SPECIAL NOTICE
A -- National Standard for Normal Fetal Growth: Data Coordinating Center
- Notice Date
- 6/20/2007
- Notice Type
- Special 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- RFPNIHNICHD-DESPR-2007-4
- Response Due
- 8/4/2007
- Archive Date
- 8/19/2007
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DCOMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The The National Institute of Diabetes and Digestive and Kidney Diseases, Office of Acquisitions, The National Institute of Child Health and Human Development (NICHD) Branch, at the National Institutes of Health intends to negotiate and award a contract modification on a noncompetitive basis to the Emmes Corporation,401 North Washington Street, Suite 700, Rockville, MD 20870. The contractor is to provide for expert coordination, monitoring, data management and statistical oversight ensuring data compliance for a multicenter, prospective study of the National Standard for Normal Fetal Growth. The National Institute of Child Health and Human Development (NICHD), Division of Epidemiology, Statistics and Prevention Research (DESPR) proposes to conduct a multicenter prospective observational study to: (1) establish a U.S. national standard for normal fetal growth (velocity) and size for gestational age; (2) create an individualized standard for optimal fetal growth; and (3) improve accuracy of fetal weight estimation. This study will recruit 2,400 healthy, low risk pregnant women. Approximately 600 women each will come from the following self-identified race/ethnicity background: African American, Asian, Caucasian, and Hispanics. Women will be recruited in the first trimester and followed up through pregnancy. Each woman will receive 5 scheduled ultrasound exams, which include 2-dimensional (2D) and 3-dimentinoal (3D) fetal anthropometric measurements. Uterine artery and fetal Doppler studies will be performed at selected gestational weeks. After delivery, neonatal anthropometric measures will be carefully taken. Obstetric and neonatal information will be extracted from medical charts. Normal fetal growth is a critical component for a healthy pregnancy and for the long-term health of the child. An objective assessment of normal and abnormal fetal growth has enormous implications for prenatal care, neonatal care and outcome-based research. How to define fetal growth restriction is a long-standing challenge in modern obstetrics. Small-for-gestational-age, defined as a birthweight or estimated fetal weight below the 10th percentile at a given gestational week, is commonly used as a surrogate to fetal growth restriction. The main problem with this definition is that babies with a weight less than 10th percentile are not necessarily growth restricted (e.g., constitutionally small but healthy babies). On the other hand, a weight above the 10th percentile does not necessarily mean a normal fetal growth. For example, the rate of fetal growth may undergo pathological decline in late gestation (say, from 75th percentile in early pregnancy to 25th percentile at birth). In such a case, the birthweight is still above the 10th percentile but the fetus may have suffered from growth restriction indicated by higher perinatal mortality and morbidity. The key to solving this problem is to develop a method that can identify growth potential for individual fetuses. The underlying concept proposed by Gardosi et al.(1992) was that fetuses who significantly deviate from their individual optimal fetal size at a given gestation are considered either overgrown or growth restricted. Mounting evidence demonstrates that this method is a significant improvement over the 10th percentile in identifying and classifying fetal growth restriction. However, no good standard currently exists for fetal anthropometric parameters measured longitudinally throughout pregnancy in a sufficiently large number of normal pregnancies in the U.S. The Government proposes to conduct a multicenter prospective study to establish a U.S. national standard for normal fetal growth. The purpose of this acquisition is to provide a Data Coordinating Center for the above project. Specifically, the Contractor shall work closely with the NICHD Project Officer and study sites to provide support for data management and coordination. The requirement to be fulfilled in the proposed contract modification is for expert coordination, monitoring, data management and statistical oversight ensuring data compliance. Included in this requirement is the use of a web-based data management system for managing the data of a multi-center prospective study. The contract to be modified is contract N01-DK-3425 with the Emmes Corporation for the project entitled Data Coordinating Center for the Consortium on Safe Labor. This sole source determination is made under the authority set forth in FAR 6.302-1(a) (2)(ii), only one responsible source and no other supplies or services will satisfy the agency requirements due to a duplication of costs that could not be recovered through competition. This sole source determination is based up the fact that the Emmes Corporation has developed a web-based data management and specimen tracking system responsive to the research study's needs (e.g. multiple remote users; privacy and confidentiality protection; monitoring recruitment; collecting data; tracking biological specimen) under Contract N01- N01-HD-3-3358. By virtue of their development of a web-based data management and specimen tracking system that matches the requirements of the proposed study, they are uniquely qualified to perform the proposed effort. Further, the web based system that has been developed under this contract needs minor modifications in order for it to be used in the proposed action. For another web-based data management system to be developed a duplication of costs would result. This duplication is not expected to be recovered through competition. The North American Industry Classification (NAICS) Code is 541710 and the size standard is 500 employees. The purpose of this synopsis is to determine whether there are other sources capable of meeting the Governments requirements as described. Contractors are encouraged to submit three (3) copies of their written Capability Statements to Elizabeth Shanahan, Contract Specialist, at the address provided within 45 days of publication of this synopsis. Capability Statements will be evaluated using the following technical evaluation criteria: 1) TECHNICAL APPROACH / UNDERSTANDING THE REQUIREMENTS: a. Demonstrated understanding of the purpose of the project; b. Adequacy of the proposed web-based data management system to ensure accurate, reliable and timely data collection; c. Adequacy of the proposed technical approach to randomize subjects and monitor recruitment in a timely fashion; d. Adequacy of the proposed technical approach to implement quality control procedures on accuracy of ultrasound image reading; e. Adequacy of proposed strategies for successfully completing various tasks with multiple research sites and ensuring their timely completion. 2) STAFFING PLAN / EXPERIENCE AND QUALIFICATIONS OF PROPOSED PERSONNEL: The adequacy, feasibility, and cost-effectiveness of the proposed Staffing Plan for the conduct of the project, including: a. Adequacy of the Principal Investigators knowledge in pregnancy and evidence of peer reviewed publications involving reproduction and prospective clinical/epidemiological investigations. b. Adequacy of demonstrated evidence of prior PI experience directing multi-site clinical/epidemiologic investigations. c. Adequacy of demonstrated experience by the PI and key staff in a contemporary web-based data management and specimen tracking system and excellent writing and communication skills with multiple sites. d. Efficiency and cost-effectiveness of the proposed Staffing Plan. 3) EXPERIENCE AND QUALIFICATIONS OF THE ORGANIZATION: a. Demonstrated capability, facilities and equipment to compile, store and transmit the information necessary for the web-based database, including the large, digital sonographic images; b. Demonstrated capability to resolve unforeseen difficulties in randomization, data entry and data transfer; c. Adequacy of the proposed real-time, web-based data management and biospecimen tracking system. Past Performance of the contractor on the same or similar projects will be evaluated as well. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. Overnight deliveries should be mailed to the National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Boulevard, MSC 7510 Bethesda, Maryland 20852. See Numbered Note 22 ****. No collect calls or facsimile transmissions will be accepted.
- Place of Performance
- Address: 401 North Washington Street, Suite 700, Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01323377-W 20070622/070620220554 (fbodaily.com)
- Source
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