3. RFP Attachment 1-22.pdf

RFP Number 75N95024R00004 Attachment 1

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.

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

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:

1. The total page count of the Technical proposal shall not exceed 50 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; and

b. Required requested attachments, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not exceed 3 pages and is not included in the page count.

4. 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 2

NCATS Scientific and Technology Support Services

Statement of Work

Contents

1. Introduction, Background and Purpose

1.1. Introduction and Background

1.2. Objective

1.3. Scope of Work

2. Specific Task Areas

2.1 Task Area 1 – Program Management Office (PMO) Support

2.2 Task Area 2 – Scientific and Technology Operations Services

2.3 Task Area 3 – Scientific Support Services

2.4 Task Area 4 – Scientific Platform Services

2.5 Task Area 5 – Data Science Services

1. Introduction, Background and Purpose

1.1. Introduction and Background

The objective of the NCATS Scientific and Technology Support Services (STSS) contract is to provide comprehensive support for the integrated scientific environment supporting the National Center for Advancing Translational Sciences (NCATS), one of the 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). This environment consists of the scientific and technology systems (both physical and virtual) that advance the scientific mission of NCATS. STSS also provides the technical and scientific subject matter expertise that permits full exploitation of the environment to support NCATS scientists and collaborators.

NCATS is transforming translational science to get more treatments to more patients more quickly.

NCATS relies on the power of data, new technologies and teamwork to develop, demonstrate, and disseminate innovations that reduce, remove, or bypass costly and time-consuming bottlenecks in translational research.

The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Rather than targeting a particular disease or area of fundamental science, NCATS focuses on what is common across diseases and the translational process.

The Center conducts and supports research on both the scientific and operational aspects of translation to lead to more predictive and successful development of new medical interventions, such as drugs, diagnostics, and medical devices, for all human diseases.

NCATS programs and initiatives span the translational science spectrum, which covers each stage of research. These stages include basic research, preclinical research, clinical research, clinical implementation, and public health. The translational process is multi-directional, starting at any stage and potentially going directly to any other stage. NCATS scientists typically do not conduct basic research. However, insights gained from the Center's studies can inform basic research. At all stages of the spectrum, NCATS develops new approaches, demonstrates their usefulness, and disseminates the findings.

Significantly, NCATS is at the forefront of automated biomedical experimentation, replacing hours of time-consuming basic laboratory work with systems and robots capable of conducting experiments with a fraction of the resources. This technology can both cut costs and increase productivity, which acts as a multiplier effect on research efficiency and raw output.

By design, NCATS' efforts complement and empower those of other NIH ICs, academic scientists, the private sector, and the nonprofit community. By emphasizing collaboration, innovation, deliverables and team science, the Center serves as a catalyst to enable others in the translational research ecosystem to work more effectively.

Nearly every NCATS initiative is completely dependent on secure, collaborative platforms as the foundation for the center to meet its administrative and scientific objectives. The integrated scientific environment at NCATS – the integrated physical and virtual environment - is most accurately considered to be a laboratory instrument itself. This intelligent instrument is greater than the sum of its parts, which includes the physical environment, all the connected information acquisition, storage, and processing systems, laboratory control systems, data services (cloud and on-premises), and software. Although support for the integrated scientific environment is organizationally located in the Information Technology Resources Branch, the environment is a scientific resource, not an IT resource. NCATS does not arbitrarily segregate IT from non-IT in the support of its scientific mission, nor does it treat the horizontally and vertically integrated systems that comprise the scientific and technical infrastructure as a mere aggregation of disparate devices.

1.2. Objective

The objective of the NCATS Scientific and Technology Support Services (STSS) contract is to provide comprehensive support for the integrated scientific environment supporting NCATS. This environment consists of the scientific and technology systems (both physical and virtual) that advance the scientific mission of

NCATS. STSS also provides the technical and scientific subject matter expertise that permits full exploitation of the environment to support NCATS scientists and collaborators.

The STSS contract provides task

• Maintenance and operation of the NCATS scientific environment.

• Cutting edge integration and automation of laboratory devices.

• Cutting edge integration, control, and automation of the laboratory environment with information systems.

• Generation, acquisition, processing, management, and reporting of data and information generated by or acquired through the operation of the NCATS integrated scientific environment.

• Installation, configuration, operation, and maintenance of all components of the NCATS integrated scientific environment, to include platform services, analytic environments, data services, laboratory instrumentation and equipment, and all supporting IT.

• Security across all dimensions (systems, platforms, devices, data, and users).

• User support, to include subject matter expertise, scientific support, training, application support, and service desk.

1.3. Scope of Work

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the following services as defined in this SOW except for those items specified as government furnished property and services:

• Scientific and Technology Operations Services

• Scientific Support Services

• Scientific Platform Services

• Data Science Services

2. Specific Task Areas

2.1 Task Area 1 – Program Management Office (PMO) Support

The NCATS Program Management Office (PMO) responsible for the inherently governmental functions relative to this contract resides within NCATS. The Contractor shall provide PMO support for the overall administration of the contract and development, tracking and management of all work orders issued under this contract. The Contractor’s PMO support staff shall work in coordination with designated federal staff; and be responsible for performing all the non-inherently governmental activities associated with administration of this contract. The Contractor shall serve as the primary liaison to government stakeholders and designated federal staff such as the Contracting Officer (CO), the designated Contracting

Officer’s Representative (COR), Federal task leads (FTLs)/points of contact (POCs), administrative officers, etc.

In support of the PMO, the Contractor shall effectively and efficiently manage cost, schedule, and performance under this contract by using integrated program management systems and processes across all aspects of performance and in a manner that yields cost savings and/or performance efficiencies throughout the execution of all work orders issued under this SOW.

The Contractor’s PMO support duties shall also include, but not be limited to, the following client services support activities:

• Performing liaison responsibilities that include, but not be limited to, gathering initial project requirements; developing work order plans and packages; providing ongoing technical and administrative support of active work orders, such as budget, travel approvals, ad hoc reporting, etc.; communicating and reporting.

• Assisting government stakeholders in defining their need.

• Facilitating submission of work orders and tracking their progress.

• Developing and maintaining standard work order templates, processes, and workflows; all elements of which shall be consistent with industry best practices and contract requirements.

• Documenting all management processes as well as recommending and implementing technologies/systems to ensure and support their execution.

• Obtaining the necessary approval prior to the adoption of any standard process or template.

The Contractor shall employ appropriate measures and safeguards required by the Contractor’s PMO support staff to accomplish its responsibilities. Upon request, the Contractor shall perform project evaluation to ensure that activities are on track, within budget, and above all, meet requirements.

Contract Management Plan: The Contractor shall prepare a Contract Management Plan to ensure that the Contractor’s staff (including any subcontractor’s staff) follow individual Project Plans established in support of the work performed under this SOW. The COR will closely monitor the cost and schedule of the work to minimize the potential for cost and/or schedule variance.

The Contractor shall follow the work process flow, methodology, procedures, deliverables and best practices that conform to the standards dictated by the Project Management Body of Knowledge (PMBOK)

Guide, and Project Management Life Cycle defined and published by the Project Management Institute

(PMI).

The Contract Management Plan shall include:

1. Detailing the understanding and approach that will be used to keep the project on track;

2. Ensuring risks are understood and managed;

3. Handling changes to scope, and

4. Communicating with stakeholders.

The Contract Management Plan shall be kept current and updated throughout the period of performance;

and shall address, but is not limited to, the following:

• Team organization and responsibilities

• Project execution

• Project constraints and assumptions

• Project schedule and milestones

• Project risks identification and management

• Budgeted costs

• Project monitoring

The Contractor shall submit a draft of the Contract Management Plan to the COR no later than fifteen (15) business days after the award of the contract. Following the timely receipt of comments from the COR, the Contractor shall submit a final version of the Contract Management Plan to the COR no later than fifteen (15) business days after award of the contract.

Monthly Activity and Financial Status Reports: The Contractor shall provide separate written Monthly

Activity and Financial Status Reports that monitor the progress, cost, schedule, quality assurance, configuration management, and security management as applicable to the work orders issued under this

SOW. The reports shall include, but are not limited to, progress updates on recruiting, outstanding administrative or technical issues, and cost projections. The Contractor shall provide other reports as requested by the COR.

Although the activity and financial status reports are due monthly, this shall not relieve the Contractor of the responsibility to pro-actively keep the Government informed of issues or problems as they occur

(including technical, cost, or schedule issues).

Reports in a computer-readable format of the Contractor’s staff leave schedules are required to enable the Government to be notified of anticipated absences and vacation schedules.

2.2 Task Area 2 – Scientific and Technology Operations Services The Contractor shall assist ITRB to deploy and continuously improve various research and engineering technologies; provide services for governance, change management, configuration management, capacity planning, performance management, disaster recovery, and availability management. The Contractor shall also work to improve technology service delivery to NCATS staff by documenting each service, aligning the service with industry best practices, and presenting that information to NCATS staff.

The contractor shall enable NCATS to offer its scientific projects an environment of simplified implementation, deployment, and operations with operational reliability. Through these services, the contractor shall enable NCATS scientific development teams to gain a self-service capability. The contractor shall provide for a four-tiered service model: Infrastructure as a Service (IaaS), Platform as a

Service (PaaS), Software as a Service (SaaS) and Data as a Service as well as providing Common Cloud

Engineering Support Services.

Examples of task orders that may be issued under this include but not limited to:

• Research and Research engineering Governance and Management Support

• Hosting, Cloud Computing and Engineering Support

• Cloud Brokering Services

• Cloud Engineering Support Services

The contractor shall employ effective and efficient strategies for research data management including software for data record keeping, analysis, sharing, and streamlining processes and protocols. The contractor shall customize, deploy, build, or procure and manage as appropriate software implementation for laboratory processes and data management including but not limited to:

• Collaborative sites and apps to streamline processes, protocols and enhance communication and collaboration within NCATS research laboratories

• Biospecimens and other sample inventory and tracking management systems

• Electronic Laboratory Notebooks (ELNs) to enable electronic documentation of experimental procedures performed in a laboratory and provide a secure method of storing/retrieving research data and enable customized templating, automated approvals, witnessing workflows, and sharing

• Laboratory Information Management Systems (LIMS) to provide custom workflows and electronic forms within research team collaboration sites to replace tedious paper record keeping, and automate lab processes and protocols

• Create and implement a comprehensive data storage and management strategy to serve the increasing data storage needs of NCATS researchers

Examples of task orders that may be issued under this include but not limited to:

• Laboratory Systems Operations and Management

• On-prem and Cloud based Datacenter Operations and Management

• End User and Scientific Instrument Desktop Support

• Scientific and Systems Training Support

2.3 Task Area 3 – Scientific Support Services

NCATS requires contractor services with scientific laboratory research activities and laboratory management support across all NCATS laboratories. The contractor will be assisting in studies across various scientific disciplines, perform a variety of complex procedures and calibrate laboratory equipment, provide laboratory management support and training, and ensure compliance with safety procedures. NCATS also requires contractor services with scientific laboratory automation and equipment configuration, management, maintenance, and support across all NCATS laboratories. Examples of work performed within this task include but not limited to operating and performing maintenance and validation procedures on low volume liquid dispensation systems, such as Beckman Coulter BioRAPTRs, the CyBi well array-based liquid aspirator/dispenser systems used in compound library titration and compression, the Kalypsys pintool, LabCyte Echo acoustic liquid handlers and other off-line liquid handling systems

The objective of the 3D Tissue Bioprinting Laboratory (3DTBL) at NCATS is to generate 3D tissues that closely resemble the architecture and function of native human tissues, in multi-well plate platforms for disease modeling and drug screening. The laboratory produces and validates a portfolio of normal and disease tissues and develops quantitative assays that enable the screening of compounds for their ability to rescue a disease phenotype. The contractor will provide support for all activities pertaining to the

3DTBL in addition to exploring novel technologies and techniques as this is a rapidly changing field. The contractor will also provide support for additional research areas, both established and emerging, within the 3DTBL.

The contractor shall provide scientific research support services. Activities under this task include scientific/technical writing and editing, graphic design, grants management, and outreach activities. In addition, the contractor may be required to present findings at meetings both inside and outside of the government. All information must be cleared by the task leader before being disseminated outside of

NCATS/NIH

Examples of task orders that may be issued under this include but not limited to:

• Laboratory Automation and Equipment Support

• 3D Tissue Bioprinting Support

• 3DTBL Program Support

• Scientific Research Program Support

2.4 Task Area 4 – Scientific Platform Services

It is rapidly becoming recognized across the translational science community that there are significant opportunities for bringing artificial intelligence and automation to bear on medicinal chemistry. Briefly, this may expand the repertoire of chemical reaction types utilized in medicinal chemistry, enable the degree of chemical space explored during medicinal chemistry campaigns, and bring a systematic approach to structure-activity studies. To address the many scientific and operational opportunities for translational science, NCATS develops, demonstrates, and disseminates various scientific research tools and resources. NCATS also provides relevant expertise to the broader scientific community. One approach is through the continuous expansion of the Center’s Research Services Center (RSC) that enables efficiencies in all its translational research activities through automation and compound management.

NCATS’ automation engineers are not only responsible for the maintenance, operation and continuous improvement of the center’s laboratory, but also for continuous innovation in laboratory systems automation. For continuous improvement in laboratory instrumentation, automation and processes for high-throughput screening, and assay development and optimization, these staff members evaluate and implement novel technologies and methods, and develop custom solutions for hardware, software, and automation. Examples of task orders that may be issued under this area include but not limited to support for NCATS’ innovation in new and ongoing initiatives for advancing translational science, thus enabling

ITRB to act as a research and development incubator:

• Strategic Planning, Capability and Performance Management

• Strategic Systems and Project Analysis

• Logistical Operations Support

The NCATS initiative called A Specialized Platform for Innovative Research Execution (ASPIRE) aims to integrate automated synthetic chemistry (ASC), artificial intelligence, and biological testing into a modular platform to design and build new chemical structures. Through this platform, scientists will apply new

ASC techniques and testing capabilities to accelerate the development of new therapeutics. Put simply, ASPIRE is driven by the goal of bringing technologies to the chemistry laboratory that match those of biology in a high-throughput screening environment. The goal is to build a fully automated modular platform for both intramural and extramural collaborators to access; including the ability to incorporate custom modules developed within a standardized framework to introduce new ASC techniques and testing capabilities. Examples of task orders that may be issued under this area include but not limited to providing support for all activities related to ASPIRE Automation:

• ASPIRE Informatics

• ASPIRE Consumables

• ASPIRE Analytical/Purification

• ASPIRE Biology

• ASPIRE Technology Advancement

2.5 Task Area 5 – Data Science Services

The Contractor shall provide expertise and assistance in bioinformatics, cheminformatics, and computational analysis in support of small molecule and genomic research being performed by NCATS

Investigators and within the Division of Pre-Clinical Innovation (DPI) Research Core Facilities (Informatics and Scientific Computing, Computational Chemistry and Biology, Statistics, High Throughput Screening, High Content Screening, Center for Regenerative Medicine, RNAi Screening, Toxicity Profiling, Pathway

Analysis, Medicinal Chemistry, Assay Development, Drug Repurposing). To that end, scientific programmers shall develop and implement computational tools for effective and efficient analysis of large-scale chemical biology and genomic data, to include small molecule profiling data, therapeutic development data, medicinal chemistry optimization, pathway analysis, drug combination screening, and high-throughput screening data. Since many NCATS laboratories have similar needs, Data Science solutions shall be developed as "generalized solutions" that can then be tailored to the specific needs of a specific NCATS Investigator's research program. Scientific programmers shall also develop solutions for the efficient management and analysis of experimental datasets. This includes development of software to capture information being generated by high-throughput instrumentation (e.g., chemical, bioassay, HTS, and HCS data).

Services under this task shall include specialized support in the areas of bioinformatics, high-throughput genomic sequencing, image analysis, computational and systems biology, and data analysis for both basic and clinical research projects. Tools shall include those for biomedical research experimentation, data management, sharing and analysis, data extraction, and algorithm development. Examples of task orders that may be issued under this area include but not limited to:

• Platforms, Applications and Pipeline Development

• Clinical Informatics Services

• Data Science and Data Engineering Services

• Cloud based High Performance Computing

• AI/ML Model Development, Governance and Management Services

Nothing follows.

GOVERNMENT FURNISHED PROPERTY

The following Government-furnished property will be made available to the successful offeror for use in performance of the resultant contract [To be specified if applicable in resultant

TORFP]:

Description:

[Name, Part Number and Description, manufacturer, and National Stock Number (if needed for additional identification tracking and/or disposition).]

Quantity/ Unit of Measure

Unit Acquisition

Cost Item

Identifier

Furnished “As-Is”

* YES NO

*When property will be furnished in “as-is” condition, the Contractor will be given the opportunity to inspect such property prior to the property being provided at a time and place mutually agreed upon by the Government and the Contractor.

The following statement is applicable for competitive solicitations:

The Contractor shall be responsible for all costs related to making the property available for use, such as payment of all transportation, installation or rehabilitation costs.

Government Furnished Property Page 1 of 1 (2/2011)

Attachment 4

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

Update per FAC 2023-06 Last updated: 12/2023

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

52.204-8 Annual Representations and Certifications.

As prescribed in 4.1202(a), insert the following provision:

ANNUAL REPRESENTATIONS AND CERTIFICATIONS (Mar 2023)

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is_______________________.

(2) The small business size standard is _______________________________.

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition—

(i)Is set aside for small business and has a value above the simplified acquisition threshold;

(ii)Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii)Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation.

The Offeror shall indicate which option applies by checking one of the following boxes:

RFP Number 75N95024R0004 Attachment 5 https://www.acquisition.gov/far/4.1202#FAR_4_1202 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7

(i) Paragraph (d) applies.

(ii) Paragraph (d) does not apply and the offeror has completed the individualrepresentations and certifications in the solicitation.

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless–

(A) The acquisition is to be made under the simplified acquisition procedures in part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that-

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.204-26, Covered Telecommunications Equipment or Services-Representation.

This provision applies to all solicitations.

https://www.acquisition.gov/far/52.203-2#FAR_52_203_2 https://www.acquisition.gov/far/part-13#FAR_Part_13 https://www.acquisition.gov/far/52.203-11#FAR_52_203_11 https://www.acquisition.gov/far/52.203-18#FAR_52_203_18 https://www.acquisition.gov/far/52.204-3#FAR_52_204_3 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-5#FAR_52_204_5 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26

(vii) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations- Representation.

(viii) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(ix) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(x) 52.214-14, Place of Performance-Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(xi) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xii) 52.219-1, Small Business Program Representations (Basic, Alternates I, and II).

This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

(xiii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiv) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xvi) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements.

This provision applies to solicitations when it is anticipated the contract award will exceed https://www.acquisition.gov/far/52.209-2#FAR_52_209_2 https://www.acquisition.gov/far/52.209-5#FAR_52_209_5 https://www.acquisition.gov/far/52.209-11#FAR_52_209_11 https://www.acquisition.gov/far/52.214-14#FAR_52_214_14 https://www.acquisition.gov/far/52.215-6#FAR_52_215_6 https://www.acquisition.gov/far/52.219-1#FAR_52_219_1 https://www.acquisition.gov/far/52.219-2#FAR_52_219_2 https://www.acquisition.gov/far/52.222-22#FAR_52_222_22 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-25#FAR_52_222_25 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-38#FAR_52_222_38 the simplified acquisition threshold and the contract is not for acquisition of commercial products or commercial services.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals-Representation. This provision applies to solicitations that include the clause at 52.204- 7.)

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate.

(Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $92,319, the provision with its Alternate II applies.

(D) If the acquisition value is $92,319 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications. This provision applies to all solicitations.

https://www.acquisition.gov/far/52.223-1#FAR_52_223_1 https://www.acquisition.gov/far/52.223-2#FAR_52_223_2 https://www.acquisition.gov/far/52.223-4#FAR_52_223_4 https://www.acquisition.gov/far/52.223-22#FAR_52_223_22 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.225-2#FAR_52_225_2 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 https://www.acquisition.gov/far/52.225-4#FAR_52_225_4 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-6#FAR_52_225_6 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 https://www.acquisition.gov/far/52.225-20#FAR_52_225_20 https://www.acquisition.gov/far/52.225-25#FAR_52_225_25

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

__ (i) 52.204-17, Ownership or Control of Offeror.

__ (ii) 52.204-20, Predecessor of Offeror.

__ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

__ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Certification.

__ (v) 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification.

__ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA–Designated Products (Alternate I only).

__ (vii) 52.227-6, Royalty Information.

__ (A) Basic.

__ (B) Alternate I.

__ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically in SAM website accessed through https://www.sam.gov. After reviewing the SAM information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended https://www.acquisition.gov/far/52.226-2#FAR_52_226_2 https://www.acquisition.gov/far/52.204-17#FAR_52_204_17 https://www.acquisition.gov/far/52.204-20#FAR_52_204_20 https://www.acquisition.gov/far/52.222-18#FAR_52_222_18 https://www.acquisition.gov/far/52.222-48#FAR_52_222_48 https://www.acquisition.gov/far/52.222-52#FAR_52_222_52 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 https://www.acquisition.gov/far/52.227-6#FAR_52_227_6 https://www.acquisition.gov/far/52.227-15#FAR_52_227_15 https://www.sam.gov/ https://www.acquisition.gov/far/4.1201#FAR_4_1201 representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause # Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of provision)

Alternate I (SEP 2021). As prescribed in 4.1202(a), substitute the following paragraph (a) for paragraph (a) of the basic provision:

(a)(1) The North American Industry Classification System (NAICS) codes and corresponding size standards for this acquisition are as follows; the categories or portions these NAICS codes are assigned to are specified elsewhere in the solicitation:

SNAICS Code Size standard

[Contracting Officer to insert NAICS codes and size standards].

(2) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce, (i.e., nonmanufacturer), is 500 employees if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or https://www.acquisition.gov/far/4.1202#FAR_4_1202

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

CERTIFICATION:

Name of Authorized Individual Signature of Authorized Individual Date

Title Name of Organization

TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR

AND DIRECT COSTS

DIRECT LABOR:

Labor Category (Hours)

Year 1 (Hours)

Year 2 (Hours)

Year 3 (Hours)

Year 4 (Hours)

Year 5 (Hours)

Year 6 (Hours)

Year 7 (Hours) Total

(Title and Name - use additional pages as necessary)

Total Hours

DIRECT LABOR COST:

MATERIAL COST:

TRAVEL COST: $ $ $ $ $ $ $ $

OTHER (Specify):

TOTAL DIRECT COST:

Specific Instructions:

1. Do not include any individual salary information

2. Do not include any indirect cost or fee.

3. Do not submit the total amount of proposal.

4. Submit this information as a portion of the Technical Proposal.

Technical Proposal Cost Information/Summary of Labor and Direct Costs Page 1 of 1 (1/2011)

Attachment 6

SUMMARY OF RELATED ACTIVITIES

The following specific information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract.

a. Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals* in this proposal.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*If an individual has no obligation(s), so state.

b. Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals*.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*If no commitment of effort is intended, so state.

c. Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal.

Name Title/Position Total Proposed Effort

Summary of Related Activities Page 1 of 1 (1/2011)

Attachment 7

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

PROPOSAL SUMMARY AND DATA RECORD

PROJECT TITLE (Title or RFP or Contract Proposal)

RFP/CONTRACT NUMBER

LEGAL NAME AND ADDRESS OF OFFEROR PLACE OF PERFORMANCE (Full address including ZIP)

TYPE OF CONTRACT PROPOSED

� COST-REIMBURSEMENT � FIXED PRICE

ESTIMATED TIME REQUIRED TO COMPLETE PROJECT

ESTIMATED DIRECT COSTS IN PROPOSED YEAR (From Budget

� COST-PLUS-FIXED-FEE

PROPOSED STARTING DATE

� OTHER

DOES THIS PROPOSAL INCLUDE A SUBCONTRACT � YES � NO (If yes, please furnish name and location of organization, description of services, basis for selection, responsible person employed by subcontractor and cost information.)

NAME AND TITLE OF PRINCIPAL INVESTIGATOR SOCIAL SECURITY

NO.

EST. HOURS

WEEKLY

AREA

CODE/TEL.NO.

NAME AND TITLE OF CO-INVESTIGATOR (Use attachment if necessary.)

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO

NEGOTIATE CONTRACTS

AREA CODE/TELEPHONE NUMBER

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO

EXECUTE CONTRACTS

AREA CODE/TELEPHONE NUMBER

DOES THIS PROPOSAL INVOLVE EXPERIMENTS WITH HUMAN SUBJECTS � YES � NO

Institution’s General Assurance re: Human Subjects DATE APPROVED � PENDING Institution’s Review Board’s Approval of this Proposal DATE APPROVED � PENDING An example of the informed consent for this study is enclosed � YES � NO A Clinical Protocol is enclosed � YES � NO

OFFEROR’S ACKNOWLEDGMENT OF AMENDMENTS TO THE RFP (Use attachment if necessary)

ERRATA NUMBER DATE ERRATA NUMBER DATE

NAME, ADDRESS, AND PHONE NUMBER OF

COGNIZANT GOVERNMENT AUDIT AGENCY

NUMBER OF EMPLOYEES CURRENTLY EMPLOYED

DOLLAR VOLUME OF BUSINESS PER ANNUM

THIS OFFER EXPIRES DAYS FROM THE

DATE OF THIS OFFER (120 days if not specified)

FOR THE INSTITUTION

SIGNATURE OF PRINCIPAL INVESTIGATOR SIGNATURE OF BUSINESS REPRESENTATIVE

TYPED NAME AND TITLE TYPED NAME AND TITLE

EMPLOYER IDENTIFICATION NUMBER DATE OF OFFER

NIH-2043

June 1982

Attachment 8

Provision of the Social Security Number is voluntary. Social Security

Numbers are requested for the purpose of accurate and efficient identification, review, and management of NIH Extramural Programs.

Authority for requesting this information is provided by Title III, Section

301, and Title IV of the Public Health Service Act, as amended.

NIH-2043

June 1982

Subcontracting Plan Template (Rev. April 2017)

HHS SUBCONTRACTING PLAN TEMPLATE

A Subcontracting Plan is required if the estimated cost of the contract may exceed $750,000 ($1,500,000 for construction) Small businesses are excluded.

The following outline meets the minimum requirements of section 8(d) of the Small Business Act, as amended, and implemented by the Federal Acquisition Regulations (FAR) Subpart 19.7. The U.S. Department of Health and Human Services (HHS), Office of Small and Disadvantaged Business Utilization (OSDBU) recommends that offerors use the following format to submit proposed Individual Subcontracting Plans. It is not intended to replace any existing Corporate/Commercial Plan that is more extensive.

Questions should be forwarded to the Contracting Officer and/or Small Business Subcontracting Program Manager.

PROJECT INFORMATION

Solicitation/Contract No.: MOD No. (If applicable):

Title of Acquisition:

Contractor’s Name:

Period of Performance:

Total Contract Amount (including options, and any modifications if this submission is due to a modification): $

Total Modification Amount: (if applicable) $ Base Period (if there are options): $

Option 1 (if applicable): $ Option 2 (if applicable): $

Option 3 (if applicable): $ Option 4 (if applicable): $

FAR 52.217-8 (if applicable): $

Contracting Officer/Specialist Name: Tel & Fax:

OPDIV/Division/Branch (including location): Email:

SUBCONTRACT PLAN REQUIREMENTS- Failure to include the essential information of FAR Subpart 19.7 may be cause for either a delay in acceptance or the rejection of a bid or offer when a subcontracting plan is required. “SUBCONTRACT,” as used in this clause, means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime contractor or subcontractor requesting supplies or services required for performance of the contract or subcontract.

If assistance is needed to locate small business sources, contact the Small Business Specialist (SBS) supporting the OPDIV. SBS contact information is located on the OSDBU website (http://www.hhs.gov/about/smallbusiness/osdbustaff.html) or you may contact the OSDBU headquarters at (202) 690-7300.

HHS currently has the following subcontracting goals for Fiscal Year 2022:

Type of Concern Goal (%) Small Business 22.85% Small Disadvantaged Business, including 8(a) Program Participants, Alaska Native Corporations (ANC) and Indian Tribes

13.08%

Women Owed Small Business 5.00% Service Disabled Veteran Owned Small Business 3.00% HUBZone 3.00%

For this procurement, or modification, HHS expects all proposed subcontracting plans to contain at a minimum the aforementioned percentages.

RFP Number 75N95024R00004 Attachment 9 https://www.hhs.gov/grants/grants-business-contacts/small-business-staff/index.html

1. Type of Plan (check one):

Individual *Master (Addendum) *Commercial *When Master is checked, Individual must also be checked and submission must include both.

*If Commercial is checked, please stop here and attach a copy of your commercial plan.

For Informational Purposes:

Individual plan - all elements developed specifically for this contract and applicable for the full term of this contract.

Master plan - goals developed for this contract, all other elements standardized and approved by a lead agency Federal Official; must be renewed every three years and contractor must provide copy of lead agency approval.

Commercial products/service plan - goals are negotiated with the initial agency on a company-wide basis rather than for individual contracts; this plan applies to the entire production of…