Diabetes Risk Across Women's Life Span

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Epidemiology Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), intends to negotiate, under the authority of 41 U.S.C. 253(c) (1) and FAR 6.302-1, a modification to its current contract no. HHSN275201000020C entitled "Diabetes Risk Across Women's Life Span." The NICHD anticipates that their services are congruent with the current services provided by Harvard University and the monitoring reports from these tasks will be incorporated into the already existing infrastructure for regulatory reporting for the "Diabetes Risk Across Women's Life Span" Study. Background This action would result in a modification to contract Number HHSN275201000020C to extend the period of performance for one year in order to allow the current contractor to complete the statement of work. The overarching goal of the study is to assess genetic and environmental factors and their interactions underlying the progression of glucose intolerance during pregnancy to type 2 diabetes and comorbidities. The existing "Diabetes Risk Across Women's Life Span" Study infrastructure provides the efficient requisite of unique data and resources to address the above mentioned research aims. The services will include the following: re-contact, screen, recruit, consent, collect, process, store, and ship all requested questionnaire data and biospecimens as specified in the study manual of procedures from eligible women with a documented history of gestational diabetes in at least one of their pregnancies that was at least 10 years prior to enrollment in the present study, to fulfill the ultimate goal of enrollment of approximately 4000 eligible women for the entire study; Prospectively follow and retain women in compliance with the study protocol. Successful recruitment denotes obtaining consent, completion of the enrollment questionnaires and the collection of blood, urine and saliva samples; Maintain an eligibility and recruitment database enumerating all women approached for recruitment into the study, women excluded and reasons for exclusion. The database will include items specified by the study protocol and updated according to a study protocol and in collaboration with the NICHD Contracting Officer's Representative (COR), and will be instrumental for assessing possible selection/information biases; Participate in weekly or biweekly telephone conferences and annual steering committee meeting at NICHD with the COR and other investigators; Maintain IRB approval throughout the conduct of the study per the requirements of the Contractor's IRB(s) and prepare the final IRB report. The NICHD anticipates that the services described above can only be conducted as part of the existing infrastructure of the Diabetes Risk across Women's Life Span study. Awarding a new contract to another contractor would require them to duplicate the infrastructure for regulatory reporting that already exists. This would result in unacceptable delays, substantial duplication of effort, and increased costs to the government. This is not a request for proposals. However, if any responsible source believes it can perform the above requirement, they may submit three (3) copies of their capability statement for consideration by the NICHD to Jacquelin Jones, Contracting Officer, NICHD, CMB, NIH, 6100 Executive Boulevard, MSC 7510, Bethesda, Maryland, 20892-7510 (or overnight courier: 6100 Executive Boulevard, Rockville, Maryland, 20852). Phone number (301) 435-6965, and fax number (301) 402-3676. Secondary point of contact is Adelola Kellum, Contracting Officer, NICHD, CMB, NIH, 6100 Executive Boulevard, MSC 7510, Bethesda, Maryland, 20892-7510 (or overnight courier: 6100 Executive Boulevard, Rockville, Maryland, 20852). Phone number (301) 435-6955, and fax number (301) 402-3676. All responses must be received in writing and must contain material in sufficient detail to allow the NICHD to determine if the party can perform this requirement. The capability statement 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.