CPR_BAA_FY2019_-_RFP_75D301-19-R-67904_5-10-2019_Revision.pdf

CENTERS FOR DISEASE CONTROL AND PREVENTION

BROAD AGENCY ANNOUNCEMENT

75D301-19-R-67904

PUBLIC HEALTH EMERGENCY PREPAREDNESS AND RESPONSE

APPLIED RESEARCH (PHEPRAR)

ISSUE DATE: April 17, 2019 CLOSE DATE: May 17, 2019

TABLE OF CONTENTS

PART I – INTRODUCTION…

General Aims Authority Specific Rights Reserved for the Government Overview of Award Process Step 1 – Electronic Contact - OPTIONAL Step 2 – Submission of Concept Paper (Technical Dialogue) Step 3 - Submission of Formal Research Proposal Step 4 - Contract Award for Selected Projects Government obligation

PART II – RESEARCH AREAS OF INTEREST AND ELIGIBILITY…

CDC RESEARCH INTERESTS

Eligibility

PART III – OVERVIEW OF SUBMISSION PROCESS…

Step 1 – Electronic Contact – OPTIONAL Step 2 – Submission of Informal Concept Paper (Technical Dialogue) Step 3 - Submission of Formal Research Proposal Step 4 - Contract Award for Selected Projects

BAA POINTS OF CONTACT

PART IV - CONCEPT PAPER SUBMISSION

Concept Paper Format and Content Concept Paper Submission Deadline Eligibility to Submit a Formal Proposal

PART V - PROPOSAL PREPARATION AND SUBMISSION…

GENERAL INFORMATION…

Eligibility Post-Employment Conflict of Interest Restrictive Markings on Proposals Reporting Requirements Other Requirements Rights in Data and Publication - Non-universities………20 Rights in Data and Publication - Universities and other eligible institutions of higher education………21 Non-U.S. Citizen Participation… HHSAR Part 304 Policy Period of Performance Contract Types Funding Proposal Submission

PROPOSAL PREPARATION INSTRUCTIONS

Proposal Copies Proposal Content

Section I - Technical Section Offeror’s Statement of Work (SOW) 508 Compliance Data Management Plan… Protection of Human Subjects Certificates of Confidentiality

Paperwork Reduction Act Public Access to Archived Publications…….32 Public Access to CDC Funded Digital Public Health Data……32

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 (Only Applicable to Large Businesses) Title to Equipment

Section III - Cost Section Contents – No page limit Period of Performance Direct Labor Materials Other Direct Costs Travel Subcontracts Consultants Miscellaneous Indirect Costs Fee/Profit

PART VI - PROPOSAL EVALUATION…

INITIAL REVIEW

PEER/SCIENTIFIC REVIEW

Technical Evaluation Criteria Cost/Price Reasonableness and Realism Evaluation of the Data Management Plan… Administrative Proposal Proposal Comparisons

PART VII - PROPOSAL FORMS AND ATTACHMENTS

PART I - INTRODUCTION

ALL POTENTIAL OFFERORS SHALL REVIEW THIS ANNOUNCEMENT IN FULL PRIOR TO

PREPARING A RESPONSE.

This Broad Agency Announcement (BAA) seeks proposals to conduct innovative research to improve the ability of Centers for Disease Control and Prevention (CDC) and its partners, especially state and local health departments, to effectively prepare for and respond to public health emergencies and disasters. CDC’s Center for Preparedness and Response (CPR) anticipates that the knowledge resulting from awards made under this announcement will contribute significantly to the evidence base for preparedness and response and lead to improved efficiency, effectiveness, and outcomes in several domains.

This BAA will utilize contracts as the instrument of funding. The Government will decide on the type of contract awarded based on Offerors’ proposals and the best interest of the Government. The Government will consider proposals for firm-fixed price, cost reimbursable, and cost-plus-fixed-fee contracts.

General Aims

This BAA is a competitive approach to consider proposals that harness scientific research and innovation to enhance preparedness for, response to (and ultimately recovery from) public health emergencies and disasters, allowing CDC to:

1. Identify potential contract recipients with recognized expertise in relevant areas or capability to develop and execute promising scientific approaches, and

2. Encourage synergies through collaboration across research and practice entities (e.g. through subcontracting or informal partnerships), and

3. Engage scientifically with funding recipients, depending on the interests of the Government, the availability of CDC science staff, and the nature of the project.

Authority

CDC issues this BAA under the provisions of Federal Acquisition Regulations 35.016 and 6.102(d)(2), which provide for solicitation of proposals and the acquisition of basic and applied research and that part of development not related to the development of a specific system or hardware procurement. The use of the BAA mechanism to solicit proposals is authorized under 48 CFR 35.016. Contracts that are awarded based on responses to this BAA are the 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."

Specific Rights Reserved for the Government

This BAA reserves specific rights for the Government, in addition to rights described elsewhere in this document or by law or regulation, including:

1. The right to select for negotiation and award all, some, one, or none of the proposals received in response to this solicitation.

2. The right to make awards without discussions, or to conduct discussions and/or negotiations, whichever is determined to be in the Government’s interest.

3. The right to accept proposals in their entirety or to select only portions of proposals for award.

4. The right to provide direction and input on projects with one or more submitters under this BAA, when it is in the best interest of the Government.

5. The right to request any additional, necessary documentation upon initial review. Such additional information may include, but is not limited to, a further detailed proposal, additional budget information, and representations and certifications.

6. The right to remove proposers from award consideration should the parties fail to reach agreement on award terms, conditions, and cost/price within a reasonable time, the Offeror fails to timely provide requested additional information, or the Government believes it is in its best interest.

Overview of Award Process

Offerors contemplating submission of a proposal under this BAA will follow a four-step process, as described in detail within the announcement.

Step 1 – Electronic Contact - OPTIONAL

Potential Offerors interested in responding to the BAA may (but are not required to) contact CDC by email to the Contracting Officer specified in this announcement with questions regarding concept paper submission or other aspects of the acquisition process.

Step 2 – Submission of Concept Paper (Technical Dialogue)

Potential Offerors interested in submission of a proposal must first submit a concept paper. This step is a continuation of technical dialogue.

Step 3 - Submission of Formal Research Proposal

This step ends the technical dialogue. If there is sufficient interest by the Government in a proposed project based on the concept paper, the Contracting Officer will invite the Offeror to submit a formal research proposal. The decision to solicit a formal proposal from an Offeror is strictly at the discretion of the Government. The Government may solicit any number of formal proposals or may opt to solicit none.

Step 4 - Contract Award for Selected Projects

Formal proposals will undergo initial review by agency Contracting Officer and those that meet the requirements specified in this BAA will be formally evaluated.

Government Obligation

Offerors are cautioned that the submission of a white paper (concept paper) and a proposal is strictly voluntary. The Government is under no obligation to pay for any cost associated with a white paper or proposal. Offerors submitting white papers and proposals are cautioned that only a Contracting Officer may obligate the Government to any agreement involving expenditure of Government funds. There is no commitment on behalf of the Government to fund any proposal received under this Announcement.

PART II – RESEARCH AREAS OF INTEREST AND ELIGIBILITY

CDC RESEARCH INTERESTS

The Government’s three research areas of interest for this announcement are listed below. Offerors may respond to one or more topics, but each topic requires a separate concept paper.

Offerors shall note that the maximum individual award (ceiling) varies by topic as listed below. Award ceilings are for the entire period of performance. Offerors may submit proposals of any magnitude below the award ceiling for the topic.

Note: As stated in Part III of this announcement, an Offeror may submit no more than two (2) concept papers/proposals under this BAA. An “Offeror” refers to an institution or organization. Examples include: state or local agencies, institutions of higher education, research institutes, consulting firms, and professional associations. For universities, an Offeror is an organizational unit at the level of an academic department, multi-departmental school or program, or interdisciplinary research center. An “Offeror” is not an individual researcher or informal partnership of researchers for purposes of this solicitation.

Topic 1: Assessment of U.S. clinical laboratories’ willingness and ability to support public health emergency response

Topic 2: Public health use of current resources and existing surveillance systems to monitor mental and behavioral health after an emergency

Topic 3: Determining the ease of reverting select agent excluded strains or modified toxins to restore pathogenicity, transmissibility, virulence, or toxicity

TOPIC 1: Assessment of U.S. clinical laboratories’ willingness and ability to support public health emergency response

Individual Award Ceiling for Topic 1: $2,500,000

Background statement – Clinical laboratories are often the first line of defense in a public health response as they conduct testing at the request of physicians to diagnose, monitor, or treat disease. As part of these functions, many clinical laboratories are responsible for referring suspicious or unusual specimens to public health reference laboratories for further characterization and analysis. More recently, select clinical laboratories with high-throughput testing capacity ensured timely diagnostic testing to inform medical care follow-up for individuals in a large-scale outbreak. As such, clinical laboratories serve as a critical gateway between every day medical care of individuals and public health. Although CDC has considerable information on the capabilities of public health laboratories, the same level of information is not available for the clinical laboratory sector, which includes small, medium, and large organizations in both private, non-profit, and other non-public health settings.

The government seeks proposals from Offerors to conduct a multi-faceted study to assess the capabilities, capacities, and willingness of the nation’s clinical laboratories to support large-scale response to chemical, biological, radiological, and/or emerging threats. The desired outcome of the research is a significant yield of information that will inform CDC and its state and local public health stakeholders how to better leverage and integrate clinical laboratories into large-scale emergency responses, and to identify critical gaps or vulnerabilities that need to be addressed.

Offerors must address all four of the elements below, including the research questions listed below each element, within their proposed research study. Offerors have substantial latitude as to research designs and methods (surveys, interviews, expert panels, review of existing data sources) that may be utilized in the proposed research. Offerors may address minor variants of the questions listed, so long as the rationale is solid and the information to be obtained will meet the government’s stated need. Offerors may also supplement the requirements below with additional proposed questions to address, so long as such additional questions are germane to the overall aims of the project.

Element 1: Understanding capacities and capabilities of commercial, academic, and other non-public health clinical laboratories to participate in emergency response.

Need - The US Government needs to understand the technical capabilities that clinical laboratories currently possess, including equipment, facilities, competencies, and training to support surge testing. There are 260,000 certified clinical laboratories in the United States. Approximately 70,000 of those laboratories can conduct moderate- and high-complexity testing, as defined by FDA. The specialties and capabilities within those moderate- and high-complexity laboratories vary widely. As part of the US Government certification process, clinical laboratories report their general technical specialties, in which proficiency programs they participate, their general staff size, and their test volume. But the US Government lacks additional information about these laboratories specific capabilities to support public health emergency responses.

A. Testing capabilities: Which laboratories are most capable of conducting laboratory testing for biological, chemical, and radiological agents during an emergency? Which laboratories can develop and obtain an Emergency Use Authorization (EUA) for new assays during an emergency? Which have the ability to quickly validate new laboratory tests, and to monitor the quality of those newly implemented laboratory tests? Which laboratories would rely on CDC assays that have already received an EUA for testing during an emergency? Which laboratories would rely on commercial assays that have received an EUA? Which laboratories would rely entirely on referring specimens to public health laboratories during an emergency?

B. Testing capacity: Which laboratories are most capable of high-volume, high-throughput laboratory testing for biological, chemical, and radiological agents during an emergency?

C. Equipment: What equipment is available to conduct testing using molecular methods, serological methods, and whole genome sequencing/bioinformatics analysis? Examples might include, but are not limited to, real-time polymerase chain reaction, enzyme-linked immunosorbent assay, mass spectrometry, antibiotic susceptibility testing, etc. Are labs using in-house assays or commercial kits?

D. Workforce: What training or certifications (technical and safety) are required for laboratory staff?

Are competency assessments conducted? Does the laboratory have the ability to augment staff during emergencies to support high-volume testing?

E. Laboratory informatics: Which laboratories are most capable of using advanced informatics systems to communicate results to a wide variety of partners and organizations, and the ability to modify or adapt their informatics systems based on the unique requirements of the public health emergency?

What specimen or sample accessioning capacity do these laboratories have? How quickly can their laboratory information management systems be updated to add new tests and results?

F. Laboratory safety: Which laboratories are most capable of implementing personnel and environmental systems to safety conduct laboratory testing for a wide variety of biological, chemical, and radiological agents during an emergency? Do laboratories routinely perform risk assessments for new methods?

G. Specialized Licensure: Which laboratories have Drug Enforcement Administration licenses to support drug testing? How are state licensure requirements met?

Element 2: Understanding the organizational ability, willingness, and challenges of commercial, academic, and other non-public health clinical laboratories to participate in emergency response.

Market research is required to understand clinical laboratories’ level of willingness to participate in an emergency response, including barriers to participation, potential incentives and other relevant factors.

A. This research should examine different incentives and motivations, perceptions of opportunity and risk, and triggers to support or not support a response.

B. Are clinical laboratories receptive to specialized training on new methods and willing to participate in CDC laboratory qualification for new tests for which CDC has received an EUA?

C. Are laboratories willing to adapt existing systems to meet testing and reporting needs during public health emergencies? [Specific examples of potential system adaptations might include: modification of data entry or information systems, adherence to a testing algorithm defined in an EUA, ability to capture associated clinical metadata that would help characterize a new threat or monitor at risk populations, and development of processes to ensure laboratory testing is compliant with the terms of an EUA.] Are laboratories willing and do they have processes in place to share results with public health if needed during a public health response?

D. What information could CDC provide clinical laboratories to implement new methods during an emergency response (e.g., specimen stability data to inform centralized versus distributed testing capability, test validation materials, biosafety considerations, etc.)?

E. Are there some organizations or business models that may be more inclined to participate in emergency responses than others?

F. Are there certain types of emergencies that specific laboratories would be more or less likely to support?

G. What criteria are used to decide whether clinical laboratories would provide testing support during a public health response (e.g., specimen type, specimens from individuals exposed to specific chemicals/radiological agents or infected by specific pathogens, etc.)?

Element 3: Understanding the regional reach, strengths, and distribution of commercial, academic, and other non-public health clinical laboratories to participate in emergency response.

The US Government would like to organize its knowledge of the ability (Element 1) and willingness (Element

2) of clinical laboratories to support emergency response geographically and by laboratory type. For each of the 10 HHS regions in the United States, we would like to know which of the following types of clinical laboratories should be targeted for collaboration during a public health emergency:

1. Large academic medical centers

2. Regional hospital/healthcare systems

3. Regional commercial laboratory companies

A review and analysis of secondary data sources may be carried out to develop an appropriate sampling strategy.

Primary data collection for this element of the project should include surveys of a minimum of 30 clinical laboratories in each of the above three categories for each of the 10 HHS regions. Thus, the sample should comprise at least 1000 clinical laboratories in the United States. The specific sample size may be larger and should be justified by a sound rationale. Based on analysis of the resultant survey data, including clinical laboratory capabilities and willingness, the Offeror shall identify and prioritize a top five (approximately) clinical laboratories in each of the above three categories, for each of the 10 HHS regions. At the conclusion of this project, at least 150 clinical laboratories will be identified and prioritized for engagement in future public health emergencies.

Element 4: Understanding how best to develop partnerships between public health and the clinical laboratory sector.

Need – Evidence-based guidance on how to foster partnerships between public health and clinical laboratories to strengthen preparedness and response. Offerors shall develop a proposed study to address this element, making use of review of secondary data as well as primary data collection (may include surveys, focus groups, individual interviews, and expert panels) to address at minimum the following questions.

A. How should the US and state governments work with the private clinical laboratories to strengthen emergency response?

B. How do government needs align to private business models? What non-monetary incentives might encourage participation in response activities? What should the government do in advance of the next emergency to improve response?

C. What should the government do at the outset of the next emergency to encourage the private sector to participate in the response?

D. What information can the government provide to the private sector to streamline clinical laboratory testing during an emergency?

What we are looking for (Topic 1):

Offerors shall take into consideration the following points and incorporate them into submissions for Topic 1 as appropriate (these are listed in no particular order of importance and do not need to be addressed in order):

1. Offerors shall describe their understanding applicable research methods, including the conduct of complex, national-level, corporate, and academic market research.

2. Offerors shall demonstrate specific expertise in industrial market research.

3. Offerors shall demonstrate specific expertise in clinical laboratory medicine.

4. Offerors shall demonstrate specific expertise in public health emergency response.

5. Offerors shall address their research sampling strategy, including follow-up strategies to ensure sufficient numbers of respondents for proposed data collections.

6. Offerors shall state statistically defensible sampling parameters, including power calculations.

7. Offerors shall state their methodology for conducting surveys, interviews, and/or focus groups as part of their proposed projects. Although CDC anticipates proposed projects will rely on primary data collection, Offerors may also propose the use and analysis of existing data as an adjunct to primary data collection; however, the knowledge gaps identified must be filled by primary data collection. Offerors should be specific as to sources of existing data to be utilized.

8. Although CDC anticipates proposed projects will rely on primary data collection, Offerors may also propose the use and analysis of existing data as an adjunct to primary data collection however the knowledge gaps identified must be filled by primary data collection. Offerors should be specific as to sources of existing data to be utilized.

9. Offerors shall incorporate an Office of Management and Budget / Paperwork Reduction Act (OMB/PRA) package development task into the proposed project, if applicable to the proposed project.

A PRA package is required for most federally-sponsored collections of information from the public involving 10 or more persons. Approval of a full PRA package can require 12 months; expedited clearance is possible only for certain types of information collections (e.g., when limited to state or local governmental public health staff under narrow circumstances). Expedited clearances can require 4 months from submission of a package. Offerors must consider these requirements in development of project timelines in the proposed Statement of Work, since information cannot be collected from subjects or respondents until PRA approval is received.

10. CDC expects that research carried out through this BAA will result in publication(s) in peer-reviewed scientific journals; proposals should address support for manuscript generation.

11. Offerors shall demonstrate familiarity with US Government purchasing and contract procedures.

TOPIC 2: Public health use of current resources and existing surveillance systems to monitor mental and behavioral health after an emergency

Individual Award Ceiling for Topic 2: $1,500,000

Public health emergencies can have a significant impact on individuals’ mental and behavioral health. When people experience an emergency, they experience a variety of reactions, many of which are natural responses to a difficult situation. Most people show resilience after a disaster. Resilience is the ability to endure during difficult situations, cope with adversity, and bounce back. It is also common for some people who are exposed to natural or human-caused disasters or other events to show signs of increased anxiety and depression. In some cases, symptoms will persist following the adverse event and a subset of individuals will develop conditions such as PTSD or other mental health disorders. Both sub-clinical and clinical levels of mental health symptomatology can affect an individual’s physical health, quality of life, and ability to function at home, in work/school, and in their communities. It is important to monitor the physical and emotional health of those affected by adverse events, as well as of those who respond to the needs of others during emergencies or disasters. To understand the mental health impact of an emergency or other adverse public health event, it is important monitor data to detect changes in mental status and emotional functioning, including symptoms of psychological distress. Because specific surveillance systems for mental health following an emergency do not exist in most jurisdictions, state, territorial, local, and tribal (STLT) health departments must rely on existing surveys and surveillance systems (e.g., BRFSS, CASPERs, poison-center calls, domestic-violence hotlines) to monitor changes in mental health symptoms.

Previously, CDC has compiled lists of surveys and surveillance systems that are available to monitor mental health issues at a national level. Similar efforts have not been conducted at the STLT level. In 2013, CDC and CSTE conducted an assessment, Disaster Mental Health Surveillance Needs Assessment for State Agencies, to characterize important aspects of state preparedness for a post-disaster mental health response. This report found that there is a gap in surveillance for mental health symptoms following an emergency. Standardized surveillance is critical for identifying needs, targeting interventions, monitoring conditions, and evaluating the efficacy of intervention. Currently, response to emergencies is challenged by limitations in the existing surveillance infrastructure, existing data collection methods, and the compartmentalization of public health and mental health at the STLT levels. Guidance for STLT health departments on using existing surveillance systems and other resources for mental health surveillance during an emergency is needed. Additionally, guidance for https://www.cdc.gov/mentalhealth/data_publications/index.ht https://c.ymcdn.com/sites/www.cste.org/resource/resmgr/EnvironmentalHealth/DMHSFinalReport.pdf

STLT public health and mental health agencies on how to interpret and use the data to address mental health issues is needed.

Phase 1 A systematic review of the literature and subsequent data collection, including surveys of public health and mental health agencies, are required to: 1) understand what current resources and existing surveillance systems at the local, state, and national level exist to monitor mental health symptoms after an emergency, 2) identify core, standardized, and validated measures of mental health issues, mental health care utilization, 3) identify best practices and availability of mental health data sources, 4) understand how mental health data can be used to address mental health issues, including acute mental health problems and longer-term health and psychological effects of the emergency, and 5) characterize the relationship between mental health agencies and public health during emergency response and recovery to identify and address health issues.

Phase 2 Development of the following: 1) conceptual and operational public health definitions of terms so that a common language is used to discuss mental health in the context of emergencies to ensure that the magnitude and prevalence is monitored consistently, 2) strategies for using existing surveillance systems, community assessments, or surveys at the local, state, and national level to monitor changes in mental health, and 3) recommendations for interpretation and use of mental health surveillance and data for public health action. An expert panel should be convened to review findings from the literature review and survey, and reconvened to review and comment on a final guidance document.

WHAT WE ARE LOOKING FOR (Topic 2)

Offerors shall take into consideration the following points and incorporate them into submissions for Topic 2 as appropriate (these are listed in no particular order of importance and do not need to be addressed in order):

1. The Offeror shall demonstrate previous work related to mental health issues following emergencies or disasters.

2. Offerors shall describe their understanding of relevant literature related to the research to be conducted and the gaps in knowledge that currently exist.

3. Offerors must demonstrate they have the experience and capability to translate research findings into useful public health guidance.

4. Offerors shall address in sufficient detail how they intend to survey public health and mental health agencies to identify current strategies/methods/data being used and gaps in information.

5. Offerors shall address in sufficient detail how they intend to develop a sampling strategy, and shall state a proposed (and scientifically defensible) response rate and power calculations. Offerors shall also state specific numbers of interviews or focus groups (including numbers of individuals within each), they intend to complete as part of their proposed projects, or additional relevant quantifiable information on data collection efforts.

6. Offerors shall incorporate an Office of Management and Budget / Paperwork Reduction Act (OMB/PRA) package development task into the proposed project, if applicable to the proposed project. A PRA package is required for most federally-sponsored collections of information from the public involving 10 or more persons.

Approval of a full PRA package can require 12 months; expedited clearance is possible only for certain types of information collections (e.g., when limited to state or local governmental public health staff under narrow circumstances). Expedited clearances can require 4 months from submission of a package. Offerors must consider these requirements in development of project timelines in the proposed Statement of Work, since information cannot be collected from subjects or respondents until PRA approval is received.

7. Offeror shall describe deliverables, such as guidance document, for the use by public health agencies to monitor mental health effects from emergencies.

8. Offerors may propose projects that entail travel to one or more sites within the United States for data collection or other relevant project purposes.

9. CDC intends for projects funded through this BAA to be carried out in a collaborative manner between the winning Offeror(s) and Government staff. The division of labor between CDC and the winning Offeror for any given project will be specific to that project and established during the proposal negotiation and contracting phases. Depending on availability of CDC staff and particulars of the project, the nature and extent of the collaboration may vary. In all cases, CDC shall have final decision-making authority about the technical direction of the project.

10. CDC expects that research carried out through this BAA will also result in publication(s) in peer-reviewed scientific journals with CDC coauthors; proposals should address support for manuscript generation.

TOPIC 3: Determining the ease of reverting select agent excluded strains or modified toxins to restore pathogenicity, transmissibility, virulence, or toxicity

Individual Award Ceiling for Topic 3: $1,500,000

The select agent regulations (42 CFR Part 73) established a procedure by which an attenuated strain of a select biological agent or modified toxin that does not pose a severe threat to public health and safety, animal health, or animal products may be excluded from the requirements of the select agent regulations. Exclusion of an attenuated strain or modified toxin is based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions. An excluded select agent strain or modified toxin will be subject to the regulations if there is a reintroduction of factor(s) associated with virulence, toxic activity, or other manipulations that modify the attenuation such that virulence or toxic activity is restored.

Studies are needed to determine how simple it would be to revert an excluded strain (bacteria and viruses) or modified toxin back to being considered regulated by the Federal Select Agent Program. While the primary priority should be to focus on excluded strains or toxins of Tier 1 select agents (such as restoring virulence to Bacillus anthracis Sterne), reversion of all excluded strains and toxins are of interest. As part of the initial work plan, the offeror should conduct a literature search to determine if these types of experiments have been performed on currently excluded strains or toxins, and then summarize the methods of reversion that will be performed. The ease of reversion of excluded strains and toxins must consider various types of modifications including but not limited to, point mutations, deletions, additions, etc. Once the excluded organisms or modified toxins have been engineered to restore virulence or toxicity, then the organisms or toxins must be tested against regulated strains or toxins to determine the level of pathogenicity, transmissibility, virulence, or toxicity using in vitro and in vivo techniques. A threshold for virulence and toxic activity that would trigger engineered strains to fall back under the select agent regulations must be determined.

WHAT WE ARE LOOKING FOR (Topic 3) Offerors shall take into consideration the following points and incorporate them into submissions for Topic 3 as appropriate (these are listed in no particular order of importance and do not need to be addressed in order):

1. The Offeror must be registered for BSL-2,3,4 HHS-only or overlap select agents and toxins, and capable of comparing excluded strains or toxins that have been restored against regulated strains or toxins to determine the degree of pathogenicity, transmissibility, virulence, or toxicity.

2. The Offeror shall create a review article that discusses the biosafety and security risks posed by excluded select agent strains (bacteria and viruses) and toxins. This article should include a discussion on their scientific benefit and utility weighed against the increased risk if virulence is easily restored.

3. The Offeror must attain approval for any recombinant manipulation of excluded strains or toxins from their Institutional Biosafety Committee following the requirements in the National Institutes of Health Office of Science Policy Guidelines for Research on Recombinant or Synthetic Nucleic Acid Molecules.

4. The Offeror must perform a risk assessment before starting this project to determine the biosafety and security risks associated with the restoration of the excluded strains or toxins.

5. Offerors shall address in sufficient detail how they intend to ensure that the method(s) employed reach the desired result, and achieve scientifically defensible performance standards.

6. Offerors shall articulate specific research, scientific and/or technical questions upon which their proposed projects will be based.

7. Offeror shall make recommendations for virulence and toxic activity thresholds that would trigger regulation of engineered strains or toxins.

8. Although CDC anticipates proposed projects will rely on primary data collection, Offerors may also propose the use and analysis of existing data as an adjunct to primary data collection; however, the knowledge gaps identified must be filled by primary data collection. Offerors should be specific as to sources of existing data to be utilized.

9. CDC expects that research carried out through this BAA will result in publication(s) in peer-reviewed scientific journals; proposals should address support for manuscript generation.

Eligibility Public, private, for-profit, and non-profit organizations, as well as institutions of higher education, non-governmental organizations, and government organizations in the U.S. are eligible under this BAA. Eligibility includes:

Accredited U.S. schools and programs of public health Other accredited U.S. institutions of higher education and academic departments Private or public research institutes and centers based in the U.S.

For-profit and non-profit scientific, consulting, and advisory organizations in the U.S.

State or local government agencies within the U.S.

Federally Funded Research and Development Centers (FFRDCs) and U.S. Government entities (e.g., Government/National laboratories; military educational institutions, etc.) may be subject to applicable direct competition limitations. The burden to prove eligibility shall rest solely with the proposer. FFRDCs and Government entities must provide a letter on official letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to Government solicitations. FFRDCs or Government entities that receive awards pursuant to this solicitation may receive those awards via either contract or an interagency agreement

(IAA).

The intent of this BAA is to allow for co-creation and co-design where deemed in the best interest of the Government to ensure high quality research projects that meet the needs of the agency. After potential Offerors submit Concept Papers, the Government, represented by the contracting officer and aided by a Program Subject Matter Expert, may at its discretion, discuss elements of these papers with Offerors to clarify proposed methods, scope, or other matters pertinent to the Government’s specific research needs.

For successful proposals, funding recipients may be required to coordinate scientifically with CDC scientific staff.

Coordination may include CDC input into study design, CDC participating in data analyses, CDC participating in development of tools or products, and/or CDC leading or participating in authorship of scientific publications resulting from the research. The extent of this coordination will be specifically delineated in all final awards.

Academic or non-governmental Offerors are highly encouraged to develop proposals in partnership or collaboration with state and/or local departments of health.

Offerors may formulate proposals that include subcontracting with other entities.

PART III – OVERVIEW OF SUBMISSION PROCESS

The following four-step sequence is established for Offerors contemplating submission of a proposal to 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 – Electronic Contact - OPTIONAL

This step initiates a technical dialogue between the Government and the potential offerors. Potential Offerors may (but are not required to) e-mail the Contract Specialist, Michael Crow at cprbaa2019@cdc.gov with questions regarding the concept paper submission process or other aspects of the acquisition process no later than Monday, April 29, 2019 at 12:00 pm Eastern Standard Time (EST). The Contract Specialist will seek input from the CDC Scientific Program Officer for this BAA as needed to provide responses to topic-specific (scientific) questions. The Government, at its discretion, may post questions and answers from Offerors (without identifying Offerors) on the FedBizOpps website. The Government may also contact Offerors to clarify submitted questions. The Offeror is asked to provide a point of contact with an email address and a telephone number.

Step 2 – Submission of Informal Concept Paper (Technical Dialogue)

This step is a continuation of the technical dialogue for projects of interest. Potential offerors must submit an informal concept paper of no more than 4 pages in length (exclusive of resumes, bios, CVs and references) describing the scientific and technical aspects of the proposed research project. See Part IV for more details on submission of concept papers. Concept papers should contain information related to background/problem, an overview of the proposed project, the main intent/purpose of the project and its value proposition, brief statement of data collection methods, data sources, analyses and proposed information products. Use of the concept paper is intended to determine which efforts are of sufficient technical merit and applicability to the Government’s goals and interests prior to submission of a formal research proposal as described in Part V; therefore, concept papers will not be as lengthy or detailed as a formal proposal. Concept papers should contain a Rough Order of Magnitude estimate (Estimated Cost).

All submitted concept papers will undergo an initial review for technical merit and program applicability. If the Government deems it necessary to clarify or discuss scientific or technical aspects of a submitted concept paper, the Contracting Officer will facilitate communication between the Scientific Program Officer or his/her designated technical point of contacts in the agency and the Offeror. Submission of a concept paper does not obligate the government to solicit a formal proposal from any Offeror. The Government reserves the right to reject any concept paper without comment.

Concept papers may be submitted to the Government via cprbaa2019@cdc.gov beginning on April 17, 2019 and must be submitted no later than 12:00 p.m. EST on May 17, 2019. There are no exceptions to this deadline. Concept papers received after this date and time are considered late, and will not be evaluated by the Government.

Step 3 - Submission of Formal Research Proposal

This step ends the technical dialogue. If there is sufficient interest by the Government in a proposed research project, the Contracting Officer will invite the Offeror to submit a formal research proposal (see Part V). The decision to solicit a formal proposal from an Offeror is strictly at the discretion of the Government. The Government may solicit any number of proposals at its discretion or may opt to solicit none. Once the Contracting Office receives a research proposal, communication between scientific personnel and the Offeror is permitted only as authorized by the Contracting Officer.

mailto:ophprbaa2019@cdc.gov

Step 4 - Contract Award for Selected Projects

All formal proposals will receive an initial review (see Part VI). Of these, proposals meeting the requirements stipulated in this announcement will be reviewed more thoroughly by a Technical Evaluation Panel. The primary basis for selecting proposals for award shall be scientific/technical merit, feasibility of implementation and prior experience. Cost realism, reasonableness and fund availability will also be considered to the extent appropriate. See Part VI for specific evaluation criteria. The Contracting Officer will notify the Offeror(s), in writing, whether the proposal will be processed for award. The Government has the right to make single or multiple awards.

GOVERNMENT OBLIGATION

Offerors submitting concept papers and proposals are cautioned that only a Contracting Officer may obligate the Government to any agreement involving expenditure of Government funds. The Government is under no obligation to pay for any cost associated with development or submission of a concept paper or proposal.

There is no commitment on behalf of the Government to fund any proposal received under this Announcement. Offerors are cautioned that the submission of a concept paper and a proposal is strictly voluntary.

BAA POINT OF CONTACT

CDC’s Contract Specialist for this requirement is Michael Crow, who may be reached at 770-488-3208 or by email at: cprbaa2019@cdc.gov.

PART IV - CONCEPT PAPER SUBMISSION

Steps 1 and 2 provide for technical interchange prior to the submission of a formal proposal, and include the key elements for consideration in developing a concept paper (and, if requested by the Government, a formal proposal).

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. Submission of a concept paper is considered part of the Technical Dialogue.

Concept paper Format and Content

Offerors are not asked to provide a detailed Statement of Work or step-by-step list of tasks as part of their concept papers; instead, Offerors are to provide a more general description of their proposed approach to the study of the topic, including summary of methods, solutions to be developed, geographical sites, and other key characteristics relevant to the specific topic as described in Part II of this BAA. Offerors are encouraged to ensure that submitted concept papers demonstrate a clear grasp of content area for the topic as well as an equally clear grasp of the methodological challenges (and potential solutions) for addressing the topic effectively.

Offerors should also briefly address how the results of the research will be translated to practice or otherwise implemented and to the extent appropriate to the specific topic, to incorporate a translation or implementation component within the project.

Each concept paper must address all of the following elements and should be no more than 4 pages in length (exclusive of resumes and appendices):

Concept 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. Number and title of this announcement

Concept paper submissions shall not contain Classified information.

Project description briefly addressing the parameters and characteristics identified in Part I, as relevant to the topic.

Tables and charts are permitted in the concept paper

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

An estimated timeline not to exceed 3 years (36 months) to complete the project.

• Offerors may submit a maximum of two (2) concept papers in response to this announcement.

See top of Part II for definition of “Offeror.”

A concept paper must be no more than 4 pages in length. Resumes, bios, CVs and references are not counted against the 4 pages.

Resumes of Key Personnel: Key personnel are those skilled, experienced, professional and technical personnel essential for successful accomplishment of the proposal objectives, such as the principal investigator, team leader, etc. Information regarding the qualifications, capabilities, and experience of the proposed key personnel should be addressed. Include the resumes of the prime contractor, subcontractor, and consultant personnel to include the names, brief biography, and list of recent publications of the Offeror’s key personnel. Documentation of previous work or experience in the field of the proposer is especially important. Resumes should not exceed 4 pages per person and shall not count as a part of your concept paper proposal page limit. Offerors may, but are not required, to utilize the NIH biosketch format for resumes.

http://grants.nih.gov/grants/funding/phs398/biosketch.pdf

Include as an appendix a description of any current or previous (in the last 5 years) work similar or related to the project proposed in the concept paper. Appendices shall not count toward the 4-page limit for the Concept paper.

In no more than 1 page (not to be counted against the 4-page limit), Offerors may provide a listing and basic qualifications of likely organizational partners, sub-contractors, etc., with whom you propose to partner for additional subject-matter expertise or collaboration.

Concept Paper Submission Deadline

This BAA is open and in effect from the date of release April 17, 2019 through May 17, 2019. THIS IS AN IMMEDIATE CALL FOR CONCEPT PAPERS. Concept papers must be received by 12:00 p.m. EST on May 17, 2019 to be considered. There are no exceptions to this deadline. Concept papers must be submitted electronically to the Contract Specialist, Michael Crow at cprbaa2019@cdc.gov.

Eligibility to Submit a Formal Proposal

Concept papers will be reviewed by the Scientific Program Officer or his/her designated program technical experts within the agency. Scientific/technical merit, relevance of the proposed project for CDC’s programmatic needs, and anticipated funding availability are of equal importance in concept paper review. CDC reserves the right to determine which Offerors will be requested to provide a formal proposal, based solely on review of submitted concept papers. Concept papers not considered to have sufficient scientific/technical merit or relevance to CDC’s needs, or those in areas for which funds are not expected to be available, will not result in an invitation to submit a formal proposal. As stated above, the Government reserves the right to reject any concept paper without comment.

Offerors will be notified by the Contracting Officer if they are invited to submit a formal proposal. Invitation to submit a proposal does not constitute selection of the proposed effort for contract award and does not establish a binding commitment for the Government to fund the effort in whole or in part.

http://grants.nih.gov/grants/funding/phs398/biosketch.pdf mailto:ophprbaa2018@cdc.gov

PART V - 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.