BAA_-2017_Zika_Virus_Research_Topics_NCEZID_9_27_16.docx

CENTERS FOR DISEASE CONTROL AND PREVENTION

ADVANCED AND INNOVATIVE SOLUTIONS TO IMPROVE

PUBLIC HEALTH

BROAD AGENCY ANNOUNCEMENT (BAA)

2017-N-18041

TABLE OF CONTENTS

Page

PART I – INTRODUCTION………………………………………………………………….……….……….4

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……………………………………….7

CDC RESEARCH INTERESTS

· Area of Interest 1: Zika Diagnostics Development: Diagnosing recent and remote Zika infections

· Area of Interest 2: Improving our understanding of the biology and ecology of Zika virus mosquito vectors and the dynamics of virus transmission within the mosquito and at the mosquito-human interface

· Area of Interest 3: Development and evaluation of strategies to suppress Zika virus mosquito vectors, prevent mosquito bites and reduce Zika virus transmission to humans

· Area of Interest 4: Understanding, pathogenesis and viral persistence in the host as well as the host immune response to Zika virus infection

WHAT WE ARE LOOKING FOR

WHAT WE ARE NOT LOOKING FOR

Eligibility

PART III – OVERVIEW OF SUBMISSION PROCESS……………………………………………………..13

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………………………………………………………………..15

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

PART V - PROPOSAL PREPARATION AND SUBMISSION……………………………………….……..17

GENERAL INFORMATION

Eligibility Post-Employment Conflict of Interest Restrictive Markings on Proposals Reporting Requirements Other Requirements Rights in Data and Publication Non-U.S. Citizen Participation Period of Performance Contract Types Funding Proposal Submission Follow-On Contracts

PROPOSAL PREPARATION INSTRUCTIONS……………..………………………………………………..21

Proposal Copies Proposal Content

Section I - Technical Section……………………………………………………………………………………22 Offeror’s Statement of Work (SOW) 508 Compliance OCISO IT Security Determination Animal Welfare Human Subjects 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……………………………………………………………..35 Period of Performance Direct Labor Materials Other Direct Costs Travel Subcontracts Consultants Miscellaneous Indirect Costs Fee/Profit

Part VI - Proposal Evaluation……………………………………………………………………………..……..38 Initial Review Peer/Scientific Review Technical Evaluation Criteria Administrative Proposal Proposal Comparisons

Part VII - Proposal Forms…………………………………………………………………………………..……41

PART I - INTRODUCTION

The Centers for Disease Control and Prevention (CDC) works nationally and globally to promote health; prevent disease, injury, disability, and death; and protect against emerging health threats. CDC is the lead federal agency responsible for protecting the American public from invasive, epidemic diseases carried by vectors – insects and ticks. In this capacity, CDC blends world-class scientific research in vector-borne disease with operational response to vector-borne disease epidemics and bioterrorism; provides science-based guidance and recommendations for prevention; strives to control both natural and potential bioterrorism-related outbreaks; investigates national and international disease outbreaks; conducts multidisciplinary research to improve public health outcomes; collaborates with universities, industry, and public health partners in promoting sound disease prevention policies and practices, and serve as a national and international reference diagnostic laboratory.

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, including state and local health departments, and health care entities, educational institutions, nonprofit organizations, and private industry for research and development (R&D) to effectively respond to public health outbreaks, conduct research and perform disease prevention and control activities. CDC anticipates that the knowledge resulting from awards made under this announcement will contribute significantly to the evidence base for prevention and control of vector-borne diseases.

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

General Aims

This BAA is a competitive approach to consider proposals that harness scientific research and innovation to enhance CDC’s ability to respond to vector-borne disease endemic and exotic vector-borne diseases allowing CDC to:

1. Identify potential funding 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. Collaborate scientifically with funding recipients, depending on the interests of the Government, the availability of CDC science staff, and the nature of the project.

CDC is particularly interested in new applications of science, technologies, and innovations that provide the best value to the Government and have the potential to substantially contribute to CDC’s goals as described in this BAA.

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 co-create 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, budget, 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:

Step 1 – Electronic Contact - OPTIONAL

Potential Offerors interested in responding to the BAA are 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. If necessary to address the Offeror’s questions, the Contracting Officer will seek input from the CDC scientific coordinator for this BAA.

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. Concept papers will be limited to 4 pages in length (exclusive of resumes, bios, and references) and are aimed at facilitating an understanding of the scientific and technical aspects of the proposed research project. The concept paper is used to determine whether the concept is of sufficient technical merit and relevance to the Government’s programmatic needs prior to submission of a formal proposal. Concept papers should contain a Rough Order of Magnitude estimate (Estimated Cost). The BAA Scientific Coordinator or his/her designated technical point of contacts in the agency may reach back to the Offeror, if the Government deems it necessary to clarify or discuss scientific or technical aspects of the concept paper. The Contracting Officer will assist in this process as needed.

The Government assumes no obligation to the Offeror to continue technical dialogue following its request for, or receipt of concept papers. The Government reserves the right to reject any concept paper without comment. Similarly, receipt of a concept paper does not constitute an obligation or agreement by the Government to request submission of a formal research proposal from an Offeror.

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 proposals or may opt to solicit none.

Once the Contracting Office receives a formal research proposal, communication between scientific and programmatic personnel and the Offeror is permitted only as authorized by the Contracting Officer.

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. The primary basis for selecting proposals for award is primarily scientific/technical merit, feasibility of implementation and prior experience. Cost realism, reasonableness and fund availability will also be considered to the extent appropriate. The Contracting Officer will notify the Offeror, in writing, whether a proposal will be processed for award.

Issuance of this BAA does not constitute an award commitment on the part of CDC, nor does it commit CDC or any potential funding partners to pay for costs incurred in the preparation and submission of proposals. Further, CDC reserves the right to reject any or all proposals received.

Government obligation

Offerors are cautioned that the submission of a white 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 research areas of interest for this announcement are listed within four broad categories below. Specific topics are expressed as general questions within the category. Offerors may address any single “bulleted” topic within a category or may address multiple topics in a category if they can be feasibly addressed within the proposed project. Offerors are expected to further develop the selected topic(s) into well-defined research questions.

Note: As described in Part III of this announcement, an Offeror may submit multiple concept papers/proposals under this BAA.

Area of Interest #1: Zika Diagnostics Development: Diagnosing recent and remote Zika infections

Zika virus is a mosquito-borne flavivirus closely related to the four dengue viruses. RT-PCR based assays can specifically detect and identify Zika virus during the acute viremic phase of the infection, which in general lasts for approximately one week, yet occasionally persists beyond two weeks. The CDC IgM ELISA detects IgM antibody which generally appears during the first week of infection and remains detectable for several months. However, the antibodies produced in response to Zika virus infection (both IgM and IgG) are primarily directed against cross-reactive epitopes on the viral glycoprotein which results in a high degree of cross-reactivity to other flaviviruses, in particular with the four dengue virus serotypes. This cross-reactive immune response is particularly confounding with respect to accurate diagnosis since Zika virus co-circulates in many of the same areas as the four dengue viruses. In addition, if Zika infection is a secondary flavivirus exposure (i.e. a previous dengue infection occurred) the initial and predominant IgM response is typically more robust to the primary infecting flavivirus (i.e. dengue), further confounding diagnosis. Applied research conducted over the past 30 years has been unsuccessful at resolving this problem. For recent infections, a serodiagnostic for the specific diagnosis of acute Zika virus infection is currently unavailable. Furthermore, there is not a reliable “IgG equivalent,” for the specific diagnosis of remote Zika virus infections. CDC is seeking proposals from academic, commercial, or other entities to develop reliable assays for both recent (< 12 weeks) and remote infections (at least 12 weeks previously) with Zika virus such that a specific diagnosis can be inferred in both primary and secondary flavivirus infections. This might involve development of enhanced antibody-based tests, molecular detection tests, cellular-based test platforms, as well as newer technologies such as relying on host immune response.

Focus Areas:

1.1 Development of a serodiagnostic assay for the detection of a recent (< 12 weeks) infection with Zika virus with these desired performance characteristics:

· High sensitivity and specificity for Zika, including in the context of other flavivirus infections

· More rapid result turn-around time, since the time consuming plaque reduction neutralization test would be unnecessary

· Available to be conducted readily in clinical settings

· Able to be scaled up for large-scale testing if necessary and indicated

· Ideally

· Results available within 24-48 hours

· Able to be used in resource-poor settings without sophisticated laboratory equipment, if possible as a point-of-care test

1.2 Development of an easy Dengue and/or Zika antibody depletion kit that can be used to deplete cross-reactive antibodies from human specimens. Pre-absorption of sample through DENV antigen coated microbeads/spin column could potentially remove majority of cross-reactive antibodies, and the pre-treatment could permit more specific IgM and/or IgG-ELISA for detecting Zika infection. The pre-absorption kit should possess a high throughput potential, effectively remove cross-reactive antibodies while retaining ZIKV-specific antibodies for sufficient detection sensitivity, use only small amounts of sample, and result in high sample volume recovery. The development may include evaluation of suitable DENV antigens (e.g. 1-4 seroytypes of DENV, inactivated whole virus particles, VLP, and/or recombinant E antigens), optimization of antigen coating on various types of solid materials (e.g. microbeads and disc), and development of both DENV and ZIKV pre-absorption kits to be used crisscross before ELISA for ZIKV and DENV, respectively. In addition, pre-absorbed samples can be evaluated for virus-specific neutralization antibodies using neutralization assay. Virus specific neutralization antibody evaluation is critical for evaluation of vaccine efficacy and antibody enhancement of infection potential.

1.3 Development of ELISA based E domain-III (EDIII) of ZIKV. EDIII of flaviviruses contains highly virus specific antibody epitopes, and ELISA assay based on detecting antibody to the recombinant EDIII of ZIKV could be highly ZIKV specific. However, such an assay may result in very low sensitivity because of the weak human antibody responses to most EDIII of flaviviruses, in general. Sensitivity of such ELISA for diagnosis should be carefully evaluated with large panel of human specimens.

1.4 Development of a diagnostic assay for remote infection (>12 weeks) with the Zika virus will address the following:

· Better understanding of the epidemiology of Zika virus, including:

· Which areas have had Zika infection in the past;

· Patterns of infections in a community where Zika is present; and

· What areas are at risk for epidemic spread in the future in order to help prioritize countries or parts of countries for strengthened early detection and response and birth defects monitoring.

· Ability to monitor vaccine effectiveness and waning of vaccine-induced immunity.

· Ability to differentiate between vaccine-induced immunity and natural infection-induced immunity

· Clinical testing for couples in which either or both have had exposure to Zika and are considering conception (including men who may be at risk for harboring Zika and transmitting the infection sexually).

· If a vaccine becomes available, screening for prior Zika infection, which if present would likely indicate that vaccine is not indicated.

The remote assay should possess these desired performance characteristics:

· High sensitivity and specificity for Zika, including in the context of other flavivirus infections

· Detects an indicator of immunity that doesn’t wane over time and remains positive at least 6 months, and ideally for many years, after infection

· Available to be conducted readily in clinical settings

· Able to be scaled up for large-scale testing if necessary and indicated

· Ideally

· Results available within 24-48 hours

· Able to be used in resource-poor settings without sophisticated laboratory equipment, if possible as a point-of-care test

1.5 Conduct B-cell antibody repertoire analysis by next-generation sequencing to identify biomarkers/profiles of primary vs. secondary immune responses to ZIKA infections as well as novel antigens or epitopes for improved ZIKA-specific serodiagnostics.

1.6 Differentiation of secondary ZIKA infections by single cell analysis of cross-reactive- and ZIKA-specific- antibody secreting B cells in peripheral blood through the development of a B cell ELISpot assay that would enumerate cross-reactive B cells versus ZIKA-specific B cells in peripheral blood mononuclear cells (PBMCs). The goal would be to identify a ratio or threshold of ZIKA-specific B cells compared to dengue cross-reactive B cells to classify ZIKA secondary infections.

1.7 Enrichment of ZIKA specific antibody responses by depletion of memory B cells in peripheral blood through the development of an antibody in lymphocyte supernatant (ALS) assay. Memory (cross-reactive) B cells could be depleted from PBMCs enriching naïve, activated (ZIKA specific) B cells. Culture of enriched naïve B cells would result in the secretion of antibody into culture supernatant that could then be used in ELISA or PRNT assays to assess ZIKA specific antibody.

Area of Interest #2: Improving our understanding of the biology and ecology of Zika virus mosquito vectors and the dynamics of virus transmission within the mosquito and at the mosquito-human interface

Successful implementation of effective measures to suppress populations of Zika virus mosquito vectors (Aedes aegypti and Aedes albopictus) and to disrupt virus transmission to humans is dependent on understanding the biology and ecology of these mosquitoes as well as the virus transmission dynamics in the mosquito-human cycle. New knowledge of vector mosquitoes and virus transmission dynamics may allow for more effective/better targeted implementation of existing control methods as well as reveal novel potential control approaches. Specific topics of interest include but are not restricted to:

· Better defining the relative roles of indoor versus outdoor human biting and resting in various settings, especially for Aedes aegypti

· Investigate novel ways to determine key larval development sites in various settings for Aedes aegypti and Aedes albopictus, including tracking and relating indicators found in adult mosquitoes that could reveal the container type they emerged from (e.g., stable isotopes, rare elements, microorganisms)

· Better defining dispersal in the environment of host-seeking and gravid females of Aedes aegypti and Aedes albopictus

· Investigating novel ways to improve attraction and capture of Aedes aegypti and Aedes albopictus male and female adults

· Clarifying the ecological niches and feeding preferences of Aedes aegypti and Aedes albopictus where these species co-occur

· Clarifying the vector competence and vectorial capacity of other commonly human-biting mosquito species for Zika virus

· Studies on Zika virus dynamics within Aedes aegypti and Aedes albopictus, including virus dissemination and transmission, and the impact of environmental factors on the extrinsic incubation period

· Clarifying associations between entomological indices, including those based on virus-infected females and human infection

Area of Interest #3: Development and evaluation of strategies to suppress Zika virus mosquito vectors, prevent mosquito bites and reduce Zika virus transmission to humans

In the absence of a human vaccine, our ability to prevent Zika virus disease and effectively respond to disease outbreaks depends on access to prevention and control methods, for example integrated vector management strategies, which have been proven to reduce populations of Zika virus mosquito vectors, prevent mosquito bites and, ultimately, reduce Zika virus transmission to humans. Both development of novel control methods and field evaluation of existing as well as novel integrated vector management strategies are needed to increase public health capacity to respond to outbreaks of arboviral diseases associated with Aedes aegypti and Aedes albopictus. Specific topics of interest include but are not restricted to:

· Development of novel approaches to suppress populations of Aedes aegypti and Aedes albopictus, including non-insecticide based methods and insecticides based on natural products/biological agents

· Development of novel approaches to reduce bites by Aedes aegypti and Aedes albopictus

· Field evaluation of integrated vector management strategies, including mosquito-based outcomes and human infection

· Field evaluation of the potential for personal protective measures (e.g., use of repellents or protective clothing) to reduce human infection

· Better defining the correlation between intensity of insecticide resistance and operational vector control outcome

· Field evaluation of insecticide resistance management strategies

· Studies on the acceptability and cost of different integrated vector management strategies

· Development and evaluation of communication models leading to greater community engagement in integrated vector management strategies

· Developing safe and 100% effective sex sorting techniques for vector control methods that rely on releasing male-modified mosquitoes

Area of Interest #4: Understanding, pathogenesis and viral persistence in the host as well as the host immune response to Zika virus infection

One of the most critical elements needed for eventual control of ZIKV is an understanding of how the virus causes disease and how the patterns of pathogenesis can be disrupted. To this end, it is critical to develop animal models for determining how the host would respond to either treatment options or vaccines. Here, CDC seeks studies that would examine a range of potential animal models and determine specific tissue infectivity patterns along with immune responses generated. In this way, we can identify appropriate host cells/targets for therapeutic or prophylactic options. Specifically, CDC seeks studies to focus on:

1.1 Comparison of a range of animal models (including non-human primates) to determine patterns of pathogenesis by both vector-borne and sexual routes of transmission. The comparisons should be performed to identify the most relevant model that mimics the patterns of disease associated with human infection. The models should include identification of minimum infectious dose of virus through different infection routes, tissues and cell types infected by each route, concentration and duration of viral load in body fluids (serum, urine, semen, etc.) and tissues, severity of disease associated with each, and critical points that could be targets of disruption by therapeutics or vaccine approaches.

1.2 Determine if sexual route of transmission results in greater rates of infection of the fetus or severity of outcome in the fetus as compared with non-sexual infection of the mother in model selected.

1.3 Evaluate the role of various immune factors (CMI, antibody, pre-existing immunity, innate immunity, etc.) in modulating the pathogenesis of disease; particularly in pregnant model systems. How does the natural modulation of the immune response during pregnancy affect the course of infection and pathogenesis? Is this course of pathogenesis altered due to the presence of pre-existing flavivirus immunity?

1.4 Evaluate the role of viral genetics in understanding the pathogenesis in the various models. Does genotype (Asian versus African, etc.) affect pathogenesis patterns that could be relevant in vaccine or therapeutic efforts Evaluate potential antivirals or vaccine candidates in selected animal model systems to determine safety, efficacy, and course of administration necessary to prevent disease or fetal infection.

1.5 Evaluate potential antivirals or vaccine candidates in selected animal model systems to determine safety, efficacy, and course of administration necessary to prevent disease or fetal infection.

WHAT WE ARE LOOKING FOR

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

1. Offerors shall describe their understanding of relevant scientific literature related to the research to be conducted.

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

3. Offerors are encouraged to engage with relevant partners and entities with advanced subject matter expertise in relevant disciplines, if applicable to the proposed project.

4. Although CDC anticipates proposed projects will rely on primary data collection, Offerors may also propose use and analysis of existing data.

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

6. 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 features of the project, the nature of the collaboration may vary. In all cases CDC shall have final decision-making authority about the technical direction of the project. Data, tools, products, and other deliverables resulting from the project remain the property of the U.S. government, although they may become part of the public domain in accordance with applicable laws and regulations.

7. Offerors must specify in proposals how the resulting knowledge, practices, or tools can be effectively implemented, and include a project component that addresses dissemination of knowledge and support for translation.

WHAT WE ARE NOT LOOKING FOR

1. Research that replicates knowledge gained from prior studies, without adding significant new information to the evidence base or providing a useful extension of current knowledge.

2. Solutions or practices that are less efficacious than current technologies or approaches.

3. Proven approaches that are already in use in the field.

4. Projects that lead to knowledge, tools, or practices that cannot be feasibly translated to policy or practice and evaluated for impact.

Eligibility

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

· Accredited U.S. schools 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.

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 a Program Subject Matter Expert, may at its discretion, discuss elements of these papers with Offerors to clarify ideas, proposed methods, scope, or other matters pertinent to the Government’s specific research needs.

For successful proposals, funding recipients may be required to collaborate scientifically with CDC scientific staff. Collaboration may include CDC input into study design; CDC participating in data analyses; CDC participating in development of tools or products, and CDC leading or participating in authorship of scientific publications resulting from the research. The extent and nature of the collaboration will depend on availability of CDC resources and expertise relevant to the project. Final decision authority regarding the nature and extent of scientific collaboration is held by the CDC.

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

This step initiates a technical dialogue between the Government and the potential offerors. Potential Offerors are required to e-mail questions regarding the concept paper submission process or other aspects of the acquisition process no later than October 18, 2016 at 2:00 pm Eastern Standard Time (EST). The CDC POC is Berta Alldredge at boh9@cdc.gov. If necessary, the Contracting Officer will solicit input from the CDC Scientific Coordinator for this BAA. The responses to all questions will be posted on the FedBizOpps website. The Government may reach out to the Offeror 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 page 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 (see Part IV). Concept papers shall contain a Rough Order of Magnitude estimate (Estimated Cost).

All submitted concept papers will undergo an initial review for technical merit and program applicability. The Scientific Coordinator and/or members of the technical review team may discuss the proposed project with the potential Offeror, as required, to facilitate the Government’s understanding of the scientific and technical aspects of the proposed research project. The Contracting Officer will assist in this process as needed. 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 no later than 2:00 p.m. EST on October 20, 2016. There are no exceptions to this deadline.

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 IV). 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.

Step 4 - Contract Award for Selected Projects

All proposals will receive an initial review (see Part V). Of these, all, some or none of the proposals will be reviewed more thoroughly by a Technical Evaluation Panel. The Contracting Officer will notify the Offeror(s), in writing, whether the proposal will be processed for award. 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 Government has the right to make 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 Berta Alldredge, who may be reached by email at: boh9@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. Any questions or clarification of project objectives or methods may be directly discussed between the Scientific Coordinator (or his/her designated technical points of contact) 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. 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 encouraged to provide more general statements about their proposed approach to the study of the topic, including, methods, solutions to be developed, and other characteristics listed in Part I of this BAA. Offerors are encouraged to ensure that submitted concept papers demonstrate a clear grasp of content area for this project as well as an equally clear grasp of the methodological challenges (and potential solutions) for studying the topic effectively. Proposals that approach the challenges through novel, cross-disciplinary, or mixed-method approaches are highly encouraged. Offerors should also briefly address how the research will be translated to practice or otherwise implemented and are highly encouraged 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 work proposed.

· 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 5 years (60 months) to complete the project.

· Offerors may submit a multiple concept papers in response to this announcement. 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), provide a listing and basic qualifications of likely organizational partners, sub-contractors, etc., with whom you would work if additional subject-matter expertise or other assistance is likely to be needed

Concept Paper Submission

This BAA is open and in effect from the date of release September 30, 2016 through October 20, 2016. THIS IS AN IMMEDIATE CALL FOR CONCEPT PAPERS. Concept papers must be received by 2:00 p.m. EST on October 20, 2016 to be considered. There are no exceptions to this deadline. Concept papers shall be submitted electronically to Berta Alldredge at boh9@cdc.gov.

Eligibility to Submit a Formal Proposal

Concept papers will be reviewed by the Scientific Coordinator and designated program technical experts within the agency. Scientific/technical merit, relevance and utility of the proposed project for CDC’s programmatic needs, and availability of funding are of equal importance. 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 in Part I, 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.

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. Blank proposal forms are included in Part VII 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.

Proposals shall not be submitted until after the concept paper due date and review period. Offerors will be notified by the Contracting Officer if they are invited to submit a formal proposal.

Any questions concerning the preparation or content of the research proposal should be directed to the Contracting Officer.

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.

Offerors must be registered in SAM.GOV in order to be considered.

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 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

In addition to all other required deliverables, the winning Offeror (Contractor) shall provide the COR with a bi-monthly (every two months) progress report detailing tangible accomplishments and progress towards benchmarks, milestones, and production of deliverables as well as identify key risks and challenges (and potential solutions) to successful completion of specific deliverables or the overall project. The Contractor shall provide, either as part of the bi-monthly progress report or the billing invoice, a breakdown of labor hours by personnel (including rates charged), as well as a brief summary of work undertaken/completed by each person performing work during the invoiced period. Finally, the Contractor shall, in partnership with the COR, develop a mutually agreed upon plan for communicating by conference call or in-person (including frequency of such communications) with the COR (and/or other staff, as determined by COR), and shall adhere to that plan.

Other Requirements

The Contractor and all project staff shall agree to sign and be bound by the requirements of CDC’s non-disclosure agreement. The Contractor further agrees not to publish or disseminate information obtained or generated from this project during or following the conclusion of the period of performance without express written permission from CDC. In addition, the Contractor shall agree to share project management information, data and/or documentation related to resource allocations and expenditures, to include but not be limited to individual or aggregate labor hours per task, activity or sub-task; progress tracking; burn rates; and forecasting, upon request by CDC. Finally, the Contractor shall, upon request by CDC, provide requested documentation, files, or other information related to the project (data, output, meeting notes, etc.) within two working days of request.

Rights in Data and Publication

FAR Clause 52.227-14 Rights in Data-General (May 2014) shall be observed

All data, deliverables and products developed in the performance of this work shall become and remain the property of the US Government. All material developed in the performance of this contract for publication, including derivative works, shall be identified and approved by CDC prior to initiation, and processes must follow CDC’s Authorship and Scientific Clearance Policies, as applicable, prior to submission for publication. CDC shall have final approval over manuscripts and publication of reports, articles in scientific journals, derivative works and the dissemination of findings developed in the performance of this contract. Final approval shall be in writing. Development of manuscripts, publication of reports, articles in scientific journals, and derivative works utilizing data obtained through the performance of the contract shall be the result of collaboration between the CDC and the contractor and all such products shall include CDC authorship unless declined by the Government.

CDC requires a data management plan (DMP) to be developed during the project planning phase, prior to the initiation of collecting or generating public health data. A DMP plan will address data security, documentation and preservation of data, data and mechanisms for data access and data sharing, or explanation of why long-term preservation and access are not justified. Any recipient of funding whose terms of award do not include submitting data to CDC should seek to deposit a de-identified data set, accompanying data dictionary, and other documentation relevant to use of the data set in a sustainable repository for archival and long-term preservation. Awardees will be required to inform the appropriate CDC point-of-contact identified by the CIO, via an update to their DMP, the location of where the data are stored. Data underlying scientific publication should be made available coincident with publication of the paper, unless the data set is already available via a release or sharing mechanism.

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.