NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Infectious Diseases Data Coordinating Center
MODIFICATION: This solicitation has been issued today, August 4, 2017. The due date is now September 20, 2017 at 4:00 pm.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) requires a Coordinating Center that will provide continuous and recurring logistical, technical, and administrative support to maintain, coordinate, and manage a multi-site network of domestic and international clinical centers conducting research on treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease and its infectious and non-infectious complications in pediatric, adolescent, and maternal patient populations, as well as other high priority infectious diseases affecting children and pregnant women.
The Coordinating Center Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities needed to implement, maintain, coordinate, and manage a multi-site network of clinical centers to conduct current and future clinical trials for evaluation of investigational therapies, diagnostic techniques, prevention strategies, epidemiology and natural history of multiple aspects of HIV infection and disease and other high priority infections, including but not limited, to Zika virus infection, in pediatric, adolescent, and maternal patient populations. The Coordinating Center contract currently manages a network of 29 clinical research sites throughout the world, specifically at this time, the United States (15), Latin America (10), Africa (2) and Thailand (2). These clinical research sites participate in studies through multiple research networks.
The proposed acquisition will involve the following types of activities:
1. Serve as the coordinating center for all aspects of management and monitoring of clinical research sites in the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network ("NICHD Network"). Sites are currently located in the US, Latin America, Africa, Asia and may be located in other regions during the project period.
The 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 NICHD Network enrolls patients into trials conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network, the Adult AIDS Clinical Trials Group (AACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), and the NICHD-funded Adolescent HIV Medicine Trials Network (ATN). The Network also has collaborated on clinical trials in the past and could collaborate in the future with the Centers for Disease Controls and Prevention (CDC) and the Pediatric European Network for Treatment of AIDS (PENTA). Domestically, the Network consists of 15 centers, located in 13 cities, in 11 states/territories (including Puerto Rico); there are 14 international clinical trials sites: 8 sites in different areas of Brazil, 2 in Argentina, 2 in Africa and 2 in Thailand.
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 Pediatric AIDS clinical trials protocols. The Coordinating Center provides special support to international sites, such as providing specimen transport.
2. Perform Site Monitoring of Phase III NICHD-Funded Investigator Initiated International trials in pregnant and non-pregnant women, infants, children and adolescents.
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 Data Coordinating Center will conduct site monitoring for selected NICHD grantees conducting large clinical trials to ensure appropriate trial conduct.
3. As the HIV epidemic has evolved and other infectious diseases have emerged in the United State and globally, this contract and clinical trial sites address or will address gaps as they arise, including HIV-associated co- infections (such as tuberculosis, hepatitis, and malaria) in children and pregnant women. Also, these clinical trial sites are anticipated to address research into the epidemiology, natural history, pathogenesis, transmission, treatment, and prevention of other significant infectious diseases, including: congenital infections, such as Zika virus and cytomegalovirus; tropical diseases, specifically those that affect children and pregnant women; and vaccine-preventable disease in infants, children, adolescents, and women.
It is anticipated that an Indefinite Delivery Indefinite Quantity (IDIQ) contract will be awarded, with an ordering period of 5 years, beginning approximately December 1, 2017. The RFP is anticipated to be posted on or after July 7, 2017, 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 September 12, 2017. 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 541711. Any questions concerning this announcement must be submitted by email to Elizabeth Osinski, eo43m@nih.gov, Alice Pagan, Contracting Officer, at pagana@mail.nih.gov
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-MPIDB-2018-1. All correspondence must cite the reference number as provided.
Elizabeth J Osinski, Contracting Officer, Phone 301-526-0347, Email eo43m@nih.gov - Alice M. Pagan, Contract Specialist, Phone 301-435-6959, Fax 301-402-3676, Email ap425k@nih.gov
