RFP-75N95025R00013.pdf

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Pathology Monitoring of Aged Rodent Colonies
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RFP-75N95025R00013
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This document is a Request for Proposals (RFP) for an Indefinite Quantity Contract to provide pathology monitoring services for aged rodent colonies on behalf of the National Institutes of Health National Institute on Drug Abuse. The Contractor will be required to furnish all necessary personnel, material, equipment, and services to perform independent surveillance of the health status of rodents maintained in contractor facilities, including gross pathology, histopathology, microbiology, parasitology, and serology. The ordering period is from March 1, 2025 through February 28, 2030, with a minimum contract value of $50,000 and a maximum of $1,500,000. Proposals are due by 4:00 PM local time on December 18, 2024. The RFP includes specific reporting requirements and deliverables, as well as references to applicable FAR clauses and HHS-specific contract terms and conditions.

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- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 99-158 as amended

2. Request for Proposal (RFP) Number:

RFP-75N95025R00013

3. Issue Date:

11/19/2024

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Pathology Monitoring of Aged Rodent Colonies

6. ISSUED BY:

Office of Acquisitions National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

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 4:00 P.M. local time on December 18, 2024. 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) at the time of proposal submission and prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov.

11. FOR INFORMATION CALL: Eric McKay

PHONE: 301-480-2406

e-MAIL: eric.mckay@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

All questions pertaining to this RFP must be submitted via e-mail to eric.mckay@nih.gov, no later than November 26, 2024.

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. PRICES/COSTS

4. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications

1. REPORTING REQUIREMENTS

SECTION D - Packaging and Marking

SECTION E - Inspection and Acceptance

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

3. FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. METHOD OF ORDERING

3. INVOICE SUBMISSION

4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

5. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023) .. 12

6. HHSAR 352.237-75 Key Personnel. (DEC 2015)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. ACKNOWLEDGEMENT OF FEDERAL FUNDING

3. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

4. ANIMAL WELFARE

5. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

6. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

7. GUN CONTROL

8. SUBCONTRACTING PROVISIONS

9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

10. HHSAR 352.239-78 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE, (March 2024) (DEVIATION)

11. HHSAR 352.239-79 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY, HHSAR (March 2024) (DEVIATION)………………………………………………………………………………………………………………18

12. HHSAR 352.270-5 a Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. (DEC 2015)

SECTION I - Contract Clauses

SECTION J - List of Documents, Exhibits and Other Attachments

SECTION K - Representations, Certifications, and Other Statements of Bidders

SECTION L - Instructions,Conditions, and Notices to Bidders

SECTION M - Evaluation Factors for Award

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/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide all the necessary services, qualified personnel, material, equipment, and services (except for those to be furnished by the Government as specified elsewhere in this contract) to perform the work required by this contract.

The Contractor shall provide an independent surveillance of the health status of rodents maintained in contractor facilities for the aged rodent colonies. The evaluation to be performed will include gross pathology, histopathology, microbiology, parasitology and serology2. PRICES/COSTS

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

3. PRICES/COSTS

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 $ 50,000.00 (minimum) nor more than a total of $ 1,500,000.00 (maximum) for successful performance of this contract.

b. The prices set forth in this ARTICLE will cover the contract period 3/1/2025 through 2/28/2030 .

c. The Government will issue Task Orders based on the work described in SECTION C of this contract and the following schedule. Upon delivery and acceptance of the item(s) described in each Task Order, the Government shall pay to the Contractor the [unit price(s)/costs] set forth below:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Description of Item Unit Price(or Cost) / Unit Mice - Basic Profile Mice - Comprehensive Profile RAT - Basic Profile RAT - Comprehensive Profile

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.

SECTION C - Description/Specifications

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 July 2024, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

1. 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) hard copies of these reports will be required as follows:

[ X ] Pathology

[ X ] Annually

[ X ] Final - Upon completion of the contract

1. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

SECTION D - Packaging and Marking

A. 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.

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, The Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

NIH/NIA

Bethesda, MD 20892

1. Inspect by Individual

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

2. This contract incorporates the following clause 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.

2. FAR 52.246-4 Inspection of Services - Fixed-Price. (AUG 1996)

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

The ordering period of this contract shall be from March 1, 2025 through February 28, 2030.

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 [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Quantity Delivery Schedule

(1) Pathology Report 1 Within sixty (60) calendar days of each animal shipment

(2) Annual Report 2 Within ninety (90) calendar days of the completion of each contract year

(3) Final Report 2 On or before contract expiration

(4) Summary of Salient Results 2 On or before contract expiration

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

Addressee Deliverable Item No Format Contracting Officer's Representative 1 - 4 Electronic by e-mail

Contracting Officer 2 - 4 Electronic by e-mail

3. FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far

(End of clause)

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.

SECTION G - Contract Administration Data

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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

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.

2. METHOD OF ORDERING

a. Orders issued under this contract may be placed as follows:

[X] in writing

[X] via electronic mail (e-mail)

b. The Contracting Officer is authorized to issue orders and provide written confirmation of oral orders, if applicable, under the contract.

a. The Contractor must 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.

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- To be specified prior to award Email Address- To be specified prior to award

Contracting Officer Representative

Name- To be specified prior to award Email Address- To be specified prior to award

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.

1. 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:

c. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA/NIA Contracts Management Branch Blue.

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.

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:

Pathology Monitoring of Aged Rodent Colonies

g. Contract Line Items as follows:

Line Item # Line Item Description As specified in the task order award

2. Inquiries regarding payment of invoices shall be directed to the designated billing office,

(301) 496-6088 .

3. INVOICE SUBMISSION

1. 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.

a. The Contractor must 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.

b. 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 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.

4. 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 on the completion of each contract year.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty 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.

a. 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.

End of clause.

5. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(MAR 2023)

(a)(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after 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.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the 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, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause)

6. HHSAR 352.237-75 Key Personnel. (DEC 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.

SECTION H - Special Contract Requirements

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.

2. 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.

3. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

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

4. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: https://olaw.nih.gov/policies-laws/phs-policy.htm .

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated TBD , which is incorporated by reference.

5. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

No rodent or rodent product shall be delivered into the NIH, NIA environment (NIH) directly, or through collaborative research or holding facilities under contract to NIA except by permit. Direct shipments to NIH from a Division of Veterinary Resources (DVR), Office of Research Services (ORS) approved source will be considered exempt. Non-exempt sources must be approved by permit issued through the DVR, ORS. The permit must be obtained by the Contractor prior to the shipment to NIH of the rodents and/or rodent products. The Contractor must be sure that this permit exists and is current before transferring rodents or rodent products into the NIH, NIA environment. Refusal or negligence to do so will be considered a material breach of contract and may be treated as any other such material breach. Applications for permits should be submitted by facsimile not less than 30 days prior (60 days in situations where quarantine is likely) to shipping date to: NIH Division of Veterinary Resources (DVR), Office of Research Services (ORS), Building 14G, Service Rd. South, Room 102, BETHESDA MD 20892-

5210, (301)496-2527, FAX: (301) 402-0352.

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.

7. GUN CONTROL

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

8. 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.

2. The official point of receipt for determining timely submission of an offeror's subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

3. If an offeror's subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late in accordance with subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offeror-Competition Acquisition. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday - Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and a representative will respond within the presented client support hours of operation for assistance.

5. Individual Subcontract Reports ( ISR)

The Contractor must submit the following Subcontracting reports electronically via the Subcontracting Reporting System (eSRS) at https://www.esrs.gov/.

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

6. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report must be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer must be included as a contact for notification purposes at the following e- mail address:

To be specified prior to award Contracting Officer

9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-line is:

https://oig.hhs.gov/fraud/report-fraud/ and the mailing address is:

US Department of Health and Human Services Office of Inspector General

ATTN: OIG HOTLINE OPERATIONS

P.O. Box 23489 Washington, D.C. 20026

10. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE,

HHSAR 352.239-78 (March 2024) (DEVIATION).

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions.

The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an 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, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT 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 at https://Section508.gov/.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/

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

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an 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.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria.

Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(End of provision).

11. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY, HHSAR

352.239-79 (March 2024) (DEVIATION).

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic

Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause).

12. HHSAR 352.270-5 a Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. (DEC 2015)

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities, and procedures. Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (Email: olaw@od.nih.gov; Phone: 301-496-7163).

(End of provision)

PART II - CONTRACT CLAUSES

SECTION I - Contract Clauses

This solicitation incorporates the following clauses 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.

Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at:

https://www.acquisition.gov/ . HHSAR Clauses at: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html .

1. FAR 52.202-1 Definitions. (JUN 2020)

2. FAR 52.203-3 Gratuities. (APR 1984)

3. FAR 52.203-5 Covenant Against Contingent Fees. (MAY 2014)

4. FAR 52.203-6 Restrictions on Subcontractor Sales to the Government. (JUN 2020)

5. FAR 52.203-7 Anti-Kickback Procedures. (JUN 2020)

6. FAR 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity. (MAY 2014)

7. FAR 52.203-10 Price or Fee Adjustment for Illegal or Improper Activity. (MAY 2014)

8. FAR 52.203-12 Limitation on Payments to Influence Certain Federal Transactions.

(JUN 2020)

9. FAR 52.203-17 Contractor Employee Whistleblower Rights. (NOV 2023)

10. FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. (JAN 2017)

11. FAR 52.204-7 System for Award Management. (OCT 2018)

12. FAR 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards. (JUN 2020)

13. FAR 52.204-13 System for Award Management Maintenance. (OCT 2018) https://www.acquisition.gov/ https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

14. FAR 52.204-19 Incorporation by Reference of Representations and Certifications.

(DEC 2014)

15. FAR 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities. (DEC 2023)

16. 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 and 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 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) Representations. 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);

(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…

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