MODIFICATION
A -- NICHD International and Domestic Pediatric and Maternal HIV Sutdies Coordinating Center
- Notice Date
- 11/1/2006
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, MD, 20892-7510, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NICHD-CRMC-SS-2007-05
- Response Due
- 11/6/2006
- Archive Date
- 11/21/2006
- Description
- The receipt date for capability statements is extended until November 6, 2006. Background: The National Institute of Child Health and Human Development (NICHD) requires logistical, technical, and administrative support to maintain, coordinate, and manage a multi-site network of clinical centers conducting research on treatment, prevention, diagno?sis, epidemiology, and natural history of HIV infection and disease in pediatric, adolescent, and maternal patient populations, including both domestic and international clinical sites. The NICHD is interested in identifying whether there any interested Small Business Concerns with the requisite capabilities to serve as the NICHD International and Domestic Pediatric and Maternal HIV Clinical Studies Coordinating Center, which encompasses both clinical trials on the treatment and management of HIV infection in infants, children, adolescents, and pregnant and non-pregnant women domestically and internationally, including infrastructure development as well as clinical trials. The Coordinating Center contract currently encompasses several inter-related projects: the NICHD Network of clinical trials sites; the Latin American/Caribbean NICHD International Site Development Initiative (NISDI); a trial of post-exposure prophylaxis of HIV-exposed infants (NICHD/HPTN 040 Trial); the India Perinatal Project; and site monitoring for phase III investigator-initiated clinical trials. Scope of activities: Current activities conducted within the Coordinating Center contract include the following: 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 Pediatric AIDS Clinical Trials Group (PACTG) and Adult ACTG funded by the National Institute of Allergy and Infectious Diseases (NIAID), the NICHD-funded Adolescent HIV Medicine Trials Network (ATN), and Pediatric European Network for Treatment of AIDS (PENTA). Domestically, the Network consists of 20 centers, located in 18 cities, in 10 states/territories (including Puerto Rico); there are six international clinical trials sites: five sites in different areas of Brazil, and one in the Bahamas. 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. Latin American/Caribbean NICHD International Site Development Initiative Through the experience of the NICHD Network with directly opening antiretroviral drug treatment trials in sites in Brazil and Bahamas in 1998 and 1999, NICHD identified a need for further training and development to increase Latin American and Caribbean capacity for the conduct of clinical trials, particularly those involving experimental drugs. During 2000, NICHD and Coordinating Center began the NICHD International Site Development Initiative in Latin America and the Caribbean (NISDI) to address this need. NISDI is designed to provide capacity-building and training to international sites through the conduct of two observational studies: one in HIV-infected pregnant women and their infants; and the other in HIV-exposed, but uninfected infants and HIV-infected infants, children, and adolescents. The goal of this initiative is to train investigators and develop sites that will be able to participate in future international prevention and treatment trials. The Coordinating Center currently subcontracts with 25 sites in six countries participating in the protocols from Mexico, Argentina, Brazil, Bahamas, Jamaica and Peru. As of July 2006 there were 1,136 pregnant women and 1,522 pediatric patients enrolled into their respective protocols. Clinical Trial of Post-Exposure Prophylaxis of HIV-Exposed Infants in Latin America and the U.S. NICHD, through the Coordinating Center contract, is conducting a study to evaluate the efficacy of antiretroviral prophylaxis provided only to the infant in situations in which the mother has not received any antiretroviral therapy prior to delivery. This includes women who are first identified as HIV-infected during labor, and therefore are unable to receive antepartum or intrapartum prophylaxis. This study compares three different types of post-exposure prophylaxis in such infants standard zidovudine for six weeks to the infant (standard in Brazil and U.S.); a combination of zidovudine with nevirapine; and a triple combination of zidovudine, nevirapine and nelfinavir. The Coordinating Center is responsible for all aspects of clinical trials management, including protocol and forms design, drug repository and dispensation, regulatory issues, data management and data analysis. Participating sites include 6 sites in the US, 8 sites in Brazil, 1 site in Argentina, and 1 site in South Africa in Johannesburg with a second site in Cape Town about to open. India Perinatal Initiative Collaboration with investigators in southern India on a perinatal HIV prevention project was initiated in late 2000, entitled "An observational study of the seroprevalence of, and interventions to decrease the risk of maternal to child transmission of HIV in Tamil Nadu, India". During Stage I of the study, all pregnant women registered in the antenatal clinics were offered the opportunity to participate in an educational session about HIV infection and transmission. Pre- and post-session assessments of knowledge, attitudes, and beliefs were administered to a random sample of women. Voluntary counseling and HIV testing were offered to all women, and the seroprevalence rated was estimated. Enrollment into this part of the protocol took place between December 2003 and December 2004. During Stage II, those women identified as HIV-infected were offered enrollment in a prospective cohort study and offered antiretroviral prophylaxis to prevent mother to child transmission (initially zidovudine, then zidovudine plus single-dose nevirapine). Enrollment into this part of the protocol began in early 2004, and the final subject study visits were completed in May 2006. It is anticipated that close-out of sites, analyses and laboratory testing of stored samples from this study will continue into the new Coordinating Center project period. 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 performing site monitoring for the NICHD-funded NEVEREST (Nevirapine Resistance Study) trial evaluating response to therapy in women and children exposed to single-dose nevirapine for prevention of mother to child transmission being conducted in South Africa. Technical requirements To be deemed capable to serve the Coordinating Center, a Small Business Concern must submit a written capability statement that clearly demonstrates the ability of the 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 in pediatric, adolescent, and maternal patient populations. This includes: Providing personnel, facilities, and other services necessary to maintain and coordinate clinical treatment, prevention, natural history, epidemiologic, and diagnostic research studies at participating centers of studies conducted within the NICHD International and Domestic Pediatric and Maternal HIV Studies Coordinating Center contract. Continuing the research studies within the NICHD Network described above in addition to new studies requested and approved by NICHD. Providing through subcontracts the clinical trial sites and laboratory services, including drafting, negotiating, executing, administering, monitoring, renewing and/or modifying as needed subcontracts with all current participating sites and laboratories (domestic and international) and any new clinical centers or laboratories as designated by NICHD, and provide support for subcontracted clinical and laboratory centers of the NICHD network. Providing services to assure regulatory compliance for research activ?ities of sites subcontracted by Coordinating Center for performance of aforementioned studies, including maintaining a communications system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Adverse Experience Reports; plans for acquisition, distribution, dispensing, handling, administration, and accountability of study drugs; site monitoring for quality assurance of research conducted at all subcontracted clinical and laboratory sites and for selected international clinical trials Providing clinical and statistical analysis services, including scientific, technical, and administrative support for the development, implementation, and analysis of the specified research, development of data elements and forms, ensure timely and accurate data collection, central data entry, data quality assurance, retrieval of source documentation, and generation of data and safety monitoring reports; training for staff of subcontracted clinical and laboratory centers in data management procedures; provision for data input, editing, electronic data storage, database management, data retrieval, and statistical analysis; electronic data transmission and electronic mail transmission between Contractor, subcontracted clinical and laboratory centers, and collaborating Statis?tical and Data Analysis Center databases. Providing services for implementation and monitoring of clinical trials. at all participating NICHD clinical and laboratory centers and for selected international clinical trials; assuring compliance by sites with all requirements for protocol implementation, including IRB review and approval prior to protocol initiation, patient consent and confidentiality requirements, and Federal bioresearch regulations and requirements for security and confidentiality of research records, and that each relevant clinical site staff member completes annual human subjects training; developing site-specific, protocol-specific budget for each protocol ; training for staff of subcontracted clinical and laboratory centers in procedures for implementation and conduct of specific protocols. Providing services for development and review of new and ongoing re?search activities, including a protocol development team and protocol development plan; draft and edit protocols; maintain necessary documentation for application submissions in compliance with FDA requirements; support for the planning and conduct of meetings of protocol committees and subcommittees, data and safety monitoring boards, and investigators; administrative, technical, and logistical support for research activities. Providing consultants with specialized expertise related to clinical trial efforts, as required by NICHD. AT THIS TIME THE NICHD IS ONLY REQUESTING CAPABILITY STATEMENTS FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The applicable North American Industry Classification System (NAICS) code for this requirement is 541710. Therefore, the small business size standard for this announcement is 500 employees or less. See http://www.sba.gov/size/ for information on what is a small business and part 121.106 of the SBA's Small Business Size Regulations on how the SBA calculates number of employees. Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit 3 copies of a written Capability Statement to attention of Walter A. Knott, Contracting Officer, at the address provided by 3:00 PM Local Time on October 31, 2006. Overnight deliveries should be mailed to National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, Rockville Maryland 20852. See numbered note 25. The Capability Statement should be limited to no more than 15 pages and it should address each of the competencies stated above. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated subsequent Request for Proposals will be set-aside for small businesses. Point of Contact Walter A. Knott, Contracting Officer, Phone: 301-435-6924, Fax: 301-402-3696, email: knottwal@niddk.nih.gov.
- Place of Performance
- Address: Unknown
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01174185-W 20061103/061101220215 (fbodaily.com)
- Source
-
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