A19. REQUEST FOR QUOTATIONS.doc

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ

PAGE OF PAGES

1. REQUEST NO.

75D301-23-Q-77198

2. DATE ISSUED

09/05/2023

3. REQUISITION/PURCHASE REQUEST NO.

000HCCJC-2023-77096

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

NIOSH Morgantown - Primary Mailing Address

1000 Frederick Lane

MORGANTOWN WV 265052845

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

c. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

“See Continuation Page”

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NOTE: Additional provisions and representations

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

c. COUNTY

AREA CODE

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 18 (REV. 6-95)

Previous edition not usable

Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

Section B

Line Items

NIOSH is soliciting expert research support on the potential benefit and risk exposure associated with construction workers’ use of passive exoskeletons to perform manual material handling tasks on construction elevators.

Custodial Account #: 00379

Period of Performance is one (1) year from contract award date.

This is a non-severable service

1 Job

TOTAL:

Section C STATEMENT OF WORK

Background:

Construction elevators are found at many construction sites. When used properly they can facilitate completion of many construction tasks. Over the past decade, the use of construction elevators has increased significantly in construction. Their growing popularity makes construction elevator safety an important issue. The scaffolding industry has long recognized fall hazards associated with work on construction elevators (CPWR, 2019). Falls to a lower level were the leading event/exposure for construction elevator-related fatal injuries and the second leading event/exposure for construction elevator-related nonfatal injuries (CPWR 2019). Between 2011 and 2016, the construction industry was the leading industry for both elevator-related fatal injuries (145 out of 286) and non-fatal injuries (2,410 out of 10,310) (CPWR 2019). Use of exoskeletons may improve productivity and reduce MSD related hazards, but their weight and size may impact the balance of workers which can contribute to increased risk of falls on the same level (Kim et al. 2018).

SHAPE \* MERGEFORMAT

Figure 1. Construction Elevators

Construction worker tasks often involve high force exertion and other repetitive handling tasks during construction elevator (Figure 1) ingress/egress. Such activity is strongly associated with musculoskeletal disorders (MSDs) and slips/trips/falls (STFs). Over the past few years, exoskeletons have been adopted and used for the prevention of musculoskeletal injuries by an increasing number of companies. To date, there have been some biomechanical studies using electromyography (EMG) measures, motion analyses, and modeling techniques to assess use applications for passive exoskeletons (Kim et al. 2018; Picchiotti et al. 2019; Weston et al. 2018). These studies have found that use of passive exoskeletons at ground level can reduce MSDs. Unlike working at ground level, construction elevators are flexible and workers using them can experience postural instability during ingress/egress activities or manual material handling while working at elevation (Pan et al. 2012; Pan et al. 2017). No research, however, has been conducted on MSDs and STFs or additional postural instability associated with using exoskeletons on elevated work platforms that are routinely used in dynamic construction operations. The usefulness and benefit of passive exoskeletons for construction workers frequently working on elevated work platforms remains unclear. This information is very important for the construction trades, the OSHA Construction Directorate, and related consensus standards.

NIOSH is soliciting expert research support on the potential benefit and risk exposure associated with construction workers’ use of passive exoskeletons to perform manual material handling tasks on construction elevators. To this end, this statement of work will result in a deliverable product that quantitatively defines the musculoskeletal injury and postural instability risk exposure in this environment.

Objectives:

The objective of this study is to assess the impact of using a passive exoskeleton to perform manual material handling tasks while working on a construction elevator. This work will be used to help determine postural instability, while performing ingress/egress activities on a construction elevator.

Scope of Work:

The vendor should provide the following services:

Nine human subjects are expected to participate in this study. This number was derived from our previous study (Pan et al. 2017) and tools for power and sample size analysis. A simulated workstation representing a mechanical-equivalent system of a typical construction elevator and reproducing the dynamic characteristics experienced by workers on the construction elevator should be built. Pan, et. al. (2021) described one such simulated workstation designed with an adjustable suspension system and support structure to provide dynamic responses equivalent to that of an elevated construction elevator, although the simulated workstation for the study was on the ground.

Vendors should design and conduct a laboratory empirical study to evaluate the applications and limitations of different types of passive exoskeletons for construction workers doing both manual material handling and ingress/egress tasks working on a construction elevator. These exoskeletons, while potentially reducing the risk of upper extremity MSDs, also add weight to a user and limit their range of motion when working on elevated work platforms (Kim et al., 2018). The wearing of an exoskeleton could change a user’s center of mass, maneuverability, and spinal loading and consequently increase risk of fatal and non-fatal falls and musculoskeletal injuries, especially when used on an elevated construction elevator. NIOSH will provide some testing exoskeletons (Figure 2) at no cost to the vendor if the awarded vendor requests them.

Figure 2. Examples of the three passive upper extremity exoskeletons that can be utilized in this testing.

Depending on the final study design, NIOSH is looking to obtain a de-identified dataset that includes but is not limited to muscular electromyographic, whole body motion, balance and stability data while performing manual material handling tasks on a simulated construction elevator with/without wearing exoskeletons. The dataset collected needs to be sufficient to include center of pressure (COP) related variables including but not limited to: COP total excursion, average COP sway velocity, COP sway area (95% confidence circle area of the sway profile) (Zolghadr et al., 2018), etc. The collected kinematics data should be sufficient to include gait characteristics and motion data of different body segments such as head, shoulder, and trunk. The collected muscular EMG data should be sufficient to include dynamic normalized EMG from multiple muscle groups.

Vendors should develop a plan that demonstrates their ability to obtain approval from their Institutional Review Board (IRB) to conduct this human subject research, with the consideration of any COVID-19 guidelines or policies in place at their facility at the time the study will be performed. This plan should also include a detailed data processing procedure in order to deliver de-identified human subjects data to NIOSH.

Vendor Qualifications

Key research personnel need to provide evidence of ability to build a simulated construction elevator platform and conduct biomechanical research with exoskeleton vests to complete this statement of work.

Deliverables

A monthly status update virtual meeting will be required between the NIOSH project officer and the vendor.

The human subjects testing protocol for this study will need to be approved by the vendor’s IRB. The vendor must send and a copy of the IRB protocol and documentation of IRB approval to the NIOSH project officer before data collection starts.

Six months after the start date, human subjects data collection is to be completed. Motion data, balance data and muscular EMG data will all be de-noised and synchronized. Any lost signals will be treated as missing data, outliers will be identified and removed with plausible reasons arising from participant-related or apparatus-related (including data acquisition apparatus) reasons.

Eight months after the start date, data analysis is to be completed. Human balance, motion-related key variables as well as muscular EMG-related key variables will be identified. These variables should represent unique characteristics of human performance in close association with relevant work scenarios and the use of exoskeletons on construction elevators. Statistical analysis will also be completed; this process includes statistical model formation, assumption testing, data transformation and hypothesis testing.

Ten months after the start date, a draft written report on the findings is to be completed. This report will contain a comprehensive literature review, which includes public and private surveillance records that sufficiently identify the etiology, severity, cost and related issues for the use of exoskeleton vests. A full description of the participant consent procedure, apparatus structure and the data collection procedure will also be included. A summary of results from the statistical analysis will be provided, with a complete discussion of the meaning of results and its relevance to the future design and use of exoskeletons.

NIOSH shall have full and exclusive rights to any portion of this work not part of a preexisting copyrighted product. NIOSH shall have rights to distribution of the findings and analyses. NIOSH assumes full and exclusive rights to publication and presentation of this work.

All deliverables (e.g., the final written report and results of data analyses) are due to the project officer within ten months of the contract award date. Half of the contract funds will be remitted at the end of human subjects data collection.

The balance of the task order will be remitted upon final receipt of all deliverables. More specifically, this full payment will be made upon receiving experimental data, preliminary analysis results, and final report.

NIOSH will request all data be sent within twelve months electronically using secure methods. The secure method of choice is to have the vendor place electronic data onto an encrypted Secure File Transfer Protocol (SFTP) server or the new “MoveIt” system hosted by CDC’s Information Technology Services Office.

Selection Criteria:

Proposal will be evaluated for technical merit using the criteria below. Technical merit will outweigh total costs, although total cost is an important factor.

1. (40%) The vendor has the special expertise and relevant experience necessary to accomplish the work as proposed and required.

2. (30%) A thorough understanding of the exoskeletons to be utilized on a simulated construction elevator platform, with evidence indicating the capability and availability to provide the services proposed.

3. (20%) The assigned staff, time, and qualifications are appropriate for the tasks proposed.

4. (10%) Ability to follow COVID-19 guidelines or policies in place at their facility at the time of the study and obtain timely IRB approval.

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

402 Closed Functionality

403 Biometrics

404 Preservation of Information Provided for Accessibility

405 Privacy

406 Standard Connections

407 Operable Parts

408 Display Screens

409 Status Indicators

410 Color Coding

411 Audible Signals

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, 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.

References:

CPWR (2019). Death and injuries involving elevators or escalators in construction and general population. Silver Spring, MD: CPWR- the Center for Construction Research and Training. https://www.cpwr.com/publications/deaths-and-injuries-involving-elevators-or-escalators-construction-and-general

Kim SK, Nussbaum MA, Esfahani MIM, Alemi MM, Jia B, Rashedi E “Assessing the influence of a passive, upper extremity exoskeletal vest for tasks requiring arm elevation: Part II – ‘Unexpected’ effects on shoulder motion, balance, and spine loading,” Applied Ergonomics, 70, pp. 323-330, 2018.

Pan CS, Chiou S, Hsiao H, Keane P “Ergonomic hazards and controls for elevating devices in construction.” In Bhattacharya, A., & J. D., McGlothlin (Eds.), Occupational Ergonomics: Theory and Applications, Chapter 25, pp. 653-693, 2012.

Pan CS, Chiou S, Kau Y, Wimer B, Ning X, Keane P “Evaluation of postural sway and impact forces during ingress and egress of scissor lifts at elevations,” Applied Ergonomics, 65, pp. 152-162, 2017.

Pan, C.S., Ning, X., Wimer, B., Zwiener, J., and Kao, Y “Biomechanical Assessment of Using Production Tables on Mast Climbing Work Platforms,” Applied Ergonomics. 90, January 2021.

Picchiotti, MT, Weston EB, Knapik, GG, Dufour, JS, Marras, WS “Impact of two postural assist exoskeletons on biomechanical loading of the lumbar spine,” Applied Ergonomics, 75, pp. 1-7, 2019.

Weston EB, Alizadeh M, Knapik GG, Wang X, Marras WS “Biomechanical evaluation of exoskeleton use on loading of the lumbar spine,” Applied Ergonomics, 68, pp. 101-108, 2018.

Zolghadr, M, Hu, B, Vaglienti, R, Ning, X “Effects of Lumbar Facet Nerve Block on Standing Balance among Lower Back Pain Patients.” International Annual Meeting of the Human Factors and Ergonomics Society, Philadelphia, PA, USA Oct 1-5, 2018.

NIOSH Project Officer:

Christopher S. Pan, Ph.D.

NIOSH, DSR, MS G800

1095 Willowdale Road

Morgantown, WV 26505

Phone: (304)-285-5978

Email: syp4@cdc.gov

Access to Government Information or Systems Security Language

Standard Language

A. Baseline Security Requirements

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

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.

Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee 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.

Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC/NIOSH policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

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 the:

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

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

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

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.

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.

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

Categorize all information owned and/or collected/managed on behalf of HHS/CDC/NIOSH and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, 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

Integrity:

Availability:

Overall Risk Level:

[ ] Low [ × ] Moderate [ ] High

Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/CDC/NIOSH regardless of location or purpose.

Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/CDC/NIOSH Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or HHS/CDC/NIOSH security and/or privacy officials.

Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/CDC/NIOSH privacy policies, and complete all the requirements below:

a.

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

b.

To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how HHS collects, disseminates, maintains, or disposes of the public's PII.

c.

The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

i.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within [OpDiv to insert contract-specific timeline] after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

ii.

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

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 32 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;

disclosed to authorized personnel on a Need-To-Know basis;

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 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.

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 by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

a.

Per NIOSH Security and Privacy requirement, the Contractor (and/or any subcontractor) shall employ a formal sanctions process for individuals failing to comply with established privacy policies and procedures.

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 [CDC] policies. Unauthorized disclosure of information will be subject to the HHS/[CDC] sanction policies and/or governed by the following laws and regulations:

a.

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

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

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

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). .

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.

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

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.

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.

Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC-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).

Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor shall provide a written copy of the validation documentation to the COR.

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 CDC Office of Chief Information Security Officer (OCISO).

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 CDC non-disclosure agreement, as applicable. Contractors (and/or subcontractors) must a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

a.

The Contractor shall assist the CDC 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 CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce new or increased privacy risks), whichever comes first.

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/CDC 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 CDC Security Awareness Training (SAT), 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 (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least 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.

a.

All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

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.

B.

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, HHS Rules of Behavior for Privileged Users.

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 CDC Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

Incident Response

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 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.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information” (03 January 2017) states:

Definition of an Incident:

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.

Definition of a Breach:

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.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII 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”.

Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC shall include the following requirements:

1) The contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage a suspected or confirmed breach.

The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/CDC IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

All contractors and subcontractors shall participate in regular training on how to identify and report a breach.

a.

All contractors and subcontractors shall report a suspected or confirmed breach in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC, incident management policy, and United States Computer Emergency Readiness Team (US-CERT) notification guidelines. To this end, the Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC) or CDC Computer Incident Response Team (CSIRT) within 24 hours via email at csirt@cdc.gov or telephone at 866-655-2245, whether the response is positive or negative. The types of information required in an incident report must include at a minimum: company and point of contact information, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

i.

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

ii.

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

Encrypt sensitive information in attachments to email, media, etc.

Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS/CDC privacy breach response policies when handling PII breaches.

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.

All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

All contractors and subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

Identify roles and responsibilities, in accordance with HHS/CDC Breach Response Policy and the HHS/CDC Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with HHS/CDC Breach Response Plan, and the Contractor shall then send CDC- approved notifications to affected individuals; and, Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards for PII.

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).

All contractors with routine access to PII requires both a valid need to know and requires a Tier 2S background investigation to ensure the individual being provided access is suitable. These requirements extend to developers of information systems containing PII and PHI.

[ ] Tier 1

[ × ] Tier 2s

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

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 shall be submitted to the COR and/or CO by the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted immediately upon change. 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.

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 and in accordance with the HHS Contract Closeout Guide (2012).

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

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 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.

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

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 CDC policies.

The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Out-Processing Checklist…