RFP No. 75N95023R00071.pdf

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Investigating the effects of novel medications for alcohol and substance use disorders in improving HIV-related outcomes and providing health benefits in people living with HIV

(PLWH)

RFQ: 75N95023R00071

(i) This is a combined synopsis/solicitation for a commercial service prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95023R00071 and the solicitation is issued as a Request for Quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13.5— Simplified Procedures for Certain Commercial Products and Commercial Services.; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, and is not expected to exceed the dollar value authorized under FAR Part 13.5. A fixed-price type of purchase order is contemplated for this requirement.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-05, dated August 8, 2023.

(iv) The North American Industry Classification System (NAICS) code for this procurement is 541690 – Other Scientific and Technical Consulting Services, and the small business size standard is $19,000,000 in revenue or less. This requirement shall be solicited using full and open competitive procedures.

(v) DESCRIPTION

The Government requires the following Services

1. Data extraction, management, analysis, and report of a propensity-score matched pharmacoepidemiological study of baclofen and spironolactone, prescribed for any indication, on HIV- and ASUD-related outcomes in a general patient population and a naturalistic setting, using the Veterans Aging Cohort Study (VACS).

(vi) Please refer to Attachment 1 – Statement of Work for details and information describing the specific requirements.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the contractor shall provide data analysis services for a period of twelve

(12) months from the date of award, with four 12-month option periods.

(viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (MAR 2023) is applicable and incorporated by reference into this solicitation.

(ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) is applicable and incorporated by reference into this solicitation. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Each quote will be evaluated in strict conformity with the evaluation factors. The evaluation will be based upon the demonstrated capabilities of the prospective Contractor in relation to the needs of the project as set forth in the solicitation.

The quote will also be evaluated taking into consideration any price reductions for the requirement being ordered. A price reasonableness determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and past performance. The analysis will document that the award represents the best value to the Government (considering technical evaluation factors, past performance, and price) to meet the Government’s needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered.

All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the Contractor will ensure the technical and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical and price quote to the Contracting Officer.

The Government may request clarifying information from the Contractor, as it relates to its quote.

If an award will be made without conducting discussions, Contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the contract, the Contractor's past performance information, and adverse past performance information to which the Contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. Discussions will not be held with any Offeror determined to be technically unacceptable.

The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet the Government’s requirements.

A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors other than cost or price, when combined, are more important than cost or price. For this acquisition, the following considerations will be part of the trade-off process: Technical Evaluation Factors including Past Performance, and Price.

The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed in order of its relative importance for evaluation purposes.

1. Technical Approach & Understanding of the Project

We will evaluate a vendor’s technical approach for soundness, practicality, and feasibility to accomplish the tasks and requirements in all Performance Areas of the Statement of Work. We will evaluate the vendor’s technical approach for their ability to meet performance/delivery schedules under the required tasks. Also, we will evaluate their technical proposal on how well it shows a comprehensive understanding of the project’s goals, objectives, and tasks as called for in the Statement of Work (SOW). We will evaluate their understanding of the tasks to be performed, their interrelation and complexity. We will evaluate the vendor’s discussion of anticipated problems and constraints likely to be encountered in performing the work, and their plans, solutions, and approaches to resolving them.

2. Key Personnel

We will evaluate resumes of key personnel, consultants, and any subcontractors for appropriateness of credentials, training, qualifications, experience, and competence to carry out the project. Basic credentials for proposed personnel will be evaluated for experience in relevant data analysis and ability to execute the requirements of the Statement of Work.

MANDATORY CRITERIA:

The Contractor must possess full access to the Veterans Aging Cohort Study (VACS) data and other sources needed for these analyses, as well as an already built data analysis pipeline, at the time of proposal submission.

PAST PERFORMANCE

The Offeror should provide past performance information. Past performance information shall cover a minimum of 1 year in relevant services and deliveries of comparable services. The Offeror should provide at least one reference for any project identified under the experience factor that has a performance period within the past three years.

For each reference, the offeror should provide: (1) Organization/contracting partner's name; (2) Point of contact's (POC) name and contact information: Current phone numbers. Valid email addresses; (3) Description that precisely explains: General scope of the contract. Specific requirements of the contract.

Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

Furthermore, the Government will assess the relative risks associated with each offeror.

Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information.

PRICE EVALUATION

Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable.

EVALUATION OF OPTIONS

It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s). In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s).

(x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (DEC 2022), is applicable and incorporated by reference into this solicitation.

(xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (DEC 2022), applies to this acquisition. See Attachment 2.

(xii) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JUN 2023), applies to this acquisition. See Attachment 3.

(xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation.

Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; and prompt payment discount terms.

The Contractor shall submit its quote electronically.

Offerors MUST verify the valid certifications, registrations, and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.

In addition the vendor Unique Entity Identifier (UEI) and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received no later than September 1, 2023, 2:00 PM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95023R00071. Responses must be submitted electronically to the Contracting Officer, Tracy Cain, at tracy.cain@nih.gov. For information regarding this solicitation, please contact Tracy Cain by email at tracy.cain@nih.gov or by phone at 301-451-7586.

(xvi) DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to the Contracting Officer, Tracy Cain, at tracy.cain@nih.gov on or before 2:00 PM EST, August 29, 2023. Fax responses will NOT be accepted.

ATTACHMENTS

(xvii) Attachment 1 – Statement of Work

(xviii) Attachment 2 - FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (DEC 2022)

(xix) Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders - Commercial Products and Commercial Services (JUN 2023)

(xx) Attachment 4 – Invoice and Payment Instructions http://www.sam.gov/ http://www.sam.gov/ mailto:rob.bailey@nih.gov mailto:rob.bailey@nih.gov mailto:rob.bailey@nih.gov

STATEMENT OF WORK

(SOW)

GENERAL INFORMATION

Title of Project:

Technical Consulting Services and Data Analysis of novel medications for alcohol and substance use disorders in improving HIV-related outcomes and providing health benefits in people living with HIV (PLWH)

Statement of Need and Purpose:

The National Institute on Drug Abuse (NIDA), Intramural Research Program (IRP) Clinical Psychoneuroendocrinology (CPN) laboratory is conducting a study is to examine emerging pharmacotherapies and their potential health benefits for PLWH, in addition to alcohol and substance use disorders outcomes, using extensive pharmacoepidemiologic data. This approach is consistent with the overall goal of our lab, and the NIDA IRP at large, to identifying new pharmacological targets and develop an effective treatment for patients afflicted with drug addiction.

Technical consulting services and data analysis is needed to provide additional support for these studies.

Background Information:

Dr. Leggio's NIDA Clinical Psychoneuroendocrinology (CPN) laboratory, jointly with NIAAA, conducts clinical and translational inpatient and outpatient studies to identify possible novel medications for addiction. His group uses a combination of state-of-the-art, innovative biobehavioral and pharmacological procedures performed under well-controlled human laboratory conditions. Dr. Leggio and his team are particularly interested in the role of neuroendocrine pathways in alcohol- and drug-seeking behaviors and identifying novel effective pharmacotherapies in this regard. Previous literature supports the overall hypothesis that both baclofen and spironolactone may have beneficial effects on HIV-related outcomes in PLWH and comorbid alcohol and substance use disorders (ASUDs) by decreasing HIV RNA levels, increasing CD4 count, improving retention on antiretroviral therapy (ART), and improving liver function.

We plan to conduct two studies to examine emerging pharmacotherapies and their potential health benefits for PLWH, in addition to ASUD outcomes. The first study will focus on the GABA- B receptor agonist baclofen, for which longstanding evidence from preclinical studies and randomized clinical trials support its potential efficacy in addictions and its use off-label in some countries such as France. The second study will focus on the non-selective mineralocorticoid receptor (MR) antagonist spironolactone, for which preclinical studies and pharmacoepidemiology human studies indicated its potential efficacy in addictions. Both medications are old, generic, and low cost that have been used for decades to treat neurological (baclofen) or cardiovascular (spironolactone) conditions in clinical practice. Therefore, if proven effective in improving HIV-related outcomes and providing health benefits in PLWH, these medications could be rapidly implemented in clinical practice. Of special note, liver damage is often present in PLWH and both baclofen and spironolactone have been extensively used in patients with advanced liver diseases, further supporting their safety and potential efficacy in PLWH.

For each study, the co-primary aims will be whether the medication under investigation leads to

1) improvements in direct HIV-related biomarkers, i.e. decrease in HIV RNA levels and/or increase in CD4 count, 2) improved retention on ART, 3) improvement in liver function as measured by clinically relevant biomarkers of liver damage and function (FIB-4, AST, ALT, GGT, bilirubin, alkaline phosphatase, albumin, prothrombin time); 4) improvement in physical health and physiological frailty; and 5) reduction in pain level. We will also assess relevant secondary aims in each study.

We aim to conduct pharmacoepidemiological studies using state-of-the-art methods leveraging longitudinal electronic health record data from the Veterans Aging Cohort Study (VACS). We will apply approaches consistent with the emerging role of data science in biomedical research and with cutting-edge pharmacoepidemiologic approaches, which have been used in other fields and recently gained traction in the addiction field. Robust pharmacoepidemiology analyses have the potential of expanding our real-world understanding about the relationship between ASUD and HIV-related outcomes and identifying early efficacy signals with medications that can then be tested in prospective randomized controlled trials. This approach is not only cost-effective but also represents a translational bridge that takes advantage of existing detailed real-world data on people who already received the medication under investigation, for any indication, to generate clinically-relevant novel information for outcomes of interest.

Period of Performance:

Twelve Months from Date of Award, with an additional four twelve-month option periods.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the work below:

Data extraction, management, analysis, and report of a propensity-score matched pharmacoepidemiological study of baclofen and spironolactone, prescribed for any indication, on HIV- and ASUD-related outcomes in a general patient population and a naturalistic setting, using the Veterans Aging Cohort Study (VACS).

The contractor should abide by outlined standards of only sharing De-identified data if and when necessary. Sharing requires approval of the research proposal. Only aggregate information and data will be shared with the NIH research team. No personal identifiable information or raw data will be shared with the NIH research team.

Specific Requirements:

The objective of the proposed project is to examine emerging pharmacotherapies and their potential health benefits for PLWH, in addition to alcohol and substance use disorders outcomes. Using electronic health record data from the VACS, the Contractor shall provide data analysis on the association between baclofen and spironolactone receipt (prescribed for any indication) and HIV- and ASUD-related outcomes in adults. Individuals exposed to baclofen and spironolactone shall be propensity-score matched to up to five unexposed individuals, based on parameters provided by the NIDA COR, and multivariable linear regression models shall be used to estimate changes in HIV- and ASUD-related outcomes before and after exposure.

Per each study, pharmacy records shall be extracted to identify patients who did and did not receive the medication under investigation dispensed at VA pharmacies. Exposure to the medication is defined as receipt of two or more fills for a minimum number of continuous days (determined as part of the analysis), for any indication, from VA outpatient clinics. For unexposed comparators, patients who attended at least one of the same clinics, but never received the medication, should be selected, ensuring that unexposed patients came from the same source population, were exposed to an overall similar medical care, and had equal opportunities to receive the same medication.

To balance the distribution of all potential confounders across treatment groups, the Contractor shall apply propensity score approaches (e.g., matching, weighting) in consultation with the NIDA research team. This shall be done by first modelling the probability (i.e., propensity) of receiving the medication as a function of measured covariates associated with the exposure and outcome using a multivariable logistic regression model. These covariates must be already created and ready for analysis. Covariates shall be summarized, using descriptive statistics and shall be stratified by treatment group. To assess balance, absolute standardized mean differences (SMD) shall be calculated and interpreted in consultation with the research team. Variables included in the propensity score model should be guided by previous work in this field and using the same database. Therefore, given timeline restrictions and the important of research integrity/replication, it is required that the Contractor possess full access to the VACS data and other sources needed for these analyses, as well as an already built data analysis pipeline as a necessary requirement.

The contractor will be responsible for pulling, organizing, and cleaning the data needed for this project, formulating a data analysis plan in consultation with the NIH research team, running the analyses and reviewing aggregate results with the NIH research team, and drafting the methods use and detailed results. The NIH research team will lead the development of the manuscript for publication.

The contractor shall perform the following tasks:

1. Extract pharmacy records to identify patients who did and did not receive the FDA-approved medications (to be specified by the NIDA COR) at VA pharmacies.’

2. Apply propensity score approaches (e.g., matching, weighting) in consultation with the NIDA research team to balance the distribution of all potential confounders across treatment groups.

Variables included in the propensity score model shall be guided by previous work in this field and using the same database.

3. Model the probability (i.e., propensity) of receiving the medication as a function of measured covariates associated with the exposure and outcome using a multivariable logistic regression model. These covariates must be already created and ready for analysis.

4. Covariates shall be summarized, using descriptive statistics and shall be stratified by treatment group.

5. Absolute standardized mean differences (SMD) shall be calculated and interpreted in consultation with the research team.

6. Due to timeline restrictions and the importance of research integrity/replication, it is required that the contractor possess full access to the Veteran Aging Cohort Study (VACS) data and other sources needed for these analyses, as well as an already built data analysis pipeline.

7. The contractor will be responsible for pulling, organizing, and cleaning the data needed for this project;

8. Formulating a data analysis plan in consultation with the NIH research team;

9. Running analyses and reviewing aggregate results with the NIH research team;

10. Drafting the methods used and detailing the results;

11. Organizing data management and analysis to support CPN with their study;

12. Meeting regularly with the NIDA IRP research team to brainstorm about and outline the specifics of the project; and

13. Preparing and delivering an annual (if options are exercised) and final report of the methods used and aggregated data results.

Level of Effort:

We estimate performance will require 1,500 hours of professional work (data management, analysis, preparing drafts, etc.) and 100 hours of administrative support.

GOVERNMENT RESPONSIBILITIES

The NIH research team will meet regularly with the contractor to guide the analysis plan, review aggregate results, plan further analyses, etc. The NIH research team will oversee the project and will lead the development and preparation of the manuscript after they receive the aggregate data (i.e., a summary of the methods and results).

DELIVERY OR DELIVERABLES

Deliverables will include a comprehensive and detailed summary of the method and results. The deliverables will be used by NIDA IRP to develop conference abstracts and peer-reviewed publications to disseminate the findings to the scientific community. The contractor will also need to send monthly reports to the NIH research team on tasks performed and the overall progress of the project, as well as a final report at contract expiration and an annual report summarizing yearly progress (if options are exercised).

REPORTING REQUIREMENTS

NIH research team will not receive any raw data or personally identifiable information. Only aggregate information will be received.

1. Recurring Meetings - The contractor will regularly meet with the NIDA CPN research team to discuss the project’s progress. Any issues impacting the project should be immediately addressed at these meetings. A summary of progress should be provided at each meeting.

NIDA IRP CPN should not receive any raw data or personally identifiable information, only aggregate information will be accepted.

2. Monthly Report - The contractor shall develop and provide a monthly status report (MSR) by the tenth of each month via electronic mail to the NIH COR. The MSR shall include the activities performed during the reporting period (include on-going activities, new activities, activities completed; progress to date on all above-mentioned activities).

3. Annual Report - The contractor shall develop and provide an annual report within thirty (30) days of the end of the contract period via electronic mail to the NIH COR. The Annual Report shall include a summary of the activities performed during the contract period.

TRAVEL

N/A

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.

OTHER CONSIDERATIONS

Information System Security Plan:

N/A

Data Rights:

52.227-14 Rights in Data-General

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

The contractor will produce abstracts and manuscripts as a result of this project. The NIH research team will lead the development and preparation of the final manuscript for publication.

The Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows: "This project has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No. TBD"

Confidentiality of Information:

The government will not be providing any confidential information to the contractor. All data and results are confidential until reported to the public in resulting manuscript. Aggregate results will be reported and no person-level data will be identifiable.

Contracting Officer’s Representative:

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

TBD

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 evaluations 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 the contract.

The Government may unilaterally change the COR designation for this contract.

Statement of Work – Addenda

Article 1. Non-Personal Service Statement:

Contractor employees performing services under this order will be controlled, directed and supervised at all times by management personnel of the contractor.

Contractor employees will perform independent of and without the supervision of any Government official. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

Specifically:

• Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

• Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way to change the contract and that if the other Contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

• The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

Article 2 – Options

52.217-5 EVALUATION OF OPTIONS (JULY 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement.

Evaluation of options will not obligate the Government to exercise the option(s).

FAR Clause 52.217-9, Option to Extend the Term of the Contract.

a. The Government may extend the term of this contract by written notice to the Contractor prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the contract expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended contract shall be considered to include this option clause.

c. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

ARTICLE 3 - 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."

a. 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)

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/Contract Specialist/title of alternate designee] must be included as a contact for notification purposes at the following e-mail address:

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

[Contracting Officer/Contract Specialist]

ARTICLE 4: 52.204–27 Prohibition on a ByteDance Covered Application.

Prohibition on a Bytedance Covered Application (June 2023)

(a) Definitions. As used in this clause—

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117–328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M–23–13, dated February 27, 2023, ‘‘No TikTok on Government Devices’’ Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M–23–13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

CONTRACT TERMS AND CONDITIONS – COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

Update per FAC 2023-01 Last updated: 12/2022

FAR 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services (DEC 2022).

As prescribed in 12.301(b)(3), insert the following clause:

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights --

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C.3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71,Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

https://www.acquisition.gov/far/12.301#FAR_12_301

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice. (1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include --

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer— System for Award Management, or

52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C.

3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt Payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest. (i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period at fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.