Final_RFP_11-26-18.pdf

BAA 75D301-19-R-67835

CENTERS FOR DISEASE CONTROL AND

PREVENTION (CDC)

BROAD AGENCY ANNOUNCEMENT (BAA)

75D301-19-R-67835

ISSUANCE DATE: November 21, 2018

CLOSING DATE: December 17, 2018

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. 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

Topic 3. Address Critical Gaps in Knowledge of the Total Preventive Benefit of Influenza Vaccines

Topic 4. Compare the Immunogenicity of Alternative Influenza Vaccines and Vaccine Strategies

Topic 5. Use Modeling and Forecasting Tools to Improve the U.S. Response to Seasonal and Pandemic Influenza

Topic 6. Virology, Surveillance and Diagnosis Branch in the Influenza Division, NCIRD, CDC is seeking technologies that will improve vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses

Topic 7. Develop approaches to assess the level of pre-existing immunity to influenza viruses

Topic 8. Evaluate risk and diagnosis of Pertussis

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

Topic 10. Understanding the underlying causes of the continued increase in reported Legionnaires’ disease cases in the United States. .. 19

Topic 11. Understanding carriage of Influenza

Topic 12. Assess prevalence of complement system and Meningitis

Topic 13. New Diagnostic, Sequencing, and Metagenomic Tools for AR Detection, Microbiome Analysis, and Improved Antibiotic Use 21

Topic 14. International Transmission, Colonization, and Prevention of AR Pathogens

Topic 15. Domestic Transmission, Colonization, and Prevention of AR Pathogens and CDI

Topic 16. Antibiotic resistant pathogens and genes in water systems and the environment and their contribution to human infections

Topic 17. Evaluating and Improving Antibiotic Use

Topic 18. Approaches to Prevention and Control of Soil Transmitted Helminth Infections in the United States

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………………………………………………………………………………………………..35

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 the Associate Director for Science

(OADS) 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 FedBizOpps.

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, copy the

CDC BAA Technical Coordinator on all emails.

The following four-step sequence is established for offerors contemplating submission of 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 supported.

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.

Research Interests SME Technical POC

Email

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 (NCCDPHP)

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.

Bryce Smith Bsmith6@cdc.gov

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 # 2: Increase engagement and participation of persons living with diabetes in Diabetes Self-Management, Education and Support (DSMES) Services (NCCDPHP)

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.

Topic #3: Address Critical Gaps in Knowledge of the Total Preventive Benefit of Influenza Vaccines (NCIRD)

3.1: Investigations of Influenza Vaccine Effectiveness in

Preventing Influenza-Associated Intensive Care

FLU: Jill Ferdinands &

Mark Thompson fluvaccine@cdc.gov

Topic #4: Compare the Immunogenicity of Alternative Influenza Vaccines and Vaccine Strategies

4.1: Improve Laboratory Methods to Compare Immune

Response to Seasonal Influenza Vaccines

FLU: Min Levine &

Mark Thompson fluvaccine@cdc.gov

Topic #5: Use Modeling and Forecasting Tools to Improve the U.S. Response to Seasonal and Pandemic Influenza

(NCIRD)

5.1: Develop a Network of Modeling Centers to Inform the

Public Health Response During Seasonal and Pandemic

Influenza

FLU: Melissa Rolfes &

Mark Thompson fluvaccine@cdc.gov

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

ICU: Anita Patel apatel7@cdc.gov

Topic #6: Virology, Surveillance and Diagnosis Branch in the Influenza Division, NCIRD, CDC is seeking technologies that will improve vaccines through in-depth virus characterization and by identifying/selecting optimal candidate vaccine viruses. (NCIRD) mailto:flu_vaccine@cdc.gov mailto:flu_vaccine@cdc.gov mailto:flu_vaccine@cdc.gov mailto:apatel7@cdc.gov

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.

FLU: David Wentworth BAA.VSDB_4@cdc.gov

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).

FLU: David Wentworth BAA.VSDB_4@cdc.gov

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.

FLU: Rebecca Garten BAA.VSDB_4@cdc.gov

6.4 Create strategy to experimentally identify antigenically

advanced viruses likely to predominate in the human population in future influenza seasons.

FLU: Bin Zhou BAA.VSDB_4@cdc.gov

Topic #7: Develop approaches to assess the level of pre-existing immunity to influenza viruses. (NCIRD)

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.

FLU: Min Levine fluvaccine@cdc.gov

Topic #8: Approaches to prevention and control of bacterial vaccine-preventable diseases (NCIRD)

8.1 Maternal Tdap and risk of pertussis in U.S. children MVPDB: Fiona Havers, Susan Hariri, Tami

Skoff, Anna Acosta wja7@cdc.gov, bse4@cdc.gov, tlh9@cdc.gov, vhy8@cdc.gov

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

MVPDB: Susan Hariri, Catherine Bozio, Fiona

Havers, Amanda

Faulkner, Anna Acosta bse4@cdc.gov, wja7@cdc.gov, vhy8@cdc.gov, ise7@cdc.gov, iqq2@cdc.gov

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.)

MVPDB: Michael

Weigand yrh8@cdc.gov

8.4 Development of a meningitis point-of-care next

generation rapid diagnostic test (International Transmission, Colonization, and Prevention of AR Pathogens)

MVPDB: Xin Wang gqe8@cdc.gov

8.5 Natural history and immune response to maternal and

primary acellular pertussis vaccination in U.S. children aged

0-4 years

MVPDB: Susan Hariri, Fiona Havers, M. Lucia

Tondella, Jarad Schiffer bse4@cdc.gov, wja7@cdc.gov, mlt5@cdc.gov, aku3@cdc.gov

8.6 Perform molecular characterization of invasive isolates

of H. influenza, comparing to carriage isolates from both household contacts of patients with invasive disease and possibly a control population

MVPDB: Sara Oliver, Heidi Soeters, Caelin

Potts yxo4@cdc.gov, hzx8@cdc.gov, lyi3@cdc.gov

8.7 Assess prevalence of complement system

mutations/defects among meningococcal disease cases

MVPDB: Lucy

McNamara xdf4@cdc.gov

8.8 Evaluate H. influenza vaginal carriage among pregnant

females

MVPDB: Sara Oliver, Heidi Soeters yxo4@cdc.gov, hzx8@cdc.gov

Topic #9: Building the evidence base for maternal group B streptococcal vaccine decision making (NCIRD) mailto:BAA.VSDB_4@cdc.gov mailto:BAA.VSDB_4@cdc.gov mailto:BAA.VSDB_4@cdc.gov mailto:flu_vaccine@cdc.gov mailto:wja7@cdc.gov mailto:bse4@cdc.gov mailto:tlh9@cdc.gov mailto:bse4@cdc.gov mailto:wja7@cdc.gov mailto:vhy8@cdc.gov mailto:ise7@cdc.gov mailto:bse4@cdc.gov mailto:wja7@cdc.gov mailto:mlt5@cdc.gov mailto:aku3@cdc.gov mailto:yxo4@cdc.gov mailto:hzx8@cdc.gov mailto:yxo4@cdc.gov mailto:hzx8@cdc.gov

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

RDB: Stephanie Schrag zha6@cdc.gov

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.

RDB: Stephanie Schrag zha6@cdc.gov

Topic #10: Developing information needed to advance Legionnaires’ disease prevention (NCIRD)

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.

RDB: Brian Raphael, Chris Edens, Laura

Cooley elx9@cdc.gov, iek4@cdc.gov, whz3@cdc.gov

10.2: Design and develop a rapid viability assay for

Legionella bacteria present in environmental water samples.

RDB: Brian Raphael, Chris Edens, Laura

Cooley elx9@cdc.gov, iek4@cdc.gov, whz3@cdc.gov

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.

RDB: Brian Raphael, Chris Edens, Laura

Cooley elx9@cdc.gov, iek4@cdc.gov, whz3@cdc.gov

10.4: Assess geographic differences in testing for

Legionnaires’ disease as well as changes in testing practices over time.

RDB: Brian Raphael, Chris Edens, Laura

Cooley elx9@cdc.gov, iek4@cdc.gov, whz3@cdc.gov

10.5: Learning more about the diversity of non-Lp1 disease strains in the U.S.

RDB: Brian Raphael, Chris Edens, Laura

Cooley elx9@cdc.gov, iek4@cdc.gov, whz3@cdc.gov

Topic #11: Surveillance for non-invasive pneumococcal pneumonia (NCIRD)

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.

RDB: Tamara Pilishvili tdp4@cdc.gov

Topic #12: Natural immunity to mitis-group streptococci and homologies with pneumococcal immunity (NCIRD)

12.1 Support evaluations of natural immunity to

encapsulated Mitis-group streptococci strains, especially serotype 1, by using human challenge models.

RDB: Fernanda Lessa dta3@cdc.gov

Topic #13: New Diagnostic, Sequencing, and Metagenomic Tools for AR Detection, Microbiome Analysis, and

Improved Antibiotic Use (NCEZID)

13.1: Development and evaluation of new diagnostic tools to detect antibiotic resistance and antibiotic resistance markers in Neisseria Gonorrhoeae

Kim M Gernert nin1@cdc.gov

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.

Cheng Y Chen, Brunie White, Allan Pillay cyc1@cdc.gov, wri2@cdc.gov, ajp7@cdc.gov

13.3: Characterizing plasmid diversity and distribution among Salmonella enterica

Jason Folster

Cindy Friedman gux8@cdc.gov ccf6@cdc.gov

13.4: Validation of previously established human microbiome model for early phase testing in drug development

Alison Laufer Halpin

Cliff McDonald vif0@cdc.gov ljm3@cdc.gov

13.5: Rate of clearance of B. pertussis following different treatment regimens of azithromycin

Susan Hariri

Tami Skoff

Anna Acosta bse4@cdc.gov tlh9@cdc.gov vhy8@cdc.gov mailto:zha6@cdc.gov mailto:zha6@cdc.gov mailto:elx9@cdc.gov mailto:iek4@cdc.gov mailto:whz3@cdc.gov mailto:elx9@cdc.gov mailto:iek4@cdc.gov mailto:whz3@cdc.gov mailto:elx9@cdc.gov mailto:iek4@cdc.gov mailto:whz3@cdc.gov mailto:elx9@cdc.gov mailto:iek4@cdc.gov mailto:whz3@cdc.gov mailto:elx9@cdc.gov mailto:iek4@cdc.gov mailto:whz3@cdc.gov mailto:tdp4@cdc.gov mailto:dta3@cdc.gov mailto:nin1@cdc.gov mailto:cyc1@cdc.gov mailto:wri2@cdc.gov mailto:ajp7@cdc.gov mailto:gux8@cdc.gov mailto:ccf6@cdc.gov mailto:vif0@cdc.gov mailto:ljm3@cdc.gov

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

Alison Laufer Halpin

Chris Elkins vif0@cdc.gov nme0@cdc.gov

13.7: Microbiome indices/leveraging the microbiome to improve patient management and control of antibiotic resistance in cystic fibrosis patients

Alison Laufer Halpin

Cliff McDonald vif0@cdc.gov ljm3@cdc.gov

Topic #14: International Transmission, Colonization, and Prevention of AR Pathogens (NCEZID)

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

Ben Park bip5@cdc.gov

14.2: Develop an infection control assessment and monitoring tool aimed at neonatal settings in resource limited settings

Ben Park bip5@cdc.gov

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

Ben Park bip5@cdc.gov

Topic #15: Domestic Transmission, Colonization, and Prevention of AR Pathogens and CDI (NCEZID)

15.1: Control of Candida auris Transmission in Healthcare

Settings

Snigdha Valllabhaneni

Rory Welsh fco6@cdc.gov mpo6@cdc.gov

15.2: Identify and characterize routes of entry and factors that lead to persistence of antimicrobial resistant

Salmonella in the food chain

Cindy Friedman

Jean Whichard ccf6@cdc.gov zyr3@cdc.gov

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

John Jernigan jqj9@cdc.gov

15.4: Assessing the burden, mortality and preventability of non-ventilator-associated hospital-acquired pneumonia

(NV-HAP)

Shelley Magill fxe9@cdc.gov

15.5: Source control as a means to prevent Staphylococcus aureus infections in hemodialysis

Priti Patel pgp0@cdc.gov

15.6: Improving bathing practices for patients with long-term hemodialysis catheters

Priti Patel pgp0@cdc.gov

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

Nimalie Stone eiy2@cdc.gov

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

Krista Powell

Alex Kallen duf8@cdc.gov ffp0@cdc.gov

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

Almea Matanock xdf2@cdc.gov mailto:vif0@cdc.gov mailto:nme0@cdc.gov mailto:vif0@cdc.gov mailto:ljm3@cdc.gov mailto:bip5@cdc.gov mailto:bip5@cdc.gov mailto:bip5@cdc.gov mailto:fco6@cdc.gov mailto:mpo6@cdc.gov mailto:ccf6@cdc.gov mailto:zyr3@cdc.gov mailto:jqj9@cdc.gov mailto:fxe9@cdc.gov mailto:pgp0@cdc.gov mailto:pgp0@cdc.gov mailto:eiy2@cdc.gov mailto:duf8@cdc.gov mailto:ffp0@cdc.gov mailto:xdf2@cdc.gov

15.10: GAS burden, trends and pharyngitis-associated strain types in the US

Chris Van Beneden cav7@cdc.gov

15.11: Supporting collaborative research between health departments and academic medical centers

Arjun Srinivasan beu8@cdc.gov

Topic #16: Antibiotic resistant pathogens and genes in water systems and the environment and their contribution to human infections (NCEZID)

16.1: Impact of extreme flooding events on environmental antibiotic resistance

Amy Kirby

Lee Voth-Gaeddert agk1@cdc.gov

16.2: Detection of azole-resistant Aspergillus fumigatus in the United States

Shawn Lockhart

Karlyn Beer gyi2@cdc.gov ydh7@cdc.gov

16.3: Assessing human exposure to antibiotic resistant pathogens in environmental waters

Jean Patel

Amy Kirby

Aditya Sharma vzp4@cdc.gov agk1@cdc.gov xdh3@cdc.gov

16.4: Assessing the effectiveness of interventions to reduce concentrations of antibiotic resistant bacteria in hospital effluent

Matt Arduino

Rod Donlan mja4@cdc.gov rld8@cdc.gov

Topic #17: Evaluating and Improving Antibiotic Use (NCEZID)

17.1: Development and dissemination of training resources to support improvements in newborn antibiotic use

Arjun Srinivasan beu8@cdc.gov

17.2: Assess effects of prenatal/intrapartum/neonatal antibiotic exposures on subsequent risk of infection/sepsis in children

Athena Kourtis apk3@cdc.gov

Topic #18: Approaches to Prevention and Control of Soil Transmitted Helminth Infections in the United States

(CGH)

18.1: Determination of prevalence of soil transmitted helminth infections in the southern United States

Stephanie R. Bialek zqg7@cdc.gov

18.2: Evaluation of approaches to preventing and managing soil transmitted helminth infections in areas in the United States where they may remain endemic

Stephanie R. Bialek zqg7@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. However, the scientific point of contact may request submission of an informal white paper no more than 4 pages in length to facilitate their 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 (Estimated Cost).

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

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

Part III – Use of Non-Government Personnel).

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

Part III for specific evaluation criteria.

NOTE: Once white papers are submitted technical dialogue STOPS!

mailto:cav7@cdc.gov mailto:agk1@cdc.gov mailto:gyi2@cdc.gov mailto:ydh7@cdc.gov mailto:vzp4@cdc.gov mailto:agk1@cdc.gov mailto:xdh3@cdc.gov mailto:mja4@cdc.gov mailto:rld8@cdc.gov mailto:beu8@cdc.gov mailto:apk3@cdc.gov mailto:zqg7@cdc.gov mailto:zqg7@cdc.gov

Step 3 - Submission of Formal Research Proposal

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

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

Step 4 - Contract Award for Selected Projects

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

NOTE: Projects will be funded as contracts, not grants.

Government obligation

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

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

BAA POINTS OF CONTACT

CDC’s BAA Technical Coordinator and point of contact is Dr. Mim Kelly, PhD who may be reached by email at lzk6@cdc.gov.

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

Name Research Topic Area Telephone Number Email

Ms. Pamela Bolling #4, #9, #14 770.488.2725 Boo6@cdc.gov

Ms. Sheena Delaine #2, #3, #10, #13 770.488.2974 Kpz5@cdc.gov

Ms. Ashia Everett #1, #7, #15, #18 404.498.5229 Oiv4@cdc.gov

Ms. Akela Brown Long #8, #12, #16, #17 404.498.5635 Oga1@cdc.gov

Mr. Jaren Turner #5, #6, #11 770.488.2053 Wpn2@cdc.gov mailto:lzk6@cdc.gov.

mailto:Kpz5@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 provide public health leadership and training.

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

(NCCDPHP)

Approximately 84 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.

Research has shown that the more sessions of an LCP a person attends, the better the outcomes. National DPP

LCPs have identified retaining people in their sessions, especially after the initial 16 weeks, as a challenge.

Analysis of National DPP evaluation data has demonstrated significant dropout at different points of the program.

Since the National DPP was launched in 2012, over 1,700 organizations have provided the lifestyle change program to over 250,000 people at high risk for type 2 diabetes. But with 84 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 increase recruitment and enrollment into the National DPP Lifestyle Change Program, particularly for underserved populations.

Dimensions that can be considered for these innovations include but are not limited to delivery locations (e.g., worksites, community centers, religious institutions, virtual, on-demand), demographic affinity (e.g., age, gender, race/ethnicity, sexual orientation), health care context (e.g., doctor’s offices, pharmacies, dentist offices, local health departments, vision exam sites), referral mechanisms (e.g., EHRs, health care providers, social http://www.cdc.gov/diabetes/prevention/index.html referrals, opt-in v. opt out, other systems), workforce expansion, public/private partnerships (e.g., insurance companies, pharmaceutical companies, professional organizations), disease management companies, urban/suburban/rural contexts, and others.

CDC is open to considering all types of novel methods including but not limited to those based on behavioral economics, human centered design, use of novel incentives, healthy habit formation strategies, behavioral change theories, behavioral science, gamification, marketing approaches, digital technologies, social influence methods, behavioral mapping, adult learning theories, and others.

While novel delivery methods and mechanisms are welcome, the content, number of sessions, and length of the intervention (12 months) cannot be changed as those are all essential elements in the original and translational research which has found the program to be effective.

Topic #2: Increase Engagement and Participation of Persons Living with Diabetes in Diabetes Self-

Management, Education and Support (DSMES) Services (NCCDPHP)

Over 30 million people in the US have diabetes. Diabetes, a serious and costly condition, is characterized by illness and death from long-term microvascular and macro vascular complications. Additionally, numerous well-known comorbidities can accompany diabetes, including cardiovascular disease, retinopathy, amputations, and nephropathy. Often these complications and comorbidities interfere with a person’s ability to self-manage their diabetes. The Centers for Disease Control and Prevention (CDC) projects that as many as 1 in 3 adults could have diabetes by 2050. In 2017, the United States spent an estimated $327 billion on diabetes care, including

$237 billion in direct medical costs and $90 billion in indirect costs from lost workdays, restricted activity, disability, and early death. Many costly complications effecting people with diabetes can be prevented or delayed with appropriate self-management. Diabetes Self-Management Education and Support (DSMES) services help people with diabetes learn how to take the best care of themselves. DSMES services are provided by trained health providers who help people with type 1 and type 2 diabetes set, reach, and maintain their health goals.

Through DSMES, diabetes educators teach a variety of skills and provide support to help people take ownership of their daily diabetes management, including how to check blood sugar, develop routines to take medication, incorporate healthy eating and activity into daily life, and cope with stress and diabetes distress. DSMES is offered both through in-person and online programs.

DSMES services must meet standards established by the Centers for Medicare and Medicaid and they are officially accredited (recognized) by either the American Association of Diabetes Educators (AADE) or the

American Diabetes Association (ADA). DSMES is covered under Medicare Part B and most private health insurance companies because it is recognized as part of comprehensive diabetes care. To be reimbursed, a patient must be referred to DSMES by a physician. Unfortunately, only 6.8% of newly diagnosed patients with private insurance participated in DSMES within one year of being diagnosed and less than 5% of Medicare beneficiaries living with diabetes have ever received DSMES services.

Dimensions that can be considered for these innovations include but are not limited to delivery locations (e.g., worksites, community locations, virtual, on-demand), demographic affinity (e.g., age, gender, race/ethnicity, sexual orientation), health care context (e.g., doctor’s offices, pharmacies, dentist offices, local health departments, vision exam sites), referral mechanisms (e.g., EHRs, health care providers, social referrals, opt-in

v. opt out, other systems), workforce expansion, public/private partnerships (e.g., insurance companies, pharmaceutical companies, professional organizations), disease management companies, urban/suburban/rural contexts, and others.

CDC is open to considering all types of novel methods including but not limited to those based on behavioral economics, human centered design, use of novel incentives, healthy habit formation strategies, behavioral change theories, behavioral science, gamification, marketing approaches, digital technologies, social influence methods, behavioral mapping, adult learning theories, and others.

Topic #3: Address Critical Gaps in Knowledge of the Total Preventive Benefit of Currently Available

Influenza Vaccines (NCIRD)

3.1: Investigations of Influenza Vaccine Effectiveness in Preventing Influenza-Associated Intensive Care

Admissions

CDC seeks to assess influenza vaccine effectiveness (IVE) in preventing influenza-associated intensive care unit (ICU) admissions through prospective studies that gather and pool data using a common protocol across multiple healthcare systems and/or existing pediatric and adult ICU research networks in the U.S. This effort will:

Assess IVE against ICU admissions and other indicators of very severe influenza during hospitalization (e.g., mechanical ventilation, ECMO, prolonged length of stay) and after hospitalization (e.g., readmissions, rehabilitation and long-term care, death) in pediatric and adult settings, by multiple age strata, and by underlying medical conditions and risk factors.

Examine both acute respiratory and non-respiratory manifestations of influenza virus infection.

Examine influenza-associated sepsis or other mechanisms behind fulminant and rapidly progressive influenza illness/death in otherwise healthy hosts.

Assess influenza vaccine effectiveness (IVE) in preventing laboratory-confirmed influenza illness

(by molecular diagnostics, such as rRT-PCR, including [sub]type and lineage characterization) as the primary outcome; secondary complications (such as coronary artery disease related events) and less specific influenza indicators and composites (e.g., influenza or pneumonia clinical diagnoses with antiviral agent prescription) will also be examined.

Document influenza vaccine status (including vaccination date, vaccine products, and lot numbers) and vaccination history; utilize previously validated registries and/or conduct validation evaluations as part of the effort.

Consider alternative influenza vaccines to include those with adjuvant, higher antigen or cell culture-based production.

Topic #4: Compare the Immunogenicity of Alternative Influenza Vaccines and Vaccine Strategies

(NCIRD)

4.1: Improve Laboratory Methods to Compare Immune Response to Seasonal Influenza Vaccines

CDC seeks to partner with scientists and laboratory centers to apply standard and innovative laboratory methods to describe and explain individual and population differences in immune response to influenza vaccination and natural influenza virus infections. CDC is particularly interested in understanding the mechanisms underlying heterogeneity in immunogenicity to seasonal influenza vaccines for some populations (e.g., older adults; repeated influenza vaccines; immune compromised). Innovative methods are also needed to identify and compare the immune advantages offered by alternative vaccine types and strategies. This effort will identify and create collaboration with laboratory centers and scientists with expertise and capacity to:

Conduct standard hem agglutination inhibition (HAI) assays along with more advanced (and labor-intensive) serologic methods such as micro neutralization (MN) assay, neuraminidase (NA) inhibition

(NAI) assay by enzyme-linked lectin assay (ELLA), mapping anti-HA response to multiple virus strains (antibody landscape), and/or assessing antibody focusing by testing HI binding to site-specific monoclonal antibodies (mAbs) by ELISA.

Apply cell mediated immunity (CMI) assays, including identifying innate lymphoid cells, and antigen-specific T-cell and B-cells. CMI assays involve phenotypic, functional characterization of antigen specific T-cell and B-cells by Flow Cytometry, cytokine ELISAs, ELISPOT and assessing breadth of T and B cell repertoire.

Develop and validate innovative methods to understand the heterogeneity in immunogenicity to seasonal influenza vaccines and describe the differential impact of alternative influenza vaccine types and strategies.

Utilize sera and PBMCs from previous and ongoing CDC-funded studies (including a multi-country prospective cohort study of influenza vaccination among healthcare personnel) and from the projects described in this announcement to address their primary and secondary objectives.

Topic #5: Use Modeling and Forecasting Tools to Improve the U.S. Response to Seasonal and Pandemic

Influenza (NCIRD)

5.1: Develop a Network of Modeling Centers to Inform the Public Health Response during Seasonal and

Pandemic Influenza. CDC seeks to establish a network of Centers that facilitates the real-time sharing of standard modeling assumptions and inputs and the comparison of validated mathematical modeling results.

During influenza seasons and pandemics, public health authorities have to make appropriate recommendations for prevention and control measures. Advancements in the rapid sharing of modeling assumptions, as well as results from multiple models, would improve the public health response and policy development. For example, modeling could help inform the implementation of pharmaceutical (e.g.

influenza vaccines, influenza antiviral prophylaxis and treatment) and non-pharmaceutical mitigation measures (e.g. temporary school closures and dismissals, the use of respiratory protection devices) during an emerging influenza pandemic. Towards these objectives, CDC is seeking to support modeling projects for seasonal and pandemic influenza in the following areas:

Developing tools that evaluate the impact of layered pharmaceutical (including vaccination) and non-pharmaceutical interventions on the timing and impact of an emerging influenza pandemic at various geographic levels.

Estimating the direct and indirect effects of different seasonal and pandemic influenza vaccination strategies.

Evaluating the impact of different strategies that vary the timing of influenza vaccine administration and duration of vaccine effectiveness on the burden of seasonal and pandemic influenza.

Estimating the impact of repeated influenza vaccination over short (1-5 years), medium (5–10 years), and long (10+ year) time horizons on the burden of seasonal influenza.

Evaluating novel strategies that optimize the use of different vaccination types (e.g. the broader use of high dose or adjuvanted influenza vaccines) or vaccination approaches (e.g. an intra-season influenza vaccine booster dose) during influenza seasons in the United States.

CDC seeks organizations that can make individual contributions to these goals and one or more organization that can centrally coordinate these efforts.

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.

CDC seeks to develop mobile based approaches to improve various response activities in a pandemic or other public health event. This effort will:

Develop and test a mobile phone texting platform that allows for monitoring of persons that may have been exposed to disease. System should allow for public health departments to customize protocols for a low burden solutions allowing for timely text responses that will inform public health action.

Develop and test a mobile application platform that supports various protocols for medication information and compliance during a response. Platform should include tools to improve medication compliance, vaccine reminders, and also allow for information and public health messages to reach the end user.

Support activation of mobile phone texting and application solutions during a public health emergency response.

Qualities that strengthen the competitiveness of a proposal include:

Expertise in development and launch of health-related texting and application platforms that are user-friendly and based on multi-layered protocols

Ability to support and sustain without significant interruption, activation of health-related texting and application platforms that will be marketed nationally and may be simultaneously used by thousands of users

Experience working with public health and understanding of threat/preparedness needs to design and develop emergency response mobile phone and application platforms

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

Under this Topic, 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.

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. 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 produce antisera that effectively differentiates contemporary A(H1N1pdm09) viruses (e.g., A/California/07/2009 vs

A/Michigan/45/2015) and 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.

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). The goal is to develop a sustainable approach, capable of analyzing each specimen with up to 14 different antisera. Rapid nanoscale/Nano fluidic, or similar, approaches that conserve sera and antigen are optimal. Projects need to be scaled for a 12-24 month period of performance.

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.

The goal of this interest area is to develop and implement bioinformatics that efficiently predicts optimal vaccine targets for each of the four lineages of influenza viruses circulating in humans and would be deployable within VSDB’s informatics infrastructure. Projects need to be scaled for a 12-24 month period of performance.

6.4 Create strategy to experimentally identify antigenically advanced viruses likely to predominate in the human population in future influenza seasons. The goal should be to use experimental approaches to complement the current vaccine strain selection process, by using human convalescent sera to select antigenic variants from human influenza virus populations. Awardees will work closely with VSDB to identify specific progenitor viruses based on surveillance data. Projects need to be scaled for a 12-24 month period of performance.

Topic #7: Develop approaches to assess the level of pre-existing immunity to influenza viruses. (NCIRD)

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. The goals of this interest area include improving the understanding of how existing immune pressure in human populations could drive the evolution of influenza viruses for influenza virus fitness forecasting that could be applied in influenza vaccine virus selection process as well as more precise characterization of the levels and frequency of serum cross-reactive antibodies to emerging viruses including new antigenic drift variants of seasonal influenza viruses for vaccine strain selection and novel subtype influenza viruses for pandemic preparedness.

Qualities that strengthen the competitiveness of a proposal include yearly or biennial collection of human sera that are representative of the US population, with a target number of 1000 sera yearly or biennially:

Sera collection should be representative of US geographic locations: to be collected from 10 HHS regions.

Sera should be representative of wide age ranges of the population. Collection of sera should be evenly distributed across age groups: 0-4 yrs, 5-17 yrs, 18-34 yrs, 35-49 yrs, 50-64 yrs, 65-80 yrs, 80-100 yrs.

Sera should be collected during non-influenza seasons (from June-August)

Sera should be collected from healthy, non-immunocompromised individuals, both vaccinated and non-vaccinated, with current-seasonal influenza vaccine information available.

Sera will be used to assess existing immunity to characterize antibody levels to influenza current vaccine viruses, and up to 8 emerging antigenic variants of seasonal influenza viruses per subtype (H3, H1, and Bs).

Sera may also be evaluated against novel subtype influenza viruses to assess population immunity for pandemic preparedness.

Topic #8: Approaches to prevention and control of bacterial vaccine-preventable diseases (NCIRD)

8.1: Maternal Tdap and risk of pertussis in U.S. children

Maternal immunization during pregnancy provides protection to the newborn via transplacental transfer of antibodies, and since 2012, ACIP has recommended that women receive a tetanus-diphtheria-acellular pertussis (Tdap) vaccine during every pregnancy. Although vaccine effectiveness has been shown in multiple studies to be high in the first few months of life when infants are most vulnerable to severe infection, there is concern that high levels of transplacentally acquired antibodies might blunt the immune response to active immunization. Data in observational studies has not consistently shown this effect. A recent randomized control trial indicated that while antibody levels to specific antigens were higher initially in those born to mothers vaccinated with Tdap compared with those born to mothers vaccinated with Td, by 6 and 7 months antibody levels were lower in these infants compared with those whose mothers had been vaccinated with Td only. It is unknown whether these differences persist or if maternal vaccination results in any clinically meaningful blunting of the immune response to vaccination in early childhood. The proposal should address the following needs:

1. Evaluate the effect of blunting of immune response to the childhood DTaP vaccine series on risk of pertussis in children aged 1-6 years born to women who received Tdap during pregnancy

2. Estimate maternal Tdap VE in children aged 1-6 years

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

Pertussis infection is often is likely to be underdiagnosed and underreported because persons with a cough illness may delay or forego…