OSMB)/Safety Officers (SOs) activities, operations, support, and management:

1. Assist with all relevant and required DSMB/OSMB/SO related activities:

• Identify individuals with relevant clinical expertise pertaining to specific clinical trials, who are eligible to serve on DSMBs/OSMBs or as SOs.

• Coordinate nominations with NIA POs and grantees, and prepare all documents for nomination, including curriculum vitae (CVs) and Conflict of Interest (COI), for NIA review and approval.

• Maintain study-specific roster of NIA-appointed DSMB/OSMB members and SOs and the studies for which they provide oversight.

• Coordinate all DSMB/OSMB/SO logistics, such as scheduling of meetings, collection, distribution, and facilitation of the review of relevant meeting materials, meeting attendance, etc.

• Ensure that all Adverse Events (AEs)/Serious Adverse Events (SAEs) are provided to the appropriate DSMB for review, as appropriate.

• Attend meetings, serve as Executive Secretary, and generate meeting summaries for the open and closed sessions, and appropriate dissemination of final, NIA-approved open and closed summary reports, etc.

February 2023 Page 3 of 5

• Populate and maintain complete DSMB/OSMB/SO records, in an NIA-provided database with restricted, rule-based access and ensure quality control of the documents.

• Develop and maintain NIA approved compliant procedures and other documents, such as DSMB charters to define and describe the DSMB/OSMB/SO operations.

2. Serve as a knowledge base regarding applicable regulations and policies including but not limited to HHS, NIH, and NIA Office of Extramural Research (OER) policies, other…