National Children's Study Vanguard Centers

Notice Number: NOT-HD-05-002

RFP Available: RFP-NICHD-2004-07  (See Federal Business Opportunities announcement at: http://www2.fbo.gov/spg/HHS/NIH/NICHD/RFP%2DNICHD%2D2004%2D07/listing.html )

Key Dates
Release Date: November 24, 2004

Issued by
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)

The National Institute of Child Health and Human Development (NICHD) is planning to award three to eight contracts to organizations having the ability to serve as initial or Vanguard Centers for the National Children's Study (NCS or Study). Background information on the NCS is available at http://www.nationalchildrensstudy.gov. The NCS is a large, long-term longitudinal study of environmental influences on children's health and development. The 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 children's 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, infections, genetics, and social and behavioral characteristics. The Study's goal is to better understand how these factors, alone and in combination, affect or are associated with children's health, disease, and development.

The NCS 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 mother's 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 NCS-defined environmental exposures throughout childhood until at least 21 years of age. In the initial phase of this Study, data will be collected in three to eight geographic areas in the United States, referred to as Initial or Vanguard Locations. Data collection in each location will be conducted by a single Study Center, referred to as the Vanguard Centers (the RFP clarifies the definitions and sampling approach). Vanguard Centers will be expected to follow a common Study Protocol and will have primary responsibility for many aspects of the Study including, but not limited to, establishing community relationships and collection of data from Study participants and their environments. Additionally, the Vanguard Centers will pilot new Study procedures prior to incorporation of these procedures into the Study Protocol. It is expected that additional contracts will be awarded to the full complement of 30-50 Study Centers when full funding for this effort becomes available in future years. A SEPARATE SOLICITATION IS BEING RELEASED FOR A SINGLE, COMPETITIVELY AWARDED NCS COORDINATING CENTER (NCS-CC) - (see http://www.fbo.gov/servlet/Solicitation/R/HHS/NIH/NICHD/RFP-NICHD-2004-12 for the National Children's Study Coordinating Center).

Offerors for the Vanguard Centers must: 1) Demonstrate a clear understanding of the complexity of this Study, including the need for complex multi-level sampling strategies for selection of Study neighborhoods and participants within neighborhoods; 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; 2) demonstrate an ability to gain community support and input to optimize subject recruitment, retention, and dissemination of Study findings; 3) provide evidence of the ability to identify, recruit, and enroll at least 2000 maternal-infant dyads over a four-year enrollment period; 4) provide evidence of the ability to collect, process, and ship/transport biologic specimens from mothers, fathers, and offspring, as well as environmental specimens from the household and neighboring environment; 5) provide evidence of the ability to enroll participants and collect Study specimens and information (environmental, interview, and biologic) prior to conception and early in pregnancy; 6) 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 three times during pregnancy, around the time of delivery, approximately three additional times in the first year of life, annually until four years of age, and every three to five years until the age of 21. Collection of interview data may occur at more frequent intervals.); 7) provide evidence of the ability to collect cord blood and the placenta at the time of delivery; 8) provide evidence of understanding and experience in packaging and transporting biological and non-biological samples to laboratories and repository(ies) from the Vanguard Center. (Note: The NCS-CC will develop standard operating procedures in collaboration with the Study Centers.); 9) provide evidence of the ability to perform a standardized examination of the newborn, as well as other clinical and neurodevelopmental exams throughout childhood; 10) provide evidence of the ability (equipment and expertise available) to perform, at least, 3-D fetal ultrasounds; Dual-energy X-ray Absorptiometry (DXA); Bioelectric Impedance Analysis (BIA); 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.; 11) 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; 12) provide evidence of qualified personnel to oversee all aspects of the Study, as outlined above; and, 13) provide evidence of experience working with a centralized coordinating center in the development of protocols and procedures.

The required service is defined as code 541710 under the North American Industry Classification System (NAICS). The Request for Proposal (RFP) will be available on or after November 16, 2004 through the web site at http://FedBizOpps.gov (FBO). All potential offerors must also review the NCS Coordinating Center's RFP, as found in the FBO. This acquisition is NOT set-aside for small businesses, i.e., all capable organizations are invited to submit proposals.

A Pre-proposal Conference for the NCS Vanguard Centers' solicitation will be held on November 30, 2004, at a site to be determined, in the Washington DC area. The specifics of this Conference will be included when the RFP is issued/released. Responses to the RFP must be submitted on or before February 16, 2005, to: Virginia A. DeSeau, Contracting Officer, NICHD, CMB, 6100 Executive Boulevard, Suite 7A07, MSC 7510, BETHESDA MD 20892-7510 (if sending by overnight carrier, use 6100 Executive Boulevard, Suite 7A07, Rockville, MD 20852). The reference number to be used for this announcement is: RFP NICHD-2004-07. ALL correspondence must cite the reference number as provided.

Contact:

Virginia A. DeSeau
Contracting Officer
Contracts Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 7A07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-6947
FAX: (301) 402-3676
Email: nichdcmb@mail.nih.gov


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