Infertility Treatment and Child Development Disabilities

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Epidemiology Branch (EB), within the Division of Epidemiology, Statistics and Prevention Research (DESPR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to negotiate on a sole source basis, under the authority of 41 U.S.C. 253(c) (1) and FAR 6.302-1 (a) (2) and HHSAR 306.302-1 (a) (2) (ii), a modification to its current contract with Health Research, Inc. (HRI), Rensselaer, New York, entitled - Infertility Treatment, Child Growth and Development Through Age Three Years. This modification will provide for the following: (1) the acquisition of blood spots left over from mandatory neonatal screening on real-time basis from infants enrolled in the Upstate KIDS study, a 3-year longitudinal follow-up of neurodevelopmental and health outcomes; (2) the conduct of laboratory analysis to determine infants cytokine pattern and toxicity profiles of certain exposures at birth (e.g., bisphenol-A, PCBs), and (3) the conduct of standardized clinical developmental testing between 18 - 24 months postnatal. HRI is in a unique position to coordinate work with the New York State Department of Health (DOH) Wadsworth Center Laboratory. The Wadsworth Center Laboratory is the site where the blood spots are stored and that will pull the Guthrie cards (blood spots), develop the appropriate methodology for cytokine analysis in blood spots, and carry out the laboratory analysis. The toxicity testing method will be selected, refined and the analysis conducted by the same laboratory. Investigators from Wadsworth Center Laboratory who can direct this work can be added to the current contract because HRI represents them for the purposes of contracts administration. The mission of HRI is to assist New York State DOH to effectively solicit and administer financial support for New York State DOH projects and to disseminate the benefits of New York State DOH expertise. The Wadsworth Center Laboratory through HRI is the only organization authorized to pull the Guthrie cards and perform the laboratory analysis because the New York State DOH owns the required specimens and can only authorize, in accordance with the New York State law, their designated affiliate, HRI, to obtain and disseminate the required samples from New York State DOH for use in research. The developmental testing component will be supervised by the Pediatric Director of the Division of Family Health, New York State DOH, who is already also represented by HRI, an investigator under the contract, and currently developing the appropriate algorithm for follow-up of infants and children with neurodevelopmental abnormalities. Only the State Pediatric Director will have authorized access to the clinical records, the patients and their physicians who are part of our study and be in a position to carry out this requirement. Interested persons may identify their interest and capability to respond to the requirement by submitting information (5 page limit) required in Numbered Note 22 within 45 days of publication of this synopsis. This notice of intent is not a request for competitive proposals. However, all proposals received within 45 days of publication of this synopsis will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Deliveries should be sent to: Hand Delivered or Delivery Service Contracting Officer Office of Acquisitions, NIDDK NICHD Contracts Management Branch National Institutes of Health 6100 EXECUTIVE BLVD, Suite 7A07 ROCKVILLE MD 20852 U.S. Postal Service Contracting Officer Office of Acquisitions, NIDDK NICHD Contracts Management Branch 6100 Executive Boulevard, Suite 7A07 MSC 7510 Bethesda, Maryland 20892-7510 No collect calls or facsimile transmissions will be accepted.