Population Health Research Support

This is a Small Business Sources Sought Notice. This is not a solicitation for proposals, proposal abstracts or quotations. The purpose of this notice is to obtain information regarding:( 1) the availability and capability of qualified small business sources; (2) whether they are small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; HUBZone small businesses; woman-owned small businesses; or small disadvantaged businesses and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: The Division of Intramural Population Health Research (DIPHR) is an intramural research division at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) whose mission is to improve population health across the life course by maximizing health and preventing disease [http://www.nichd.nih.gov/about/org/DIPHR/Pages/default.aspx]. The Division comprises the Office of the Director along with three research branches: Biostatistics and Bioinformatics, Epidemiology, and Health Behavior. As an intramural research entity, the Division designs and conducts innovative, high-risk research aimed at answering critical data gaps regarding human fecundity, reproduction and development; pregnancy and delivery, including adverse pregnancy outcomes; offspring health, growth and development from birth to adulthood, and adolescent behavior. In addition, the Division conducts original methodologic research aimed at developing novel statistical tools for analytic purposes. The Division's research focuses on various population subgroups including couples or individuals of reproductive age, pregnant women, infants, children, and adolescents. Increasingly, research is designed to assess the early origins of health and disease underscoring the need for the development of accurate methods for measuring environmental (non-genetic) exposures during sensitive windows of human development in the context of genetics, with the overarching goal of identifying population level interventions for maximizing health across the lifespan. The multi-faceted nature of the Division's research includes normative, etiologic and interventional research, examples which follow: 1) studies aimed at defining - normal' or recruiting generally healthy participants include the NICHD Fetal Growth Studies and BioCycle Study, and 2) studies aimed at determining the relation between environmental (non-genetic) exposures (e.g., Upstate KIDS Study, ENDO Study and LIFE Study), 3) bio-behaviors (e.g., Naturalistic Teen Driving Studies and NEXT Study), and 4) genes (e.g., Diabetes and Women's Health and Genetic Determinants of Birth Defects) and a spectrum of outcomes. In addition, the Division conducts interventional research involving but not restricted to families (e.g., CHEF Trial and FMOD Trial) and clinical populations (e.g., EAGeR Trial and FAZST Trial). The Division also conducts perinatal epidemiologic studies involving detailed collection of information from medical records (e.g. Consortium on Safe Labor and NICHD Consecutive Pregnancies Study). Innovative and flexible research centers capable of implementing epidemiologic and behavioral research focusing on human reproduction; pregnancy; infant, child and adolescent health, growth and development; and human behavior are needed to assist the Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in the successful completion of original population health research. The breadth and complexity of population health research undertaken by Division investigators poses unique challenges with regard to several aspects: defining sampling frameworks that can be enumerated, incorporating varying units of analysis (e.g., individuals, menstrual or treatment cycles, couples, twins/siblings, families) into study designs; specifically targeted recruitment and retention of study participants; and longitudinal questionnaire data and biospecimen collection to capture of time-varying covariates and outcomes. Of note is the hierarchical data structure generated by much of the Division's research reflecting the recruitment of triads/dyads or genome wide analytic studies (GWAS) or multi-scale data from study participants (e.g., day, cycle, woman and couple level data collection for fecundity and fertility research, schools, census levels). Therefore, DIPHR aims to establish three to five research support centers capable of implementing sophisticated initiatives, from preconception through adulthood, using scientifically valid and rigorous methodologies, to assist in the conduct of population health research initiatives. It is anticipated that initially 1-2 new research (observational cohorts and/or intervention trials) initiatives would be implemented each year utilizing one or more centers per initiative. Potential sources must demonstrate and document the following in their capability statements: - Ability to recruit targeted and diverse population-based study cohorts (e.g., inclusive of vulnerable population subgroups such as pregnant women, infants, children, adolescents). Specifically, to address upcoming task orders, each site will be required to demonstrate an ability to recruit & retain: a. 600-800 women seeking OI/IUI fertility treatment across the range of adiposity (including all BMI categories) per year. In addition, potential sites will be evaluated on their ability to recruit/retain 200 women seeking OI/IUI per minority group (Black, Hispanic, Asian) per year or the ability to recruit/retain one particular minority group at a rate of 400 per year. b. 2000-3000 pregnant women/deliveries per year. c. 200 families of first-born children per year, with ability to reach families with diverse socioeconomic and racial make-up. Note, subcontracts are permitted to enhance targeted recruitment goals. - Ability to follow and retain study cohorts across time, including outside of clinical settings. - Ability to capably collect and process a range of biospecimen types (e.g., blood, urine, saliva, semen, hair, placenta, cord blood, microbiome, etc.). - Ability to meet and comply with regulatory and administrative processes such as human subjects protection, Investigational New Drug/Device requirements, Federal Information Security Management Act (FISMA), or the registrations of clinical trials. Capability statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: - Ability to work as a part of a multi-site collaborative research team including the use of web-based data management structures hosted by a separate contract (i.e., data coordinating center) - experience in the design, conduct and successful completion of observational prospective cohorts and randomized trials involving individuals and couples of reproductive age, pregnant women, infants and children, and adolescents. - Resumes of proposed personnel shall be submitted. Trans-disciplinary research teams comprising population health specialists, subject matter experts and clinicians with demonstrated research training and experience in the conduct of population health (observational and interventional) research as demonstrated by history of extramurally funded research grants, peer reviewed publications in top tier population health and clinical journals, and graduate level academic training in population health at offerors' academic institutions are needed. Organizational Capacity will evaluate the organizational capacity of the Offeror's facilities and research environment. This includes: organizational support, equipment and other physical resources; effectiveness of the proposed features of the organizational environment, infrastructure, and/or personnel for the project proposed. Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that your organization has met the above qualifications. Interested parties must identify at least three other projects of similar size and complexity. Responses: Capability statements in response to this announcement should be no longer than 15 pages inclusive of all material. Responses will be evaluated on the basis of experience, expertise, and capabilities in the areas cited above. The anticipated contract type will be an Indefinite Delivery Indefinite Quantity Task Order contract with an ordering period of approximately 7 years. The RFP is anticipated to be posted on or about March 1, 2018 on FedBizOps (FBO) website: http://www.fedbizops.gov Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDIENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Businesses that believe they possess the capabilities necessary to undertake this project should submit electronic copies of their capability statement, addressing the areas above. Please limit responses to 15 pages or less. Any proprietary information should be so marked. Capability Statements should be received by the Contracting Officer by no later than 2:00 PM Eastern Time on January 30, 2018. Capability statements must identify the business status of the organization (i.e. educational institution, non- profit, large business, small business, 8 (a), or other corporate or non-corporate entity). Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort;(2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project officer: (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, and a statement regarding industrial security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement.