75N93022R00037 - Amendment No. 2.pdf

sIRB RFP 75N93022R00037 Page 1 of 5 Amendment 2

AMENDMENT OF SOLICITATION

Solicitation Number: 75N93022R00037 Amendment Number: 2

AMENDMENT TWO (2)

Issued by: National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisitions 5601 Fishers Lane Rockville, MD 20852

Solicitation Number:

Date of Solicitation Issuance:

Date of Amendment No.2 Issuance:

Number of Pages:

NIAID Point of Contact:

75N93022R00037

May 4, 2023

July 27, 2023

5 Pages-Amendment 2; 99 Pages-Solicitation

PRIMARY:

Mary Smith, Contract Specialist Email: mary.smith@nih.gov Phone: (240) 627-3377

Offerors MUST acknowledge receipt of this Amendment, by Amendment number(s) and date of the Amendment.

FAILURE TO ACKNOWLEDGE THIS AMENDMENT WITHIN YOUR PROPOSAL MAY

RESULT IN REJECTION OF YOUR OFFER.

Except as provided herein, all terms and conditions of solicitation 75N93022R00037 remain unchanged and in full force and effect.

Purpose of Solicitation Amendment:

The purpose of Amendment No. 2 is to 1) extend the proposal submission deadline to August 25, 2023, 2) extend the deadline for receipt of questions to August 4, 2023, and 3) to provide clarifications to the solicitation.

ALL OTHER TERMS AND CONDITIONS OF THE SOLICITATION REMAIN

UNCHANGED.

mailto:mary.smith@nih.gov sIRB RFP 75N93022R00037 Page 2 of 5

I. The proposal submission deadline is extended to Friday, August 25, 2023.

Solicitation cover page change:

8. Proposals for furnishing the supplies and/or services stated in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, “Packaging and Delivery of the Proposal,” until 3:00 PM local time on Friday, August 25, 2023.

Offers will be valid for 120 days, unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

II. The deadline for receipt of questions is extended to Friday, August 4, 2023.

Solicitation cover page changes:

Deadline for Receipt of Questions: Friday, August 4, 2023 When submitting questions, the solicitation number must be included in the subject line. Send all questions to Mary Smith, mary.smith@nih.gov, with a copy to Greg Durham, greg.durham@nih.gov.

III. Clarifications Clarifications on the following are included below:

1) Proposal Submission

2) Technical Proposal Contents

3) Business Proposal Contents

4) Technical Requirements

Except as they incorporate the amended terms set forth in Sections I and II above, clarifications set forth in Section III of this Amendment Number 2 do not modify Solicitation Number:

75N93022R00037 issued May 4, 2023, in any way. For complete information regarding the solicitation, all offerors should refer to Solicitation Number: 75N93022R00037 in its entirety.

1) Proposal Submission:

a. Proposals must be submitted via eCPS at https://ecps.nih.gov, per the instructions in

Attachment 1, Packaging and Delivery of the Proposal, by 3:00 PM local time on Friday, August 25, 2023.

b. Proposals submitted by facsimile or e-mail will not be accepted.

c. Offerors that have previously submitted a proposal via the electronic Contract Proposal

Submission (eCPS) website may revise and resubmit their proposals via eCPS at https://ecps.nih.gov, per the instructions in Attachment 1, Packaging and Delivery of the Proposal, and clarifications provided in Amendment No. 2, by 3:00 PM local time on Friday, August 25, 2023.

d. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto.

mailto:mary.smith@nih.gov mailto:greg.durham@nih.gov https://ecps.nih.gov/ https://ecps.nih.gov/ https://ecps.nih.gov/home/howto sIRB RFP 75N93022R00037 Page 3 of 5

i. The Technical Proposal, must be comprised of the following:

Required: A single PDF of your Technical Proposal, including all attachments and/or appendices as required by the solicitation, see additional clarifications below.

The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the single Technical PDF file. Do NOT password-protect or encrypt the PDF file.

ii. The Business Proposal must be comprised of the following:

1. Required: A single PDF of your Business Proposal, including all attachments and/or appendices as required by the solicitation, see additional clarifications below. The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the single Business Proposal PDF file. Do NOT password-protect or encrypt the PDF file.

2. Required Excel Files:

a. Two Excel Budget Cost breakdowns as required by the solicitation (one each for Task Area A and Task Area B Sample Task Orders), in their original Excel format, not the PDF format. The budgets (cost breakdowns) in excel must be identical to the ones in the Business Proposal PDF.

b. A fixed-price per unit cost fee schedule for all services as required by the solicitation, in its original Excel format, not the PDF format. The fixed-price per unit cost fee schedule in excel must be identical to the one in the Business Proposal PDF.

e. Once a proposal has been uploaded and submitted, it can only be revised by overwriting previously uploaded documents. You can find submissions to revise or view under My Submission History. You have up until the closing date and time of the solicitation as amended, 3:00 PM local time on Friday, August 25, 2023, to make as many revisions as needed.

f. When a revised proposal is submitted in eCPS, the prior proposal submitted is overwritten.

g. A proposal cannot be deleted once it is uploaded. It can, however, be revised up to the closing date and time, 3:00 PM local time on Friday, August 25, 2023. For example, if you decide that of the two proposals you uploaded, Business Proposal and Technical Proposal, that the Business Proposal was unsatisfactory, you can upload a revised version of the Business Proposal up to the closing date and time.

h. For technical questions about eCPS, contact eCPSAdministrator@niaid.nih.gov.

i. For Frequently Asked Questions about eCPS, see https://ecps.nih.gov/faq.

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2) Technical Proposal Contents:

a. See Section L.2.c., Technical Proposal Instructions, of the solicitation for further instructions.

b. See Attachment 7, Additional Technical Proposal Instructions, Format for Technical

Proposal, and Table of Contents for additional instructions and requirements specific to the solicitation as well as the below elements that must be addressed in the technical proposal:

Section 1 – Title Page and Table of Contents The following must be addressed within the 7-page limit:

Section 2 – Technical Proposal Overview Section 3 – Technical Plan/Approach for Task Area B: Single IRB Review Service Section 4 – Scientific and Technical Personnel Section 5 – Facilities, Equipment, and Other Resources Section 6 – Project Management Section 7 – Other Considerations

c. See Formatting and Page Limitations in Attachment 1, Packaging and Delivery of the Proposal, of the solicitation for further detail on formatting requirements and page limitations for the technical proposal (7 pages) and CVs (2-3 pages).

i. Pages exceeding limitations will be removed from the proposal and will not be considered.

ii. Failure to adhere to the formatting requirements may impact whether your proposal is reviewed in its entirety.

3) Business Proposal Contents:

a. See Section L.2.c., Business Proposal Instructions, for further detail on the following elements of the Business Proposal that must be addressed as applicable:

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Data Other than Certified Cost or Pricing Data

4. Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor-Protégé Program

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

15. Certification of Visas for Non-U.S. Citizens

b. See Attachment 8, Additional Business Proposal Instructions and Uniform Cost Assumptions, for uniform cost assumptions and business clarifications specific to the solicitation.

sIRB RFP 75N93022R00037 Page 5 of 5

i. Note: the contents of the business proposal should follow the same general order of the business proposal elements listed in items 1 – 15, bullet 3) a., above.

ii. The two Excel Cost breakdown(s) as required by the solicitation (one each for Task Area A and Task Area B Sample Task Orders)

iii. As requested in Section 3, Uniform Cost Assumptions of the Attachment 8, Additional Business Proposal Instructions, the Offeror shall provide:

a. A fixed-price per unit cost budget for each Sample Task Order – i.e., one Excel budget for Task Area A costs, and one Excel budget for Task Area B costs.

b. A fixed-price per unit cost fee schedule for all services as required by the solicitation – i.e., a fee schedule (this should be included within the PDF Business Proposal, as well as in a separate Excel file.

4) Technical Requirements:

a. Offerors must demonstrate AAHRPP accreditation by providing the following information:

a. Date of initial accreditation

b. Accreditation type

c. Accreditation status

b. As requested in Section 5, Facilities, Equipment, and Other Resources of Attachment 7, Additional Technical Proposal Instructions, the Offeror shall provide confirmation of AAHRPP accreditation, IRB registration, and FWA.

End of Amendment 2

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: FAR 1.602-1

2. Request for Proposal (RFP) Number: 75N93022R00037

3. Issue Date:

May 4, 2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Single Institutional Review Board (sIRB)

6. ISSUED BY:

Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health, DHHS 5601 Fishers Lane Rockville, MD 20892

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 PM local time on Friday, August 25, 2023. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Mary Smith, Contract Specialist

PHONE: (240) 627-3377

e-MAIL: Mary.Smith@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Deadline for Receipt of Questions: Friday, August 4, 2023

When submitting questions, the solicitation number must be included in the subject line. Send all questions to Mary Smith, mary.smith@nih.gov, with a copy to Greg Durham, greg.durham@nih.gov.

Mary Smith, Contract Specialist Shane Ryan, Contracting Officer National Institute of Allergy and Infectious Diseases Office of Acquisitions https://www.sam.gov/SAM/ smithm7 Highlight smithm7 Highlight smithm7 Highlight smithm7 Highlight smithm7 Highlight

RFP Number : 75N93022R00037

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Institutional Responsibility Regarding Investigator Conflicts of Interest

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11. ROTC Access and Federal Military Recruiting on Campus

12. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

13. Past Performance Information

14. Prohibition on Contractor Involvement with Terrorist Activities

15. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

15. Certification of Visas for Non-U.S. Citizens

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and Department of Health and Human Services (DHHS), supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. NIAID has a mandate to respond rapidly to new and emerging infectious disease public health threats and is required by NIH Policy to use a single institutional review board (sIRB) for multi-site, non-exempt human subjects research using the same research protocol.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $10,000 (minimum) nor more than a total of $13,999,465 (maximum) for successful performance of this contract.

b. The prices set forth in this ARTICLE will cover the contract period TBD through TBD.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

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ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

The below Advance Understandings are applicable to this solicitation.

a. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022).

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ''Content of Invoices'' and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at https:// www.ipp.gov/ or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause).

b. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/ data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

https://www.ipp.gov/ https://www.ipp.gov/

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated April 17, 2023, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at: https://www.section508.gov/create/documents, "Create Accessible Documents."

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 0 hard copies of these reports will be required as follows:

[X] Monthly [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part

94. 45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.ecfr.gov/current/title-45/part-94

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(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/ default/files/web/508/contracting/technology/section_508_annual_report.doc.

REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website:

https://erds.niaid.nih.gov/. All electronic reports submitted must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section-508/index.html and at: https:// www.section508.gov/create/documents, "Create Accessible Documents."

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://erds.niaid.nih.gov/ https://www.hhs.gov/web/section-508/index.html

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

DHHS, National Institutes of Health National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases (DMID) 5601 Fishers Lane Rockville, MD 20852

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

FAR Clause 52.246-16, Responsibility for Supplies (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from TBD through TBD.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule (1) (2) (3)

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998).

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

Alternate I (April 1984) is not applicable to this contract.

52.242-17, Government Delay of Work (April 1984).

52.211-11, Liquidated Damages--Supplies, Services or Research and Development (September 2000).

"(a) If the Contractor fails to deliver the supplies or perform the services within the time specified in this contract, the Contractor shall, in place of actual damages, pay to the Government liquidated damages of $ per calendar day of delay."

https://www.acquisition.gov/?q=browsefar

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

To be specified prior to award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause).

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

To be specified prior to award

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained in this contract shall be incorporated in the TORFP and the resultant task order. If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

c. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor.

ARTICLE G.4. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor shall submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

2. Until the Contract has transitioned to IPP as specified on the OALM IPP website, the Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH https://www.ipp.gov

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Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice submitted to the NIH/OFM must be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

3. The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name – TBD Email Address - ____________

Official: Contracting Officer Representative

Name – TBD Email Address - ____________

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m.

to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

4. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Institute for Allergy and Infectious Diseases.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is:

Single Institutional Review Board (sIRB)

g. Contract Line Items as follow:

Line Item # Line Item Description

TBD TBD

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Nov 2021).

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of clause).

ARTICLE G.6. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer Representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

https://www.cpars.gov https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. CORONAVIRUS DISEASE 2019 (COVID-19) - HHS RECOVERY EFFORTS

“HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.”

ARTICLE H.3. CORONAVIRUS DISEASE 2019 (COVID - 19) - ONSITE CONTRACTORS

RETURN TO PHYSICAL WORKSPACE

Coronavirus disease 2019 (COVID-19) - NIH policy may allow for voluntary or mandatory COVID-19 testing for contractor personnel. Contractor personnel who test positive for COVID-19 or who do not wish to submit to mandatory COVID-19 testing will not have access to or be permitted to work in NIH [ICs] until they have satisfied the access requirements in the NIH policy. A contractor personnel's decision to opt out of mandatory COVID-19 testing will not automatically constitute grounds for any performance delays or establish any government liability for additional costs.

The Contracting Officer may determine that an excusable delay is appropriate under applicable FAR clauses (e.g., 52.242-14 (Suspension of Work), 52.242-15 (Stop-work Order), 52.249-14 (Excusable Delays), and 52.212-4(f) (Excusable Delays)) in cases where a positive test result is recorded and contract personnel must be quarantined due to an exposure to COVID-19. However, cases where a positive test result is recorded will not establish any government liability for additional costs.

Contractors shall ensure compliance with all Federal, HHS, NIH and individual IC COVID-19 policies related to health and safety, including relevant Codes of Conduct and reporting requirements applicable to contractor personnel. The Contractor shall discuss the Code of Conduct with contractor personnel, retain signed Codes of Conduct, and confirm their signature with the Contracting Officer. Reporting requirements include: 1) Ensure open reporting of safety and health related concerns; 2) Ensure staff understand reporting of COVID-like symptoms to contract supervisors, if they have had a high-risk exposure to someone with COVID disease, or if they have tested positive for COVID-19, and that staff do not report to the workplace with symptoms or if they have tested positive for COVID-19; 3) Ensure staff are complying with the return to work plans, policies and reporting requirements and enforcing these requirements when necessary; and 4) Ensure contract supervisors inform the Contracting Officer of personnel with COVID-19 symptoms.

The Return-to-Work Guidance and Code of Conduct for On-Site Contractors (Appendix 1) are incorporated into this contract. Contractors shall ensure contract personnel are aware they are to contact their company/supervisor for guidance.

Testing conducted by the NIH Occupational Medical Service (OMS) falls within Privacy Act System of Records Notice (SORN), 09-25-0105, Administration: Health Records of Employees, Visiting Scientists and Others Who Receive Medical Care through Employees Health Unit, HHS/NIH/ORS.

Information regarding the Countermeasures Injury Compensation Program under the Health Resources and Services Administration is available at 1-855-266-2427 or http://www.hrsa.gov/cicp/.

(If your IC is not doing testing through CC OMS, the IC would they have to identify another SORN and incorporate prior to beginning any testing) http://www.hrsa.gov/cicp/

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ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.6. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE H.7. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.8. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract.

Pursuant to FAR Clause 52.217-6, Option for Increased Quantity, FAR Clause 52.217-7, Option for Increased Quantity – Separately Priced Line Item; FAR Clause 52.217-8, Option to Extend Services; and/or FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 30 days prior to the expiration date of this contract, and the estimated cost of the contract will be increased as set forth in the ESTIMATED COST Article in SECTION B of this contract.

ARTICLE H.9. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror( s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and cost proposals. An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled " Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, " Liquidated Damages- Subcontracting Plan."

b. Subcontracting Reports

1. An offeror is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https:// osdbu.hhs.gov. The offeror shall follow the instructions outlined in the SBCX Industry Guide at: https:// oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan by the proposal submission deadline.

https://osdbu.hhs.gov https://osdbu.hhs.gov https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

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2. The official point of receipt for determining timely submission of an offeror's…