Small Business Sources Sought (SBSS): Diabetes Risk across Women's Lifespan: A study of long-term health implications of glucose intolerance in pregnancy for Division of Epidemiology, Statistical and Prevention Research (DESPR)

Purpose of this Announcement: 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; 8(a) small businesses, veteran-owned 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. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees or less. Background and Project Requirements: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to acquire valid and reliable data from a cohort of women with a history of gestational diabetes to: 1).Investigate the role of genetic variants important for glucose homeostasis in the progression of gestational diabetes to type 2 diabetes; 2)To quantify the role of selected environmental factors (e.g., body weight and weight history characteristics, dietary factors, or physical activity) in the progression of gestational diabetes to type 2 diabetes; 3)To assess the interactions of genetic and environmental factors in the progression of gestational diabetes to type 2 diabetes; and 4)To identify biochemical markers (in blood, urine, or toenails) for type 2 diabetes and for subsequent use in predicting the development of type 2 diabetes among women with a history of gestational diabetes. A secondary goal of this study is to obtain baseline data on the children born from a pregnancy complicated by GDM and evaluate the feasibility of studying their long-term health conditions, possibly by establishing a new cohort comprising offspring. To achieve these goals, the offeror shall identify a historical cohort of 2,500-5,000 women with a history of gestational diabetes who have been followed for a minimum of 10 years after the index pregnancy complicated by gestational diabetes or for whom there are updated medical data available for the 10 or more years after the index pregnancy complicated by gestational diabetes. Existing data for cohort members during the historical follow-up should at least include information on the diagnosis of type 2 diabetes and related co-morbidities, time of the diagnosis, medical history, reproductive history, and anthropometric characteristics before type 2 diabetes developed in the years after the index pregnancy. Women with pre-gestational diabetes and evidence suggestive of undiagnosed diabetes before the index pregnancy (i.e. women diagnosed with diabetes within one year following a diagnosis of gestational diabetes are often regarded as having had undiagnosed diabetes prior to pregnancy.) are not eligible for the cohort. After the cohort of women were identified, they will be re-contacted, recruited, and evaluated at recruitment and followed for a minimum of an additional four years (i.e. active follow-up). Data collection for the prospective component (i.e. active follow-up) of this retrospective cohort design includes: 1) completion of self-administered questionnaires to collect information including, but not limited to, detailed medical and reproductive factors, socio-economic status, diet, physical activity, lifestyle and behavior factors annually; 2) anthropometric assessment using a standardized protocol annually, and 3) collection of timed bio-specimens including blood, urine, toenails, and other types of media as may be defined in the protocol at baseline and the end of follow-up. Minimal requirements for the processing of blood specimens include separation of plasma and serum, isolation of buffy coat, and red blood cells. Type 2 diabetes diagnosis (identified either during the historical follow-up or active follow-up) must be validated by clinical information (i.e. medication, blood glucose levels, etc.) and/or biochemical assays subject to finalization of the protocols. Newly collected data will be appended to the relevant existing data for the creation of a new database needed for answering the study's research questions. Anticipated Period of Performance: The anticipated period of performance is five years from September 2010 to September 2015. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. Small Business organizations must submit Capability Statements in response to this notice and these will be evaluated against the following technical areas of experience and expertise: 1. Accessibility to the study populations as supported by the following evidence. a) Documented evidence of capacity of identifying and recruiting at least 2,500 and up to 5,000 women with a history of gestational diabetes for a minimum of 10 years before the enrollment into the present study to address study questions. b) Documented past and current and anticipated future number of type 2 diabetes events in the targeted population by years after the index pregnancy complicated by gestational diabetes to demonstrate the capacity of having at least 1,000 type 2 diabetes events by the end of the contract. Moreover, among the approximately 1,000 type 2 diabetes cases, evidence should be provided that a minimum of 200 women as incident cases can be identified during the 4-year active follow-up. A higher proportion of incident type 2 diabetes cases is desirable. c). Documented validated data or documented evidence of capacities to validate the diagnosis of type 2 diabetes and co-morbidities (e.g. hypercholesterolemia, cardiovascular diseases, etc.), and time of diagnosis of these events in the years after the index pregnancy during the historical follow-up. 2. Availability of data resources and adequacy of the offeror's data resources for major exposures in the historical follow-up to address research questions, in particular, the role of gene-environment interactions. Documented evidence of the availability and complexity of data on major environmental and modifiable factors that have been significantly related to the risk of type 2 diabetes, in the years after the index pregnancy during the historical follow-up (i.e. body weight characteristics, dietary factors, physical activity status). These factors are crucial for the investigation of gene-environment interactions. Evaluation will also be made based on documented evidence regarding how these data were validated and how comprehensive the dietary and physical activity measurements are in characterizing study participants habitual lifestyle before type 2 diabetes developed. 3. Qualifications of offeror, personnel and expertise. a). Demonstrated relevant qualifications, capabilities and experience of the investigators, research staff, and the research organization in successfully conducting and coordinating large longitudinal studies with long-term follow-up including the recruitment and retention of study participants, collection and processing of data, in particular medical, dietary, and lifestyle data and management of large numbers of biological specimen. These shall be documented by a full CurriculumVitae for the Principal Investigator, Co-Investigators, and other key research personnel, biographical sketches for all other named study staff, and position descriptions for personnel not yet designated for the study. b) Documented prior experience and/or research expertise in the conduct of genetic and/or molecular epidemiologic studies, which are helpful for participation in protocol development and sampling design and oversight of the study. Such expertise and/or experience can be demonstrated in a number of ways, that is, as measured by education, relevant peer-reviewed publications, funded grants or contracts, etc.. Experience in diabetes research is desirable, but not required. c). Ability to recruit and train research staff for recruitment, data collection and bio-specimen processing. 4. Understanding project requirements and ability to retain. The offeror should show adequacy of the offeror's demonstrated ability and adequate strategy and personnel to a)recognize the complexities in identifying and recruiting eligible study participants with required data available in the past years after the index pregnancy, prospectively following them up for additional years or linking their data with other available health database, and collecting baseline data on the children born from a pregnancy complicated by GDM to evaluate the feasibility of studying long-term health conditions of the children; b)follow up study participants in longitudinal and long-term studies with minimal loss- to-follow-up and collect, process, store, and ship bio-specimens (blood, urine, and toenails) per protocol; c) employ adequate facilities and equipment for data and specimen collection and storage and other aspects of the study. 5. An understanding of adherence to Federal regulations pertaining to human research, and requirements for security and confidentiality of research records, as documented by reporting to a responsible IRB. 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 to 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. CONFIDENTIALITY: 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). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies (e-mail to rw17g@nih.gov) in addition to four (4) hard copies of their capability statement addressing the areas above (hard copies to be mail to Rachel Weiszer at the address listed below). Please limit responses to 20 pages or less. These pages exclude resumes. Written capability statements should be received by the Contracting Officer by 4:00PM fifteen days after publication of this notice. Capability statements must identify the business status of the organization. No collect calls will be accepted. Inquiries should be directed to: Ms. Rachel Weiszer, Contract Specialist, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-8869, FAX 301-402-3676, e-mail rw17@nih.gov. OR, Ms. Lisa Coleman, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6955, FAX 301-402-3676, e-mail lc304t@nih.gov.