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This document contains a solicitation for Small Business Innovation Research (SBIR) contract proposals from the Advanced Research Project Agency for Health (ARPA-H). ARPA-H is seeking proposals for research and development of innovative health technologies that have the potential for patient impact. Proposals are due by February 28, 2023 and must follow the formatting requirements and provide the information requested in Appendices A through G, including technical details of the proposed project, pricing, and the qualifications of the principal investigators. Awards will be made as fixed-price SBIR contracts. The National Institutes of Health and National Institute of Allergy and Infectious Diseases will administer any resulting contracts. Eligible applicants are domestic small businesses as defined by the Small Business Act and SBA regulations.

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Solicitation 75N91023R00041 Amendment #3 – Solicitation Question and Responses

APPENDIX B

PHASE I BUSINESS PROPOSAL

NAME, ADDRESS, AND TELEPHONE NUMBER OF OFFEROR ORGANIZATION:

SOLICITATION NUMBER:

TOPIC NUMBER:

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 APPENDIX E – PROPOSAL FUNDAMENTALS ☐ Yes ☐ No to determine if this applies to your organization.

2. Proof of SBA Company Registry SBA Company Registry ☐ 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.

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

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 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). 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.

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

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