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FBO DAILY ISSUE OF APRIL 08, 2012 FBO #3788
SOLICITATION NOTICE

A -- NICHD International and Domestic Pediatric and Maternal HIV Studies Coordinating Center

Notice Date
4/6/2012
 
Notice Type
Presolicitation
 
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 Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
 
ZIP Code
20892-7510
 
Solicitation Number
RFP-NIH-NICHD-CRMC-2013-01
 
Archive Date
8/1/2012
 
Point of Contact
Lynn L Salo, Phone: 301-435-6962, Elizabeth J. Osinski, Phone: 301-435-6947
 
E-Mail Address
ls59u@nih.gov, eo43m@nih.gov
(ls59u@nih.gov, eo43m@nih.gov)
 
Small Business Set-Aside
N/A
 
Description
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) requires logistical, technical, and administrative support to maintain, coordinate, train, monitor and manage a multi-site network of clinical centers conduct¬ing intervention trials and other research on treatment, prevention, diagno¬sis, epidemiology, and natural history of HIV infec¬tion and disease in pediatric, adoles¬cent, and maternal patient popula-tions, including both domestic and international clinical sites. The NICHD is announcing a competitive Request for Proposal for a Contractor to serve as the NICHD International and Domestic Pediatric and Maternal HIV Clinical Studies Coordinating center, which encompasses clinical studies and clinical trials on the treatment and management of HIV infection and associated co-infections and co-morbidities in infants, children, adolescents and pregnant and non-pregnant women domestically and internationally. The Coordinating Center contract currently manages a network of 34 clinical research sites throughout the United States (25) and in Latin America (9) that participate in studies through multiple research networks. The current contractor for this effort is WESTAT, Inc. Scope of activities: Current activities conducted within the Coordinating Center contract include the following: 1) NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network The NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network ("NICHD Network") has been funded through the NICHD Coordinating Center contract since 1987. The NICHD Network consists of domestic and international clinical sites that enroll study subjects in trials related to preventing and treating HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women, as well as selected clinical trials of gender-specific manifestations of HIV infection in non-pregnant women. The Network enrolls into trials conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network and Adult AIDS Clinical Trials Group (AACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), the NICHD-funded Adolescent HIV Medicine Trials Network (ATN), the Centers for Disease Controls and Prevention (CDC), and Pediatric European Network for Treatment of AIDS (PENTA). Domestically, the Network consists of 25 centers, located in 18 cities, in 10 states/territories (including Puerto Rico); there are nine international clinical trials sites: eight sites in different areas of Brazil, and one in Argentina. It is anticipated that network sites will be re-competed in 2014 and will potentially include sites in Africa, Asia and Eastern Europe in addition to Latin America and the United States. NICHD also supports laboratory-based pathogenesis-oriented research in the context of clinical trials. The Coordinating Center provides support to clinical trials site investigators with special laboratory expertise for the conduct of specialized pathogenesis-based studies in the context of PACTG protocols. The Coordinating Center provides special support to international sites, such as providing specimen transport through a central Coordinating Center contract with World Courier. 2) Site Monitoring of Phase III NICHD-Funded Investigator Initiated International trials As the NICHD international research grant portfolio has increased to include large phase III clinical trials conducted in resource-limited countries, there is an increasing need to ensure that such investigator-initiated trials are conducted ethically, in accordance with Good Clinical Practices, and with attention to human subject safety. The Coordinating Center will conduct site monitoring for selected NICHD grantees conducting large clinical trials to ensure appropriate trial conduct. The Coordinating Center is currently conducting monitoring for clinical trials in Botswana (Mpeu trial), Kenya (OPH03 and OPH612), South Africa (NEVEREST trial); Thailand (PHPT-5 trial); and Uganda (PROMOTE trials). 3. Data Analysis from Completed NICHD-Sponsored Clinical Studies and Trials The NICHD International Site Development Initiative (NISDI) consisted of two observational studies conducted in Latin America, one study (LILAC) in HIV-infected pregnant women and their infants, and one study (PLACES) in HIV-infected children. This study will be completed before November 2012 but analyses of data from this study will continue into the new contract period. Additionally, the NICHD/HPTN 040-PACTG 1043 clinical trial, which evaluated infant combination antiretroviral prophylaxis when the mother did not receive antepartum antiretroviral drugs, was completed during 2011, but analyses of data from this study will continue into the new contract period. Thus, statistical/analytic capabilities for analyses of data from these completed studies are necessary for the Coordinating Center. It is anticipated that one term form cost-reimbursement contract will be awarded, for a period of performance of 5 years, beginning approximately December 1, 2012. The RFP is anticipated to be posted on or about April 20, 2012 on FedBizOpps (FBO) website: http://www.fedbizopps.gov. The due date for submission of proposals in response to the RFP is anticipated to be on or about June 27, 2012. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541712. Any questions concerning this announcement must be submitted in writing to Lynn Salo at ls59u@nih.gov, or Contracting Officer or Elizabeth Osinski, Contracting Officer, at eo43m@nih.gov, or addressed to, NICHD Contracts Management Branch, Office of Acquisitions, NICHD, NIH, 6100 Executive Boulevard, Room 7A-07, MSC 7510, Bethesda, Maryland 20892-7510 (if hand-delivered or sending by delivery service--6100 Executive Boulevard, Suite 7A-07, Rockville, Maryland 20852). No collect calls will be accepted. This is not an RFP and this announcement does not commit the Government to award a contract. The reference number to be used for this announcement is: RFP NIH-NICHD-CRMC-2013-01. All correspondence must cite the reference number as provided.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/RFP-NIH-NICHD-CRMC-2013-01/listing.html)
 
Record
SN02716696-W 20120408/120406235447-cce40b21597494296d504a125ec9ec8a (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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