Solicitation_FINAL (rev. 1).pdf

COMBINED SYNOPSIS / SOLICITATION

COMPETITIVE

Solicitation Number: NIH-NINDS-CSS-21-005053

Solicitation Title: Biostatistics Consulting Services

Introductory Statement: This is a combined synopsis/solicitation (Solicitation) for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

The Government reserves the right to make one award, multiple awards, or no awards at all as a result of this solicitation.

The solicitation number is NIH-NINDS-CSS-21-005053 and the solicitation is issued as a Request for Quotation (RFQ).

Solicitation Authority: This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, FAR Part 12—Acquisition of Commercial Items; and is not expected to exceed the simplified acquisition threshold.

This solicitation and the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-07, dated 08/11/2021.

The associated NAICS code is 541690 “Other Scientific and Technical Services” and the small business size standard is $16.5 million.

Set Aside Status: This acquisition is a total small business set-aside.

Contract Type: The Government intends to award a Labor-Hour Contract/Order with Options to Extend the Term of the Contract and Options for Increased Quantity.

STATEMENT OF WORK (SERVICES)

Biostatistics Consulting Services

Title of Project: Biostatistics Consulting Services

Statement of Need and Purpose:

The National Institute of Neurological Disorders and Stroke’s (NINDS) Clinical Trials Unit (CTU) requires a biostatistics consultant (Contractor) to provide biostatistics consulting services to support and enhance NINDS’ mission-driven program and initiatives. The biostatistics consulting services will include providing expert-level technical guidance to NINDS investigators and other National Institutes of Health (NIH) investigators as to conception, design, implementation, execution, analysis, and reporting of clinical research results; clinical research methodology; gender and minority tracking methodology; safety monitoring, clinical research data sharing; and clinical trial reporting.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people’s health and save lives.

The National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) staff work with investigators of the NINDS Division of Intramural Research (DIR) in specific areas of neurological and clinical research, which include protocol development of interventional and non-interventional clinical research studies of neurological disorders and stroke. In addition to advising intramural investigators in the conception, development, implementation, and execution of clinical research studies and clinical trials, CTU staff work with the extramural Office of Translational Research (OTR) and Office of Clinical Research (OCR) to support the mission of NINDS.

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, needed to perform the requirements outlined in this Statement of Work (SOW).

Specific Requirements:

The Contractor shall provide the following biostatistics consulting services to the NINDS CTU:

• Provide expert and strategic statistical technical support, guidance, education, and advice on advancing NINDS projects through nonclinical and clinical development.

• Perform complex statistical analyses, prepare, and review statistical analysis plans, provide detailed specifications for electronic analysis files, and quality check statistical analyses including tables and figures.

• Communicate with Government staff and investigators regarding statistical protocol design and data analysis issues.

• Evaluate the design of NINDS’ proposed studies and milestones using sound statistical analysis methodology to ensure studies are sufficiently powered and controlled with experimental and statistical rigor that will lend a high degree of confidence in study results.

• Interpret and as needed, perform biostatistical/statistical analyses of datasets.

• Assist in the writing of statistical sections of study reports.

• Explain statistics in plain language and lead similar educational activities.

• Provide verbal and written feedback and technical recommendations regarding biostatistical data relating to NINDS projects.

• Provide technical review and feedback on statistical data to inform project milestones, progress reports, development plans, study design, database design, and data interpretation.

• Communicate with Government staff and clinical trial investigators to facilitate discussions to support the NINDS’ research strategy.

• Provide written guidance to Government staff and clinical trial investigators on the appropriate statistical methods to employ to accurately interpret clinical trial results.

• Assist the NINDS CTU staff in preparing investigational and research study protocols.

Key Personnel Requirements:

The Contractor staff providing services outlined in the SOW shall be considered Key personnel.

Key Personnel requirements are as follows:

1. A Ph.D. degree in biostatistics or a closely related discipline.

2. At least ten (10) years of biostatistics experience in the biotechnology or academic sector.

3. At least five (5) years of demonstrated experience in:

• Designing and reviewing nonclinical animal research plans and/or analysis of nonclinical animal research results for Investigational New Drug (IND)-enabling studies or clinical studies.

• Designing adaptive clinical trial protocols.

• Developing and reviewing statistical analysis plans, and data validations plans.

• Providing statistical interpretation of published results or critique of scientific proposals.

• Providing statistical support on nonclinical and/or clinical development projects.

• **Experience designing adaptive clinical protocols for the NINDS Division of

Intramural Research is desired.

Key Personnel will be subject to the Health and Human Services Acquisition Regulation (HHSAR) Clause 352.237-75 Key Personnel as follows:

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. 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.

Collaboration Requirement:

All contractors involved with the NINDS community are required to work collaboratively with federal staff and other contractors in support of the NINDS mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, and support, development, knowledge transfer, and creating and sharing of documentation when required.

Level of Effort:

The estimated level of effort for this requirement is one (1) consultant providing biostatistics consulting services on a part-time basis.

Though the required level of effort will vary depending on the complexity of the biostatistics services required at any given time, it is estimated that one hundred (100) hours of biostatistics consulting services will be required annually. Hours exceeding the annual minimum shall be exercised, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Period of Performance:

The anticipated period of performance is a one-year base period from the effective date of award and two (2) subsequent one-year option periods as follows:

Base Period: September 30, 2021 - September 29, 2022 Option Period 1: September 30, 2022 - September 29, 2023 Option Period 2: September 30, 2023 - September 29, 2024

Place of Performance:

The primary place of performance shall be the Contractor’s site. Conference calls and emails between the Contractor and NINDS staff shall be the primary mode of communication. The Contractor shall submit required deliverables electronically.

Government Furnished Information and Property:

Government-furnished property, in the form of a laptop and charging adapter, shall be provided to the Contractor. The Government will also provide the Contractor with access to Microsoft applications, CiSTAR, and any other applications necessary to perform the SOW. Project-related data files for performing requested services will be provided to the Contractor by NINDS on each occasion that consulting services are requested. All such data provided to the Contractor must be treated as confidential and not disclosed to any third party.

The Contractor may store project-related data up to twelve (12) months after initial receipt. After that time, the Contractor shall delete the project-related data and sanitize its computer using NIST SP 800-88, Guidelines for Media Sanitization. If any project-related data is needed for the performance of services under the SOW for longer than 12 months, the Contractor shall obtain approval from the designated Contracting Officer’s Representative to continue storage and usage of the project-related data.

Travel:

The Contractor may be required to travel within the contiguous United States to provide the services described above. Allowable travel costs for such travel will be reimbursed by the Government.

All travel arrangements must be made in accordance with the Federal Travel Regulations in effect at the time of travel, approved by the Contracting Officer, and authorized by the COR prior to being finalized and invoiced.

A Not to Exceed (NTE) annual amount of up to $1,200 for travel shall be exercised, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Annually, approximately eight (8) hours of travel time are anticipated for this requirement.

Please note that travel time may not be billed to the Government per the Federal Travel Regulation.

OTHER CONSIDERATIONS

Information Systems Security:

The following definitions and clauses are required for Information System Security and are incorporated into any resulting contract by reference:

• FAR Clause 52.204-9 Personal Identity Verification of Contractor Personnel (Jan 2011) -https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

• FAR Subpart 4.13 Personal Identity Verification -https://www.acquisition.gov/far/subpart-4.13

• FAR Clause 52.239-1 Privacy or Security Safeguards (Aug 996) -https://www.acquisition.gov/far/52.239-1

• FAR Clause 11.002(g) - https://www.acquisition.gov/far/11.002

• HHSAR Clause 352.224-71 Confidential Information (Dec 2015) -https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71

The Contractor must ensure that any computer system used in the course of this contract include the following features:

• Have virus protection loaded and running with definition files that are updated at least daily.

• Have up-to-date IT security patches.

• Have all hard drives and portable media encrypted using the FIPS 140-2 standard.

• Be backed up on an external hard drive that is password protected.

• Have auditing enabled such that if a security incident occurs, that event can be reconstructed.

• Be password protected. All passwords must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters: capital letters; lower case letters; numeric characters; special characters

• Employ two-factor authentication.

• Undergo vulnerability scans regularly. If a scan produces any high-risk results, they must be corrected within 30 days. If a scan produces any medium-risk results, they must be corrected within 90 days.

In addition, the Contractor shall be:

• Required annually to complete NIH Security and Privacy Training, accessible at http://irtsectraining.nih.gov/.

• Required to sign and agree to the NIH Non-Disclosure Agreement accessible at http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf.

• Required to report any lost or stolen NIH data to the NINDS Information Systems Security

Officer (ISSO) within one hour of knowing of the loss or theft.

https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel https://www.acquisition.gov/far/subpart-4.13 https://www.acquisition.gov/far/52.239-1 https://www.acquisition.gov/far/11.002 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71 http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

• Required to adhere to the NIH IT Rules of Behavior published at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx.

Data Rights:

The National Institute of Neurological Disorders and Stroke shall have unlimited rights to, and ownership of all deliverables provided for this requirement, including reports, analyses, recommendations, and all other deliverables, including those required as a result of modification of the governing contract.

The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, Definitions. FAR clause 52.227-14, Rights in Data-General, shall be incorporated by reference into any contract/order resulting from this solicitation.

Intellectual Property:

Key Personnel who contribute to the creation of new intellectual property will be named as inventors in accordance with U.S. prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator’s institution regarding assignment of rights and royalty distributions prior to advising on any activities. Key Personnel shall provide copies of all existing intellectual property agreements to the NIH COR, for documentation purposes.

Section 508 Compliance:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The FAR Final Rule on Section 508 (EIT Accessibility) can be found at https://www.section508.gov/manage/laws-and-policies.

To provide services/support for this requirement, the Contractor must agree in writing to comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information as related to this requirement, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Non-Personal Services Statement:

Key Personnel performing services for this requirement will be controlled, directed, and supervised at all times by management personnel of the Contractor, if applicable. Actions of the Contractor may not be interpreted or implemented in any manner that results in any Contractor or Contractor’s agent 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 Regulations (FAR).

https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx https://www.section508.gov/manage/laws-and-policies https://www.section508.gov/manage/laws-and-policies

Invoicing shall be in accordance with FAR Clause 52.212-4(g) and Attachment 5 – NIH Invoice and Payment Provisions. Payment of invoices shall be made via Electronic Funds Transfer (EFT), in accordance with the Prompt Payment Act.

INSTRUCTIONS TO OFFERORS

Technical Proposal Instructions:

Technical Proposals must include clear and convincing evidence of the Offeror’s understanding of the requirements in the SOW and technical capability to meet those requirements. Technical proposals must also include clear and convincing evidence that the proposed Key Personnel meet the Key Personnel Requirements in the SOW.

Offeror’s technical proposal shall be no more than ten (10) single-sided pages in length. This page limit includes:

(i) Cover Page, if applicable

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative

(v) Key Personnel Resume(s)

(vi) Past Performance Examples

This page limit does NOT include:

(i) Representations and Certifications

(ii) Completed Price Template

The Technical Proposal must be signed by an authorized Business Representative (person authorized to negotiate and sign on behalf of the organization).

1. Technical Capability: The technical proposal shall include clear and convincing of the

Offeror’s technical capability to meet the requirements in the SOW.

2. Personnel Qualifications: The technical proposal shall describe the relevant work experience, education, and qualifications of all proposed Key Personnel.

3. Resumes: The technical proposal shall also include complete, up-to-date resumes of all proposed Key Personnel. Each resume must detail educational background, recent experience, specific or technical accomplishments, and a list of relevant publications.

Resumes are limited to 3 pages in length.

4. Past Performance: Offeror shall identify 1 to 2 awards with the Federal Government and/or commercial customers that demonstrate recent and relevant work performance. Relevant is defined as work similar in complexity and magnitude to the work outlined in the SOW.

Past performance examples shall include the following information:

• Project title

• Description of the project

• Contract number and, if applicable, task order number

• Contract amount

• Government Agency/Organization

• Point of contact name, address, and phone number

• Current status, e.g., completed and/or if in progress, start and estimated completion dates

• Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)

• A statement explaining why the past performance is relevant to the Statement of Work

Business Proposal Instructions:

Offeror must complete Attachment 1 – Price Template and include it in its response. Offeror is to fill out only the highlighted cells; all other cells will then auto-populate. Offeror shall include in its response to this Solicitation its completed Price Template in Excel format (do not convert to PDF). The price template may not be combined or embedded with other proposal materials.

The Government anticipates annual funding for an estimated amount of 100 labor hours. In addition, the Government will reimburse the Contractor up to $1,200.00 in travel-related expenses that are necessary for performance of the work for this requirement. These funds shall be provided only after it is determined there is a need for travel. All travel requests require advance approval by the Government. In recognition of these facts, Offeror shall include the following statement in its proposal:

“It is anticipated that the Government will fund an estimated amount of 100 hours during each period of performance of the contract. It is also understood that a travel amount not-to-exceed $1,200.00 may be funded and exercised during each contract period and may only be used with advance approval.” Any billable travel expenses must follow the Federal Travel Regulation (FTR).”

If the Offeror proposes additional personnel labor hours in the Price Template, it must provide its rationale and specify how work time of additional personnel will be charged (e.g., direct hourly rate or included within overhead cost) in a separate price narrative. If Offeror adds any Other Direct Costs (ODCs) besides travel in its Price Template, the Offeror must provide its rationale in the separate Price Narrative.

Salary Rate Limitation:

Offeror is advised that no NIH funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A)costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Offeror pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Offeror.

This does not preclude the Offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The Executive Schedule, Level II* annual salary rate limitation also applies to proposed subcontractors as well as consultants.

Link to Executive Schedule Rates of Pay: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ (For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

*Note to Offerors: Offeror must adhere to the current Fiscal Year Executive Level II Salary Rate when preparing its response. All costs associated with any resultant contract award shall fully comply with the current Fiscal Year Executive Level II Salary rates.

Offeror shall certify that its quoted labor rates comply with the Department of Health and Human Services Acquisition Regulation (HHSAR) Clause 352.231-70 Salary Rate Limitation by completing Attachment 2 – Offeror Representations and Certification.

EVALUATION FACTORS

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (Sep 2021), applies to the acquisition of these services. The following instructions are included as an addendum.

The Government will award a purchase order resulting from this Solicitation on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price. The technical factors and their respective weights are as follows:

Factor Weight

Factor 1: Technical Capability/Approach

The offeror’s proposal will be evaluated for how well it addresses each area of the statement of work requirements and demonstrates a clear understanding of the statement of work and compliance with requirements.

50 points

Factor 2: Key Personnel Qualifications

Technical proposals will be evaluated for level of conformance to the key personnel qualifications identified in the statement of work. Offeror proposals must contain complete resumes for all proposed key personnel.

25 points

Factor 3: Past Performance

Past Performance will be evaluated for relevance to the requirement described in this Solicitation.

25 points https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/

*Note to Offerors: Offeror’s quote must adhere to the current Fiscal Year Executive Level II Salary Rate. All costs associated with any resultant contract award shall fully comply with the current Fiscal Year Executive Level II Salary Rate.

Important:

The Government may elect to discuss or obtain additional information and/or request revisions from one or more offerors at any point during the evaluation and source selection process, in accordance with FAR Part 13 procedures. The Government also reserves the right to evaluate responses and award a purchase order without discussions as well as the right to make no award at all.

APPLICABLE PROVISIONS AND CLAUSES

The following Federal Acquisition Regulations (FAR) provisions and clauses and HHS Acquisition Regulations (HHSAR) shall apply to this Solicitation and to the resulting contract/order award and are included herein by reference:

1. FAR Provision 52.212-1 Instructions to Offerors- Commercial Items (Jun 2020).

2. FAR Clause 52.212-4 Contract Terms and Conditions – Commercial Items, Alternate I (Jan 2017).

3. FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes of

Executive Orders-Commercial Items (Jan 2021).

a. The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that will be incorporated into the contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

i. 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

ii. 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018)

iii. 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)

iv. 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

v. 52.233-3, Protest After Award (Aug 1996)

vi. 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)

vii. 52.219-28, Post Award Small Business Program Representation (Nov

2020)

viii. 52.222-3, Convict Labor (Jun 2003)

ix. 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

x. 52.222-26, Equal Opportunity (Sept 2016)

xi. 52.222-50, Combating Trafficking in Persons (Oct 2020)

xii. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While

Driving (Jun 2020)

xiii. 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008)

xiv. 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

xv. 52.239-1, Privacy or Security Safeguards (Aug 1996)

xvi. 52.222-41, Service Contract Labor Standards (Aug 2018)

xvii. 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

xviii. 52.222-43, Fair Labor Standards Act and Service Contract Labor

Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018)

xix. 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020)

xx. 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017)

4. FAR Clause 52.216-31, Time-and-Materials/Labor-Hour Proposal Requirements-

Commercial Item Acquisition (Feb 2007) applies to this acquisition as follows:

(a) The Government contemplates award of a Time-and-Materials or Labor-Hour contract resulting from this solicitation.

(b) The offeror must specify fixed hourly rates in its quote that include wages, overhead, general and administrative expenses, and profit. The offeror must specify whether the fixed hourly rate for each labor category applies to labor performed by-

(1) The offeror;

(2) Subcontractors; and/or

(3) Divisions, subsidiaries, or affiliates of the offeror under common control.

5. FAR Clause 52.217-5, Evaluation of Options (July 1990) applies to this acquisition as follows:

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 quotes 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).

6. FAR Clause 52.217-7, Option for Increased Quantity – Separately Priced Line Item (Mar 1989) applies to this acquisition as follows:

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within five

(5) days. Delivery of added items shall continue at the same rate that like items as are called for under the contract unless the parties otherwise agree.

7. FAR Clause 52.217-8, Option to Extend Services (Nov 1999) applies to this acquisition as follows:

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the contract period of performance.

https://www.acquisition.gov/far/17.206#FAR_17_206

8. FAR Clause 52.217-9: Option to Extend the Term of the Contract (March 2000) applies to this acquisition as follows:

(a) The Government may extend the term of this contract by written notice to the Contractor within the contract period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least fourteen

(14) 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 three (3) years.

9. The Defense Priorities and Allocations System (DPAS) is not applicable to this acquisition.

10. HHSAR Clause 352.231-70, Salary Rate Limitation (December 18, 2015) applies to this acquisition as follows:

(a) The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.

(b) For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary,” have the same meaning and are collectively referred to as “direct salary,” in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract.

Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with contract funds.

(c) The salary rate limitation also applies to individuals under subcontracts.

(d) If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.

(e) See the salaries and wages pay tables on the Office of Personnel Management website for Federal Executive Schedule salary levels. (Note: The Salary Rate Limitation for these services is at the Executive Level II Rate. Executive Schedule Rates are accessible at: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/EX.pdf )

11. Information and Physical Security provisions and clauses applicable to this requirement are contained in Attachment 3 – Information and Physical Access Security Provisions.

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/EX.pdf https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/EX.pdf

Contracting Officer’s Representative and Contracting Officer The Contracting Officer's Representative (COR) designated for the contract shall be:

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 evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

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

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

Please note: To be considered for award, an Offeror must be actively registered in the System for Award Management (SAM), accessible at www.sam.gov, at the time of quote submission.

QUOTES DUE: Quotations including all required materials specified above must be received by September 19, 2021 at 4:00 PM Eastern Time and must reference Solicitation Number NIH- NINDS-CSS-21-005053. Quotes must be submitted via email to Marlene Milgram at marlene.milgram@nih.gov Fax responses will not be accepted.

All timely and responsive quotes that fully comply with these solicitation instructions and are submitted by responsible Offerors will be evaluated by the Technical Evaluation Panel (TEP).

Late submissions shall be treated in accordance with FAR Provision 52.212-1(f).

Closing Information Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before contract award.

Please be advised that the National Institute on Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) is a Federal agency. Your mass-market commercial sales and/or license agreement terms and conditions may include provisions that are customarily found in the commercial sector, but which are not enforceable under a contract with a Federal agency.

http://www.sam.gov/ mailto:marlene.milgram@nih.gov

In accordance with FAR 52.212-4(u), NIH considers unenforceable any provision in your mass-market commercial sales and/or license agreement terms and conditions that are inapplicable to Federal procurement contracts, including, without limitation, any term or condition that:

(1) Contravenes a right granted NIH under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan),

(2) Violates the Federal Acquisition Regulation or other Federal law (e.g., Antideficiency Act, Principles of Federal Appropriations Law),

(3) Departs from reasonable consumer expectations, or

(4) Violates fundamental public policy.

By submission of a quote/offer and execution of a resultant order/contract, the Contractor hereby accepts and agrees to the terms and conditions of the order/contract.

Attachments:

Attachment 1 – Price Template Attachment 2 – Offeror Representations and Certification Attachment 3 – Information and Physical Access Security Provisions Attachment 4 – System of Records Notice 09-25-0118 Attachment 5 – NIH Invoice and Payment Provisions