Combined_Synopsis_Solicitation-NIH-NINDS-CSS-19-007542A.pdf

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE

NIH-NINDS-CSS-19-007542A

Title: Chemistry Manufacturing Control [CMC] / Pharmaceutics / Formulation Consultant Support Services

This is a combined synopsis/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; proposals are being requested and a written solicitation will not be issued.

The solicitation number is NIH-NINDS-CSS-19-007542A and the solicitation is issued as an request for quote (RFQ).

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 Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-05, dated 13 August 2019.

The associated NAICS code 541990 “All Other Professional, Scientific and Technical Services” with a Size Standard of $15 million.

SET ASIDE STATUS: This acquisition is 100% set aside for small businesses.

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 NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development.

The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

Statement of Need and Purpose:

The purpose of this requirement is to procure consultant services to provide technical recommendations to the NIH Blueprint Neurotherapeutics Network drug discovery and development programs in the area of Chemistry Manufacturing Control [CMC] / Pharmaceutics / Formulation.

Project 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 Statement of Work below.

The Contractor shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

The Contractor is expected to provide support services in a collaborative way. Lead Development Teams the Contractor is assigned to may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows:

CMC / Pharmaceutics / Formulation

CMC / Pharmaceutics / Formulation consultants will be expected to provide senior-level CMC / Pharmaceutics / Formulation expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the CMC / Pharmaceutics / Formulation consultant may include but is not limited to the following responsibilities and tasks:

• Evaluate Chemical Manufacturing and Controls [CMC] activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines.

• Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN and LDTs. Develop CMC strategies which accord with US and international guidelines.

• Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules.

• Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules.

• Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines

Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications.

• Provide expertise in activities related to API development.

• Recommend dose form selection and API development strategies for BPN efforts.

• Develop plans to assist NIH BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.

• Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract with BPN. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff.

• Assist NIH BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed.

• Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts..

Level of Effort

The estimated level of effort for this requirement is one (1) contractor employee on a part-time basis.

The required level of effort varies depending on the quantity and complexity of BPN projects at any given time. It is anticipated that a minimum of 20 hours of support is required annually. A Not to Exceed (NTE) amount of 800 Optional Hours shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Government Furnished Information/Property

No Government furnished property shall be provided. Project related data will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party.

Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service.

Key Personnel:

The Contractor employee providing services for this effort shall be considered Key personnel. Key Personnel requirements are as follows:

General requirements

Consultants must have extensive experience in managing or being a senior leader in drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred.

Consultants must be able to work in a cross-functional team environment and manage competing priorities.

Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.

Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.

Must participate actively in LDT discussions.

Education and work experience requirements

• A PhD in a life or physical science discipline is required.

• Minimum 15 years of experience in CMC activities.

• Experience in executing and managing drug development tasks, particularly for nervous system conditions.

• A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market.

• Previous experiences in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered as signs of a strong track record in drug development.

• Expertise leading CMC efforts performed by contract research organizations and managing drug project portfolios.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 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.

Travel The consultant may be required to travel within the contiguous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel.

All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced.

A Not to Exceed (NTE) amount of $ 3,000 annually for travel shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Approximately 8 hours of travel time are anticipated for this requirement. Please note that travel time may not be billed to the Government, in accordance with the Federal Travel Regulation.

Information Security The following definitions and clauses are required for Information System Security:

FAR clause 52.239-1, Privacy or Security Safeguards (Section 2.A.2.b.)

https://www.acquisition.gov/content/52239-1-privacy-or-security-safeguards

HHSAR Clause 352.224-71 (Section 2.A.2.e.) https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71

FAR 7.105(b)(5) (Section 2.A.7.) https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935

FAR 11.002(g) (Section 2.A.7.) https://www.acquisition.gov/content/11002-policy

FAR 52.239-1(c) (Section 2.D.3.b.) https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272

FAR Subpart 4.13 (Section 2.F) https://acquisition.gov/content/41300-scope-subpart

FAR Subpart 52.204-9 (Section 2.F) https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

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

1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard.

https://www.acquisition.gov/content/52239-1-privacy-or-security-safeguards 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 https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935 https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935 https://www.acquisition.gov/content/11002-policy https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 https://acquisition.gov/content/41300-scope-subpart https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication.

12. Any computer used in relation to this contract must be password protected. All Password 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:

a) capital letters

b) lower case letters

c) numeric characters

d) special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)

Data Rights The National Institute of Neurological Disorders and Stroke shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. 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 into any resulting award by reference.

Intellectual Property Consultants who contribute to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator’s institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all 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 Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Non-Personal Services Statement Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. 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 Regulations (FAR).

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 under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH 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, support, development, knowledge transfer and creating and sharing documentation when required.

Period of Performance The required period of performance is a one-year base period from September 14, 2019 through September 13, 2020 and two (2) subsequent one-year option periods.

Place of Performance The primary place of performance shall be Contractor site. Conference calls and email shall be the primary mode of communication; however, the contractor may be required to work at Government facilities or facilities of selected principal investigators, on an as needed basis.

Contract Type A Labor Hour Purchase Order with Options to Extend the Term of the Contract and Options for Increased Quantity Separately Priced Line Item is contemplated. Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT).

RESPONSE FORMAT

https://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical response and 2) a separate price quotation.

The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single-sided pages.

The price quotation must include an hourly rate as well as extended pricing for the full level of effort of each contract period. Options for increased quantity must also be detailed. A summary of the whole contract price should all options be exercised must also be included.

Please also include the following language in the price quotations:

“It is understood that a minimum of 20 hours is required and that up to 800 hours may be exercised during each contract period. It is also understood that a not-to-exceed travel amount of $3,000 annually applies to each contract period and may only be used with advanced approval.”

Contractors must provide their Company Name, Dun and Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contract Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov .

EVALUATION CRITERIA

The Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below.

NOTE: The Contractor’s proposal must include a resume or curriculum vitae for proposed key personnel as this will be the primary document evaluated.

Factor 1: Key Personnel Professional Experience in Drug Discovery and Development

Key personnel proposed shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to Chemistry Manufacturing Control / Pharmaceutics / Formulation .

Hands-on and leadership and management experience in drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.

Key personnel’s professional experience shall also be evaluated for preparation of successful investigational new drug applications, as well as publications, patents, and work on drugs brought to market. In addition, experience showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered favorably.

Finally, key personnel’s professional experience shall be evaluated for efforts involving compliance and familiarity with regulatory procedures and guidelines relevant to small molecule drug discovery development.

Factor 2: Key Personnel Education and Certifications

Key personnel proposed shall be evaluated for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. Advanced education and board certifications, as well as other evidence of advanced expertise applicable to Chemistry Manufacturing Control / Pharmaceutics / Formulation shall be considered favorably.

Factor 3: Key Personnel Collaborative Team Experience

Key personnel proposed shall be evaluated for length and breadth of experience collaborating with multi-disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.

Factor 4: Past Performance

The Contractor shall provide at least two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements outlined in this Statement of Work.

References shall include the following information:

a) Name of Organization

b) Brief Description of Contractor’s Responsibilities

c) Point of Contact Name, Title, and Telephone Number

Past Performance shall be evaluated for relevance to the current requirement.

EVALUATION METHOD

Technical proposals will be evaluated using numerical rating in accordance with the following scale.

Scores up to first decimal place will be used.

Numerical Rating: 5

A combination of following factors is likely to result in excellent performance as a Chemistry Manufacturing Control / Pharmaceutics / Formulation consultant.

• Over 10 years’ experience leading Chemistry Manufacturing Control / Pharmaceutics / Formulation team’s small molecule drug discovery efforts as demonstrated by holding a senior level position.

• 15 years’ participation in small molecule Chemistry Manufacturing Control / Pharmaceutics / Formulation teams throughout the drug discovery and development process.

• Preparation and submission of Chemistry Manufacturing Control / Pharmaceutics / Formulation components of INDs for 5+ drug candidates.

• 3+ years providing Chemistry Manufacturing Control / Pharmaceutics / Formulation consulting to small companies and academics.

• PhD degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation with adequate post-doctoral preparation and at least 15+ years Chemistry Manufacturing Control / Pharmaceutics / Formulation experience in the pharmaceutical industry.

OR

MS degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation with more than 20 years hands-on Chemistry Manufacturing Control / Pharmaceutics / Formulation experience in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

Engaging the offeror as Chemistry Manufacturing Control / Pharmaceutics / Formulation consultant represents a benefit to the BPN program.

Numerical Rating: 4

A combination of following factors is likely to result in good performance as a Chemistry Manufacturing Control / Pharmaceutics / Formulation consultant.

• 10 years’ experience leading Chemistry Manufacturing Control / Pharmaceutics / Formulation team’s small molecule drug discovery efforts as demonstrated by holding a senior level position.

• 15 years’ participation in small molecule Chemistry Manufacturing Control / Pharmaceutics / Formulation teams throughout the drug discovery and development process.

• Preparation and submission of Chemistry Manufacturing Control / Pharmaceutics / Formulation components of INDs for several drug candidates.

• 1+ years providing Chemistry Manufacturing Control / Pharmaceutics / Formulation consulting to small companies and academics.

• PhD degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation with adequate post-doctoral preparation and at least 15+ years Chemistry Manufacturing Control / Pharmaceutics / Formulation experience in the pharmaceutical industry.

OR

MS degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation with 20 years hands-on Chemistry Manufacturing Control / Pharmaceutics / Formulation experience in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

represents no risk to the BPN program.

Numerical Rating: 3 A combination of following factors is likely to result in acceptable performance as a Chemistry

• 5 years’ experience leading Chemistry Manufacturing Control / Pharmaceutics / Formulation team’s small molecule drug discovery efforts as demonstrated by holding a senior level position.

• 10 years’ participation in small molecule Chemistry Manufacturing Control / Pharmaceutics / Formulation teams throughout the drug discovery and development process

• Preparation and submission of Chemistry Manufacturing Control / Pharmaceutics / Formulation components of INDs for several drug candidates.

• PhD degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation with adequate post-doctoral preparation and at least 10+ years Chemistry Manufacturing Control / Pharmaceutics / Formulation experience in the pharmaceutical industry.

OR

MS degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation with 15 years hands-on Chemistry Manufacturing Control / Pharmaceutics / Formulation experience in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

represents a neutral risk to the BPN program.

Numerical Rating: 2

A combination of following factors is likely to result in marginal performance as a Chemistry

• Limited experience leading small molecule drug development Chemistry Manufacturing Control / Pharmaceutics / Formulation team through the whole drug development process.

• Limited experience leading a drug discovery and development Chemistry Manufacturing Control / Pharmaceutics / Formulation team through drug development process.

• Limited experience in team preparation and submission of Chemistry Manufacturing Control / Pharmaceutics / Formulation components of INDs.

• PhD degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation without adequate post-doctoral preparation or Chemistry Manufacturing Control / Pharmaceutics / Formulation pharmaceutical industry experience.

OR

MS degree in chemistry or pharmaceutical sciences without adequate hands-on experience in pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

represents a degree of risk to the BPN program.

Numerical Rating: 1

A combination of the following factors is likely to result in unsatisfactory performance as a Chemistry

• Lack of graduate degree in chemistry or Chemistry Manufacturing Control / Pharmaceutics / Formulation .

• Lack of or limited hands-on participation in a drug discovery and development Chemistry Manufacturing Control / Pharmaceutics / Formulation team throughout the drug development process.

• Lack of or limited experience leading small molecule drug development Chemistry Manufacturing Control / Pharmaceutics / Formulation team through the whole drug development process.

• Lack of or limited experience in preparation and submission of Chemistry Manufacturing Control / Pharmaceutics / Formulation components of INDs.

represents a very high degree of risk to the BPN program.

APPLICABLE CLAUSES AND PROVISIONS

The following FAR clauses and provisions shall apply to this solicitation:

1. All Offerors must be actively registered in the System for Award Management (SAM) www.sam.gov .

2. The FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

3. The provision at FAR clause 52.212-1 Instructions to Offerors- Commercial Items (October

2018), applies to this acquisition.

4. The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer.

5. The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, Alternate I applies to this acquisition.

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

Executive Orders-Commercial Items apply to this acquisition. The following clauses shall be checked/included in this clause:

a. 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006)

b. 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards

(Oct 2018)

c. 52.204-14, Service Contract Reporting Requirements (Oct 2016)

d. 52.209-6, Protecting the Government's Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015)

e. 52.209-9, Updates of Publicly Available Information Regarding Responsibility

Matters (Oct 2018)

f. 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)

g. 52.219-8, Utilization of Small Business Concerns (Oct 2018)

h. 52.219-13, Notice of Set-Aside of Orders (Nov 2011)

i. 52.219-14, Limitations on Subcontracting (Jan 2017)

j. 52.219-28, Post Award Small Business Program Representation (Jul 2013)

k. 52.222-3, Convict Labor (June 2003)

l. 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018)

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

n. 52.222-26, Equal Opportunity (Sep 2016)

o. 52.222-35, Equal Opportunity for Veterans (Oct 2015)

p. 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)

q. 52.222-37, Employment Reports on Veterans (FEB 2016)

r. 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act (Dec 2010)

s. 52.222-50, Combating Trafficking in Persons (Jan 2019)

t. 52.222-54, Employment Eligibility Verification (OCT 2015)

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

Driving (AUG 2011)

v. 52.225-13, Restrictions on Certain Foreign Purchases (June 2008)

w. 52.232-33, Payment by Electronic Funds Transfer-System for Award

Management (Oct 2018)

7. 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 type of contract resulting from this solicitation.

(b) The offeror must specify fixed hourly rates in its offer 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 a common control.

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

9. FAR Clause 52.217-7 Option for Increased Quantity – Separately Priced Line Item (Mar 1989)

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 one (1) day. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. (End of clause)

10. 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 thirty (30) 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.

11. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), 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."

12. HHSAR Clause 352.231-70, Salary Rate Limitation (December 2015)

Note : The Salary Rate Limitation is at the Executive Level II Rate.

See the following website for 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 .)

http://www.sam.gov/ https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/

13. Information and Physical Access Security Provisions

INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

1. Applicability- The requirements herein apply whether the entire contract or order (hereafter

"contract"), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section 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.

2. Safeguarding Information and Information Systems- In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability , which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov .

d. Comply with the Privacy Act requirements.

3. Information Security Categorization- In accordance with FIPS 199 and National Institute of

Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to mailto:fisma@hhs.gov mailto:fisma@hhs.gov

Guide for Mapping Types of Information and Information Systems to Security Categories, Contractor Non-Disclosure Agreement and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [ X] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High Availability: [ ] Low [ X] Moderate [ ] High Overall Risk Level: [ ] Low [ X ] Moderate [ ] High Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [ X] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, "PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother's maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] Low [ X] Moderate [ ] High

4. Controlled Unclassified Information (CUI)- CUI is defined as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. Marked appropriately;

b. Disclosed to authorized personnel on a Need-To-Know basis;

c. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5. Protection of Sensitive Information- For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

6. Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

7. Internet Protocol Version 6 (IPv6)- All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8. Government Websites- All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9. Contract Documentation- The Contractor shall use provided templates, policies, forms and other agency documents provided by the Contracting Officer and the Contracting Officer's Representative to comply with contract deliverables as appropriate.

10. Standard for Encryption- The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative within 15 days of the validation .

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

11. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

12. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)- The Contractor shall assist the NIH Office of the Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed. The NIH PIA guide is located at https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf .

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the OpDiv

SOP or designee with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

b. The Contractor shall assist the NIH Office of the SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. TRAINING

1. Mandatory Training for All Contractor Staff- All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

2. Role-based Training- All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx

3. Training Records- The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy.