Attachment 2 - SOW.pdf

STATEMENT OF WORK (SOW)

(SERVICES)

1. GENERAL INFORMATION

1.1. Title of Project

Impact of the Collaborative Hubs for International Research in Mental Health

1.2. Statement of Need and Purpose

The National Institute of Health (NIH), National Institute of Mental Health (NIMH) is interested in evaluating the impact of the Collaborative Hubs for International Research on Mental Health (CHIRMH) launched in 2010 (RFA-MH-11-070). The objective of that RFA was to establish regional hubs in low- and middle-income countries (LMICs) that would conduct innovative public health-relevant mental health research, build research infrastructure, and develop research capacity.

This RFA aimed to expand research activities in LMICs with the goal of providing the necessary knowledge, tools, and sustainable research-based strategies for use by government agencies, non-governmental organizations, academic institutions and health care institutions to reduce the mental health treatment gap. Lessons learned from these contexts can inform mental health service delivery in other low-resource settings.

The purpose of this acquisition is to evaluate the performance outcomes and programmatic impact of a NIMH-funded global mental health research program, the CHIRMH program

(RFA-MH-11-070).

The successful completion of the overall contract will result in: (a) a synthesized summary of the outcomes for each Hub based on (1) knowledge development; (2) strength of partnerships developed and/or enhanced; (3) development of research capacity; (4) impact on policy and practices; (5) implementation or enhancement of programs; (b) a report describing barriers and facilitators impacting the success of the goals of the FOA and recommendations to guide the CGMHR’s future investments, as well to share lessons learned with the Global Mental Health research community.

1.3. Background Information and Objective

The proportion of people who need, but do not receive care—the mental health treatment gap— is exacerbated by the dearth of health care workers available to provide evidence-based mental health services that meet minimum standards. Although a growing evidence base for reducing the treatment gap exists for higher income countries like the United States, far less research has been conducted in countries identified by the World Bank as low- and middle-income (LMICs).

Evidence also suggests that the majority of LMICs have limitations in a number of mental health specialties: 67% showed a shortage of psychiatrists, 95% a shortage of nurses and 79% a shortage of psychological care providers.1 2 Although human resource inadequacies for mental health worldwide have been well established, researchers, policy-makers, and international agencies have called for scale-up of mental health services3. Task shifting—that is, delegating tasks to varied cadres of health professionals with specialized training—has shown promise with certain mental health interventions.4,5,6 These studies suggest that the delivery of mental health services in primary healthcare settings through community-based and task-shifting approaches, in combination with appropriate training and increased capacity, can be used as a strategy for reducing the burden on caregivers and coordinating care of individuals with mental disorders.7 To tackle this issue, NIMH established the Collaborative Hubs for International Research on Mental Health (CHIRMH) in 2011-2012 (RFA-MH-11-070 and RFA-MH-12-110)8 to increase the evidence base for mental health interventions in World Bank designated LMICs.

Five projects grants were awarded. The CHIRMH program used an innovative model with a three-fold purpose:

Increase scientific knowledge about mental health interventions delivered by non-specialist providers under the supervision of mental health specialists (i.e., task sharing) in low- and middle-income countries (LMICs) to expand access to care.

Strengthening of partnerships among local researchers, policymakers, and health care providers to maximize the chances that resulting research findings would respond to local needs and would be applied in practice and policy once the grant ended.

Develop research capacity of LMIC investigators to increase their representation and LMIC research in the scientific literature on mental health. Each hub was to develop its own capacity-building activities and the five hubs were to network with one another to (a) facilitate cross-hub knowledge development, (b) expand individual hubs’ research development opportunities, and

(c) facilitate new research partnerships.

Each hub was to conduct research and provide capacity-building opportunities in one of six geographical regions (i.e., East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa). As a group, awardees were to constitute a collaborative network of regional hubs for mental health research in LMICs with capabilities for answering research questions (within and across regions) aimed at improving mental health outcomes for men, women, and children.

https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://grants.nih.gov/grants/guide/rfa-files/rfa-mh-11-070.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-11-070.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-12-110.html http://data.worldbank.org/about/country-classifications

Five Cooperative agreements were awarded: 1) Africa Focus on Intervention Research for Mental Health – AFFIRM (Ethiopia, Ghana, Malawi, South Africa, Uganda, Zimbabwe);

2) Latin America Treatment & Innovation Network in Mental Health – LATIN-MH (Brazil, Colombia, Ecuador, Guatemala, Peru, United States); 3) Partnership for Mental Health Development in Sub-Saharan Africa — PaM-D (Ghana, Kenya, Liberia, Nigeria, South Africa);

4) Regional Network for Mental Health Research in Latin America — RedeAmerica (Argentina, Brazil, Chile, Colombia, USA); and 5) South Asian Hub for Advocacy, Research & Education on Mental Health — SHARE (Afghanistan, Bangladesh, India, Nepal, Pakistan, Sri Lanka)9.

Each hub supported research on task-shifting/task-sharing for the delivery of mental health services and provides research capacity-building opportunities.

Rationale: An independent, objective assessment of the CHIRMH program will be useful for a large range of stakeholders including, but not limited to funding agencies, governmental and non-governmental organizations, academic institutions and health care institutions for several reasons. First, CHIRMH used an innovative program model to develop new scientific knowledge and build in-country research capacity through stakeholder partnerships and international networking. The standard metric of scientific publications is insufficient for capturing the intended impact of this program model. Second, two NIMH initiatives currently underway are based on the CHIRMH model; they are Research Partnerships for Scaling Up Mental Health Interventions in LMICs, and Collaborative Hubs to Reduce the Burden of Suicide among American Indian and Alaska Native Youth. A better understanding the CHIRMH model’s productivity several years post grant period will help in guiding these two follow-on initiatives and in maximizing their output. Third, the CHIRMH model required substantial amounts of NIMH staff time compared with more typical NIMH project models (e.g., R01, U19 without research capacity building). This was appropriate in 2011 given the nascent status of mental health research across most LMICs; eight years on, it will be useful to consider program accomplishments in relation to NIMH staff effort under the CHIRMH model.

1.4. Period of Performance

The Period of Performance is one (1) 12-month base period, and one (1) 3-month period option period.

https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-350.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-350.html

2. SCOPE OF WORK

2.1. General Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

2.2. Specific Requirements

The Contractor shall provide services and materials necessary to complete the following tasks:

2.2.1. Framework

Present a multi-level framework by which different aspects of the Hubs goals will be evaluated. Those aspects should include, but are not limited to:

Knowledge development. Outcomes/Metrics may include intervention impact on mental health outcomes; development of novel mental health interventions; numbers of intra- and inter-hub publications; impact factors of journals in which publications appear; numbers of citations; numbers of intra- and inter-hub presentations at conferences and meetings;

identification of research gaps and/or development of new research directions.

Strength of partnerships developed and/or enhanced. Outcomes/ Metrics may include numbers of implementing partners where research studies were conducted and/or where capacity building research components were conducted; other resources leveraged by individual hubs such as subsequent research studies by PIs or senior key personnel that stem from the Collaborative Hubs research; the CHIRMH program and other partners (e.g., WHO expertise in economic analysis); lessons learned about hub and partnership management, including facilitators and hindrances; partnerships relevance to sustainability of the interventions.

Development of research capacity. Outcomes/Metrics may include numbers of research trainees/fellows engaged; numbers of trainee/fellow-initiated publications; numbers of trainee/fellow grant applications submitted and grants awarded; numbers of intra- and inter-hub courses and workshops given, with attendance and completion rates, evaluations and skills addressed; institutionalization of new research courses and career pathways in LMIC institutions of higher education; trainee/fellow career trajectories and involvement in further degree training;

new intra- and inter-hub research partnerships; impact on the capacity of mental health services in the countries; successes and challenges with mental health research methodology and study designs.

Impact on policy or practices. Outcomes/ Metrics may include uptake and application of research findings in LMICs post or during grant period into evidence-based policy recommendations and/or adoption by government agencies, NGOs, and health care institutions; how the research findings benefited or were applied in other countries including the US; change in service system capacity to meet local mental health needs; evidence-based policy development; cost-effectiveness or budgetary impact of task-shifting/ task-sharing models new researcher-policymaker and/or researcher-provider collaborations; other secondary impacts (e.g. job creation, economic benefits); public communication of the research study and its impact on public awareness and public health priority of mental health.

Implementation or enhancement of programs. Outcomes/Metrics may include: assessment of new or enhanced programs implemented; how well did the program facilitate communities of practice and help to move the field forward with new science, consolidation of data sources, additional sources of funding, etc.; how well did the program contribute to building connections and relationships with local policymakers and strengthen evidence-to-policy practices?

2.2.2. Kick-Off Meeting

The Contractor shall contact the Contracting Officer’s Representative (COR) after the contract is signed to schedule a conference call/or in-person meeting with the NIMH Program Officers (POs), Contracting Officer (CO), and other relevant NIMH staff. The meeting goals include discussing the development of a work plan, roles of participants, and timeline. The contractor shall outline a systematic approach to obtain the necessary information required and outlined under section 2.2.1 above, including a framework of needed information, data sources required, and an assessment plan, which could include, but is not limited to: interviews with PIs and /or key personnel from each Hub; peer-reviewed publications; conference abstracts and proceedings; government reports and memos; white papers; internal operating documentation; interviews with policymakers.

2.2.3. Site Conference calls

The contractor shall arrange with each of the 5 Hubs listed below to develop a signed agreement with the Hubs teams to collaborate and provide required information and resources needed to complete this project which should include: 1) an identified research liaison who shall be supported by this contract and shall coordinate securing the necessary information; 2) an approved work plan for data collection to complete the items mentioned in section 2.2.1; and 3) develop a plan to address any other issues impacting successfully accomplishing this project.

1. Africa Focus on Intervention Research for Mental Health – AFFIRM

PIs: Crick Lund, Atalay Alem, Ezra Susser Activity Sites: Ethiopia, Ghana, Malawi, South Africa, Uganda, Zimbabwe

2. Latin America Treatment & Innovation Network in Mental Health – LATIN-MH PIs: Paulo Menezes, Ricardo Arraya Activity Sites: Brazil, Colombia, Ecuador, Guatemala, Peru, United States

3. Partnership for Mental Health Development in Sub-Saharan Africa — PaM-D PI: Oye Gureje Activity Sites: Ghana, Kenya, Liberia, Nigeria, South Africa

4. Regional Network for Mental Health Research in Latin America — RedeAmerica PIs: Ezra Susser, Sandro Galea, Ruben Alvarado, Graciela Rojas Activity Sites: Argentina, Brazil, Chile, Colombia, USA

5. South Asian Hub for Advocacy, Research & Education on Mental Health — SHARE PIs: Vikram Patel, Atif Rahman Activity Sites: Afghanistan, Bangladesh, India, Nepal, Pakistan, Sri Lanka

2.2.4. Site Reports

The contractor shall provide a report of each of the conference calls which will include: the signed agreements with the Hubs and an outline the necessary resources to complete this project; details of the work plan and SOPs developed; specific actions that were discussed during the call, including potential issues that may impede data collection and a plan to resolve them; and a timeline for data collection. Through these discussions the need for a site visit may be addressed and will require specific justification for the visit. The format and content of this report shall be based on the guidance and direction of the COR.

2.2.5. Reports

The contractor shall provide NIMH with a semi-annual progress report and final report with an analysis of the data collected based on the content of research outlined in the SOW framework, consisting of data compiled from site calls, research conducted, and site visits if relevant and any other areas of data collection. This report shall include tasks completed, outcomes of each, timelines within which they were accomplished, challenges encountered and how they were resolved, lessons learned, and a summary of outcomes, and customer feedback where applicable. The final report also should present the findings of each Hub based on the multi-level framework described on section 2.2.1 by which different aspects of the Hubs goals will be evaluated. Those aspects should include, but are not limited to:

Knowledge development; Strength of partnerships developed and/or enhanced;

Development of research capacity; Impact on policy or practices. Implementation or enhancement of programs. The final report should also present an analysis of those findings with summary of outcomes and lessons learned. This material may be used by NIMH for development of a manuscript.

Additionally, the Contractor shall keep abreast of all changes in Federal specific requirements governing NIMH policies related to this scope of this contract. The Contractor shall update SOPs, as necessary, within thirty (30) calendar days of the effective date of all such changes; and submit updated SOPs to the COR for review and approval. Updated SOPs shall be implemented by the Contractor only after receipt of written NIMH POs and COR approval.

2.2.6. Budget Reports

The Contractor shall prepare and submit a semi- annual budget report and a final report, in chart format, showing task and sub-tasks, and, the amount allocated for the task. The report shall also include the budget expenditures for the month, the remaining balance, and the percentage of funds used to date.

2.2.7. Level of Effort

The following table depicts the estimated LEVEL OF EFFORT in unit number of hours per labor category per contract year that the Government anticipates will be required for the contractor to successfully perform the requirement described in this Statement of Work. The Program Director, Data Analyst, and Researcher requires a Ph.D. or M.D, and the Project Manager requires a Master’s Degree or experience in Project Management.

Data: survey, qualitative and quantitative tools, among others.

Quantity Labor Category Year 1

Year 2

1 Program Director Level expertise: PhD or MD

Time calendar year:

Y1-384 hrs.-768hrs./year - Y2-192 hrs.- 384 hrs./year **

20- 40%

20-40%

1 Data analyst Level expertise: PhD or MD

Time calendar year : Y1-192 hrs./ year ; Y2 96 hrs./year

40% 60%

5 Research Coordinator Liaison at each Hubs involved from the Collaborative Hubs for International

Y1-192 hrs./ year ; Y2 96 hrs./year

80%

20%

1 Research (CMIRMH) Level expertise: PhD or MD

Time calendar year:Y1- 960 hrs./ year; Y2 480 hrs. /year

50% 50%

1 Project Manager Level expertise: may only require a Master’s Degree or experience in PM.

Time calendar year Y1- 960 hrs./ year; Y2 480 hrs. /year

50% 50%

** Note, the total of 20% - 40% depends on the need for having a research coordinator or not.

2.2.8. Government Responsibilities

The Government will participate in conference calls with the Contractor every 6 months to discuss the content, and requirements described above.

The Government will be responsible for reviewing and approving reports and final products generated under the contract. The Contractor shall guarantee strict confidentiality of the information/data obtained from any participant on the project. No government furnished property shall be provided. No government workspace, desktop computers and telephones for contractor personnel will be provided. The Contractor will not require routine access to government facilities.

2.2.9. End Results/ Deliverables

The following tables describes 1) the products and tangible end results that are expected from each task contained in the previous section, 2) the date each deliverable is due, and 3) the Government acceptance criteria. All days are business days unless otherwise specified.

End Result/Deliverable Due Date Acceptance Criteria

Multi-level framework

Within 5 days of award.

Description on 2.2.1

Kick-Off Meeting Within 5 days of award.

The kick-off meeting must be scheduled in coordination with the COR in accordance with SOW section 2.2.2

Site Conference Calls Within 30 days of award directed by the PO

The site conference calls must be scheduled with each of the five hubs. The contractor shall schedule a total of five (5) site conference calls in accordance with SOW section 2.2.3 and 2.2.4.

Site Report for AFFIRM Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for LATIN-MH Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for PaM-D Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for RedeAmerica Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Site Report for SHARE Within 60 days after award

The site reports shall be in accordance with SOW section 2.2.4 and based on the guidance and direction of the COR and PO.

Semi-annual progress report Within 180 days after the kick-off meeting.

The semi-annual progress report shall be in accordance with SOW section 2.2.5.

Final Report Within 360 days after the kick-off meeting.

The final report shall be in accordance with SOW section 2.2.5.

Semi-annual budget report Within 180 days after the kick-off meeting.

The semi-annual budget report shall be in accordance with SOW section 2.2.6.

Final budget report Within 360 days after the kick-off meeting.

The final budget report shall be in accordance with SOW section 2.2.6.

2.2.10. REPORTING REQUIREMENTS:

All site reports, semi-annual, annual reports, semi-annul budget, and final report shall be delivered electronically to NIMH as described above in section 2.2.8.

3. OTHER CONSIDERATIONS

3.1.1. Travel

If determined necessary, one Contractor person shall perform a site visit to one or more of the Hubs from the CHIRMH FOA. The purpose of the SV would be to gather information to complete this assignment as described above on specific requirements item 4.

3.1.2. Key Personnel

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

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows;

Quantity Position

1 Program Director

1 Program Manager

1 Research Analysist

5 Research Coordinator Liaison at each Hubs involved from the Collaborative Hubs for International Research (CMIRMH)

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

The following individual(s) are essential to the work being performed here under:

Name Title To be determined in the contract award

3.1.3. Information System Security Plan

Schedule of Deliverables Deliverable Description Due Date Roster and Personnel Security Responsibilities

Roster Changes Onboarding Offboarding List of Personnel with defined roles and responsibilities

Onboarding- Prior to performing any work on behalf of NIH/NIMH, and monthly thereafter. Offboarding-documentation, equipment and badge when leaving contract within 3 business days

Contractor Employee Non- Disclosure Agreement (NDA)

Contractor Employee Non- Disclosure Agreement (NDA)

Prior to performing any work on behalf of NIH/NIMH

Incident Response

Incident Report (as incidents or breaches occur)

NIH/NIMH policy states as soon as possible or no later than 1 hour of discovery

Certification of Sanitization of Government and Government Activity- Related Files, Information, and Devices.

Form or deliverables required by NIH

NIH/NIMH requires NIH Form NH270 Certification: Removal of Data and Software

Contract Initiation and Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/Decommission Plan

At contract expiration.

Standard for Encryption

Include the Standard for Encryption NIH/NIMH requires this prior to publishing.

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

ARTICLE. INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

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

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

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

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

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

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

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

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

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

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

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

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location.

In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

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

d. Comply with the Privacy Act requirements.

3. Information Security Categorization- In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II:

Appendices to 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 [ ] Moderate [ ] High mailto:fisma@hhs.gov

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

[X ] No PII [ ] Yes PII

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

All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. Marked appropriately;

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

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

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

d. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf 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 identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

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

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

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

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

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

B. TRAINING

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

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf http://irtsectraining.nih.gov/

Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

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

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

https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx http://irtsectraining.nih.gov/

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 identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable 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, the Contractor shall send NIH approved notifications to affected individuals 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 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 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

Identifiable 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.

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

E. 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 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.

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.

F. 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 https://www.hhs.gov/ocio/ea/documents/proplans.html https://www.hhs.gov/ocio/ea/documents/proplans.html https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf 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.

3.1.4. Data Rights

The CGMHR shall have unlimited rights to and ownership of all deliverables provided under this contract including any reports, recommendations, briefings, work plans, and all other deliverables. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” and is hereby incorporated by reference and made a part of this contract.

3.1.5. Section 508 Electronic and Information Technology Standards The Contractor shall use Electronic and Information Technology (EIT) in the performance of the SOW. The public will NOT have access to the EIT.

[In December 2000, the Architectural and Transportation Barriers Compliance Board (Access Board), pursuant to Section 508(2)(A) of the Rehabilitation Act Amendments of 1998, established information technology accessibility standards for the federal government. Section 508(a)(1) requires that when federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology (EIT), they shall ensure that the EIT allows federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a federal department or agency. Section 508 text is available at http://www.opm.gov/HTML/508-textOfLaw.htm or http://www.section508.gov/index.cfm?FuseAction=Content&ID=14] http://www.opm.gov/HTML/508-http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

3.1.6. Publications and Publicity

The Contractor shall ONLY write or publish articles of data produced as a result of the requirements of the SOW with agreement of NIMH staff and sites involved, who will also participate on the manuscript.

3.1.7. Confidentiality of Information

The Contractor shall have no other rights to use the confidential information involving patients and providers for any purpose other than as set forth under Project Purpose of this Agreement.

a. Confidential information, as used in this article, means information or data of a personal nature about individual or proprietary information or data submitted by or pertaining to an institution or organization.

b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate…