SOURCES SOUGHT
A -- Genetic Factors in Birth Defects
- Notice Date
- 9/28/2005
- Notice Type
- Sources Sought
- 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
- Reference-Number-NICHD-DESPR-PES-SS-2006-01
- Response Due
- 10/19/2005
- Archive Date
- 11/2/2005
- Description
- The National Institute of Child Health and Human Development (NICHD)is interested in identifying Small Business organizations with requisite qualifications to assist with investigating genetic risk factors for birth defects. The mapping of the human genome has made it possible to identify genes that are etiologically important in birth defects. For example, the knowledge that folate was important in the etiology of neural tube defects (NTDs)(Medical Research Council, Czeizel) led to the identification of a variant in the enzyme methylenetetrahydrofolate reductase that increases the risk of having an NTD (Whitehead). There is great potential for finding other gene related birth defects because recurrence risks indicate that there is a genetic component and because of the enormous genetic variability in the human population?any two individuals have approximately 3,000,000 differences in their genomes. One of the limiting factors in this research area has been the availability of samples from a sufficient number of affected subjects (or families). Because the etiology of many birth defects is multifactorial and because the penetrance of these genes is low (sometimes because of environmental factors), large numbers of cases must be studied to identify risks. The possibility that defects are the result of gene-gene interactions also demands larger sample sizes to identify enough subjects with the combination of alleles in question. Even a relatively common type of birth defect such as a neural tube defect occurs in only about 1 pregnancy in 1000. Hundreds of cases of any birth defect are required to address even the simplest research questions. Other birth defects of interest are much less common than neural tube defects. Therefore, a large underlying population is needed to identify enough defects of interest. Many important defects are too uncommon for even a large institution to accrue enough cases to conduct etiologic investigations. There are few resources available to redress these problems. The objective of this research is: to acquire DNA from a large number of children who have major birth defects and from normal control children to investigate the role of genetic variants in birth defects. The Government requires that these samples come from conceptuses delivered within a defined geographical area, and to include almost all birth defect cases born within that geographical area. The Government also requires medical documentation sufficient to describe the birth defects, such as International Classification of Disease (ICD) codes or the equivalent. Other relevant information such as additional data from medical records and information on risk factors (family history, exposure to teratogens) is highly desirable. To be deemed capable a small business must demonstrate the following abilities: 1. Possess information on all registered births occurring over a specified time frame (years) in a large, well-defined geographical area such as a state or province. 2. Identify from among these births essentially all infants with major birth defects identified at birth as defined by a standard coding system such as the International Classification of Diseases. This requires staff members with documented expertise and experience in reviewing medical and vital records to classify birth defects. 3. From the same population, identify a group of control subjects of sufficient size to provide at least one matched control for each birth defect case, and ensure that these control subjects do not have major birth defects identified at birth. 4. Possess sufficient socio-demographic information on cases and controls to allow for matching on important risk factors such as race and maternal age. 5. Have in their possession prior to the award of a contract, material containing DNA from the above mentioned cases and controls. This DNA must be of sufficient quality and quantity to be usable for genotyping. The quality and utility of the DNA must be demonstrated by prior successful extraction and genotyping. This may be documented by research using samples from this source. 6. Demonstrate a record of experience and expertise in the collection and maintenance of the above mentioned records and DNA-containing samples. 7. Demonstrate expertise in, and experience with, producing, maintaining, and ensuring the quality of large data files. 8. Demonstrate competence in storage, retrieval, and transport of information and biological specimens. 9. Have the legal authority to obtain information from vital records (birth certificates, death certificates, etc.) and medical sources to collect data on birth defects and other outcomes of interest. AT THIS TIME THE NICHD IS ONLY REQUESTING CAPABILITY STATEMENTS FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The applicable North American Industry Classification System (NAICS) code for this requirement is 541710. Therefore, the small business size standard for this announcement is 500 employees. SUBMITTED CAPABILITY STATEMENTS MUST ALSO ADDRESS HOW THE BUSINESS MEETS THE APPLICABLE SIZE STANDARD. Please include your DUNS number with your Capability Statement. Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit a written Capability Statement to the attention of Jason Williams at the address provided by 3:00 PM Local Time on Wednesday, October 19, 2005. The Capability Statement should be limited to no more than 15 pages and it should address each of the competencies stated above. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns the anticipated Request for Proposals will be set-aside for small businesses only.
- Record
- SN00905580-W 20050930/050928211644 (fbodaily.com)
- Source
-
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