A19 - FY22 CDC BAA Posting 75D301-22-R-72097 - Amendment 0001.pdf

BAA 75D301-22-R-72097; Amendment 0001

CENTERS FOR DISEASE CONTROL AND

PREVENTION (CDC)

BROAD AGENCY ANNOUNCEMENT (BAA)

75D301-22-R-72097

“Applied Research to Address Emerging Public Health Priorities”

(Amendment 0001)

ISSUANCE DATE: December 6, 2021

CLOSING DATE: January 14, 2022

TABLE OF CONTENT

PART I - INTRODUCTION

Authority

Process Step 1 - E-mail Contact (Technical Dialogue) Step 2 - Informal White Paper (Technical Dialogue) Step 3 - Submission of Formal Research Proposal Step 4 - Contract Award for Selected Projects

Government Obligation

BAA Points of Contact

PART II CDC RESEARCH INTERESTS

OVERVIEW

Topic 1: Exploring best strategies to interrupt poliovirus transmission in outbreak-affected countries

(CGH)

Topic 2: Public Health Communication Approaches to Increase Trust in Public Health Emergency

Preparedness (CPR)………………………………………………………………………………….……………10

Topic 3: Address critical gaps in knowledge regarding personal protective equipment (PPE) standards in a laboratory setting (CPR)…………………………………………..……

Topic 4: Address Critical Knowledge Gaps related to Emerging and Re-emerging Infectious Diseases During

Pregnancy and the Risks, Benefits and Acceptance of Prevention and Treatment Strategies (NCBDDD).…13

Topic 5: Expand the portfolio of effective interventions to prevent or delay type 2 diabetes and manage diabetes among populations who are underserved (NCCDPHP)……………………………………………...14

Topic 6: Wastewater Surveillance (NCEZID)………………..………………………………………………

Topic 7: Genomic sequencing of SARS-CoV-2 to investigate viral evolution, and emergence and spread of variants in communities and populations. (NCEZID)…………………………………………………….……17

Topic 8: Strengthening emerging, re-emerging, and biothreat infectious disease surveillance, detection, and preparedness (NCEZID)…………………..…………………………………………………………………..…18

Topic 9: Address gaps in direct detection diagnostic assays for Lyme borreliosis (NCEZID).……………..18

Topic 10: Address critical gaps in human tick bite prevention (NCEZID).…………………………………..19

Topic 11. Novel prevention methods to reduce transmission of Rickettsia rickettsii by brown dog ticks

(NCEZID)……………………………………………………………………………………………………...…..19

Topic 12: Evaluation of novel Aedes aegypti control tools (NCEZID)…..…………………………………….20

Topic 13: Novel Assays for Dengue Vaccine Evaluation (NCEZID)

Topic 14: Implementation of Wolbachia-based strategies for dengue control in Central America

(NCEZID)…………………………………………………………………………………………….……………21

Topic 15: Towards dengue elimination: enhanced vector control and surveillance in Puerto Rico (NCEZID)..22

Topic 16: Research to inform optimal approaches to environmental sampling and understanding of the prevalence and distribution of pathogenic fungi in healthcare settings (NCEZID)………………………..…23

Topic 17: Understanding the impact of climate change and other predictors on the distribution and severity of fungal diseases (NCEZID)…………………………………...…….…………………………………………...23

Topic 18: Development of rapid point-of-care (POC) syphilis diagnostic tests (NCHHSTP).……………

Topic 19: Decreasing disparities in the incidence, morbidity, and mortality associated with HIV, viral hepatitis, other sexually transmitted infections (STIs), tuberculosis and adolescent health (NCHHSTP)…25

Topic 20: Influenza and Other Acute Respiratory Infections (NCIRD)…………………………………..….25

Topic 21: SARS-CoV-2 (COVID-19) and Children (NCIRD)………………………………….……………..28

Topic 22: Bacterial Respiratory and Vaccine-Preventable Diseases (NCIRD)..……………………………..32

PART III - WHITE PAPER SUBMISSION

Use of Non-Government Personnel

White Paper Evaluation Criteria

White Paper Format and Content

White Paper Submission

PART IV - PROPOSAL PREPARATION AND SUBMISSION

General Information Eligibility Post-Employment Conflict of Interest Restrictive Markings on Proposals Reporting Requirements Non-U.S.Citizen Participation Period of Performance Contract Types

Cost Certification………………………………………………………………………………………………..38

Funding Proposal Submission Follow-On Contracts Proposal Copies

Proposal Preparation Instructions Section I - Technical Section Contents Section II - Administrative Section Contents

Contract Type Environmental Considerations Organizational Conflicts of Interest Disclosure Requirement Understanding of Evaluation Policy Representations, Certifications and Other Statements of Offerors Subcontracting Plan Title to Equipment Section III - Cost Section Contents Period of Performance Direct Labor Materials Other Direct Costs

Travel

Subcontracts Consultants Miscellaneous Indirect Costs Fee/Profit

PART V - PROPOSAL EVALUATION

Initial Review

Scientific Review Proposed Research Potential Contribution

Offeror’s Qualifications Personnel Cost Realism Administrative Proposal

Proposal Comparisons

PART VI - FORMS and ATTACHMENTS

Document Number of Pages

FORM 1: White Paper Cover Page and Checklist.…………………………………………………………... 1

FORM 2: Research Proposal Cover Page and Checklist.…………………………….……………………

FORM 3: Representations, Certifications and Statements of Understanding.……………………………..… 17

FORM 4: Contract Clearances.…………………………………………………..……………………….…... 1

FORM 5: Past /Present Performance Questionnaire.…………………………………………………………...3

FORM 6: ACH Vendor /Miscellaneous Payment Enrollment Form _ CDC 0.4433.……………………..…... 1

ATTACHMENT 1: Contract Clauses.…………………………………………………………….……...…... 10

ATTACHMENT 2: Contractor Performance Assessment Reporting System (CPARS) ....………………

ATTACHMENT 3: SAMPLE Statement of Work (SOW) .…………………………………….……………... 1

ATTACHMENT 4: SAMPLE Cost Proposal Format.………………………………….……………………... 1

PART I - INTRODUCTION

Authority

The Centers for Disease Control and Prevention (CDC), the Office of Science (OS) issues this Broad Agency

Announcement (BAA) under the provisions of FAR 35.016 and FAR 6.102(d)(2) which provides for the competitive selection of research proposals. Contracts that are awarded based on responses to this BAA are as a result of full and open competition and therefore in full compliance with the provisions of PL 98-369, "The

Competition in Contracting Act of 1984."

The CDC may award contracts with educational institutions, nonprofit organizations, not for profit organizations, state and local government, and private industry for research and development (R&D) in those areas covered in Part

II of this BAA.

Within the meaning of FAR 6.102 and 35.016, this announcement constitutes the government’s solicitation for this effort. There will be no other solicitation issued in regard to this requirement. Offerors should be alert for any BAA amendments that may be posted on beta.SAM.gov.

Process

Funding of research within CDC will be determined by funding constraints and research priorities set during each fiscal year. Therefore, those contemplating submission of a white paper are encouraged to contact the

CDC BAA technical point of contact as noted below to determine whether the research warrants further inquiry.

If the research warrants further inquiry and if funding is available, then submission of a white paper/proposal will be entertained. For all email inquiries to the Subject Matter Expert Technical POC, please copy the

CDC BAA Technical Coordinator as well.

The following four-step sequence is established for offerors contemplating submission of a white paper or a proposal under this BAA. This sequence allows for an early determination of the potential for interest based on technical merit, applicability to CDC and projected funding. This process is designed to limit offeror and

Government expenditure of effort to prepare and review formal proposals for research that may have little chance of being funded.

Step 1 – Email Contact (Technical Dialogue)

Once the BAA is issued, technical dialogue can began. Technical dialogue between the Government and the potential offeror is the first step. The initial point of contact may direct offerors to a specific scientific/technical point of contact based on the topic area and specifics of the proposed research project. The initial contact points for each area of research interest identified in Part II is listed below.

Research Interests Point of Contact (POC) POC e-mail address

Topic 1. Exploring best strategies to interrupt poliovirus transmission in outbreak-affected countries (CGH)

Removed – Amendment 0001

1.1. Modeling to inform effective polio outbreak response strategies

Gabe AnayaCGH

Extramural Research

Program Office gda1@cdc.gov cgherpo@cdc.gov

Topic 2. Public Health Communication Approaches to Increase Trust in Public Health Emergency Preparedness (CPR)

2.1 Public Health Communication Approaches to Increase Trust in

Public Health Emergency Preparedness

Kimberly Leeks kleeks@cdc.gov

Topic 3. Address critical gaps in knowledge regarding personal protective equipment (PPE) standards in a laboratory setting (CPR)

3.1. Comparison of PPE used in the United States and globally in terms of physical and barrier resistance using standardized performance tests

(e.g., water resistance, viral penetration tests)

Christy Ottendorfer

Selcen Kilinc-Balci uyk0@cdc.gov jcq8@cdc.gov mailto:gda1@cdc.gov mailto:cgherpo@cdc.gov mailto:kleeks@cdc.gov mailto:uyk0@cdc.gov mailto:jcq8@cdc.gov

3.2. Effects of chemical decontamination on the durability and reliability of PPE in standardized performance tests (e.g., water resistance, viral penetration tests)

Christy Ottendorfer

Selcen Kilinc-Balci uyk0@cdc.gov jcq8@cdc.gov

3.3. Effects of reuse of PPE in standardized performance tests (e.g., viral penetration tests)

Christy Ottendorfer

Selcen Kilinc-Balci uyk0@cdc.gov jcq8@cdc.gov

Topic 4. Address Critical Knowledge Gaps related to Emerging and Re-emerging Infectious Diseases During Pregnancy and the Risks, Benefits and Acceptance of Prevention and Treatment Strategies (NCBDDD)

4.1. Mother-baby linked longitudinal cohort studies to examine the impact of emerging and re-emerging infectious diseases and prevention and treatment strategies on pregnancy, birth, and early childhood outcomes

Suzanne Gilboa

Dana Meaney-Delman

Van Tong

Kara Polen suz0@cdc.gov vmo0@cdc.gov vct2@cdc.gov fvc1@cdc.gov

Topic 5: Expand the portfolio of effective interventions to prevent or delay type 2 diabetes and manage diabetes among populations who are underserved (NCCDPHP)

5.1. Identify, test, implement, and evaluate innovative evidence-based interventions, strategies, programs, or policies that reduce health inequities in type 2 diabetes prevention.

Bryce Smith Bsmith6@cdc.gov

5.2. Identify, test, implement, and evaluate innovative evidence-based interventions, strategies, programs, or policies that reduce health inequities in diabetes management.

Bryce Smith Bsmith6@cdc.gov

5.3. Study the effectiveness of various approaches/supports currently used by recognized organizations in the National Diabetes Prevention

Program (National DPP) to eliminate or reduce barriers to enrollment and retention in the National DPP lifestyle change program related to the social determinants of health (e.g., food insecurity/limited access to healthy foods, lack of reliable transportation or internet access, lack of safe places to get physical activity, others). Determine which approaches are effective in addressing these barriers for populations currently underrepresented in the program.

Bryce Smith Bsmith6@cdc.gov

Topic 6. Wastewater Surveillance (NCEZID)

6.1. Detection and typing of disease targets from wastewater Rory Welsh Mpo6@cdc.gov

6.2. Fecal shedding of SARS-CoV-2 RNA Amy Kirby Agk1@cdc.gov

Topic 7. Genomic sequencing of SARS-CoV-2 to investigate viral evolution, and emergence and spread of variants in communities and populations. (NCEZID)

7.1. Incorporate viral genomic data, clinical and demographic data to better predict poor outcomes of SARS-CoV-2 infection, increased likelihood of reinfection and risk factors for vaccine breakthrough.

Ellie Click

Duncan MacCannell

Eoc9@cdc.gov fms2@cdc.gov

7.2. Conduct studies that compare SARS-CoV-2 sequence diversity and viral phylodynamics within and between regions with different public health response timelines and strategies, especially studies that evaluate changes in viral diversity in the context of vaccination campaigns.

Ellie Click

Duncan MacCannell

Eoc9@cdc.gov fms2@cdc.gov

7.3. Adapt and optimize sequencing instrumentation, reagents and workflows for the specific needs of public health infectious disease laboratories and field activities.

Ellie Click

Duncan MacCannell

Eoc9@cdc.gov

Fms2@cdc.gov

7.4. Develop or enhance open source bioinformatic tools, databases and visualization software that improve the availability, utility, integration and interpretation of genomic data from SARS-CoV-2 and other pathogens of public health concern.

Ellie Click

Duncan MacCannell

Eoc9@cdc.gov

Fms2@cdc.gov

Topic 8. Strengthening emerging, re-emerging, and biothreat infectious disease surveillance, detection, and preparedness

(NCEZID)

8.1. Strengthening emerging, re-emerging, and biothreat infectious disease surveillance, detection, and preparedness by distributing assays through the Laboratory Response Network (LRN)

Julie Villanueva Jfv3@cdc.gov

Topic 9. Address gaps in direct detection diagnostic assays for Lyme borreliosis (NCEZID)

9.1 Investigations to discover chemoattractants for B. burgdorferi in tick saliva for development of a xenodiagnostic-like assay for direct detection of the Lyme spirochete in infected individuals

Bob Gilmore rbg9@cdc.gov

Topic 10. Address critical gaps in human tick bite prevention (NCEZID) mailto:uyk0@cdc.gov mailto:jcq8@cdc.gov mailto:uyk0@cdc.gov mailto:jcq8@cdc.gov mailto:suz0@cdc.gov mailto:vmo0@cdc.gov mailto:vct2@cdc.gov mailto:fvc1@cdc.gov mailto:Bsmith6@cdc.gov mailto:Bsmith6@cdc.gov mailto:Bsmith6@cdc.gov mailto:Mpo6@cdc.gov mailto:Agk1@cdc.gov mailto:Eoc9@cdc.gov mailto:Eoc9@cdc.gov mailto:Eoc9@cdc.gov mailto:Eoc9@cdc.gov mailto:Fms2@cdc.gov mailto:Jfv3@cdc.gov mailto:rbg9@cdc.gov

10.1. Development and evaluation of human tick bite prevention methods

Lars Eisen evp4@cdc.gov

10.2. Killing of ticks that go undetected while biting humans Lars Eisen evp4@cdc.gov

Topic 11. Novel prevention methods to reduce transmission of Rickettsia rickettsii by brown dog ticks(NCEZID)

11.1 Development of a canine vaccine against Rickettsia rickettsii William Nicholson wan6@cdc.gov

Topic 12. Evaluation of novel Aedes aegypti control tools (NCEZID)

12.1 Evaluate effectiveness of dried attractive bait stations to control

Aedes aegypti, the main vector of dengue viruses Ryan Hemme rhemme@cdc.gov

Topic 13. Novel Assays for Dengue Vaccine Evaluation (NCEZID)

13.1. Correlates of protective immunity against dengue Jorge L. Munoz-Jordan ckq2@cdc.gov

13.2. Measurement of dengue type-specific antibody binding Jorge L. Munoz-Jordan ckq2@cdc.gov

13.3. Assessments of dengue vaccine immunogenicity Jorge L. Munoz-Jordan ckq2@cdc.gov

13.4. Dengue immunoassay development or optimization Jorge L. Munoz-Jordan ckq2@cdc.gov

13.5. Sample collections for test development or validation Jorge L. Munoz-Jordan ckq2@cdc.gov

Topic 14. Implementation of Wolbachia-based strategies for dengue control in Central America (NCEZID)

14.1. Establish surveillance systems to track climate-sensitive mosquito-borne diseases and monitor if they are increasing or shifting over time.

Gabriela Paz-Bailey gmb5@cdc.gov

14.2. Evaluate the implementation and sustainability of Wolbachia replacement intervention in Central America

Gabriela Paz-Bailey gmb5@cdc.gov

14.3. Develop the evidence base for Wolbachia replacement

implementation in international settings to support implementation of effective strategies in the United States and help reduce risk of importation of vector borne diseases to the U.S.

Gabriela Paz-Bailey gmb5@cdc.gov

Topic 15. Towards dengue elimination: enhanced vector control and surveillance in Puerto Rico (NCEZID)

15.1. Develop and implement methods for enhanced surveillance and response to dengue hotspots in Puerto Rico

Gabriela Paz-Bailey gmb5@cdc.gov

15.2. Evaluate the effectiveness of hotspot responses in preventing additional disease spread

Gabriela Paz-Bailey gmb5@cdc.gov

Topic 16. Research to inform optimal approaches to environmental sampling and understanding of the prevalence and distribution of pathogenic fungi in healthcare settings (NCEZID)

16.1. Develop innovative methods for detection and surveillance of pathogenic fungi in healthcare environments

Ana Litvintseva, Jeremy Gold

Joe Sexton frq8@cdc.gov leo3@cdc.gov ogi3@cdc.gov

16.2. Quantify baseline levels of pathogenic fungi within healthcare environments

Ana Litvintseva, Jeremy Gold

Joe Sexton frq8@cdc.gov leo3@cdc.gov ogi3@cdc.gov

16.3. Correlate fungal quantitative data with episodes of fungal infections or transmission in patients.

Ana Litvintseva, Jeremy Gold

Joe Sexton frq8@cdc.gov leo3@cdc.gov ogi3@cdc.gov

16.4. Pilot early detection and surveillance methods for invasive mold and other fungi in patients and in the environment to guide public health efforts.

Ana Litvintseva, Jeremy Gold

Joe Sexton frq8@cdc.gov leo3@cdc.gov ogi3@cdc.gov

16.5. Evaluate the feasibility and utility of different environmental sampling approaches for pathogenic fungi in healthcare environments.

Ana Litvintseva, Jeremy Gold

Joe Sexton frq8@cdc.gov leo3@cdc.gov ogi3@cdc.gov

Topic 17. Understanding the impact of climate change and other predictors on the distribution and severity of fungal diseases (NCEZID)

17.1. Evaluate the influence of climate on diversity and abundance of human-pathogenic fungi in the environment -

Brendan Jackson

Mitsuru Toda iyn0@cdc.gov, nrk7@cdc.gov

17.2. Model geographic spread of fungal diseases based on predicted and observed climate changes

Brendan Jackson

Mitsuru Toda iyn0@cdc.gov, nrk7@cdc.gov

17.3. Understand the effect of severe weather events on the incidence of fungal infections

Brendan Jackson

Mitsuru Toda iyn0@cdc.gov, nrk7@cdc.gov

17.4. Assess role of social factors (e.g., health disparities) in determining severity of fungal diseases.

Brendan Jackson

Mitsuru Toda iyn0@cdc.gov, nrk7@cdc.gov

17.5. Assess role of host factors on determining severity of fungal diseases.

Brendan Jackson

Mitsuru Toda iyn0@cdc.gov, nrk7@cdc.gov

Topic 18. Development of rapid point-of-care (POC) syphilis diagnostic tests (NCHHSTP) mailto:evp4@cdc.gov mailto:evp4@cdc.gov mailto:wan6@cdc.gov mailto:rhemme@cdc.gov mailto:ckq2@cdc.gov mailto:ckq2@cdc.gov mailto:ckq2@cdc.gov mailto:ckq2@cdc.gov mailto:ckq2@cdc.gov mailto:gmb5@cdc.gov mailto:gmb5@cdc.gov mailto:gmb5@cdc.gov mailto:gmb5@cdc.gov mailto:gmb5@cdc.gov mailto:frq8@cdc.gov mailto:leo3@cdc.gov mailto:ogi3@cdc.gov mailto:frq8@cdc.gov mailto:leo3@cdc.gov mailto:ogi3@cdc.gov mailto:frq8@cdc.gov mailto:leo3@cdc.gov mailto:ogi3@cdc.gov mailto:frq8@cdc.gov mailto:leo3@cdc.gov mailto:ogi3@cdc.gov mailto:frq8@cdc.gov mailto:leo3@cdc.gov mailto:ogi3@cdc.gov mailto:iyn0@cdc.gov mailto:nrk7@cdc.gov mailto:iyn0@cdc.gov mailto:nrk7@cdc.gov mailto:iyn0@cdc.gov mailto:nrk7@cdc.gov mailto:iyn0@cdc.gov mailto:nrk7@cdc.gov mailto:iyn0@cdc.gov mailto:nrk7@cdc.gov

18.1 Development of a rapid point-of-care combo treponemal/

nontreponemal antibody test for active syphilis diagnosis

Mayur Shukla

Kim Kitzler

Iun9@cdc.gov nin1@cdc.gov

18.2 Development of a direct detection test for T. pallidum, ideally for all stages of syphilis

Allan Pillay

Kim Kitzler ajp7@cdc.gov nin1@cdc.gov

Topic 19. Decreasing disparities in the incidence, morbidity, and mortality associated with HIV, viral hepatitis, other sexually transmitted infections (STIs), tuberculosis and adolescent health (NCHHSTP).

19.1 Develop, implement, and/or evaluate innovative evidence-based interventions to reduce population-level disparities in the incidence, morbidity and mortality associated with HIV, viral hepatitis, STIs, or tuberculosis.

Kirk Henny

Harrell Chesson

KHenny@cdc.gov

HChesson@cdc.gov

Topic 20. Influenza and Other Acute Respiratory Infections (NCIRD)

20.1. CRISPR-Based Diagnostic Assays for Multi-Pathogen and Multi-

Analyte Detection

Marie K. Kirby pbi0@cdc.gov

20.2. Assessing the role of non-pharmaceutical interventions (NPI) in preventing influenza

Sonja Olsen sco2@cdc.gov

Topic 21. SARS-CoV-2 (COVID-19) and Children (NCIRD)

21.1. Describing respiratory virus transmission in educational settings. Hannah Kirking hrj7@cdc.gov

21.2 Evaluating COVID-19 vaccine effectiveness in schools. Hannah Kirking hrj7@cdc.gov

21.3. Children 5-17 years: Evaluating the duration of immune

protection following COVID-19 vaccination

Hannah Kirking hrj7@cdc.gov

21.4. Children 0-17 years: Estimating COVID-19 vaccine

effectiveness in ambulatory healthcare settings

Leora Feldstein nqw5@cdc.gov

21.5. COVID-19 and Multisystem Inflammatory Syndrome in Children

(MIS-C)

Angela Campbell app4@cdc.gov

21.6. COVID-19 and Acute Otitis Media (AOM) Katherine Fleming-Dutra ftu2@cdc.gov

Topic 22. Bacterial Respiratory and Vaccine-Preventable Diseases (NCIRD)

22.1. Assessing the molecular epidemiology of group A Streptococcus

(GAS) isolates among children.

Katherine Fleming-Dutra ftu2@cdc.gov

22.2. Understanding the spectrum of clinical pertussis. Susan Hariri bse4@cdc.gov

22.3. Understanding immune response to pertussis infection. Susan Hariri bse4@cdc.gov

Step 2 – Submission of Informal White Paper (Technical Dialogue)

This step is a continuation of the technical dialogue for projects of interest. Submission of a white paper does not require an explicit request or invitation from CDC. Offerors may submit a white paper even if there was no technical dialogue with the SME. Additionally, from time to time, the scientific point of contact may request that an offeror submit an informal white paper. The white paper can be no more than 4 pages in length, all inclusive.

The purpose of the white paper is to facilitate the SME’s understanding of the scientific and technical aspects of the proposed research project. Use of the white paper is intended to determine which efforts are of sufficient scientific and technical merit prior to submission of a formal research proposal as described in Part IV; therefore, informal white papers should not be so lengthy or detailed as to constitute a formal proposal (see Part IV). Informal white papers should contain a Rough Order of Magnitude (ROM) (e.g. “Estimated Cost”). A ROM is NOT a full blown business proposal. Instead, it is merely a “statement or a range” that provides a high level estimate of what the offeror believes the project will cost.

NOTE: CDC cannot discuss budget estimates or number of awards expected and cannot review draft white papers prior to submission.

Please note that the Government may use non-Government participants during the white paper review process (See

Part III – Use of Non-Government Personnel).

All submitted white papers will undergo an initial review for technical merit and program applicability. See

Part III for specific evaluation criteria.

NOTE: Once white papers are submitted technical dialogue STOPS!

mailto:Iun9@cdc.gov mailto:nin1@cdc.gov mailto:ajp7@cdc.gov mailto:nin1@cdc.gov mailto:KHenny@cdc.gov mailto:HChesson@cdc.gov mailto:pbi0@cdc.gov mailto:sco2@cdc.gov mailto:hrj7@cdc.gov mailto:hrj7@cdc.gov mailto:hrj7@cdc.gov mailto:nqw5@cdc.gov mailto:app4@cdc.gov mailto:ftu2@cdc.gov mailto:ftu2@cdc.gov mailto:bse4@cdc.gov mailto:bse4@cdc.gov

Step 3 - Submission of Formal Research Proposal

If there is sufficient interest in a proposed research project, the Contracting Officer will invite the offeror to submit a formal research proposal (see Part IV). During the preparation of the offeror’s proposal, technical dialogue may resume. The purpose of the technical dialogue is to facilitate the Government’s understanding of the scientific and technical aspects of the proposed research project. However, once proposals are submitted, communication between scientific personnel and the technical review team STOPS!

Please note that the Government may use non-Government participants during the evaluation of the proposals technical section (See Part III – Use of Non-Government Personnel).

Step 4 - Contract Award for Selected Projects

All proposals will receive an initial review (see Part V) and the Contracting Officer will notify the offeror, in writing, whether the proposal will be processed for award. The primary basis for selecting proposals for award shall be scientific/technical merit, importance to agency programs, corporate capabilities, and personnel. Cost realism, reasonableness and fund availability will also be considered to the extent appropriate. Past performance will also be considered. Any contract resulting from this process will include all standard FAR clauses or the appropriate alternates applicable to the contract type for the proposed project and offeror institution. See Part V for specific evaluation criteria. The Government has the right to make multiple awards.

NOTE: Projects will be funded as contracts, NOT GRANTS.

Government obligation

Persons submitting white papers and proposals are cautioned that only a Contracting Officer may obligate the

Government to any contract involving expenditure of Government funds. The Government is under no obligation to pay for the cost of for the development of white papers or proposals. Furthermore, there is no commitment on behalf of the Government to fund any proposal. Contractors are caution that the submission of a white paper and a proposal is submitted strictly on a voluntary bases.

BAA POINTS OF CONTACT

CDC’s BAA Technical Coordinator and point of contact is Diana Bartlett, MPH, MPP who may be reached by email at dbartlett@cdc.gov.

Based on the research topic area, CDC has multiple contractual points of contact. The POCs and the research areas they are responsible for is listed below.

Name Research Topic Area Email

Mr. Timothy Barnes 1 krz3@cdc.gov

Mr. Tray Burch 5, 6 vwa8@cdc.gov

Elizabeth Cole Greenblatt

William O’Bryan

3 qst7@cdc.gov rvq0@cdc.gov

Ms. Latoya Hill 7, 8, 9 mdx7@cdc.gov

Mr. Kristopher Lemaster 10 ene3@cdc.gov

Ms. Marva D. Lewis 2 knn5@cdc.gov

Mr. Marty Nemec 18, 19 oga2@cdc.gov

Ms. Jasmine Powell 11, 12, 13 qes1@cdc.gov

Ms. Denedra Threatt 4 qfa5@cdc.gov

Mr. Ronnie Williams 14, 15, 16, 17 oga3@cdc.gov

Mr. Tim Williams 20, 21, 22 tpw8@cdc.gov mailto:dbartlett@cdc.gov mailto:krz3@cdc.gov mailto:vwa8@cdc.gov mailto:qst7@cdc.gov mailto:rvq0@cdc.gov mailto:mdx7@cdc.gov mailto:ene3@cdc.gov mailto:knn5@cdc.gov mailto:oga2@cdc.gov mailto:qes1@cdc.gov mailto:qfa5@cdc.gov mailto:oga3@cdc.gov mailto:tpw8@cdc.gov

PART II - CDC RESEARCH INTERESTS

Overview

The Centers for Disease Control and Prevention (CDC) works to protect the U.S. from health, safety and security threats, both foreign and domestic. Specifically, CDC works with its partners to monitor health, detect and investigate health problems, conduct research to enhance and implement prevention strategies, develop and promote sound public health policies, promote healthy behaviors, foster safe and healthful environments, respond to current and emerging threats, and CDC’s role as the nation’s health protection agency is to operate

24/7 in order to keep people healthy and safe. The agency accomplishes this goal by working to: detect and respond to new and emerging health threats; address the biggest health problems causing death and disability;

move science and advanced technology into actions to prevent disease; promote health and safe behaviors, communities and environments; develop leaders by training the public health workforce; and understand the health pulse of the nation.

For this announcement, CDC is requesting white papers for the following areas, which are further described below:

Removed – Amendment 00001

Topic 1. Exploring best strategies to interrupt poliovirus transmission in outbreak-affected countries

(CGH)

1.1. Modeling to inform effective polio outbreak response strategies

Wild poliovirus type 2 was declared eradicated in 2015 and thereafter in April of 2016, routine immunization (RI) programs across the globe switched (“global switch”) from the trivalent oral poliovirus vaccine (tOPV; contains types 1, 2, and 3) to the bivalent vaccine OPV (bOPV; contains types 1 and 3). In addition, a single dose of the trivalent inactivated poliovirus vaccine (IPV) was introduced into routine immunization programs to provide protection against type 2 paralysis which does not lead to intestinal immunity necessary to stop virus transmission like OPV. A second dose is being introduced into routine immunization programs in OPV-using low and lower-middle income countries to increase the proportion protected. Outbreaks of circulating vaccine-derived poliovirus (cVDPV) result from use of OPV in under-immunized and unimmunized populations, permitting the vaccine virus to spread among susceptible individuals for prolonged periods, increasing the chance for the virus to revert and re-acquire the ability to cause paralysis. Despite intentions to boost type 2 intestinal immunity ahead of the global switch in 2016, pockets of susceptible children remained in countries with chronically low polio vaccination coverage. The increasing number of susceptible cohorts of infants without type 2 intestinal immunity increases the risk and spread of virus. As of 14 October 2021, cVDPV2 outbreaks have been detected in 19 countries, affecting 333 individuals. Responding to cVDPV2 outbreaks requires the use of monovalent Sabin strain oral poliovirus vaccine type 2 (mOPV2) in Supplementary Immunization Activities (SIAs) to quickly increase type 2 population intestinal immunity and halt the spread of the virus. When high quality SIAs are not achieved, the mOPV2 virus continues to spread unabated, increasing the potential for emergence of a new VDPV, and transmission of the originally detected cVDPV2 continues.

To respond to cVDPV2 outbreaks effectively, policy makers must weigh response scenarios to inform optimal response strategies to quickly interrupt virus transmission. For example, the promptness in which

SIAs are conducted (i.e., time between initial virus detection and first SIA), quality of the SIAs (i.e., true coverage effectiveness vis-á-vis performance indicators assessing vaccine coverage), number of SIA rounds, vaccine choice, geographic scope of SIAs, and age group targeted for SIAs. Modeling is one approach that can be used to inform outbreak responses.

CDC seeks to identify effective strategies to hasten the end of poliovirus transmission in cVDPV2 outbreak-affected countries. Key to this will be the development of an infectious disease model that can serve as the testing environment for different response strategies. Evaluation will include the identification of strategies that result in 1) no breakthrough cases (i.e., no cases occur after the standard operating procedure recommended initial number of outbreak response SIAs); 2) interrupt virus transmission with the fewest number of vaccination campaigns; 3) interrupt virus transmission in the least amount of time; and 4) lead to the fewest overall number of cases of paralysis.

Topic 2. Public Health Communication Approaches to Increase Trust in Public Health Emergency

Preparedness (CPR)

2.1 Public Health Communication Approaches to Increase Trust in Public Health Emergency Preparedness

Public trust in science is of heightened importance during a public health emergency, which is further compounded by the need for clear, correct, and targeted messages to effectively garner public health trust. Johns

Hopkins University surveyed 1,468 adults in the US and found that about half (54%) trusted science “a lot” with

46% split across other response categories (“some”, “not much”, and “not at all”). Public trust in science is essential when the risks and benefits of new policies and practices are not well understood because the public must rely on the decision-makers to make informed judgments, as demonstrated during the COVID-19 pandemic. For example, the public may not adhere to mitigation strategies if they do not know, understand, or trust the evidence supporting the strategy. There are a number of plausible explanations for the decline in the trust of science including the politicization of scientific issues. CDC and other key stakeholders, including the public, would benefit from the development of evidence-based knowledge about the state of the public's current knowledge of and attitudes towards public health emergency preparedness and response (PHEPR) science. This evidence-based knowledge will allow us to develop effective strategies to establish and maintain public confidence and trust in PHEPR science.

Communication approaches have been effectively used to change public perceptions standard marketing for products such as food or automobiles as well as health messages related to smoking, exercise, preventive care, and medication adherence. Effective communication approaches that promote public health preparedness and response awareness, dialogue, trust-building, and knowledge, while also combating misperceptions and complacency, particularly about the scientific underpinnings of public health recommendations and how science evolves are urgently needed.

With a focus on risk communication, white papers should describe communication approaches or interventions that use an existing (e.g., mass media, small media, social media, application) or innovative channel and are supported by formative research (either completed prior to or as part of the contract), process evaluation, and outcome evaluation. Formative research can identify and prioritize needs, desires, and values of the target audience and test message frames. Determining the theoretical conceptual foundation and examining the prospective target audience’s their behavior(s) and the factors which influence their behavior(s) are also key to successful messaging. Overall, white papers should include a description of the problem, market research, a defined market strategy, newly developed communication approaches, and evaluation of the communication approaches.

The objectives are to:

• Develop, implement, and evaluate communication approaches to increase trust in PHEPR science in subpopulations, jurisdictions, or the entire United States and its territories

• Build public health trust around PHEPR and various types of emergencies, hazards, and public health crises

• Increase the evidence-base, skills, and capacities of the state, tribal, local, and territory (STLT) health departments and communities

Priority will be given to offerors who:

• Have a successful track record of development, implementation, and evaluation of similar intervention activities

• Have the capacity to enroll and maintain large cohorts that include diversity in sociodemographic characteristics while minimizing selection and participation biases

• Experience in PHEPR research and evaluation

• Experience in conducting inclusive and population appropriate research

• Capacity to collect and manage the data required by this effort

• Can initiate and implement the study in a timely manner

• Are or work in partnership with an academic institution

• Are or work in partnership with STLT health departments

• Provide a plan to scale the approach as well as a sustainability plan (if the studied communication approach is effective)

• Be designed to increase trust in people who are traditionally underserved and underrepresented in the

US

• Not focus on single issues, but more broadly on science or the scientific process (e.g., COVID-19, vaccines)

• Include measurement outcomes that address general awareness and knowledge about PHEPR; increased understanding of how to prepare for various types of emergencies; an overall increase in public trust, particularly during a public health crisis; and an increase in intentions to follow future public health guidance during public health emergencies

• Include knowledge, translation, and dissemination into practice products (for example, how to implement an approach determined to be effective) or messages (for example, translating the results into a webinar for practitioners) to share information to large audiences.

Topic 3. Address critical gaps in knowledge regarding personal protective equipment (PPE) standards in a laboratory setting (CPR)

CDC seeks to investigate the performance of personal protective equipment (PPE) manufactured domestically and globally (and met certain local and global standards) for impact penetration, tensile strength, tear resistance, and viral penetration with a simulated laboratory environment and the effects of chemical decontamination and reuse on PPE efficacy. PPE serves a critical function in protecting laboratory workers from biohazards with enhanced PPE providing an increasingly important line of defense for poliovirus post-eradication. Although new research has become available since the COVID-19 pandemic, most information is focused on healthcare settings and may not have comparable characteristics to poliovirus, a 20-30 nm non-enveloped virus resistant to many disinfectants, and common laboratory matrices that may impact surface tension properties important in

PPE testing standards. This effort will: 1) evaluate national and international standards that assess performance requirements for PPE manufactured domestically and globally such as: impact penetration, tensile strength, tear resistance, viral penetration analyzed with and without the introduction of a chemical disinfectant (i.e. sodium hypochlorite or alcohol) and/or reuse in a simulated laboratory environment, 2) conduct standard test methods for PPE based on PPE commonly used in a laboratory setting using a poliovirus or surrogate virus, common laboratory matrices, with and without chemical decontamination and/or reuse for articles of PPE (e.g., gloves, gowns, coveralls), 3) develop evidence-based guidance on selection of PPE for biohazardous agents in a laboratory setting that consider chemical decontamination and reuse of articles of PPE, and 4) investigation of leakage through glove and protective clothing interface and the impact of mitigation methods (e.g. taping).

3.1. Comparison of PPE used in the United States and globally in terms of physical and barrier resistance using standardized performance tests (e.g., water resistance, viral penetration tests)

3.2. Effects of chemical decontamination on the durability and reliability of PPE in standardized performance tests (e.g., water resistance, viral penetration tests)

3.3. Effects of reuse of PPE in standardized performance tests (e.g., viral penetration tests)

Priority will be given to offerors who:

• Have a successful track record in conducting standardized testing methods for PPE

• Have demonstrated experience and capacity to perform virological studies

• Are interested and motivated to collaborate with CDC on testing projects and timely dissemination of the scientific data; and

• Are interested and motivated to use these data to inform public health and laboratory biosafety practice

Topic 4. Address Critical Knowledge Gaps related to Emerging and Re-emerging Infectious Diseases

During Pregnancy and the Risks, Benefits and Acceptance of Prevention and Treatment Strategies

(NCBDDD)

Current research about infectious diseases during pregnancy and their impact on pregnant individuals and infants is limited for several reasons. First, pregnancy status is not routinely captured in electronic health records and there are no standard data linkages in clinical or administrative datasets to capture the mother-infant dyad. Second, pregnant people are often excluded from randomized clinical trials of preventive therapies or treatment for infectious diseases leaving pregnant people and their health care providers to rely on small non-comparative cohort studies to make clinical decisions about these therapies. Finally, many studies do not capture a diverse group of pregnant people and infants. As part of this BAA focused on data modernization and health equity, CDC is seeking white papers to address research questions related to the primary objectives below, around the pregnancy, birth, and early childhood outcomes associated with emerging and reemerging infectious diseases in pregnancy and the risks and benefits of preventive and treatment strategies for these infectious diseases and their sequelae.

Given the period of performance for the contracts developed under this BAA mechanism, the most competitive applicants are those with existing cohorts in which data about the pregnant person and the infant are already linked (i.e., mother-baby linked longitudinal cohort). These data can include linked clinical data, administrative data, or other sources. Cohorts with existing protocols, procedures and institutional review board (IRB) approvals with existing infrastructure to address research questions may be most competitive, and able to accomplish the objectives within the period of performance of the contract. Using the pregnancy and infant cohort along with the appropriate comparison group(s), the research should assess the impact of infectious disease on mothers, infants and young children, as well as the acceptance of and use of applicable preventive strategies (e.g., masking, social distancing, routine testing, vaccination, mosquito repellent use, hand washing and other infection control practices, prophylactic medications) and treatments (e.g. antivirals, antimicrobials, novel therapeutics, intensive care). Existing protocols, including linked electronic datasets are encouraged to include the appropriate comparison cohort(s) (e.g., pregnant and/or non-pregnant; unexposed pregnancies and infants). Proposed target subpopulations of interest are also encouraged to include pregnant people from diverse racial/ethnic minority groups and sociodemographic backgrounds.

4.1. Mother-baby linked longitudinal cohort studies to examine the impact of emerging and re-emerging infectious diseases and prevention and treatment strategies on pregnancy, birth, and early childhood outcomes

Objectives of analyses of the electronic mother-baby linked longitudinal cohort may include the following:

• Examine susceptibility to the infectious disease by comparing the incidence of selected emerging and reemerging infectious diseases among pregnant and non-pregnant people.

• Compare the clinical severity of infection during pregnancy to the clinical severity of infection among non-pregnant people and describe risk factors and characteristics that increase the risk of severe disease.

• Estimate the risk of adverse outcomes associated with emerging and reemerging infectious disease during pregnancy, including, but not limited to early pregnancy loss, stillbirth, preterm delivery, preeclampsia, fetal distress perinatal transmission of infection, congenital infection, birth defects, and neonatal and post-neonatal morbidity and mortality. To understand the risks of these outcomes with untreated infection requires an appropriate comparison group of uninfected pregnant people matched for potential confounding characteristics.

• Estimate the risks and benefits of prevention and treatment strategies by comparing maternal, fetal, neonatal, and infant outcomes and other clinical parameters between pregnant people receiving and not receiving timely and appropriate prevention and/or treatment for the disease.

To address secondary objectives, ancillary quantitative or qualitative data collection (e.g., focus groups and surveys) of subpopulations within the cohort are encouraged to assess the uptake and acceptance of prevention

(e.g., vaccine) and treatment (e.g., antivirals) strategies during pregnancy, and any barriers and challenges to acceptance among healthcare providers and patients. For the ancillary quantitative and qualitative data collection, proposed target subpopulations of interest would include pregnant people from diverse racial/ethnic minority groups and sociodemographic backgrounds as well as diversity in the healthcare provider population caring for pregnant people and infants in the main cohort and in the comparison groups. Assessment of uptake and acceptance of prevention and treatment strategies are encouraged to include but healthcare providers of various racial and ethnic backgrounds, those in private and academic clinical practice, and those with different medical specialties (e.g., obstetrics and gynecology, midwifery, family medicine, infectious disease, pediatrics, neonatology).

Objectives of ancillary data collections (e.g., focus groups and surveys) include:

• Compare acceptance of preventive and treatment strategies by pregnancy status using a cohort of pregnant and similar-aged non-pregnant people.

• Compare acceptance of preventive and treatment strategies for pregnant people based on racial/ethnic diversity and other sociodemographic characteristics and clinical factors such as prior pregnancy status and prior acceptance of preventive strategies (e.g., vaccines and prophylactic medications) and treatments (e.g., antivirals and antimicrobials).

• Assess acceptance of preventive and treatment strategies by provider type, provider characteristics, practice type, provider age and other factors and monitor over time.

• Elicit barriers and challenges to acceptance of preventive and treatment during pregnancy (e.g., availability of medications/vaccines, accessibility, and the role of myths and misinformation).

This announcement is not restricted to any specific infectious diseases; however, the emerging and re-emerging infectious diseases in pregnancy monitored and tracked by the Centers for Disease Control and Prevention, and specifically those included in the Surveillance for Emerging Threats to Mothers and Babies Network (SET-

NET) are of particular interest https://www.cdc.gov/ncbddd/aboutus/pregnancy/emerging-threats.html.

Priority will be given to applicants who

• Have an established history of successful implementation of similar activities with cohorts of pregnant people, infants, and appropriate comparators;

• Demonstrate experience designing and implementing electronic cohorts with defined, appropriate analytic questions;

• Demonstrate capacity to collect, manage, analyze, and publish the data required by this effort with a focus on data modernization and health equity;

• Are most likely to initiate and implement the study in a timely manner using innovative methodology;

• Are interested and motivated to collaborate with CDC on analytic projects and timely dissemination of the scientific data; and

• Are interested and motivated to use these data to inform public health and clinical practice.

Topic 5: Expand the portfolio of effective interventions to prevent or delay type 2 diabetes and manage diabetes among populations who are underserved (NCCDPHP)

CDC currently has one evidence-based intervention [the National Diabetes Prevention Program (DPP)’s lifestyle change program (LCP)] that has been shown to reduce or delay the onset of type 2 diabetes and a limited number of evidence-based interventions (i.e., diabetes self-management education and support services, clinical efforts to improve detection of chronic kidney disease (CKD), screening for diabetic retinopathy) that have been shown to improve outcomes for those living with diabetes. CDC seeks to expand this portfolio to support other evidence-based interventions, strategies, programs, or policies to achieve these goals. CDC is particularly interested in white papers that reduce health inequities through interventions, strategies, programs, or policies that are targeted to populations who are historically underserved by these interventions (Black or African

American persons, Hispanic or Latino persons, Asian and Pacific Islander persons, persons with disabilities, men, young adults, and others).

5.1. Identify, test, implement, and evaluate innovative evidence-based interventions, strategies, programs, or policies that reduce health inequities in type 2 diabetes prevention.

Issues to consider:

• Scalability: CDC seeks to support interventions, strategies, programs, or policies that can demonstrate a feasible path to scaling beyond the context in which they are tested, but interventions should still be tailored to reach populations who are underserved.

• Sustainability: To expand access interventions, strategies, programs, or policies need to be easy to access for the population being served. Interventions, strategies, programs, or policies should not place a consider burden on the recipient/participant.

• All interventions, strategies, programs, or policies for type 2 diabetes prevention should be targeted to persons living with prediabetes [as determined by the CDC risk test

(https://www.cdc.gov/prediabetes/takethetest/) or a HbA1c of 5.7-6.4].

• Outcomes for type 2 diabetes prevention interventions could include one of the following: reduction of weight by 5%-7%, or reduction of HbA1c by 0.2% coupled with weight loss of 4%.

• CDC is also interested in intermediate implementation improvement strategies (e.g., acceptability, adoption, length, cost, etc.).

Use of the National DPP LCP curriculum is not required, but not disallowed. Alternative versions of the LCP

(e.g., difference in length, unique tailoring to specific audiences, other delivery mode or implementation modifications) are eligible for consideration but not required. Two alternate versions that are already developed but not required include the Road to Health (https://www.cdc.gov/diabetes/professional-info/toolkits/road-to-health.html) and On Your Way (https://www.cdc.gov/diabetes/prevent-type-2/guide-prevent-type2-diabetes.html).

Place-based or venue-based (e.g., Federally Qualified Health Center, faith-based institutions, employers, community-based organizations) interventions, strategies, programs, or policies are encouraged.

5.2. Identify, test, implement, and evaluate innovative evidence-based interventions, strategies, programs, or policies that reduce health inequities in diabetes management.

Issues to consider:

• Scalability: CDC seeks to support interventions, strategies, programs, or policies that can demonstrate a feasible path to scaling beyond the context in which they are tested, but interventions should be tailored to reach populations who are underserved.

• Sustainability: To expand access interventions, strategies, programs, or policies need to be easy to access for the population being…