SOURCES SOUGHT
A -- NIAID/Division of AIDS Regulatory Support Center
- Notice Date
- 1/15/2009
- Notice Type
- Sources Sought
- 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
- NIH-NIAID-DAIDS-A-1006
- Archive Date
- 9/30/2010
- Point of Contact
- Joshua J LaVine,, Phone: 301-496-0612, Anita Hughes,, Phone: 301-451-3694
- E-Mail Address
-
jl276z@nih.gov, anhughes@niaid.nih.gov
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This SOURCES SOUGHT NOTICE is to determine the availability of potential small businesses (e.g., 8(a), service disabled veteran-owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) that can provide: Scientific, technical and operational support to enable the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases to fulfill its regulatory responsibilities as sponsor of Investigational New Drug Applications (INDs) and to assist DAIDS staff in arranging provisions of investigational drug and vaccine products for clinical trials by pharmaceutical and biotechnology companies. The information from this market research will help the NIAID, DAIDS plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC. THIS IS STRICLY MARKET RESEARCH. NIAID/DAIDS WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. BACKGROUND 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. RESPONSE INFORMATION In order to respond to this notice, 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. NOTE: This contract will NOT support clinical research auditing or clinical site monitoring functions, to be carried out under separate, independent NIAID/DAIDS support contracts unaffiliated with the Regulatory Support Center contract. 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. It is also 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. In addition, interested offerors should demonstrate that they have available, accessible, and adequate facilities, equipment, space and other resources necessary to carry out the aforementioned functions, including proposed plans and procedures to accommodate the need for DAIDS to have easy and rapid access to staff and documents housed at offeror’s main facility or at subcontractor facilities. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company’s experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed for being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Project Director, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work Each response should include the following Business Information: a. DUNS b. Company Name c. Company Address d. Company Point of Contact, Phone and Email address and FAX e. Current GSA Schedule appropriate to this Sources Sought. f. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the activities set forth in the Statement of Work (SOW). The Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted not later than 4:00 PM, January 30, 2009. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Joshua J. LaVine, Contract Specialist. He can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: NIH-NIAID-DAIDS-A1006. A paper copy can be sent via regular mail at the address provided below. Joshua J. LaVine Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 GENERAL INFORMATION This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. Capability statements will not be returned and will not be accepted after the due date. As previously stated, the Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following address: Contract Specialist: Joshua J. LaVine Email Address: JLaVine@niaid.nih.gov Contracting Officer: Anita Hughes Email Address: anhughes@niaid.nih.gov
- Web Link
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FedBizOpps Complete View
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- Place of Performance
- Address: N/A, United States
- Record
- SN01733470-W 20090117/090115220310-cb53004359c2a8119ecafcb3bfcc8d73 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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