RFQ 75D30126Q78873.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 59

1. REQUEST NO.

75D301-26-Q-78873

2. DATE ISSUED

3. REQUISITION/PURCHASE REQUEST NO.

0000HCCL-2026-95078

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

Centers for Disease Control and Prevention

Chamblee Campus Building 102, MS S102-4

4770 Buford Hwy

Atlanta GA 303413717

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Paula Taylor (770) 488-2433 x

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

c. STREET ADDRESS b. STREET ADDRESS

c. CITY

d. CITY e. STATE f. ZIP CODE d. STATE e. ZIP CODE

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)

The Center for Disease Control and Prevention

(CDC), has a requirement for a Validation study and user experience study for a face measuring mobile application for NIOSH, in Pittburgh, PA .

Please submit quotation to Paula Taylor at

Vga8@cdc.gov, no later than 3:00PM EST on

3/7/2026.

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA FAR (48 CFR) 53.215-1(a)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule) mailto:Vga8@cdc.gov

Section B: Supplies or Services and Price/Costs

Base Tasks –Base Period

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Testing of 200 Test Subjects for: validation testing for both app and low-cost paper tool, and app user experience study. Respirator fit testing for 50 of these subjects. Includes protocol development, test subject protections, data processing analysis, and reporting.

July 1, 2026 – June 30, 2027

Severable Services

Firm-fixed-price

Paid 1/12th of the value monthly

1 Job

Optional Task 1 – Base Period

Testing of an additional 25 Test Subjects for:

validation testing for both app and low-cost paper tool, and app user experience study.

Includes protocol development, test subject protections, data processing analysis, and reporting. This will only be exercised once the

200 subjects have been tested in the base work. Exercised at the discretion of NIOSH.

July 1, 2026 – June 30, 2027

Severable Services

Firm-fixed-price

Paid 1/xth of the value monthly

Optional Task 2 – Base Period

0003 Secure an approved Institutional Review Board

(IRB) protocol for all human subject testing.

NIOSH will determine if an IRB protocol is necessary. Task is to cover all aspects of an

IRB protocol, including opening, maintaining, and closing protocol. Exercised at the discretion of NIOSH.

July 1, 2026 – June 30, 2027

Severable Services

Firm-fixed-price P

Paid 1/xth of the value monthly

Section C: Statement of Work

Period of Performance

Base Tasks (Item 00001) July 1, 2026 – June 30, 2027. Testing of 200 Test Subjects for: validation testing for both app and low-cost paper tool, and app user experience study. Respirator fit testing for 50 of these subjects. Includes protocol development, test subject protections, data processing analysis, and reporting.

Optional Task 1 (Item 00002): July 1, 2026 – June 30, 2027. Testing of an additional 25 Test Subjects for: validation testing for both app and low-cost paper tool, and app user experience study. Includes protocol development, test subject protections, data processing analysis, and reporting. This will only be exercised once the 200 subjects have been tested in the base work. Exercised at the discretion of

NIOSH.

Optional Task 2 (Item 00003): July 1, 2026 – June 30, 2027. Secure an approved Institutional Review

Board (IRB) protocol for all human subject testing. NIOSH will determine if an IRB protocol is necessary. Task is to cover all aspects of an IRB protocol, including opening, maintaining, and closing protocol. Exercised at the discretion of NIOSH.

SECTION 1 – BACKGROUND

Overview: Respiratory protection research and panel sizing requirements currently rely on manual measurements based on the NIOSH Bivariate Panel (face length and width measurements) and the

NIOSH Principal Component Analysis (PCA) Panel (10 facial measurements). NIOSH has developed a beta version of a mobile application for smartphones and tablets for measuring people’s faces and classifying them into the NIOSH panels. Additionally, the application will provide a prediction of respirator models with a likelihood to fit. This contract is for the application validation testing, user experience study testing, development of a low-cost face measuring tool (such as a paper-printed ruler or paper face size template) and its assessment, and additional respirator fit testing to support the application’s respirator fit predictions.

SECTION 2 – PURPOSE/OBJECTIVE

This contract requires human participant testing to support validation of a mobile application Beta version developed by NIOSH. The primary objective of NIOSH’s validation study is to estimate discrepancies between panel classifications and facial dimension measurements determined by calipers, currently the standard instrument for taking such measurements, and those determined by the mobile application. The contractor shall assist NIOSH in refining the study design and developing test protocols. The contractor shall recruit test participants of diverse face sizes and races/skin tones, to potentially include some participants whose face/head size fall outside the panels. The contractor shall perform all participant measurements and respirator fit testing. To complement the validation study, the contractor shall work with NIOSH to develop a survey-based user experience study. Additionally, to accommodate those who do not have access to mobile devices, the contractor shall develop a low-cost face measuring tool (such as a paper-printed ruler or paper face size template) and work with NIOSH to assess the performance of this tool relative to the calipers and mobile application. The contractor shall work closely with NIOSH to ensure the success of this project.

SECTION 3 – SCOPE OF WORK

The contractor is expected to perform human participants testing to support the validation of a mobile application Beta version developed by NIOSH. The application was developed for measuring faces and predicting respirator models that are likely to fit the person who scans their face. The contractor shall use both calipers and the application to collect anthropometric face/head size data of the test participants. The contractor shall also perform a user experience study for the application. Additionally, the contractor shall perform human participant quantitative fit testing for 10 models of N95 filtering facepiece respirators which will support providing the application user a prediction of respirator fit. The contractor shall develop a low-cost face measuring tool (such as a paper-printed ruler or paper face size template) to accommodate those who do not have access to mobile devices. The contractor shall also assess this low-cost tool on test participants.

SECTION 4 – TASKS TO BE PERFORMED

BASE TASKS

Task 1: Protocol Development

1. Work with NIOSH to develop study protocols

a. Work with NIOSH NPPTL staff to develop protocols for the validation study, user experience study, development of the low-cost face measuring paper tool, and respirator fit test study.

b. The contractor shall participate with NIOSH on Microsoft Teams calls discuss protocol development. The contractor shall contribute to this task by providing their input, expertise, and experience to protocol development.

Task 2: Test Participants Protections

1. Develop protocols/procedures aligned with the Agency determination of whether human participants are engaged.

Task 3: Development of Low-Cost Face Measuring Tool

1. The contractor shall work with NIOSH to develop a low-cost face measuring tool that can be used by people without access to mobile devices. The paper tool will later be available for printing in the future on a NIOSH website. NIOSH envisions the paper tool will be a type of ruler or cut-out template that will aid in face or head sizing.

a. Work with NIOSH to develop the tool.

b. The contractor shall assess the tool in human participant testing as specified in Task 4 below.

Task 4: Application Validation Study and Low-Cost Paper tool Validation Study

1. The validation study requires that test technicians collect anthropometric measurements of the head/face by traditional tools (calipers and measuring tape) and the face scanning application.

The anthropometric dimensions to be measured are in Table 1.

a. Two raters (test technicians) shall collect caliper data to determine inter-rater variability for the study.

b. The base work specifies 200 test participants which is required.

c. Mobile application data shall be collected in two different ways: 1) by use of a test rig which holds three of the same model mobile devices (each pointing at the participant at a different angle) and, 2) by the test participant taking their own “selfie” scan by themselves.

d. Three device models shall be used for the study: an upper tier Apple iPhone model

(three of the same model), a mid-tier Android system phone model (three of the same model), and a budget Android system phone model (three of the same model).

e. For the mobile application testing, a stable test rig is needed to hold a minimum of three devices at a time, with each device placement to have angular and height adjustments.

The contractor shall build the test rig with advisement from NIOSH.

f. The contract requires the contractor to recruit test participants of diverse races/skin tones and face sizes and classify them into the cells of NIOSH Bivariate and PCA test panels.

Based on the protocols developed, we also anticipate the contractor shall test some participants whose face/head size fall outside of these panels.

g. For both the mobile application and the paper tool validation studies, the 200 test subjects shall be classified into face/head size categories. The contractor shall record the results and assist NIOSH in analyzing data.

Table 1: List of 16 Facial Dimensions adapted from Zhuang and Bradtmiller (2005)*

1 Bigonial breadth 11 Menton-Sellion length

2 Bitragion chin arc 12 Minimum frontal breadth

3 Bitragion coronal arc 13 Nasal root breadth

4 Bitragion frontal arc 14 Nose breadth

5 Bitragion subnasale arc 15 Nose protrusion

6 Bizygomatic breadth 16 Subnasale-Sellion

7 Head breadth

8 Interpupillary distance

9 Lip length

10 Maximum frontal breadth

* Zhuang and Bradtmiller (2005). Head-and-Face Anthropometric Survey of U.S.

Respirator Users, Journal of Occupational and Environmental Hygiene. 2:11, 567-

2. Data Processing and Analysis

a. The contractor shall be responsible for downloading the captured mobile application images and recording anthropometric dimensions from the test devices in a mutually agreed upon format with NIOSH.

b. The contractor shall work with NIOSH to analyze the data.

Task 4: User Experience Study

1. All participants in the study shall participate in a user experience study when they undergo the mobile application validation testing.

1. The contractor shall work with NIOSH to design the mobile application user experience study.

2. The contractor shall work with NIOSH to analyze the data.

3. The contractor shall summarize the results of the study in a written report

Task 5. Respirator Fit Test Data Collection

1. To develop recommendations within the application for respirator fit predictions, the contractor shall conduct respirator fit testing with NIOSH-approved N95 filtering facepiece respirators

(FFR) for 50 of the 200 test participants.

a. The contractor shall work with NIOSH to design the fit test study and analyze the data.

b. 50 test participants from the base work will undergo PortaCount fit testing of 10 N95

FFR respirator models (to be determined by NIOSH). The PortaCount must have the

“N-95 mode” feature. The contractor shall purchase the respirators.

c. For each of the 10 FFR models, each test participant shall perform three fit tests on one sample of FFR.

Task 6: Reporting

1. Monthly report and Final Report

d. A monthly progress report shall be required to be sent to the project officer and COR.

e. At the conclusion of the project, a final summary report is required. The final summary report shall be an inclusive summary of all testing (methods, observations, and summary descriptions). The final report also requires the contractor’s conclusions and recommendations.

f. Throughout the project and at the conclusion of the project, data shall be shared with

NIOSH.

g. At the conclusion of the project, all data shall be transferred to NIOSH and the contractor shall have no rights to use the data for any purpose outside of this contract.

OPTIONAL TASKS

1. Optional Task 1.

a. Testing of an additional 25 Test Subjects for: validation testing for both app and low-cost paper tool, and app user experience study. Includes protocol development, test subject protections, data processing analysis, and reporting.

This will only be exercised once the 200 subjects have been tested in the base work. Exercised at the discretion of NIOSH.

2. Optional Task 2.

a. Secure an approved Institutional Review Board (IRB) protocol for all human subject testing. NIOSH will determine if an IRB protocol is necessary. Task is to cover all aspects of an IRB protocol, including opening, maintaining, and closing protocol. Exercised at the discretion of NIOSH.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

The Government will not furnish any property for the project.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

• The contractor shall perform the studies either at their own facility or other location they determine necessary to obtain test participants.

SUBSECTION B – CONTRACT SUPPORT HOURS

• Work hours are at the discretion of the contractor.

SECTION 7 – TRAVEL

Travel shall be in accordance with / and not to exceed the Federal Travel Regulation rates. Travel costs need to be approved in advance by the COR. The contractor shall be required to provide their travel policy to the Government for review.

Travel does not include conferences. Conference Approval Management Systems (CAMS) approval is required in advance of any travel for conferences. If the need for conference travel occurs, the contract will be modified to separately add funding.

• The contractor should include all travel costs in their bid to perform the studies.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Deliverables/Reporting

Task Deliverable Quantity/Format Due Date Deliver To

Monthly technical report

Written report PDF document 10 business days after the first of the month

NIOSH project officer and COR

Procedure for test participants protections

Written procedure

PDF document 3 months after award

NIOSH project officer and COR

Comprehensive data transfer

All image and measurement data collected in the project

PDF document 2 months after close of the project

NIOSH project officer and COR

Final report Written report PDF document 2 months after close of the project

NIOSH project officer and COR

SECTION 9 – REFERENCE MATERIALS

1. Zhuang and Bradtmiller (2005). Head-and-Face Anthropometric Survey of U.S. Respirator

Users, Journal of Occupational and Environmental Hygiene. 2:11, 567-576

2. Zhuang Z, Bradtmiller B, Shaffer RE (2007). New respirator fit test panels representing the current U.S. civilian work force. J Occup Environ Hyg. 2007 Sep;4(9):647-59. doi:

10.1080/15459620701497538. PMID: 17613722.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

• The contractor must demonstrate experience and proficiency in conducting human participant testing, securing participant personally identifiable information (PII), using calipers to record face/head anthropometric measurements, performing participant respirator fit testing, and administering survey questions to study participants.

• The contractor must demonstrate their experience conducting human participant surveys, data https://easi.cdc.gov/Modules analysis, and report writing of those surveys.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

The contractor shall be required to adhere by all security and privacy requirements specified in the contract.

Human Subjects Protections in Research

• The contractor shall develop protocols/procedures aligned with the Agency determination of whether human participants are engaged. This may require the contractor to secure approval of an IRB protocol.

Paperwork Reduction Act (PRA)

• NIOSH will determine if PRA applies. If PRA applies, the contractor shall be required to work with NIOSH to meet PRA documentation requirements.

Section 508 Compliance

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:

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.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm http://hhs.gov/web/508 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 is 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.

SPECIAL CONSIDERATIONS

Deliverables

The following table details a listing of possible deliverables that may be completed by the contractor (at a minimum) and included in the Schedule of Deliverables. These should be added to the existing schedule and not in a separate security deliverable schedule.

Deliverable Title/Description Due Date

Roster By effective date of this contract

Contractor Employee Non- Disclosure

Agreement (NDA)

Prior to performing any work on behalf of HHS

Assist in the completion of a PTA/PIA form

Within specified date after contract award

Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Signed ROB for all employees Initiation of contract and at least annually thereafter

Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Incident and Breach Response Plan Upon request from government

List of Personnel with defined roles and responsibilities

Prior to performing any work on behalf of HHS

Off-boarding documentation, equipment and badge when leaving contract

Within 7 days of contractor departure and at contract expiration

Onboarding documentation when beginning contract

Prior to performing any work on behalf of HHS

Form or deliverables required by CDC/NIOSH At contract expiration

If the procurement involves a system or cloud service, Disposition/Decommission Plan

At contract expiration

Contract initiation and expiration Due after contract award http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

SA&A Package

BSI, SSP, RAR/SAR, POA&M, CP and CPT

Report, E-Auth (if applicable), PTA/PIA (if applicable), SSN Usage Approval Request (if applicable), RoB (if applicable), Interconnection/Data Use Agreements (if applicable), Authorization Letter, Configuration

Management Plan (if applicable), Configuration

Baseline

Due in accordance with the timeline prescribed in the

CDC SA&A SOP.

Retirement Checklist, All deliverables and data/records retained in accordance with Records Management and other requirements, Device sanitization documentation, Destruction documentation for all other CDC data/information (soft/hard copy)

Prior to system retirement/decommissioning

Protection of Information in a Cloud Environment

Due after contract award.

POA&M updates; Revised security documentation/Agreements

Monthly/as requested by CDC

Security Alerts, Advisories, and Directives : List of personnel with designated roles and responsibilities

Prior to performing any work on behalf of HHS/CDC.

Incident reports (as needed) Incident Response

Plan

As requested by CDC

Computer software, including the source code Prior to performing any work on behalf of HHS

Standard Language

Section I: Procurements Requiring Information Security and/or Physical Access Security

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:

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.

2) 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:

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: [ ] Low [ ] Moderate [ ] High

Availability: [ ] Low [ ] Moderate [ ] High

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.

3) Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and

HHSAR clauses as needed.

4) 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:

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.

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.

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.

o 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.

o 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.

5) 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:

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.

6) 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.

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.

7) 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:

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).

8) 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). .

9) 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.

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

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

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).

12) 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.

13) 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.

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.

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.

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.

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

Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual 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.

2) 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)."

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

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:

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

o Not include any sensitive information in the subject or body of any reporting e-mail; and o 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/CDC privacy breach 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.

6) 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.

7) 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.

8) 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.

9) 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,

10) 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;…