National Children's Study Coordinating Center

Notice Number: NOT-HD-05-001

RFP Available: RFP-NICHD-2004-12  (See Federal Business Opportunities announcement at: http://www.fbo.gov/servlet/Solicitation/R/HHS/NIH/NICHD/RFP-NICHD-2004-12)

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 a contract for a coordinating center 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. Vanguard Centers will start enrollment in 2007 and full Study Centers are anticipated to begin enrolling in 2008. 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. A leading strategy for enrollment of Study participants is to recruit through approximately 30-50 Study Centers across the country using a probability-based sampling framework. The Government intends to directly award competitive contracts to each of the 30-50 Study Centers, with a separate contract award for the coordinating center (the subject of this solicitation).

The NCS Coordinating Center (NCS-CC) will work with the NCS Project Officer (NCS-PO) and with the NCS Information Technology contractor (IT contractor, previously awarded under a separate contract), the Study Centers, Central Laboratories, and Central Repository(ies) to complete the initial implementation of the Study, conduct pilot studies of proposed protocol elements, coordinate large-scale pilot field studies of the full protocol, conduct various statistical analyses, provide reports on Study results as needed and directed by the NCS-PO, and serve as an independent Study Center, when needed. As an independent Study Center, the NCS-CC must be capable of handling the responsibilities of a Study Center, which will initially include those activities found in the Vanguard Centers RFP (see http://www2.fbo.gov/spg/HHS/NIH/NICHD/RFP%2DNICHD%2D2004%2D07/listing.html for National Children's Study Vanguard Centers). An offeror for the NCS-CC must have the ability to: 1) organize, conduct, and manage large multi-site longitudinal studies involving the collection of interview, biologic, clinical, and environmental data; 2) develop a detailed Manual of Operating Procedures specifying procedures for participant enrollment, retention, confidentiality and ethics, plus data and sample collection, testing, management, transportation, and storage; 3) organize, conduct, and manage a range of methods development and pilot studies, including pilot testing of the full NCS Protocol at the Vanguard Centers (however, not all methods development studies will utilize the Vanguard Centers); 4) assist the NCS Study Centers in designation and recruitment of Study participants; 5) demonstrate statistical expertise to assist the NCS Project Officer in identifying additional Study sites and participants following selection of the Vanguard Centers; 6) maintain and augment the nationwide network of Study Centers should the need arise for establishing new Study Centers to supplement recruitment of specific subgroups or follow-up of Study subjects that relocate out of the established network; 7) assist the Project Officer and Study sites in preparation of materials to be submitted for required reports and clearances e.g., reviews and clearances by the Office of Management and Budget (OMB) and Institutional Review Boards (IRBs), application(s) for Certificates of Confidentiality, etc; 8) assist Study Centers in gaining community support and input to optimize subject recruitment and retention, and dissemination of Study findings, and coordinate national public outreach; 9) track Study participants throughout the course of the NCS, including assisting sites in their participant retention efforts, as needed, and in tracking participants when they move from their original Study site; 10) schedule the collection of interview data and biologic, clinical, and environmental samples; cataloguing and tracking the data and samples from Centers to the NCS-CC, laboratories, or repository(ies); linking the data and results to the appropriate individuals; and identifying missing data components for individual participants; 11) collaborate with the NCS IT contractor to develop, maintain, and provide the resources for the information systems needed to support such a large multi-site Study, including management of data from disparate sources described above, and potential data management issues associated with the collection and analysis of genetic data; 12) monitor the quality of data collection, editing, auditing, entry, and analysis, including a plan for monitoring potential adverse events among Study participants; 13) develop and implement quality control procedures, including adherence to good clinical and laboratory practices, Center audits, in-house data audits, and database validation, audits of field data collection procedures including accompanying field data collectors for a sample of visits; 14) train and certify data collectors in each of the Study sites; 15) provide evidence of having qualified and experienced personnel to establish working relationships with Study sites (Vanguard and subsequent), Central Laboratories and Repository(ies), and oversee all aspects of the Study; 16) prepare data for various statistical analyses, as needed; 17) conduct statistical analyses and provide results of these analyses to Study investigators, as needed; 18) carry out methods development and feasibility analyses to aid in the identification of the additional Study Centers and characterization of participants within each Study Center; 19) develop and distribute public use and restricted access datasets; 20) participate in the preparation of scientific articles and reports summarizing results of the Study; and 21) implement a probability-based sampling framework for Study participant recruitment.

The required service is defined as code 541990 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). It is imperative that all potential offerors also review the NCS Vanguard Centers' RFP, as referenced in the FBO. This acquisition is NOT set-aside for small businesses, i.e., all capable organizations are invited to submit proposals. While this acquisition is being conducted using full and open competition, proposals must include maximum utilization of small business subcontracting, as appropriate. Of course, small businesses may compete, alone, for the full acquisition.

A Pre-proposal Conference for the NCS-CC solicitation will be held on December 1, 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 January 21, 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-2004-12. All correspondence must cite the reference number as provided. Again, all responses must be submitted on or before January 21, 2005.

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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