FY19_BAA_Webinar_slides_combined_11.30.2018.ppt

Centers for Disease Control and Prevention

Webinar for Center for Disease Control and Prevention Fiscal Year 19 Broad Agency Announcement (BAA)

RFP #75D301-18-R-67835

November 30, 2018 Presented by: Office of Acquisition Services Branch 3

CDC’s 2019 Broad Agency Announcement :

National Center for Chronic Disease Prevention and Health Promotion Areas of Interest

1.1: Development and evaluation of innovative methods, tools, and strategies to increase recruitment and enrollment of underserved persons into the National DPP Lifestyle Change Program.

1.2: Development and evaluation of innovative methods, tools, and strategies to increase retention of underserved persons in the National DPP Lifestyle Change Program.

1.3: Development and evaluation of innovative methods, tools, and strategies to increase employer adoption of the National DPP as part of their worksite wellness programs (preferably as a covered health benefit).

1.4: Development and evaluation of innovative methods, tools, and strategies to help participants adopt and maintain healthier habits in the context of the National DPP to increase retention and effectiveness.

Topic # 1: Increasing Engagement of Underserved Persons Living With Prediabetes and at high risk for developing type 2 diabetes in the National Diabetes Prevention Program (DPP) Lifestyle Change Program

Topic # 2: Increase engagement and participation of persons living with diabetes in Diabetes Self-Management, Education and Support (DSMES) Services 2.1: Development and evaluation of innovative methods, tools, and strategies to increase engagement and participation in DSMES by people with diabetes.

2.2: Development and evaluation of innovative methods, tools, and strategies to increase referrals to DSMES programs from health care providers.

2.3: Development and evaluation of innovative methods, tools, and strategies to help participants adopt and maintain healthier habits in the context of DSMES to increase retention and effectiveness.

FAQs Can proposals focus on increasing the supply of National DPP Lifestyle Change Programs or DSMES services?

Yes! While the topics and subtopics focus more on the consumer side of the effort, we are also interested in innovative strategies to expand availability of effective and sustainable programs.

Do proposals have to include partner National DPP Lifestyle Change Programs or DSMES programs?

No. While it would certainly be a valuable asset and partnership, CDC can also help to find programs for testing and evaluation.

National Center for Immunization and Respiratory Diseases Areas of Interest

Topic Area #3:Address Critical Gaps in Knowledge of the Total Preventive Benefit of Currently Available Influenza Vaccines 3.1: Investigations of Influenza Vaccine Effectiveness in Preventing Influenza-Associated Intensive Care Admissions

Topic Area #4: Compare the Immunogenicity of Alternative Influenza Vaccines and Vaccine Strategies 4.1: Improve Laboratory Methods to Compare Immune Response to Seasonal Influenza Vaccines

Topic Area #5: Use Modeling and Forecasting Tools to Improve the U.S. Response to Seasonal and Pandemic Influenza 5.1: Develop a Network of Modeling Centers to Inform the Public Health Response during Seasonal and Pandemic Influenza.

5.2: Improve the uptake of medical countermeasures during a pandemic or other public health emergency with mobile based approaches to support monitoring of exposed individuals, provide vaccine reminders, and improve medication adherence.

Topic Area #6: Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses.

6.1: Map/define the epitopes (antigenic sites) targeted by human antibodies upon infection by contemporary A(H1N1pdm09) viruses (e.g., A/MI/45/2015 cell culture isolate) and develop a sustainable strategy to identify and characterize antigenic drift.

6.2: Exploit new techniques to establish virus neutralization assays to directly antigenically characterize influenza viruses present in human specimens (i.e., avoid need for virus culture).

6.3: Develop bioinformatics/artificial intelligence techniques that accurately forecast viral fitness to identify HA and NA clades that will predominate in humans 1 year in advance.

Topic Area #6: Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses.

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

Area of interest #7: Develop approaches to assess the level of pre-existing immunity to influenza viruses.

7.1: Develop approaches to assess the level of existing immunity to influenza viruses (population immunity), including the existing immunity to both vaccine viruses and emerging new drift variants, to improve the understanding of how immune pressure in human populations could drive the evolution of influenza viruses.

Topic Area #8: Approaches to prevention and control of bacterial vaccine-preventable diseases 8.1: Maternal Tdap and risk of pertussis in U.S. children.

8.2: Burden of undiagnosed clinical pertussis in U.S. patients seeking medical care.

8.3: Evaluate infection by genetically diverse Bordetella pertussis clinical isolates under current and potential new pertussis vaccination strategies. (Laboratory characterization of divergent, circulating respiratory bacterial pathogens and vaccination strategies.)

8.4: Development of a meningitis point-of-care next generation rapid diagnostic test (International Transmission, Colonization, and Prevention of AR Pathogens).

Topic Area #8: Approaches to prevention and control of bacterial vaccine-preventable diseases 8.5: Natural history and immune response to maternal and primary acellular pertussis vaccination in U.S. children aged 0-4 years 8.6: Perform molecular characterization of invasive isolates of H. influenzae, comparing to carriage isolates from both household contacts of patients with invasive disease and possibly a control population.

8.7: Assess prevalence of complement system mutations/defects among meningococcal disease cases.

8.8: Evaluate H. influenzae vaginal carriage among pregnant females.

Topic Area # 9: Building the evidence base for maternal group B streptococcal vaccine decision making.

9.1: Develop and apply methods for ascertaining the proportion of stillbirths associated with GBS in the US.

9.2: Develop an innovative study design to collect serum and GBS isolates from U.S. mothers and infants to shed light on maternal and newborn GBS seroepidemiology.

Topic Area #10: Developing information needed to advance Legionnaires’ disease prevention 10.1: Determine if Legionella bacteria is commonly found in smaller, simpler, household water systems, and in particular how often it is found in the homes of laboratory-confirmed cases of Legionnaires’ disease.

10.2: Design and develop a rapid viability assay for Legionella bacteria present in environmental water samples.

10.3: Provide knowledge on possible genetic or other factors associated with increased survival of Legionella bacteria to heat, disinfectants, biocides, and other common remediation tools.

10.4: Assess geographic differences in testing for Legionnaires’ disease as well as changes in testing practices over time.

Topic Area #10: Developing information needed to advance Legionnaires’ disease prevention 10.5: Learning more about the diversity of non-Lp1 disease strains in the U.S.

Topic Area #11: Surveillance for non-invasive pneumococcal pneumonia.

11.1: Establish active pneumococcal urine antigen testing in adults 18 years of age or older with chest x-ray confirmed pneumonia in a defined catchment area.

Topic Area #12: Natural immunity to mitis-group streptococci and homologies with pneumococcal immunity.

12.1: Support evaluations of natural immunity to encapsulated Mitis-group streptococci strains, especially serotype 1, by using human challenge models.

NCEZID Areas of Interest Michael Craig, MPP Senior Advisor for Antibiotic Resistance Antibiotic Resistance Coordination and Strategy Unit Division for Healthcare Quality and Promotion National Center for Emerging and Zoonotic Infectious Diseases

Topic Area #13: New Diagnostic, Sequencing, and Metagenomic Tools for AR Detection, Microbiome Analysis, and Improved Antibiotic Use 13.1: Development and evaluation of new diagnostic tools to detect antibiotic resistance and antibiotic resistance markers in Neisseria Gonorrhoeae 13.2: Development and evaluation of molecular diagnostic tools for detection of a sexually transmitted disease panel (HSV-1, HSV-2, T. pallidum, and LGV C. trachomatis) associated with genital and/or anorectal lesions.

13.3: Characterizing plasmid diversity and distribution among Salmonella enterica 13.4: Validation of previously established human microbiome model for early phase testing in drug development

Topic Area #13: New Diagnostic, Sequencing, and Metagenomic Tools for AR Detection, Microbiome Analysis, and Improved Antibiotic Use 13.5: Rate of clearance of B. pertussis following different treatment regimens of azithromycin 13.6: Across geographically distinct neonatal intensive care units, investigate intra-setting baseline genomic “diversity index” of Staphylococcus aureus for use in identifying transmission-type events 13.7: Microbiome indices/leveraging the microbiome to improve patient management and control of antibiotic resistance in cystic fibrosis patients

Topic #14: International Transmission, Colonization, and Prevention of AR Pathogens 14.1: Develop a methodology to adjust bloodstream incidence rates accounting for actual clinical blood culture practices in facilities in low or middle income countries 14.2: Develop an infection control assessment and monitoring tool aimed at neonatal settings in resource limited settings 14.3: Develop and pilot a user-centered application for retail pharmacists in low or middle income countries that provides user services (e.g., clinical decision support, stock, or other), and provides data to ministries of health on antibiotic use

Topic #15: Domestic Transmission, Colonization, and Prevention of AR Pathogens and 15.1: Control of Candida auris Transmission in Healthcare Settings 15.2: Identify and characterize routes of entry and factors that lead to persistence of antimicrobial resistant Salmonella in the food chain 15.3: Investigate unintended consequences of decolonization agents on the ecology of individual microbial species and broader microbiome, both within the patient care environment and on patient’s skin 15.4: Assessing the burden, mortality and preventability of non-ventilator-associated hospital-acquired pneumonia (NV-HAP) 15.5: Source control as a means to prevent Staphylococcus aureus infections in hemodialysis

15.6: Improving bathing practices for patients with long-term hemodialysis catheters 15.7: Evaluating the targeted use of gown and gloves to prevent transmission of pathogens, including antibiotic resistant organisms, within ventilator units in nursing homes 15.8: Sampling inpatient and outpatient areas beyond hospital patient rooms to inform the distribution of microbial bioburden and risk of healthcare-associated infection transmission to patients

15.9: Assessing effect of PCV13 use on incidence of antibiotic-resistant pathogens causing otitis media in children using routine tympanocentesis in outpatient primary care pediatrics 15.10: GAS burden, trends and pharyngitis-associated strain types in the US 15.11: Supporting collaborative research between health departments and academic medical centers

Topic #16: Antibiotic resistant pathogens and genes in water systems and the environment and their contribution to human infections 16.1: Impact of extreme flooding events on environmental antibiotic resistance 16.2: Detection of azole-resistant Aspergillus fumigatus in the United States 16.3: Assessing human exposure to antibiotic resistant pathogens in environmental waters 16.4: Assessing the effectiveness of interventions to reduce concentrations of antibiotic resistant bacteria in hospital effluent

Topic #17: Evaluating and Improving Antibiotic Use 17.1: Development and dissemination of training resources to support improvements in newborn antibiotic use 17.2: Assess effects of prenatal/intrapartum/neonatal antibiotic exposures on subsequent risk of infection/sepsis in children

Parasitic Diseases Area of Interest:

Approaches to Prevention and Control of Soil Transmitted Helminth Infections in the United States

Anne Straily, DVM, MPH, DACVPM Epidemiologist Parasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Center for Global Health

Topic #18.1: Determination of prevalence of STH infections in the United States Improvements in sanitation and hygiene in U.S. thought to have decreased or eliminated STH infections Currently no surveillance exists for STH infections; concern within communities in formerly endemic areas of the southern U.S. that it remains a problem Recent data suggests the possibility that STH infections may persist in areas of low socioeconomic status and inadequate sanitation CDC seeks to support implementation of projects to investigate prevalence and persistence in formerly endemic areas and to identify risk factors for infection

Topic #18.2: Evaluation of approaches to prevent and manage STH infections in the U.S.

Some known risk factors for STH include appropriate environmental conditions and inadequate sanitation Control programs for managing and treating STH infections are established in developing countries, but have not been implemented in the U.S. for many years Approaches to control programs may include behavioral change, clinical interventions, environmental or other interventions CDC seeks to support development and implementation of effective and cost-effective approaches to managing STH infections in at-risk U.S. communities

The BAA Process & Timeline Issuance of the BAA Submission of Informal White Paper Submission of Formal Research Proposal Contract Award for Selected Projects

Issuance of the BAA Technical Dialogue Begins Technical Point of Contact for topic/subtopics General Contractual Questions (2019BAA@cdc.gov)

Informal White Paper Submission Purpose Pages Evaluation Criteria Format & Content Technical Merit Program Applicability Timeframe Feasibility After White Paper Submission - Technical Dialogue Stops

Formal Proposal Submission RFP Letter (if Favorable) Technical Dialogue Begins Again Evaluation Criteria Proposed Research Potential Contributions Offeror’s Qualifications Personnel Cost Realism Administrative Proposal Proposal Comparisons After Submission of Proposal - Technical Dialogue Stops

Contract Type Firm-Fixed Price Cost Reimbursement Approved Accounting & Purchasing System

Proposal Instructions Technical Content - Section I Sections a – i Statement of Work (SOW) Administrative Content - Section II Identify contract type Organizational Conflicts of Interest Representations and Certs Completion of Required Attachments Subcontracting Plan (Large Businesses Only over $700K) Cost Content - Section III Direct Labor Materials Other Direct Cost Fee/Profit

Commonly Applicable Clearances Human Subjects Paperwork Reduction Information Technology & Security

Forms & Attachments Research Cover Page Disclosure Requirement & Evaluation Policy Understanding Representations & Certifications Contractor Performance Assessment Reporting System (CPARS) & Contractor Evaluation Past/Performance Questionnaires Clauses Clearances Payment enrollment form Cost proposal sample format

QUESTIONS