CDC COVID-19 BAA 75D301-20-R-68023.pdf

BAA 75D301-20-R-68023

CENTERS FOR DISEASE CONTROL AND

PREVENTION (CDC)

BROAD AGENCY ANNOUNCEMENT (BAA)

75D301-20-R-68023

Applied Research to Address The Coronavirus (COVID-19)

Continued Public Health Emergency – Developing Strategies for Protection, Prevention & Control in Communities

ORIGINAL ISSUANCE DATE: June 10, 2020

CLOSING DATE: June 24, 2020

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: Strategies for Protection and Monitoring of Worker Health……………………………………….…8

Topic 2: Strategies to Reduce Spread in Communities.……………………………………………...…………..9

Topic 3: Protections for COVID-19 vulnerable populations in high risk congregate settings such as, long-term care, nursing homes and correctional facilities …………………………………………………….…………..10

Topic 4: Natural history of SARS-CoV-2 infection …………………………………………………………….10

Topic 5: Environmental controls …….……

Topic 6: Genomic sequencing of SARS-CoV-2 to investigate the evolution, emergence and spread of infections in communities and populations…………………………………………………………………………………….12

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………………………………………………………………………………………………..18

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), National Center of Immunization and Respiratory Diseases

(NCIRD) 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.

Area of

Interest

Title Division/Branch SME Name SME Email

Area of

1:

Strategies for Protection and Monitoring of Worker Health (Healthcare and Non-

Healthcare Related)

NCEZID/DHQP,

NIOSH

Rachel

Holloway

COVID19BAA@cdc.gov

Topic 1.1 Personal protective equipment (PPE) for workers, including healthcare and laboratory workers and workers in high density and congregate workplace settings such as correctional facilities, manufacturing and processing facilities, meat packing plants, etc.

Topic 1.2 Develop and assess effectiveness, cost and unintended consequences of novel approaches for mailto:COVID19BAA@cdc.gov interventions, including but not limited to effective use of PPE, social distancing, cleaning and disinfection, physical barriers and modified workstations Topic 1.3 Assess the utility of COVID-19 symptom screening and/or SARS-CoV-2 testing (viral, serologic, other) for healthcare personnel and other workers to assist in detection and control of

SARS-CoV-2 transmission in the workplace

2:

Strategies to Reduce Spread in

Communities

NCIRD/NIOSH

Rachel

Holloway

COVID19BAA@cdc.gov

Topic 2.1 Assess the ability of cloth or improved low-cost, easily manufactured face coverings to control transmission at its source and the potential impact of such source control in workplace and community transmission

Topic 2.2 Assess the utility (uptake and acceptability, sensitivity and specificity of contact determination, mitigation of transmission) of monitoring tools and devices to identify and inform contacts to COVID-19 cases in the workplace and community

3:

Protections for COVID-19 vulnerable populations in high risk congregate settings such as, long-term care, nursing homes and correctional facilities

NCEZID/DHQP,

NCIRD

Rachel

Holloway

COVID19BAA@cdc.gov

Topic 3.1 Assess utility of COVID-19 symptom monitoring and SARS-CoV-2 testing (viral, serologic, other) for patients or residents in identifying COVID-19 cases

Topic 3.2 Assess the effectiveness of cohorting and other strategies for SARS-CoV-2 transmission containment

Topic 3.3 Determine the risk and protective factors for

SARS-CoV-2 transmission in ambulatory care settings involving highly vulnerable patients (e.g., nursing home patients in emergency rooms, ambulatory cancer care settings, outpatient dialysis settings, HIV and transplant patient clinics, prenatal clinics)

Natural history of SARS-CoV-2 infection

NCIRD,

NCEZID/DHQP

Rachel

Holloway

COVID19BAA@cdc.gov

Topic 4.1 Conduct clinical studies to identify and characterize non-pulmonary complications of acute infection, including impact on multiple organ systems and vasculitic and thrombotic (e.g., venous, pulmonary and arterial thromboembolism) consequences among populations by age and comorbidity

Topic 4.2 Study the risk of re-infections with SARS-CoV-2 and association with immune response including antibody types and titers, and the risk of re-infections with SARS-CoV-2.

Topic 4.3 Determine the epidemiology and risk factors for secondary co-infections and role of antibiotic resistant organisms in COVID-19 patients

Environmental controls NCEZID/DHQP/

DFWED,

NIOSH

Rachel

Holloway

COVID19BAA@cdc.gov mailto:COVID19BAA@cdc.gov mailto:COVID19BAA@cdc.gov

Topic 5.1 Assess contamination and survivability of SARS-

CoV-2 on surfaces in the patient care environment and on reusable hospital equipment

Topic 5.2 5.2 Evaluate the use of UV light to inactivate

SARS-CoV-2 in the environment

Topic 5.3 5.3 Assess the impact of hand hygiene, cleaning and disinfecting behaviors on risk of SARS-CoV-2 infection

Topic 5.4 5.4 Evaluate the effectiveness of alcohol-based hand sanitizer vs benzalkonium chloride-based hand sanitizer at varying product amounts and rubbing times to decrease viral burden on hands.

Topic 5.5 5.5 Determine the potential for SARS-CoV-2 exposure and infection from sewage by assessing

SARS-CoV-2 viability and persistence in sewage samples in which the virus is detected.

Genomic sequencing of SARS-CoV-2 to investigate the evolution, emergence and spread of infections in communities and populations

NCEZID/OAMD Rachel

Holloway

COVID19BAA@cdc.gov

Topic 6.1 6.1 Incorporate viral genomic data with host genomic, immunogenetic, serologic and other host data to better understand patient risk factors and clinical outcomes

Topic 6.2 6.2 Integrate viral genomic data with epidemiologic, clinical and demographic data

(e.g., patient age, gender, race/ethnicity, travel history, locality, treatment history, outcomes) to better understand transmission dynamics

Topic 6.3 6.3 Conduct large-scale sequencing studies to establish national and regional baselines in viral diversity, and to identify the emergence of clinically important variants (e.g., unusual virulence, potential disruption of diagnostic, antigenic or therapeutic targets; minor sequence variants)

Topic 6.4 6.4 Conduct studies comparing sequence diversity and viral phylodynamics within and between regions with different public health response timelines, implementations and strategies

Topic 6.5 6.5 Develop or enhance open bioinformatic tools, databases, visualizations and other tools that improve the availability, utility and impact of

SARS-CoV-2 sequence data in the public domain

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 (include cover page, appendices, etc..). The purpose of the white paper is to facilitate the SME’s understanding of the scientific and technical aspects of the proposed research project. Use of the white paper is intended to determine which efforts are of sufficient scientific and technical merit prior to submission of a formal research proposal as described in Part

IV; therefore, informal white papers should not be so lengthy or detailed as to constitute a formal proposal (see Part

IV). Informal white papers should contain a Rough Order of Magnitude (ROM) (e.g. “Estimated Cost”). A ROM is

NOT a full blown business proposal. Instead, it is merely a “statement or a range” that provides a high level estimate of what the offeror believes the project will cost.

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

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

Part III – Use of Non-Government Personnel).

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

Part III for specific evaluation criteria.

NOTE: Once white papers are submitted technical dialogue STOPS!

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 COVID-19 BAA Technical Coordinator and point of contact is Rachel Holloway, who may be reached by email at COVID19BAA@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. Ronnie Williams #1, #2 oga3@cdc.gov

Mr. Steve Lester #3, #4, #5 Svl3@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: Strategies for protection and monitoring of worker health (healthcare and non-healthcare related)

Program leads: NCEZID/DHQP, NIOSH

1.1 Personal protective equipment (PPE) for workers, including healthcare and laboratory workers and workers in high density and congregate workplace settings such as correctional facilities, manufacturing and processing facilities, meat packing plants, etc.

- Description: The most urgent PPE need is in developing sensors for existing or novel PPE to provide real time monitoring of fit and PPE contamination as well as developing designs to address improvements in comfort and fit to improve user acceptance.

a. Develop testing methods for assessing new types of or novel PPE, including PPE that can be usable for extended periods of time and/or reused in a variety of conditions

b. Develop materials and construction for new types of or novel PPE as well as develop improved particulate filtering facepiece respirators for workers in various occupations, including first responders

1.2 Develop and assess effectiveness, cost and unintended consequences of novel approaches for interventions to protect workers.

- Description: CDC seeks to sponsor one or more demonstration projects to document transitioning from current PPE strategies to strategies that provide improvements in worker safety through application of measures across the hierarchy of controls. Emphasis on transitioning from using filtering facepiece respirators to using reusable respirators is a priority.

mailto:oga3@cdc.gov mailto:Svl3@cdc.gov

The focus should include but not limited to effective use of PPE, social distancing, cleaning and disinfection, physical barriers and modified workstations to protect:

a. Workers, especially those in high-density and confined settings, such as factories, food packing and processing plants

b. Workers and residents in congregate settings (e.g., dormitories, correctional institutions, and shelters)

c. Workers and passengers on conveyances such as airplanes and ships

1.3 Assess the utility of COVID-19 symptom screening and/or SARS-CoV-2 testing (viral, serologic, other) for healthcare personnel and other workers to assist in detection and control of SARS-CoV-2 transmission in the workplace

- Description: CDC is seeking innovative proposals to develop, demonstrate, and test the effectiveness of innovative approaches to using health monitoring and/or SARS-CoV-2 testing (viral, serologic, other) to minimize or even eliminate transmission of SARS-CoV-2 in workplaces. Priority populations include workers experiencing very high or high risk of transmission, such as healthcare personnel, workers in high density settings, workers with frequent contact with the public, workers at risk of severe outcomes, and workers frequently in contact with clients or patients at high risk of severe outcomes (e.g., nursing home residents, immunocompromised patients). Proposals should address optimal approaches to mitigate SARS-CoV-2 transmission related to asymptomatic and pre-symptomatic infected individuals in workplace settings. Priority workplace challenges include optimizing health screening and/or testing to (1) detect asymptomatic or pre-symptomatic workers with COVID-19; (2) document resolution of contagiousness; (3) allow safe return to work for close contacts of COVID-19 patients earlier than 14 days after exposure; (4) use testing algorithms that optimize test performance, such as sensitivity, specificity, positive predictive value and negative predictive value; and (5) identify and decrease barriers to testing.

Topic # 2: Strategies to reduce spread in communities

Program leads: NCIRD/NIOSH

2.1 Assess the ability of cloth or improved low-cost, easily manufactured face coverings to control transmission at its source and the potential impact of such source control in workplace and community transmission

- Description: Proposals should consider cloth face covering designs that address some of the features identified in the draft AATCC Guidance and Considerations for General Purpose Textile Face

Coverings and document the features considered, including the utility of various head suspension designs, and the quantitative performance of the face coverings. Safety considerations such as CO2 build-up and biocompatibility should be considered as well.

2.2 Assess the utility (uptake and acceptability, sensitivity and specificity of contact determination, mitigation of transmission) of monitoring tools and devices to identify and inform contacts to COVID-19 cases in the workplace and community

- Description: Traditional contact tracing is a time and labor-intensive practice which historically has been performed by public health officials. There are emerging tools that have been designed to improve the timeliness, contact identification accuracy, and completeness that rely on more innovative methods, such as smart phone tracking, apps, and wearable devices and/or other digital technologies to support contract tracing efforts in a variety of settings. CDC seeks partners to identify the best products or applications to be used in combination with more traditional public health contact tracking systems and to evaluate their utility, acceptability, sensitivity and specificity of contact identification, and to quantify their potential impact on reducing onward transmission of SARS-CoV-2 in both community and workplace settings. Approaches should aim to provide data for public health investigations and to aid in making the determination of which individuals within a setting would be considered a close contact of an individual determined to have suspected or confirmed COVID-19 while still properly safeguarding individual’s privacy and confidentiality in a range of settings.

Topic #3: Protections for COVID-19 vulnerable populations in high risk congregate settings such as, long-term care, nursing homes and correctional facilities

Program leads: NCEZID/DHQP, NCIRD

3.1 Assess utility of COVID-19 symptom monitoring and SARS-CoV-2 testing (viral, serologic, other) for patients or residents in identifying COVID-19 cases

- Description: In nursing homes, other long-term care, outpatient dialysis, correctional facilities and other high risk congregate settings, assess the utility of COVID-19 symptom screening and/or SARS-CoV-2 testing (viral, serologic, other) for patients and residents to assist in detection and control of SARS-

CoV-2 transmission. For example, determine the optimum frequency of viral testing in addition to baseline symptom screening, along with any added role for serology, for preventing infections.

3.2 Assess the effectiveness of cohorting and other strategies for SARS-CoV-2 transmission containment

- Description: The combination of either symptom screening or SARS-CoV-2 testing strategies (virologic or serologic) with patient/resident cohorting in congregate facilities requires further design and evaluation to better understand both feasibility and reduction in transmission. Standardized strategies should be developed that account for different patient/resident populations, environmental considerations, and/or patient/resident medical comorbidities. Strategies related to cohorting for transmission containment may be completed and described within a single facility or may take the approach of comparing different strategies across different facilities for comparison.

3.3 Determine the risk and protective factors for SARS-CoV-2 transmission in ambulatory care settings involving highly vulnerable patients

- Description: Special patient populations may have unique vulnerabilities that should be considered when designing site-specific COVID-19 transmission reduction strategies. Cohort or case-control studies within highly vulnerable patient populations are methodologies that could help identify risk and/or protective factors. Topics to be included in evaluations should include individual patient factors, but also setting-specific environmental and/or managerial/administrative controls. Patient populations may include, but are not limited to patients presenting to emergency rooms, ambulatory cancer care settings, outpatient dialysis settings, HIV and transplant patient clinics, and prenatal clinics.

Topic #4: Natural history of SARS-CoV-2 infection

Program lead: NCIRD, NCEZID/DHQP

4.1 Conduct clinical studies to identify and characterize non-pulmonary complications of acute infection, including impact on multiple organ systems and vasculitic and thrombotic (e.g., venous, pulmonary and arterial thromboembolism) consequences among populations by age and comorbidity

- Description: Ideal study designs will allow for the determination of rates of these complications among identified cases over time in different age groups, among special populations (pregnant women or those with various underlying conditions), and by severity of clinical illness.

4.2 Study the protective immune response to SARS-CoV-2 infection, including antibody types and titers, and the risk of re-infections with SARS-CoV-2.

- Description: Studies are needed to better describe the short-term durability of protective immunity to

SARS-CoV-2 and differentiate SARS-CoV-2 reinfection from prolonged viral shedding or viral reactivation in different populations. These studies should account for factors that may influence the duration of shedding and potential for repeated exposure that may influence reinfection.

4.3 Determine the epidemiology and risk factors for secondary co-infections and role of antibiotic resistant organisms in COVID-19 patients

- Description: In hospitalized patients, perform retrospective observational studies that measure the incidence and factors associated with bacterial or fungal co-infections; for example, comorbidities, antibiotic and antifungal use, and role of invasive devices such as ventilators and catheters.

Topic #5: Environmental controls

Program lead: NCEZID/DHQP/DFWED, NIOSH

5.1 Assess contamination and survivability of SARS-CoV-2 on surfaces in the patient care environment and on reusable hospital equipment

- Description: Perform field studies in the hospitalized patient care environment, including reusable hospital equipment, to assess the level of SARS-CoV-2 contamination, and either model or measure directly the decay in infectivity over time.

5.2 Evaluate the use of UV light to inactivate SARS-CoV-2 in the environment

- Description: Conduct experimental studies paired with field studies in health care settings, other workplaces and/or congregate settings, to determine the effectiveness of UV light for SARS-CoV-2 disinfection.

5.3 Assess the impact of hand hygiene, cleaning and disinfecting behaviors on risk of SARS-CoV-2 infection

- Description: As part of the COVID-19 response, recommendations related to appropriate cleaning, disinfection, and hand hygiene behaviors in community settings are critical components of prevention activities the general US public can engage in. Little is known about the impact of hand hygiene and/or cleaning and disinfecting behaviors in community settings have on risk of SARS-CoV2 infection. For this project innovative methods should be used to evaluate the impact of hand hygiene, and/or cleaning and disinfecting behaviors in community settings (e.g., homes, churches, schools, etc.) have on individual risk of SARS-CoV-2 infection. Proposals focused on the following vulnerable populations are highly encouraged: people experiencing homeless, low income people living in rural or urban settings, farmworkers, recent immigrants or refugees, non-English speakers, those living with developmental or physical disabilities, underinsured or uninsured, and racial/ethnic minorities.

5.4 Evaluate the effectiveness of alcohol-based hand sanitizer versus benzalkonium chloride-based hand sanitizer at varying product amounts and rubbing times to decrease viral burden on hands.

- Description: Many settings often incur challenges in access to clean water, soap, and hand sanitizers, especially under crisis or pandemic conditions, such as the ongoing COVID-19 pandemic. There is a need to understand the effectiveness of alternative hand sanitizers to improve public health guidance and increase the availability of effective products to protect the public’s health in pandemic scenarios. For this topic, studies should evaluate the effectiveness of alcohol-based hand sanitizer (containing at least

60% alcohol) versus benzalkonium chloride-based sanitizer for inactivating coronavirus surrogates.

Studies should evaluate varying product volumes applied and varying contact times.

5.5 Determine the potential for SARS-CoV-2 exposure and infection from sewage by assessing SARS-CoV-2 viability and persistence in sewage samples in which the virus is detected.

- Description: Fecal shedding is a common feature of clinical infection; thus it is critical to understand the infection risk associated with fecal contamination and sewage. RT-PCR analyses have detected SARS-

CoV-2 RNA in stool, municipal sewage, and aerosols, but it is not clear if fecally-derived virus is infectious. CDC seeks studies that will provide data on the persistence and survival of SARS-CoV-2 in environmental matrices that may receive fecal contamination. Studies are also encouraged to quantify

SARS-CoV-2 in feces as a component of investigations quantifying the virus in sewage.

Topic #6: Genomic sequencing of SARS-CoV-2 to investigate the evolution, emergence and spread of infections in communities and populations

Program lead: NCEZID/OAMD

6.1 Incorporate viral genomic data with host genomic, immunogenetic, serologic and other host data to better understand patient risk factors and clinical outcomes

- Description: Conduct studies of SARS-CoV-2 infection that include both viral genomics and detailed host profiling to help define the host-pathogen interface, risk factors that mediate the pathogenic process, and variables that may influence both typical and atypical phenotypes and presentations.

Proposals may include the study of rare or unusual outcomes and syndromes (such as multisystem inflammatory syndrome in children), or assess the role of viral genomics and coinfection among specific patient groups, using metagenomics or other broad-based molecular technologies and approaches.

6.2 Integrate viral genomic data with epidemiologic, clinical and demographic data (e.g., patient age, gender, race/ethnicity, travel history, locality, treatment history, outcomes) to better understand transmission dynamics

- Description: This includes longitudinal studies that establish local, regional, national and global patterns of SARS-CoV-2 transmission, especially those that combine viral genomic data with detailed epidemiologic, clinical and demographic data, including travel and mobility data sources, electronic medical and laboratory records.

6.3 Conduct large-scale sequencing studies to establish national and regional baselines in viral diversity, and to identify the emergence of clinically important variants (e.g., unusual virulence, potential disruption of diagnostic, antigenic or therapeutic targets; minor sequence variants)

- Description: Participation, support or enhancement of large-scale, coordinated sequencing efforts, such as SARS-CoV-2 SPHERES, with an aim to monitor the diversity and characteristics of circulating viruses, either locally, regionally or nationally. This could include support to extend or maintain local or regional sequencing activities, support metadata collection and standardization, sampling strategy, or improving the overall quality, timeliness and representativeness of SARS-CoV-2 genomic data shared in open public sequence repositories.

6.4 Conduct studies comparing sequence diversity and viral phylodynamics within and between regions with different public health response timelines, implementations and strategies

- Description: As states begin to implement safe re-open strategies, monitoring circulating viruses and patterns of transmission will help adjust the timing and nature of public health prevention and mitigation efforts. Studies that establish sustainable, population-based surveillance of circulating SARS-CoV-2 sequence variants within a state or region, and assess patterns of regional introductions and transmission over time, are of particular interest.

6.5 Develop or enhance open bioinformatic tools, databases, visualizations and other tools that improve the availability, utility and impact of SARS-CoV-2 sequence data in the public domain

- Description: The SARS-CoV-2 pandemic has led to unprecedented viral genomic sequence data sharing from laboratories throughout the world. CDC is soliciting the development or enhancement of open source tools, databases, standards and curation efforts that improve the overall accessibility, quality and usefulness of publicly-shared sequence data in public repositories, such as GISAID EpiCoV and NCBI

GenBank/SRA. Data visualization and dashboarding tools that improve the interpretation and reporting of public domain/public access sequence data are encouraged, as are those that facilitate the linking and deduplication of sequence records between public repositories, and simplify association to clinical electronic laboratory reporting and medical records systems.

PART III - WHITE PAPER SUBMISSION

Steps 1 and 2 provide for technical interchange prior to the submission of a formal proposal. Any questions or clarification of project objectives or methods may be directly discussed between the Government technical representatives and the potential offerors during the Technical Dialogue. The purpose of the Technical Dialogue is to obviate excessive expenditure of resources for projects that do not warrant consideration based on insufficient technical merits or funding limitations.

Use of Non-Government Personnel

Offerors are hereby notified that non-Government participants may have access to the offerors’ white papers and that providing a white paper shall constitute consent to the disclosure of proprietary information to all non-

Government participants in the white paper review process. The non-Government participants are employees of commercial firms under contract to the Government and they will be authorized access to only those portions of the white paper and discussions that are necessary to enable them to provide specific technical advice on specialized matters or on particular problems, and for tracking and recording purposes. All non-Government participants have executed a Certificate of Non-Disclosure.

WHITE PAPER EVALUATION CRITERIA

White papers will be reviewed to determine if the proposed effort supports the research interest identified in Part II of this BAA. White papers will be evaluated by a technical review team using the following criteria:

• Technical Merit (Novelty, Impact, Scientific Rigor)

• Program Applicability (Priority, Gap)

• Timeframe Feasibility (Risk, Experience, Resource)

Offerors receiving a favorable review of their white paper will be requested to submit a formal proposal. Offerors receiving an unfavorable review of their white paper will not receive a request to submit a formal proposal. To be eligible for award a white paper must be submitted.

Upon completion of white paper evaluations, offerors will be notified whether or not their white paper was favorably received. Favorable review of a white paper does not constitute selection of the proposed effort for contract award and will not establish a binding commitment for the Government to fund the effort in whole or in part.

WHITE PAPER FORMAT AND CONTENT

Each white paper must adhere to all of the following requirements and should be no more than 4 pages in length per subtopic area. The email subject line for the white paper shall include research topic number and subtopic title.

• White Paper must be written in the following format:

a. Font size: 12-point, unreduced

b. Single-spaced

c. Paper size: 8.5 by 11 inches

d. Page Margin Size: One inch

e. Printed only on one side of page

f. Descriptive Title of the Proposed Project

g. BAA Number

• White paper submissions shall be unclassified.

• Project description addressing in sufficient detail the characteristics identified in Part II. The offeror may submit an individual white paper for any or all of the topic areas under Part II.

• Point of contact.

• A rough order of magnitude (ROM) cost estimate to implement the research effort.

• An estimated timeline to complete the project.

WHITE PAPER SUBMISSION

This BAA is open and in effect for 14 days from the date of release (June 10, 2020 through June 24, 2020). THIS

IS AN IMMEDIATE CALL FOR WHITE PAPERS. Prior to submission of a white paper offerors are strongly encouraged to contact the CDC BAA technical point of contact for the research topic/subtopic of interest. White papers must be received electronically by 3:00 PM EST on June 24, 2020 in order to be considered for further evaluation. White papers should be submitted electronically to the COVID-19 NCEZID BAA Technical

Coordinator, Rachel Holloway at COVID19BAA@cdc.gov.

**Please allow adequate time for your submission to get through the CDC firewall. We highly recommend allowing 5 or more minutes for this process. All white papers received after the 3:00 p.m. deadline will not be considered for review*

PART IV - PROPOSAL PREPARATION AND SUBMISSION

General Information

This section is intended to provide information needed in preparing research proposals for submission to CDC.

Proposals submitted under this BAA must contain technical, administrative, cost, and other supporting information as described below.

Most of the information needed to prepare a proposal will be found within this section. Blank proposal forms are included in Part VI and are designed to provide the required information needed for contracting purposes.

Use of the enclosed proposal forms will expedite award of the research contract.

All proposals should include the information specified in this announcement in order to avoid delays in evaluation.

CDC encourages nonprofit organizations, educational institutions, small business, small disadvantaged business concerns, HubZones, Service-Disabled Veteran-Owned Small Businesses (SDVOSBS) and Woman Owned

Small Businesses (WOSB) concerns to submit white papers for consideration.

This announcement is an expression of interest only and does not commit the Government to reimburse any proposal preparation cost for responding. The cost of the proposal preparation in response to this announcement is not considered an allowable expense to the normal bid and proposal indirect costs as specified in FAR 31.205-

18. Any request for white paper or submission of a full proposal does not guarantee award. The Government reserves the right to cancel this requirement at any time and shall not be liable for any cost of proposal preparation or submission.

Any contractual questions concerning the preparation or content of the research proposal should be directed to:

Name Research Topic Area Email

Mr. Ronnie Williams #1, #2, #3 oga3@cdc.gov

Mr. Steve Lester #4, #5, #6 Svl3@cdc.gov

Eligibility

To be eligible for award of a contract, a prospective contractor (except other Governments, including State and

Local Governments) must meet certain minimum standards pertaining to financial resources, ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical skills, facilities, and equipment.

Post-Employment Conflict of Interest

There are certain post-employment restrictions on former federal officers and employees, including special

Government employees (Section 207 of Title 18, United States Code). If a prospective offeror believes that a conflict of interest may exist, the situation should be brought to the attention of the Contracting Officer before time and effort is expended in preparing a proposal.

Restrictive Markings on Proposals

Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes shall:

(a) Mark the title page with the following legend: “This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed -- in whole or in part --for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as mailto:oga3@cdc.gov mailto:Svl3@cdc.gov a result of -- or in connection with -- the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets];” and

(b) Mark each sheet of data it wishes to restrict with the following legend: “Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal.”

All offerors should also complete the Research Proposal Cover Page Attachment (1) and should complete the statements of Attachment (2) indicating their preference for release of information contained in proposals and their understanding of the policy regarding evaluation of the proposals.

The offeror is cautioned, however, that portions of the proposal may be subject to release pursuant to the Freedom of

Information Act, 5 U.S.C. 552, as amended.

Reporting Requirements

The contractor will provide a quarterly summary of monthly conference calls. Quarterly Progress reports should include detailed descriptions of activities conducted during the previous quarter, planned activities for the upcoming next three months, and a section on challenges or barriers to meeting timelines and completing tasks, and how the contractor has already or plans to overcome these challenges.

Non-U.S. Citizen Participation

If the proposed research (or a portion of the proposed research) requires access to critical technology, sensitive unclassified information, For Official Use Only material, or intelligence material, non-U.S. citizens may participate in the resultant contract (or portion of the resultant contract) only if special written permission is granted by the Contracting Officer. The Contracting Officer will require the review and concurrence of the

CDC Foreign Disclosure Officer (FDO) before granting this permission.

If the proposed research (or a portion of the proposed research) requires access to classified information (i.e., confidential or secret), non-U.S. citizens may participate in the resultant contract (or portion of the resultant contract) only if a Limited Access Authorization (LAA) is granted. A LAA can be granted only in the event that there are no U.S. citizens that can perform the effort. Granting of LAAs is not anticipated under this Broad

Agency Announcement.

If any non-U.S. citizen requires access to CDC buildings, or other Government facilities, special written permission must be requested and obtained from the Contracting Officer and Security Officer through the resultant contract’s Technical Point of Contact. Requests shall specify purpose, duration, frequency, and location (specific room, lab, etc.).

Period of Performance

The period of performance will be based on the research project. This BAA will include a proposed period of performance which may be negotiated later. In the past, projects have had a period of performance of 12-24 months or have included options.

Contract Types

For this BAA, offerors can propose firm-fixed price or cost reimbursement [cost plus fixed fee, cost (no fee)].

The contract type should be based on the offerors risk associated with performing the research. As a reminder, per FAR 16.301-3(a)(3), offerors proposing a cost type contracts must have an approved accounting and purchasing system in order to receive a cost contract award. As a result, if proposing a cost type contract, please submit documentation of the approved accounting system along with the proposal.

Cost Certification

Per FAR 15.403-4, certified cost and pricing data are required for offers exceeding $750,000.00 total value. As a result, a Certificate of Current Cost or Pricing Data, in the format specified in FAR 15406-2, shall be submitted along with the offeror’s proposal if the work is projected to exceed $750,000.00.

Funding

• Fiscal Year Funds: 2020

• Approximate Total Funding: $10,000,000.00 (This amount is an estimate, and is subject to availability of funds.)

• Anticipated Award Date: July/August, 2020

• Period of Performance: TBD (Based on the research project)

• Estimated number of awards: Multiple

Proposal Submission

To be considered for award, an offeror must have submitted a white paper which was favorably reviewed by CDC.

Offeror will then be formally notified by the Contracting Officer to submit a formal proposal. The Request for

Proposal (RFP) will identify a due date for submitting the proposal. The offeror must follow the proposal submission guideline as identified in this section and the Request for Proposal (RFP) letter.

Follow-On Contracts

A proposal for continuation of a given research project will be considered on the same basis as proposals for new research. The proposal should be submitted sufficiently in advance of the termination of the existing contract so that if it is accepted, contract performance may be continued without interruption.

Proposal Copies

Offerors shall submit copies of their proposal as follows:

Proposal Section Electronic

Technical Proposal One

Administrative Proposal One

Timeline and Cost Proposal One

The electronic copy must be in a format compatible with Microsoft Office 2016. The Government is not requiring a hard copy proposal submission. The electronic proposal shall be the official proposal and must be received by the submission date and time identified in the official Request for Proposal. The Government will also identify the email address required for proposal submittal in the official Request for Proposal.

PROPOSAL PREPARATION INSTRUCTIONS

The proposal is the only vehicle available to the offeror for receiving consideration for award. The proposal must stand on its own merit; only information provided in the proposal can be used in the evaluation process leading to an award. The proposal shall be prepared simply and economically, providing straightforward, concise delineation of capabilities necessary to perform the proposed work. The technical proposal must be accompanied by a fully supported cost proposal as cost and technical considerations are reviewed simultaneously.

Each proposal shall be submitted under cover of Attachment (1) and shall contain three distinct sections. The first section shall contain the technical approach. The second section shall contain contractual information, certifications, and other documentation. The last section shall contain a breakdown of the anticipated costs.

Section I - Technical Section Contents

The nature of the effort to be performed will determine its acceptability for award under this BAA. Proposed efforts shall be scientific in nature and explore innovative public health practicing concepts. The Technical

Section shall contain the following:

Technical Proposal – Limited to 10 Pages

a. Cover Page: The cover page shall include the BAA Number, research topic and reference number, name and telephone number for the principal points of contact (both technical and contractual), and any other information that identifies the proposal. The cover page shall also contain the proprietary data disclosure statement, if applicable. The cover page shall not count as part of your technical proposal page limit.

b. Table of Content: It is highly recommended that the Offeror prepares a table of contents and use it for a final quality-control checklist. The table of content shall not count as part of your technical proposal page limit.

c. List of Illustrations/Tables: This list is a quick reference of charts, graphs, and other important information. A separate list of Tables is recommended. List of illustrations/tables shall not count as part of your technical proposal page limit.

d. Executive Summary: The executive summary allows the offeror to present briefly and concisely the important aspects of its proposal to key management personnel. The summary shall present an organized progression of the work to be accomplished, without the technical details, such that the reader can grasp the core issues of the proposed program. The Executive

Summary shall not exceed two pages and shall not count as a part of your technical proposal page limit.

e. Technical Approach: In this section, the Offeror shall provide as much technical detail and analysis as is necessary or useful to support the technical approach they are proposing. One must clearly identify the core of the intended approach. It is not effective to address a variety of possible solutions to the technology methodological problems.

(1) Technical Discussion: No technical approach is without its limitations or shortcomings. Every issue shall be identified and compared with the successes/failures of previous approaches. A tradeoff analysis is a good way to make this comparison and shall be supported by theory, modeling, experimental data, or other sound scientific practices. If the offeror has a "new and creative" solution to the problem(s), that solution shall be developed and analyzed in this section. The preferred technical approach shall be described in as much detail as is necessary or useful to establish confidence in the approach.

(2) Technical Program Summary: This section summarizes the above technical discussion in an orderly progression through the program, emphasizing the strong points of the proposed technical approach.

(3) Potential Contribution: Discuss the potential contribution to research programs relating to CDC initiatives, including the topic areas of interest

*In addition to the information above, your response in this area shall also focus on the information provided in Part II of this BAA.

(4) Risk Analysis and Alternatives: Every technical approach has its limitations and shortcomings.