RFP ANNOUNCEMENT: REGULATORY COMPLIANCE CENTER - NIH-NIAID-DAIDS-03-26 Release Date: April 10, 2002 NOTICE: NOT-AI-02-014 National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov) Receipt Date: July 15, 2002 DESCRIPTION The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is recompeting their current contract with Social and Scientific Systems, Inc., Contract Number N01-AI-65275. This solicitation will be a 100% Small Business Set-Aside, NAICS Code 541710, 500 employees. This new contract will be awarded as a performance-based contract with the emphasis being on the contractor's ability to provide rapid response to requests for support to the Division of AIDS. The DAIDS is seeking capable small business organizations having regulatory, clinical and technical expertise and facilities to provide the Regulatory Affairs Branch (RAB) in DAIDS with regulatory and technical support to facilitate management of regulatory aspects of DAIDS-sponsored clinical trials. This critical contract will exist within a complex research environment and a consortium of multiple clinical trials groups, which are increasingly international in scope. International research is predominantly conducted in countries with high prevalence of HIV/AIDS. The clinical trials networks to be supported include, but are not limited to: HIV Vaccine Trials Network (HVTN); HIV Prevention Trials Network (HPTN); Adult AIDS Clinical Trials Group (AACTG); Pediatric AIDS Clinical Trials Group (PACTG); Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT); The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA); and Acute HIV Infection and Early Disease Research Program (AIEDRP). These networks interact with a complex research environment composed of, but not limited to, clinical investigators and their institutions, the statistical and data analysis centers, operational centers of the networks, the Food and Drug Administration (FDA), the Office of Human Research Protection (OHRP), the Fogarty International Center (FIC), the pharmaceutical industry, local and national Internal Review Board/Ethics Committees, patients with HIV/AIDS and their advocates, populations at risk for HIV infection, and the DAIDS' scientific and administrative personnel. These networks make key decisions about HIV/AIDS treatment and prevention research and conduct numerous clinical trials of all phases. The clinical research organization must: (1) provide regulatory, clinical and technical expertise to enable DAIDS to fulfill its responsibilities as a sponsor of a large portfolio of Investigational New Drug (IND) Applications and other large clinical trials not conducted under IND; (2) manage the Serious Adverse Experience (SAE) System for both IND and non-IND studies of all phases; (3) provide technical ability to write concept sheet and protocol review summaries and related letters for DAIDS; (4) maintain the protocol registration and informed consent review systems; (5) develop in collaboration with DAIDS and the pharmaceutical industry lists of risks associated with approved/investigational drugs/vaccines used in DAIDS- sponsored clinical trials; (6) assist or lead in negotiation of clinical trials agreements with pharmaceutical collaborators; (7) coordinate and prepare for meetings and conference calls with the FDA, OHRP or other groups collaborating with the networks and other such activities as may be necessary to successfully conduct DAIDS-sponsored clinical trials; (8) establish and maintain a computerized information system to produce reports and track existing and evolving information related to major responsibilities of the contract; (9) provide extensive international travel of contractor staff and set up international conference calls for the purpose of providing updated information about regulatory issues and site regulatory responsibilities; and, (10) participate in electronic communication between DAIDS and clinical trials groups' operational offices and sites for the purpose of information exchange. It is anticipated that the period of performance for this contract will be a total of seven years to be award as a three-year base period with two, two- year, options. Any responsible Offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. RFP-NIH-NIAID-DAIDS-03-26 may be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and was posted on FedBizOpps. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Nancy Hershey, Contract Specialist, Phone 301-496-0193, Fax 301-402-0972, Email nh11x@nih.gov Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301- 402-0972, Email bs92y@nih.gov This announcement does not commit the Government to award a contract. No collect calls will be accepted.
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