A19. 75D301-23-R-72545.pdf

BAA 75D301-23-R-72545

CENTERS FOR DISEASE CONTROL AND

PREVENTION (CDC)

BROAD AGENCY ANNOUNCEMENT

(BAA)

75D301-23-R-72545

ISSUANCE DATE: December 28, 2022 CLOSING DATE: February 3, 2023

TABLE OF CONTENTS

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: Studies assessing Ebola vaccine efficacy and acceptance (CGH)……………………………………13

Topic 2: Investigations into the spread of malaria vector, An. stephensi, in non-endemic areas and developing and evaluating vector control approaches to prevent further impacts on global malaria (CGH) ……………………………………………………………………………………………………………………...16

Topic 3: Exploration of Infection and Environmental Stressors, Folic Acid Intake, Folate Metabolism and Risk of Folate-sensitive Birth Defects (NCBDDD)……………………

Topic 4: Studies to increase utilization of diabetes management services (NCCDPHP)……………….….…20

Topic 5: Examination of retail alcohol marketing and pricing to inform excessive alcohol use prevetion efforts (NCCDPHP)………

Topic 6: Identify and Assess Effective Communication Methods for Mosquito-Borne Disease Prevention

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

Topic 7: Assess mechanisms of persistence of IgM and enhanced diagnostic procedures for determining timing of California serogroup viral infections (NCEZID)…………………………………………………

Topic 8: Evaluation of affordable, acceptable tick bite prevnetion and tick control strategies for Ixodes species on high-use public lands in Lyme disease endemic areas (NCEZID).……………………………..…24

Topic 9: Strengthening Lyme disease surveillance and research using electronic health records

(NCEZID)…………………………………………………………………………………………………………25

Topic 10: Improve dengue clicnical management through targeted medical education (NCEZID)………..27

Topic 11: Address Critical Gaps in Controlling Aedes aegypti Mosquitoes within Households and Communities using Outdoor Residual Insecticide Application (NCEZID)…………….……………………..28

Topic 12: Genomic Sequencing and ancillary methods for detection of infectious pathogen and prediction of their emergence and spread for public health use (NCEZID)………………………………………………..29

Topic 13: A modeling approach to assessing healthcare associated infections surveillance definitions

(NCEZID)…………………………………………………………………………….…….……………………..31

Topic 14: Determining effective multimodal strategies for improving environmental cleaning in low-resource healthcare settings in low-and middle-income families (LMIC) (NCEZID)..………………………32

Topic 15: Increasing understanding of biofilm formation in blood platelet collection kits and the effectiveness of bacterial risk mitigation strategies in reducing the risk of bacterial contamination of platelets in presence of biofilm formation (NCEZID)…………………….…………….……………………33

Topic 16: Increasing understanding of unrecognized transmission of human herpesvirus 8 (HHV-8) among deceased organ donors who have history of nonmedical drug use (NCEZID)..……….……………………..34

Topic 17: Novel methods tho dervie sepsis estimates in adult and pediatric populations and assess the relationship between cumulative antibiotic exposure and sepsis (NCEZID)………….……………………..35

Topic 18: Increasing feasibility and sustainability of methods to rapidly detect patients colonized with antimicrobial resistant organisms in low- and middle-income countries (NCEZID)……………..…………35

Topic 19: Strategies to improve Health Equity with Healthcare Associated Infections and Antibiotic Prescribing (NCEZID)…………………………………………………………………….……………………..39

Topic 20:Improving Detection and/or Data Collection of Antimicrobial Resistant Pathogens (NCEZID)...40

Topic 21: Improving Antibiotic Use (NCEZID)………………………………………….……………………..42

Topic 22: Preventing Transmission of Antimicrobial Resistant Pathogens (NCEZID)…………….………..45

Topic 23: Studies to reduce Antimicrobial Resistance in Animals and the Environment (NCEZID)..……..51

Topic 24: Novel prevention methods to reduce transmission of Rickettsia rickettsii by brown dog ticks

(NCEZID)………………………………………………………………………………………………………

Topic 25: Increasing Access to Gonorrhea Testing through Development of a Self-test or of a Specimen Self-Collection Device for Non-Clinical Setting (NCHHSTP)…………….…………….……………………..56

Topic 26: Development of a confirmatory serologic assay for Herpes Simplex Virus (HSV-1/2) diagnosis

(NCHHSTP)………………………………………………………………….…………….……………………..58

Topic 27: Increasing Access to HIV Testing through the Development of Novel, Self-administered Testing Modalities………………………………………………………………………………………………………….59

Topic 28: Identification and assessment of potentially sources of community-associated Legionnaires' disease (NCIRD)……………………………………………………………..…………….……………………..61

Topic 29: Innovative methods to optimize protection from licensed influenza vaccines (NCIRD)…………63

Topic 30: Innovative strategies for characterizing, predicting, and assessing influenza severity, disease burden, and transmission dynamics (NCIRD)……………………………..…………….……………………..66

Topic 31: Evaluationof maternal COVID-19 vaccination for prevention of COVID-19 in pregnant people and infants (NCIRD)……………………………………………………………………….……………………..67

Topic 32: Estimating Transmission Dynamics and Evaluating Effectiveness of Annual Vaccines for Reducing Transmission of Influenza and Other Respiratory Viruses in Household Settings …..…………..67

Topic 33: Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses (NCIRD)……………………………………………………….……………………..70

Topic 34: Using electronic health records data to produce timely estimates of COVID-19 and influenza vaccine effectiveness and characterize the clinical epidemiology of COVID-19, influenza, and other respiratory viruses (NCIRD)………………………………………………...…………….……………………..70

Topic 35: Use of Ventilation and Environmental Interventions (i.e., Engineering Controls) to Reduce Respiratory Virus Transmission (NCIRD)……………………………………………….……………………..72

Topic 36: Using an established Controlled Human Infection Model (CHIM) platform to accelerate development and licensure of next-generation pertussis vaccines in the United States

(NCIRD)…………………………………………………………………………………….……………………..73

Topic 37: Establishing surveillance of respiratory infections by Mycoplasma pneumoniae, including strain characterization and determination of macrolide resistance (NCIRD)…………….………………………

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……………………………………………………………………………………………..…80 Funding

Proposal Submission Follow-On Contracts Proposal Copies Mailing Addresses

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

Offeror's Performance Assessment Rating (CPARS)… ……………………………………………... 84 Past Performance…………………………………………………………………………………………..85

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 - PROPOSAL FORMS and ATTACHMENTS

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. Foreign entities are not permitted to respond to this requirement.

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

Priorities and funding for CDC research initiatives are determined each fiscal year. Potential offerors are encouraged to contact the respective CDC BAA technical point of contact noted in the table below to determine whether their research may warrant the submission of a white paper. 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 announced, technical dialogue can begin. 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 Technical Point of Contact (POC) POC e-mail address

Topic 1. Studies assessing Ebola vaccine efficacy and acceptance (CGH)

1.1 Ebola Vaccine efficacy studies Terri Hyde thyde@cdc.gov

1.2 Community and Healthcare worker acceptance of Ebola vaccine Terri Hyde thyde@cdc.gov

1.3 Vaccination of Contacts of Ebola Disease Survivors Terri Hyde thyde@cdc.gov

Topic 2. Investigations into the spread of malaria vector, An. stephensi, in non-endemic areas and developing and evaluating vector control approaches to prevent further impacts on global malaria (CGH)

2.1 Use innovative population genomics methods and tools to determine patterns of An. stephensi invasion and expansion in non-endemic countries and leverage this work to further bridge molecular entomology sequencing capacity.

Sarah Zohdy ykr2@cdc.gov

2.2 Develop and evaluate innovative vector control approaches, tools, and strategies targeting urban invasive An. stephensi populations, which require different tools than those typically used for Anopheles malaria control.

Audrey Lenhart ajl8@cdc.gov

Topic 3. Exploration of Infection and Environmental Stressors, Folic Acid Intake, Folate Metabolism and Risk of Folate-sensitive Birth Defects (NCBDDD)

3.1 Identify and study the relationship between environmental hazards and risk of folate-sensitive birth defects

Jennifer Williams Krista Crider znv8@cdc.gov kvc3@cdc.gov

3.2 Identify and study the relationship between folate status, COVID-19, and risk of folate-sensitive birth defects, specifically neural tube defects (NTDs)

Jennifer Williams Krista Crider znv8@cdc.gov kvc3@cdc.gov

Topic 4. Studies to increase utilization of diabetes management services (NCCDPHP)

4.1 Develop, test, implement and assess innovative methods, tools, and strategies to engage and enroll more persons living with diabetes into diabetes self-management education and support (DSMES) services.

Bryce Smith Bsmith6@cdc.gov

4.2 Rigorously study the effectiveness of New Beginnings as a diabetes management social support intervention. Bryce Smith Bsmith6@cdc.gov

Topic 5. Examination of retail alcohol marketing and pricing to inform excessive alcohol use prevention efforts

(NCCDPHP)

5.1 Development and use of a feasible method for assessing youth exposure to digital alcohol marketing and identifying disparities

Marissa Esser jwv7@cdc.gov

5.2 Use of alcoholic beverage pricing data to inform the implementation and evaluation of alcohol pricing policies

Marissa Esser jwv7@cdc.gov

Topic 6. Identify and Assess Effective Communication Methods for Mosquito-Borne Disease Prevention (NCEZID)

6.1. Assess effectiveness of community-based interventions in increasing knowledge and reported protective behaviors for mosquito-borne disease prevention

Margaret Silver uvt8@cdc.gov

6.2 Assess messages and methods for increasing support of local mosquito control activities

Margaret Silver uvt8@cdc.gov

6.3 Identify innovative or easily replicated communication activities that can be used across the country to prevent mosquito-borne diseases

Margaret Silver uvt8@cdc.gov

Topic 7. Assess mechanisms of persistence of IgM and enhanced diagnostic procedures for determining timing of California serogroup viral infections (NCEZID)

7.1 Develop non-human primate model for Jamestown Canyon and

LaCrosse viruses for assessing IgM persistence in serum and cerebrospinal fluid

Aaron C. Brault

Zlu5@cdc.gov

7.2 Evaluate novel immunological methodologies/assays for determining timing of California serogroup virus infections using defined samples from experimentally inoculated non-human primates

Amanda Calvert Zpz0@cdc.gov

7.3 Validate temporal serological assessment methodologies for California serogroup virus infections from human clinical samples

J. Erin Staples Aaron C. Brault

Auv1@cdc.gov Zlu5@cdc.gov

Topic 8. Evaluation of affordable, acceptable tick bite prevention and tick control strategies for Ixodes species on high-use public lands in Lyme disease endemic areas (NCEZID)

8.1 Evaluation of affordable, acceptable tick bite prevention and tick control strategies for Ixodes species on high-use public lands in Lyme disease endemic areas

James Burtis ptd6@cdc.gov

Topic 9. Strengthening Lyme disease surveillance and research using electronic health records (NCEZID)

9.1 Produce routine estimates of Lyme disease incidence using electronic health records.

Sarah Hook vhx8@cdc.gov https://www.cdc.gov/diabetes/professional-info/toolkits/new-beginnings/index.html#:%7E:text=New%20Beginnings%20uses%20stories%2C%20activities,and%20build%20positive%2C%20supportive%20relationships

9.2 Monitor trends in the clinical manifestations and epidemiology of Lyme disease.

Sarah Hook vhx8@cdc.gov

9.3 Conduct vaccine impact studies once a Lyme disease vaccine or other preventive is available.

Sarah Hook vhx8@cdc.gov

9.4 Conduct clinical research studies to address questions regarding Lyme disease in certain patient populations.

Sarah Hook vhx8@cdc.gov

Topic 10. Improve dengue clinical management through targeted medical education (NCEZID)

10.1 Review of literature on existing evaluations of innovative methods, tools, and strategies for effective healthcare provider education online.

Liliana Sanchez naq5@cdc.gov

10.2 Development of a novel clinician education tool for dengue clinical management based on the most effective teaching tools identified through strategy 10.1.

Liliana Sanchez naq5@cdc.gov

10.3 Development of pre- and post-tests to evaluate healthcare provider information uptake and retention from the dengue clinical management tool.

Liliana Sanchez naq5@cdc.gov

10.4 Design of a clinical evaluation of dengue case management before and after completion of the dengue clinical management tool.

Liliana Sanchez naq5@cdc.gov

Topic 11. Address Critical Gaps in Controlling Aedes aegypti Mosquitoes within Households and Communities using Outdoor Residual Insecticide Application (NCEZID) Confirm the effectiveness of type II pyrethroids for the control of Aedes aegypti in the field using outdoor residual spraying treatments and develop and evaluate a protocol/techniques capable of suppressing Aedes aegypti populations below levels needed to maintain transmission of arboviruses for 4-5 weeks using entomological-endpoints of surveillance.

Ryan Hemme, Roberto Barrera rhemme@cdc.gov, amz9@cdc.gov

Topic 12. Genomic sequencing and ancillary methods for detection of infectious pathogens and prediction of their emergence and spread for public health use (NCEZID)

12.1 Advance pathogen agnostic surveillance, biological threat early warning, and investigation of outbreaks due to emerging pathogens or clinical presentations with unknown etiology.

Eleanor Click Duncan MacCannell eoc9@cdc.gov fms2@cdc.gov

12.2 Develop models and software tools to predict the source or geographic origin of pathogens or to identify anomalous patterns that may signify the emergence, re-emergence, or persistence of strains over time using whole genome sequencing and epidemiological data.

Eleanor Click Duncan MacCannell eoc9@cdc.gov fms2@cdc.gov

12.3. Develop tools to streamline or automate sharing of pathogen sequencing and other public health data.

Eleanor Click Duncan MacCannell eoc9@cdc.gov fms2@cdc.gov

12.4 Use genomics to improve the diagnostic and surveillance pipelines for pathogens of public health importance

Eleanor Click Duncan MacCannell eoc9@cdc.gov fms2@cdc.gov

Topic 13. A modeling approach to assessing healthcare associated infections surveillance definitions (NCEZID)

13.1 Develop a modeling approach to provide comparison of user-defined Healthcare-Associated Infections (HAI) surveillance definitions to gold standard/accepted HAI definitions using simulated clinical data.

Matthew Westercamp xzj3@cdc.gov

Topic 14. Determining effective multimodal strategies for improving environmental cleaning in low-resource healthcare settings in low- and middle-income countries (LMIC) (NCEZID)

14.1 Determine the most effective interventions for improving environmental cleaning in low-resource settings

Molly Patrick jmpatrick@cdc.gov

14.2 Develop a prioritized set of multimodal strategies for improving the effectiveness of environmental cleaning programs in low-resource settings

Molly Patrick jmpatrick@cdc.gov

Topic 15. Increasing understanding of biofilm formation in blood platelet collection kits and the effectiveness of bacterial risk mitigation strategies in reducing the risk of bacterial contamination of platelets in presence of biofilm formation

(NCEZID)

15.1 Development and evaluation of innovative methods to identify whether bacterial biofilms can form in blood platelet collection kits with an emphasis on Staphylococcus saprophyticus and Acinetobacter calcoaceticus-baumannii complex.

Sridhar Basavaraju, Margaret Williams, Judith Noble-Wang, Alison etu7@cdc.gov, cux2@cdc.gov, cux6@cdc.gov, mailto:eoc9@cdc.gov mailto:eoc9@cdc.gov mailto:eoc9@cdc.gov mailto:eoc9@cdc.gov

Laufer Halpin, Christopher Elkins vif0@cdc.gov, nme0@cdc.gov

15.2 Development and evaluation of methods to identify the effectiveness of pathogen-reduction technology and other bacterial contamination control strategies to effectively mitigate the risk of bacterial biofilm formation with an emphasis on Staphylococcus saprophyticus and Acinetobacter calcoaceticus-baumannii complex.

Sridhar Basavaraju, Margaret Williams, Judith Noble-Wang, Alison Laufer Halpin, Christopher Elkins etu7@cdc.gov, cux2@cdc.gov, cux6@cdc.gov, vif0@cdc.gov, nme0@cdc.gov

Topic 16. Increasing understanding of unrecognized transmission of human herpesvirus 8 (HHV-8) among deceased organ donors who have history of nonmedical drug use (NCEZID)

16.1 Development and evaluation of an human herpesvirus 8 (HHV-8) IgG serologic test for HHV-8

Pallavi Annambhotla Yfn7@cdc.gov

16.2 Design and implement a study to ascertain prevalence and incidence of human herpesvirus 8 (HHV-8) among deceased organ donors with history of nonmedical drug use serum specimens.

Pallavi Annambhotla Yfn7@cdc.gov

Topic 17. Novel methods to derive sepsis estimates in pediatric populations (NCEZID)

17.1 Development of an electronic surveillance definition, national burden estimate, and hospital toolkit for pediatric sepsis

Shelley Magill Fxe9@cdc.gov

Topic 18. Increasing feasibility and sustainability of methods to rapidly detect patients colonized with antimicrobial resistant organisms in low- and middle-income countries (LMIC) (NCEZID)

18.1 Cost and impact of implementing national action plan for antimicrobial resistance in low- and middle-income countries (LMIC)

Fernanda Lessa Dta3@cdc.gov

18.2 Validation of low-cost, commercially available alternative rectal swab collection devices for use with GeneXpert CARBA-R

Charlene Siza Xch7@cdc.gov

18.3 Development of innovative methods and strategies to prevent carbapenem-resistant organism (CRO) transmission in resource-limited neonatal intensive care units (NICU) in low- and middle-income countries

(LMIC)

Katie Wilson kwilson8@cdc.gov

18.4 Assessing the impact of urine antibiotic and biocide residues on Antimicrobial Resistant colonization in low- and middle-income countries

(LMIC)

Ashley Styczynski Yxn2@cdc.gov

Topic 19. Strategies to improve Health Equity with Healthcare Associated Infections and Antibiotic Prescribing

(NCEZID)

19.1 Identify Nursing Homes at Increased Risk of Health Inequities to Focus Strategic Interventions

Kara Jacobs Slifka Ipf8@cdc.gov

19.2 Qualitative evaluation of mechanisms leading to inequities in antibiotic prescribing

Sarah Kabbani nfq8@cdc.gov

Topic 20. Improving Detection and/or Data Collection of Antimicrobial Resistant Pathogens (NCEZID)

20.1 Understanding the burden of urinary traction infection among US adults (≥18 years of age) from 2000-2022

Preeta Kutty pkutty@cdc.gov

20.2 Evaluation of the clinical impact of infection with multiple different strains of Clostridioides difficile

Camden Gowler nrt8@cdc.gov

20.3 Using laboratory data for respiratory pathogen surveillance for nursing homes

Andrea Benin Rachel Slayton aqb4@cdc.gov Via3@cdc.gov

Topic 21. Improving Antibiotic Use (NCEZID)

21.1 Antibiotic stewardship staffing calculator for inpatient settings Melinda Neuhauser ikf5@cdc.gov

21.2 Electronic health record-based assessment of appropriate antibiotic use for inpatient community-acquired pneumonia

Melinda Neuhauser ikf5@cdc.gov

21.3 Electronic health record-based intervention to improve antibiotic use in long-term care settings

Sarah Kabbani nfq8@cdc.gov

21.4 Optimizing antibiotic use in telemedicine services Guillermo (Memo) Sanchez xkv4@cdc.gov

21.5 Communications Skills Training to Optimize Antibiotic Prescribing in Outpatient Settings

Sarah Kabbani nfq8@cdc.gov

Topic 22. Preventing Transmission of Antimicrobial Resistant Pathogens (NCEZID)

22.1 Assess effectiveness of foaming chemical disinfectant for wastewater plumbing on multidrug-resistant gram-negative bacilli in healthcare settings

Maroya Walters vii0@cdc.gov

22.2 Assess effectiveness of commonly used hospital disinfectants against carbapenem-resistant and carbapenem-susceptible Acinetobacter baumannii and characterize persisting strains

Magdalena Medrzycki Lnu6@cdc.gov

22.3 Feasibility of providing ‘waterless’ care in the Neonatal Intensive Care Unit in an attempt to limit neonatal exposure to Gram-negative bacteria from the environment

Christopher Prestel okn0@cdc.gov

22.4 Develop and propose studies needed to define clinical and/or surrogate endpoints that can be used for the regulatory approval of decolonizing agents, microbiome therapies, or similar products that can prevent the transmission of pathogens (especially those that are antimicrobial resistant) in and across healthcare setting

John Jernigan Jqj9@cdc.gov

22.5 Development of a standardized approach to detecting and quantifying colonization with antimicrobial resistant organisms

John Jernigan Jqj9@cdc.gov

22.6 Impact of staffing on the prevention of hospital-associated infections Sujan Reddy Kuj0@cdc.gov Topic 23. Studies to reduce Antimicrobial Resistance in Animals and the Environment (NCEZID)

23.1 Research to understand the epidemiology of antifungal-resistant dermatophytosis in the United States

Jeremy Gold leo3@cdc.gov

23.2 Research to understand the distribution of antifungal-resistant Aspergillus fumigatus in outdoor environments.

Anastasia Litvintseva frq8@cdc.gov

23.3 One Health Antimicrobial resistance: carbapenem-resistant Enterobacterale in companion animals

Misha Robyn Ydi4@cdc.gov

23.4 Pangenome and antimicrobial ecology in Public Health Kaitlin Tagg nnp2@cdc.gov

23.5 Backyard Poultry Hattie Webb opq7@cdc.gov

Topic 24. Novel prevention methods to reduce transmission of Rickettsia rickettsii by brown dog ticks (NCEZID)

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

24.2 Tick, pathogen, and dog abundance in Northern Mexico Chris Paddock cdp9@cdc.gov Topic 25. Increasing Access to Gonorrhea Testing through Development of a Self-test or of a Specimen Self-Collection Device for Non-clinical Settings (NCHHSTP)

25.1 Development and evaluation of a specimen self-collection device for NAAT detection of Neisseria gonorrhoeae and Chlamydia trachomatis in nonclinical settings, leading to the submission of a regulatory package to

FDA

Kim Gernert Weiping Cao

Nin1@cdc.gov jgz9@cdc.gov

25.2 Development and evaluation of an affordable lateral flow test for Neisseria gonorrhoeae detection, leading to the submission of a regulatory package to FDA with self-testing indication or a CLIA waiver or both

Kim Gernert Weiping Cao

Nin1@cdc.gov jgz9@cdc.gov

Topic 26. Development of a confirmatory serologic assay for Herpes Simplex Virus (HSV-1/2) diagnosis (NCHHSTP) Development of a confirmatory serologic assay for diagnosing Herpes Simplex Virus (HSV-1/2) including a user interface and linkage to commercial submitter laboratories

Weiping Cao Kim M Gernert

Jgz9@cdc.gov Nin1@cdc.gov

Topic 27. Increasing Access to HIV Testing through the Development of Novel, Self-administered Testing Modalities

(NCHHSTP)

27.1 Development and evaluation of new HIV serologic (antigen and/or antibody) self-tests, leading to the submission of a regulatory package to

FDA

Elizabeth DiNenno Eid8@cdc,gov

27.2 Development and evaluation of nucleic acid self-tests, to offer options for tests with improved sensitivity in detecting or monitoring HIV to clinically monitor people on antiretrovirals for treatment and/or prevention

Elizabeth DiNenno Eid8@cdc.gov

Topic 28. Identification and assessment of potentially sources of community-associated Legionnaires’ disease (NCIRD)

28.1 Rapid identification of cooling towers from aerial satellite imagery using computer vision and machine learning

Chris Edens iek4@cdc.gov

28.2 Assessment of factors associated with Legionella detection in household water systems

Chris Edens iek4@cdc.gov mailto:Nin1@cdc.gov mailto:Nin1@cdc.gov

28.3 Exposure ascertainment study of environmental sources for Legionnaires’ disease cases

Chris Edens iek4@cdc.gov

Topic 29. Innovative methods to optimize protection from licensed influenza vaccines (NCIRD)

29.1 Develop the knowledge base to correlate immunogenicity with enhanced clinical protection of second-generation parenteral influenza vaccines vs standard inactivated influenza vaccines

Brendan Flannery bif4@cdc.gov

29.2 Develop innovative strategies using advanced immunologic assays to advance understanding of immune responses to enhanced influenza vaccines among participants in randomized studies of vaccine immunogenicity

Brendan Flannery bif4@cdc.gov

29.3 Identify optimal strategies to prevent influenza through vaccination for the general population and groups at increased risk of severe influenza.

Fatimah Dawood hgj0@cdc.gov

Topic 30. Innovative strategies for characterizing, predicting, and assessing influenza severity, disease burden, and transmission dynamics (NCIRD) Innovative strategies for characterizing, predicting, and assessing influenza severity, disease burden, and transmission dynamics

Matthew Biggerstaff zmo2@cdc.gov

Topic 31. Evaluation of maternal COVID-19 vaccination for prevention of COVID-19 in pregnant people and infants

(NCIRD)

Evaluate the effectiveness of maternal COVID-19 vaccination at preventing COVID-19, including severe COVID-19, among pregnant people, preventing adverse pregnancy outcomes, and in preventing COVID-19, including severe disease, in infants <6 months of age

Katherine Fleming-Dutra ftu2@cdc.gov

Topic 32. Estimating Transmission Dynamics and Evaluating Effectiveness of Annual Vaccines for Reducing Transmission of Influenza and Other Respiratory Viruses in Household Settings (NCRID)

32.1 Use innovative methods to study household transmission of influenza and assess transmission dynamics and effectiveness of annual vaccines in near real-time

Melissa Rolfes ydi8@cdc.gov

32.2 Use innovative methods to study household transmission of SARS- CoV-2, RSV, and/or other respiratory viruses in near real-time

Hannah Kirking hrj7@cdc.gov

Topic 33. Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses (NCIRD)

33.1 Map/define the epitopes (antigenic sites) targeted by human antibodies upon infection by contemporary A and B viruses and develop a sustainable strategy to rapidly identify and characterize antigenic drift

John Steel pdx1@cdc.gov

33.2 Develop bioinformatics techniques for fitness forecasting to identify virus groups/clades that will predominate in humans 1 year in advance

Rebecca Kondor dqy5@cdc.gov

33.3 Create strategy to experimentally identify antigenically advanced influenza A viruses likely to predominate in the human population in future influenza seasons.

Bin Zhou nmb7@cdc.gov

Topic 34. Using electronic health records data to produce timely estimates of COVID-19 and influenza vaccine effectiveness and characterize the clinical epidemiology of COVID-19, influenza, and other respiratory viruses (NCIRD) Development and evaluation of innovative methods to assess the preventive benefit of currently available COVID-19 and seasonal influenza vaccines across various healthcare settings, different levels of disease severity, and among special patient populations; and methods to assess the clinical epidemiology of COVID-19, influenza, and respiratory syncytial virus (RSV) across various healthcare settings, different levels of disease severity, and among special patient populations

Mark Tenforde and Ruth Link-Gelles

Pji6@cdc.gov, hzt7@cdc.gov

Topic 35. Use of Ventilation and Environmental Interventions (i.e. Engineering Controls) to Reduce Respiratory Virus Transmission (NCIRD) Measuring effectiveness of ventilation and environmental upgrades in reducing respiratory virus transmission and illness in non-healthcare settings

Hannah Kirking and Phil Salvatore hrj7@cdc.gov pgx5@cdc.gov

Topic 36. Using an established Controlled Human Infection Model (CHIM) platform to accelerate development and licensure of next-generation pertussis vaccines in the United States (NCIRD)

Using a controlled human infection model, evaluate the human immune response to pertussis disease and B. pertussis transmission dynamics in healthy adults (by pertussis vaccine priming status) using a clinically characterized pertactin-deficient B. pertussis isolate that is representative of strains currently circulating in the United States

Susan Hariri bse4@cdc.gov

Topic 37. Establishing surveillance of respiratory infections caused by Mycoplasma pneumoniae, including strain characterization and determination of macrolide resistance (NCIRD) Perform sentinel surveillance for M. pneumoniae to estimate overall burden of disease and proportion of infections caused by macrolide-resistant M.

pneumoniae

Maureen Diaz iqs5@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 technical/scientific point of contact and/or Subject Matter Expert (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. Any white paper response that exceeds 4 pages may be considered ineligible for evaluation. 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 will not 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!

Step 3 - Submission of Formal Research Proposal

If sufficient interests in a proposed research project exists the Contracting Officer will invite (in writing) the white paper submitter to offer a formal research proposal (See Part IV). After the CO request proposal submission communications may resume during proposal preparation. Once proposals are submitted, communications between the offeror and the scientific/technical personnel STOPS. Continued communications after proposal receipt may make offerors ineligible for award.

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

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 the development of white papers or proposals. Furthermore, there is no commitment on behalf of the Government to fund any proposal. Offerors are cautioned that the submission of a white paper and a proposal is strictly on a voluntary basis.

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 Contracting Officer(s) and the research areas they are responsible for are listed below.

Name Research Topic Area Email Ms. Jasmine Powell 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 27, 28, 29 jpowell5@cdc.gov

Ms. LaToya Hill

30, 31, 32, 33, 34, 35, 36, mdx7@cdc.gov

Ms. Liubov Kriel 25,26 vyh1@cdc.gov Ms. Denedra Threatt 3 qfa5@cdc.gov Ms. Robin Meyer 1,2 Rcm2@cdc.gov Mr. Tray Burch 4,5,6,7,8, 9, 10, 11, 12, 13,14 vwa8@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 mailto:dbartlett@cdc.gov mailto:jpowell5@cdc.gov mailto:mdx7@cdc.gov mailto:vyh1@cdc.gov mailto:qfa5@cdc.gov mailto:Rcm2@cdc.gov mailto:vwa8@cdc.gov mailto:vwa8@cdc.gov

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 research interest areas, which are further described below:

Topic 1. Studies assessing Ebola vaccine efficacy and acceptance (CGH) Ebola vaccination is a relatively new pillar of the Ebola response, being introduced during the 2018-2020 Ebola virus disease (EVD) outbreak in Eastern Democratic Republic of the Congo (DRC). Ebola vaccines were used under compassionate use/expanded access from 2018-2020 and under a clinical trial protocol, and the first EVD vaccine was licensed in 2019. There is also an ongoing outbreak of Sudan Ebolavirus (SUDV) in Uganda and multiple new vaccines will begin clinical trials.

To date, there has only been one efficacy study for Merck’s ERVEBO Ebolavirus vaccine and no efficacy studies for the J&J two dose regimen Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). The duration of protection for all Ebola vaccines are unknown.

Additionally, the COVID-19 has resulted in reductions in trust of vaccines and vaccinations programs in many countries, therefore it is of interest to monitor attitudes and perceptions about Ebola vaccines and how they change overtime. Finally, as outbreaks increase in frequency and magnitude it will be important to assess and try and innovative vaccination strategies that may prevent future outbreaks.

Our objectives in this effort are to 1) assess the real-world effectiveness of Ebola vaccines during outbreaks, the duration of protection, and if effectiveness wanes over time, 2) improve our understanding of the community attitudes surrounding EVD/SUDV vaccines and 3) assess new vaccination strategies that may expand protection beyond outbreak timelines as concern for Ebola survivor transmission grows with the increasing number of survivors.

1.1: Conduct Ebola Vaccine effectiveness studies.

Ebola vaccine development was fast tracked due to the large West African EVD outbreak from 2014-16.

Currently the only vaccine with efficacy data is ERVEBO (rVSVΔG -ZEBOV-GP), which was licensed in 2019 by the US FDA to prevent disease caused by Zaire ebolavirus. In addition, the J&J Zaire Ebolavirus vaccine has been licensed by the EMA and given to tens of thousands of individuals in geographic areas surrounding EVD outbreaks. There are additional vaccines currently in development and in clinical trials against SUDV. The only vaccine with human clinical efficacy data is the ERVEBO vaccine, which was assessed during an open-label, randomized cluster (ring) vaccination study conducted in the Republic of Guinea during the 2014 outbreak. To date, the effectiveness of the vaccine and all other vaccines in the real-world have not been evaluated. Additionally, the duration of protection is currently unknown. With the increasing frequency of EVD outbreaks, it is critical to determine the effectiveness and duration of protection of Ebola vaccines in real-world settings.

CDC seeks projects that would assess:

a. VE in preventing laboratory-confirmed Ebola This work would utilize Ebola immunization and case investigation data collected on suspect Ebola cases in new outbreaks. The study would be a test-negative design with case-control groups. The case group would be those suspect cases testing positive for EVD in a future outbreak and the control group would be suspect cases who test negative for EVD. Vaccination status would be ascertained for both cases and controls and VE would be calculated.

b. VE in preventing severe Ebola In addition, projects would also assess the VE of Ebola vaccines in preventing severe disease. Most outbreaks of Ebola generally have high case high fatality rates, ranging from 25% to 90% by outbreak, and there are several theories as to why some cases can recover and survive as compared to others. We would like projects to assess if previous vaccination against Ebola is associated with increased chances of survival and improved outcomes, including severity of disease and death. WHO suggests that ERVEBO, when given as post exposure prophylaxis, leads to a reduction in mortality, however there is limited data to support this statement. As discussed in objective 1.1, projects would assess VE using a test negative design.

c. the duration of protection for Ebola vaccines and whether VE wanes over time Current SAGE recommendations indicate revaccination of all Ebola contacts or contacts of contact (during an outbreak of EVD) if they have not been vaccinated in the last 6 months. This 6-month timeframe is arbitrary and needs evaluation to determine the most effective strategy because the duration of protection is currently unknown. Many individuals in Ebola affected areas have received the Ebola vaccine after being identified as a high-risk individual, either as a contact, contact of contact, or healthcare or front-line workers. As new outbreaks emerge, some individuals are eligible to receive an additional dose(s) of vaccine due to a new high-risk exposure.

CDC would prefer projects that create multiple cohorts of individuals who were vaccinated against Ebola.

Projects would develop a cohort who was vaccinated with one dose, two doses, and potentially three doses (depending on the number of individuals). Cohorts would include individual from various outbreaks across selected outbreak areas, which may include DRC, Guinea, or Uganda. Cohorts will be followed and provide blood at pre-selected timepoints for serological testing to measure antibody concentrations overtime. This data will be used to guide decision making for Ebola vaccination policies.

At this time, there is no data and evidence-based recommendations on revaccination are needed.

This work would involve working with Ministries of Health in affected countries such as the DRC, Guinea, and Uganda, where the Vaccine Introduction Team is already currently engaged with through other work collaborations. The team has provided technical support to these countries in previous Ebola outbreaks specifically on vaccination strategy and response. Ebola outbreaks have been occurring more frequently in recent decades and the scope of the current Sudan Ebolavirus outbreak in Uganda illustrates the need and urgency of developing a protocol for these studies and collecting the data to assess the effectiveness of the vaccines and duration of protection being used.

1.2: Community and Healthcare worker acceptance of Ebola vaccine During the response to the 2018–2020 EVD outbreak in the eastern part of the DRC, implementation of prevention and control measures, such as Ebola vaccination were complicated due to trust issues and the cooperation of local communities, including among health care workers (HCWs). Community resistance to Ebola response measures continues to be a challenge faced in each new EVD outbreak declared. In addition, the COVID-19 pandemic has further eroded trust in vaccination among community members. In the 2022, EVD outbreak in Equateur, Ebola vaccination teams faced increased community resistance that resulted in reduced demand and acceptance. As new candidate vaccines (SUDV) are introduced to communities and may eventually become part of the response to SUDV outbreaks, continued investigation and understanding on the attitudes and perceptions of all Ebola vaccines are critical to develop appropriate messaging in a successful vaccine program.

CDC requests the following:

Conduct regular assessments targeted at documenting the social and behavioral determinants of Ebola vaccination, including reasons for both vaccine refusal and vaccine acceptance in healthcare workers and other community members and how they may change over time.

We are interested in projects that conduct regular surveys to monitor knowledge, attitudes, and beliefs about Ebola vaccine and how they change over time among populations and health care workers in regions with or at risk of Ebola outbreaks. The data collected through these surveys can provide information on relevant cultural concerns and rumors. These surveys can serve both to inform community and healthcare worker messaging as part of outbreak response, but also may monitor assess if community engagement strategies have improved vaccine demand and acceptance. Conducting these surveys at more regular intervals (every 6 months or annually) can allow us to monitor changes over time and provide insight on community responses over several geographic areas. Ultimately, we will have additional information to identify and address concerns early on to ensure Ebola vaccination demand and acceptance is high.

1.3 Evaluation of Innovative Vaccination Strategies: Vaccination of Ebola Survivors and their contacts Ebola outbreaks are becoming larger and more frequent. Flare-ups of outbreaks and new outbreaks in the same location have occurred several times over recent years. Whereas animal spillover events have been implicated in past outbreaks, flare-ups due to disease relapse within survivors or persistently infected survivors exposing new individuals through contact with bodily fluids are expected and are now well documented. Transmission events linked to EVD survivors have occurred in Liberia in 2015, Sierra Leone in 2015, Guinea in 2016 and 2021, and the DRC in 2019, 2020 and 2021. Ebola virus can persist in immune-privileged sites in survivors and viral shedding and relapse has been documented five years post recovery. Surveillance strategies post-outbreaks need to take this risk of transmission into account for up to several years following a declared outbreak. Epidemiologic investigation of these newly arising cases supports the concern that viral persistence in EVD survivors has the potential to generate transmission, mostly to EVD survivors’ close contacts. Therefore, there is a need for a vaccination program that will be incorporated into survivor clinics that offers vaccination to survivors and close contacts of survivors.

• 1.3.1 Assess the feasibility and acceptability of incorporating vaccination into survivor clinics and among survivors and survivor contacts

This novel strategy would target Ebola survivors’ and their contacts, making vaccination available to these high-risk individuals outside of EVD outbreaks. Currently SAGE recommendations on the use of Ebola vaccines are limited to an EVD outbreak, however, there is now substantial data to show that Ebola survivorship is associated with viral persistence and survivors can still transmit the virus to others causing infection up to years past the date of recover. This vaccination strategy targets individuals surrounding EVD survivors with the goal of preventing or limiting future EVD outbreaks by immunizing the close contacts of survivors. This includes those who would be at risk of infection in the case of a viral relapse or transmission through persistently infected bodily fluids by a survivor and assumes that survivor contacts are not static and can change over time.

The assessment will determine the feasibility and acceptability of incorporating this strategy into survivor clinics and would also assess survivor and survivor contact acceptability. This is important to determining the frequency of vaccination and how best to offer it to this population in the context of high stigma around Ebola survivors.

• 1.3.2 Assess the immunogenicity and safety of vaccinating survivors

Currently, survivors are not offered vaccination. More research is needed to determine if the vaccine is safe and induces an immune response in survivors. Given, that we are proposing an innovative vaccination strategy that targets survivors and their close contacts, additional safety monitoring and serologic data can be collected to determine if these strategies should be incorporated into survivor programs earlier after recovery.

The vaccine introduction team would work closely in the ministries of health and the implementing partner in countries where there are active survivor programs (DRC, Guinea) to provide technical assistance for the implementation as needed.

Topic 2. Investigations into the spread of malaria vector, An. stephensi, in non-endemic areas and developing and evaluating vector control approaches to prevent further impacts on global malaria

(CGH).

An invasive malaria vector, Anopheles stephensi, endemic to south Asia, has been detected in Africa and significant increases in malaria have been associated with its establishment.