SOURCES SOUGHT
A -- Development and Support of Collaborative Studies of Exposure to Environmental Contaminants in Relation to Child Health in the Generation R Study
- Notice Date
- 10/18/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIEHS2012002
- Archive Date
- 11/17/2011
- Point of Contact
- Jennifer Smith, Phone: 919-541-0424, Terry Wyche, Phone: 919-541-7950
- E-Mail Address
-
smithj3@niehs.nih.gov, wychetl@niehs.nih.gov
(smithj3@niehs.nih.gov, wychetl@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified organizations to perform a potential requirement. Background: The widespread use of organophosphate (OP) pesticides results in human exposure through a variety of sources including residues in food. Upon intake, most OP pesticides are metabolized to one or more of six (6) dialkyl phosphate (DAP) metabolites. Thus, levels of DAP metabolites in urine reflect exposure to one or more OP pesticides. Experimental studies have suggested developmental neurotoxicity from low level exposure to OP pesticides, resulting in neurobehavioral symptoms. Human data in populations with background-level exposure to OP pesticides are suggestive of an adverse effect, but additional data of higher quality than the existing data are needed to assess risk in greater detail. Several aspects of study design and population affect the quality of results. To achieve an improvement in quality over existing studies the following attributes are needed: a) improved estimate of exposure, b) level of exposure higher than in previous studies, c) larger sample size, and d) assessment of outcome at least as good as has been done in existing studies (meaning an in-person examination). NIEHS recently published the results of an analysis of urine samples from pregnant women in the Generation R cohort study (the cohort is described later in this document). Metabolites were measured in urine from 100 women collected from February of 2004 through April 2006. The data indicate that Generation R mothers had higher levels of OP exposure than did US women. Furthermore, Generation R mothers had 3-fold higher levels of total dimethyl alkyl metabolites than did pregnant women in CHAMACOS study in California where an association between prenatal OP exposure and screening positive for autism and ADHD in children was observed. The dimethyl alkyl metabolite levels in Generation R was also 4-fold higher than in the Mount Sinai Children's Environmental Health Cohort Study (New York), where prenatal levels of DAP metabolites were associated with anomalies in primitive reflexes, a critical marker of neurologic integrity. OPs are metabolized and excreted in the urine usually within 24-48 hours of exposure. This short half life means that measuring OP metabolites in one (1) or two (2) urine specimens provides a poor measure of exposure over pregnancy. Use of three (3) urine specimens from different times in pregnancy greatly improves the ability to estimate exposure. The Generation R Study enrolled pregnant women and their partners and is following them and their children over time (Jaddoe et al., 2006; Jaddoe et al., 2008). Nearly all pregnant women in Rotterdam were eligible. Enrollment began in 2002 and ended in 2006. Nearly 10,000 pregnant women and their offspring were enrolled. Women in the study provided biologic specimens and completed questionnaires about themselves and their children, and in-person follow-up examinations take place on a regular basis. The Generation R Study has many specific goals, although the general purpose of this study is to find causes of serious diseases among mothers and children. In February of 2004, NIEHS began supporting an increase in the number of urine specimens collected from each pregnant woman from 1 to 3 (at <18, 18-25, and > 25 weeks of gestation). As each pregnant woman presented for an ultrasound examination of her fetus, she provided a spot urine specimen that was divided into three 20 ml aliquots and frozen at -20 oC in polypropylene containers. Two of these aliquots are reserved for collaborative studies with NIEHS. Before NIEHS initiated collection of additional urine specimens, urine was collected only at the <18 weeks of pregnancy (initial) study ultrasound visit. When the collection of additional urine specimens was implemented, all women presenting for their study ultrasound (at <18, 18-25, and >25 weeks of gestation) provided a urine specimen that was stored, regardless of whether urine specimens had been collected at earlier ultrasound visits. Thus, for Generation R Study subjects enrolled from February 2004 through January 2006, there exists a complete set of three (3) urines for 2,025 women, two (2) urines for 970 women, and one (1) urine for 356 women. The urine specimens collected with NIEHS support can be used to assess the level of exposure to selected environmental contaminants and other compounds. The Generation R Study Management Team at Erasmus University governs the use of the samples and associated data. As part of the Generation R Study in-person follow-up examination of children at age five (5)years, the examination will include: 1) the Berkeley Puppet Interview for children's self perceptions in six (6) domains (academic competence, achievement motivation, social competence, peer acceptance, depression-anxiety, and aggression-hostility); 2) the Diagnostic Interview Schedule for Children (DISC-IV) for ADHD Diagnoses and other Clinical DSM Disorders; 3) an Autism Trait List (SCQ), administered by a child psychiatrist (in selected children after pre-screening on e.g. parent/teacher reported symptoms; and 4) an assessment of cognitive performance using both verbal intelligence and non-verbal intelligence testing (Dutch SON-R test). Thus, examining levels of environmental contaminants, as measured in urine specimens, in relation to risk of attention deficit hyperactivity disorder, cognitive abilities, and other neuropsychiatric and behavioral abnormalities will be possible. The age five (5) follow-up is scheduled to end in 2011. The expected number of subjects who will have both three (3) urine specimens and in-person follow up is approximately 1,200, making the sample size much larger than existing studies. The ongoing work of the Generation R Study involves primarily three types of activities: a) follow-up of subjects and collection of specimens, b) specimen processing, storage, and management in support of research, and c) data processing, storage, and management in support of research. This requirement is not only to support continuation of the work in items b) and c), but also supports personnel and develops tools to enhance use of the samples and data by NIEHS, and collaboration with NIEHS. These personnel and tools include relationships and administrative procedures and support to facilitate: the development and evaluation of projects initiated at NIEHS; obtaining human subjects approval in the Netherlands for projects initiated at NIEHS; identification, pulling and shipping of specimens for specific studies; and responses to requests for various types of data. The environmental studies based on the Generation R Study are coordinated by Dr. Frank Pierik, who is at TNO (Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek, or Netherlands Organization for Applied Scientific Research), which is a separate organization from Erasmus University, where the Generation R Study is based. Purpose and Objectives: NIEHS is seeking capability statements from interested and qualified businesses to provide support for the ongoing work of the Generation R Study. This support would involve primarily three types of activities: a) specimen processing, storage, and management in support of research, b) data processing, storage, and management in support of research, and c) support of personnel and development of tools to enhance use of the samples and data by NIEHS, and collaboration with NIEHS. These personnel and tools include relationships and administrative procedures and support to facilitate: the development and evaluation of projects initiated at NIEHS; obtaining human subjects approval in the Netherlands for projects initiated at NIEHS; identification, pulling and shipping of specimens for specific studies; and responses to requests for various types of data. Project Requirements: This project requires direct access to the specimens stored at Star Medisch Diagnostic Centrum, Vlambloem 21, 3068 JE Rotterdam, the Netherlands. This project also requires direct access to the Generation R Study databases containing information on specimens, subject tracking, questionnaire responses, and the results of in-person examinations. It also requires working directly with Dr. Frank Pierik, who is at TNO (Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek, or Netherlands Organization for Applied Scientific Research), which is a separate organization from Erasmus University, where the Generation R Study is based. Dr. Pierik coordinates the environmental research projects based on the Generation R Study. Anticipated Period of Performance: The anticipated period of performance is five (5) years beginning May 1, 2012 and ending April 30, 2017. Submitting a Capability Statement: Organizations that submit capability statements in response to this announcement should provide general information regarding the ability to access the specimens, conduct the work described, and meet the technical requirements. Organizations responding to this announcement should submit a written capability statement that demonstrates relevant experience, skills, and ability to fulfill the requirements described herein. The capability statement should contain sufficient enough detail for the Government to adequately assess your organization's experience and capabilities. Standard company brochures will not be considered a sufficient response to this sources sought synopsis. In the capability statement, respondents should provide their size status for the NAICS Code (541712) and whether or not they are a certified HUBZone, 8(a), Woman-Owned, Small Disadvantaged and/or Service Disabled Veteran-Owned or Veteran-Owned Small Business concern. Technical and administrative points of contact should also be provided. Due Date, Delivery and Number of Copies: Interested organizations should submit three (3) copies of their capability statement not to exceed twenty (20) pages in length, excluding standard brochures, resumes, etc., for receipt by the agency no later than 5:00pm EST, November 2, 2011. Documents submitted electronically or by fax will not be accepted. Acknowledgement of receipt of responses will not be made nor will respondents be notified of the Government's assessment of the information received.Please submit information to: Jennifer Smith, Contract Specialist National Institute of Environmental Health Sciences Post Office Box 12874 Research Triangle Park, NC 27709. Overnight address: 530 Davis Drive MD K1-05 Durham, NC 27713
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIEHS2012002/listing.html)
- Place of Performance
- Address: Rotterdam, the Netherlands, United States
- Record
- SN02609017-W 20111020/111018234143-70d65e142d39de0e5babe608c9f29076 (fbodaily.com)
- Source
-
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