SOLICITATION NOTICE
A -- National Children's Study Centers
- Notice Date
- 2/15/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- RFP-NIH-NICHD-NCS-07-11
- Response Due
- 4/16/2007
- Archive Date
- 5/1/2007
- Description
- The National Institute of Child Health and Human Development (NICHD) is planning to award up to 20 contracts to organizations having the ability to serve as Study Centers for the National Childrens Study (Study). This announcement is intended to inform interested organizations of a planned Request for Proposals (RFP), of important background information, and of some key requirements essential for responding to the RFP. Background information on the Study is available at www.nationalchildrensstudy.gov. The Study is a large, long-term longitudinal study of environmental influences on childrens health and development. This Study will explore a broad range of environmental factors, both helpful and harmful, that influence the health and development of children. For this Study, environment is broadly defined to include biological, chemical, physical, social and behavioral influences on children. The range of outcomes includes, for example, obesity, diabetes and physical development; injuries; asthma; pregnancy-related outcomes; and mental health issues. Likewise, a wide range of environmental influences will be examined for their impact on childrens health and development. These include, but are not limited to air pollutants, drinking water contaminants, soil and dust contaminants, dietary nutrients, dietary contaminants, parental occupational exposures, infectious and allergic agents, genetics and social and behavioral characteristics. The Studys goal is to better understand the role of how these factors, alone and in combination, affect or are associated with childrens health, disease and development. The Study will include a sample of approximately 100,000 children born in the U.S. Enrolled women and, when possible, their partners will be assessed for a wide range of exposures and personal characteristics early in pregnancy or upon pre-pregnancy enrollment. Monitoring of the mothers exposures will continue throughout pregnancy to birth, and possibly beyond. The child will then be followed for a wide range of health and developmental outcomes and environmental exposures throughout childhood until at least 21 years of age. Information will be collected from participants in the Study who reside in one of the 105 locations (counties selected as primary sampling units for the first stage of a multi-stage sampling process). The Study locations are identified on the map and list of Study Locations at http://www.nationalchildrensstudy.gov/about/locations/. The information will be collected by Study Centers that perform the data collection activities in the locations or counties. It is important to distinguish the Study Centers (organizations or institutions engaged in conducting the study) from the Locations (geographic areas, counties) where eligible participants reside. In the initial phase of this Study, which was awarded in September of 2005, data will be collected in seven geographic areas in the United States. Data collection in each of these seven geographic locations is being conducted by a single Study Center, referred to as a Vanguard Center. Thus, there are a total of seven Vanguard Centers. The Vanguard Centers will begin enrollment of Study participants up to one year prior to initiation of enrollment in the wave 1 Study Locations. Additional contracts are needed to establish Study Centers to conduct the data collections in the remaining 98 Study Locations from the original sample of 105 locations (See study locations at http://www.nationalchildrensstudy.gov/about/locations/) and to engage in developing the protocol for subsequent phases of the Study. It is anticipated that approximately 15 to 20 contracts will be awarded as a result of this solicitation for data collections in up to 30 additional Study Locations. Future solicitations for additional Study Centers to cover the remaining locations will be dependent upon availability of funds. Offerors responding to this solicitation must demonstrate the ability to conduct the Study in one or more of the 98 remaining Study Locations . (Contracts have already been awarded for collection of data in the seven Vanguard Locations.) Specifically, offerors must document in their technical proposal, the following: 1. Offerors proposing to become a Study Center must propose to carry out the Study at one or more of the 98 previously designated Study locations (see http://www.nationalchildrensstudy.gov/about/locations/). 2. Study Locations (Counties) where a proposing Study Center offers to conduct the study must be located either: a) in the state where the proposing Study Center is located; or b) in a state that is contiguous with the state of the proposing Study Center. The location of the Study Center is considered to be that of the location of the primary institution in the proposal. 3. Demonstrate a clear understanding of the complexity of this Study, including the use of complex multi-level sampling strategies for selection of Study locations and neighborhoods within locations from which participants will be recruited; the longitudinal nature of the data collection; the need to collect, process, and ship environmental samples and biologic specimens from multiple sites; and the need to collect interview data from multiple participants including pregnant women, fathers, and other primary caregivers, and children; 4. Demonstrate an ability to gain community support and input to optimize subject recruitment, retention, and dissemination of Study findings; 5. Provide an understanding of the household sampling approach being used in the study and an ability to identify, recruit, and enroll a sufficiently large population of women, both prior to pregnancy and during early pregnancy, such that 1000 live births are enrolled in the study over a 4-year enrollment period in each Study Location; 6. Provide evidence of the ability to enroll participants prior to conception and early in pregnancy; 7. Demonstrate the ability to retain and follow Study participants from all socioeconomic groups, including the medically underserved. [It is anticipated that measurements that require in-person contact will occur at least once in a subset of participants enrolled prior to pregnancy, two times during pregnancy, around the time of delivery, at 6 months, one year, 3 years, 5 years and every 3-5 years until the age of 21 years. Other remote contacts (e.g. telephone interviews) will occur at more frequent intervals]; 8. Provide evidence of the ability to collect Study specimens and information (biologic specimens and interview data) from mothers, fathers, and offspring; and environmental specimens from the household and neighborhood environment; 9. Provide evidence of the ability to collect cord blood and placental tissue at the time of delivery; 10. Provide evidence of understanding and experience in packaging and transporting biological and non-biological samples to a laboratory(ies) and repository(ies) from the Study Center. (Note: The National Childrens Study, Coordinating Center (CC) will develop standard operating procedures in collaboration with the Study Centers.); 11. Provide evidence of the ability to perform a standardized examination of the newborn as well as other clinical and neurodevelopmental exams throughout childhood; 12. Provide evidence of the ability (equipment and expertise available) to perform fetal ultrasounds; Dual-energy X-ray Absorptiometry (DXA); detailed developmental and psychometric assessments; placement, calibration and use of instruments to collect environmental samples, and other measures as selected in the development of the Study Protocol; 13. Demonstrate previous experience in the implementation of Quality Assurance/Quality Control activities covering the collection of interview data; collection, storage, and shipping of biologic and environmental specimens; and collection of field observational data; 14. Provide evidence of qualified personnel to oversee and conduct data collections and other aspects of the Study, as outlined above; and 15. Provide evidence of previous work with a centralized coordination center in the development of protocols and procedures. Other instructions to offerors include: 1. Where feasible, offerors are strongly encouraged to propose to be a Study Center for data collection in multiple locations. There is no limit to the maximum number of locations that an offeror may include in the proposal. However, proposals will be evaluated based on technical merit of which one aspect includes ability to engage relevant community entities within each location. 2. The Study anticipates accruing study locations in three waves or stages separated by one to two years depending on availability of funding. It is desirable to maintain a representative sample as much as possible with each wave of location accrual. Therefore, in addition to the technical merit of the proposals, geographic distribution and maintaining sample representativeness will be a factor in selection of centers. 3. Only one center will conduct the Study at any single location. Locations or counties may not be shared or split between more than one Study Center; however, organizations and institutions are encouraged to establish partnerships and teams with other entities where appropriate or necessary to establish the strongest capability to perform the Study. 4. Each newly established Study Center awarded through this procurement will operate on an equal level with the already established Vanguard Centers. Both the Vanguard Centers and the newly established Study Centers will operate under federal contract guidelines and will be equally accountable to the Program and Contracting Offices of NICHD. 5. A pre-proposal conference to answer questions and provide clarification about this solicitation will be conducted on March 7, 2007 at 1:00pm EST. It will be held in the Washington, D.C. area. The pre-proposal conference will also be a live webcast. The specific location for the conference will be announced with the RFP and on the Study website www.nationalchildrensstudy.gov. 6. Current Vanguard Centers are eligible to submit proposals to serve as Study Centers for additional locations as outlined above. The Request for Proposals is anticipated to be issued in approximately two weeks. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. The due date for proposals in response to this solicitation is anticipated to be on or about April 16, 2007. Any questions concerning this announcement must be submitted in writing to Elizabeth J. Osinski, Contracting Officer, at eo43m@nih.gov or addressed to Ms. Elizabeth Osinski, Office of Acquisitions, NIDDK, NICHD Branch, Executive Building, Suite 7A-07, 6100 Executive Boulevard, MSC 7510, Bethesda, MD. 20892-7510 (if sending by overnight carrier?6100 Executive Boulevard, Suite 7A-07, Rockville, Maryland 20852). The secondary Point of Contact is Fred Ettehadieh, Contracting Officer, at: fe19w@nih.gov at the same address as above.
- Record
- SN01232745-W 20070217/070215220337 (fbodaily.com)
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