3-CSS_75N96024Q00019.pdf

NIEHS, Office of Acquisitions

CENTRALIZED MEDIA PROCESSING AND GLASSWARE SERVICES

Combined Synopsis/Solicitation for Commercial Products and Commercial Services

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

Document Type:

Solicitation Number:

Posted Date:

General Information

Combined Solicitation/Synopsis 75N96024Q00019 March 13, 2024

Original Response Date: April 4, 2024@11:00AM

Current Response Date: April 4, 2024@11:00AM Product or Service Code: S201 Set Aside: Small Business – 100% NAICS Code: 561210

Contracting Office Address

530 Davis Drive Morrisville, NC 27560

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” and Part 13, Simplified Acquisition Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

75N96024Q00019

This solicitation is a request for quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-03 published in the Federal Register on February 23, 2024.

The associated North American Industrial Classification System (NAICS) code for this procurement is 561210, Facilities Support Services with a small business size standard of $47.0M.

The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina (RTP), is one of the 27 Institutes and centers composing the National Institutes of Health (NIH). The mission of NIEHS is dedicated to reducing the burden of diseases and dysfunctions associated with the environment. This mission is accomplished by conducting basic and applied research into the effects of environmental exposures on biological systems and human health; on the identification of susceptible human subpopulations; and on the interaction between the environment, genetics and age.

The purpose of this effort is to provide on-site personnel to complete the actions and tasks necessary to provide centralized media processing and glassware services.

All interested companies shall provide quotation(s) for the following services in accordance with the Statement of Work (SOW) contained herein.

The period of performance is for a one-year base period and four one-year option periods.

Place of Performance Address: 111 T.W. Alexander Drive

RTP, NC 27709

Country: United States

Award shall be made to the quoter whose quote is found to be in the best interest of the government, considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: (1) technical capability factor meeting or exceeding the requirement, (2) past performance, and (3) price.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” (Sep 2023)

2. FAR 52.212-2, “Evaluation – Commercial Items” (Nov 2021)

3. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (Feb 2024) http://acquisition.gov/comp/far/index.html

Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

• FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (Feb 2024)

• FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (Feb 2024)

All quoters shall submit one copy of quote via e-mail to the Contracting Officer, Odessa McGlown, Odessa.mcglown@nih.gov. Submission of quotes shall be received not later than April 4, 2024, at 1100 AM EST via e- mail to Odessa.mcglown@nih.gov. Late submissions shall be treated in accordance with the solicitation provision at 52.212-1(f). Only e-mailed quotes will be accepted.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Contracting Officer at odessa.mcglown@nih.gov Questions shall be received until March 19, 2024, at 11:00 AM EST.

This is an open-market combined synopsis/solicitation for services as defined herein. The government intends to award a Firm Fixed Price Purchase Order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

75N96024Q00019 mailto:Odessa.mcglown@nih.gov mailto:Odessa.mcglown@nih.gov mailto:odessa.mcglown@nih.gov mailto:Odessa.mcglown@nih.gov

1. SUPPLIES OR SERVICES AND PRICING/COSTS

1.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide reliable, efficient, compliant service of Glassware and Media support to the National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, North Carolina.

1.2 GENERAL - CONTRACT TYPE

The Government contemplates award of a single source, Firm Fixed Price contract in accordance with Federal Acquisition Regulation (FAR) Part 12 – Acquisition of Commercial Products and Services, in conjunction with FAR Part 13 - Simplified Acquisition Procedures.

1.3 CONTRACT LINE ITEMS AND PRICING

1.3.1 LINE ITEMS AND PRICE SCHEDULE

Firm Fixed Price Services

Glassware and Media Support Services Line Item

Description Quantity Unit Price Total Price

1 Base Period: Glassware and Media Support (05/01/2024-04/30/2025)

2 Option Period 1: Glassware and Media Support (05/01/2025-04/30/2026)

3 Option Period 2: Glassware and Media Support (05/01/2026-04/30/2027)

4 Option Period 3: Glassware and Media Support (05/01/2027-04/30/2028)

5 Option Period 4: Glassware and Media Support (05/01/2028-04/30/2029)

6 Option to Extend (up to 6 months): Glassware and Media Support (05/01/2029-10/31/2029)

2. STATEMENT OF WORK

I. Introduction and Background

The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina (RTP), is one of the 27 Institutes and centers composing the National Institutes of Health (NIH). The mission of NIEHS is dedicated to reducing the burden of diseases and dysfunctions associated with the environment. This mission is accomplished by conducting basic and applied research into the effects of environmental exposures on biological systems and human health; on the identification of susceptible human subpopulations; and on the interaction between the environment, genetics, and age.

II. Scope and Requirements

The purpose of this effort is to provide on-site personnel for the preparation of biological media, tissue cultures, and “buffers” as well as washing, sterilizing, stocking, issuance, and collection of glassware.

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services and qualified technical personnel, not otherwise provided by the Government to provide preparation of biological media, tissue cultures, and “buffers”, as well as washing, sterilizing, issuance, and collection of glassware as required at the NIEHS in RTP.

Additionally, the Contractor shall provide restocking service for disposable plastic ware and service to prepare sterile custom media using Government-furnished chemicals and media supplies.

The Contractor shall provide trained personnel with experience in preparation of sterile custom media and sterile laboratory glassware. All workmanship performed by the Contractor shall be of acceptable industry standard quality and shall be immediately rectified at no additional cost to the Government upon notification of non-acceptability by the Government. In addition, the Contractor shall observe commercially accepted safety and precautionary procedures pertaining to handling of laboratory equipment and biological and chemical materials. The Contractor shall provide and require its employees to use appropriate personal protective equipment (i.e. safety glasses, uniforms, safety shoes, respiratory protection, etc.) as provided by the Government.

See complete Statement of Work (Attachment 1).

3. PACKAGING, MARKING AND SHIPPING

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

The reports shall be delivered F.O.B. Destination as set forth in FAR Clause 52-247-35, F.O.B.

Destination, Within Consignee Premises (April 1984). Unless otherwise specified, deliveries shall be made to the Delivery Point specified Mondays through Fridays (excluding Federal Holidays and Executive Orders).

4. INSPECTION AND ACCEPTANCE TERMS

4.1 INSPECTION AND ACCEPTANCE REQUIREMENTS

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

a. For the purpose of this section, the contract COR is the authorized representative of the Contracting Officer.

b. Inspection and acceptance will be performed at:

111 TW Alexander Drive Research Triangle Park, NC 27709

All work under this contract is subject to inspection and final acceptance by the Contracting Officer or duly authorized representative of the Government.

The Government’s Contracting Officer’s Representative (COR) is a duly authorized representative of the Government and is responsible for inspection and acceptance of all items to be delivered under this contract. Unless otherwise specified in the contract, or by the COR, the general quality measures, as set forth below, will be applied to each work product received from the Contractor.

The Government reserves the right to an Inspection period of 7 calendar days, unless a different time period is stated when (the Record of Call/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

PERFORMANCE REQUIREMENT SUMMARY

The Government will monitor the Contractor performance under this contract and shall retain the right to perform unscheduled inspections, as it deems necessary. Furthermore, the Government retains all rights provided by the Federal Acquisition Regulations (FAR) clause entitled Inspection of Services Fixed Price and any other inspection clause, which may be specified in the contract. The COR and/or the Alternate COR will monitor the Contractor’s activities and accomplishments and will indicate acceptance or non-acceptance of the deliverables. The deliverables identified below will be inspected and either approved or, if they are not acceptable, rejected by the COR and/or the Alternate COR. Such inspections will occur as determined to be necessary by the COR and/or Alternate COR.

The Contractor shall provide a copy of each deliverable in draft format to the COR and other program personnel as instructed by the COR. Within ten (10) business days of receipt (or as set forth in the individual task orders), the COR or designee will review the deliverable and suggest any changes and/or accept or reject the deliverable.

In the event the Government rejects any deliverable, the COR shall notify the Contractor in writing explaining the specific reason(s) for the rejection. If the Government suggests changes, or rejects, the Contractor shall resubmit the revised deliverable within ten (10) business days (or as set forth in the individual task orders) after receiving the Government’s input.

If the Contractor does not receive suggestions or comments within ten (10) business days of submitting a deliverable, the Government has accepted the deliverable unless stated otherwise by the COR.

The Contractor shall make all documentation available in a designated area that is accessible to the COR or their designee.

Deliverables are scalable relative to the risk, size and complexity of the project. The Contractor shall work with the Government to determine the appropriate level of deliverables and milestones to ensure a successful outcome.

All deliverables and other contract work products shall be considered to be solely owned by the Government and shall not be labeled ‘copyright’, ‘proprietary’ or anything similar that might preempt the desired environment of fluid sharing and partnership. The Contractor shall provide to the Government access to all work products including but not limited to: research, designs, code, constructs, databases, and documentation.

Inspection and acceptance shall be performed either at 111 T.W. Alexander Drive, Research Triangle Park, NC, 27709 or at 530 Davis Drive, Morrisville, NC, 27560.

5. PERFORMANCE

5.1 PERIOD OF PERFORMANCE/DELIVERY DATE/ORDERING PERIOD

a. The period of performance of this contract shall be from 05/01/2024 through 04/30/2029.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION of this contract, the period of performance will be increased as listed below:

Glassware and Media Support Services

Period Deliverable Period of Performance

Base Period Glassware and Media Support 05/01/2024-04/30/2025

Option Period 1 Glassware and Media Support 05/01/2025-04/30/2026

Option Period 2 Glassware and Media Support 05/01/2026-04/30/2027

Option Period 3 Glassware and Media Support 05/01/2027-04/30/2028

Option Period 4 Glassware and Media Support 05/01/2028-04/30/2029

Option to Extend (up to 6 months) Glassware and Media Support 05/01/2029-10/31/2029

The total period of performance for this effort shall be for a base period of twelve months and four twelve-month option periods. This solicitation/contract also includes the clause at FAR 52.217-8, “Option to Extend Services”. The total period of performance shall not exceed five years and six months if that clause is exercised.

PLACE OF PERFORMANCE/DELIVERY

The Government expects all work to be performed at the Contractor’s site. The Government’s physical location is:

NIEHS Campus National Institute of Environmental Health Sciences 111 T.W. Alexander Drive Research Triangle Park, NC USA 27709

5.2 HOURS OF OPERATIONS, HOLIDAYS, AND CLOSINGS

The normal hours of operation are 8:30 A.M. to 5:00 P.M. Eastern Time (ET), Monday through Friday, exclusive of Government holidays and closings.

The Government is closed on the holidays and closings listed below. Specific dates for the holidays can be found at the Office of Personnel Management (OPM) website located at:

https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/#url=Overview

• New Year’s Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Independence Day

• Juneteenth National Independence Day

75N96024Q00019 https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/#url=Overview https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/#url=Overview

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

• Any other day designated by Federal statute

• Any other day designated by Executive Order

• Any other day designated by the President

• Unscheduled closings mandated by the Government (e.g., weather emergencies, etc.)

In the case of a Government shutdown caused by a failure to pass funding legislation to finance the Government, the Contractor shall seek guidance from the COR.

Observance of the days listed above by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the Contract. In addition, the Contractor shall obtain additional blackout dates from the COR.

6. CONTRACT ADMINISTRATION DATA

6.1 GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO):

Odessa McGlown Odesssa.McGlown@nih.gov

Contracting Officer’s Representative (COR):

TBD

TBD

6.2 CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of the contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO, including work outside the scope of the contract.

6.3 CONTRACTING OFFICER’S REPRESENTATIVE

The Contracting Officer’s Representative (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.

The Government may unilaterally change its COR designation.

6.4 CONTRACTOR KEY PERSONNEL

KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

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

(End of Clause)

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

6.5 TRAVEL

There are no reimbursable travel costs authorized under this contract.

6.6 GENERAL INVOICING INSTRUCTIONS

All invoices shall meet the requirements of Federal Acquisition Regulation (FAR) Subpart

32.9. Detailed invoicing instructions are as follows: See Attachment 4.

6.7 CONTRACTOR PERFORMANCE EVALUATIONS

a. Contractor Performance Evaluations

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

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

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

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov.

Name Title TBD Project Manager http://www.cpars.gov/

7. SPECIAL CONTRACT REQUIREMENTS

7.1 SECURITY

APPENDIX A - HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION IT PROCUREMENTS

SECTION A - INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

1. Baseline Security Requirements

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

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

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

ii. 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/NIH policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

• 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.

ii. Categorize all information owned and/or collected/managed on behalf of HHS/NIH and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories. Based on information provided by the NIEHS ISSO, NIEHS SOP, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ X ] Low [ ] Moderate [ ] High Integrity: [ X ] Low [ ] Moderate [ ] High Availability: [ X ] Low [ ] Moderate [ ] High Overall Impact Level: [ X ] Low [ ] Moderate [ ] High

75N96024Q00019 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/NIH regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/NIH 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 all applicable security and privacy policies by contacting the CO/COR or HHS/NIH security and/or privacy officials.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/NIH/NIEHS privacy policies, and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (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.

ii. Based on information provided by the ISSO, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ X ] No PII [ ] PII

e. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

f. 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must 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 must 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 must 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:

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

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

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

g. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents. NIH will specify which documents/forms will be provided to comply with contract deliverables as appropriate.

h. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

iii. 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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR within 15 days of the validation.

v. 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 http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

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

2. Training Requirements

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

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based

75N96024Q00019 http://csrc.nist.gov/publications/ https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf http://irtsectraining.nih.gov/ 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 at:

https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/security-awareness-training/index.html .

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual NIH Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. In accordance with OMB M- 17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

b. In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) must:

75N96024Q00019 https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/security-awareness-training/index.html https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/security-awareness-training/index.html

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

ii. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor must send NIH approved notifications to affected individuals in accordance with https://wiki.ocio.nih.gov/wiki/index.php/US- CERT_Federal_Incident_Notification_Guidelines .

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the NIEHS ISSO team via e-mail at isso@niehs.nih.gov, NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov , COR, CO, NIH/NIEHS SOP (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable NIH/NIEHS and HHS policy and procedures, NIST standards and guidelines, as well as US- CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

Not include any sensitive information in the subject or body of any reporting e-mail; and

Encrypt sensitive information in attachments to email, media, etc.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally

Identifiable Information, and HHS/NIH and NIH privacy breach response policies when handling PII breaches.

v. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls.

This may also involve physical access to contractor facilities during a breach/incident investigation within an hour of discovery.

5. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and “Q” access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

75N96024Q00019 https://wiki.ocio.nih.gov/wiki/index.php/US-CERT_Federal_Incident_Notification_Guidelines https://wiki.ocio.nih.gov/wiki/index.php/US-CERT_Federal_Incident_Notification_Guidelines mailto:isso@niehs.nih.gov mailto:IRT@mail.nih.gov

[ ]Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and “L” access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[ X ] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

6. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12

7. Roster

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO within fourteen (14) calendar days of the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for Contractor use at: https://oamp.od.nih.gov/nih-document-generation- system/dgs-workform-information/attachment-files-section-j If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Directive (2018) located at:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive- 2018.pdf . HHS EA requirements are located at: https://www.hhs.gov/web/governance/digital-

75N96024Q00019 https://www.dhs.gov/homeland-security-presidential-directive-12 https://www.dhs.gov/homeland-security-presidential-directive-12 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 https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html and NIH EA requirements are located at: https://ocio.nih.gov/PM/Pages/EPLC.aspx .

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within fifteen days before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The Contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the NIH Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS Policy for Records Management and NIH policies and must not dispose of any records unless authorized by HHS/

NIH.

b. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a oper authorization, he/she must document and report the incident in accordance with HHS/ NIH policies.

10. Physical Access to Government Controlled Facilities

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

75N96024Q00019 https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html https://ocio.nih.gov/PM/Pages/EPLC.aspx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf

7.2 COORDINATION WITH OTHER PERFORMING ACTIVITIES

The Contractor shall coordinate with NIEHS employees, other federal employees and third-party contractor personnel to meet the requirements of this contract. Examples include security and continuity functions, application and Web development, audits, inspections, program and project management, delivery services, construction, and telecommunication services. The NIEHS COR will notify the CO prior to facilitating initial contact between the Contractor and other third-party contractors performing work for NIEHS, as necessary.

7.3 NON-PERSONAL SERVICES

In accordance with FAR Subpart 37.104(b), Personal services contracts, no personal services shall be performed under this Contract. No Contractor employee will be directly supervised by a Government employee. All individual contractor 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.

7.4 INHERENTLY GOVERNMENTAL FUNCTIONS

The Contractor shall not perform any inherently governmental actions under this contract as defined by FAR Subpart 7.5. 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 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 the contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

7.5 ORGANIZATIONAL CONFLICT OF INTEREST

Organizational conflict of interest” means that because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person's objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage. (FAR 2.101) An organizational conflict of interest may result when factors create an actual or potential conflict of interest on an instant contract, or when the nature of the work to be performed on the instant contract creates an actual or potential conflict of interest on a future acquisition. In the latter case, some restrictions on future activities of the contractor may be required. (FAR 9.5) The Contractor shall proactively manage Organizational Conflicts of Interest (OCI) to minimize and negate adverse impacts.

7.6 SUBCONTRACTING AND TEAMING

The use of subcontractors is permitted under this contract with approval granted from the CO and COR. A subcontracting plan shall be submitted as part of the quote to the CO and must be approved prior to onboarding any subcontract staff.

7.7 RIGHTS IN DATA

The Contractor agrees that upon completion (or termination with or without cause) of this contract, it shall have no property or possessor rights to any of the correspondence, files, or materials of whatever kind or description, or any copies or duplicates of such, whether developed or prepared by it or furnished to it by the Government in connection with the performance of this contract; and that upon demand it shall surrender immediately to the CO such items, matters, materials, and copies.