SOURCES SOUGHT
A -- Environmental Chemicals and Gynecologic Health
- Notice Date
- 12/5/2005
- 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-2006-04
- Response Due
- 12/22/2005
- Archive Date
- 1/6/2006
- Description
- The National Institute of Child Health and Human Development (NICHD) is interested in identifying whether there any interested Small Business Concerns with the requisite capabilities to assist in conducting an epidemiologic study assessing the relation between environmental factors and the development of gynecologic diseases such as endometriosis. Endometriosis is a gynecologic disorder in which endometrial glands and stroma are located outside the uterine cavity. These implants can be found anywhere in the pelvic, abdominal or thoracic cavity and eventually produce vesicles or hemorrhages that visually appear as blue, brown or black lesions. Incidence of endometriosis is relatively unknown; prevalence is estimated to be approximately 10%-15% of women of reproductive age but can be higher among women seeking gynecologic care. The disease may be accompanied by considerable co-morbidity (e.g., infertility or impaired fecundity) and possibly other chronic diseases such as autoimmune disorders and reproductive site cancers. Clinical diagnosis is exceedingly difficult and requires direct visualization of the lesions by laparoscopy or laparotomy. Often, histologic confirmation in excised tissue is needed to corroborate disease. Other diagnostic modalities have been tried, though with varying degrees of sensitivity and specificity (e.g., magnetic resonance imaging, serum biomarkers, gynecologic examination, ultrasonography, and self reported symptomology). The gold standard for diagnosis remains visual confirmation by a trained gynecologic surgeon. Human evidence suggesting a possible role of environmental chemicals in the development of endometriosis comes from a handful of studies; however, the results are far from conclusive. Etiologic study of endometriosis is difficult, in part, given the requirement that the disease be visualized impacting choice of comparison group. Environmental investigation is further complicated by lifestyle and reproductive factors such as pregnancy and lactation history, which may impact serum concentrations of environmental chemicals. To advance the scientific community?s understanding of the impact, if any, of environmental factors and the development of endometriosis, a clinical sampling framework is needed for the recruitment of cases and a gynecologic comparison group. However, a second comparison group comprising women randomly selected from the referent population for women seeking medical care and who are allegedly free of disease also is needed. This latter population-based comparison group will undergo magnetic resonance imaging (MRI) to rule out endometriosis, to the extent possible. Should another biomarker of endometriosis emerge in the near future, its incorporation into the study will be considered in lieu of the MRI to assess the presence or absence of disease. The NICHD is planning to conduct an epidemiologic study assessing the relation between environmental factors and the development of gynecologic diseases such as endometriosis. This study is in response to a growing body of evidence suggesting a relation between persistent environmental chemicals (e.g., organochlorine pesticides, polyhalogenated aromatic hydrocarbons, polybrominated diphenyl ethers) and development of endometriosis in women. It is anticipated that up to two clinical research sites will be needed for the study. Scope: It is estimated that approximately 850 women aged 18-44 years undergoing laparoscopy or laparotomy and approximately 187 population-based control women aged 18-44 years will need to be recruited and to complete the study protocol. Women undergoing laparoscopy or laparotomy will need to have a thorough diagnostic evaluation by trained gynecologic surgeons with regard to the presence or absence of gynecologic disorders including endometriosis. At least three types of biologic specimens (e.g., blood, urine, adipose tissue) will be collected for the quantification of environmental chemicals and metabolites of lifestyle exposures (e.g., cotinine and phytoestrogens). All toxicologic analyses will be performed by a single state-of-the-art laboratory for the detection and quantification of the agents of interest to the study. A statistical analytic plan will be fully developed and implemented by the National Institute of Child Health & Human Development for the analysis of all data. Objective: The goal of this study is to investigate the impact of environmental factors with regard to the etiology of endometriosis. The environment is defined to include environmental agents and lifestyle factors (e.g., diet and cigarette smoking) purported to influence human reproduction including the development of endometriosis. An added methodologic goal of this study is to empirically evaluate study findings with regard to choice of comparison group, given the challenges in sampling study participants introduced by the need for visualization of disease and other nuances related to care seeking behavior for gynecologic reasons. To be deemed capable to serve as one of two anticipated research sites for this study, a Small Business Concern must submit a written Capability Statement that clearly demonstrates the ability to: 1) within 24 months, recruit at least 425 women aged 18-44 years prior to undergoing incident laparoscopy or laparotomy and retain them through completion of the study; 2) ascertain disease status from medical records including operative reports for the 425 women; 3) within 24 months, recruit and retain in the study at least 94 women aged 18-44 years randomly selected from the referent population of women undergoing laparoscopy or laparotomy and who are free of endometriosis as determined by MRI; 4) collect all interview and medical record data and MRI images; 5) collect all required and desired biospecimens such as blood, urine, adipose tissue, peritoneal fluid, and endometrial tissue; 6) create a repository of residual biospecimens; and 7) produce, maintain, and ensure the quality of the large database for this study. 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 or less. See http://www.sba.gov/size/ for information on what is a small business and part 121.106 of the SBA's Small Business Size Regulations on how the SBA calculates number of employees. 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 attention of Charles Newman, Contracting Officer, at the address provided by 3:00 PM Local Time on December 22, 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 subsequent Request for Proposals will be set-aside or partially set-aside for small businesses.
- Record
- SN00944703-W 20051207/051205211809 (fbodaily.com)
- Source
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