75R60226R00026 Amend 0001.pdf

(x)

75R60226R00026 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

OAMP

Rockville MD 20857 5600 Fishers Lane

HHS/HRSA/OFAAM/OAMP

OAMP

Rockville MD 20857 5600 Fishers Lane Office of Acquisition Management and Policy

HHS/HRSA/OFAAM/OAMP

09/02/20260001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/02/2026

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Title: HRSA/MCHB Newborn Screening Systematic Evidence Review IDIQ (with Concurrent Award of Task Order 1)

Task Order Type: Firm Fixed

AMENDMENT 0001 – SOLICITATION 75R60226R00026

HRSA/MCHB Newborn Screening Systematic Evidence Review IDIQ

CONCURRENT AWARD STREAM FOR TASK ORDER 1

The purpose of this amendment is to officially modify Solicitation #75R60226R00026 to address industry pre-proposal inquiries, issue official Government Q&A responses, publish revised technical proposal page layout exemptions, and distribute Attachment 2a – Pricing

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16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

ELIZABETH VANABSHER

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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Spreadsheet (Amended Template - Rev 2) to resolve structural pricing and formula artifacts.

SECTION A: ADMINISTRATIVE DEADLINES &

SOLICITATION INTEGRITY

1. Past Performance Questionnaire (PPQ) Clarification: The clerical discrepancy between

Attachment 2 and the Attachment 2b template letter has been resolved. Offerors are instructed to inform their client references that completed

PPQs must be sent directly to the Government via email no later than Friday, September 18, 2026, by 5:00 PM EDT.

2. Proposal Submission Deadline: The electronic proposal closing date remains completely unchanged. All final proposal volumes must be submitted electronically via email to the

Contracting Officer and Contract Specialist no later than Tuesday, September 22, 2026, by 5:00

PM EDT. No extensions will be granted under any circumstances due to urgent public health capacity mandates.

SECTION B: VOLUME I (TECHNICAL) REVISIONS &

MATERIAL CHANGES

3. Acronym List Appendix Page Exemption:

Attachment 2, Section 5 (Formatting and Page

Limits) is officially modified to add a List of

Acronyms to the list of components excluded from the strict 25-page limitation. The list of acronyms may be submitted as an un-evaluated, standalone Appendix to Volume I.

4. Technical Proposal Page Count Exemptions and Layout Re-Baseline: To ensure the Government receives the level of resource granularity necessary to execute a rigorous price realism and technical capability evaluation under Subfactor

(c), Attachment 2, Section 5 is officially amended to expand the list of items excluded from the strict 25-page limitation for Volume I.

o Newly Exempt Items (Appendix): Offerors may place the administrative Compliance Matrix and the comprehensive Staff Loading Chart (mapping specific personnel names, labor categories, and hours to individual SOW tasks) within a standalone, page-exempt Appendix to Volume I.

These components will not count against the

25-page narrative ceiling.

o Items Remaining Counted: Introductory transmittal letters, organizational charts, and

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Sponsored by GSA

FAR (48 CFR) 53.110

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75R60226R00026/0001 all narrative management workflows remain strictly counted toward the 25-page narrative ceiling.

o Electronic Document Configuration: To maintain legibility of comprehensive datasets without visual degradation, offerors are authorized and encouraged to configure page sizes for the Staff

Loading Chart or complex timeline graphics to an

11 x 17-inch landscape "Tabloid" format within their digital PDF submissions.

5. Primary Principal Investigator (PI) Mandate:

Bidders are permitted to name multiple co-PIs or workstream leads across the varied newborn screening scientific focus tasks to maximize specialized scientific coverage. However, the proposal must clearly designate one single

Primary Principal Investigator whose resume will be evaluated as the regulatory baseline for subfactor (b) compliance.

6. Collective Evaluation of Subcontractor and Consultant Specialized Expertise: In accordance with the newly issued clarifications within the

Consolidated Government Q&A Log, the Government will evaluate the specialized clinical, rare-disease, newborn-screening, and systematic-review expertise of the proposed project team collectively. Proposed subcontractors, academic institution staff, and independent consultants are explicitly permitted to fulfill Key Personnel roles, provided that signed Letters of Commitment are included within the page-exempt Technical Appendix. The technical capabilities, advanced clinical degrees, and documented project experience of proposed major subcontractors or consultants will be evaluated and credited under Technical Subfactor (c) to assess the overall structural feasibility and capability of the proposed team framework.

7. Eradication of Standalone Task 8 Framework:

Offerors are advised that the master procurement vehicle contains seven (7) evaluated Core Tasks.

To maintain strict structural consistency, the requirements for the post-award "Artificial

Intelligence Compliance and Risk Management

Plan"—previously designated as a standalone Task

8—have been completely removed as an independent task area. The AI Compliance requirements are officially absorbed as a sub-component under Task

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2 (Program Management). Both Attachment 1c (Task

Order 1 SOW) and Attachment 1d (Task Order 1

Schedule of Deliverables) have been fully amended to delete all standalone "Task 8" references.

Offerors shall address their management capability to fulfill this post-award compliance item within their general Task 2 narrative, carrying a page-exempt footnote tracking footprint.

8. GSA MAS Prerequisite Deletion: Section 6.1 of the solicitation package is hereby amended to delete the text reference indicating that an active GSA Multiple Award Schedule (MAS) contract is an ordering prerequisite. This is a standalone, full and open competitive procurement vehicle.

SECTION C: VOLUME III (PRICE) REVISIONS & PRICING

SPREADSHEET RE-BASELINE

8. Spreadsheet Utilization Mandate: Offerors are strictly required to use the newly released

"Attachment 2a – Pricing Spreadsheet – Amended

Template (Rev 2)" for their proposal submission.

Proposals utilizing the original version 1 spreadsheet template will be rendered non-responsive and excluded from the Best Value

Trade-off evaluation pool.

9. Travel NTE Plug Evaluation Realignment: To align with the fact that Task Order 1 carries a defined 2-year maximum duration (Base Year plus

Option Period 1), the embedded formula on the

Summary Tab has been corrected. Option Periods 2, 3, and 4 are now hardcoded to "NA" for travel.

This lowers the pre-populated Travel NTE evaluation footprint from $175,000.00 down to

$70,000.00, ensuring an accurate calculation of the Total Evaluated Price (TEP).

10. Senior Medical Officer/Clinician LCAT Entry Activation: Part A (Master IDIQ Ceiling Labor

Rate Matrix) has been structurally corrected to add data-entry fields for the Senior Medical

Officer / Clinician role. The cell mapping formulas on Tab 4 have been unlinked from the

Epidemiologist role to permit independent labor rate evaluation.

11. Base Year Exclusions for Optional Tasks: On the Summary Pricing Block, Optional Tasks 1, 2, and 3 are marked N/A for the Base Year. In accordance with the SOW, these optional tasks are

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75R60226R00026/0001 strictly eligible for execution during Option

Period 1. Offerors shall not propose costs for these items in the Base Year.

12. Task Order 1 Deliverable Duration Rules: In Part B, Option Period 1 cells for the Biliary

Atresia Clinical Evidence Review and the

Framework/Manual of Procedures (MOP) lines are marked N/A, as these are defined strictly as

Base-Year-only deliverables within the Statement of Work. Offerors must leave these cells blank as formatted.

13. Task 6 Capacity Lot Model Unit Instructions:

Offerors are instructed that Task 6 (Simultaneous

Systematic Evidence Reviews) represents a single, all-inclusive lot pricing structure for baseline workload capacity. For the sub-line

“Consumer-Friendly Summaries per individual reviewed condition,” offerors must provide a unit price per summary that multiplies out to the total lot quantity of 10. No per-condition execution pricing models or downward modifications for under-utilization will be permitted.

14. Elimination of Other Direct Cost (ODC) Leakage: Offerors are re-reminded that ODCs are strictly excluded from this vehicle. All auxiliary operational costs—including expert panel honoraria, software/meeting registration platforms, interpretive services, and participant travel—must be completely built into the offeror’s fully burdened hourly labor rates or overhead structures.

15. Parent IDIQ to Task Order 1 Labor BOE Mapping Matrix: To ensure consistency within the Tab 4

"TO1 Labor BOE Mapping" schedule, offerors shall utilize the following structural crosswalk when mapping staff hours from the Task Order 1

Statement of Work back to the Parent IDIQ baseline labor categories:

o SOW TO1 Task 1 (Federal Records Management) & SOW TO1 Task 2 (Program Management) -> Map to

Dropdown: "Tasks 2, 7: Project Management and compliance" o SOW TO1 Task 3 (Biliary Atresia Review) & SOW TO1 Task 4 (MOP Development) -> Map to Dropdown:

"Tasks 1, 4, 5.1 Manual of Procedures (MOP) and

Protocol Tasks" o SOW TO1 Task 5 (Evidence Scans) -> Map to Dropdown: "Task 5: Evidence Scans and Summaries" o SOW TO1 Task 6 (Systematic RUSP Reviews) & SOW Continued ...

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TO1 Task 7 (Security Tracking) -> Map to

Dropdown: "Task 6: Systematic RUSP Reviews"

16. Spreadsheet Unit Modification: On Attachment 2a, Part B (Task Order 1 FFP Schedule), the Unit

Type designation for the main Task 6 Systematic

Review capacity line item is officially re-baselined from "Each" to "LOT" to reinforce that this deliverable operates on a firm-fixed capacity lot model, rather than a piecemeal per-condition execution model.

SECTION D: LIST OF ATTACHMENTS INCORPORATED VIA

AMENDMENT

17. Incorporated Attachment Log: The following amended files are uploaded to Sam.gov and incorporated into the RFP package with full legal force:

o Attachment 1c- TO 1 SOW-A1 (PDF) o Attachment 1d - TO Deliverables-A1 (PDF) o Attachment 1e – TO 1 QASP (PDF) o Attachment 2 - Instructions to Offerors-A1 (PDF) o Attachment 2a-Pricing Template -A1 (Excel) o Attachment 2b -PPQ-A1 (Word) o HRSA-75R60226R00026-Consolidated Questions (PDF)

All other terms, clauses, and conditions of the initial Request for Proposal announcement remain entirely unchanged and in full legal force.

Offerors must acknowledge receipt of this

Amendment 0001 by signing and returning the completed SF-30 form within Volume III (Price and

Administrative Proposal) of their final submission packet.

Period of Performance: 09/29/2026 to 09/28/2027

Attachments are hereby incorporated into and made a part of this solicitation:

HRSA-75R60226R00026-Consolidated Questions

Attachment 1c-TO 1 SOW-A1

Attachment 1d-TO Deliverables-A1

Attachment 1e-TO 1 QASP-A1

Attachment 2-Instructions to Offeror-A1

Attachment 2b PPQ-A1

Attachment 2a_Pricing_Template-A1

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