Gestational diabetes and male congenital anomalies studies

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, EPS Suite 600, Room 6076, Rockville, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP), plans to procure on a sole source basis with Maccabi Institute for Health Services Research, 27 Hamered St., Tel-Aviv, Isreal 68125 for services regarding the evaluation of gestational diabetes and male congenital anomalies. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System Code is 541990 and the business size standard is $7 M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance shall be twelve (12) months from date of award. The Epidemiology and Biostatistics Program (EBP) conducts independent and collaborative epidemiologic and biostatistical investigations to identify the distribution, characteristics, and causes of cancer in human populations. Testicular germ cell tumor (TGCT) incidence has been increasing for decades for reasons that are poorly understood. TGCT is associated with several male congenital anomalies, including cryptorchidism (failure of one or both testicles to descend into the scrotum), hypospadias (urethral opening on the ventral side of the penis) and inguinal hernia (protrusion of abdominal-cavity contents). Some evidence indicates that the prevalence of these anomalies is increasing; suggesting that changes in perinatal risk factors may be responsible. Gestational diabetes mellitus (GDM) has increased in the last decade, and pregnancies complicated with GDM are at increased risk for many maternal and fetal complications, including congenital malformations. The purpose of this procurement is to obtain analytic results (completed tables and analyses) from a case-control analysis of gestational diabetes mellitus (GDM) and male congenital anomalies in the Maccabi Healthcare Services (MHS) HMO population. These data are required in order to investigate the relationship between pre-existing diabetes, GDM and risk of cryptorchidism, hypospadias and inguinal hernia. MHS is the 2nd largest publicly funded HMO in Israel, serving 1.95 million members or 24% of the total population. The annual number of births in MHS (n = 39,291) comprised one quarter of all births in Israel. MHS has linkage between detailed administrative and disease databases, which enables epidemiologic studies to be conducted using high-quality medical data. Since 2002, approximately 7,000 cases of cryptorchidism have been diagnosed within MHS. MHS is the only known source capable of performing the required analysis. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on August 11, 2011. No electronic capability statements will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI Office of Acquisitions to the address stated above. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Karri Mares, Contract Specialist at maresk@mail.nih.gov. 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. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-110122-KM on all correspondences.