RFQ 75D30126Q78873 Amendment 2.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

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

PAGE OF PAGES

1 31

1. REQUEST NO. AMENDMENT 1

75D301-26-Q-78873

2. DATE ISSUED

5/14/26

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)

7. DELIVERY

FOB OTHER

DESTINATION (See Schedule)

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 Pittsburgh, PA .

Please submit questions to Paula Taylor, VGA8@cdc.gov no later than May 22, 2026 by 12pm EST. All quotes also due to Paula Taylor at VGA8@CDC.gov, no later than 12pm EST on June 12, 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) mailto:VGA8@cdc.gov mailto:VGA8@CDC.gov

Section B: Supplies or Services and Price/Costs Base Period – 9/15/26 –9/14/27

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Testing of 200 human subjects for:

application validation testing and user experience study. Includes protocol development, test subject protections, data processing analysis, and reporting.

September 15, 2026 – September 14, 2027

Severable Services

Firm-fixed-price

Paid 1/12th of the value monthly

1 Job

0002 Test Rig Development and Support

The Contractor shall provide all labor, materials, equipment, and technical support necessary to build, configure, modify, operate, and maintain a test rig to hold smartphones in support of human subject testing under this contract. Includes adjustable intensity lighting and adjustable height and angle settings. Made with rigid aluminum frame. The scope includes fabrication and assembly.

The total amount payable under this CLIN shall not exceed the ceiling price of $3,500 without prior written approval of the Contracting Officer.

Work under this CLIN shall be performed only as authorized by the Government.

September 15, 2026 – September 14, 2027

Time-and-Materials (T&M)

Invoiced based on actual hours worked and materials incurred.

1 Job

Optional Tasks– Base Period – 9/15/26 – 9/14/27

0003 Base Period Optional Task 1 – Additional 25 Subject Testing

Testing of an additional 25 human subjects for:

application validation testing and user experience study. This option may only be exercised after completion of testing for the 200 human subjects under the base task. Includes protocol development, test subject protections, data processing analysis, and reporting. Exercised at the discretion of NIOSH.

September 15, 2026 – September 14, 2027

Severable Services

Firm-fixed-price

Paid 1/12th of the value monthly

1 Job

0004 Base Period Optional Task 2 – IRB Protocol

Secure an approved Institutional Review Board (IRB) protocol for human subject testing. This task shall only be required if NIOSH determines that an IRB protocol is necessary. Task is to cover all aspects of an IRB protocol, including opening, maintaining, amending, and closing protocol.

Exercised at the discretion of NIOSH.

September 15, 2026 – September 14, 2027

Severable Services

Firm-fixed-price

Paid 1/12th of the value monthly

BASE PERIOD TOTAL:

Option Period 1 – 9/15/27 – 9/14/28

1001 Option Period 1 – Fit Testing

The contractor shall conduct fit testing of 25 human subjects. This includes protocol development, test subject protections, data processing, analysis, and reporting. Testing may require implementation under an Institutional Review Board (IRB) protocol, as determined by NIOSH. The contractor shall perform PortaCount fit testing on each subject using five different N95 respirator models and shall conduct three fit tests per subject for each respirator model, using a new respirator for each fit test. NIOSH will provide the specific N95 respirator models at the time the option is exercised. This option is exercised at the discretion of NIOSH.

September 15, 2027 – September 14, 2028

Severable Services

Firm-fixed-price

Paid 1/12th of the value monthly

1 Job

1002 Option Period 1 – IRB Protocol For Fit Testing

Secure an approved Institutional Review Board (IRB) protocol for fit testing of 25 human subjects.

This task shall only be required if NIOSH determines that an IRB protocol is necessary. Task is to cover all aspects of an IRB protocol, including opening, maintaining, amending, and closing protocol. Exercised at the discretion of NIOSH.

August 15, 2027 – August 14, 2028

Severable Services

Firm-fixed-price

Paid 1/12th of the value monthly

OPTION PERIOD 1 TOTAL:

TOTAL CONTRACT VALUE:

Section C: Statement of Work Period of Performance

Base Task (Item 0001): August 15, 2026 – August 14, 2027 (Base Period). Testing of 200 human subjects for:

application validation testing and user experience study. Includes protocol development, test subject protections, data processing analysis, and reporting.

Base Task (Item 0002): August 15, 2026 – August 14, 2027 (Base Period). The Contractor shall provide all labor, materials, equipment, and technical support necessary to build, configure, modify, operate, and maintain a test rig to hold smartphones in support of human subject testing under this contract. Includes adjustable intensity lighting and adjustable height and angle settings. Made with rigid aluminum frame. The scope includes fabrication and assembly.

Optional Task 1: (Item 0003): August 15, 2026 – August 14, 2027 (Base Period). Testing of an additional 25 human subjects for: application validation testing and user experience study. Includes protocol development, test subject protections, data processing analysis, and reporting. This option may only be exercised after completion of testing for the 200 human subjects under the base task.

Optional Task 2 (Item 0004): August 15, 2026 – August 14, 2027. Secure an approved Institutional Review Board (IRB) protocol for human subject testing. This task shall only be required if NIOSH determines that an IRB protocol is necessary. Task is to cover all aspects of an IRB protocol, including opening, maintaining, amending, and closing protocol.

Option Period 1 (Item 1001): August 15, 2027 – August 14, 2028. Fit testing of 25 human subjects. Includes protocol development, test subject protections, data processing analysis, and reporting.

Option Period 1 (Item 1002): August 15, 2027 – August 14, 2028. Secure an approved Institutional Review Board (IRB) protocol for fit testing of 25 human subjects. This task shall only be required if NIOSH determines that an IRB protocol is necessary. Task is to cover all aspects of an IRB protocol, including opening, maintaining, amending, and closing protocol.

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 and user experience study testing.

Section 2 – Purpose/Objective

This contract requires human subject 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 human subjects of diverse face sizes and races, and skin tones, to potentially include some human subjects whose face/head size fall outside the panels. The contractor shall perform all human subject measurements specified in the Statement of Work (SOW). To complement the required testing, the contractor shall work with NIOSH to develop and administer a survey-based user experience study. The contractor shall work closely with NIOSH to ensure the success of this project.

Section 3 – Scope of Work

The contractor shall perform human subject 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 human subjects. The contractor shall also perform a user experience study for the application. Optional tasks are specified in this Scope of Work, and can only be exercised at the discretion of NIOSH. These optional tasks can be exercised [once, multiple times] and will not be exercised with fewer than x days left in the period of performance.

Section 4 – Tasks to Be Performed

BASE TASKS

Task 1: Protocol Development

1. Work with NIOSH to develop study protocols

a. Work with NIOSH National Personal Protective Technology Laboratory (NPPTL) staff to develop a protocol for the validation study and a protocol for the user experience study.

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

Task 2: Human Subject Protections

1. Develop procedures in cooperation with NIOSH to secure private human subject data.

Task 3: Application Validation Study (CLIN 0001)

1. The validation study requires that test technicians collect anthropometric measurements of the head/face by traditional tools (sliding and spreading calipers and measuring tape, as applicable) 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 requires 200 human subjects.

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 human subject at a different angle) and, 2) by the human subject 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). All devices will be provided by the contractor.

e. The contractor shall build, fabricate, assemble, configure, and modify the test rig, including troubleshooting, calibration, and adjustments as necessary to support testing, with advisement from NIOSH. Includes adjustable intensity lighting and adjustable height and angle settings. Made with rigid aluminum frame. (CLIN 0002)

f. The contractor shall recruit human subjects 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, The contractor shall test some human subjects whose face/head size fall outside of these panels.

g. The contractor shall classify the 200 human subjects into face/head size categories in accordance with the study protocol and NIOSH guidance.

h. The contractor shall prepare and submit a comprehensive written report summarizing the results of the study. At a minimum, the report shall include a description of the study objectives, methodology, and test protocols; characteristics of the test subjects; data collection procedures; and a detailed analysis of results.

The report shall present findings in a clear and organized manner, including tables, figures, and supporting data as appropriate. The contractor shall also identify any limitations of the study, discuss observed trends or anomalies, and provide conclusions and, where applicable, recommendations based on the results.

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, 567-576

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. The contractor may utilize specialized software tools, as necessary, to perform this task.

b. The contractor shall work with NIOSH to analyze the data generated under this effort. This shall include preliminary data processing activities such as organizing, cleaning, validating, and sorting data to ensure accuracy and completeness. The contractor shall structure and format datasets for analysis, including development of data dictionaries and standardized variable definitions, as appropriate. The contractor shall then support and conduct analyses in coordination with NIOSH, including generating summary statistics, identifying trends, and preparing tables, figures, and other analytical outputs as requested.

c. The contractor shall interface with NIOSH and the application developer once a month to share collected data and obtain input throughout the data collection process.

Task 4: User Experience Study

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

a. The contractor shall work with NIOSH and the application developer to design the mobile application user experience study.

b. The contractor shall work with NIOSH to analyze the data generated under this effort. This shall include preliminary data processing activities such as organizing, cleaning, validating, and sorting data to ensure accuracy and completeness. The contractor shall structure and format datasets for analysis, including development of data dictionaries and standardized variable definitions, as appropriate. The contractor shall then support and conduct analyses in coordination with NIOSH, including generating summary statistics, identifying trends, and preparing tables, figures, and other analytical outputs as requested. The contractor may utilize specialized software tools, as necessary, to perform data processing and analysis under this effort.

c. The contractor shall prepare and submit a comprehensive written report summarizing the results of the study. At a minimum, the report shall include a description of the study objectives, methodology, and test protocols; characteristics of the test subjects; data collection procedures; and a detailed analysis of results.

The report shall present findings in a clear and organized manner, including tables, figures, and supporting data as appropriate. The contractor shall also identify any limitations of the study, discuss observed trends or anomalies, and provide conclusions and, where applicable, recommendations based on the results.

Task 5: Reporting

1. Monthly Progress Report and Final Report

a. A Monthly Progress Report shall be required to be sent to the project officer and COR via email. NIOSH will review the report and ask for clarifications and corrections to be made.

b. At the conclusion of the project, a Final Report is required. The Final 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.

c. At the conclusion of the project, all data shall be transferred to NIOSH and the contractor shall not use, release, or disclose data generated under this contract for any purpose outside of this contract without prior written approval from the Government.

OPTIONAL TASKS (BASE PERIOD)

1. Optional Task 1 (CLIN 0003)

a. The contractor shall conduct testing of an additional 25 human subjects for application validation testing and user experience study. This includes protocol development, test subject protections, data processing, analysis, and reporting. This option may only be exercised after completion of testing for the 200 human subjects under CLIN 0001 and at the discretion of NIOSH.

2. Optional Task 2 (CLIN 0004)

a. The contractor shall secure an approved Institutional Review Board (IRB) protocol for human subject testing, if required. This task shall only be performed if NIOSH determines that an IRB protocol is necessary. The contractor shall perform all activities required to obtain and maintain IRB approval, including protocol development, submission, maintenance, amendment, and closure. This option is exercised at the discretion of NIOSH.

OPTION PERIODS

1. Option Period 1 – (CLIN 1001)

a. The contractor shall conduct fit testing of 25 human subjects. This includes protocol development, test subject protections, data processing, analysis, and reporting. Testing may require implementation under an Institutional Review Board (IRB) protocol, as determined by NIOSH. The contractor shall perform PortaCount fit testing on each subject using five different N95 respirator models and shall conduct three fit tests per subject for each respirator model, using a new respirator for each fit test. NIOSH will provide the specific N95 respirator models at the time the option is exercised. This option is exercised at the discretion of NIOSH.

2. Option Period 1 – IRB protocol for fit testing (CLIN 1002)

a. The contractor shall secure an approved Institutional Review Board (IRB) protocol for fit testing of 25 human subjects, if required. This task shall only be performed if NIOSH determines that an IRB protocol is necessary. The contractor shall perform all activities required to obtain and maintain IRB approval, including protocol development, submission, maintenance, amendment, and closure. This option is 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 will be conducted within normal business hours.

SECTION 7 – TRAVEL

Travel is not required for this task; however, if travel becomes necessary, it will 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.

SECTION 8 – DELIVERABLES/REPORTING

Task Deliverable Quantity / Format Due Date Deliver To Task 1 – Protocol Development

Validation Study Protocol and User Experience Study Protocol

Two PDF documents Within 90 days after award

NIOSH Project Officer and COR

Task 2 – Human Subject Protections

Written procedures for human subject data protection and handling

One PDF document Within 90 days after award

NIOSH Project Officer and COR

Task 3 (CLIN 0002) – Test Rig Development

Operational test rig and brief documentation describing configuration and use

One physical item + PDF document

Prior to initiation of data collection or within 120 days after award, whichever comes first

NIOSH Project Officer and COR

Task 5 – Reporting

Monthly Progress Report including activity updates, testing status, and study progress

Monthly PDF document

Within 10 business days after the end of each reporting month

NIOSH Project Officer and COR

Task 3 & 4 – Data Collection and Analysis

Ongoing Data Deliveries (image and measurement data) in mutually agreed format

Electronic files Monthly or as otherwise requested by NIOSH throughout the period of performance

NIOSH Project Officer and COR

Task 3 & 4 – Data Collection and Analysis

Final Comprehensive Dataset including all image and measurement data collected under the contract

Electronic files (format agreed upon with

NIOSH)

Within 60 days after completion of the period of performance

NIOSH Project Officer and COR

Task 3 & 4 – Reporting

Draft Final Report (Validation Study and User Experience Study results)

One PDF document Within 45 days after completion of the period of performance

NIOSH Project Officer and COR

Task 5 – Reporting

Final Report (incorporating Government comments;

includes validation and user experience study results, analysis, and conclusions)

One PDF document Within 60 days after completion of the period of performance

NIOSH Project Officer and COR https://easi.cdc.gov/Modules

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 and surveys, securing participant personally identifiable information (PII), obtaining and managing IRB protocols, 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 with data analysis of human anthropometric data and report writing relative to the tasks described in this contract.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy

1. Baseline Security Requirements:

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter

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

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

ii. Operate a Federal System Containing Information: A contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the CDC 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.

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

i. 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.

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit CDC 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. Based on information provided by the System Security and Privacy Officer (previously http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf referred to as ISSO), CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ X ] Low [ ] Moderate [ ] High Integrity: [ ] Low [ X ] Moderate [ ] High Availability: [ X ] Low [ ] Moderate [ ] High Overall Impact Level: [X ] Low [ ] Moderate [ ] High

iii. 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 CDC regardless of location or purpose.

iv. 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 hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC 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 CDC security and/or privacy officials.

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

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

i. 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.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC'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 CDC collects, disseminates, maintains, or disposes of the public's PII.

iii. 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 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.

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 timeline specified in CDC Assessment and Authorization (A&A) Standard Operating Procedure after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

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.

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

CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

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

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

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

Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. 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) must 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.

g. Confidentiality and Nondisclosure of Information. Any information provided to the Contractor (and/or any subcontractor) by CDC or collected by the Contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor.

Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must 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 must be protected in accordance with HHS/CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

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

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

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

h. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB

Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115- 232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR

52.204.25. The Contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

j. 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 must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to always assume HTTPS to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended. Consult HHS/CDC Policy for Internet and Email Security for additional information. According to the CDC Web policy, all CDC web content must reside on a CDC.gov domain and must be hosted on CDC or CDC-authorized information systems .

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

l. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

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

iv. 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 must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the CDC 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 http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

m. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the CDC non-disclosure agreement. Contractors (and/or subcontractors) must submit 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.

2. Training Requirements:

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete CDC Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC training policies.

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

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

3. Rules of Behavior:

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing agency 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 Information Security Awareness Training. If the training is provided by the Contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. Incident Response:

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, http://csrc.nist.gov/publications/ 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)29, 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 CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information (PII).30"

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

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

ii. All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-

130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST

CMVP.

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

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send CDC-approved notifications to affected individuals in accordance with CDC privacy breach response policies, including the CDC/OCIO Standard for Responding to Breaches of Personally Identifiable Information (PII).

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) at csirt@cdc.gov or telephone at 1-866-655-2245, COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one hour, and consistent with the applicable CDC Component and CDC policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

Not include any sensitive information in the subject or body of any reporting e-mail; and Encrypt sensitive information in attachments to email, media, etc.

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

vii. 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.

viii. 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.

ix. 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.

x. 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.

mailto:csirt@cdc.gov

5. Position Sensitivity Designations:

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract.

Not Applicable

X Level 1: Non-sensitive

Level 2: Non-critical Sensitive

Level 3: Critical Sensitive

Level 4: Special Sensitive

Level 5: Public Trust/Moderate Risk

Level 6: Public Trust/High Risk

6. Homeland Security Presidential Directive (HSPD)-12:

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors;

OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS/CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster:

The Contractor (and/or any subcontractor) must 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 must 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 must 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 must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration:

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, CDC 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 must follow the CDC EPLC framework and methodology and in accordance with the CDC Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC System Development Life Cycle requirements, 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.

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

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and System Security and Privacy Officer (previously referred to as ISSO) before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The Contractor (and/or any subcontractors) must 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 must 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.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the CDC Out-Processing Checklist when an employee terminates work under this contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention:

a. The Contractor (and/or any subcontractor) must maintain all information in accordance with Executive Order

13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and CDC Records Management Policy and must not dispose of any records unless authorized by CDC.

b. If a Contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC policies.

10. High Value Asset (HVA):

If a system is identified as HVA, the Contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the Department of…