FINAL RFQ FDA-SOL-1243687_08162021.pdf

Request for Quotation (RFQ) No. FDA-SOL-21-1243687

Center for Devices and Radiological Health (CDRH) Mental Health First Aid and General Wellness

1. DESCRIPTION/COMMERCIAL ITEM PROCUREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. This is a Request for Quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 Acquisition of Commercial Items and Part 13 Simplified Acquisition Procedures.

The associated North American Industry Classification System (NAICS) Code is 611430 – Professional and Management Development Training.

This is a small business set-aside solicitation in accordance with FAR Subpart 19.5 Set-Asides for Small Business.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-06, effective July 12, 2021.

FAR provisions and clauses referenced in this solicitation can be found on the following website:

www.acquisition.gov

HHSAR provisions and clauses referenced in this solicitation can be found on the following website:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. PURCHASE ORDER REQUIREMENTS

See Section 6, Statement of Work, for a full description of the supplies/services to be acquired.

4. CONTRACT TYPE

The Government anticipates awarding one (1) Firm-Fixed-Price (FFP) type purchase order. The total purchase order period of performance consists of a base year and one (1) option year.

5. PRICING

Services shall be provided in accordance with the services described in the Statement of Work – Services to be performed during the anticipated periods of: September 17, 2021 through September 16, 2022 (Base Year); and if exercised from September 17, 2022 through September 16, 2023 (Option Year 1).

http://www.acquisition.gov/

Base Year: September 8, 2021 through September 7, 2022 (estimated)

Requirement Firm-Fixed Price Mental Health First Aid and General Wellness $

Option Year 1: September 8, 2022 through September 7, 2023 (estimated)

Requirement Firm-Fixed Price Mental Health First Aid and General Wellness $

6. STATEMENT OF WORK

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

MENTAL HEALTH FIRST AID AND GENERAL WELLNESS

1. Background

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. The CDRH assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

CDRH identified Employee Engagement, Opportunity, and Success as a Strategic Priority for 2018-2020. This goal “aims to improve our work life and work environment by reducing unnecessary burdens, promoting an environment of trust and mutual respect, facilitating open dialogue, fostering creativity and teamwork, providing a reasonable work life balance, and creating opportunities for professional growth and personal development.”

The Division of the Employee Training and Development (DETD) is part of the CDRH’s Office of Communication and Education (OCE) which provides training to all Center staff including scientific, medical and administrative professionals.

To help fulfil CDRH’s engagement efforts and commitment to its employees, DETD in collaboration with the Office of Management (OM) requires contractor support to offer training in Mental Health First Aid and General Wellness. This training must address the importance of wellbeing, identification of distress, and actionable measures CDRH employees can take to assist themselves or coworkers. The half-day training should be instructor led and may be provided virtually or onsite.

Information from related work previously done by FDA will be shared by the COR, at least in part, with the Contractor to help facilitate completion of the requirements in this SOW.

2. Objective

The primary objective is to provide training addressing mental heal and general wellness for CDRH employees; the Contractor shall conduct up to eight (8) sessions each year (one 12-month base period and one 12-month option year, if exercised) to provide training for 120 CDRH employees, the majority of whom will be serving in management or supervisory roles.

3. Scope

The Contractor shall provide training that offers an introduction to Mental Health First Aid and General Wellness. This training must summarize potential situations of mental distress, address how to identify signs of stress, and propose methods to handle situations that could represent potential mental health crises.

Additionally, the training must address support options for general wellness to negate stress or other more significant situation that may arise from mental distress. While these presentations may include statistics and definitions, the majority of the course must focus on actionable items and response plans for attendees.

The Contractor shall provide an instructor-led training event focused on mental health and wellness issues.

The training courses shall be 4.5-5 hours in length, including up to two (2) hours of pre-work to be completed prior to the course session. This training must inform the participants about mental health disorders and provide instruction on how CDRH managers and staff can provide an adequate “first aid” response when interacting with coworkers.

Note: This instructor led training must be able to be presented both in-person and virtually considering the current complications of the COVID-19 Pandemic. Sessions are expected to be instructor led virtually until it is safe for a return to campus. At that time, future courses may be provided on-site at CDRH facilities.

Within this training, the Contractor shall:

• Provide information and statistics regarding mental health disorders from most common to rare;

• Provide information on actions that participants can take to migrate stress and mental health crisis in support of general wellness,

• Provide instruction on identifying potential mental health issues in the workplace,

• Provide specific examples that relate to the training with actual events that have happened at FDA or similar workplaces such as other government agencies (as provided by the CDRH at the Kick-Off Meeting);

• Provide brief exercises, roleplay scenarios, case studies, and/or videos to aid class discussions;

• Provide instruction on appropriately reacting and responding to mental health crisis situations so attendees are prepared with actionable plans for the future.

4. Tasks

The Contractor shall provide a qualified instructor for up to eight (8) training sessions in Mental Health First Aid and General Wellness for an audience of CDRH Staff, the majority of whom serve in supervisory roles.

The Contractor shall supply all necessary training materials. The training courses shall be 4.5-5 hours in length, including up to two (2) hours of pre-work for completion prior to each training session. Dates and times for training sessions shall be agreed upon in collaboration with the CDRH.

The CDRH will provide information regarding narrative information related to specific CDRH scenarios at the Kick-off Meeting as defined in Section 4.1.1.

4.1. Task One: Project Management

4.1.1Kick-off Meeting Within five (5) days of award, the contractor shall meet with FDA Staff to discuss the training administration to include the logistics. This meeting shall be held at least one month prior to the first scheduled training session.

The contractor shall supply the intended curriculum for review and approval from DETD and other FDA Staff as identified.

4.1.2 Instructor Requirements

The instructor shall be an expert in mental health and general wellness with broad knowledge of mental health and crisis migration in the workplace. The instructor shall have experience facilitating mental health and general wellness training including but not limited to group discussions and case studies activities.

The class instructor’s bio shall be included with all quotes. Their experience shall be documented by their past performance as included in their bio.

4.2 Task Two: Mental Health First Aid and General Wellness Training Course

The Contractor shall explore and answer the following questions:

• Why is general wellness and mental health important in the workplace?

• What are some of the causes of workplace stress?

• How can workplace stress be avoided or controlled?

• What are general wellness activities that support work-life balance?

• How can CDRH managers and supervisors promote general wellness?

• How can work-life balance help with stress management?

• What are common mental health disorders?

• How are mental health crises identifiable?

• What action can an individual take to mitigate the effects of mental health issues for both themselves and others in the workplace?

4.2.1 Topics for Training

During the training, the instructor shall provide information across a variety of topics related to identifying and taking action related to mental health and general wellness conditions. The contractor shall educate attendees on possible conditions, then explain, in detail, signs, symptoms, and actionable items attendees can make to mitigate mental health crises. While the vendor is tasked with providing background information regarding a variety of conditions, the focus of the training shall be on how attendees can respond to situations to aid themselves, their families, or coworkers.

The instructor shall engage attendees with activities such as brief exercises, interactive role playing, case studies, and or videos to aid in discussion. The government will provide examples of actual events that have occurred within FDA to build around during the Kick-Off Meeting.

A. Information About Mental Health Conditions Information, symptoms, and statistics related to mental health conditions from most common to rare;

including but not limited to:

• Stress; both workplace and personal, with an emphasis on personal stressors that may affect work (like financial, family, divorce, death, or health issues);

• Depression;

• Anxiety;

• Panic Attacks;

• Traumatic Events;

• Aggressive Behavior;

• Suicidal Thoughts and Behavior;

• Non-Suicidal Self-Injury;

• Psychosis;

• Substance Abuse Disorders; and

• Potential harm to others.

B. Information About General Wellness Information regarding general wellness, methods for incorporating wellness activities into your day-to-day life at home and in the workplace, as well as barriers to wellness. Statistics regarding general wellness and its impact on your home and workplace environments. Additional information regarding best practices for achieving optimal wellness in mental, spiritual and physical health. General wellness information includes, but is not limited to:

• Exercise

• Healthy Eating

• Establishing and Maintaining Healthy Relationships;

• Work life Balance

• Taking Timeouts

• Regular Health Check-ups

• Meditation

• Hobbies

• Recreation

C. Mental Health First Aid Response The contractor shall instruct participants in actionable response strategies to the mental health situations identified in Section 4.2.1. These action items shall consider responses for both supervisors and non-supervisors to properly aid those experiencing mental health crises.

The instructor shall provide attendees with a Mental Health First Aid Action Plan handout on steps to consider if a mental issue arises in their home or work environment.

D. General Wellness Actions and Activities The contractor shall instruct participants in actionable wellness strategies based on the activities identified above. These action items must be appropriate and teachable for both supervisors and non-supervisors.

The instructor shall provide attendees with resources for achieving general wellness in their day-to-day activities at home and in their work environment.

E. Training Exercises The contractor shall use a variety of activities to supplement any lecture or written materials.

Potential activities include:

• Individual or group breakout exercises,

• Video presentations,

• Role-playing scenarios,

• Discussions about Real World Case Studies,

• Question and Answer Sessions, and

• Other individual or group activities to encourage engagement with participants.

4.3 Task Three: Training Materials

The contractor shall provide all training materials required for specified courses to all participants. The training materials shall include handouts. For virtual classes, all training materials shall be provided in digital formats for all participants.

The Instructor shall provide the PowerPoint slides and handouts and any electronic reference materials (graphics, statistics, etc.) to participants at the conclusion of each training session.

5. Deliverables

5.1 Format of Deliverables

Electronic deliverables shall be provided in soft copy using the current FDA version of Microsoft Office products.

5.2 Submission Procedures

The Contractor shall submit all deliverables to the COR, unless otherwise stated. The COR will be responsible for the review of all draft and final deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with the requirements of the task. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives.

Unless specified otherwise, the government shall have ten (10) working days to complete the review and approve the deliverables. If deficiencies are found or areas require modification, the Contractor will be notified and shall have five (5) calendar days to correct the deficiencies. Upon re-submission by the Contractor, the government will reapply the same acceptance criteria. If the deliverable does not meet the acceptance criteria a second time, the government may consider the Contractor as having deficient performance with respect to the subject task.

5.3 Summary of Deliverables

Table 1: Deliverables

Number Task Deliverables Quantity/Frequency Due Date

1 4.1 Kick-Off Meeting One/once Within 5 days After Award

2 4.1.1 Proposed Curriculum for Review One / Once 5 Days After Award

3 4.1.2 Mental Health First Aid Action Plan

One / Per Training Session At Each Training Session

4 4.3 Training Materials One / Per Training Session At Each Training Session

5 4.3 PowerPoint Slides and/or Other Electronic Resources

One / Per Training Session

At the Conclusion of Each Training Session

6. Contract Type

The contract is anticipated to be a firm-fixed price type contract.

7. Place of Performance

The training site will be designated by CDRH. All training will be virtual until it is safe to return to the White Oak Headquarters; training space may be provided on campus after CDRH Staff returns to the White Oak facilities.

White Oak Campus Building 66 10903 New Hampshire Ave.

Silver Spring, MD 20993

8. Period of Performance

The anticipated term shall be for a 12-month base year and one 12-month option year.

Base: September 17, 2021 through September 16, 2022, anticipated

Option Year: September 17, 2022 through September 16, 2023, if exercised.

9. 508 Compliance

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technologies (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical

Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

10. Security and Privacy Considerations

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 FDA network or operated by the Contractor on behalf of FDA 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. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA

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 FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

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, Appendix C, and based on information provided by the ISSO 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: [X] Low [ ] Moderate [ ] High Integrity: [X] Low [ ] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Risk Level: [X] Low [ ] Moderate [ ] High

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

[X] No PII [ ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

Personally Identifiable Information (PII). Per the 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: [X] Low [ ] 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 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;

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

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 FDA 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 and the FDA IS2P Appendix T: Sanitization of Computer- Related Storage Media.

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.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA 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 FDA 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 FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA 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).

6) 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).

7) 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.

8) Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

9) 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. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-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 are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

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 (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

10) 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 FDA non-disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

11) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA 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.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /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 FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete FDA 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 and FDA 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 and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

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 and FDA 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.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior

(ROB) before accessing HHS and FDA 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 FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

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)/FDA SMC /Incident Response Team (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 cybersecurity 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 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 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 FDA approved notifications to affected individuals as directed by FDA’s SOP.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the

FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “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 of discovery/detection, and consistent with the applicable FDA 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, contract 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 and HHS and FDA 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 demand.

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: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

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 Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. 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 and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes shall be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

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

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 FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here:

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.aspx

HHS EA requirements may be located here:

https://www.hhs.gov/about/agencies/asa/ocio/index.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 FDA OAGS SMGs 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 and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee will stop 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 FDA policies.

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the

Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.

htm as soon as it is known that an employee will terminate work under this contract within 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/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

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/FDA policies.

http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm

11. Government Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

Government-owned computer or laptop to be used for any training that is held on-site. The COR will provide a template work plan and, at least in part, information from related work previously done by

FDA.

12. Invoice Submission

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is TBD (TBD@fda.hhs.gov).

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses

52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than

NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information

Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

13. Federal Acquisition Regulation (FAR) Clauses

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es):

FAR: www.acquisition.gov

HHSAR:

https://www.hhs.gov/grants/contracts/contract-policies- regulations/hhsar/index.html

(End of Clause)

FAR CLAUSE # TITLE DATE

FAR 52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY

(JAN 2017)

FAR 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES

OR EQUIPMENT

(AUG 2020)

FAR 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES

REPRESENTATION

(OCT 2020)

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

FAR 52.227-14 RIGHTS IN DATA – GENERAL (MAY 2014)

FAR 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

CONTRACTORS (DEC 2013)

FAR…