Solicitation_SAM.GOV.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 60

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-Q-76524

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

000HCCLG-2023-73565

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 626 Cochrans Mill Rd Pittsburgh, PA 15236-0070

Approved as to Form and Legality: _____________________________ NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until local time CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Spencer Kahn

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

412-386-6112

C. E-MAIL ADDRESS

qnt8@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 27

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 36

X D PACKAGING AND MARKING 18 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 19 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 20 X K OTHER STATEMENTS OF OFFERORS 37

X G CONTRACT ADMINISTRATION DATA 21 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 41

X H SPECIAL CONTRACT REQUIREMENTS 24 X M EVALUATION FACTORS FOR AWARD 47

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILIT

Y

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta GA 30333 0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies Or Services And Prices/Costs

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Task 1: Development of Project Plan

Task 1 Summary of gaps in education guidance and respirator fit testing for the public and workers without an RPP – and how these gaps inform the project plan for this work. Deliver 6 months after award.

Custodial Account #: 003734

1 Each

0002 Task 2 A Dev Fit Testing Prog. Deliver 18 months after award.

Task 2 AB: Development of fit testing program and train-the-trainer program applicable for workers without an RPP and the public. Deliver 18 months after award.

Task 2C: Development of psychometrically valid pre-/post-evaluation instruments for end users and trainers. Deliver 18 months after award.

Task 2D: Complete IRB protocol to secure ability to collect human subjects data from external entity. Deliver 22 months after award.

Custodial Account #: 003734

1 Each

000301 3-01: Pilot Test - Location 1

Task 03-01: Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 1. Deliver 28 months after award.

Custodial Account #: 003734

1 Each

000302 3-02: Pilot Test - Location 2

Task 3-02: Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 2. Deliver 36 months after award.

Custodial Account #: 003734

1 Each

000303 3-03: Pilot Test - Location 3

Task 03-03: Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 3. Deliver 42 months after award.

Custodial Account #: 003734

1 Each

0004 4: Sum of Eval Feedback

Task 4. Provide summary of evaluation feedback including the trainer evaluations of experiences using the train-the-trainer program provided and end user evaluations, including aggregated reports of results by location. Deliver 54 months after award.

Custodial Account #: 003734

1 Each

0005 5: Finalize Training Framework

Task 5. Finalize a 508 compliant generic training framework that includes a train-the-trainer program and fit test training that can be used by community entities to deliver complete 508 compliant implementation toolkit. Deliver 60 months after award.

Custodial Account #: 003734

1 Each

000601 Travel Year 1

Task 6-01: Travel for year 1

Travel shall be in accordance with the Federal Travel Regulations.

000602 Travel Year 2

Task 6-02: Travel for year 2

Travel shall be in accordance with the Federal Travel Regulations.

Custodial Account #: 003734

1 Each

000603 Travel Year 3

Task 6-03: Travel for year 3

Travel shall be in accordance with the Federal Travel Regulations.

000604 Travel Year 4

Task 6-04: Travel for year 4

Travel shall be in accordance with the Federal Travel Regulations.

B.1 TYPE OF CONTRACT

This contract is a Firm Fixed Price as defined in Federal Acquisition Regulation (FAR) section 16.202.

B.2 PERFORMANCE OF INHERENTLY GOVERNMENTAL, CRITICAL, OR OTHER FUNCTIONS

The services contemplated under this contract are considered to be an Other Function as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition Policy Memorandum 2012-01.

B.3 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

Funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

B.4 REIMBURSEMENT OF TRAVEL COSTS

When authorized in the contract as a direct cost, travel costs that are directly related to specific contract performance may be billed as a direct cost. Travel will be reimbursed in accordance with the Federal Travel Regulations and the travel cost detail should show:

(a) Name of traveler and official title,

(b) Purpose of trip,

(c) Dates of departure and return to starting point (station or airport),

(d) Transportation costs, identified as to rail, air, private automobile (including mileage and rate) and taxi.

(e) If claim for subsistence is on per diem basis, show number of days, rate and amount, as authorized in contract. If claim is based on actual cost of subsistence, show, on a daily basis, the amounts claimed for lodging and meals separately.

(1) All travel costs plus per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract. These costs will be in accordance with the Contractor’s policy and subject to the following:

(i) Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).

(ii) Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.

(iii) Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

(iv) Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.

(b) Except as stated herein, the Contractor shall not incur costs unless the prior written authorization of the Contracting Officer has been obtained. When costs are incurred without such prior authorization, with the intent of claiming reimbursement as direct costs, it shall be at the contractor’s risk.

(End of Clause)

B.5 External Peer Review

NIOSH policy requires that all NIOSH research projects that generate technical or scientific data be peer reviewed by external experts within the first year of the project. The awardee’s technical proposal will be distributed to approximately 3 to 5 technical experts related to the area of study for external review. Reviewers for this research project will be determined by the NIOSH NPPTL Associate Director for Science. The selected reviewers must be free of an existing or perceived conflict of interest. Reviewers shall assess the overall impact that the research project could have on the field taking into account, among other factors:

1. The significance of the goals of the proposed research, from a scientific or technical standpoint; [NIOSH will provide content to external reviewers regarding this factor – i.e., your technical proposal does not need to justify this research]

2. The adequacy of the approach and methodology proposed to carry out the research;

3. The innovativeness and originality of the proposed research;

4. The qualifications and experience of the principal investigator and proposed staff;

5. The scientific environment and reasonable availability of resources necessary to the research;

6. The reasonableness of the proposed budget and duration in relation to the proposed research; and

7. The adequacy of the proposed protection for humans, animals, and the environment, to the extent they may be adversely affected by the project proposed in the application.

Unless the awardee has concerns regarding proprietary or otherwise sensitive information within their technical proposal, the requested reviews will be sought by email with the following disclaimer, If you agree to provide peer review for this research proposal, you acknowledge that you fully understand the confidential nature of the review process and agree: a) to destroy all materials related to it; b) not to discuss the materials associated with the review, your evaluation, or other information associated with your review with any other individual except as authorized by the designated NIOSH official; and c) to refer all inquiries concerning the review to the designated NIOSH official.

Section C - Description/Specification/Work Statement

STATEMENT OF

WORK

Procurement Request #: 000HCCLG-2023-73565 Title: Development and Evaluation of a Train-the-Trainer

Program to Support Equitable and Effective Respiratory Protective Device Use

Period of Performance: September 29, 2023 –September 28, 2028

CONTENTS

SECTION 1 – BACKGROUND

SECTION 2 – PURPOSE

SECTION 3 – SCOPE OF WORK

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Development of a Project Plan Task 2: Develop respirator fit test training and train-the-trainer framework with complementary data collection instruments and research protocols Task 3: Pilot test fit test training with built-in evaluations with end users and trainers Task 4: Training evaluation, refinement and report delivery Task 5: Final deliverables in the form of a report and complementary implementation toolkit ...11 Deliverables/Reporting Schedule for Base Contract Standard Language ...................................................................... Error! Bookmark not defined.

A. Baseline Security Requirements ............................................. Error! Bookmark not defined.

B. Training .................................................................................... Error! Bookmark not defined.

C. Rules of Behavior ..................................................................... Error! Bookmark not defined.

D. Incident Response .................................................................... Error! Bookmark not defined.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally

Identifiable Information” (03 January 2017) states: .... Error! Bookmark not defined.

Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC shall include the following requirements:Error! Bookmark n E. Position Sensitivity Designations ............................................ Error! Bookmark not defined.

F. Homeland Security Presidential Directive (HSPD)-12 ........ Error! Bookmark not defined.

G. Contract Initiation and Expiration ........................................ Error! Bookmark not defined.

H. Records Management and Retention .................................... Error! Bookmark not defined.

I. Hardware ................................................................................. Error! Bookmark not defined.

J. Information Technology Application Design, Development, or SupportError! Bookmark not defined.

K. Non-Commercial and Open Source Computer Software ProcurementsError! Bookmark not defined.

REFERENCE MATERIALS

Federal Laws, Directives and Policies HHS Policy NIST Guidance

POINT OF CONTACT INFORMATION

PAYMENT TERMS

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

SECTION 12 – ADDITIONAL CLAUSES

SECTION 1 – BACKGROUND

Changes and improvements are needed in the national approach taken to support respiratory protection for workers and for the general population (National Academy of Sciences [NAS], 2022). The National Institute for Occupational Safety and Health (NIOSH) is seeking to address this need through the development of a training framework and implementation plan – encompassing a train-the-trainer program and fit test training that can be used with multiple end user populations. The availability of such resources can support equitable competency building regarding the selection and fit of respirators for workers without an OSHA respiratory protection program (RPP) and the public. The current effort will inform NIOSH’s National Personal Protective Technology Laboratory (NPPTL) strategic research and service priorities for equitable PPE protections.

Community mitigation measures were employed during the COVID-19 pandemic, including the increased procurement and use of respirators. All respirators used in American workplaces must be evaluated and approved for use by NIOSH. Those respirators are supported by decades of research and testing that determined their expected level of protection when used in an OSHA RPP. Employers administer the RPP including the selection, use, and maintenance of NIOSH-approved respirators and conduct fit testing to ensure workers are properly protected.

However, workers without RPPs (e.g., “gig workers,” independent contractors, or self-employed individuals) and public wearers of NIOSH Approved® respirators are not supported by an RPP and therefore, do not have a readily available source to ensure their respirator fits properly. It is important for these individuals to have access to the applicable information, training, and resources that is contained in RPPs as there have been health and safety benefits observed from the presence of RPPs in organizations (Cowan et al., 2017). Additionally, such a program would help reduce the misinformation and general confusion around the types and purposes of respirator (e.g., filtering facepiece respirators (FFRs), elastomeric half mask respirators (EHMRs), etc.).

A recent National Academies of Science report described an urgent need for the nation to provide community mitigation strategies to address these gaps (NAS, 2022). Through a robust partnership with a public health department and volunteer fire departments (VFDs), it is possible to provide the public much-needed respirator fit testing and education. The National Fire Protection Agency (NFPA) estimates there are over 24,215 VFDs in the United States, representing 67% of the total number of firefighters (Fahy et al., 2022). VFDs often provide public service outside of fire department services to support the communities (e.g., support for installing child car seats).

These responders can be trained and equipped to provide community respirator fit testing services through a train-the-trainer program. Currently there is no national program or processes to enable this expert capability to support these worker and community respiratory protection needs.

Consequently, a training should not just serve to help the public understand their fit, but it also should serve to help educate and build knowledge around respirators to build confidence in their protection efficacy. Although respirators are supported by decades of research and testing, an infodemic emerged during the COVID-19 pandemic that contributed to mistrust and opposition toward their use (Taylor & Asmundson, 2021). Thus, the availability of consistent training, education and communication is even more essential to support community mitigation (Batova, 2021). Like fit testing, there is no national program or process to engage and train the public, build trust, and support worker and community respirator needs.

To this end, the NAS report identified a gap in trust and cooperation in wearing respirators during the COVID-19 pandemic, recommending that NIOSH develop culturally appropriate guidance and training on the use of respirators by the public and workers without an RPP (2022). The report argued that training should address which respirator should be used, when, and how they should be worn to provide adequate protection. The following actions can fill these gaps: 1.) develop, deploy, and evaluate training solutions for public wearers and workers of NIOSH-approved respirators that are not supported by an RPP and do not have a readily available resource to ensure their respirator fits, 2.) develop and test messages about respirator along with strategies to ensure their appropriate selection and use by diverse communities, and 3.) determine how training and guidance provided by trusted communicators can influence respirator perceptions, knowledge, attitudes, and behaviors (PKAB) to finalize training modules for national use.

The current infodemic and misinformation concerning respirator in the U.S. has prompted changes in preferences and trust in public health sources (Chowdhury et al., 2021; Lau et al., 2011) making the need for consistent training and education across public and workplace settings critical. The expected outcomes for this project are threefold: 1) validated guidance and fit test training for public health/safety agencies to provide respirator fit test services to workers and public wearers of NIOSH Approved respirator without RPPs on a national level, to focus on locations with potential or on-going exposure to respiratory hazards (e.g., SARS-CoV-2, wildfire smoke) as well as communities that are underserved and may not be able to afford these types of programs; 2) validated guidance to assist on respirator selection and use; and 3) complementary train-the-trainer educational training/modules for trusted messengers to navigate these materials.

This project will produce a train-the-trainer framework and a series of complementary training modules for public adoption and use. It will use the specialized expertise and response capacity of public health/safety agencies as conduits to sustain the program. As a result, workers, and public wearers of NIOSH Approved respirators will have greater confidence that their respirators are providing the intended level of respiratory protection and fit. Modules will ensure consistent communication and inform how messages should be designed to promote effective use of respirator for different audiences. A selection framework that is accessible to everyone, including trusted messengers, will positively impact and empower individual user knowledge, attitudes, trust, and effective use of respirators.

SECTION 2 – PURPOSE

The two primary barriers to preventing safe respirator use are first, the lack of information and misinformation about respirators and second, the lack of infrastructure to provide fit testing (Hoidal, 2017). Proposed solutions to these challenges include train the trainer approaches and other outreach efforts to improve end user PKABs. Although public health professionals provided guidance on the use of respirators during the pandemic, this guidance was not complemented with adequate training and resources for end users of respirators (NASEM, 2022). Similarly, the public and workers without RPPs lack the resources needed to ensure their respirators provide the protection needed.

This project will produce a framework and service to fill these gaps. NIOSH will provide guidance to assist the contracted vendor to provide vital fit test services for both the public use and the occupational use of NIOSH Approved respirators.

The primary purpose of this request is to work with a vendor, that works to protect the public’s health to shape positive health outcomes for individuals, families, and communities. This investment will leverage recent advancements within NIOSH that have identified the need to enhance national resilience, improve knowledge, and training around respirator selection and subsequent fit testing for workers without an RPP and the public. This project will develop and define a framework for community-based processes using resources and expertise available through the vendor and select VFDs to provide fit testing services for workers without RPPs and for the public. If workers without RPPs and public wearers can be assured their respirator properly fits, they can have confidence, their respirator is providing the expected level of protection.

The objectives are to enhance national resilience and trust in respirators for workers without RPPs and the public by leveraging partnerships with trusted communicators (e.g., public health institutes and VFDs) to:

1) develop, test, and pilot a respirator fit test training program for each of the two groups to improve PKAB about the proper use of respirators

2) conduct a pre-/post-training survey to determine occupational and public participation in respirators mitigation strategies during the pandemic, including areas with high social vulnerability

3) evaluate changes in efficacy toward respirators upon knowing they have a proper fit

4) using results of the pilot program, finalize and deploy a national train-the-trainer framework that includes training and guidance needed for public health/safety agencies to use in their communities

This effort will be used to determine the value and impact of a train-the-trainer framework and will serve as an example of implementation science within the institute. At the completion of this contract, NIOSH will determine next steps, if any, for this effort.

SECTION 3 – SCOPE OF WORK

This project will support national, sustained efforts to educate both workers without RPPs and the public on the importance of proper respirator use, fit, and provide the skills to effectively sustain this behavior. The contractor will be a vendor in the public health field that has extensive membership/partnerships across the U.S. and is geographically located in an area that more often requires the use of respirators by the public. Specifically, the increase of wildland fires in the western part of the U.S. has required the need for adults and children to wear NIOSH-approved respirator to protect from smoke and related inhalation of contaminants as well as concerns related to infectious diseases (e.g., SARS-CoV-2) in areas with dense populations. The vendor may choose to subcontract task deliverables to other state, regional, or local public health/safety departments (e.g., VFDs) and provide an incentive for participating department’s time in piloting programs, collecting data, and providing a valuable service to the public and workers without RPPs.

Under this contract, the vendor will engage in instrument development, training development, training implementation and evaluation, and program refinement for final dissemination. This Statement of Work includes:

The base contract train-the-trainer demonstration project will develop an respirator fit test program and train-the-trainer program, based on identified gaps in training and education around respirator, including information about respirator selection guidance for both the public and for workers who do not have an RPP. These two pilot programs will have an evaluation mechanism including pre/post data surveys for end users and trainers to complete either before and after their fit test training or before and after trainers provided the training to end users. The contractor will be responsible for drafting the data collection instruments, in cooperation with NIOSH. The contractor will be responsible for securing IRB approval to allow human subjects data collection and storage. Contractor will also work with NIOSH to ensure data transfer can occur via an approved NIOSH ODIT modality (to be determined).

The train-the-trainer program and fit test program will be piloted at at least three locations to the discretion of the contractor, if it serves a diverse community, and they can obtain end user participants who work for an organization not covered by an RPP or desire personal respiratory protection. The contractor will (1) recruit, deploy, and evaluate the train-the-trainer program with at least five individuals per location who could sustain such a program moving forward, and (2) recruit and pilot the fit test trainings using the pre- and post-surveys with at least 30 end users per location about changes in perceptions, knowledge, attitudes, and behaviors toward respirators, including confidence in fit and protection as well as messengers who relayed the training as a trusted source. If trainings need to occur more than once at a location to secure enough end users, that is fine. However, additional trainings do not count as additional locations.

A report, including the pre/post evaluation data will be prepared by the contractor. The report will include (a) a review and copy of the two training (train-the-trainer and fit testing) frameworks and what was required to successfully deploy the fit testing, education, and training activities, (b) the aggregate results of the evaluation metrics, (c) observations reported by the contractor about the feasibility of end user respirator fit testing, experiences, and perceptions during and after being fit tested, and (d) an updated, generic train-the-trainer program that community entities (e.g., VFDs, retail workers, teachers/students) could adopt and use the program to provide fit testing to their employees, families, or colleagues. The report will include a generic training framework that includes a train-the-trainer program and fit test training for workers without an RPP and the public. Taken together, these materials can be used to create an implementation toolkit in the form of: 1) fit-test training that encompasses a Word document and other communication medium identified by the vendor (e.g., PowerPoint presentation, training video, etc.); 2) train-the-trainer program that encompasses both a Word document and PowerPoint presentation that can be used; 3) a framework on respirator selection and use for public health agencies to assist in program feasibility and national expansion; and 4) promotional materials discussing the value of this framework/program.

SECTION 4 – TASKS TO BE PERFORMED

TASKS TO BE PERFORMED

Task 1: Development of a Project Plan

1. Literature and training exist to support organizations in executing their RPP (e.g., Hines et al., 2014; Alfano-

Sobsey et al., 2006); however, a gap remains to support those organizations and end users with no RPP coverage. The contractor will need to identify gaps in this area and develop a project plan to complete this project in a way that caters to those workers without an RPP and the public. Steps will be detailed in the plan, based on the tasks below. Allow the NIOSH technical monitor two weeks to review and approve the plan.

Task 2: Develop respirator fit test training and train-the-trainer framework with complementary data collection instruments and research protocols

2a. Based on the project plan, the vendor will develop an respirator fit test program (e.g., quantitative and/or qualitative) and complementary train the trainer document for pilot testing. It is anticipated that components of the fit test program would include basic instruction on how to don and doff the respirator properly, limitations of the respirator for the hazard in question, the need to dispose of the respirator after one-time use or how to clean it, how to disinfect an respirator, safely storing the respirator if it is reusable, and how to perform user-seal checks.

2b. Pre/post data surveys for end users to complete during participation in fit test training will be drafted and shared with NIOSH for review and comment. Questions should focus on changes in end user perceptions, knowledge, attitudes, and intended behaviors toward respirator use. Prior to fit testing, facial landmarks (i.e., head breadth, minimal frontal breadth, nasal root breadth, interpupillary breadth, face width, nose breadth, bigonial breadth, lip length, nose length, nose protrusion, face length, menton subnasale length, and head circumference) shall be manually measured allowing the participant to be anthropometrically categorized. Fit testing shall be be conducted in accordance with the Occupational Safety and Health Administration’s (OSHA) requirements with the fit factor (a quantitative estimate of the fit of a particular respirator to a specific individual) of each trial being retained.

2c. Develop instruments that will be used with trainers piloting the materials provided by the vendor. It is expected these will be quantitative and qualitative in nature.

2d. Complete and submit any necessary IRB documents/protocols and work with NIOSH to develop an OMB package for compliance with 45 Code of Federal Regulations Part 46 and the Paperwork Reduction Act, respectively. It is anticipated that the vendor will not be in possession of subject names or contact information to conduct this study. For example, it is anticipated that the vendor will be permitted to waive documentation of human subject consent (i.e., consent will be verbal only) and will do open calls to the public so that there is no need to collect, handle, transmit, or dispose of names or contact information for any of the subjects.

Task 3: Pilot test fit test training with built-in evaluations with end users and trainers

3. At least 15 trainers will receive the train-the-trainer program and deploy the fit test training. Pilot test the fit test training at a minimum of three locations that serve diverse communities (i.e., areas with different levels of social vulnerability) where a breadth of individuals can be recruited for participation. The pilot training should be evaluated using pre- and post-surveys with at least 90 end user participants about the changes in perceptions, knowledge, attitudes, and behaviors toward respirators.The information collected, hosted, processed, analyzed, transmitted, and disposed of shall include the participants’

• confidence in (1) the quality of fit experienced, (2) the level of protection provided by the respirator, and

(3) the individual who performed the fit testing.

• The fit factors and P/F outcome for each trial If the vendor’s information system does not have an Authority to Operate (ATO) with any federal agency, the vendor must use the CDC REDCap system. Disclosing the need to use the CDC REDCap system and the number of vendor personnel who would need access is required upon submission of the offer – note that the number of vendor personnel requiring access to the CDC REDCap system has cost implications for NIOSH, which are considered in the Evaluation Factors later in this Statement of Work. If the vendor has an ATO with a federal agency other than the CDC, the projected timeline shall include a 4-month processing timeline for the CDC to (potentially) grant an Authority to Use (ATU) for this system. If the vendor must use the CDC REDCap system, the projected timeline shall include a 2-month processing timeline to onboard the vendor’s personnel.

Task 4: Training evaluation, refinement and report delivery

4. The contractor will analyze the pre/post data collected from end users about their training experiences as well as the data collected from trainers who piloted the program. The vendor will transmit (1) pre/post survey evaluation https://academic.oup.com/annweh/article/54/4/391/273534?login=true https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134#:%7E:text=Fit%20factor%20means%20a%20quantitative%20estimate%20of%20the,to%20its%20concentration%20inside%20the%20respirator%20when%20worn.

https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134#:%7E:text=Fit%20factor%20means%20a%20quantitative%20estimate%20of%20the,to%20its%20concentration%20inside%20the%20respirator%20when%20worn.

data, (2) fit factors and P/F outcome for every fit testing trial, and (3) manually measured facial landmarks for each participant to NIOSH. Upon confirmation of receipt, the vendor shall dispose of all data. A report will be provided to NIOSH that includes a summary of results and changes recommended/made to the final materials because of these evaluations. Suggestions for ideal trainers will be made based on the perceptual data collected. The report will include a generic training framework that includes a train-the-trainer program and fit test training for workers without an RPP and the general public.

Task 5: Final deliverables in the form of a report and complementary implementation toolkit

5. The contractor will finalize the materials requested from this contract and compile them to create an implementation toolkit. Materials required include:

• Train-the-trainer program that can be adapted based on end user audience

• Fit test training that can accommodate single-use (FFRs) and reusable respirators (such as

EHMRs)

• Framework on respirator selection and use for public health agencies to assist in program feasibility and national expansion

• Pre/post end user survey for optional use by future trainers

Deliverables/Reporting Schedule for Base Contract Task Deliverable Delivery Date Delivery To

Task 1 Development of a Project Plan 6 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 2a Development of fit testing program applicable for workers without an RPP and the public

18 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 2b Development of train-the-trainer program and respirator selection framework for agencies to utilize during fit testing with workers without an RPP and the public

18 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 2c Develop psychometrically validated pre-/post-evaluation instruments to be completed by end users and trainers

18 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 2d Completion and submission of IRB protocol as well as OMB support for NIOSH, including IT security approvals for data storage and transfer

22 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 3 Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 1

28 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 3 Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 2

36 months after award Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 3 Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 3

42 months after exercise award

Matthew Horvatin kjq0@cdc.gov 412.386.4483

Task 3 Provide summary of evaluation feedback including the trainer evaluations of experiences using the train-

54 months after exercise award

Matthew Horvatin kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov mailto:kjq0@cdc.gov the-trainer program provided and end user evaluations 412.386.4483 Task 4 Finalize and deliver a 508 compliant implementation toolkit that includes a basic fit test training framework, a train-the-trainer program and other dissemination materials that can be used by other community entities

60 months after exercise award

Matthew Horvatin kjq0@cdc.gov

REFERENCE MATERIALS

Federal Laws, Directives and Policies

• United States Code (U.S.C.) of Federal Regulation (CFR), as amended (http://www.ecfr.gov/cgi-bin/ECFR?page=browse).

• Federal Acquisition Regulation (FAR), as amended (https://www.acquisition.gov/?q=browsefar).

• Federal Information Security Management Act (FISMA) of 2002 (Pub. L. No. 107-347, Title III)

(http://csrc.nist.gov/).

• Federal Information Security Modernization Act (FISMA) of 2014 (44 U.S.C. 101), as amended

(https://www.congress.gov/).

• Federal Information Technology Acquisition Reform Act (FITARA) H.R. 1232, as amended

(https://www.congress.gov/).

• Executive Order 13556 – Controlled Unclassified Information (CUI), (implemented at 3 CFR, Part 2002), as amended (https://obamawhitehouse.archives.gov/).

• Homeland Security Presidential Directive 12 (HSPD-12), Policy for a Common Identification

Standard for Federal Employees and Contractors, as amended (https://www.dhs.gov/).

• FedRAMP Standard Contract Clauses, as amended (http://www.fedramp.gov/).

• FedRAMP Control-Specific Contract Clauses, as amended (http://www.fedramp.gov/).

• The Health Insurance Portability and Accountability Act (HIPAA), as amended

(https://www.hhs.gov/hipaa/for-professionals/index.html).

• The Health Information Technology for Economic and Clinical Health Act (HITECH), as amended (https://www.healthit.gov/).

• National Archives and Records Administration (NARA) Bulletin 20013-02 (2013), as amended

(www.archives.gov).

• National Industrial Security Program Operating Manual (NISPOM), as amended

(https://intranet.hhs.gov/security/index.html).

• Office of Personnel Management (OPM) Position Sensitivity Designation Automated Tool, as amended (https://www.opm.gov/investigations/).

• The Privacy Act of 1974, as amended (https://www.justice.gov/opcl/privacy-act-1974).

• Public Law 96-511 Paperwork Reduction Act of 1980, as amended (https://www.gpo.gov/).

• United States Government Configuration Baseline (USGCB), as amended (http://usgcb.nist.gov/).

• OMB Policy and Memoranda (https://obamawhitehouse.archives.gov/omb//)

• OMB Circular A-130, Managing Information as a Strategic Resource, as amended.

• OMB Encryption Guidance, as amended.

• OMB M-17-12, Preparing for and Responding to a Breach of PII.

• OMB Memorandum 07-18, Ensuring New Procurements Include Common Security

Configurations, as amended.

• OMB M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable

Information,

• OMB M-06-19, Safeguarding Against and Responding to the Breach of Personally Identifiable

Information.

• OMB M-06-15, Safeguarding Personally Identifiable Information.

• OMB M-04-16, Software Acquisition.

mailto:kjq0@cdc.gov http://www.ecfr.gov/cgi-bin/ECFR?page=browse http://www.ecfr.gov/cgi-bin/ECFR?page=browse https://www.acquisition.gov/?q=browsefar http://csrc.nist.gov/ https://www.congress.gov/ https://www.congress.gov/ https://obamawhitehouse.archives.gov/ https://www.dhs.gov/ https://www.healthit.gov/ https://www.opm.gov/investigations/ https://www.justice.gov/opcl/privacy-act-1974 https://www.gpo.gov/ http://usgcb.nist.gov/

• OMB M-04-04, E-Authentication Guidance for Federal Agencies.

• OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of

2002.

HHS Policy

• HHS Cloud Computing and Federal Risk and Authorization Management Program [FedRAMP] Guidance, as amended (http://intranet.hhs.gov/it/cybersecurity/policies/).

• HHS Contract Closeout Guide, as amended, (http://intranet.hhs.gov/abouthhs/contracts-grants-support/).

• HHS Enterprise Performance Life Cycle [EPLC], as amended (http://www.hhs.gov/ocio/).

• HHS Minimum Security Configuration Standards for Departmental Operating Systems and

Applications, as amended (http://intranet.hhs.gov/it/cybersecurity/docs/policies_guides/).

• HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities

Memorandum, as amended (http://intranet.hhs.gov/it/cybersecurity/policies/index.html).

• HHS-OCIO Policy for Information Systems Security and Privacy Policy, as amended

(http://intranet.hhs.gov/it/ocio/).

• HHS Guidance for Purchasing Noncommercial Computer Software and “Open Source”

Licenses, as amended (http://www.hhs.gov/ocio/policy/).

• HHS Standard for the Definition of Sensitive Information, as amended

(http://intranet.hhs.gov/it/cybersecurity/docs/policies_guides/).

• HHS Standard for Encryption of Computing Devices and Information, as amended

(https://intranet.hhs.gov/it/cybersecurity/policies/index.html).

• HHS Standard for Plan of Action and Milestones, as amended

(http://intranet.hhs.gov/it/cybersecurity/policies/).

• Health and Human Services Acquisition Regulation (HHSAR), as amended

(https://www.gpo.gov/fdsys/pkg/CFR-2015-title48-vol4/pdf/CFR-2015-title48-vol4-chap3.pdf).

• HHS Personnel Security & Suitability Handbook, as amended

(http://intranet.hhs.gov/security/ossi/documents/).

• HHS Privacy Incident Response Team [PIRT] Standard Operating Procedures [SOP], as amended

(http://intranet.hhs.gov/it/cybersecurity/docs/).

• Rules of Behavior for use of HHS Information Resources, as amended

(http://www.hhs.gov/ocio/policy/).

• HHS Security and Privacy Language for Information and Information Technology Procurements v2, as amended (https://intranet.hhs.gov/it/strategy-policy-governance/policies-standards-guides/standards/index.html)

NIST Guidance

• NIST IR 7511 Revision 4, Security Content Automation Protocol (SCAP) Version 1.2 Validation Program Test Requirements, as amended.

• NIST SP 800-171 Rev 1, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations, as amended.

• NIST SP 800-145, The NIST Definition of Cloud Computing, as amended.

• NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal Information

Systems and Organizations, as amended.

• NIST SP 800-124, Rev. 1, Guidelines for Managing the Security of Mobile Devices in the

Enterprise, as amended.

• NIST SP 800-122, Guide to Protecting the Confidentiality of Personally Identifiable Information, as amended.

• NIST SP 800-88 Rev 1, Guidelines for Media Sanitization, as amended.

• NIST SP 800-64 Revision 2, Security Considerations in the Information System Development http://intranet.hhs.gov/it/cybersecurity/policies/ http://intranet.hhs.gov/abouthhs/contracts-grants-support/ http://intranet.hhs.gov/abouthhs/contracts-grants-support/ http://www.hhs.gov/ocio/ http://intranet.hhs.gov/it/cybersecurity/docs/policies_guides/ http://intranet.hhs.gov/it/cybersecurity/policies/index.html http://intranet.hhs.gov/it/ocio/ http://www.hhs.gov/ocio/policy/ http://intranet.hhs.gov/it/cybersecurity/docs/policies_guides/ http://intranet.hhs.gov/it/cybersecurity/policies/ http://www.hhs.gov/grants/contracts/ http://intranet.hhs.gov/security/ossi/documents/ http://intranet.hhs.gov/it/cybersecurity/docs/ http://www.hhs.gov/ocio/policy/ https://intranet.hhs.gov/it/strategy-policy-governance/policies-standards-guides/standards/index.html https://intranet.hhs.gov/it/strategy-policy-governance/policies-standards-guides/standards/index.html

Lifecycle, as amended.

• NIST SP 800-63-3, Digital Identity Guidelines: Authentication and Lifecycle Management.

• NIST SP 800-61 Rev 2, Computer Security Incident Handling Guide, as amended.

• NIST SP 800-60 Revision 1, Guide for Mapping Types of Information and Information Systems to

Security Categories: (2 Volumes) – Volume 1: Guide, Volume 2: Appendices, as amended.

• NIST SP 800-53 Revision 4, Security and Privacy Controls for Federal Information Systems and

Organizations, as amended.

• NIST SP 800-53A Revision 1, Guide for Assessing the Security Controls in Federal Information

Systems and Organizations, Building Effective Security Assessment Plans, as amended.

• NIST SP 800-37 Revision 1, Guide for Applying the Risk Management Framework to Federal

Information Systems: A Security Life Cycle Approach, as amended.

• NIST SP 800-34 Revision 1, Contingency Planning Guide for Information Technology Systems, as amended.

• NIST SP 800-30 Revision 1, Guide for Conducting Risk Assessments, as amended.

• NIST SP 800-18 Revision 1, Guide for Developing Security Plans for Federal Information

Systems, as amended.

• FIPS PUB 200, Minimum Security Requirements for Federal Information and Information

Systems, as amended.

• FIPS PUB 201-2, Personal Identity Verification (PIV) of Federal Employees and Contractors, as amended.

• FIPS PUB 199, Standards for Security Categorization of Federal Information and Information

Systems, as amended.

• FIPS 140-2, Security Requirements for Cryptographic Modules, as amended.

POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

NIOSH/NPPTL

Attn: Matt Horvatin 626 Cochrans Mills Road Pittsburgh, PA 15236 kjq0@cdc.gov

Preferred method of communication: Email or phone

PAYMENT TERMS

A performance-based payment schedule will be used as described below.

Deliverable Quantity Cost Task 1 Development of a Project Plan that encompasses education guidance and respirator fit testing plans for the public and workers without an RPP

Task 2a-d

Development of fit testing program and train-the-trainer program applicable for workers without an RPP and the public as well as evaluation instruments for end users and trainers – all materials to go into completed IRB protocol

Task 3 Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 1

Task 3 Pilot test and evaluate train-the-trainer program that 1 includes a fit testing training and end user evaluation at Location 2

Task 3 Pilot test and evaluate train-the-trainer program that includes a fit testing training and end user evaluation at Location 3

Task 4 Provide summary of evaluation feedback including the trainer evaluations of experiences using the train-the-trainer program provided and end user evaluations, including aggregated reports of results by location

Task 5 Finalize and deliver a 508 compliant implementation toolkit to include a generic training framework that includes a train-the-trainer program and fit test training that can be used by other VFDs and other entities

SECTION 5 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF

EFFORT

The vendor must meet the following requirements:

• The ability to onboard volunteer fire departments or other community settings, as deemed appropriate by NIOSH, in areas with different levels of social vulnerability

• An established public health implementation toolkit. This includes an established RPP that has already been deployed across the United States

• Detailed experience and knowledge of respiratory protection

• Expertise in social science and statistical research to develop psychometrically valid data collection instruments to evaluate perceptions of training materials – in other words, rigorous experience with survey design, data collection, analysis, and interpretation

• Ability to complete and submit IRB documents/protocols to a non-NIOSH IRB and conduct information collection in compliance with federal laws

• Strong relationships with impacted parties/beneficiaries within the fire service and community health departments

• Recent experience developing and implementing curriculum for train-the-trainer sessions on respirator fit testing for audiences without fit testing experience

• Has a specific curriculum development and implementation process.

SECTION 6 – ADDITIONAL CLAUSES

Special Considerations 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…