fin_combine_synopsis_sol.pdf

COMBINED SYNOPSIS / SOLICITATION

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: February 18

(3) Year: 2021

(4) Contracting Office Zip Code: 20892

(5) Classification Code: R499

(6) Contracting Office Address:

6701 Rockledge Drive Bethesda, MD 20892

(7) Subject/Title: Orthopedic Surgical and Research Services

(8) Solicitation Number: 75N92021Q0063

(9) Closing Response Date:03/01/2021

(10) Contact Point(s):Tahir Seeba, Contract Specialist

(11) Contract Award and Solicitation Number: TBD

(12) Contract Award Dollar Amount: TBD

(13) Contract Line Item Number(s): See 1449

(14) Contractor Award Date: TBD

(15) Contractor Name: TBD

(16) Description:

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

(ii) The solicitation number 75N92021Q0063 and a statement that the solicitation is issued as a request for quotation (RFQ).

(iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2021-04 effective January 19, 2021.

(iv) The associated NAICS code for this acquisition is 541990 and the small business size standard is $15.0 Million. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

(v) It is anticipated that the award from this combine synopsis solicitation will be a Firm Fixed Price with one (1) twelve (12) months base period and four (4) twelve

(12) months options as follows:

Item Description Unit Quantity 1 Base: Professional Services – Orthopedic

Surgeon. POP: 3/30/2021 – 3/29/2022 Hours 480

2 Option 1: Professional Services – Orthopedic Surgeon. POP: 3/30/2022 – 3/29/2023

Hours 480

3 Option 2: Professional Services – Orthopedic Surgeon. POP: 3/30/2023 – 3/29/2024

Hours 480

4 Option 3: Professional Services – Orthopedic Surgeon. POP: 3/30/2024 – 3/29/2025

Hours 480

5 Option 4: Professional Services – Orthopedic Surgeon. POP: 3/30/2025 – 3/29/2026

Hours 480

(vi) Statement of Work.

Background Information:

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is one of the nation’s premier research institutions in the area of clinical research in rheumatic, autoinflammatory and autoimmune diseases. With the unique characteristics and availability of the state-of-the-art NIH Clinical Center, NIAMS has expanded its clinical research into new areas, including the biology of bone and bone diseases. To continue this effort, we currently seek the expertise of a board-certified orthopedic surgeon/investigator to lead Orthopedics Research within the Clinical Trials and Outcomes Branch (CTOB).

The primary goals of the CTOB are to understand the factors that influence health and health outcomes of patients with rheumatic diseases, develop new tools and techniques to measure these outcomes, assess rheumatic disease in an underserved minority community, and compare outcomes among patients who have had orthopedic surgery.

NIAMS requires that the contractor provide an experienced orthopedic surgeon researcher who has 1) an outstanding reputation for basic and/or clinical research based on publications in high-quality journals; 2) a history of leading a basic and/or clinical research team; 3) experienced in laboratory and/or epidemiology and outcomes research; and 4) a record of productivity as demonstrated by an ongoing record of publication in peer-reviewed journals and presentation of work at national and international meetings. In addition, the identif ied individual must be board certif ied in orthopedics and must be able to be credentialed to see patients with orthopedic problems in the NIH Clinical Center.

Scope of Work:

Independently and not as an agent of the US Government, the Contractor shall furnish all the necessary services and qualif ied personnel, not otherwise provided by the US Government as needed to establish and maintain an orthopedic outcomes research program in collaboration with the NIAMS. This includes providing clinical consultations as requested for patients in the NIH Clinical Center, developing and executing research protocols focused on patients with orthopedic conditions, and overseeing laboratory research.

The contractor will conduct clinical outcomes research in NIAMS’ Clinical program at the NIH Clinical Research Center. Responsibilities would include:

• Develop a mentoring committee to assist in identifying appropriate research topics:

o Utilize existing databases to provide new insights into orthopedic outcomes, including Medicare, the National Inpatient Sample, and others as appropriate to the research.

o Develop protocols as needed to study subjects with orthopedic conditions at the NIH clinical.

• Conduct meetings and interviews with other NIAMS researchers to identify areas of potential collaborations utilizing subjects enrolled in existing studies.

• Oversee a program of laboratory research.

• Teach NIAMS fellows about orthopedic problems that relate to the practice of rheumatology.

• Conduct innovative clinical outcomes research. This should include studies of disease outcomes, prognosis, and pathogenesis that have been understudied or of great public health impact. This will be accomplished through collaborative research protocols with NIAMS investigators addressing questions in orthopedic outcomes. The interactions between NIAMS and contractor staff in caring out their collaborative activities will follow the academic model.

• Carry out a variety of studies, as jointly identif ied by the contractor, the mentoring team, and NIAMS leadership.

• Initiate clinical research studies either independently or in collaboration with other NIH investigators.

• Achieve and maintain quality control of protocol implementation and data collection, including appropriate data management plans and procedures.

Protocols will be subject to review by the branch chief, Clinical Director, the IRB (as applicable), and will be monitored consistent with the established plans in the Institute for clinical protocols.

• Coordinate with the NIAMS and participating investigators in the use of the NIAMS clinical database and any other databases directed by protocol.

• Encourage other orthopedists and other medical specialists to develop working relationships with the researchers participating in the protocols. This will include providing seminars on the research both internally in the NIH Clinical Center, and in the local community of orthopedic surgeons, as well as at national scientif ic meetings, with a goal of publicizing the research in orthopedics done at NIAMS Intramural Research Program. The purpose of this contract is to distribute as widely as possible the benefits of the orthopedic surgery outcomes innovations and techniques. The facilitation of such working relationships will be an important element in furthering that purpose.

General/Personnel Requirements

The contractor must have the following credentials:

• Orthopedic surgical training in the US.

• Current valid American Board of Orthopedics board certification in orthopedic surgery.

• Basic and clinical research training in orthopedic surgery

• Prior experience as an independent investigator.

• Evidence of research productivity in basic and clinical research as evidenced by recent (within the past 9 years) peer-reviewed publications, reviews, and book chapters.

• Experience in supporting clinical research protocols (11-AR-0165 and 11-AR- 0156).

• Past Performance at NIH with 10+ years of experience.

• Be able to be credentialed by the NIH Medical Executive Committee (MEC).

• Have malpractice coverage in the amount of $1 million per occurrence and $3 million in the aggregate.

Clinical Research/Human Subjects:

Clinical research activity will be conducted under the auspices of the NIAMS and shall be subject to the review and approval of the NIAMS Board of Scientif ic Counselors and the NIH IRB. For research conducting outside of the NIH Clinical Center, Contractor’s Institutional Review Board shall approve all clinical protocols prior to their being performed on human subjects and notice of this approval shall be provided to the Contracting Officer.

Government Furnished Equipment (GFE) and Facility:

NIAMS will provide on-site contractors with standard office furniture, telephone, computer equipment and software, necessary documentation, and access to a printer, facsimile machine, copier, and other items necessary to perform the work. The Government will provide all necessary office supplies for use at the Government site. Special furniture and equipment required for health-related issues or personal convenience shall be the responsibility of the Contractor and shall meet all NIH and leased building rules/regulations.

The contractor shall maintain a list of Government Furnished Equipment (GFE) with quantity, cost, and item identif ication and ensure that it is kept up to date. At contract close, the contractor shall provide a list of all GFE provided and obtain certif ication of return.

Deliverables:

• Document patient f indings in the medical and research record - As stipulated in the SOW.

• Publish manuscripts to report research results

• Establish and maintain protocols to study subjects with orthopedic problems

Level of Effort:

Estimated Level of Effort (LOE) required is approximated up to 8 hours per week during normal business hours, Monday-Friday, with occasional work during weekends and Holidays. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

(vii) Period of Performance:

Base Year: 3/30/2021 – 3/29/2022 Option Year 1: 3/30/2022 – 3/29/2023 Option Year 2: 3/30/2023 – 3/29/2024 Option Year 3: 3/30/2024 – 3/29/2025 Option Year 4: 3/30/2025 – 3/29/2026

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items is applicable to this acquisition.

A. The award will be made to the Contractor providing the most advantageous offer to the Government. Technical factors and cost are considered. Technical factors outweigh cost.

Technical Factors: The Contractor will be evaluated on their

POP Total Labor Hours Comments Base (12 months) 480 Approximately 40 labor hours per month Option Period 1 (12 Months)

480 Approximately 40 labor hours per month

Option Period 2 (12 Months)

480 Approximately 40 labor hours per month

Option Period 3 (12 Months)

480 Approximately 40 labor hours per month

Option Period 4 (12 Months)

480 Approximately 40 labor hours per month

TOTAL 2400

demonstrated ability to meet the General/Personnel requirements listed in the SOW.

The contractor shall be evaluated using the following criteria:

• Meets the requirements in the Statement of Work.

• 10 or more years of experience working at the NIH.

(x) FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov.

If an offeror has not completed the annual representations and certif ications electronically at the System for Award

Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(xi) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition.

Including the following clauses and Prohibitions:

I. 52.219-28, Post Award Small Business Program Representation

II. 52.222-3, Convict Labor III. 52.222-21, Prohibition of Segregated Facilities IV. 52.222-26, Equal Opportunity V. 52.222-36, Equal Opportunity for Workers with Disabilities

VI. 52.222-50 Combating Trafficking in Persons VII. 52.225-13, Restrictions on Certain Foreign Purchases

VIII. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving

IX. 52.225-13, Restrictions on Certain Foreign Purchase X. 52.204-24, Representation Regarding Certain

Telecommunications and Video Surveillance Services or Equipment.

XI. 52.232-39, Unenforceability of Unauthorized Obligations XII. 52.204-25, Prohibition on Contracting for Certain

Telecommunications and Video Surveillance Services or Equipment.

XIII. FAR 52.227-14, Rights in Data - Alternate IV (December 2007) XIV. 52.232-33, Payment by Electronic Funds Transfer—System for

Award Management (JUL 2013) (31 U.S.C. 3332)

(xiii) Additional Contract Requirements: See attachment 1.

(xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable.

(xv) Offers shall be submitted via the FedConnect web portal (www.fedconnect.net).

The due date for receipt of offers is 12:00 noon Eastern Time on March 01, 2021.

Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm. Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Read y_Set_Go.pdf.

For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net.

(xvi) Contact Points Tahir Seeba, Contract Specialist http://www.fedconnect.net/solicitation/75N92021Q0063

(17) Place of Performance:

NIH Clinical Research Center 9000 Rockville Pike Building 10-CRC Room- 4-2339 Bethesda, MD 20892

(18) Set-aside Status: Total Small Business http://www.fedconnect.net/ https://www.fedconnect.net/FedConnect/default.htm https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf mailto:support@fedconnect.net

Attachment 1

The following Information Security Requirements apply to the subject Combined Synopsis Solicitation.

INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

1. Applicability- The requirements herein apply whether the entire contract or order (hereafter "contract"), or portion thereof, includes either or both of the following:

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

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart

2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2. Safeguarding Information and Information Systems- In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

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

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

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

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

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

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

d. Comply with the Privacy Act requirements.

3. Information Security Categorization- In accordance with FIPS 199 and National Institute of mailto:fisma@hhs.gov

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

Confidentiality: [ ] Low [ x] Moderate [ ] High Integrity: [ ] Low [ x ] Moderate [ ] High Availability: [ x ] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ x ] Moderate [ ] High

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

[ ] No PII [ x] Yes PII

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

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

4. Controlled Unclassified Information (CUI)- CUI is defined as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI.

32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. All sensitive information that has been identif ied as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. Marked appropriately;

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

c. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

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

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

5. Protection of Sensitive Information- For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability.

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

6. Confidentiality and Nondisclosure of Information- Any information provided to the contractor

(and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract.

The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notif ied in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

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

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

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

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

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

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

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

8. Government Websites- All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP.

For internal-facing websites, the HTTPS is not required, but it is highly recommended.

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

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

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

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

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

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

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

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

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

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the OpDiv SOP or designee with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002.

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

B. TRAINING

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

2. Role-based Training- All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities http://irtsectraining.nih.gov/

Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/ rolebasedtraining.aspx

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

C. RULES OF BEHAVIOR

1. The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx, which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov

2. 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 Rules of Behavior must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

D. INCIDENT RESPONSE

The Contractor (and/or any subcontractor) shall 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.. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cyber security and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as 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 identif iable information or (2) an authorized user accesses or potentially accesses personally identif iable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as "a suspected or confirmed incident involving PII" .

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

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx http://irtsectraining.nih.gov/ the Contractor shall send NIH approved notif ications to affected individuals in accordance with https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ ir_guidelines.aspx

3) Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov, COR, CO, the NIH Office of the SOP (or his or her designee), and other stakeholders, including incidents 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 notif ication 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 shall:

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

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

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identif iable Information HHS and NIH incident response policies when handling PII breaches.

5) 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.

E. 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:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[x ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

F. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identif ication Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx mailto:IRT@mail.nih.gov

(PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

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

Roster-

a. The Contractor (and/or any subcontractor) shall 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 shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revision to the roster as a result of staffing changes shall 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://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15- 12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the

Government will determine the appropriate suitability level. Upon receipt of the Government's notif ication of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notif ication.

c. 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.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identif ication badges to the https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

Contracting Officer or designee.

G. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall 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 shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST

SP 800-64, Security Considerations in the System Development Life Cycle, 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.

3. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall 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.

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

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/or any subcontractors) shall 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 shall provide a certif ication 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.

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

H. RECORDS MANAGEMENT AND RETENTION

The Contractor (and/or any subcontractor) shall 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/NIH policies and shall not dispose of any records unless authorized by HHS/NIH.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/NIH policies.

https://www.hhs.gov/ocio/ea/documents/proplans.html

GOVERNMENT INFORMATION PROCESSED ON GOCO OR COCO SYSTEMS

A. SECURITY REQUIREMENTS FOR GOVERNMENT-OWNED/CONTRACTOR-OPERATED

(GOCO )AND CONTRACTOR-OWNED/CONTRACTOR-OPERATED (COCO) RESOURCES

1. Federal Policies- The Contractor (and/or any subcontractor) shall comply with applicable federal laws 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, Security and Privacy Controls for Federal 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.

2. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO) certif ies 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) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three

(3) months after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

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.

a. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

● System Security Plan (SSP) - due within 30 days after contract award. The SSP shall 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 Federal 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 shall 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 shall 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 shall update the SSP at least annually thereafter.

● Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall be conducted by the 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.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment.

Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

● Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall 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 shall address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

● POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identif ied and documented. The 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, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

● Contingency Plan and Contingency Plan Test - due 60 days 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, shall 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 shall update and test the Contingency Plan at least annually.

● E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary.

System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

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 policies.

b. 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…