SOLICITATION NOTICE
A -- National Children's Study Coordinating Center
- Notice Date
- 6/1/2004
- 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
- ZIP Code
- 20892-7510
- Solicitation Number
- SS-NICHD-2004-12
- Response Due
- 7/15/2004
- Archive Date
- 9/15/2004
- Point of Contact
- Virginia DeSeau, Contracting Officer, Phone 301-435-6947, Fax 301-402-3676, - Charles Grewe, Deputy Chief, Contracts Management Branch, Phone 301-435-6957, Fax 301-402-3676,
- E-Mail Address
-
vd9t@nih.gov, cg59b@nih.gov
- Description
- The National Institute of Child Health and Human Development (NICHD) is interested in identifying Small Business organizations with requisite qualifications to serve as the Coordinating Center for the National Children?s Study (NCS-CC). Background information on the NCS is available at www.nationalchildrensStudy.gov. The National Children?s Study is a longitudinal cohort study that intends to examine the effects of environmental influences on the health and development of approximately 100,000 U.S. children. The environment is broadly defined to include biological, physical, chemical, and social/cultural influences on children?s health and development. Priority outcomes are expected to include obesity, diabetes, and physical development; injuries; asthma; pregnancy-related outcomes; child development and mental health. Study participants will be followed from before birth until at least 21 years of age. The goal of the Study is to gain information leading to improvement in the health and well being of children. A leading strategy for enrollment of Study participants is to recruit through approximately 30-50 sites across the country. The Government intends to directly award competitive contracts to each of the 30-50 field sites, with a separate contract award for the Coordinating Center. Approximately five field sites will be selected to serve as initial or Vanguard sites (to be identified through a separate solicitation). More sites will be added after protocol pilot testing and as funding becomes available. The role of the NCS-CC will be to: assist the NICHD NCS Program Office in completing initial planning for the Study by carrying out methods development and feasibility studies, including testing of the full Study protocol at the Vanguard sites; provide statistical expertise to aid in the identification of the additional Study sites and characterization of participants within each Study site; implement the full Study protocol including drafting the NCS Manual of Operations and coordinating the Study sites, laboratory services, repository(ies), and Information Technology (IT) support; provide data management support, statistical analyses, and reporting services, as needed. The NCS-CC must also have the ability to maintain and augment the nationwide network of field sites should the need arise for establishing new field sites to supplement recruitment of specific subgroups or follow-up of study subjects that relocate out of the established network. Therefore, the NCS-CC must meet all requirements of the field sites as outlined in the Sources Sought Announcement for the Initial/Vanguard sites (see FedBizOpps announcement at http://www.eps.gov/spg/HHS/NIH/NICHD/SS%2DNICHD%2D2004%2D07/listing.html To be deemed capable, a small business must demonstrate the ability to: 1) organize, conduct, and manage large multi-site longitudinal studies involving the collection of interview, biologic, clinical, and environmental data. Include evidence of the ability to 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; 2) organize, conduct, and manage a range of methods development and pilot studies, including pilot testing of the full NCS protocol at the Vanguard sites (however, not all methods development studies will utilize the Vanguard sites); 3) assist the NCS sites in designation and recruitment of Study participants; 4) demonstrate statistical expertise to assist the NCS Program Office in identifying additional Study sites and participants following selection of the Vanguard sites; 5) assist the Program Office 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; 6) assist Study sites in gaining community support and input to optimize subject recruitment, retention and dissemination of Study findings and coordinate national public outreach; 7) 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; 8) schedule the collection of interview data and biologic, clinical, and environmental samples; cataloguing and tracking the data and samples from sites to the Coordinating Center, laboratories, or repository(ies); linking the data and results to the appropriate individuals; and identifying missing data components for individual participants; 9) 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; 10) monitor the quality of data collection, editing, auditing, entry and analysis, including a plan for monitoring potential adverse events among Study participants; 11) develop and implement quality control procedures, including adherence to good clinical and laboratory practices, site audits, in-house data audits, and database validation, audits of field data collection procedures including accompanying field data collectors for a sample of visits; 12) train and certify data collectors in each of the Study sites; 13) provide evidence of having qualified and experienced personnel to establish working relationships with Study sites (Vanguard and subsequent), central laboratories, and the Study repository(ies) and oversee all aspects of the Study; 14) prepare data for statistical analyses, as needed; 15) conduct statistical analyses and provide results of these analyses to Study investigators, as needed; 16) develop and distribute public use and restricted access datasets; and, 17) participate in the preparation of scientific articles and reports summarizing results of the Study. AT THIS TIME, ONLY CAPABILITY STATEMENTS ARE BEING REQUESTED FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The required service is defined as code 541710 under the North American Industry Classification System (NAICS). For the purposes of this announcement, a small business is defined as one that has <500 employees. Small businesses that believe that they have the ability to satisfy all of the above stated capabilities, and who meet the stated size standards, are encouraged to submit a capability statement to the address indicated below within 45 days of the publication of this announcement. The capability statement should be limited to no more than fifteen (15) pages and it should address each of the competencies indicated above. If responses indicate the likelihood of satisfactory competition among qualified small businesses, the anticipated solicitation will be restricted to small businesses only. The reference number to be used for this announcement is: SS-NICHD-2004-12. Interested organizations should submit a letter of interest and a capability statement to Ms. Virginia A. DeSeau via E-mail, FAX or postal mail at the numbers and address listed below. All correspondence must cite the reference number as provided above. All sources that consider themselves qualified are encouraged to respond. See numbered note 26. Responses shall be sent to Virginia A. DeSeau, Contracting Officer, at nichdcmb@mail.nih.gov or addressed to the same at NICHD, CMB, Executive Building, Suite 7A07, 6100 EXECUTIVE BLVD MSC 7510, BETHESDA MD 20892-7510 ( if sending by overnight carrier-- 6100 Executive Boulevard, Suite 7A07, Rockville, Maryland 20852), or by fax to 301-402-3676. Questions may be referred by phone to (301) 435-6947.
- Record
- SN00595165-W 20040603/040601211721 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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