BAA_2017-Q-66210.pdf

CENTERS FOR DISEASE CONTROL AND PREVENTION

MONITORING AND EVALUATION OF THE ZIKA CONTRACEPTION

ACCESS NETWORK (Z-CAN) IN PUERTO RICO

BROAD AGENCY ANNOUNCEMENT (BAA)

2017-Q-66210

ISSUE DATE: December 20, 2016

EXPIRATION DATE: January 20, 2017

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: Monitoring and evaluation of the Zika Contraception Access Network (Z-CAN) in Puerto Rico

WHAT WE ARE LOOKING FOR

WHAT WE ARE NOT LOOKING FOR

Eligibility

PART III – OVERVIEW OF SUBMISSION PROCESS……………………………………………………..15

Step 1 – Electronic Contact – OPTIONAL…

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

Step 3 - Submission of Formal Research Proposal

BAA POINTS OF CONTACT

PART IV - CONCEPT PAPER SUBMISSION………………………………………………………………..16

Concept paper Format and Content

Concept Paper Submission

Eligibility to Submit a Formal Proposal

PART V - PROPOSAL PREPARATION AND SUBMISSION……………………………………….……..18

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…………………………………………….………………..22

Proposal Copies

Proposal Content

Section I - Technical Section……………………………………………………………………………………24

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……………………………………………………………..33

Period of Performance

Direct Labor

Materials

Other Direct Costs

Travel

Subcontracts

Consultants

Miscellaneous

Indirect Costs

Fee/Profit

Part IV - Proposal Evaluation……………………………………………………………………………..……..35

Initial Review

Peer/Scientific Review

Technical Evaluation Criteria

Administrative Proposal

Proposal Comparisons

Part V - Proposal Forms…………………………………………………………………………………..……38

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’s mission is to protect and improve health through science, policy, partnership and evidence-based public health action.

Achieving this objective has become increasingly complex as a result of the emergence of new microbes and biologic threats. Recent outbreaks, such as Zika, has demonstrated the need for CDC to rapidly collect, integrate and analyze data and quickly translate complex information into action. The provision of science-based guidance and recommendations is based, in part, on public health surveillance and research.

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 improve understanding of health outcomes associated with Zika virus, pregnancy and birth defects. CDC anticipates that the knowledge resulting from awards made under this announcement will contribute significantly to the evidence base for prevention and response to adverse pregnancy, birth and developmental outcomes.

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 shall 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.

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 is listed below.within three 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.

1. Area of Interest 1-Cohort Studies

a. Area 1(a): Zika Virus Longitudinal Study to Assess Long Term Health and Developmental

Effects of Infants with Congenital Zika Virus Infection up to 5-years of Age in Colombia

b. Area 1(b): Assessing Congenital Infection and Developmental Outcomes among Liveborn

Infants Prenatally Exposed to Zika Virus Infection

2. Area of Interest 2-Expanding Access to Appropriate Diagnostic Testing, Health Services, and Early

Intervention Services for the Management of Zika Virus Infection During Pregnancy and Congenital

Zika Virus Syndrome

3. Area of Interest 3-Monitoring and Evaluation of the Zika Contraception Access Network (ZCAN) in

Puerto Rico

Area of Interest #1(a): Longitudinal cohort study to assess the long-term health and developmental effects of infants with congenital Zika Virus infection up to 5-years of age in Colombia

Zika virus (ZIKV) is a mosquito-borne flavivirus transmitted primarily by Aedes aegypti mosquitoes.

Transmission of Zika virus from mother to fetus and sexual transmission have been reported. The Zika virus outbreak was first reported in Colombia in October 2015: to date there are over 150,000 cases of Zika virus disease reported with nearly 20,000 in pregnant women. A causal link has been established between Zika virus infection in pregnancy and microcephaly and other sever brain anomalies, and the phenotypic characteristics of congenital Zika syndrome have been elucidated. Infants with microcephaly can experience a range of health problems including seizures, developmental delays and intellectual disability, feeding problems such as difficulty swallowing, hearing loss, and vision problems.

The association between Zika virus infection during pregnancy and other adverse infant outcomes is not established, and there is lingering concern that infants that are born with no apparent adverse effects may experience a post-natal decrease in brain development as well as other neurological and neurodevelopmental sequelae that have yet to be fully understood. CDC is seeking to fill these gaps in our knowledge through the execution of longitudinal follow-up infant study in Colombia.

CDC is currently launching a longitudinal pregnancy cohort study called ZEN (Zika en Embarazadas y Ninos) in which pregnant women, theory partners, and their infants will be followed up to age 6-months in four cities in

Colombia. ZEN expects to recruit 5,000 pregnant women during the first trimester of pregnancy. Pregnant women will be regularly followed with frequent ZIKV testing to detect incident infection. In addition, ZEN expects to enroll 1,250 male partners and follow them throughout the pregnancy to detect incident infection.

Finally, it is expected that 4,500 infants will be born into the study. All infants will be followed up for 6-months during which time they will receive a cranial ultrasound (at delivery or within 72 hours), head circumference measurements, vision and hearing screening, and neurodevelopmental assessments. The main objectives of ZEN are to understand the risk factors for ZIKV infection in pregnant women and their infants, and assess the risks and the modifiers of those risks, for adverse maternal, fetal and infant outcomes associated with infection.

1.1a Conduct a new longitudinal cohort study to examine the relationship between ZIKV infection during pregnancy and the full spectrum of possible adverse infant and child outcomes occurring between age 6-months to 5-years. The study will follow a cohort of up to 900 infants into the ZEN cohort and will monitor and document the full range of potential adverse health and developmental outcomes associated with congenital

ZIKA virus infection. The infants will be randomly sampled from the total population of the existing ZEN infants, stratified by ZIKA infection status of the mother. The cohort will consist of 2 arms. Arm 1 will include infants born to Zika infected mothers (i.e. the exposed population). Those infants could have microcephaly or other central nervous system defects, as well as be infants born with no apparent abnormalities. Arm 2 will be the comparison population of infants born to mothers with no evidence of Zika Virus infection during pregnancy. Study clinic visits will correspond to regular well-baby visits at 9, 12, and 18 months and at 2-years, 3, 4, and 5. Specific components of the study protocol may include: laboratory testing for ZIKV and other infections, administration of questionnaires to mothers/caregivers, medical records abstractions of routine well-baby checks and sick visits, hearing and vision screenings, developmental and cognitive assessments, both directly-observed and parent-reported, and neuroimaging, if necessary, including CT scans and/or MRI. This study protocol will be developed in close collaboration between CDC and the Instituto Nacional de Salud (INS) of Colombia.

Area of Interest #1(b): Assessing congenital infection and developmental outcomes among live-born infants prenatally exposed to Zika virus infection

Zika virus (ZIKV) is a mosquito-borne flavivirus transmitted by Aedes species mosquitoes that can be spread mother-to-child, sexually, and through laboratory infection.1-3 ZIKV in pregnancy can cause microcephaly and related brain abnormalities when fetuses are exposed in utero. Other adverse pregnancy outcomes related to

ZIKV infection remain under study, and include pregnancy loss, other major birth defects, arthrogryposis, eye abnormalities, and neurologic abnormalities.4-6

CDC currently recommends ZIKV testing in infants within 2-days after birth to women with laboratory evidence of ZIKV infection during pregnancy and infants who have abnormal clinical or neuroimaging findings suggestive of congenital Zika syndrome, regardless of maternal Zika virus test results.7

Recommended infant laboratory evaluation includes both molecular (real-time reverse transcription-polymerase chain reaction {rRT-PCR} and serologic {immunoglobulin [IgM]} testing. In addition, PRNT testing is recommended for mother-infant pairs with positive or equivocal IgM testing. PRNT testing is recommended for either mother or infant to confirm that Zika IgM is not a false positive result. Current guidance relies on infant testing to confirm infant ZIKV infection, indicated by a positive infant serum or urine rRT-PCR test, or to determine a diagnosis of probable congenital Zika virus infection as indicated by an IgM positive test, with a negative rRT-PCR result. While cord blood testing was initially recommended to diagnose fetal infection, cord blood testing is no longer recommended because of concerns of false positive results. For infants with a diagnosis of probable Zika virus infection, infant PRNT testing is recommended at 18 months of age, a time which maternally-derived IgG is no longer expected to be present in the infant serum. The infant testing protocol was based on expert opinion and relies on extrapolation of data for the diagnosis of other congenital infections.

A recent case study reported a male child born in Brazil with microcephaly with ZIKV RNA cleared by day

216.8 The infant exhibited no obvious illness or evidence of any immunocompromising condition when examined on day 54. However, he demonstrated neuropsychomotor developmental delay, with global hypertonia and spastic hemiplegia, by 6 months of age. In general, less is known regarding the full spectrum of congenital infection related to growth and developmental outcomes after birth. A case series of infants with abnormal brain development who have molecular evidence of ZIKA RNA in amniotic fluid, placenta or fetal tissues, demonstrated the absence of IgM in infants tested after birth, calling into question the sensitivity and reliability of IgM testing of infants. Anecdotal evidence from the U.S. Zika Pregnancy Registry (USZPR) and the Puerto Rico Zika Active Pregnancy Surveillance System (ZAPSS) have also identified infants with the congenial Zika virus infection phenotype, whose mothers have laboratory evidence of Zika virus during pregnancy, but who do not have molecular or serologic evidence of Zika. Lastly, the Brazil case control study suggests that infants with congenital Zika virus syndrome may not have IgM positive results if tested beyond 3 months of age. Given the emerging evidence suggesting possible limitations of infant serum testing, there is a need to determine the ideal testing protocol to establish laboratory evidence of congenital Zika virus infection and syndrome.

This area of interest seeks to assess the performance of laboratory testing in the diagnosis of congenial Zika infection and syndrome, the correlation of laboratory testing with neurologic imaging and the correlation of laboratory testing and neurologic findings in the early neonatal period with developmental outcomes among live born infants born to mothers with any laboratory evidence of possible ZIKV infection during pregnancy. This project will assess developmental outcomes from newborn through 2 years old. Understanding how to diagnose congenital infection in infants is critical for ensuring these children receive appropriate clinical management and early intervention services to maximize their quality of life. Identifying adverse outcomes in this cohort that may present several months after birth will help parents, families, and healthcare systems develop a longitudinal care plan that will include medical and psychosocial support.

Information from this project will provide critical data to inform an evidence-based diagnostic testing and evaluation algorithm and will lead to a better understanding of the developmental risks for children born to women infected with ZIKV during pregnancy. Improved understanding of these risks will result in better counseling of women and families, an enhanced understanding of the pathogenesis of Zika, improved access to clinical services for infants unrecognized by the current testing algorithm, and may lead to new options for clinical management. These activities will also inform clinical guidance for testing, evaluation, and management of infants prenatally exposed to ZIKV.

The cohort for this project (estimated at 200 mother-infant pairs) will consist of infants born to women with any evidence of possible ZIKV infection in maternal, placental, or fetal/infant samples delivering in areas without evidence of active ZIKV transmission and in select states with a high volume of pregnant women with travel-associated ZIKV who are participating in the U.S. Zika Pregnancy Registry (USZPR). The USZPR will serve as a case registry for identification of eligible mothers.

Objectives of this study are to:

1.1b Determine the optimal testing strategy and specimen type to identify congenital infections among this cohort of infants born to women with any laboratory evidence of possible Zika virus infection during pregnancy through:

PCR, IgM, and PRNT testing of infant serum and urine at birth;

PCR and IgM testing of residual samples of cerebrospinal fluid if collected for clinical purposes;

Repeat infant urine testing once a month for any infants with PCR positive specimens at birth;

PRNT testing of infant serum at 12 months;

PRNT testing of infant serum at 18 months.

1.2b Determine the correlation between laboratory test results with postnatal neurologic imaging.

1.3b Determine the role of postnatal ultrasound and MRI imaging on the identification of brain abnormalities in comparison to those identified by postnatal cranial ultrasound, and the predictive value of findings for each imaging modality and combined on developmental outcomes.

1.4b Determine the correlation between laboratory test results and developmental outcomes using standardized methods at age 6, 12, 18, and 24 months.

References:

1. Petersen LR, Jamieson DJ, Powers AM, Honein MA. Zika Virus. N Engl J Med 2016; 374:1552-63.

2. Brooks JT, Friedman A, Kachur RE, LaFlam m, Peters PJ, Jamieson DJ. Update: Interim Guidance for

Prevention of Sexual Transmission of Zika Virus – United States, July, 2016. MMWR Morb Mortal

Wkly Rep 2016; 65; 745-7.

3. Filipe AR, Martins CM, Rocha H, Laboratory Infection with Zika Virus after Vaccination Against yellow fever. Arch Gesamte Virusforsch 1973; 43: 315-9.

4. Ventura CV, Maia M, Dias N, Ventura LO, Belfort R, Jr. Zika: neurological and ocular findings in infant without microcephaly, Lancet 2016; 387:2502.

5. Martines RB, Bhatnagar J, De Oliveira Ramos AM, et al. Pathology of congenital Zika syndrome in

Brazil: a case series. Lancet 2016; 388: 898-904.

6. Moore CA, Staples JE, dobyns WB, et al. Characterizing the Pattern of Anomalies in Congenital Zika

Syndrome for Pediatric Clinicians. JAMA Pediatr Nov 2016.

7. Russell K, Oliver SF, Lewis L, et al. Update: Interim Guidance for the Evaluation and Management of

Infants with Possible Congenital Zika Virus Infection – United States, August 2016. MMWR Morb

Mortal Wkly Rep 2016; 65: 870-78.

8. Oliveira DBL, Almeida FJ, Durigon EL, et al. Prolonged Shedding of Zika Virus Associated with

Congenital Infection. New England Journal of medicine 2016; 0:null.

Area of Interest #2: Expanding access to appropriate diagnostic testing, health services, and early intervention services for the management of Zika virus infection during pregnancy and congenital Zika virus syndrome

Diagnosing Zika Virus infection can be difficult and complex for clinicians. The decision of whether to test for

Zika virus infection should be guided by relevant exposure information and clinical history. Clinicians should have clear guidance on the indications for testing for Zika virus in their patients, with access to local or state health departments for discussion on whether testing is appropriate. Testing for Zika virus infection requires a multistep process that involves many challenges, including the need to collect different samples at various time-points, lack of access to necessary tests, and test results that are often difficult to interpret. Additionally, clinical management of Zika virus infection during pregnancy and the provision of specialized medical care for infants exposed to Zika virus infection in uteri can be complicated and necessitates specialized health services.

Improved access to appropriate health services – including appropriate diagnostic testing, specialized clinical care, and early intervention and developmental services – may potentially lessen the overall impact of Zika virus infection in pregnancy and improve long-term outcomes for Zika-affected children. CDC, in collaboration with the March of Dimes, is working to establish a specialty provider network, known as Zika Care Connect, 10 high-risk jurisdictions in the United States to connect those affected by the Zika virus to necessary healthcare services. CDC seeks to:

Expand this referral network to potentially include additional high-risk jurisdictions;

Develop an expanded set of healthcare providers and health services for Zika virus referral;

Develop a referral program for early intervention and developmental services for those diagnosed with the Zika virus;

Develop a web portal with on-line information for clinicians on available laboratory testing.

Proposed activities should include the following:

2.1 Application of lessons learned from initial development of Zika Care Connect to rapidly expand healthcare provider recruitment to facilitate further reach and greater impact.

2.2 Assessment and expansion of the distribution of healthcare providers in the Zika Care Connect network to facilitate improved access to a qualified provider for all women and families, regardless of their residence.

2.3 Assessment of the factors that influence access to early intervention services, developmental evaluation services, and occupational and physical therapists.

2.4 Implementation of a new referral component of Zika Care Connect that facilitates access for families affected by the Zika virus to early intervention services, developmental evaluation services, occupational and physical therapists, and addresses any identified barriers for referral.

2.5 Integration of program expansion components into existing program infrastructure.

2.6 Expansion and maintenance of a web portal for clinicians that provides detailed information on Zika virus laboratory testing – including laboratory locations, required specimens needing to be collected, testing algorithms, data on test performance, and guidance on interpretation of results – to facilitate a better understanding of Zika virus diagnostics and improve the identification of pregnant women and infants infected with the Zika virus.

2.7 Establishment of a standardized and systematic approach to regularly collect information from public health and commercial laboratories testing for the Zika virus.

Area of Interest #3: Monitoring and evaluation of the Zika Contraception Access Network (Z-CAN) in

Puerto Rico

Increasing evidence links Zika virus infection during pregnancy to adverse pregnancy and birth outcomes.

Because of the potential risks associated with Zika virus infection during pregnancy, CDC has recommended that health care providers discuss prevention of unintended pregnancy with women and couples who reside in areas of active Zika virus transmission and do not want to become pregnant. However, limitations in access to contraception in some of these areas might affect the ability to prevent an unintended pregnancy. Puerto Rico continues to report the highest number of Zika virus disease cases in the United States and U.S. territories. High rates of unintended and adolescent pregnancies in Puerto Rico suggest that, in the context of this outbreak emergency, access to contraception might need to be improved. CDC estimates that 138,000 women of reproductive age (ages 14-44 years) in Puerto Rico do not choose pregnancy and are not using one of the most effective or moderately effective contraceptive methods, and therefore might experience an unintended pregnancy. In response, the Zika Contraception Access Network (Z-CAN), a public health program through the

CDC Foundation, was launched in April, 2016. Z-CAN was designed to develop a network of physicians at clinics across Puerto Rico who are trained to provide patient-centered contraceptive counseling and same-day access to the full range of FDA-approved, reversible contraceptive methods to women of reproductive age who desire to delay or avoid pregnancy at no cost.

Public health monitoring activities are currently planned and will soon begin to evaluate the implementation and impact of Z-CAN, including focus groups with women of reproductive age enrolled and not enrolled in the Z-

CAN program, online surveys of Z-CAN patients, and semi-structured, individual interviews and online surveys of Z-CAN physicians and clinic staff. The specific objectives of those activities include:

1) Women’s perceived facilitators and barriers to accessing reversible contraceptive use in Puerto Rico among both Z-CAN and non-Z-CAN clients;

2) Contraceptive patterns, contraceptive continuation rates, and pregnancy rates among Z-CAN patients;

and

3) Physician and clinical staff perceptions of potential areas of Z-CAN program improvement that could improve patient access to contraception.

For this research area, CDC seeks to conduct additional monitoring and evaluation activities to further assess the implementation and impact of Z-CAN, such as:

3.1 A policy analysis of Medicaid, Title X, Federally Qualified Health Centers (FQHC), and private insurance coverage of contraception and family planning related services in Puerto Rico, to also potentially include focus groups and/or semi-structured interviews with key stakeholder groups

(e.g., policy makers, policy implementers, end-users) to assess policy implementation of Z-CAN.

3.2 A physician survey assessing provider attitudes and practices related to evidence-based contraceptive care (e.g., recommendations included in CDC’s United States Medical Eligibility

Criteria for Contraceptive Use, United States Selected Practice Recommendations for Contraceptive Use, and

Providing Quality Family Planning Services) to be sent to all

Practicing obstetrician-gynecologists (OBGYNs) in Puerto Rico, regardless of Z-CAN training status.

3.3 Enrollment of Z-CAN patients to participate in 6 and 12 month follow-up online surveys to assess contraceptive patterns, contraceptive continuation rates, and pregnancy rates among

Z-CAN patients.

3.4 Longer-term follow-up with Z-CAN patients choosing long-acting reversible contraception (LARC), at 24 and 36 months, to assess satisfaction, continuation rates, and any encountered barriers with LARC removal, if removal was desired (e.g., finding a Z-CAN provider to remove device, cost).

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.

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:

1. Accredited U.S. schools of public health

2. Other accredited U.S. institutions of higher education and academic departments

3. Private or public research institutes and centers based in the U.S.

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

5. 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 January 10, 2017 at 2:00 pm Eastern Standard Time (EST). The CDC POC is Lauren Peel at lpeel@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 January 20, 2017. 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.

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. 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 Lauren Peel, who may be reached by email at: lpeel@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):

1. 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

2. Concept paper submissions shall not contain classified information.

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

4. Tables and charts are permitted in the concept paper

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

6. An estimated timeline not to exceed 5 years (60 months) to complete the project.

7. Offerors may submit a multiple concept papers in response to this announcement. A concept paper must be no more than 4 pages in length.

8. 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

9. 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.

10. 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

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.

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

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.

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.