SOLICITATION NOTICE
A -- NAID/Division of AIDS Regulatory Support Center
- Notice Date
- 4/27/2009
- 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 Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-DAIDS-NIHAI2009064
- Archive Date
- 6/30/2010
- Point of Contact
- Joshua J LaVine,, Phone: 301-496-0612, Michelle A Scala,, Phone: 301-496-0612
- E-Mail Address
-
jl276z@nih.gov, mscala@niaid.nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS, has a requirement for scientific, technical and operational support to enable the Division of AIDS (DAIDS) to fulfill its regulatory responsibilities as sponsor of Investigational New Drug Applications (INDs) and to assist NIAID/DAIDS staff in arranging provisions of investigational drug and vaccine products for clinical trials by pharmaceutical and biotechnology companies. Description The mission of DAIDS, NIAID, National Institutes of Health (NIH), is to bring an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the advancement of therapies for HIV infection and its complications, and supporting the development of HIV/AIDS vaccines and other prevention measures. This mission is carried out by four major programs within the Division: the Basic Sciences Program, the Therapeutics Research Program, the Vaccine Research Program and the Prevention Sciences Program. In conjunction with these programs and through a variety of grants and contracts, NIAID/DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. NIAID/DAIDS currently funds more than 300 clinical trials in over 50 countries at more than 1,000 domestic and international clinical research sites. Since its inception in 1987, NIAID/DAIDS has designed, developed and sponsored extramural Clinical Trials Networks, supported investigator-initiated clinical trials, and partnered with other Government and private organizations to assist in carrying out the Division’s scientific objectives. As the U.S. Food and Drug Administration (FDA) Investigational New Drug Application (IND) sponsor for a large number of NIAID/DAIDS-supported clinical trials, there is an established requirement for NIAID/DAIDS to provide regulatory support for these clinical trials to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Parts 50, 54, 56 and 312, and Title 45 CFR Part 46. Clinical trials must also be conducted in accordance with the International Conference on Harmonization (ICH) Guidelines: E2A Clinical Safety Data Management and E6 Good Clinical Practices (GCP), and country specific regulatory requirements. In order to provide regulatory support services for NIAID/DAIDS clinical trials, a seven-year contract was awarded on October 3, 1995 to Social and Scientific Systems, Inc. to operate the Clinical and Regulatory Operations Center (CROC); the center’s name was eventually shortened to the Regulatory Operations Center (ROC). Subsequently, a recompetition of that contract resulted in the award of a 7-year contract to Technical Resources International, Inc. (TRI) on July 1, 2003 (Contract No. N01-AI-30032) under which NIAID/DAIDS regulatory support services are currently being provided. Over the past six years, TRI has operated the Regulatory Compliance Center (RCC) to provide regulatory support services to over 1,000 clinical research sites in over 50 countries, with approximately half of the sites located in the United States and the remaining sites located in developing countries with a high incidence of HIV/AIDS. The purpose of this contract is to continue and expand clinical regulatory and technical support services for NIAID/DAIDS-supported clinical trials. Interested offerors should have the following capabilities: Appropriate and adequate organizational experience, proposed plans and procedures, available personnel, and understanding of problems and deficiencies for the following clinical regulatory support functions: 1) Establishment, operation and maintenance of a Clinical Study Information Office (CSIO) to receive, abstract, distribute, and track protocol and protocol-related documents and enter key study information into the DAIDS Enterprise System (DAIDS-ES) Protocol Management and Master Contact databases. 2) Paralegal and administrative support for the preparation, negotiation and finalization of Clinical Trial Agreements (CTAs) and other research agreements. 3) Technical and administrative support for the review of concept proposals and protocols by NIAID/DAIDS Scientific Review Committees (SRCs). 4) Human Subjects Protection (HSP) support, including: maintenance of informed consent (IC) templates; regulatory review of protocol sample informed consents (SICs) and their translations; planning and conduct of training on IC issues. 5) Technical and administrative support for the preparation, tracking and distribution of IND submissions and other regulatory filings, including: preparation, distribution and tracking of initial and subsequent IND submissions; preparation of annual IND reports; regulatory review and tracking of new and amended IND protocols; maintenance of IND and related regulatory files and information systems. 6) Establishment, operation and maintenance of the RSC Protocol Registration Office (PRO) to: review and track required clinical site regulatory documents for all protocol versions at each clinical research site; plan and conduct training on protocol registration procedures and related issues; maintain protocol registration information systems. 7) Establishment, operation and maintenance of the RSC Safety Office for: receipt, evaluation, processing and triage of Adverse Experience Safety Reports; preparation of interim and final FDA IND Safety Reports and other required reports; assist in the preparation of training materials and in the conduct of training sessions on safety oversight and reporting requirements for clinical site personnel. 8) Operation, maintenance and updating of RSC related data management information systems and a government labeled RSC website. 9) Development and implementation of Standard Operating Procedures (SOPs) for multiple supporting functions including maintenance of clinical trials master files, FDA reporting, safety reporting, protocol registration and overall quality management of the contract. 10) Other regulatory support, including: Assistance in preparing responses to special requests from government and non-government entities; Responding to queries regarding safety reporting, protocol registration, and informed consent issues from clinical research sites, staff of HIV/AIDS Clinical Trials Network Coordinating and Operations Centers (CORES) and/or Network Operations Centers, and Network Evaluation Committees. 11) Appropriate and adequate staffing with the education, training, experience, expertise, qualifications and effort of clinical and technical personnel, including experience and expertise in supporting large, complex clinical trials networks/programs involving both domestic and international clinical research sites. 12) Available, accessible, and adequate facilities, equipment, space and other resources necessary to carry out the Statement of Work, including proposed plans and procedures to accommodate the need for NIAID/DAIDS to have easy and rapid access to staff and documents housed at offeror’s main facility or at subcontractor facilities. It is anticipated that one cost reimbursement, level of effort type contract will be awarded for a 1-year period of performance beginning on or about April 1, 2010 with one year options to extend the period an additional six years. In addition, an option may be exercised in year 3 for additional effort to provide for the electronic submission of IND documents when such requirements are implemented by the FDA. Also, the Government may exercise an option in any year of the contract to increase the safety staffing to provide for 24/7 coverage of the RSC Safety Office and to provide for an increase in work volume due to a change in MedWatch reporting from 30 calendar days to 15 calendar days for non-IND studies. It is anticipated that a level of effort type contract will be awarded. The performance requirement will be the delivery of 54.25 full time equivalents (FTEs) per year for the base period (Year 1) and 54.25 FTEs for the option periods (Years 2 through 7). In addition, if the Government exercises the option for electronic submission of IND documents to the FDA, the performance requirement will be the delivery of 4.80 FTEs/year for option periods 3 through 7. If the Government exercises the option for additional safety staff, the FTEs may increase by 1-4 FTE/year during years 1 through 7 of the contract. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about May 8, 2009, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c3963185148d902da2f3cbb0ce3805e8&tab=core&_cview=1)
- Record
- SN01803059-W 20090429/090427220605-c3963185148d902da2f3cbb0ce3805e8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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