2-SSN Posting_SAM.gov.pdf

SOURCES SOUGHT NOTICE (SSN)

Laboratory Services for

“A Girls First Period Protocol 19-E-0110” Agency: NIH/National Institute of Environmental Health Sciences (NIIEHS)

Office: Office of Acquisitions (OA)

SSN Document #: 75N96024Q00041

Purpose This announcement constitutes a Sources Sought Notice (SSN) in accordance with FAR Part 15.201(e) – Exchanges with Industry. THIS SSN DOES NOT CONSTITUTE A SOLICITATION (e.g., Invitation for Bids (IFB), Request for Proposal (RFP), Request for Quotation (RFQ), etc.) nor is it to be construed as a commitment by the Government. The information requested may be used as market research for planning purposes and to facilitate decision making (i.e., acquisition strategy determinations, availability of capable small business concerns, etc.). The information submitted will not be disclosed outside the Government. Proprietary information submitted shall be appropriately marked (see SSN Section 6 – Other SSN Administrative Information for additional information relating to Contractor proprietary information).

Despite being a Small Business Sources Sought / SSN, NIEHS does encourage responses from capable businesses of all sizes (i.e., small and large business concerns), to include all the socioeconomic categories.

NOTE: The Government will not be responsible for any costs incurred by interested parties in responding to this SSN (or any possible Government follow-up questions / meetings relating to this SSN).

Not responding to this SSN does not preclude participation in any potential future solicitation.

1 DESCRIPTION

The National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS) is seeking sources that possess the capability to perform comprehensive laboratory

75N96024Q00041 Page 1 of 19 services for “A Girls First Period (IRB Protocol 19-E-0110)”, including testing hormones from minimal samples collected from participants enrolled over the next 3 years. The study utilizes dried urine and dried blood spot cards, ultimately benefiting the study participant because they are minimally invasive and require a smaller collection of a blood or urine specimen. A smaller collection also provides better utilization of care for the participant. In addition, the cards are easily stored and transported.

The vendor is expected to accurately extract and analyze hormones in dried blood spots and dried urine cards from both pediatric and adult participants.

The vendor will need to test 4 hormones (LH, E1G, PdG, Cr) on approximately 8000 dried urine samples per year that will be collected from study participants. In addition, the vendor will need to test 9 hormones (Testosterone, T4, SHBG, Insulin, LH, FSH, Estradiol, Progesterone, and TSH) from dried blood spots on approximately 15 filter cards per year.

The Statement of Work (SOW) has been attached for reference purposes and includes additional requirement details.

PLACE OF PERFORMANCE

The Contractor’s place of performance shall be anywhere in the United States.

ESTIMATED PERIODS OF PERFORMANCE

Period Period Length Period Start Date Period End Date Base Period 36 months 06/01/2024 05/31/2027

2 BACKGROUND

2.1 PROGRAM INFORMATION

The Clinical Research Branch (CRB) conducts or oversees clinical research studies within the Division of Intramural Research (DIR), National Institute of Environmental Health Sciences (NIEHS). The objectives of these studies are to: 1) translate basic laboratory findings to clinical applications; 2) investigate the interaction between genetic susceptibility and environmental factors as they relate to complex traits and disease in human populations; and 3) intervene in disease development and/or progression by modifying these factors using preventative, therapeutic, and other techniques, or by altering environmental exposures, diet and lifestyles.

2.2 CURRENT CONTRACT

Incumbent Contract Number: None Incumbent Contractor: N/A Incumbent Contract Type: N/A

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Incumbent Award Value: N/A Incumbent Contract Acquisition Strategy: N/A Incumbent Contract Period of Performance: N/A

3 INFORMATION REQUESTED

Interested Parties in assisting NIEHS with this market research are requested to submit the following information in the format of a White Paper outlined below. The response should be concise (no more than 20 pages), 11 pt Calibri font, and address only the information requested below. Bulleted lists and summaries are acceptable. (Note: title pages, cover letters, etc., will not count against the total page limit).

Generic capability statements will not be provided to the requirements team for review.

Interested Parties shall provide the following information:

I. COMPANY INFORMATION

a. Company Name

b. UEI

c. CAGE Code

d. Point of Contact Name, Phone Number, and E-mail Address

e. Company Website

f. ALL government contract vehicles under which the Company holds contracts (e.g., GSA Federal Supply Schedule (FSS), NITAAC, OASIS, etc.)

II. BUSINESS SIZE

a. The anticipated NAICS for this effort is 621511 Medical Laboratories. The Small

Business Administration (SBA) small business size standard for this NAICS code is $41.5M.

b. Based on the NAICS 621511, identify your business size as Small or Large.

c. If a small business concern, identify which, if any, of the below small business socio-economic categories are applicable:

Small Disadvantaged Business (SDB

Woman-Owned Small Business (WOSB)

Economically Disadvantaged Woman-Owned Small Business (EDWOSB)

Veteran-Owned Small Business (VOSB)

Service-Disabled Veteran-Owned Small Business (SDVOSB)

HUBZone Small Business (HZ)

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d. If your company is an Other Than Small Business (OTSB) concern (i.e., large business), have you partnered or subcontracted with small business concerns to provide the same or similar services as this requirement?

III. CAPABILITIES

a. Generally, describe your company’s capabilities in fulfilling the requirements of the attached draft Statement of Work.

b. Specifically, address the information in subparagraphs i. through iv. below:

i. Concisely describe your company’s ability to perform the work described in the below areas. Include supporting information which demonstrates your company’s knowledge / capability to meet the requirements of the SOW tasks.

Supporting information shall not reiterate the language of the tasks provided in the SOW; rather it shall provide details regarding your company’s knowledge/ capability to execute these tasks. NIEHS is not asking for disclosure of specific or detailed innovative solutions; however, specific examples would assist the

Government with this SSN.

If your company does not have direct experience, please explain how you would perform tasks utilizing experienced subcontractors, through a proposed contract teaming arrangement (CTA) or hiring qualified personnel.

The specific areas are the following:

a) The vendor's ability to provide filter cards to the CRB for dried blood spot collection and filter cards for dried urine collection.

b) The vendor's ability to measure LH, E1G, PdG, Cr extracted from dried urine samples collected on filter cards. There will be approximately 666 dried urine cards per month submitted for testing for a total of 8000 dried urine cards over 12 months.

c) The vendor's ability to measure T, T4, SHBG, Insulin, LH, FSH, E2, Pg and TSH from dried blood spots collected on filter cards. There will be approximately 15 blood cards submitted for testing over 12 months.

d) The vendor's ability to provide results within 5 to 7 business days of receiving the samples for testing. Results will be transferred from the vendor to CRB via Kiteworks, a secure file transfer. Results will include ratios of LH/Crtn, E1G/Crtn, PDG/Crtn, and PDG/E1G for dried urine.

ii. Has your company performed work of the same or similar scope as this requirement within the last three (3) years? Please explain.

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For any contracts or projects for the same or similar work performed by your company within the last three (3) years, please provide the following information relating (no more than three (3) examples; government or commercial contracts):

Brief Description of the Contract/Project Contract Number Period of Performance Contract Type(s) (e.g., FFP, T&M, Labor-Hour (LH), etc.)

Commercial or Non-Commercial Requirement?

Was your company a prime or subcontractor?

Contract/Project Dollar Value Scope of the portion of the effort your company supported

iii. Provide additional relevant experience/ information that demonstrate your company’s capabilities.

4 SSN SUBMISSION INSTRUCTIONS

4.1 QUESTIONS

Questions regarding this SSN shall be received no later than 12:00 PM (Noon) Eastern Standard Time (EST) on May 22, 2024. Questions received by the due date/time will be answered and provided to all respondents in the form of an SSN Amendment. Questions received after the due date/time may not be answered.

Questions shall be submitted in writing via e-mail to Odessa McGlown at Odessa.mcglown@nih.gov and shall reference this SSN.

4.2 SSN RESPONSES

Responses to this SSN shall be received no later than 12:00 PM (Noon) EST on May 29, 2024 as identified the SSN’s online SAM.gov posting. (If there is a difference in SSN response date/time between this document and the online posting, the online posting shall take precedence.)

Responses shall be submitted electronically via e-mail to Odessa McGlown at Odessa.mcglown@nih.gov, and shall reference this SSN.

All SSN responses will be reviewed and utilized for market research.

4.3 SSN POINTS OF CONTACT

Contract Specialist: Odessa McGlown

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Contracting Officer: Odessa McGlown

5 OTHER SSN ADMINISTRATIVE INFORMATION

All information received in response to this notice that is marked “Proprietary” will be handled accordingly. The Government reserves the right to use any non-proprietary information submitted by, or obtained from, a Respondent in any manner NIEHS determines is appropriate including, but not limited to, the creation of a competitive solicitation. Any proprietary data that is included in the response must be marked appropriately at the paragraph level (or at a more granular level as required; page level is acceptable for full page table, graphs, etc.). Any response marked proprietary at the document level will not be considered.

NIEHS personnel may contact any company responding to this SSN to clarify its capabilities/product/ other matters as part of its market research.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to Responders with respect to any information submitted. Responses to this notice will not be returned.

6 ATTACHMENT(S)

Attachment 1: Statement of Work (SOW)

7 FAR PROVISIONS

The following provision is applicable to this notice and is hereby incorporated by reference:

FAR 52.215-3: Request for Information or Solicitation for Planning Purposes (Oct 1997).

The full text of this provision is available at: https://www.acquisition.gov/far/52.215-3.

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Statement of Work (SOW) Laboratory Services for “A Girls First Period

Protocol 19-E-0110”

Office of Acquisitions 04/29/2024

75N96024Q00041 Page 7 of 19

Statement of Work

TABLE OF CONTENTS

1.0 Introduction 2

1.1 Background 2

1.2 Scope 2

1.3 Objectives 3

2.0 Requirements 3

2.1 Tasks 3

2.2 Deliverables 4

2.3 Schedule 4

2.4 Assumptions 5

3.0 Government Furnished Property 5

4.0 Security Requirements 5

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1.0 INTRODUCTION/OVERVIEW

The study, A Girls First Period (IRB Protocol 19-E-0110), aims to obtain a better understanding of normal hormonal dynamics during the transition from menarche to the establishment of mature ovulatory cycles – a prerequisite for fertility. The study began in 2019 and is expected to complete in 2029. Over the last 5 years, 78 participants have enrolled towards the 350-accrual goal.

A vendor is needed to perform comprehensive laboratory services for this study, including testing hormones from minimal samples collected from participants enrolled over the next 3 years. The study utilizes dried urine and dried blood spot cards, ultimately benefiting the study participant because they are minimally invasive and require a smaller collection of a blood or urine specimen. A smaller collection also provides better utilization of care for the participant. In addition, the cards are easily stored and transported.

The vendor is expected to accurately extract and analyze hormones in dried blood spots and dried urine cards from both pediatric and adult participants.

The vendor will need to test 4 hormones (LH, E1G, PdG, Cr) on approximately 8000 dried urine samples per year that will be collected from study participants. In addition, the vendor will need to test 9 hormones (Testosterone, T4, SHBG, Insulin, LH, FSH, Estradiol, Progesterone, and TSH) from dried blood spots on approximately 15 filter cards per year.

1.1 BACKGROUND

The Clinical Research Branch (CRB) conducts or oversees clinical research studies within the Division of Intramural Research (DIR), National Institute of Environmental Health Sciences (NIEHS). The objectives of these studies are to: 1) translate basic laboratory findings to clinical applications; 2) investigate the interaction between genetic susceptibility and environmental factors as they relate to complex traits and disease in human populations; and 3) intervene in disease development and/or progression by modifying these factors using preventative, therapeutic, and other techniques, or by altering environmental exposures, diet and lifestyles.

1.2 SCOPE

The CRB expects to collect, analyze, reference and store blood and urine biomarkers to contribute towards our understanding of the interaction between genetics, environment and human health and disease. This a continuation of similar and related studies that were performed previously.

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1.3 OBJECTIVES

The objectives of these studies are to: 1) translate basic laboratory findings to clinical applications; 2) investigate the interaction between genetic susceptibility and environmental factors as they relate to complex traits and disease in human populations; and 3) intervene in disease development and/or progression by modifying these factors using preventative, therapeutic, and other techniques, or by altering environmental exposures, diet and lifestyles.

2.0 REQUIREMENTS

Independently and not as an agent of the Government, the vendor shall furnish all the necessary services, qualified personnel, material, equipment and facilities not otherwise provided by the Government to perform the following tasks:

a) The vendor must describe the method for extraction of blood or urine from the filter paper collection cards.

b) The vendor must describe the analysis methodology for assay of the 4 hormones (LH, E1G, PDG, and Crtn) being measured from dried urine cards.

c) The vendor must describe the analysis methodology for assay of the tests (T, T4, SHBG, Insulin, LH, FSH, E2, Pg and TSH) being measured from dried blood cards.

d) The vendor will be required to develop assay controls necessary to provide quality results of the above listed hormones.

e) The government retains all rights to data and must be provided all technical information including but not limited to formulations of reagents used in assay if requested, and instrumentation type used for the analysis.

2.1 TASKS

The vendor shall supply all labor, materials, equipment, facilities and supplies not otherwise provided by the government under the terms of this contract to perform the following tasks:

a) The vendor must provide filter cards to the CRB for dried blood spot collection and filter cards for dried urine collection.

b) Dried blood and urine samples will be collected from study participants on the cards by CRB staff and shipped to the vendor with attached label containing Subject ID, collection date/time, sample type (urine card or blood card), and BioSpecimen Inventory (BSI) Sample Identification.

c) On the day of the shipment, a copy of the manifest with the list of samples shipped and requested tests will be sent from the CRB to the vendor via Kiteworks, a secure file transfer.

75N96024Q00041 Page 10 of 19

d) The vendor will measure LH, E1G, PdG, Cr extracted from dried urine samples collected on filter cards. There will be approximately 666 dried urine cards per month submitted for testing for a total of 8000 dried urine cards over 12 months.

e) The vendor will measure T, T4, SHBG, Insulin, LH, FSH, E2, Pg and TSH from dried blood spots collected on filter cards. There will be approximately 15 blood cards submitted for testing over 12 months.

f) The vendor will provide results within 5 to 7 business days of receiving the samples for testing.

g) Results will be transferred from the vendor to CRB via Kiteworks, a secure file transfer.

h) Results will include ratios of LH/Crtn, E1G/Crtn, PDG/Crtn, and PDG/E1G for dried urine.

2.2 DELIVERABLES

The vendor will provide the following deliverables:

a) The vendor will supply poster absorbent type filter paper strips and cards for collection of urine and blood samples, respectively.

b) CRB will furnish to the vendor the biological samples for analysis along with a listing of samples by date and subject identification number and instructions on which hormones shall be measured on each sample, with further indication of whether the hormone is to be measured in urine and/or blood samples. No additional equipment or supplies will be furnished under this contract.

c) CRB will ship biological materials per vendor’s instruction in a suitable and protective container.

d) The vendor will notify CRB of receipt of materials on the same day as receipt.

e) The vendor will send results from testing to the individual CRB investigator within 5 to 7 business days of receiving the samples for testing via Kiteworks, a secure file transfer.

f) Any other data files with results will be transmitted to the individual CRB investigator via

Kiteworks, a secure file transfer system.

g) Routine administrative documents including invoicing will not contain Personally

Identifiable Information (PII).

h) The vendor will provide published medical references to attest their expertise and experience with accurately extracting and analyzing hormones in dried blood and dried urine spots provided on a filter cards.

2.3 SCHEDULE

The period of performance for this contract is three years from the date of award.

a) The vendor must provide filter cards to the CRB for dried blood spot collection and filter cards for dried urine collection.

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b) Dried blood and urine samples will be collected from study participants on the cards by CRB staff and shipped to the vendor with attached label containing Subject ID, collection date/time, sample type (urine card or blood card), and BSI Sample ID.

c) On the day of the shipment, a copy of the manifest with the list of samples shipped and requested tests will be sent from the CRB to the vendor via Kiteworks, a secure file transfer.

d) The vendor will complete all sample extraction and processing at the vendor’s location.

The vendor will measure LH, E1G, PdG, Cr extracted from dried urine samples collected on filter cards. There will be approximately 666 dried urine cards per month submitted for testing for a total of 8000 dried urine cards over 12 months.

The vendor will measure T, T4, SHBG, Insulin, LH, FSH, E2, Pg and TSH from dried blood spots collected on filter cards. There will be approximately 15 blood cards submitted for testing over 12 months.

e) The vendor will provide results within 5 to 7 business days of receiving the samples for testing.

f) Results will be transferred from the vendor to CRB via Kiteworks, a secure file transfer.

Results will include ratios of LH/Crtn, E1G/Crtn, PDG/Crtn, and PDG/E1G for dried urine.

2.4 ASSUMPTIONS

N/A

2.5. PLACE OF PERFORMANCE

All testing shall be performed at the contractor’s facility.

3.0 GOVERNMENT FURNISHED PROPERTY

No government furnished property will be provided.

4.0 SECURITY REQUIREMENTS

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

PROCUREMENTS is attached.

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APPENDIX A - HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND 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: [ ] Low [ X ] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High Availability: [ ] Low [ X ] Moderate [ ] High Overall Impact Level: [ ] Low [ X ] Moderate [ ] High

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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 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:

[ ] No PII [ X ] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency 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.

The Contractor must support the agency 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.

d. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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, 75N96024Q00041 Page 14 of 19

(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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

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

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

iv. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800- 88, Guidelines for Media Sanitization.

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. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with

OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

h. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

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i. 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.

j. 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. 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

75N96024Q00041 Page 16 of 19 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)."

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

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.

3. 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

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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.

4. 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-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

75N96024Q00041 Page 18 of 19 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.

5. 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 record without proper authorization, he/she must document and report the incident in accordance with HHS/ NIH policies.

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