NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Infectious Diseases Coordinating Center

Small Business Sources Sought THIS AMENDMENT IS TO CLARIFY THE DUE DATE FOR THE CAPABILITY STATEMENTS IN RESPONSE TO THIS SMALL BUSINESS SOURCES SOUGHT - Capability Statements are due on or before 4:00pm, EST, January 30, 2017. RFP-NIH-NICHD-MPIDB-2018-1 Title: NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Infectious Diseases Data Coordinating Center Background: The 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 conducting intervention trials and other research on treatment, prevention, diagnosis, 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. 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. Purpose of this Announcement: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; 8(a) small businesses, veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification system (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The requirement is assigned a code of 541711 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less. Project Requirements: The proposed acquisition will involve the following types of activities: 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. Sites are currently located in the US and Latin America and may also be located in Africa, Asia and other regions during the project period. 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, 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 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. 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. Anticipated Period of Performance: The anticipated period of performance is five years, 12/1/2017-11/30/2022 Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. Small Business organizations must submit Capability Statements in response to this notice and that will be evaluated against the following technical areas of experience and expertise: Provide a description and documented evidence of the experience and expertise of the staff to perform the tasks listed below. Provide names of projects and references. Response must include sufficient detail to demonstrate: 1. Experience to effectively and flexibly run a very large and complex multi-center international and domestic clinical trials network that implements and manages studies in collaboration with multiple other networks (with the ability to make appropriate modification of data collection and submission to match that of other networks). 2. Demonstrated capability and experience in managing over 25 million in subcontracts with multiple clinical sites, laboratories and other agencies (such as shipping agencies). 3. Demonstrated capability, as demonstrated by prior experience, to monitor an average of 30 network clinical trials at multiple domestic and international trials sites as well as monitor selected investigator initiated clinical trials. 4. Demonstrated capability to manage at least 35 simultaneous subcontracts. 5. Demonstrated capability to assume ongoing clinical trials work at multiple U.S. and international sites within 60 to 90 days following contract award. Thus, an offeror must demonstrate the ability and capacity to within 60 to 90 days following contract award assume responsibility to support 30 subcontracts valued over $25 million. 6. Demonstrated capability to support data systems that interface and interact with data systems used by 3 or more different networks using different data management systems (example the AACTG, ATN and IMPAACT). 7. Since the Coordinating Center will manage and monitor clinical trials conducted in highly vulnerable populations - neonates, children, adolescents and pregnant women that require specific knowledge of federal regulations related to research in these populations and knowledge of the unique characteristics of such populations when conducting research, the contractor is required to have substantial prior experience with HIV-related studies in these populations. The contractor must demonstrate specific knowledge of federal regulations related to research in these populations and knowledge of the unique research characteristics of such populations. 8. The contractor must demonstrate the ability and have prior experience in training, monitoring and management of clinical trials in the United States and in low-resource settings in Africa, Latin America and Asia. 9. Demonstrated capability to provide 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. 10. The Contractor must be able to continue the research studies within the NICHD Network described above in addition to new studies requested and approved by NICHD. (For example, Zika virus studies). 11. Demonstrated capability to provide the clinical trial sites and laboratory services. Currently, the work is done through multiple subcontracted research centers (domestic and international). Therefore, the Contractor must have extensive experience in subcontract award and administration preferably including international research sites, 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. 12. Demonstrated capability to provide services to assure regulatory compliance for research activities of sites subcontracted by Coordinating Center for performance of studies. This includes: 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 13. Demonstated capability to provide clinical and statistical analysis services. This includes the following: - scientific, technical, and administrative support for the development, implementation, and analysis of the specified research - development of data elements and forms - timely and accurate data collection - central data entry - data quality assurance - retrieval of source documentation - 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 with subcontracted clinical and laboratory centers, and collaborating Statistical and Data Analysis Center databases. 14. Demonstrated capability to provide services for implementation and monitoring of clinical trials at all participating NICHD clinical and laboratory centers and for selected international clinical trials. Ability to assure 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. Ability to oversee annual human subjects training for all relevant clinical site staff members. Demonstrated capability to develop site-specific, protocol-specific budgets for each protocol. Ability to train staff of subcontracted clinical and laboratory centers in procedures for implementation and conduct of specific protocols. 15. Demonstrated capability to provide services for development and review of new and ongoing research activities, including a protocol development team and protocol development plan. Ability to draft and edit protocols; maintain necessary documentation for application submissions in compliance with FDA requirements; provide 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. 16. The Contractor must be able to provide consultants with specialized expertise related to clinical trial efforts. Disclaimer and Important Notes: This notice does not obligate the government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies to Elizabeth Osinski, Contracting Officer, and (E-mail to contact@example.gov). Please limit responses to 20 pages or less. These pages exclude resumes. Electronic capability statements should be electronically received by the Contracting Officer by 4:00PM January 30, 2017, EST. Capability statements must identify the business status of the organization, NAICS code along with DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.). Inquiries should be directed to: Ms. Elizabeth Osinski - , Contracting Officer, DHHS/NIH/NICHD/CMB, Email: contact@example.gov, telephone 301-526-0347-6962, OR, Secondary Point of Contact -Ms. Alice Pagan, Contracting Officer, DHHS/NIH/NICHD/CMB, Email: contact@example.gov.