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This document is an appendix containing the Phase II Business Proposal for a federal contract opportunity. It includes the Contract Pricing Proposal, which provides a detailed breakdown of estimated direct labor, fringe benefits, overhead, other direct costs, general and administrative expenses, and fee or profit. The offeror must also provide information on any existing federal contracts, pending proposals, and the level of effort to be dedicated to the proposed contract. Additionally, the offeror must complete certifications regarding its ownership structure and the use of covered telecommunications equipment or services. The related federal contract opportunity is a solicitation issued by the General Services Administration on behalf of the Advanced Research Projects Agency for Health (ARPA-H), seeking Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Phase I and/or Direct to Phase II or Fast Track proposals in support of ARPA-H's FY2024 topic areas. The closing date for questions is July 15, 2024, and the solicitation provides webinar registration information for interested parties.

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47QFCA24R0036_Amend 0004_ARPA-H FY24 SBIR SOLITICATION (1).pdf PDF
SF30_Amendment 0004_47QFCA24R0036_.pdf PDF
APPENDIX C - Phase II Technical Proposal_Amendment 0004.docx DOCX document
APPENDIX B - Phase I Business Proposal_Amendment 0004.docx DOCX document
APPENDIX F - Self Certification Checklist.pdf PDF
APPENDIX D - Phase II Business Proposal_Amendment 0004.docx DOCX document
APPENDIX A - Phase I Technical Proposal_Amendment 0004.docx DOCX document
47QFCA24R0036 Amendment 03 QA.pdf PDF
47QFCA24R0036_Amend 0003_ARPA-H FY24 SBIR SOLITICATION.pdf PDF
SF 30_Amendment 0003_47QFCA24R0036.pdf PDF
47QFCA24R0036_Amend 0002_Solic ARPA-H.pdf PDF
APPENDIX B - Phase I Business Proposal_Amendment 0002.pdf PDF
47QFCA24R0036 Amendment 02_QA.pdf PDF
SF30 - Amendment 0002_47QFCA24R00036.pdf PDF
Standard Form 30 - Amendment 0001 Solicitation_Modification of Contract.pdf PDF
47QFCA24R0036_Amend 0001_Solic_ARPA-H .pdf PDF
47QFCA24R0036 Amendment 0001 QA.pdf PDF
APPENDIX D - Phase II Business Proposal (2).docx DOCX document
APPENDIX A - Phase I Technical Proposal (2).docx DOCX document
APPENDIX E General Clauses.docx DOCX document
APPENDIX C - Phase II Technical Proposal (2).docx DOCX document
ARPA-H FY24 SBIR SOLITICATION 47QFCA24R0036.pdf PDF
APPENDIX A.1 — HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM (4).pdf PDF
APPENDIX A.2 HumanSubjectStudy_3_0-V3.0 Form H 5-23 (3).pdf PDF
APPENDIX B - Phase I Business Proposal (2).docx DOCX document
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APPENDIX D

PHASE II BUSINESS PROPOSAL

AMENDMENT 0002

NAME, ADDRESS, AND TELEPHONE NUMBER OF OFFEROR ORGANIZATION:

SOLICITATION NUMBER:

TOPIC NUMBER:

NOTE: Please complete the required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form per Section 2.2.1 of the solicitation.

The Business Proposal includes the Pricing Proposal and Summary of Related Activities, as well as the following:

Please check the box if the following applies to you and you have included them in the proposal:

1. SBIR Application VCOC Certification, if applicable.

See Section 2.2.5 ☐ Yes ☐ No to determine if this applies to your organization.

2. All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to proposal submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company ☐ Yes ☐ No Registry recommends verification with SAM but a SAM account is not required to complete the registration.

In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site.

The offeror shall provide a statement that it has been registered in GSA ASSIST and that all information in ASSIST is up to date (assist.gsa.gov/assist-web/registration/contractor/search).

Amendment 0002

CONTRACT PRICING PROPOSAL

NAME OF OFFEROR:

GOVERNMENT SOLICITATION NO.:

PAGE NO.: NO. OF PAGES:

TITLE OF PROPOSAL:

HOME OFFICE ADDRESS

LOCATION(S) WHERE WORK IS TO BE PERFORMED: TOTAL AMOUNT OF PROPOSAL: TOPIC NUMBER:

BREAKDOWN OF COST ELEMENTS: Itemize on ‘Continuation Page’ (Page 3 of this Appendix). Refer to the Solicitation Instructions.

1. DIRECT LABOR (Specify)

ESTIMATED

HOURS

RATE/

HOURS EST COST ($)

TOTAL EST

COST REFERENCE

Principal Investigator

TOTAL DIRECT LABOR

2. FRINGE BENEFITS RATE X BASE = EST COST($)

Enter Rate as a decimal (e.g. 0.25 for 25%)

3. OVERHEAD RATE X BASE = EST COST($)

Enter Rate as a decimal (e.g. 0.39 for 39%)

4. OTHER DIRECT COSTS (Itemize all categories and state purpose for all other costs either here or on the following page)

4a. TRAVEL (Include transportation & per diem)

4b. SUBCONTRACTORS/CONSULTANTS (describe below) Identity—Purpose RATE X BASE = EST COST ($) TOTAL

EST COST

TOTAL SUBCONTRACTORS/CONSULTANTS

4.c. EQUIPMENT

4.d. SUPPLIES

4.e. OTHER ( describe )

TOTAL OTHER DIRECT COSTS Sum of Items 4a-4e

5. GENERAL AND ADMINISTRATIVE EXPENSE RATE X BASE = EST COST($)

Enter Rate as a decimal (e.g. 0.11 for 11%)

TOTAL ESTIMATED COSTS (DIRECT + INDIRECT) Sum of Items 1-5

6. FEE OR PROFIT RATE X BASE = EST COST($)

Enter Rate as a decimal (e.g. 0.07 for 7%)

TOTAL ESTIMATED COST AND FEE or PROFIT Sum of Items 1-6

This proposal reflects our best estimates as of this date, in accordance with General Information and Instructions.

TYPED NAME AND TITLE SIGNATURE

NAME OF FIRM EIN DATE OF SUBMISSION

COST EL. NO.

ITEM DESCRIPTION

For Travel : include purpose and location of travel, number of days, number of travelers.

For Subcontracts/Consultants: describe purpose, how selection was made, and how price was determined to be reasonable (e.g., market research, competition, etc.)

For Equipment, Supplies, and Other costs : provide itemized list with quantity and unit prices, indicate planned sources, and state how price was determined to be reasonable (e.g, market research, competitions, etc.)

For Indirect Rates : Attach a copy of Rate Agreement, if available, or describe how indirect rates were derived.

EST COST ($)

I. HAS ANY EXECUTIVE AGENCY OF THE UNITED STATES GOVERNMENT PERFORMED ANY REVIEW OF YOUR ACCOUNTS OR RECORDS IN CONNECTION WITH ANY OTHER GOVERNMENT PRIME CONTRACT OR SUBCONTRACTS WITHIN THE PAST TWELVE

MONTHS?

☐ Yes ☐ No (If yes, identify below)

NAME AND ADDRESS OF REVIEWING OFFICE AND INDIVIDUAL TELEPHONE NUMBER/EXTENSION

II. WILL YOU REQUIRE THE USE OF ANY GOVERNMENT PROPERTY IN THE PERFORMANCE OF THIS PROPOSED CONTRACT?

☐ Yes ☐ No (If yes, identify on Page 3 or on separate page)

III. DO YOU REQUIRE GOVERNMENT CONTRACT FINANCING TO PERFORM THIS PROPOSED CONTRACT?

☐ Yes ☐ No (If yes, identify): ☐ ADVANCED PAYMENTS ☐ PROGRESS PAYMENTS OR ☐ GUARANTEED LOANS

IV. DOES THIS COST SUMMARY CONFORM WITH THE COST PRINCIPLES SET FORTH IN AGENCY REGULATIONS?

☐ Yes ☐ No (If no, explain on following page.)

V. DOES THE ORGANIZATION AND / OR PRINCIPAL INVESTIGATOR(S) HAVE ESSENTIALLY EQUIVALENT WORK (as defined in the solicitation) BEING FUNDED OR PENDING CONSIDERATION FOR FUNDING FROM ANY OTHER FUNDING SOURCE?

☐ Yes ☐ No (If yes, use the following page to provide information)

GENERAL INFORMATION

1. This form provides a standard format for the offeror to submit a summary of estimated costs (and attached supporting information suitable for detailed review and analysis.)

2. Offerors should use indirect rates consistent with their own accounting system, even if different from the rate categories shown on page 1 of this Appendix.

3. The Contracting Officer may request additional supporting information when needed. The offeror may be required to submit a Certificate of Current Cost or Pricing Data prior to the award of a contract.

4. The Government has the right to examine the books, records, documents, and other supporting data to permit adequate verification and evaluation of cost or pricing data submitted, along with the computations and projections used by the offeror. This right may be exercised in connection with any negotiations prior to contract award.

CONTINUATION PAGE: REPLIES TO QUESTIONS II through V above & SPACE FOR ADDITIONAL PRICING

DESCRIPTION

Breakdown for Milestone Payments

Payments will be made for this effort as described in 5.3.

In accordance with the technical proposal “ REPORTS & DELIVERABLES” offerors shall describe end products and deliverables and describe periodic/final reports required to monitor work progress under the contract in a milestone format (i.e. a kick-off, midterm, and final). If the offeror chooses to propose milestones payments based on reports or deliverables,, please provide the proposed milestone payment breakdown below.

Milestone Report/Deliverable Amount

FFP Total

SUMMARY OF RELATED ACTIVITIES

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

a. Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each key individual(s) in this proposal. If an individual has no obligation(s), so state.

Professional’s Name and Title/Position:

Identifying Number Agency Total Effort Committed

b. Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals. If an individual has no obligation(s), so state.

Identifying Number Agency Total Effort Committed

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

Identifying Number Title/Position Total Proposed Effort

NIH & CDC Small Business Innovation Research Program Certification for Applicants That Are Majority-Owned by Multiple Venture Capital Operating

Companies (VCOC), Hedge Fund, or Private Equity Firms

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0001). Do not return the completed form to this address.

Any small businesses that are majority-owned by multiple venture operating companies (VCOCs), hedge funds or private equity firms and are submitting an application for an SBIR funding agreement must complete this certification prior to submitting an application. This includes checking all of the boxes and having an authorized officer of the applicant organization sign and date the certification each time it is requested.

Please read carefully the following certification statements. The Federal government relies on the information to determine whether the business is eligible for a Small Business Innovation Research (SBIR) Program award and meets the specific program requirements during the life of the funding agreement.

The definitions for the terms used in this certification are set forth in the Small Business Act, SBA regulations (13 C.F.R. Part 121), the SBIR Policy Directive and also any statutory and regulatory provisions referenced in those authorities.

If the funding agreement officer believes that the business may not meet certain eligibility requirements at the time of award, they are required to file a size protest with the U.S. Small Business Administration (SBA), who will determine eligibility. At that time, SBA will request further clarification and supporting documentation in order to assist in the verification of any of the information provided as part of a protest.

If the funding agreement officer believes, after award, that the business is not meeting certain funding agreement requirements, the agency may request further clarification and supporting documentation in order to assist in the verification of any of the information provided.

Even if correct information has been included in other materials submitted to the Federal government, any action taken with respect to this certification does not affect the Government’s right to pursue criminal, civil or administrative remedies for incorrect or incomplete information given in the certification.

Each person signing this certification may be prosecuted if they have provided false information.

The undersigned has reviewed, verified and certifies that ( all boxes must be checked ):

1. The applicant is NOT more than 50% owned by a single VCOC, hedge fund or private equity firm.

☐ Yes ☐ No

2. The applicant is more than 50% owned by multiple domestic business concerns that are VCOCs, hedge funds, or private equity firms.

☐ Yes ☐ No

3. I have registered with SBA at www.SBIR.gov as a business that is majority-owned by multiple VCOCs, hedge funds or private equity firms.

☐ Yes ☐ No

☐ I understand that the information submitted may be given to Federal, State and local agencies for determining violations of law and other purposes.

☐ All the statements and information provided in this form and any documents submitted are true, accurate and complete. If assistance was obtained in completing this form and the supporting documentation, I have personally reviewed the information and it is true and accurate. I understand that, in general, these statements are made for the purpose of determining eligibility for an SBIR funding agreement and continuing eligibility.

☐ I understand that the certifications in this document are continuing in nature. Each SBIR funding agreement for which the small business submits an offer or application or receives an award constitutes a restatement and reaffirmation of these certifications.

☐ I understand that I may not misrepresent status as small business to: 1) obtain a contract under the Small Business Act; or 2) obtain any benefit under a provision of Federal law that references the SBIR Program.

☐ I am an officer of the business concern authorized to represent it and sign this certification on its behalf. By signing this certification, I am representing on my own behalf, and on behalf of the SBIR applicant or awardee, that the information provided in this certification, the application, and all other information submitted in connection with this application, is true and correct as of the date of submission. I acknowledge that any intentional or negligent misrepresentation of the information contained in this certification may result in criminal, civil or administrative sanctions, including but not limited to:

(1) fines, restitution and/or imprisonment under 18 U.S.C. §1001;

(2) treble damages and civil penalties under the False Claims Act (31 U.S.C. §3729 et seq.);

(3) double damages and civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C. §3801 et seq.);

(4) civil recovery of award funds,

(5) suspension and/or debarment from all Federal procurement and nonprocurement transactions

(FAR Subpart 9.4 or 2 C.F.R. part 180); and

(6) other administrative penalties including termination of SBIR/STTR awards.

http://www.sbir.gov/

My signature is verification that the statements checked above are true and complete. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties.

Date

Signature

Printed Name (First, Middle, Last)

Title

Organization Name

Please complete FAR Provisions 52.204-24 and 52.204-26. This does not count towards any defined page limits.

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26 , Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3 , Offeror Representations and Certifications-Commercial Products or Commercial Services.

The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26 , or in paragraph (v)(2)(ii) of the provision at 52.212-3 .

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25 , Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub.

L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements;

or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub.

L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service

Amendment 0002 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements;

or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) ( https://www.sam.gov ) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(d) Representation. The Offeror represents that—

(1) It □ will, □ will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation.

The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It □ does, □ does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

https://www.sam.gov/

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided;

and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)

(a) Definitions. As used in this provision, "covered telecommunications equipment or services" and "reasonable inquiry" have the meaning provided in the clause 52.204-25 , Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) ( https://www.sam.gov ) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(c) (1) Representation. The Offeror represents that it □ does, □ does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it □ does, □ does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

(End of provision)

Amendment 0002 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.sam.gov/

File details come from the government source that posted it. Updated .