A23 75N99225R00005 AMD 0002.pdf

(x)

75N99225R00005 x x 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

ARPA-H

Washington, MD 20005 Suite 1200 West 1304 K Street NW NIH Advanced Research Projects Ag

04/07/20250002

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

03/27/2025

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.)

The purpose of this amendment is to:

a. Revise the proposal submission due date to 1:00PM ET on April 18, 2025.

Period of Performance: 07/01/2025 to 06/30/2030

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)

CLARE E. SANCHEZ

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 .

Section L: Instructions, conditions, and notices to offerors or respondents

Addenda to FAR 52.212-1 Instructions to Offerors – Commercial Items Products and Commercial Services

In order to maximize efficiency and ensure fairness during the proposal evaluation process, all Offerors must comply with the instructions in FAR 52.212-1 and this addendum. Offers that do not comply with these instructions may be considered non-compliant with the solicitation terms and ineligible for award.

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition is 541715 Research and Development in the Physical, Engineering, and Life Sciences (Except nanotechnology and biotechnology). To qualify as small for purposes of Government procurement, the CRO, including its affiliates, must be a concern that has no more than 1,000 employees.

(c) Period for acceptance of offers. The period of acceptance shall be changed to 180 calendar days from the date specified for receipt of offers.

(e) Multiple offers. Multiple offers from the same Offeror will not be accepted.

(End of provision)

FAR 52.216-1 Type of Contract. (APR 1984)

The Government contemplates award of a hybrid Firm Fixed Price and Time and Materials contract resulting from this solicitation.

FAR 52.204-29 Federal Acquisition Supply Chain Security Act Orders—Representation and Disclosures. (DEC 2023)

(a) Definitions. As used in this provision, Covered article, FASCSA order, Intelligence community, National security system, Reasonable inquiry, Sensitive compartmented information, Sensitive compartmented information system, and Source have the meaning provided in the clause 52.204-30, Federal Acquisition Supply Chain Security Act Orders— Prohibition.

(b) Prohibition. Contractors are prohibited from providing or using as part of the performance of the contract any covered article, or any products or services produced or provided by a source, if the prohibition is set out in an applicable Federal Acquisition Supply Chain Security Act (FASCSA) order, as described in paragraph (b)(1) of FAR 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition.

(c) Procedures.

https://www.acquisition.gov/far/part-52#FAR_52_204_30

(1) The Offeror shall search for the phrase “FASCSA order” in the System for Award Management (SAM)( https://www.sam.gov) for any covered article, or any products or services produced or provided by a source, if there is an applicable FASCSA order described in paragraph (b)(1) of FAR 52.204-30, Federal Acquisition Supply Chain Security Act Orders— Prohibition.

(2) The Offeror shall review the solicitation for any FASCSA orders that are not in SAM, but are effective and do apply to the solicitation and resultant contract (see FAR 4.2303(c)(2)).

(3) FASCSA orders issued after the date of solicitation do not apply unless added by an amendment to the solicitation.

(d) Representation. By submission of this offer, the offeror represents that it has conducted a reasonable inquiry, and that the offeror does not propose to provide or use in response to this solicitation any covered article, or any products or services produced or provided by a source, if the covered article or the source is prohibited by an applicable FASCSA order in effect on the date the solicitation was issued, except as waived by the solicitation, or as disclosed in paragraph (e).

(e) Disclosures. The purpose for this disclosure is so the Government may decide whether to issue a waiver. For any covered article, or any products or services produced or provided by a source, if the covered article or the source is subject to an applicable FASCSA order, and the Offeror is unable to represent compliance, then the Offeror shall provide the following information as part of the offer:

(1) Name of the product or service provided to the Government;

(2) Name of the covered article or source subject to a FASCSA order;

(3) If applicable, name of the vendor, including the Commercial and Government Entity code and unique entity identifier (if known), that supplied the covered article or the product or service to the Offeror;

(4) Brand;

(5) Model number (original equipment manufacturer number, manufacturer part number, or wholesaler number);

(6) Item description;

(7) Reason why the applicable covered article or the product or service is being provided or used;

(f) Executive agency review of disclosures. The contracting officer will review disclosures provided in paragraph (e) to determine if any waiver may be sought. A contracting https://www.sam.gov/ https://www.acquisition.gov/far/part-4#FAR_4_2303 officer may choose not to pursue a waiver for covered articles or sources otherwise subject to a FASCSA order and may instead make an award to an offeror that does not require a waiver.

FAR 52.233-2 Service of Protest. (SEP 2006)

Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from Clare Sanchez, clare.sanchez@arpa-h.gov.

The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/ https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

Provisions incorporated by reference

FAR

52.204-7 System for Award Management. (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (NOV 2024) 52.204-22 Alternative Line Item Proposal (JAN 2017) 52.212-1 Instructions to Offerors – Commercial Products or Commercial Services (SEP

2023) 52.217-5 Evaluation of Options

(End of Provision)

HHSAR 352.219-70 Mentor-Protégé Program (DEC 2015) https://www.acquisition.gov/ https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

(a) Large business prime contractors serving as mentors in the HHS Mentor-Protégé Program are eligible for HHS subcontracting plan credit, and shall submit a copy of their HHS Office of Small and Disadvantaged Business Utilization (OSDBU)-approved mentor-protégé agreements as part of their offers. The amount of credit provided by the Contracting Officer to a mentor firm for protégé firm developmental assistance costs shall be calculated on a dollar for dollar basis and reported by the mentor firm in the Summary Subcontract Report via the Electronic Subcontracting Reporting System (eSRS) at www.esrs.gov. The mentor firm and protégé firm shall submit to the Contracting Officer a signed joint statement agreeing on the dollar value of the developmental assistance the mentor firm provided. (For example, a mentor firm would report a $10,000 subcontract awarded to a protégé firm and provision of $5,000 of developmental assistance as $15,000 of subcontracting plan credit.) The mentor firm may use this additional credit towards attaining its subcontracting plan participation goal under this contract.

(b) The program consists of -

(1) Mentor firms - large businesses that:

(i) Demonstrate the interest, commitment, and capability to provide developmental assistance to small business protégé firms; and

(ii) Have a Mentor-Protégé agreement approved by HHS' OSDBU;

(2) Protégé firms - firms that:

(i) Seek developmental assistance;

(ii) Qualify as small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, or woman-owned small businesses; and

(iii) Have a Mentor-Protégé agreement approved by HHS' OSDBU; and

(3) Mentor-Protégé agreements - joint agreements, approved by HHS' OSDBU, which detail the specific terms, conditions, and responsibilities of the mentor-protégé relationship.

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (DEC 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document - in detail

- whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://www.hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

HHSAR 352.270-4 Notice to Offerors, Protection of Human Subjects (DEC 2015)

(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) Web site at: http://www.hhs.gov/ohrp/index.html.

These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.101(b)(1)-(6) are exempt from complying with 45 CFR part 46.

See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

(e) In accordance with 45 CFR part 46, offerors considered for award shall file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board shall ensure that: The risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;

selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply;

see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP Web site (at http://www.hhs.gov/ohrp/assurances/index.html).

(f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects.

ONLY the contracting officer may offer information concerning a solicitation.

(g) The offeror shall document in its proposal the approved FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research. If the offeror does not have an approved FWA from OHRP, the offeror must obtain an FWA before the deadline for proposal submission. When possible, the offeror shall also certify the IRB's review and approval of the research. If the offeror cannot obtain this certification by the time of proposal submission they must include an explanation in their proposal. Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research's review and approval by the IRB.

If the offeror does not have an active FWA from OHRP, the offeror shall take all necessary steps to obtain an FWA prior to the deadline for proposal submission. If the offeror cannot obtain an FWA before the proposal submission date, the proposal shall indicate the steps/actions the offeror will take to obtain OHRP approval within 30 days of award. Upon obtaining FWA approval, submit the approval notice to the Contracting Officer.

Instructions to Offerors for Proposal Submission:

ARPA-H will evaluate proposals and make award in accordance with the evaluation criteria set forth in the addenda to FAR 52.212-2. The Offeror must unconditionally accept the terms and conditions of the RFP. Offerors may not redline or condition proposals.

ARPA-H shall not be obligated to pay any cost incurred by the Offeror in the preparation and submission of a proposal in response to the solicitation. The Offeror is advised that the Contracting Officer (CO) is the only person who can legally obligate ARPA-H for the expenditure of public funds in connection with this procurement.

Questions: Offerors are requested to submit questions via email to steven.snyder@arpa-h.gov and clare.sanchez@arpa-h.gov for this solicitation no later than 1:00 PM EDT on April 3, 2025. Responses to all questions will be in the form of an amendment to this solicitation and sent electronically to all Offerors.

Proposal Due Date: Offers shall be submitted via the email to Steven Snyder (steven.snyder@arpa-h.gov) and Clare Sanchez (clare.sanchez@arpa-h.gov) before the due date and time in this solicitation. Text and graphics portions of the electronic proposals shall be in a format readable by Adobe PDF and/or Microsoft (MS) Office. Proposals that are not received by the date and time specified will be considered “late” and may not be considered for award.

(i) Failure to provide all required documentation with the required information may be considered nonresponsive and no longer considered for award.

(ii) Proposal shall be submitted no later than 1:00 PM EDT on April 18, 2025.

Volumes, Page Limits, and Format : Proposals shall consist of an administrative response and five (5) volumes as outlined in the table below:

Volume Factor/Description Page Limit

Administrative

Completed SF 1449 1 Page Section K - Representations, Certifications, and other Statements of Offerors

No Page Limit

Teammate overview/executive summary

2 Page Limit

OCI Statement No Page Limit mailto:steven.snyder@arpa-h.gov mailto:steven.snyder@arpa-h.gov mailto:clare.sanchez@arpa-h.gov mailto:clare.sanchez@arpa-h.gov

Data Rights Certification 1 Page Limit

I – Past Performance Factor A: Past Performance 2 Pages Each Contract; 6 Pages Total

II – Assay Testing Factor B: Assay Testing Assay Testing Verification Worksheet (Attachment 2)

III – Narrative Responses Factor C: Narrative Responses 10 Pages Per Question;

20 Pages Total

IV - Price Factor D: Pricing Template Excel Sheet Pricing Template (Attachment 1)

V – Subcontracting Plan Subcontracting Plan (Not required for Small Businesses)

Unlimited; HHS Subcontracting Plan Template (Attachment 3)

The following format instructions apply to all except Volume IV- Price. Text shall be easily readable (e.g., single spaced, with minimum one-inch margin, able to be printed on 8 ½ x 11-inch paper, minimum of 12-point size font, any readable font type). All pages shall be numbered consecutively. Pages submitted in excess of the page limitations stated above will not be included in evaluations. Page limits do not include cover pages, tables of content, glossaries, acronym lists, list of figures, blank pages for separation. However, page limits are hard maximums. Fonts larger than 12-point are acceptable for placing emphasis and designating headings. Table fonts, diagrams, images, screenshots, photographs, figures etc.

may be smaller or larger than 12-point but must be easily readable. Do not use compressed fonts or compressed line spacing. Each volume should include a table of contents. Identify each page header or footer with the volume number, page number, and solicitation number.

Incorporate a volume cover page that includes the volume number, solicitation number, solicitation title, company and/or team name, UEI, CAGE code, and the name/phone number/email address of the contract manager or other agent authorized to obligate your organization/team and alternate.

The proposal shall be clear, concise, and include sufficient detail for effective evaluation. The proposal shall not simply rephrase or restate the Government's requirements. Rather, it shall provide convincing rationale to address how the Offeror intends to meet the performance requirements. Reference 52.212-2 Addendum. Offerors shall assume that the Government has no prior knowledge of their experience and will base its evaluation solely on the information presented in the Offeror's proposal within each individual volume.

All price information shall be in files separate from the non-price factors.

Administrative Responses:

(i) Completed SF1449:

(ii) Section K: Offerors will complete representations, certifications, acknowledgments, and statements via System for Award Management (SAM). Offerors shall include their SAM FAR certifications and representations as part of their submission. Any additional Section K information not obtained in SAM.gov shall also be included in the proposal.

(iii) Teammate Overview: Offerors will provide no more than a two-page teammate overview/executive summary. The summary shall also include a list of all prime teaming and subcontractors with cage code, indication of large or small business, and anticipated percentage of work each subcontractor is anticipated to perform based on dollars.

(iv) Organizational Conflict of Interest (OCI) Statement: Offeror shall include a statement regarding the applicability of an OCI Analysis. If an Offeror determines that an actual or potential OCI does not currently exist, a statement to that effect as part of the proposal shall be included in the submittal and are not required to submit a mitigation plan. If an Offeror determines that an actual or potential OCI may currently exist or potentially exist as a result of this award, provide a complete OCI analysis, which will be considered by the Contracting Officer for responsibility. See below for details. This OCI Analysis does not count toward page limitations.

(A) Identify any current OCI that will or may occur as a result of this award, within ARPA-H and include a detailed mitigation plan. Conflicts must be described in adequate detail for the Contracting Officer to determine if an actual or potential conflict exists and if it has been adequately mitigated (e.g., provide contract numbers of contracts that will continue to be supported, contracts that will be terminated, or contracts that will be lapsed to terminate any conflicts, if any). Include an OCI mitigation plan that addresses how the potential OCI will be handled and mitigated on this award and future task order awards.

(B) Failure to provide adequate information on an Offeror’s avoidance or mitigation will result in the proposal being rejected and relieves the Government of any further responsibility to resolve OCI issues. See FAR 9.504(e). Notices to Offerors of OCIs and their responses thereto are not negotiations or discussion as those terms are used in FAR 15.306(d).

(v) Data Rights: Offeror shall compile a statement verifying understanding the data rights of this requirement.

Volume I: Factor A: Past Performance – All Offerors shall submit Past Performance Summaries according the to instructions below:

(i) The Offeror shall provide a summary of their performance in this Past Performance Summaries section. The Offeror shall submit past performance contract summaries for up to three (3) contracts. For the required relevant contracts, Offerors shall only submit Relevant Project Summaries from efforts where they performed as a Prime (i.e., the Offeror must have performed as the Prime Contractor, not of Offerors proposed subcontractor(s)). Each contract summary must pertain to one of the contracts that the Offeror referenced under Factor A (Past Performance). The Government will not evaluate any additional contract summaries beyond the maximum of three (3) nor will it evaluate any contract summary that pertains to a contract other than one referenced under Factor A.

(ii) Relevant Project Summaries: For the three (3) relevant contracts or projects selected, the Offeror shall summarize the following information, not to exceed two (2) pages for each contract or project:

• Identify the contract number and/or task order number (if applicable) with the Federal Government and period of performance (including month/year), for the project.

• Identify the Government customer, and provide the name, title/ role, phone number, e-mail address of a customer point of contact (POC) that is knowledgeable of the Offeror’s performance on the contract or project.

• Describe the nature of the contract or project and the specific tasks in the Statement of Work performed by the Offeror. Please provide references back to the Statement of Work.

• Describe the relevance to this requirement.

• Describe cost, schedule, and performance (include explanations for any cost and/or time growth experienced (if applicable).

Volume II: Factor B: Assay Testing Verification - The contractor shall complete Attachment 2 utilizing the requirements in PWS 5.5.2. Please list all assays that you will perform. Offeror’s may not change the format including additional columns or information not originally requested. Only rows may be added to reflect proposed assay testing and laboratories.

Offerors shall submit a copy of the licensure documentation if submitting “yes” under column CLIA-certified lab.

Volume III: Factor C: Narrative Responses - The Offeror shall submit responses to two (2) scenario response questions. The responses should answer all parts of the questions.

(i) For the ADAPT program, ADAPT TA2 performer clinical trial sites will collect patient clinical and research data before, during and after multiple contiguous treatments. How will the Offeror manage serial ADAPT data, including A) data from electronic health records (including unstructured text and imaging data) across a diversity of clinical trial sites, and B) data from tissue and blood sample test assays described in detail per PWS Section 5.5.2? The response shall include, at a minimum, a visual aid demonstrating the timeline and workflow with an accompanying narrative to detail test data collection, harmonization/processing and transfer of data as outlined in PWS Section 5.5.2 and 5.5.3.

(ii) Describe how the current regulatory status of the proposed test platforms and the Offeror’s strategic approach to support regulatory approval will minimize schedule and risks for achieving a IVD test incorporating the biomarkers developed by ADAPT performers that would be broadly available to patients.

Volume IV: Factor D: Price - The Offeror shall fill in the Attachment 1 Price Template with the proposed Firm Fixed Price Labor, Clinical Trial Site Identification, Clinical and Molecular Data, and Time & Materials Laboratory Sequencing Tests. All proposed test categories shall have rates, on a per test basis, included in the price template under tab “Sequence Testing Schedule”. Please include all assays that you will perform. Rates may be negotiated during interchanges. Offerors shall include a Price Narrative supporting the FFP and T&M pricing.

Offeror’s may not change the format including additional columns or information not originally requested. Only rows may be added to reflect proposed staff and assay testing.

Volume V: Small Business Subcontracting Plan - In accordance with FAR Subpart 19.7, and FAR 52.219-9, a Small Business Subcontracting Plan is required of all Offerors, unless the Prime Contractor is a small business. The Small Business Subcontracting Plan shall be submitted with the Offeror’s proposal submission. The Small Business Subcontracting Plan of the successful Offeror(s) will be reviewed and approved by the CO prior to contract award.

See FAR 19.702(a)(1) Statutory Requirements, regarding failure of the apparent successful Offeror to negotiate and submit a Small Business Subcontracting Plan acceptable to the CO.

The successful Offeror’s approved Subcontracting Plan will be incorporated into the resultant contract. The Offeror shall complete and submit the Attachment 3 HHS Subcontracting Plan Template, including all 15 elements.