SOL_75N97026R00001_NLM_Subx.pdf

SECTION

15A. NAME AND

ADDRESS

OF OFFEROR

SOLICITATION, OFFER, AND AWARD 1. This Contract is a Rated Order under the Defense Priorities and Allocations System (DPAS) - Code of Federal Regulations - at 15 CFR 700.

RATING PAGE

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

8. ADDRESS OFFER TO (If other than item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishings the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision Number 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR

INFORMATION

CALL:

A. NAME B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER EXTENSION

11. TABLE OF CONTENTS

(X) DESCRIPTION PAGE(S) (X) SECTION PAGE(S)DESCRIPTION

A B

C D E F G H

I

J

K

L

M EVALUATION FACTORS FOR AWARD

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

LIST OF ATTACHMENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause Number 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%)

DATEAMENDMENT NUMBERAMENDMENT NUMBER DATE

CODE FACILITY 16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

AREA CODE NUMBER EXTENSION

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL OPEN COMPETITION UNDER THE

UNITED STATES CODE AT:

10 U.S.C. 3204(a) ( )41 U.S.C. 3304(a) (

24. ADMINISTERED BY (If other than Item 7)

26. NAME OF CONTRACTING OFFICER (Type or print)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

25. PAYMENT WILL BE MADE BY

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

CODE

ITEM

STANDARD FORM 33 (REV. 12/2022)

Prescribed by GSA - FAR (48 CFR) 53.214 (c)

SEALED BID (IFB) INVITATION FOR BID

NEGOTIATED (RFP) REQUEST FOR

PROPOSAL

(Hour) (Date)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

15B. TELEPHONE NUMBER

CODE

OF PAGES

75N97026R00001

C. EMAIL ADDRESS

sneha.singh@hhs.gov

7. ISSUED BY CODE

Health and Human Services National Institutes of Health Bethesda, MD 20817

1300 ES

SNEHA V. SINGH

X

X X X X X X X X

X X

X

X

X X until local time 04/24/2026

SNEHA V. SINGH

Table of Contents SECTION A - Solicitation/Contract Form

PART I - THE SCHEDULE

SECTION B – Supplies or Services and Prices/Costs

B.1 BRIEF DESCRIPTION OF SERVICES

B.2 TYPE OF CONTRACT AND TYPE OF ORDERS

B.3 MINIMUM GUARANTEE

B.4 CONTRACT LINE ITEM NUMBERS (CLINS) – BASE AND OPTION PERIODS

B.5 PRICING NOTES

B.6 TOTAL EVALUATED PRICE

B.7 OPTION TO EXTEND SERVICES (FAR 52.217-8)

B.8 SEVERABLE SERVICES

SECTION C - Description/Specifications/Statement of Work

C.1 SCOPE OF IDIQ/STATEMENT OF WORK

C.2 REPORTING REQUIREMENTS

C.3 INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY REQUIREMENTS

C.4 PROCUREMENTS INVOLVING GOVERNMENT INFORMATION PROCESSED ON GOCO OR

COCO SYSTEMS

C.5 OTHER IT PROCUREMENTS

C.6 HHS DIGITAL ACCESSIBILITY CONFORMANCE STANDARDS – INFORMATION AND

COMMUNICATION TECHNOLOGY

SECTION D - Packaging and Marking

D.1 PACKAGING AND MARKING

D.2 PAYMENT OF POSTAGE AND FEES

SECTION E - Inspection and Acceptance

E.1 INSPECTION AND ACCEPTANCE

SECTION F - Deliveries or Performance

F.1 PERIOD OF PERFORMANCE

F.2 PLACE OF PERFORMANCE

F.3 DELIVERABLES AND DELIVERY SCHEDULE

SECTION G - Contract Administration Data

G.1 CONTRACTING OFFICER REPRESENTATIVE

G.2 AUTHORITIES OF GOVERNMENT PERSONNEL

G.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

G.4 INVOICES

SECTION H - Special Contract Requirements

H.1 KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

H.2 PROHIBITION AGAINST PERSONAL SERVICES

H.3 CONTRACTOR PERFORMANCE EVALUATIONS

H.4 POST AWARD ORGANIZATIONAL CONFLICT OF INTEREST

H.5 CONTRACTOR TRANSITION OUT

H.6 ORDERING PROCEDURES (IDIQ)

H.7 TASK ORDER INFORMATION (IDIQ)

H.8 CONTRACTOR PERSONNEL IDENTIFICATION

H.9 DEVIATED DEFINITIONS

H.10 ACKNOWLEDGEMENT OF FEDERAL FUNDING

H.11 RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

H.12 GUN CONTROL

H.13 OPTION PROVISION

H.14 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

H.15 CATALOG-BASED PRICING FOR SUBSCRIPTION SERVICES

PART II - CONTRACT CLAUSES

SECTION I - Contract Clauses

I.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

I.2 HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3)

CLAUSES

HHSAR 352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (FEB 2022)

I.3 FAR CLAUSES IN FULL TEXT

FAR 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS

(NOV 2021)

FAR 52.203-14 DISPLAY OF HOTLINE POSTER(S) (NOV 2021)

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023)

FAR 52.216-2 ECONOMIC PRICE ADJUSTMENT-STANDARD SUPPLIES (NOV 2021)

FAR 52.216-18 ORDERING (AUG 2020)

FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)

FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995)

FAR 52.217-7 OPTION FOR INCREASED QUANTITY-SEPARATELY PRICED LINE ITEM (MAR

1989)

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

FAR 52.237-3 CONTINUITY OF SERVICES (JAN 1991)

FAR 52.246-16 RESPONSIBILITY FOR SUPPLIES (APR 1984)

FAR 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020)

I.4 HHSAR CLAUSES IN FULL TEXT

HHSAR 352.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY (FEB 2024)

(DEVIATION)

PART III - List of Documents, Exhibits, and Other Attachments

SECTION J - List of Attachments

PART IV - Representations and Instructions

SECTION K - Representations, Certifications, and Other Statements of Offerors or Respondents

K.1 SPECIAL NOTICE

K.2 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM CODE

K.3 FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

K.4 FAR 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

K.5 FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS – COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES. (OCT 2025)

SECTION L - Instructions, Conditions, and Notices to Offerors or Respondents

GENERAL INFORMATION

L.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) PROVISIONS

FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (SEP 2023)

L.2 FULL TEXT FAR PROVISIONS

FAR 52.216-1 TYPE OF CONTRACT. (APR 1984)

FAR 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (NOV 2020)

L.3 FULL TEXT HHSAR PROVISIONS

L.4 TYPE OF CONTRACT

L.5 SERVICE OF PROTEST

L.6 INQUIRIES/SUBMISSION

L.7 ADDITIONAL INSTRUCTIONS

L.8 TECHNICAL PROPOSAL INSTRUCTIONS

SECTION 508 REQUIREMENTS

HHSAR 352.239-78 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY

NOTICE (FEB 2024) (DEVIATION)

L.9 BUSINESS PROPOSAL INSTRUCTIONS

L.10 PAST PERFORMANCE INFORMATION INSTRUCTIONS

L.11 MANDATORY PASS/FAIL REQUIREMENT

SECTION M - Evaluation Factors for Award

M.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE. (FEB 1998) 109

M.2 GENERAL

M.3 AWARD WITHOUT DISCUSSIONS AND COMPETITIVE RANGE DETERMINATIONS

M.4 PASS/FAIL CRITERIA

M.5 BASIS FOR AWARD (TRADE-OFF)

M.6 TECHNICAL EVALUATION METHOD (TRADE-OFF)

M.7 TECHNICAL EVALUATION CRITERIA

M.8 PRICE EVALUATION

M.9 ORGANIZATIONAL CONFLICT OF INTEREST

SECTION A - Solicitation/Contract Form

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN

CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO

THIS SOLICITATION. ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS

SECTION A - SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL

INFORMATION APPLICABLE TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS

CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT

REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF

THIS SOLICITATION. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE

OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE TERMS AND

CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B – Supplies or Services and Prices/Costs

B.1 BRIEF DESCRIPTION OF SERVICES

The purpose of this solicitation and resulting contract is to obtain subscription services and management for biomedical literature published worldwide by multinational, commercial, governmental bodies, and non-commercial organizations, in various formats and languages for the National Library of Medicine.

B.2 TYPE OF CONTRACT AND TYPE OF ORDERS

Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract with Fixed-Price orders, awarded in accordance with FAR Part 12, with pricing based on established commercial catalog or market prices and quantities varying based on Government requirements.

Orders under this IDIQ will be fixed-Price commercial services task order with variable quantity and catalog-based pricing elements

B.3 MINIMUM GUARANTEE

The Government guarantees a minimum quantity or dollar amount of $100,000.00 to be ordered under this contract.

This minimum guarantee will be satisfied through the issuance of one or more task orders during the period of performance.

The minimum guarantee represents the Government’s obligation under this Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract.

B.4 CONTRACT LINE ITEM NUMBERS (CLINS) – BASE AND OPTION PERIODS

The Contractor shall be paid in accordance with the pricing established in each task order.

Base Period

CLIN Description Pricing Type Estimated Cost/Range

Administration / Service Fee Firm-Fixed Price $__________

Subscription Services

Catalog-Based Subscription Orders – Variable Quantity (Fixed-Price with Economic Price Adjustment) NTE: $11,900,000

Consolidation Services (Up to 3,000 Subscriptions) Fixed Unit Price (Ceiling/NTE) $__________

Option Period 1

CLIN Description Pricing Type Estimated Cost/Range

Administration / Service Fee Firm-Fixed Price $__________

Subscription Services

Catalog-Based Subscription Orders – Variable Quantity (Fixed-Price with Economic Price Adjustment) NTE: $12,910,000

Consolidation Services

Option Period 2

Administration / Service Fee Firm-Fixed Price $__________

Subscription Services

Catalog-Based Subscription Orders – Variable Quantity (Fixed-Price with Economic Price Adjustment) NTE: $13,915,000

Consolidation Services

Option Period 3

Administration / Service Fee Firm-Fixed Price $__________

Subscription Services

Catalog-Based Subscription Orders – Variable Quantity (Fixed-Price with Economic Price Adjustment) NTE: $14,920,000

Consolidation Services

Option to Extend Services (FAR 52.217-8) CLIN Description Pricing Type Estimated Cost/Range

Administration / Service Fee Firm-Fixed Price $__________

Subscription Services (online only during this period)

Catalog-Based Subscription Orders – Variable Quantity (Fixed-Price with Economic Price Adjustment) NTE: $6,175,000

Consolidation Services (no consolidation services anticipated during this option) Fixed Unit Price (Ceiling/NTE) $__________

B.5 PRICING NOTES

• Administration/Service Fee: Fixed price for each period of performance.

• Subscription Services: Subscription services shall be ordered on a variable quantity basis using established commercial catalog or market prices. Pricing is subject to Economic Price Adjustment (EPA) in accordance with the terms of the contract and may vary based on publisher offerings, catalog changes, formats, and quantities. Actual obligations are subject to Government need, availability of funds, and market availability of subscription products. The Not-to-Exceed (NTE) amount represents the maximum ordering value for each period of performance.

• Consolidation Services: Consolidation services shall be priced on a fixed unit price basis.

The total number of subscriptions requiring consolidation services shall not exceed 3,000 per period of performance. Actual quantities will vary based on Government requirements.

The CLIN structure provided herein is not intended to be all-inclusive. Offerors are permitted to propose additional CLINs, as appropriate, to fully capture and price all requirements in accordance with Section C – Statement of Work.

B.6 TOTAL EVALUATED PRICE

The total evaluated price shall include:

• Base Period CLINs (0001–0003)

• All Option Year CLINs (1001–4003)

The Government reserves the right to evaluate options in accordance with FAR 52.217-5 and exercise them in accordance with FAR 52.217-9.

B.7 OPTION TO EXTEND SERVICES (FAR 52.217-8)

The Government may require continued performance of any services within the limits and at the rates specified in Option Year 4 of the contract.

The option provision may be exercised more than once but the total extension of performance hereunder shall not exceed six (6) months.

The Government may exercise this option by written notice to the Contractor prior to contract expiration.

B.8 SEVERABLE SERVICES

The services acquired under this contract are severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other CLINs.

END SECTION B

SECTION C - Description/Specifications/Statement of Work

C.1 SCOPE OF IDIQ/STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated February 2026, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

C.2 REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section 508/index.html under "Making Files Accessible.”

Item # Deliverable Frequency 1 Print issues as specified in NLM purchase orders. The Contractor must provide all material published within the paid subscription period. Issues not received must be claimed by the contractor and subsequent reports given as to the disposition of said issues.

As published

2 Schedule for consolidated shipment deliveries including all Contractor sites from which issues will be shipped.

Within 30 days of contract award

3 Claims report containing a listing of all issues that cannot be supplied due to unfulfilled claim or out of print status. Report shall be made available via the contractor’s online system exportable into spreadsheet software such as Microsoft Excel.

Monthly

4 Claims report containing a listing of claim responses received from publishers for titles mailed directly to NLM. Report shall be made available via the contractor’s online system and emailed to the

COR.

Monthly

5 EDI file containing machine-readable equivalent of paper invoice along with one (1) copies of invoices in PDF or DOC format (summary and detailed) emailed to COR, (2) copies of invoice summary in PDF or DOC format emailed to the Office of Acquisitions, and (3) original summary invoice emailed to the Office of Financial Management.

Monthly

6 Subscription status reports detailing cessations, title or frequency changes, format changes, mergers, delays in publication, or other bibliographic irregularities, and publisher or platform changes for

Weekly online subscriptions. Reports shall be made available via the contractor’s online system exportable into spreadsheet software such as Microsoft Excel and emailed to the COR.

7 Electronic list of all orders to be verified for renewal, available via the online system and exportable into spreadsheet software such as Microsoft Excel.

Upon request

8 Order data covering the contract period, including each subscription year, available via the online system and exportable into spreadsheet software such as Microsoft Excel.

Upon request

9 Projection of future subscription charges for a stated period. Upon request 10 Contingency plan detailing: (1) back-up procedures and how they would be implemented in the event of a disaster at one or more of contractor’s facilities to ensure contracted services would continue to be provided and (2) procedures and how they would be implemented for contractor’s response to changes requested by NLM in the event of a disaster at NLM.

Within 30 days of contract award

11 Reports by publisher detailing format ordered for each title exportable into spreadsheet software such as Microsoft Excel.

Upon Request

C.3 INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY REQUIREMENTS

Important Note to Contractor: In the event of a discrepancy between the following language and included HHSAR clauses, the HHSAR clauses take precedence.

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (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 ISSO, CISO, OpDiv 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: [ ] Low [X] Moderate [ ] High Availability: [ ] Low [X] Moderate [ ] High Overall Impact Level: [ ] Low [X] Moderate [ ] High

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 https://hhsgov.sharepoint.com/sites/HHSAP https://hhsgov.sharepoint.com/sites/HHSAP 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 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. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how HHS collects, disseminates, maintains, or disposes of the public's 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 PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if 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 [NIH to insert contract-specific timeline] 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.

e. 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, (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.

f. 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.

g. 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).

h. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-21-07, Completing the Transition to Internet Protocol Version 6 (1Pv6) available at https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf

i. 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.

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

k. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

l. 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 https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf 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.

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.

vi. 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 non-disclosure agreement. 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 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 NIH 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 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.

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, and [insert any NIH-specific rules, as applicable].

https://www.acquisition.gov/far/52.222-40

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. In accordance with FISMA and 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:

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.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT), COR, CO, NIH 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 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.

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: No position sensitivity designation levels apply to this solicitation.

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.

Note to the Requiring Activity Representative: 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 30 days of the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within 30 days of the change.

https://www.acquisition.gov/far/part-22

The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

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 Guide (2012).

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 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 [NIH-specific timeline] 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 Contractor Employee Separation when an employee terminates work under this contract within [insert NIH-specific timeline] 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 record without proper authorization, he/she must document and report the incident in accordance with HHS/NIH policies.

10. High Value Asset (HVA) If a system is identified as HVA, the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the DHS HVA Control Overlay in addition to the above requirements.

C.4 PROCUREMENTS INVOLVING GOVERNMENT INFORMATION PROCESSED ON GOCO

OR COCO SYSTEMS

and included HHSAR clauses, the HHSAR clauses take precedence.

1. Security Requirements for GOCO and COCO Resources

a. Federal Policies. The Contractor (and/or any subcontractor) must comply with applicable federal laws and HHS policies that include, but are not limited to, the HHS Information Security and Privacy Policy (IS2P), Federal Information Security Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, latest revision, Security and Privacy Controls for Information Systems and Organizations; Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies.

b. Assessment and Authorization (A&A). A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s). The Contractor must conduct the A&A requirements in accordance with HHS IS2P/NIH, NIST SP 800-37, Guide for Applying the Risk Management Framework to Information Systems: A Security Life Cycle Approach (latest revision), NIST SP 800-53B, Control Baselines for Information Systems and Organizations, and the NIST SP 800-53A (latest revision).

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

i. A&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an A&A package to the CO and/or COR. The following A&A deliverables are required to complete the A&A package:

System Security Plan (SSP) - due [insert specific timeline, process, and format after contract award]. The SSP must comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must review and update the SSP at least annually thereafter and if requested, provide a copy of the updated SSP.

Security Assessment Plan/Report (SAP/SAR) - due [insert specific timeline, process and format after contract award.] The security assessment must be conducted by assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies.

The assessor will document the assessment results in the SAR.

Independent Assessment - due [insert specific timeline, process, and format after contract award]. The Contractor (and/or subcontractor) must have an independent third-party validate the security and privacy controls in place for the system(s) commensurate with the risk levels per NIST SP 800-53B. The independent third party must review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor must address all "high" deficiencies before submitting the package to the Government for acceptance and document all remaining deficiencies in a system Plan of Actions and Milestones

(POA&M).

POA&M - due [insert specific timeline, process, and format after contract award]. All critical-risk weaknesses must be mitigated within [insert specific timeline], high-risk weaknesses must be mitigated within [insert specific timeline], medium weaknesses must be mitigated within [insert specific timeline], and low weaknesses must be mitigated within [insert specific timeline],from the date the weaknesses are formally identified and documented. NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, flaws and security defect in a system (that require to create a patch for remediation), and other security reviews and sources, as documented in the SAR, must be documented and tracked by the Contractor for mitigation in the POA&M document consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. Depending on the severity of the risks, NIH may require designated POA&M weaknesses to be remediated before an ATO is issued. Thereafter, continue to remediate weaknesses throughout the contract. The POA&M document must be updated at least quarterly [insert timeline, process, and format if more frequent updates are needed].

Contingency Plan and Contingency Plan Test - due [insert specific timeline, process and format after contract award]. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor must update and test the Contingency Plan at least annually.

E-Authentication Questionnaire - The contractor (and/or any subcontractor) must collaborate with government personnel to ensure that the E-Authentication requirements are implemented in accordance with OMB 04-04 and NIST SP 800-63 B.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS Guidance for Selection of e-Authentication Assurance Levels and any other applicable HHS policies.

ii. Information Security Continuous Monitoring. Upon the government issuance of an Authority to Operate (ATO), the Contractor (and/or subcontractor)-owned/operated systems that input, store, process, output, and/or transmit government information, must meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST…