HRSA-75R60226R00026-Consolidated Questions.pdf

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HRSA/MCHB Newborn Screening Systematic Evidence Review IDIQ and Task Order 1
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75R60226R00026
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This document is a consolidated questions and answers file for federal contracting solicitation HRSA-75R60226R00026, which establishes a Master Indefinite Delivery/Indefinite Quantity (IDIQ) contract for newborn screening evidence review services, with concurrent Task Order 1 award.

The procurement is for a 5-year Master IDIQ with a $15.1 million ceiling, issued under FAR Subpart 12.6 and FAR Part 15 utilizing the Revolutionary FAR Overhaul (RFO) framework. Task Order 1 covers a Base Year and Option Year 1 and includes four core tasks: a biliary atresia clinical evidence review, development of a Manual of Procedures (MOP) framework, systematic evidence reviews for up to 10 medical/genetic conditions for the Recommended Uniform Screening Panel (RUSP), and supporting analyses. Offerors must price Task Order 1 as an all-inclusive firm-fixed-price lot for the maximum capacity of 10 simultaneous condition reviews; the lot price remains fixed regardless of the actual number of conditions assigned (up to 10), with no equitable adjustments. Optional Tasks 1–3 are priced only for Option Year 1. The Government will select the Master IDIQ pool using best-value trade-off analysis (technical, past performance, and price), then award Task Order 1 to the single highest technically ranked offeror within that pool. Technical proposals are limited to 25 pages (exclusive of exempted appendices for resumes, letters of commitment, teaming arrangements, acronym lists, compliance matrices, and staff loading charts). Volume II and Volume III have no page limits. Past performance requires three references, with a maximum of one subcontractor reference; offerors may submit printed CPARS records instead of questionnaires and may use individual task orders under parent IDIQs as acceptable references. Proposals are due by September 22, 2026, at 5:00 PM EDT, with Past Performance Questionnaires due from references by September 18, 2026, at 5:00 PM EDT. Small Business Subcontracting Plans are mandatory for offerors classified as "Other than Small" (including nonprofit universities not qualifying as small under NAICS 541690) and must be submitted with the initial proposal in Volume III. The Tier 2 background investigation requirement and three-of-five-years U.S. residency requirement for foreign nationals apply to all contractor and subcontractor personnel with logical access to federal data or sensitive contract information. All deliverables and data remain exclusive property of the Federal Government; publication in peer-reviewed journals requires prior written approval from the Contracting Officer following formal internal agency clearance. Proposals must be submitted via email with a maximum 25 MB attachment size per email and may be split across multiple sequential emails using the file naming convention [Offeror Name]_Solicitation75R60226R00026_Volume [I/II/III]. Other Direct Costs are excluded, and the $35,000 annual travel plug is a strict, cost-reimbursable not-to-exceed ceiling billed at actual cost against receipts; no corporate burden, indirect rates, or profit markup may be added. Contractors are responsible for developing Information Collection Request (ICR) documentation for primary data collection from state newborn screening programs, with HRSA sponsoring OMB submission. Expert rosters require COR approval typically within 5 to 10 business days of submission, and all evidence review reports will be delivered to HRSA/MCHB to support federal oversight of the RUSP.

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HRSA-75R60226R00026-Consolidated Questions

Section 1 Q&A Topics: Technical Proposal, Page Limits, and AI Compliance

• Q1: The instructions for the Technical Subfactor (c): Management Plan and Quality Control do not make mention of a project workplan. However, the evaluation methodologies for Cross-Volume Consistency say that the labor hours in the Price Volume must match the project management workplans. Could HRSA kindly confirm that offerors are not required to include project management workplans as part of the Technical Proposal? If project management workplans are required as part of the Technical Proposal, o Government Response: Offerors are required to detail their project management timeline, tracking system, and workflow methodologies within Volume I, Section 1 to satisfy Technical Subfactor (c). For Task Order 1, specific milestones and timelines must be addressed in Volume I, Section 2. To remain compliant with the strict 25-page limit for Volume I, any project management schedule charts or timelines must be incorporated within the body of the technical proposal or utilizing the allowed 11 x 17-inch foldouts for graphics/charts.

Project management workplans cannot be placed in an exempt appendix; only Resumes, Letters of Commitment, and Joint Venture/Teaming Arrangements are exempt from the page count.

• Q2: Could HRSA confirm that the AI Compliance and Risk Management Plan is a deliverable due after award (and not as part of the proposal submission)? If the AI Compliance and Risk Management Plan is required as part of the Technical Proposal, may offerors place the Plan in an appendix that does not count against the 25-page limit?

o GOVERNMENT RESPONSE: Confirmed. The AI Compliance and Risk

Management Plan is a contract deliverable due after award and prior to the actual implementation of any Artificial Intelligence or Generative AI tools during contract performance. It is not required to be submitted as part of the initial proposal submission and therefore does not impact on the 25-page technical proposal limit.

• Q3: For ease of reading, may offerors include a list of acronyms that does not count against the 25-page limit?

GOVERNMENT RESPONSE: Yes. A list of acronyms may be placed in an appendix and excluded from the strict 25-page limit for Volume I. Attachment 2; Section 5 has been officially amended via Amendment 0001 to include the List of Acronyms as an exempt item.

• Q4: To provide the required level of detail for the staff loading chart, may offerors place that chart in an appendix that does not count against the 25-page limit?

o GOVERNMENT RESPONSE: GOVERNMENT RESPONSE: Yes. To ensure the Government receives necessary resource granularity for a rigorous evaluation under Subfactor (c), Amendment 0001 has officially modified Attachment 2, Section 5. Offerors are authorized to place the comprehensive Staff Loading Chart within a standalone, page-exempt Appendix to Volume I. It will not count against the 25-page narrative ceiling.

• Q5: Are the transmittal letter, acronym list, compliance matrix, and organizational chart excluded from the 25-page limit for Volume I, and is any page limit imposed on Volume II or Volume III?

o GOVERNMENT RESPONSE: Per Attachment 2, Section 5 (as amended by Amendment 0001), the Acronym List, Compliance Matrix, and Staff Loading Chart are explicitly excluded from the 25-page limit if placed in the standalone Technical Appendix. The introductory transmittal letter, organizational charts, and all narrative management workflows remain strictly counted toward the 25-page narrative ceiling. There are no specific page limits imposed on Volume II or Volume III.

• Q6: The Formatting and Page Limits specify, "Text must be no smaller than font size 12 Times New Roman, with no less than 1.15 line spacing...Exhibits, graphics, charts, and captions shall be no smaller than size 10 font." Could HRSA confirm that exhibits, graphics, charts, and captions may be single-spaced?

• GOVERNMENT RESPONSE: Confirmed. While narrative body text must strictly adhere to the 1.15 line spacing minimum, text contained inside exhibits, graphics, charts, tables, and captions may be single-spaced, provided the font size remains no smaller than size 10 Times New Roman.

Section 2: Pricing Spreadsheet Gaps and Template Defects (Attachment 2a)

Question / Industry Gaps Identified Government Clarification & Resolution Strategy

Q1. Optional Tasks 1, 2, and 3 have "N/A" for the Base Year in the spreadsheet, but Attachment 2 text implies pricing them across the Base and Option Year 1. Are FFP costs required for the Base Year?

The template controls. Offerors shall not propose FFP costs for Optional Tasks 1, 2, or 3 during the Base Year. As noted in the Pricing Spreadsheet, these tasks are marked N/A for the Base Year and are only eligible to be executed during Option Year 1.

Q.2 The Senior Medical Officer/Clinician row has no rate entry cells in Part A, and Task 5/Task 6 rows in Tab 4 hard-link to the Senior Epidemiologist row. How do we enter rates for this LCAT?

Defect Acknowledged. An amended Attachment 2a will be issued. Offerors must enter rates for the Senior Medical Officer/Clinician category. Correcting cell formulas to map tasks to the correct LCAT will not be penalized or considered an unauthorized alteration.

Q.3 On the Summary Tab, the Optional Task prices from Option Year 1 are drawn fourfold into Option Periods 1 through 4. Is this fourfold inclusion into the TEP intended?

Defect Acknowledged. The formula on the Summary tab of Attachment 2a mistakenly duplicates Option Year 1 pricing into subsequent IDIQ ordering periods where Task Order 1 does not exist. The formula will be corrected in the amended template to reflect the exact 2-year duration of TO1.

Q.4 On the TO1 FFP Schedule, Option Year 1 cells for the Biliary Atresia Clinical Evidence Review and MOP Framework are left blank instead of "N/A". Are prices required here?

No entry is required. Because the Statement of Work defines these as Base- Year-only deliverables, no pricing can be applied to Option Year 1. Leave these cells blank as formatted in the template.

Q.5 Since cross-volume discrepancies due to template errors are penalizable, please confirm template defects won't be held against us.

Confirmed. Any structural cross-volume inconsistency directly caused by hardcoded template flaws or missing cells in the Government's original Attachment 2a will not be evaluated negatively. Offerors are encouraged to use the corrected template issued via this amendment.

Q.6 On the TO1 FFP Schedule tab, the OPY1 Unit/Total FFP cells for the Biliary Atresia Clinical Evidence Review Report and the MOP Framework/Training Materials line items are left blank (a space character) rather than marked "N/A" as done for the optional task rows. Since the SOW describes these as Base-Year-only deliverables, please confirm no OPY1 price entry is required for these rows.

Confirmed. No Option Year 1 price entry is required or permitted for these specific rows. Because these are defined strictly as Base-Year-only deliverables within the SOW, the pricing cells must be left blank as formatted in the official template.

Section 3: Project Scope, Task Order 1, and Condition Volume

• Q1: Under Task 6 in the Task Order 1 Statement of Work, it states that the COR will assign the contractor up to 10 medical/genetic conditions to review. Should offerors provide a total fixed price cost for up to 10 conditions in both the Base and Option Year 1 or does the government want offerors to provide a price per condition that could be executed up to 10 times in both the Base and Option Year 1?

o GOVERNMENT RESPONSE: Offerors must provide a single, total firm-fixed-price (FFP) lot price for the capacity to conduct up to 10 simultaneous systematic evidence reviews in both the Base Year and Option Year 1, exactly as structured in Tab 3 of Attachment 2a. This is an all-inclusive lot price for the task workload capacity; it is not a per-condition unit price execution model.

• Q2: If fewer conditions are assigned than the maximum under the Task 6 lot, will the firm-fixed price be adjusted by modification, or does the lot price remain fixed regardless of the number of conditions actually assigned?

o GOVERNMENT RESPONSE: The lot price remains entirely fixed regardless of the actual number of conditions incrementally assigned up to the maximum ceiling of 10 conditions. Because this is a Firm-Fixed-Price task order task, no downward or upward equitable adjustments will be made if the COR assigns fewer than 10 conditions during the performance period.

• Q3: Will HRSA identify the candidate conditions for the evidence scans under Task 5 and the evidence reviews under Task 6, or the criteria and timing by which the COR will assign them?

o GOVERNMENT RESPONSE: The specific conditions will be assigned by the COR incrementally after contract award based on ongoing state nominations and programmatic priorities. Criteria for determining readiness and evaluating these conditions will be established collaboratively using the Framework/Manual of Procedures (MOP) developed under Task 4 during the initial months of the contract.

• Q4: Task 6.1 requires an economic analysis related to each newborn screening condition under review. Does HRSA require a de novo decision analytic or cost-effectiveness model for each condition, or is a synthesis of published economic evaluations acceptable where such evidence exists?

o GOVERNMENT RESPONSE: The contractor is expected to follow the guidelines and methodology for determining financial value, cost-effectiveness, and budget impact established in the Task 4 Manual of Procedures (MOP).

Where robust, high-quality published economic evaluations exist, a synthesis may be acceptable; however, the contractor must possess the capability to perform more detailed decision-analytic or budget-impact modeling if literature gaps prevent an objective assessment of the public health system impact.

• Q5: Task 6 in Attachment 1c requires assessment of the impact and cost for State public health newborn screening programs to implement screening of new conditions. Does the Government anticipate primary data collection from State newborn screening programs or laboratories? If so, will the Government provide or sponsor the required Paperwork Reduction Act clearance, or is the contractor responsible for obtaining it?

o GOVERNMENT RESPONSE: Primary data collection from public states or laboratories is within scope. The contractor is responsible for developing all necessary documentation for the Information Collection Request (ICR) package and Federal Register Notices under Master IDIQ Task 4. However, HRSA will formally sponsor and submit the package to OMB. Contractors should account for standard OMB clearance timelines when mapping execution schedules.

• Q6: Attachment 1, Section II, states that individual evidence reviews will be ordered through separately issued Task Orders. However, Attachment 1c places up to ten

(10) simultaneous systematic evidence reviews within the scope of Task Order 1.

Please confirm whether the systematic evidence reviews described in Attachment 1c, Task 6, are within the scope and price of Task Order 1, or are to be ordered as separate task orders under the master IDIQ.

o GOVERNMENT RESPONSE: The systematic evidence reviews described in Attachment 1c, Task 6, are explicitly within the core scope and firm-fixed lot price of Task Order 1 for the Base Year and Option Year 1. Future/subsequent condition reviews beyond this initial scope may be ordered via separate task orders under the master IDIQ structure.

Q7: If the Task 6 systematic evidence reviews are within the scope of Task Order 1, how many conditions should offerors assume for pricing purposes, and will the conditions be assigned as a single cohort at or near the effective date of contract or incrementally as conditions are nominated/released?

• GOVERNMENT RESPONSE: For baseline pricing purposes on Tab 3, offerors must price the maximum capacity lot size of up to ten (10) conditions as defined. The Government anticipates that these conditions will be assigned by the COR incrementally throughout the period of performance.

Q8: Can HRSA provide an estimated level of effort (LOE), an Independent Government Cost Estimate (IGCE) range, or the cost of comparable RUSP condition evidence reviews previously performed, so that offerors may propose a realistic firm-fixed price?

• GOVERNMENT RESPONSE: The Government will not disclose the Independent Government Cost Estimate (IGCE) or prior historical project costs for this procurement.

Offerors are instructed to utilize their technical experience, corporate capabilities, and proposed methodology to estimate the level of effort required to successfully execute the milestones detailed in the Statement of Work.

Section 4: Solicitation Dates, Extensions, and Administrative Clarifications

• Q1: Attachment 2 states Past Performance Questionnaires are due directly from clients "no later than Friday, September 18, 2026, by 5:00 PM EDT," but the PPQ transmittal letter template in Attachment 2b itself states a due date of "September 14, 2026, at 3:00 PM EST." Please confirm which date controls so Offerors can instruct their references correctly.

o GOVERNMENT RESPONSE: The September 18, 2026, at 5:00 PM EDT date controls. To resolve this typographical conflict, the template text within Attachment 2b is officially modified via this amendment to reflect the September 18, 2026, deadline. The final electronic proposal submission deadline remains unchanged and is strictly due no later than Tuesday, September 22, 2026, at 5:00 PM EDT. No extensions will be granted.

• Q2: For the concurrent Task Order 1 award, please clarify whether the highest technically ranked offeror will be selected primarily on technical ranking after meeting price reasonableness requirements, or whether the Government will conduct a best-value tradeoff that considers technical, past performance, and price in determining the Task Order 1 awardee.

o GOVERNMENT RESPONSE: As stated in Attachment 2, Part 1(A), the Government will establish the Master IDIQ pool using a Best Value Trade-off process considering Technical, Past Performance, and Price collectively. Once the pool is established, Task Order 1 will be awarded utilizing a Fair Opportunity Exception directly to the single highest technically ranked Offeror within that selected pool whose pricing is determined fair, reasonable, and realistic. A secondary tradeoff is not conducted for TO1 itself; technical ranking within the qualified pool drives the selection.

• Q3: The solicitation states it is issued under FAR Subpart 12.6 and FAR Part 15

"under the Revolutionary FAR Overhaul (RFO) framework," with FAR Part 12 taking precedence where inconsistent. Can HRSA identify which specific solicitation provisions are RFO-modified versus standard FAR 12.6/Part 15 procedures?

o GOVERNMENT RESPONSE: The primary RFO modification applies to post-award streamlined ordering procedures for subsequent task orders, granting the Contracting Officer broad authority to conduct rapid negotiations, request spot-discounts, or utilize oral presentations without triggering formal standard FAR Part 15 competitive discussion rules. The initial evaluation and award of the Master IDIQ pool and Task Order 1 strictly follow standard FAR Part 12 and Part 15 rules—specifically, the intent to award without discussions based on initial submissions.

• Q4: Attachment 2, Section 1, describes Volume I Section 1 as covering "capabilities to perform Tasks 1-8 over the [Master IDIQ's] 5-year period," but the Master IDIQ Statement of Work (Attachment 1) defines only seven (7) task areas. Please confirm whether this is a numbering error, or identify the eighth Master IDIQ task area.

o GOVERNMENT RESPONSE: This is a minor numbering text error in the instruction volume. The Master IDIQ SOW consists of seven (7) Core Tasks.

Volume I, Section 1 should address the offeror's capability to perform Tasks 1 through 7 over the 5-year life of the IDIQ.

• Q5: What is the maximum total email attachment size for proposal submission, may the proposal be submitted across multiple emails, is a specific file naming convention required, and will the Government confirm receipt of proposals?

o GOVERNMENT RESPONSE: The maximum total email attachment size constraint for HRSA servers is 25 MB per email. Proposals may be split across multiple sequential emails if necessary (e.g., "Email 1 of 2 - Volume I"). Files must be clearly labeled using the convention: [Offeror Name]_Solicitation75R60226R00026_Volume [I/II/III]. The Government will provide an electronic email confirmation of receipt for all submissions.

• Q6: The RFP provides an estimated funding threshold for the IDIQ per ordering period. Does the government intend to release multiple task orders within the Base and Option Year 1 or only the first task order (with subsequent task orders released in Option Years 2-4)?

o GOVERNMENT RESPONSE: While Task Order 1 represents the primary core operational requirement for the initial period, the Government reserves the right to issue subsequent, separate task orders during the Base Year and Option Year 1 if programmatic needs, emergent public health conditions, or state screening nominations demand additional review capacity.

• Q7: How many additional task orders does HRSA anticipate will be awarded through this IDIQ?

o GOVERNMENT RESPONSE: The exact number of subsequent task orders is dependent upon federal funding availability and evolving agency mission priorities. The Master IDIQ establishes a flexible capacity up to the contract ceiling, but does not guarantee a specific volume of individual task orders beyond Task Order 1.

• Q8: Can HRSA provide descriptions of the Labor Categories presented in

Attachment 2a on the "Master IDIQ Labor Schedule" tab?

o GOVERNMENT RESPONSE: No formal separate labor category descriptions will be issued. The labor categories listed on the Master IDIQ Labor Schedule represent standard professional services classifications within the fields of public health, epidemiology, clinical medicine, and federal program management.

Offerors must map their staff according to standard industry definitions aligned with the SOW task workloads.

• Q9: Are offerors permitted to propose escalated ceiling labor rates across the Base

Year and the four Option Periods, and may proposed rates be discounted below those ceilings when competing for individual task orders?

o GOVERNMENT RESPONSE: Yes. Offerors are permitted to propose realistic annual price escalation across the Master IDIQ baseline periods in Part A of the template. The fully burdened hourly rates proposed will serve as binding maximum ceiling rates for the life of the IDIQ. Offerors may voluntarily propose discounted labor rates below these ceilings when competing for subsequent individual task orders.

• Q10: Section 6.1 states that all task orders are subject to the terms and conditions of this IDIQ and the contractor's underlying GSA MAS contract. Please confirm that an active GSA Multiple Award Schedule contract is not a prerequisite for award of, or for ordering under, this IDIQ.

o GOVERNMENT RESPONSE: Confirmed. Holding a GSA Multiple Award Schedule (MAS) contract is not a prerequisite for award of this Master IDIQ. This is a standalone, full and open competitive procurement vehicle. The text reference in Section 6.1 is an administrative tracking error and is hereby deleted via this amendment.

Section 5: Past Performance and Subcontracting Rules

• Q1: Attachment 2 caps Past Performance references at a maximum of 1 subcontractor/JV reference out of 3 total. Please confirm whether a reference in which the Offeror served as a data-coordinating-center subcontractor to an academic prime under an NIH grant counts against this cap, or whether grant-funded academic subcontracts are treated differently from FAR-based prime/subcontractor relationships for this purpose.

o GOVERNMENT RESPONSE: Any reference where the Offeror did not hold the direct contract relationship as the Prime entity—including grant-funded academic subcontracts or federal subcontracts—counts against the maximum cap of one (1) subcontractor reference. The remaining two references must showcase the Offeror's performance as a Prime contractor or Joint Venture member.

• Q2: May an offeror satisfy all three past performance references using printed

CPARS records without submitting Past Performance Questionnaires, and are task orders performed under a parent IDIQ acceptable as references?

o GOVERNMENT RESPONSE: Yes. Offerors may completely satisfy Volume II requirements by attaching printed, relevant CPARS records for all three references. In this case, separate PPQs do not need to be filled out by clients.

Additionally, individual task orders performed under a parent IDIQ are highly acceptable and preferred, provided they demonstrate independent size, scope, and complexity relevant to the SOW.

• Q3: For purposes of the FAR 52.219-9 subcontracting plan requirement, how will the Government classify a nonprofit institution of higher education that is other than small under NAICS 541690? Is a subcontracting plan required from such an offeror, and if so, must it be submitted with the initial proposal?

o GOVERNMENT RESPONSE: Under Small Business Administration (SBA) guidelines, a non-profit institution or university that does not qualify as a small business under NAICS 541690 is classified as "Other than Small" (Large Business) for procurement purposes. Because the total Master IDIQ pool ceiling is $15.1 Million, a formal Small Business Subcontracting Plan is mandatory and must be submitted with the initial proposal inside Volume III. Failure to upload an acceptable plan at submission will render the offeror ineligible for award.

Section 6: Staffing, Labor Categories, and Travel Reimbursement

• Q1: Given that Task Order 1 spans multiple distinct scientific workstreams (biliary atresia review, MOP framework development, RUSP evidence reviews), must the Offeror name a single Principal Investigator across all workstreams, or may multiple co-PIs/workstream leads be named with one designated as the primary PI for resume-disqualification purposes?

o GOVERNMENT RESPONSE: Offerors may name multiple co-PIs or distinct workstream leads across the scientific tasks to ensure adequate specialized coverage. However, the offeror must clearly designate one single Primary Principal Investigator (PI) within the Technical Proposal and staff loading chart.

The designated Primary PI's resume will serve as the baseline resume evaluated for potential disqualification under Subfactor (b) rules.

• Q2: Please clarify how the Government will evaluate and credit specialized academic, clinical, newborn-screening, genetics, and systematic-review expertise provided through subcontractors or consultants, including whether such entities may contribute key personnel and corporate experience to satisfy the technical evaluation requirements.

• GOVERNMENT RESPONSE: Offerors are highly encouraged to build multi-disciplinary teams utilizing subcontractors, external consultants, and academic university networks to satisfy the specialized scientific demands of the SOW. In accordance with Attachment 2, the Government will evaluate the technical capability, qualifications, and credentials of the proposed team collectively. Proposed subcontractors and consultants may fulfill Key Personnel roles, provided signed Letters of Commitment are included in the Technical Appendix. The corporate capabilities and relevant project experience of major subcontractors will be evaluated and credited under Technical Subfactor (c) to assess the overall structural feasibility of the proposed management plan.

• Q3: May offerors propose additional and/or different labor categories, or should these labor categories be utilized for pricing?

o GOVERNMENT RESPONSE: Offerors must utilize and price all mandatory Government Labor Categories (LCATs) listed in Attachment 2a to maintain structural template compliance. However, offerors are permitted to add customized labor categories (e.g., Medical Librarian, Biostatistician, Genetic Counselor) to the Master IDIQ Labor Schedule, provided that the mandatory baseline categories remain entirely unaltered and un-deleted.

• Q4: The RFP includes an NTE travel plug of $35,000 per year. Should the $35,000 amount be inclusive of burden, or may burden be charged in addition to this amount? Section 7.3 states that travel is itemized separately against receipts and billed at actual cost with no profit markup, up to the authorized task order travel cap. Please confirm that the $35,000 annual travel amount is reimbursable at actual cost and is not to be included within the firm-fixed prices proposed for individual deliverables.

o GOVERNMENT RESPONSE: Confirmed. The $35,000.00 annual travel plug is a strict, cost-reimbursable NTE ceiling that is billed at actual cost against travel receipts. It must not be integrated into the firm-fixed prices of the baseline scientific deliverables. The $35,000.00 amount must be entered as a raw plug value on the summary tab; no corporate burden, indirect rates, or profit markup may be added to this line item.

• Q5: Other Direct Costs are excluded and travel is fixed at a Government not-to-exceed plug of $35,000 per year. How should offerors price the non-labor costs required by the Statement of Work, specifically expert panel honoraria, live closed captioning and interpretive services, meeting registration platforms, briefing book production, and travel for non-contractor participants under Optional Task 2?

o GOVERNMENT RESPONSE: Per the solicitation instructions, Other Direct Costs (ODCs) are strictly excluded from this contract vehicle. All operational costs—including expert panel honoraria, live closed captioning, software licenses for meeting registration platforms, materials production, and non-contractor participant travel—must be fully built into the contractor's fully burdened hourly labor rates or standard corporate overhead structures. They cannot be carved out as separate open-market charges.

Section 7: Operational & Policy Clarifications

• Q1: Following the termination of the Advisory Committee on Heritable Disorders in

Newborns and Children in March 2025, which body or office will receive and act upon the evidence review reports produced under this contract? Please describe the National Newborn Screening Stakeholder Workgroup referenced throughout Attachment 1c, including its composition, meeting frequency, and expected turnaround for review of draft deliverables.

o GOVERNMENT RESPONSE: Following structural leadership transitions, all evidence review reports, scoping reviews, and consumer data summaries produced under this contract will be delivered directly to the HRSA/MCHB programmatic office to support the ongoing maintenance and federal oversight of the Recommended Uniform Screening Panel (RUSP). The National NBS Stakeholder Workgroup is an active advisory group comprised of clinical geneticists, public health laboratory directors, clinicians, and family advocacy representatives. They meet routinely (typically quarterly or on an ad-needed basis per task order requirements) to review findings, validate evidence synthesis, and provide subject-matter feedback within standard programmatic turnaround timelines (typically 14 to 30 days).

• Q2: Can HRSA describe the process for COR approval of experts, including what management steps the contractor will need to take to obtain approval and expected turnaround time for the COR's decision?

o GOVERNMENT RESPONSE: The contractor must submit a formal roster detailing the names, academic credentials, conflict of interest (COI) screening results, and signed Non-Disclosure Agreements (NDAs) for all proposed experts, cERG members, or TEP panelists to the COR prior to initiating substantive review work. The COR will review the qualifications and compliance artifacts and provide formal written approval or disapproval, typically within 5 to 10 business days of receipt.

• Q3: Do the Tier 2 background investigation requirement and the three-of-five-years

United States residency requirement for foreign nationals apply to all contractor and subcontractor personnel performing work off-site at contractor facilities, including expert consultants and members of the Evidence Review Group and Technical Expert Panel?

o GOVERNMENT RESPONSE: Yes. The Tier 2 moderate-risk public trust background investigation and the 3-of-5-years U.S. residency requirement apply to all personnel (including prime contractor employees, subcontractor staff, independent expert consultants, and TEP members) who will have routine logical access to federal data, electronic systems, or sensitive non-public contract information, regardless of whether they work on-site or off-site at a contractor facility.

• Q4: Section 8.5 prohibits the contractor from publishing or disseminating information resulting from work performed under this IDIQ without prior written approval of the Contracting Officer, and states that all materials developed are the exclusive property of the Federal Government. Attachment 1, Task 7, and Attachment 1c, Task 6.6, contemplate publication of results in peer-reviewed journals. Please clarify the approval pathway and the extent to which contractor and academic personnel may publish methods and findings.

o GOVERNMENT RESPONSE: While all data and deliverables remain the exclusive property of the Federal Government, HRSA encourages the publication of systematic evidence reviews to benefit public health. The approval pathway requires the contractor to submit the complete draft manuscript, publication plan, and target journal selection to the COR for formal internal agency clearance.

No external publication or dissemination may occur until the Contracting Officer or COR provides explicit, written clearance.

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