SOURCES SOUGHT
A -- A study of long-term trans-generational health impacts of maternal obesity and gestational diabetes and their determinants
- Notice Date
- 2/9/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- NIH-NICHD-DIPHR-SBSS-2016-1
- Point of Contact
- Theresa Koomson, Phone: 301-435-6957, Alice Pagan, Phone: 301-435-6959
- E-Mail Address
-
koomsont@nih.gov, alice.pagan@nih.gov
(koomsont@nih.gov, alice.pagan@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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; service-disabled, veteran-owned small businesses; HUBZone small businesses; 8(a) 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. The designated NAICS code for this effort is 541712 and the small business size standard is 500 employees or less. Background and Project Requirements: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Division of intramural Population Health Research (DIPHR) conducts innovative etiological and interventional research to explore the health and wellbeing of pregnant women and their infants from preconception through adulthood and translates these research findings into clinical practice or public policy to maximize health. Accumulating evidence suggests that adverse intrauterine exposures may lead to permanent fetal adaptations in anatomy and physiology, which may be beneficial for short term fetal survival, but result in an altered long-term risk of disease later in life. Maternal obesity and gestational diabetes (GDM) are exposures of particular interest. Data from mechanistic studies indicates that fetal exposure to obesity and/or hyperglycemia may lead to long-term metabolic and vascular function alteration. Despite these findings, critical data gaps on research of the health impact of obesity and GDM on offspring remain. Thus, the goal of the proposed study is to follow-up the offspring of an existing cohort of others and their offspring to evaluate the impacts of GDM and maternal obesity on the metabolic, vascular, and reproductive health of the offspring, their determinants and the underlying molecular mechanisms. The study will utilize a hybrid design combining new data collected in the present study with historical data that have been prospectively and longitudinally collected. Particularly, potential sources must have an ongoing cohort with demonstrated successful follow-up from which to be able to recruit, evaluate, and collect data from the following four groups 1) 1500 GDM mother-offspring pairs; 2) 700 overweight/obese (pre-pregnancy BMI ≥27 kg/m2) mother-offspring pairs; 3) 2500 control (non-overweight/obese and non-GDM) mother-offspring pairs; and 4) a secondary cohort of 100-200 siblings discordant for GDM. It is preferred that the majority of offspring be at the following age groups in 2016: (GDM mothers: 12-18 years N=500; 18-30 years, N=500; >30 years N=500; overweight/obese mothers: 12-18 years N=350; 18-30 years=175; >30 years N=175; Non-GDM, Non-overweight/obese mothers: 12-18 years N=1000; 18-30 years, N=1000; >30 years N=500). Multiple existing cohorts can be combined to meet the sample size requirements, with preference given to those with evidence of past collaboration and established feasibility for data harmonization. However, it is anticipated that only a single contract will be awarded. Existing data for cohort mothers during the historical follow-up should at least include information on the diagnosis of GDM during the index pregnancy, information on other pregnancy complications, and of type 2 diabetes and related co-morbidities (including, but not limited to cardiovascular disorders), time of their diagnosis, other medical history, reproductive history, pregnancy history, diet and lifestyle factors before and/or during the index pregnancy, and after pregnancy, and anthropometric characteristics in the years after the index pregnancy. Existing data for the offspring during the historical follow-up should also include major developmental or chronic disorders (such as asthma and allergies), diet and lifestyle factors, and anthropometric characteristics. Capabilities and Requirements: Potential sources must demonstrate and document experience in measuring aspects of 1) metabolic health, 2) vascular health, and 3) reproductive health. In particular, differences in anthropometry (e.g. BMI, DXA), metabolomic profiles from biospecimens, vascular function (e.g., flow mediated dilation or carotid IMT or pulse wave velocity in a subsample), and semen analysis (among male offspring). 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) Documentation of feasibility for recruiting the above exposure categories from existing cohort(s). 2) Documentation of previous experience performing the above in the background. 3) Documentation of existing data as described above in the background. 4) 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. 5) Experience and expertise of a doctoral level lead investigator, as evidenced by peer reviewed publications, which demonstrate active participation in research closely related to the topics above. 6) Demonstrated relevant qualifications and experience of key research staff. 7) Documentation of the ability to collect, process and handle human biospecimens. Anticipated Period of Performance: The anticipated period of performance is five years. 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. 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). Responses: Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement clearly stating in the subject line of the email that it is in response to NIH-NICHD-DIPHR-SBSS-2016-1. Please limit responses to 5 pages or less, excluding resumes. Electronic capability statements should be received by the Contracting Officer no later than 4:00 PM Eastern time on February 24, 2016. Capability statements must identify the business status of the organization. No phone calls will be accepted. Respondents must submit their capability statement via electronic submission only. Please send your capability statement to the attention of Theresa Koomson at koomsont@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/NIH-NICHD-DIPHR-SBSS-2016-1/listing.html)
- Place of Performance
- Address: To be determined, United States
- Record
- SN04014372-W 20160211/160210042223-6e301d326025865924e438c102f7bf02 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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