75D301-21-R-71738 - FY 2021 Broad Agency Announcement Solicitation.pdf

BAA 75D301-21-R-71738

CENTERS FOR DISEASE CONTROL AND

PREVENTION (CDC)

BROAD AGENCY ANNOUNCEMENT (BAA)

75D301-21-R-71738

ISSUANCE DATE: December 16, 2020

CLOSING DATE: January 13, 2021

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: Innovative methods for maternal and infant health surveillance………………………………..……8

Topic 2: Leveraging Technology and Systems to increase enrollment of underserved persons living with diabetes, prediabetes or at high risk for developing type 2 diabetes………………………………………………………10

Topic 3: Strengthening emerging, re-emerging, and biothreat infectious disease surveillance, detection and preparedness through the Laboratory Response Network (LRN)……

Topic 4: International Transmission, Colonization, and Prevention of Antibiotic Resistant Pathogens….…11

Topic 5: Comparing the effectiveness of different vaccine types against laboratory-confirmed influenza outcomes……

Topic 6: Monitoring Trends in Healthcare Utilization and Detection of Influenza and Other Respiratory

Infections ………………………………………………………………………………………………………

Topic 7: Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses………………………………………………………………………………………

Topic 8: Genomic sequencing of SARS-CoV-2 to investigate viral evolution, and emergence and spread of infections in communities and populations.…………………………………………………………………..…16

Topic 9: COVID-19 and Evaluating Effectiveness of Respiratory Virus Vaccines…………………………..16

Topic 10: COVID-19 and Acute otitis media (AOM)…………………………………………………………..19

Topic 11: COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C)……………………..20

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………………………………………………………………………………………………..25

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 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.

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 SME Point of Contact

(POC)

SME POC e-mail address

Topic #1: Innovative methods for maternal and infant health surveillance

1.1: Development, piloting, and evaluation of innovative methods, tools, and strategies for maternal and infant health surveillance capable of producing jurisdiction population-based estimates rapidly (<3 months) in up to 2 jurisdictions.

Shanna Cox

CIO8@cdc.gov

1.2: Development, piloting, and evaluation of innovative methods, tools, and strategies to collect longitudinal data for women of reproductive age across the lifespan (e.g., adolescents, pregnancy, postpartum period) in up to 2 jurisdictions.

1.3: Development and evaluation of innovative methods, tools, and strategies to increase representation of surveillance system respondents to sampled population of interest (e.g., women with livebirths or still births).

mailto:CIO8@cdc.gov

1.4 Development, piloting and evaluation of innovative tools, methods and strategies to create multi-level data sets linking individual (e.g. birth certificate, PRAMS, early intervention data, hospital discharge data) and socio-contextual data (e.g., provider and health system characteristics, community-level indicators of social determinants of health, geo-spatial data)

Topic #2: Leveraging Technology and Systems to increase enrollment of underserved persons living with diabetes, prediabetes or at high risk for developing type 2 diabetes

2.1: Leveraging Technology and Systems to Increase Enrollment of

Underserved Persons Living With Prediabetes or at high risk for developing type 2 diabetes in National Diabetes Prevention Program

(National DPP) Lifestyle Change Programs.

Bryce Smith Bsmith6@cdc.gov

2.2:Leveraging Technology and Systems to Increase Enrollment of

Underserved Persons Living With Diabetes in Diabetes Self-Management

Education and Support (DSMES) services.

Bryce Smith Bsmith6@cdc.gov

Topic #3: Strengthening emerging, re-emerging, and biothreat infectious disease surveillance, detection and preparedness through the Laboratory Response Network (LRN)

3.1: Validation and deployment of existing innovative technologies for immediate implementation within the Laboratory Response Network community to detect and characterize existing and novel pathogens that are associated with a biothreat event or could cause a novel EID outbreak and/or public health emergency. Solutions should include a framework for data reporting and analytics necessary for determination of public health action.

Julie Villanueva Jfv3@cdc.gov

3.2: Develop and evaluate rapid, flexible, and scalable novel technologies for implementation into the Laboratory Response Network to improve the network capability to detect, report, and analyze results for existing and novel pathogens that are associated with a biothreat event or could cause a novel EID outbreak and/or public health emergency. Solutions should include a framework for data reporting and analytics necessary for determination of public health action.

Julie Villanueva Jfv3@cdc.gov

Topic #4: International Transmission, Colonization, and Prevention of Antibiotic Resistant Pathogens

4.1: Improved plasmid classification to understand antibiotic resistance epidemiology and ecology

Jason Folster

Kaitlin Tagg bhx1@cdc.gov nnp2@cdc.gov

4.2: Building whole genome sequencing capacity in PulseNet Asia Pacific and Middle East regions to improve detection and surveillance of emerging multi-drug resistant enteric bacteria

Jason Folster bhx1@cdc.gov

4.3: Estimating the prevalence of antifungal-resistant Aspergillus fumigatus in low- and middle-income countries

Shawn Lockhart gyi2@cdc.gov

4.4: Evaluate the Relatedness of Colonizing Multidrug Resistant

Organism Isolates Rachel Smith vih9@cdc.gov

4.5: Evaluation of Metrics of Admission Among Patients Colonized with

Carbapenem-resistant Enterobacteriaceae (CRE) Rachel Smith vih9@cdc.gov

4.6: Assessing Antimicrobial Stewardship Practices Internationally Fernanda Lessa dta3@cdc.gov

4.7: Review of Infection Prevention and Control (IPC) Guidelines, Policies, and Practices Implemented in Healthcare Facilities

Elizabeth Bancroft emb6@cdc.gov

4.8: Development of Operational Guidance for Hospital IPC Committees Elizabeth Bancroft emb6@cdc.gov

4.9: Development of a curated international antibiotic resistant gonorrhea specimen bank

Brian Raphael elx9@cdc.gov

Topic #5: Comparing the effectiveness of different vaccine types against laboratory-confirmed influenza outcomes

5.1: Compare laboratory-confirmed influenza among older adults

(65+years of age).

Lenee Blanton acy9@cdc.gov

5.2: Compare laboratory-confirmed influenza among adults (18-64 years of age).

Lenee Blanton acy9@cdc.gov

Topic #6: Monitoring Trends in Healthcare Utilization and Detection of Influenza and Other Respiratory Infections mailto:CIO8@cdc.gov mailto:Bsmith6@cdc.gov mailto:Bsmith6@cdc.gov mailto:Jfv3@cdc.gov mailto:Jfv3@cdc.gov mailto:bhx1@cdc.gov mailto:nnp2@cdc.gov mailto:bhx1@cdc.gov mailto:gyi2@cdc.gov mailto:vih9@cdc.gov mailto:vih9@cdc.gov mailto:dta3@cdc.gov mailto:emb6@cdc.gov mailto:emb6@cdc.gov mailto:elx9@cdc.gov mailto:acy9@cdc.gov mailto:acy9@cdc.gov

6.1: Develop innovative strategies to use electronic data to monitor trends in healthcare utilization and laboratory testing for influenza and other respiratory infections.

Carrie Reed ggj2@cdc.gov

Topic #7: Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses

7.1: Map/define epitopes targeted by human antibodies and develop strategy to rapidly identify and characterize antigenic drift.

John Steel

Rebecca Kondor pdx1@cdc.gov dqy5@cdc.gov

7.2: Exploit new techniques to establish virus neutralization assays to directly antigenically characterize influenza viruses present in human specimens.

John Steel

John Barnes pdx1@cdc.gov fzq9@cdc.gov

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

Rebecca Kondor dgy5@cdc.gov

7.4: 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 #8: Genomic sequencing of SARS-CoV-2 to investigate viral evolution, and emergence and spread of infections in communities and populations.

8.1: Incorporate viral genomic data with host genomic, immunogenetic, serologic, demographic and other relevant data to better understand patient risk factors and clinical outcomes, especially suspected cases of SARS-

CoV-2 reinfection or severe clinical outcomes such as multisystem inflammatory syndrome.

Duncan MacCannell fms2@cdc.gov

8.2: 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.

Duncan MacCannell fms2@cdc.gov

8.3: Develop or enhance open source bioinformatic software, databases, and visualization tools that improve the availability, utility and impact of

SARS-CoV-2 sequence data in the public domain, and facilitate the use of molecular epidemiology for state and local response activities.

Duncan MacCannell fms2@cdc.gov

Topic #9: COVID-19 and Evaluating Effectiveness of Respiratory Virus Vaccines

9.1: Prospective observational cohort study to assess the effectiveness of

SARS-CoV-2 vaccines against infection and infectiousness with SARS-

CoV-2.

Sharon Saydah zle0@cdc.gov

9.2: Develop innovative methods, tools and strategies to evaluate effectiveness of influenza and COVID-19 vaccines in preventing laboratory-confirmed illness.

Brendan Flannery bif4@cdc.gov

9.3:Development and evaluation of innovative methods to estimate the secondary attack rate of respiratory virus-associated illness within a household.

Melissa Rolfes ydi8@cdc.gov

Topic #10: COVID-19 and Acute otitis media (AOM)

10.1: Prevalence of nasopharyngeal carriage of common otopathogens and etiology of Acute otitis media (AOM) before and during the COVID-19 pandemic

K. Flemming-Dutra ftu2@cdc.gov

Topic #11: COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C)

11.1: Evaluation of Risk Factors for development of MIS-C among those infected with SARS-CoV-2.

Angela Campbell app4@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 mailto:ggj2@cdc.gov mailto:pdx1@cdc.gov mailto:dqy5@cdc.gov mailto:pdx1@cdc.gov mailto:fzq9@cdc.gov mailto:dgy5@cdc.gov mailto:nmb7@cdc.gov mailto:fms2@cdc.gov mailto:fms2@cdc.gov mailto:fms2@cdc.gov mailto:zle0@cdc.gov mailto:bif4@cdc.gov mailto:ydi8@cdc.gov mailto:ftu2@cdc.gov mailto:app4@cdc.gov 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!

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.

mailto: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. Tray Burch #1, #6 vwa8@cdc.gov

Ms. Latoya Hill #2 mdx7@cdc.gov

Ms. Jasmine Powell #3 qes1@cdc.gov

Mr. Ronnie Williams #4, #7 oga3@cdc.gov

Mr. Tim Williams #5 tpw8@cdc.gov

Steve Lester #8, #9 svl3@cdc.gov

Pellumbeshe Hoxhaj #10, #11 kfx2@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:

Topic #1: Innovative methods for maternal and infant health surveillance

Maternal and infant health surveillance can be used to monitor the prevalence of maternal behaviors and experiences and assesses progress of health status over time (e.g., Healthy People 2030 targets); investigate emerging issues in the field of reproductive health (e.g. opioid use, effects of COVID-19 ); and assess impacts of programs and policies aimed at reducing health problems among mothers and babies.

Jurisdiction-based systems of maternal and infant health surveillance, such as the Pregnancy Risk Assessment

Monitoring System (PRAMS), use self-reported survey data collected by mixed-mode methods (i.e., mailing, telephone calls). PRAMS is an ongoing multi-jurisdictional maternal and infant surveillance system with current participation by forty-seven states, New York City, Puerto Rico, and the District of Columbia, representing approximately 83% of all U.S. live births. Data collection procedures and instruments are standardized to allow comparisons between states and over time. Respondents are selected through a stratified systematic sample pulled monthly from the vital records (birth certificate or fetal death files) in each participating jurisdiction.

PRAMS sampling strategies have been adapted for emergency response activities; for example, for rapid data collection to inform the response to the Zika outbreak in Puerto Rico, a hospital-based sampling strategy was used. Point in time surveys for one year of data collection have been fielded in collaboration with Tribal organizations to collect robust data on Native populations.

To improve accuracy of estimates, representation from source populations is crucial to address nonresponse bias as respondents may vary from respondents in a way that cannot be controlled for with statistical methods.

mailto:vwa8@cdc.gov mailto:mdx7@cdc.gov mailto:qes1@cdc.gov mailto:oga3@cdc.gov mailto:tpw8@cdc.gov mailto:svl3@cdc.gov mailto:kfx2@cdc.gov

Development and evaluation of strategies to increase representation of respondents to source population of interest are needed. Researchers may request access to PRAMS data to answer research and programmatic questions of interest to the field of maternal and child health using analytical techniques, such as econometric or epidemiological modeling. However, multi-state research data files available by request from CDC, and included in publications released by CDC for states, must meet a response rate threshold, which has been set at

≥ 55% beginning in 2015. While this threshold incentivizes states to maintain one indicator of representativeness of this data, some populations are still less likely to respond such as mothers who are younger, Black, or of lower educational or socio-economic status. It is unclear whether the addition of a web-based option for response or innovative incentives for survey completion can address differential participation by demographic groups. Information Technology solutions which support modes of data collection without multiple steps of data entry can improve efficiency and reduce burden on grantees. Other federal surveys such as the National Survey of Family Growth (NSFG), perform intensive follow up with a sub-sample of initial non-responders to validate assumptions for statistical weighting.

Internet Panel Surveys are also often used for rapid collection and dissemination of maternal and infant health indicators. For example, the Vanderbilt Child Health COVID-19 Poll conducted from June 5 to June 10, 2020 used the Ipsos Knowledge Panel, a large online research panel created using probability-based address sampling of US households to collect and rapidly disseminate data (October 2020) on how pandemic and mitigation efforts affected the physical and emotional well-being of parents and children in the United States. Internet panel surveys are routinely used to collect and disseminate rapid data on maternal immunization practices.

Limitations to generalizability include characteristics of who opts into these panels, with lower representation from hard to reach populations. Lack of jurisdiction-based data and linkage to other sources of information like the birth certificate data impact the utility of these approaches.

Collection of multi-level indicators may further contribute to the robustness of maternal and infant health surveillance. Data on patient-centered outcomes such as respectful care and social context (e.g., participation in home visiting or WIC programs) and system level indicators (e.g., facility characteristics such as Baby Friendly

Hospital designation, Perinatal Quality Collaborative participation, and care received in facilities with appropriate levels of maternal and infant care) may allow for multilevel research. Linkages of existing data systems (e.g. Medicaid claims data, birth certificate, PRAMS, early intervention data, hospital discharge data, and community level social determinants of health, such as poverty rates and neighborhood violence) can enhance the ability to answer key questions for multiple stakeholders. Methods for small area estimates for geographic areas smaller than states (e.g., 500 cities, Census Tract) further allow for aligning of contextual community data jurisdictions.

Maternal and infant outcomes are not only influenced by experiences around the time period of pregnancy.

Longitudinal cohorts are uniquely poised to answer research question on influences across the lifespan on maternal and infant health. Key reproductive health indicators of interest include preventative care, such as quality and postpartum contraceptive care, chronic condition diagnosis and care, infertility diagnosis and treatment, and pregnancy care utilization and outcomes. Web-based models of longitudinal data collection and follow up, such as the evaluation of the Zika Contraceptive Access Network, demonstrate the feasibility of long-term participant retention.

Addressing these key gaps in maternal and infant health surveillance will inform the Division of Reproductive

Health immediate surveillance strategies and improve the ability of data to inform programs and policies that address health inequities.

Innovative methods for maternal and infant health surveillance are needed to include:

1.1: Development, piloting, and evaluation of innovative methods, tools, and strategies for maternal and infant health surveillance capable of producing jurisdiction population-based estimates rapidly (<3 months) in up to 2 jurisdictions.

1.2: Development, piloting, and evaluation of innovative methods, tools, and strategies to collect longitudinal data for women of reproductive age across the lifespan (e.g., adolescents, pregnancy, postpartum period) in up to 2 jurisdictions.

1.3: Development and evaluation of innovative methods, tools, and strategies to increase representation of surveillance system respondents to source population of interest (e.g., women with livebirths or still births).

1.4: Development, piloting and evaluation of innovative tools, methods and strategies to create multi-level data sets linking individual (e.g., birth certificate, PRAMS, early intervention data, hospital discharge data) and socio-contextual data (e.g., provider and health system characteristics, community-level indicators of social determinants of health, geo-spatial data).

Topic #2: Leveraging Technology and Systems to increase enrollment of underserved persons living with diabetes, prediabetes or at high risk for developing type 2 diabetes

Approximately 88 million Americans have prediabetes, nearly 1 in 3 adults. Prediabetes is characterized by blood glucose levels that are higher than normal but not high enough to be diagnosed as type 2 diabetes. People with prediabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke.

The CDC-led National Diabetes Prevention Program (National DPP:

http://www.cdc.gov/diabetes/prevention/index.html) is a public/private partnership working to scale and sustain an evidence-based lifestyle change program (LCP) for people with prediabetes to prevent or delay onset of type

2 diabetes. The LCP is founded on the Diabetes Prevention Program research study and subsequent translation studies which showed that making achievable behavior changes helped participants lose 5% to 7% of their body weight and reduced the risk of developing type 2 diabetes by 58% (by 71% for people 60 years and older). The

CDC-recognized LCP consists of a minimum of 16 weekly, then a minimum of six monthly group sessions conducted over a year. A trained lifestyle coach facilitates the sessions to guide people in changing their lifestyle and losing weight.

Since the National DPP was launched in 2012, over 1,700 organizations have provided the lifestyle change program to almost 500,000 people at high risk for type 2 diabetes. But with 88 million people living with prediabetes, we need to reach millions of participants to stem the tide of type 2 diabetes.

Given the vast number of people living with prediabetes and the availability of an effective intervention, CDC is seeking the development and evaluation of innovative methods, tools, and strategies to leverage technology to increase enrollment into the National DPP Lifestyle Change Program and Diabetes Self-Management Education and Support (DSMES) services, particularly for underserved populations.

2.1: Leveraging Technology and Systems to Increase Enrollment of Underserved Persons Living With

Prediabetes or at high risk for developing type 2 diabetes in National Diabetes Prevention Program (National

DPP) Lifestyle Change Programs.

2.2: Leveraging Technology and Systems to Increase Enrollment of Underserved Persons Living With Diabetes in Diabetes Self-Management Education and Support (DSMES) services.

Topic #3: Strengthening emerging, re-emerging, and biothreat infectious disease surveillance, detection and preparedness through the Laboratory Response Network (LRN)

With more than 120 national, state, and local laboratories, the Laboratory Response Network (LRN) is an integral part of the National Response Framework. The LRN ensures consistent, high confidence results by developing and distributing laboratory assays, offering specialized training, and supporting secure data reporting. In the 20 years since its creation, the LRN has played an instrumental role in boosting laboratory capacity and building a domestic public health infrastructure for response.

In order to maintain response readiness, and to support day-to-day critical, time-sensitive EID testing needs, the

LRN is pursuing cutting edge technologies that can strengthen, expand or enhance the LRN’s existing capabilities and inform public health policies and decisions. Whether a single suspect case of a novel EID or a public health emergency, authorities need to know what pathogen is causing illness for a fast response. Rapid, accurate laboratory identification and characterization of pathogens from clinical specimens or environmental samples provides public health authorities the data necessary to deploy subject matter experts, provide appropriate medical countermeasures, facilitate rapid evaluation and tracing of potentially exposed contacts, and communicate potentially lifesaving information to the public as well as decision makers.

CDC is interested in the development and evaluation of innovative methods, tools, and strategies for deployment to the LRN for detection and characterization of existing and novel pathogens that are associated with a biothreat event or could cause a novel EID outbreak and/or public health emergency. The first area of interest is in existing innovative technologies for identification and/or characterization of rare and emerging infectious disease pathogens that can be fully validated, manufactured, and deployed to LRN laboratories within a one- to two-year timeframe. The second area of interest is the development of novel strategies for identification and/or characterization of rare and emerging infectious disease pathogens that may require a longer time period for development, validation, and deployment. All solutions should include plans for automatic and/or simplified data transfer of test results to public health officials.

3.1 Validation and deployment of existing innovative technologies for immediate implementation within the

Laboratory Response Network community to detect and characterize existing and novel pathogens that are associated with a biothreat event or could cause a novel EID outbreak and/or public health emergency. Solutions should include a framework for data reporting and analytics necessary for determination of public health action.

3.2 Develop and evaluate rapid, flexible, and scalable novel technologies for implementation into the Laboratory

Response Network to improve the network capability to detect, report, and analyze results for existing and novel pathogens that are associated with a biothreat event or could cause a novel EID outbreak and/or public health emergency. Solutions should include a framework for data reporting and analytics necessary for determination of public health action.

Topic #4: International Transmission, Colonization, and Prevention of Antibiotic Resistant Pathogens

4.1: Improved plasmid classification to understand antibiotic resistance epidemiology and ecology

NARMS-CDC is interested in continuing this collaboration by utilizing this newly validated tool to investigate the distribution and diversity of plasmids in international strains of concern .A sequence-based plasmid speciation tool generating discrete clusters of plasmid taxonomic units (PTUs) has recently been published and offers improved granularity for plasmid analysis (Redondo-Salvo et al. 2020. Pathways for horizontal gene transfer in bacteria revealed by a global map of their plasmids. Nat Commun, doi:10.1038/s41467-020-17278-

2). This tool forms the basis of an existing collaboration between University of Cantabria, Spain and CDC-

NARMS (2019 BAA), which is due to end December 2020. Examples include multidrug resistant (MDR)

Shigella sonnei and extensively-drug resistant (XDR) Salmonella Typhi, both responsible for widespread outbreaks domestically and internationally. Understanding plasmid dynamics in these pathogens can help define risk estimates for the emergence and persistence of MDR and XDR strains both regionally and globally.

4.2: Building whole genome sequencing capacity in PulseNet Asia Pacific to improve detection and surveillance of emerging multi-drug resistant enteric bacteria

CDC is interested in developing and improving capacity for WGS in the PulseNet Asia Pacific (PNAP) region and ensuring that data are comparable. This region consists of 14 countries that are actively engaged in transitioning their molecular subtyping techniques to whole genome sequencing (WGS). The main objectives for this project are to:

1. Develop an action plan in collaboration with PNAP members to implement and validate WGS as a subtyping method and tool to monitor emerging antibiotic resistance mechanisms

2. Build laboratory and analysis capacity by providing training and technical assistance for PNAP member countries

3. Launch a pilot project to demonstrate the value of using WGS to characterize emerging MDR enteric bacteria

4.3: Estimating the prevalence of antifungal-resistant Aspergillus fumigatus in low- and middle-income countries

The fungal pathogen Aspergillus fumigatus is the leading cause of invasive mold infections, which have high mortality rates. Although most patients who develop aspergillosis are immunocompromised, increasing evidence suggests that people with chronic lung disease and severe respiratory viral infections are also at risk of this deadly infection, which are typically acquired by breathing in fungal spores. The primary treatments for A.

fumigatus infections are azole antifungals, primarily voriconazole, which have substantially improved survival over the older amphotericin B, a drug known for its severe side effects. However, strains of A. fumigatus resistant to azole antifungals have emerged over the last decade that carry specific mutations (known as

TR34/L98H and TR46/Y121F/T289A). Many of these strains are resistant to all azole antifungals and have been associated with treatment failure and higher mortality. Several lines of evidence suggest that these resistance mechanisms are linked to use of azole fungicides, which are highly similar to medical azoles, in plant agriculture.

A. fumigatus strains carrying these resistance genotypes have been identified across the world, but much remains unknown about their prevalence in low- and middle-income countries. This topic requests projects that will provide better data on the prevalence of antifungal-resistant A. fumigatus in the environment and/or in patients in these settings. Examination of antifungal and fungicide use practices within the region is encouraged but not required.

Methods will include laboratory surveillance. Broth microdilution is optimal but agar plate screening and gradient diffusion (Etest) are acceptable.

Regions: Asia and Latin America. Brazil found their first case recently in Campinas.

4.4: Evaluate the Relatedness of Colonizing Multidrug Resistant Organism (MDRO) Isolates

Evaluate the relatedness of colonizing MDRO isolates (of particular interest CRE, ESBL, MRSA) collected from community dwellers and hospitalized patients in the same catchment area, via whole genome sequencing.

4.5: Evaluation of Metrics of Admission Among Patients Colonized with Carbapenem-resistant

Enterobacteriaceae (CRE)

In countries with substantial burden of CRE among hospitalized patients, evaluate how metrics of admission

CRE colonization prevalence and prevalence of CRE colonization among already admitted patients can be assessed and tracked to monitor infection prevention and control practices.

4.6: Assessing Antimicrobial Stewardship Practices Internationally

To assess current antimicrobial stewardship practices and needs in multiple institutions in various countries and regions globally to inform targeted interventions to reduce antimicrobial consumption, including:

o Develop survey/assessment tool based on guidance documents from CDC, WHO, and existing literature o Assess variation in antimicrobial stewardship practices within and across countries o Understand existing resources, training-level of personnel, daily activities/interventions around antibiotic use surveillance, and perceived needs o Determine perceived successes/failures of implementation of antimicrobial stewardship interventions

4.7: Review of Infection Prevention and Control (IPC) Guidelines, Policies, and Practices Implemented in

Healthcare Facilities

The extent to which IPC guidelines, policies, and practices have been implemented in healthcare facilities is largely unknown for most countries in Latin America. This information is critical to identify gaps, inform interventions, measure the impact of interventions, and develop evidence-based guidance. This proposed project involves a national survey of healthcare facilities in 2-3 countries in Latin America (preferably at least one country in Central America and one in South America) to assess implementation of IPC policies and practices and identify factors associated with guideline implementation.

4.8: Development of Operational Guidance for Hospital IPC Committees

Experiences in a number of East African countries have shown that Hospital IPC Committees, if they exist, are not functional or do not understand what their expected duties are. This project would result in the development of a manual or guidance for the establishment, implementation, and operations of a model IPC committee at a hospital in a LMIC. It would include composition, roles and responsibilities, expected level of authority, interactions with other groups, routine activities (including data collection and dissemination, IPC observations, interactions with microbiology, pharmacy, and clinicians), and additional activities based on need (e.g. inputs on facility renovations for patient flow, building materials, etc.).

4.9: Development of a curated international antibiotic resistant gonorrhea specimen bank

Development of an international specimen bank representing residual clinical specimens and Neisseria gonorrhoeae isolates to validate novel molecular methods and expand testing capacity for detection and characterization of antibiotic resistant gonorrhea cases.

Topic #5: Comparing the effectiveness of different vaccine types against laboratory-confirmed influenza outcomes

Comparing the effectiveness of different vaccine types against laboratory-confirmed influenza outcomes.

Vaccines are the primary tool to prevent influenza. CDC seeks to improve the overall preventive benefit of the

U.S.’s influenza vaccination program. First-generation standard-dose egg-based inactivated influenza vaccines

(sIIV) have been used for many decades. In the past decade, second-generation IIVs with distinctly different immune responses compared with sIIV have been licensed for use including higher antigen dose IIV (HD-IIV), adjuvanted IIV (aIIV), recombinant protein IIV (rIIV), and cell-culture derived IIV (ccIIV). The U.S. Advisory

Committee on Immunization Practices has recommended these vaccine products with varying age indications during the 2020-2021 influenza season. However no preferential recommendations exist.

Understanding whether some vaccines offer advantages over others is urgently needed among adults. Several phase III clinical efficacy trials have shown comparative advantages of some of the second-generation vaccines compared with sIIV. Among older adults, studies have compared incidence of laboratory-confirmed influenza-associated illness between those receiving HD-IIV or aIIV vs. sIIV; among younger adults, studies have evaluated rIIV vs sIIV. Also, immunogenicity studies have compared differences in antibody titers between different influenza vaccine types. Some of these studies have found higher performance of second-generation vaccines. However, post-licensure observational comparative evaluations have shown inconsistent findings possibly due to study design related confounding, outcome differences, variations in circulating viruses and vaccine viruses, repeated vaccination, or inadequate power.

In addition, no study has compared laboratory-confirmed outcomes between second-generation egg-based vs.

nonegg-based vaccines. Innovative post-licensure evaluations are needed to better understand potential differences and advantages of second-generation influenza vaccines.

5.1: Compare laboratory-confirmed influenza among older adults (65+). CDC seeks to expand the current knowledge base of benefits offered by different vaccine types through creative and innovative methods to compare laboratory-confirmed influenza among older adults randomized to receive different second-generation influenza vaccines over a two-year period. The objectives are to:

• Determine relative vaccine effectiveness against laboratory-confirmed influenza

• Determine impact of prior history of vaccination and type of vaccine

• Determine if sequential order of vaccination is impactful

• Enhance the understanding of cellular immunity after receipt of different vaccine types

5.2: Compare laboratory-confirmed influenza among adults (18-64 years of age). CDC seeks to expand the current knowledge base of benefits offered by different vaccine types through creative and innovative methods to Compare laboratory-confirmed influenza among adults (18-64 years of age) randomized to receive different second-generation influenza or standard dose egg-based inactivated influenza vaccines over a two-year period.

The period of interest to CDC is June 2021 to August 2025. The objectives are to:

• Determine relative vaccine effectiveness against laboratory-confirmed influenza

• Determine impact of prior vaccine history and history of prior vaccine type

• Enhance the understanding of cellular immunity after receipt of different vaccine types

Priority will be given to offerors who establish:

• A track record of successful implementation of similar evaluation activities with working-age and older adults;

• Capacity to enroll and maintain large cohorts that include diversity in sociodemographic characteristics while minimizing selection and participation biases;

• Experience designing and implementing surveillance systems to identify acute illness;

• Capacity to collect sera from participants and conduct all steps of specimen processing and management;

• Capacity to collect, process, and recover peripheral blood mononuclear cells;

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

• The overall likelihood that they can initiate and implement the study in a timely manner.

• Offeror’s should describe the influenza outcomes they propose will best distinguish the preventive value of alternative influenza vaccines.

Topic #6: Monitoring Trends in Healthcare Utilization and Detection of Influenza and Other Respiratory

Infections

Each year, CDC monitors the impact of seasonal influenza and other respiratory viruses in the U.S. population and uses mathematical and statistical models to estimate the broader disease burden from these infections in the population. Not all persons seek medical care for respiratory illnesses, and not all those who do are tested to confirm infection with a specific pathogen. There are a variety of viral and bacterial respiratory illnesses that are clinically compatible with each other, however, complicating diagnosis based on symptoms or clinical findings alone. Laboratory testing for specific pathogens may be more or less common in certain care settings, for different age groups, and at differing levels of disease severity. To account for the incomplete detection of influenza and other respiratory infections through clinical testing in healthcare settings, methods to model the disease burden incorporate age-specific information on healthcare utilization and laboratory testing for respiratory viruses. CDC seeks to explore innovative methods to monitor these factors throughout the year.

6.1: Development of innovative strategies to use electronic data to monitor trends in healthcare utilization and laboratory testing for influenza and other respiratory infections. CDC seeks to explore the use of electronic health information that can be followed on a weekly basis throughout the year to monitor illness rates, the use of health services, laboratory testing, and clinical diagnosis for influenza and other respiratory viruses. Toward this objective, CDC is interested in creative solutions to monitor the following:

• Healthcare visits for different clinical syndromes (e.g., acute respiratory illnesses, specific signs and symptoms, systemic complications or exacerbations of chronic conditions that could be influenced by a respiratory infection, etc.)

o The ability to stratify on patient characteristics such as age, sex, race and ethnicity.

o Characterization of the type of provider seen (e.g., telemedicine, outpatient medical clinic, urgent care provider, emergency department, inpatient hospitalizations with and without ICU admission, etc.)

o Preference for sources that can define an active user base to calculate rates of illness and healthcare visits in addition to counts

• The proportion of patient encounters with laboratory tests performed for influenza and other respiratory viruses and the results of those tests, stratified by patient characteristics such as age group, healthcare setting, clinical syndrome, etc.

• Patient encounters with a clinical diagnosis of influenza or other specific respiratory virus, with or without laboratory testing.

• Consideration will be made to ensuring geographic representativeness across contributing data sources.

Respondents should describe the geographic coverage of their system and the smallest geographic scale available for data reporting.

Topic #7: Advancing vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses

Under this Area of Interest, the Virology, Surveillance and Diagnosis Branch (VSDB) in the Influenza Division, NCIRD, CDC is seeking technologies that will advance vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses. Offerors for these VSDB areas of interest should have demonstrated expertise in the proposed techniques/approaches. Additionally the techniques/approaches should have a maturity level that illustrates objectives can be met within 1-2 years of the award. Successful offerors will provide evidence that the proposed plan is achievable, and the product represents a transformative and deployable improvement compared to techniques/approaches currently used for each of the topics below.

7.1: Map/define the epitopes targeted by human antibodies upon infection by contemporary A and B viruses and develop a sustainable strategy to rapidly identify and characterize antigenic drift. Typically, ferrets are immunized with influenza viruses and the antisera is used to antigenically characterize influenza viruses.

Reference viruses with specific amino acid substitutions are used to generate many different antisera that are used to characterize co-circulating antigenic variants. However, ferrets don’t always produce antisera that effectively differentiates contemporary viruses ); the VSDB wants to develop system(s) that use human antibodies generated by natural infection to characterize viruses circulating in our population on an annual basis.

For example, respondents may use new technologies to identify/generate human monoclonal antibodies (Mab), which target multiple epitopes on the hemagglutinin. Projects need to be scaled for a 12-24 month period of performance.

7.2: Exploit new techniques to establish virus neutralization assays to directly antigenically characterize influenza viruses present in human specimens.