Notice Number: NOT-AI-09-038
Key Dates
Release Date: May 13, 2009
Receipt Date: July 30, 2009
Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
Introduction
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.
Contractors must be able to clearly convey their organizational experience, available personnel, understanding of problems and deficiencies, and/or ability to perform 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 data management information systems and 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.
THE NAICS Code is 541712 with a size standard of 500 employees. All responsible small businesses may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.
The RFP will be available electronically on/about May 1, 2009, and may be accessed through FedBizOpps http://www.fedbizopps.gov/.
Inquiries
Direct inquiries and technical issues to:Joshua J. LaVine
Contract Specialist
Office of Acquisitions,
Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive Room 3214, MSC 7612
(Express mail: Use Zip Code 20817-7612)
Phone: 301-496-0612
Fax: 301-480-4675
JLaVine@niaid.nih.gov
Michelle Scala
Contracting Officer
Office of Acquisitions,
Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive Room 3214, MSC 7612
(Express mail: Use Zip Code 20817-7612)
Phone: 301-496-0612
Fax: 301-480-4675
mscala@niaid.nih.gov
Contracting Office Address
Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Office of Acquisitions
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892-7612
and Human Services (HHS)
