A--Study Coordinating Center for Lung Health Cohort

Amendment / Modification

This amendment (0001) to Solicitation 75N92026R00008 provides:

• Responses to questions received from potential offerors.

• Re-inclusion of Attachment 4 (Representations, Certifications, and Other Statements from Offerors) for convenience.

• Revision to Section I, Article I.3, to add the RFO clause 52.222-90, "Addressing DEI Discrimination by Federal Contractors."

• Section J, Attachment 4 (Representations, Certifications, and Other Statements from Offerors) - Re-attached.

• Section I, Article I.3 - Revised to include new clause.

• The due date for receipt of proposals remains unchanged: June 18, 2026, at 3:00 PM ET.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding Solicitation No. 75N92026R00008.

• Subcontractor Commitment Letters: The LOI and cost proposal for each subcontractor are sufficient; a full business proposal from subcontractors is not required.
• Small Business Subcontracting Plan: This plan is only required to be submitted via SBCX.
• Attachment 4 - Section K: The document "Attachment 4 - Section K- Representations, Certifications, and Other Statements of Offerors" has been provided.
• Attachment 15 - Cost Breakdown: The Breakdown of Proposed Estimated Cost (plus Fee) and Labor Hours is required only in Excel format and does not need to be included in the PDF business proposal.
• Human Subjects Attachments: FWA documentation, IRB materials, and Human Subjects Protection Training/GCP training do not count towards the technical proposal page limit and are considered compliance-only documentation, with training required post-award.
• Technical Proposal Structure & Page Limit: Offerors can organize the technical proposal as they see fit. The 30-page limit for the technical proposal will not be increased.
• Clinical Trials: The Phase III Clinical Trial language is informational only; the contract is for a longitudinal observational study and does not include clinical trials.
• Study Website: The study website maintenance includes public-facing information and potentially a private section for study investigators/contractors. Participant data will not be input through the website, and fillable digital forms will not be present.
• Section 508 Compliance: All Information and Communication Technology (ICT) products must be 508-compliant within 6 months of award.
• OSMB Meetings: For pricing, assume $200 per OSMB member per meeting, with one 2-hour ad hoc meeting per year.

These clarifications address vendor inquiries regarding proposal submission requirements, documentation, and specific contract details, aiding bidders in preparing compliant and accurate proposals.

Form / Attachment / Pricing Sheet

This document, "Attachment 04 - Reps_and_Certs_Section_K_Forms_0526.docx," contains the required Representations, Certifications, and Other Statements of Offerors for this opportunity. It is divided into eight parts and must be completed and submitted as part of the Business Proposal.

• 52.209-7 Information Regarding Responsibility Matters: Requires offerors to disclose information regarding responsibility matters if the contract is expected to exceed $750,000. This includes reporting on past criminal, civil, or administrative proceedings that resulted in convictions, findings of fault, or penalties exceeding specified thresholds within the last five years. Information must be current, accurate, and complete in the Federal Awardee Performance and Integrity Information System (FAPIIS).
• 52.230-1 Cost Accounting Standards Notices and Certification: This provision applies to offerors other than small businesses or foreign governments. It requires examination of three parts to determine Cost Accounting Standards (CAS) applicability. Offerors must certify whether they have submitted or previously submitted a Disclosure Statement (CASB DS-1 or CASB DS-2), claim a monetary exemption, or an interim exemption. Eligibility for modified contract coverage is also addressed.
• 52.230-7 Cost Proposal Disclosure-Cost Accounting Practice Changes: Offerors must indicate if the contract award will result in a required or unilateral change in cost accounting practices. If "Yes," the price proposal must use the changed practice, and a description of the change must be submitted.
• Certification Regarding Environmental Tobacco Smoke: Requires certification of compliance with the Pro-Children Act of 1994, prohibiting smoking in facilities used for children's services funded by Federal programs.
• Certification of Institutional Policy on Financial Conflicts of Interest: Applicable to R&D Contracts (excluding Phase I SBIR/STTR and Federal Agency contracts), this certifies that the institution has a written process to identify and manage financial conflicts of interest for NIH-funded research.
• 52.226-3 Disaster or Emergency Area Representation: If the acquisition is set aside for a Disaster or Emergency Area, offerors must represent whether they reside or primarily do business in that area, providing supporting documentation if requested.
• 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction: Corporations must represent whether they have unpaid Federal tax liabilities or have been convicted of a felony within the preceding 24 months.

This document is critical for all bidders. It outlines mandatory certifications and representations that must be accurately completed and submitted with the proposal. Failure to comply with these requirements may impact the offeror's responsibility determination and the eligibility for contract award.

Solicitation / RFP / RFQ

This solicitation is for a Study Coordinating Center for the Lung Health Cohort (LHC) project. The LHC is a longitudinal study aiming to enroll up to 4,000 community-dwelling adults across 17 metropolitan regions in the U.S. to better define and characterize "ideal" versus "impaired" lung health. The current cooperative agreement supporting the LHC is set to end in early 2027. This contract will support the continuation of the LHC by completing a second in-person visit for the full cohort approximately five years after the baseline visit, and collecting other data remotely.

• Provide a study coordinating center for the Lung Health Cohort (LHC).

• Complete a second in-person visit for the full LHC cohort.

• Collect data remotely.

• Assess data and biospecimens for quality, store, analyze, and distribute as appropriate.

• Manage the study in accordance with NIH and NHLBI policies, with oversight from a single Institutional Review Board (IRB) and an NHLBI-managed Observational Study Monitoring Board (OSMB).

• Prepare and submit Technical Progress Reports (frequency to be determined prior to award).

• Submit a summary of salient results (not to exceed 200 words) with the final report.

• Submit information on the inclusion of women and members of racial and/or ethnic minority groups.

• Report Financial Conflict of Interest (FCOI).

• Submit a Section 508 Annual Report.

• Provide data sets with full documentation in accordance with NHLBI's Data Set policy.

• Report inventions.

• Contract Type: Indefinite Quantity (IQ) contract.

• Period of Performance: March 01, 2027, through February 28, 2033.

• Estimated Value: Minimum $50,000; Maximum $49,400,000.

• Task Orders will be issued based on the work described in SECTION C.

• Proposal Submission Deadline: June 18, 2026, by 3:00 PM ET.

• Proposals must be submitted through the NIH electronic Contract Proposal Submission (eCPS) Website.

• Proposal Intent Response Sheet due: May 15, 2026, by 3:00 PM ET.

• Requests for Clarification due: May 15, 2026, by 3:00 PM ET.

• Written responses to questions provided by: May 22, 2026, by 3:00 PM ET.

• Evaluation Factors: Technical (100 points total: Management Capability - 30, Personnel Experience - 25, Technical Approach - 35, Facilities - 10), Human Subjects (Acceptable/Unacceptable), Data Management/Sharing (Acceptable/Unacceptable), Cost/Price (Reasonableness and Cost Realism), Past Performance (Acceptable/Unacceptable), Section 508 Compliance (Acceptable/Unacceptable).

• This acquisition is UNRESTRICTED.

• NAICS Code: 541715

• Size Standard: 1,000 employees.

• Attachment 1: Packaging and Delivery of Proposals.

• Attachment 2: Proposal Intent Response Sheet.

• Statement of Work is attached.

• Offerors must comply with all applicable Federal laws, regulations, and HHS policies, including those related to human subjects protection, data security, and Section 508 accessibility standards.

Statement of Work (SOW) / Performance Work Statement (PWS)

To support the continuation of the Lung Health Cohort (LHC) Study by providing a study coordinating center. The goal is to clarify how potential factors might alter ideal lung health and increase the risk for future diseases, such as chronic obstructive pulmonary disease.

This SOW outlines two main task areas:

• Task 1.0: Program Management: Facilitate the management of study personnel, data, and biospecimens. This includes organizing address histories for geocoding, evaluating CT scan quality, analyzing LHC data for scientific goals and publications, performing statistical analyses, communicating with IRBs, managing study meetings, overseeing data and imaging cores, establishing governance committees, and managing travel for scientific meetings and site visits. The contractor will also oversee a data repository, manage biospecimen repositories, and ensure compliance with NHLBI Data Management and Sharing Policies. Regular progress reports to NHLBI are required.
• Task 2.0: Follow-Up Exam and Data Collection: Conduct a five-year in-clinic follow-up exam for up to 4,000 LHC participants. This includes physical assessments, spirometry, pregnancy testing, CT scans, questionnaires, and collection of various biological samples (nasal epithelial cells, blood, urine). Remote data collection will also occur, including home spirometry, actigraphy monitoring, activity logs, and vaping logs. Participants will be contacted every 3-6 months for remote follow-up data collection. The contractor must ensure all participant-facing Information and Communication Technology (ICT) is Section 508 compliant.

The cooperative agreement supporting the study coordinating center was first awarded in 2019 and is expected to end in 2026. The follow-up visits are scheduled approximately five years after the baseline visit. The study leverages the American Lung Association (ALA) Airways Clinical Research Centers (ACRC) network across 17 metropolitan regions in the USA.

• Section 508 Compliance: All Information and Communication Technology (ICT) products, including the study website, digital reports, data dashboards, participant-facing tools, and electronic communications, must meet Section 508 Standards and WCAG 2.1 A/AA. This includes requirements for screen readers, keyboard navigation, alt-text for images, and accessible downloadable documents. Deliverables will be accepted only if specific accessibility criteria are met.
• Data Management and Sharing: Compliance with NHLBI Data Management and Sharing Policies is required, including deposition of cleaned study data to an NHLBI-approved scientific data repository.
• Biospecimen Handling: Biospecimens must be stored in a dedicated repository and may be distributed to investigators for approved ancillary studies. Biospecimens will be transported to an NHLBI-approved biorepository upon study conclusion.

Form / Attachment / Pricing Sheet

This document, "HHS Industry User Guide for Subcontracting Plan Reviews," provides instructions for vendors on how to complete and submit subcontracting plans through the SBCX system. It details the navigation within the SBCX platform for reviewing and submitting these plans.

• Introduction: Explains that vendors will log into the Subcontracting Plan Review page within their registered SBCX account upon notification from HHS.
• Navigation: Directs users to the "Industry Information" section to find Subcontracting Plan Review responses.
• Sections within SBCX: Outlines four key sections: Summary (project information from the Contracting Officer), Subcontracting Goals (requirements for the plan type), Documents (for uploading/viewing supporting documentation), and Notes (for communication with the Contracting Officer and Small Business Specialist).
• Completing Subcontracting Plans: Provides step-by-step guidance on identifying the plan type, reporting eligible subcontracting dollars, providing period of performance information, detailing subcontracting goal data, identifying the Subcontracting Program Administrator, describing efforts to include small businesses, and certifying completion.
• Evaluation: Describes the three-approver review process (CO, SBS, SBA PCR).

This guide is crucial for bidders who are required to submit a subcontracting plan. It clarifies the process, the information needed, and how to use the SBCX system to meet HHS requirements for subcontracting plans, particularly for contracts exceeding $750,000 ($1,500,000 for construction).

Form / Attachment / Pricing Sheet

This document, "Att. 07_Article I.1. General Clauses.pdf", contains a comprehensive list of general clauses incorporated by reference into a cost-reimbursement contract with educational institutions, and also for non-profit organizations other than educational institutions, and for research and development contracts, and for service contracts. These clauses are essential for understanding the terms and conditions that will govern the contract.

• Federal Acquisition Regulation (FAR) Clauses: A detailed listing of FAR clauses, including their number, date, and title. These cover a wide range of contractual aspects such as definitions, gratuities, anti-kickback procedures, limitations on payments, whistleblower rights, reporting requirements, small business concerns, limitations on subcontracting, patent rights, and payment terms.
• HHS Acquisition Regulation (HHSAR) Clauses: Specific HHSAR clauses are also included, such as Anti-Lobbying, Contractor Cooperation in Equal Employment Opportunity Investigations, Publications and Publicity, Litigation and Claims, and Key Personnel.
• Contract Type: The document specifies that these clauses apply to various types of cost-reimbursement contracts.

Bidders should carefully review these general clauses to understand their rights and obligations under the contract. Key areas to note include:

• Compliance Requirements: Clauses related to ethics, anti-kickback, and whistleblower rights.
• Reporting Obligations: Requirements for reporting executive compensation, subcontract awards, and patent rights.
• Small Business Participation: Clauses pertaining to small business subcontracting plans and utilization.
• Payment Terms: Information on payment procedures, limitations, and prompt payment.
• Intellectual Property: Clauses related to patent and copyright infringement and ownership.

Understanding these clauses is critical for preparing a compliant proposal and for successful contract performance.

Form / Attachment / Pricing Sheet

This document provides instructions and a template for submitting invoice/financing requests and contract financial reports for NIH Cost-Reimbursement Contracts (NIH(RC)-4). It details the required format, frequency of submissions, and specific information needed for payment requests.

• Format: Contractors must use a self-generated form or Standard Form 1034, including specific information as illustrated in the Sample Invoice/Financing Request.
• Frequency: Submissions are generally not more frequent than bi-weekly, with exceptions for small businesses.
• Content Requirements: Detailed instructions are provided for itemizing requests, including:
  • Contractor identification (Name, Address, TIN, DUNS)
  • Invoice/Financing Request Number (unique and sequential)
  • Contract details (Number, Title, Period of Performance)
  • Cost details (Total Estimated Cost, Fixed Fee, Direct Costs, Indirect Costs, Cost of Money)
  • Specific direct cost categories (Labor, Fringe Benefits, Property, Materials, Consultants, Travel, Subcontracts, Other)
  • Certification statement.
• Financial Reporting: Instructions are provided for filling out columns related to Expenditure Category, Effort/Hours (Negotiated and Actual), Amount Billed (Current and Cumulative), Cost at Completion, Contract Value, and Variance.

This attachment is crucial for understanding the process and requirements for invoicing and receiving payment under NIH cost-reimbursement contracts. Bidders should review this document to ensure they can meet the financial reporting and submission requirements if awarded a contract. It outlines the specific data and formats needed for timely and accurate payment processing.

Form / Attachment / Pricing Sheet

This document is a "Proposal Intent Response Form" for RFP No: 75N92026R00008, titled "Study Coordinating Center for the Lung Health Cohort." It is used by potential bidders to indicate whether they intend to submit a proposal.

• Bidders must choose one of two options: "Do intend to submit a proposal" or "Do Not intend to submit a proposal."
• If not responding, bidders must provide their reason(s).
• Bidders must provide contact information, including Name, Title, Organization, and E-mail.
• The form is to be returned to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form.

This form is crucial for bidders to formally communicate their intent regarding the RFP. It helps the government in planning proposal evaluations. The submission deadline for this intent response is May 15, 2026, by 3:00 PM. Failure to submit this form does not preclude a bidder from submitting a proposal, but it is requested for planning purposes.

Form / Attachment / Pricing Sheet

This document, "SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS," is a required part of the business proposal for this opportunity. It outlines various representations and certifications that offerors must complete and submit. By signing the offer, the offeror makes these statements.

This section is divided into eight parts, covering:

• Annual Representations and Certifications (including NAICS code and small business size standard)
• Commercial and Government Entity Code Reporting
• Information Regarding Responsibility Matters
• Cost Accounting Standards
• Certification Regarding Environmental Tobacco Smoke
• Certification of Institutional Policy on Financial Conflicts of Interest
• Disaster or Emergency Area Representation
• Alternate Representation regarding Unpaid Delinquent Tax Liability or Felony Conviction

Offerors must indicate whether they are completing these representations and certifications electronically via SAM.gov or by submitting them directly with their proposal. Specific FAR provisions are cited for each representation and certification.

This document is critical for bidders as it details the mandatory compliance and status information required for their proposal. Failure to accurately complete and submit these representations and certifications may impact the eligibility or evaluation of their offer. Bidders must carefully review each section to ensure they meet all requirements and provide accurate information, including details about their business size, certifications, and any potential conflicts of interest or legal issues.

Form / Attachment / Pricing Sheet

This document is an 'Inclusion Enrollment Report' form, used to record demographic data for participants in a study. It is designed to capture information related to racial and ethnic categories, as well as gender, for both planned and cumulative enrollment.

• Inclusion Enrollment Report Title: A field to name the specific report.
• Using an Existing Dataset or Resource: A Yes/No indicator.
• Enrollment Location Type: Specifies if enrollment is 'Domestic' or 'Foreign'.
• Enrollment Country(ies): A field to list countries where enrollment occurs.
• Enrollment Location(s): A field for specific locations within countries.
• Comments: A free-text field for additional notes.
• Demographic Tables: Two tables are included: one for 'Planned' enrollment and one for 'Cumulative (Actual)' enrollment. Both tables break down participants by 'Racial Categories' (e.g., American Indian/Alaska Native, Asian, White) and 'Ethnic Categories' (Not Hispanic or Latino, Hispanic or Latino, Unknown/Not Reported Ethnicity), further categorized by 'Female' and 'Male' (and 'Unknown/Not Reported' for cumulative data).

This form is relevant to bidders as it outlines the required demographic data collection for study participants. Understanding these reporting requirements can inform a bidder's approach to study design, participant recruitment, and data management, particularly if the opportunity involves clinical trials or research requiring detailed demographic reporting.

Form / Attachment / Pricing Sheet

This document provides "Additional Business Proposal Instructions" for the "Study Coordinating Center for the Lung Health Cohort" RFP (No.: 75N92026R00008). It details specific requirements for cost/price breakdowns and subcontract information that must be included in the proposal submission.

• Contract Type: Single award Indefinite Delivery Indefinite Quantity (IDIQ) contract with a six (6) year ordering period.
• Task Orders: Two task orders will be awarded with the IDIQ contract: Task Area 1 (Program Management) and Task Area 2 (Completion of 5-year Exam and Data Collection). These task orders will be cost reimbursement with a one-year base period and five (5) one-year option periods.
• Cost/Price Breakdown: A detailed cost/price breakdown in Excel, using the template from Section J, Attachment 15 of the RFP, is required.
• Separate Spreadsheets: Bidders must submit separate Excel spreadsheets for each task area for the Base Period and each of the five Option Periods. A summary spreadsheet of both task areas is also required.
• Subcontract Costs: Each proposed subcontract must include its own separate Excel spreadsheet with a cost breakdown for the Base Period and each option period, specifying the task area. These costs must be incorporated into the subcontract line item in the spreadsheets for Task Areas 1 and 2.
• Narrative Support: Costs proposed in these spreadsheets must be supported by a narrative description in the business proposal.
• Task Area Descriptions: Task areas are further described in Attachment 3, Statement of Work, of the RFP.

This document is critical for bidders to understand the specific financial and submission requirements for their proposals, particularly concerning detailed cost breakdowns, subcontract pricing, and the required format for these submissions. Failure to adhere to these instructions may impact proposal evaluation.

Form / Attachment / Pricing Sheet

This document provides instructions for the packaging and delivery of proposals, specifically for submissions made through the NIH electronic Contract Proposal Submission (eCPS) website. It details the required formats, naming conventions, and formatting limitations for proposal components.

• Submission Method: Proposals must be submitted electronically via the eCPS website (https://ecps.nih.gov). Fax or email submissions will not be accepted.
• Account Creation: Allow up to three (3) business days for new account registration on the eCPS website.
• File Formats:
  • Technical Proposal: One PDF file, including all attachments. Should be word-searchable. Scanned forms requiring signatures must be merged.
  • Business Proposal: One PDF file, including all attachments. Should be word-searchable. Must include the "Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet".
  • Business Document Excel: The "Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet" must be included in its original Excel format, not PDF.
• File Naming Convention: Filenames should include the offeror's name, solicitation number, and proposal type (e.g., XYZ Company_NIHAI2012001_Technical.pdf).
• Formatting Limitations:
  • Page size: 8.5" x 11"
  • No internet web site addresses (URLs) or links to external information.
  • No audio or video files.
  • Font size: 10 to 12 points.
  • Spacing: Max 15 characters per inch; max six lines per vertical inch.
  • Margins: At least ½ inch on all sides (exclusive of headers/footers).
• Consequences of Non-Compliance: Failure to adhere to formatting requirements may impact proposal review. Exceeding page limitations will result in pages being removed and not considered.

This document is critical for bidders to understand the precise requirements for formatting and submitting their proposals. Adhering to these instructions is essential to ensure the proposal is accepted and reviewed by the government. Key deadlines for account creation and submission, as well as specific file naming and formatting rules, must be followed to avoid disqualification.

Form / Attachment / Pricing Sheet

This document, "Reporting Requirements and Deliverables," outlines the specific reports and deliverables required from a contractor, along with their frequency, submission schedule, and designated recipients. It serves as a guide for contractors to understand their ongoing reporting obligations throughout the contract period.

• Meeting Minutes: 12 per month.
• Reports: Includes Environmental (Geocodes), CT Quality Assessment, Annual Meeting, LHC Observational Study Monitoring Board, Quality Control, Biorepository Inventory, Third Party Agreement Summary, Semi-Annual Progress, 508 Annual, and Final Progress reports, with varying frequencies (once a year, twice a year, or prior to meetings).
• Financial: Monthly Financial Invoices and a Final Financial Report.
• Publications: Submission of final peer-reviewed journal manuscripts to PubMed Central upon acceptance for publication.
• Data & Websites: Continuous updates to study websites and submission of all data and images as directed.
• Recruitment: Weekly recruitment reports.
• Deliver To: Reports are to be delivered to COR, CO, COR/CO, OSMB members, PubMed Central, Public, or Executive Committee as specified.
• Task Areas: Indicates relevance to Task Area 1.0 and/or Task Area 2.0.

This attachment is crucial for bidders to understand the ongoing administrative and technical reporting requirements associated with the contract. It details the types of information that must be regularly submitted, the frequency of submission, and to whom it should be sent. This information is vital for accurately estimating the resources and effort required for contract performance and for developing a comprehensive proposal.

Form / Attachment / Pricing Sheet

This document is the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)" form. It is used to certify that research activities involving human subjects are either exempt from, or have been approved in accordance with, the Common Rule. Bidders may need to complete and submit this form if their proposed work involves human subjects.

• Request Type: Original, Continuation, or Exemption.
• Type of Mechanism: Grant, Contract, Fellowship, Cooperative Agreement, or Other.
• Federal Department/Agency: Identification of the sponsoring agency.
• Title of Application or Activity: Name of the research project.
• Principal Investigator/Program Director: Name of the lead researcher.
• Assurance Status: Details regarding the institution's assurance on file with HHS or other agencies, including Assurance Identification Number, Registration Number, and expiration date.
• Exemption Status: Specific paragraphs under the pre-2018 or 2018 Common Rule for which the activity qualifies for exemption.
• IRB Certification: Confirmation of IRB review and approval, including the type of review (Full or Expedited) and date.
• Comments: Section for additional remarks.
• Institution Information: Name, address, phone, email, and signature of an official representative.

If the opportunity involves research with human subjects, bidders will likely need to provide documentation of their compliance with the Common Rule. This form serves as the mechanism for certifying that compliance, including IRB review and approval or exemption status. Failure to properly complete and submit this form, if required, could impact proposal evaluation or award.

Form / Attachment / Pricing Sheet

This document outlines the "Justification for Public Health Surveillance Exclusion" which Offerors may use to request exclusion from the applicability of the "revised Common Rule" if they believe NIH-funded or -conducted activities associated with the solicitation may be "public health surveillance activities deemed not to be research."

• Offerors must provide a compelling justification explaining why NIH-funded or -conducted activities should be considered public health surveillance activities not deemed research.

• The justification must demonstrate that the proposed activity is strictly limited to what is necessary for NIH to identify, monitor, assess, or investigate public health signals, disease outbreaks, or conditions of public health importance.

• It must also show that the activities provide timely situational awareness during public health events and directly inform NIH public health decision-making or action.

• The justification must be submitted as a separate attachment to the technical proposal.

• This document is critical for bidders who wish to claim an exclusion from the "revised Common Rule" for public health surveillance activities.

• It details the specific criteria and information required for such a justification.

• Failure to provide a complete justification at the time of proposal submission may result in the request not being considered.

• It references the "revised Common Rule" (45 CFR Part 46) and NIH Notice NOT-OD-22-001 for further details.