SOLICITATION NOTICE
R -- Services for the Assessment and Development of a Protection Quality Assurance Program
- Notice Date
- 7/19/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541618
— Other Management Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- REQ1017789
- Response Due
- 8/10/2006
- Archive Date
- 8/25/2006
- Small Business Set-Aside
- Total Women-owned Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation, REQ1017789, is issued as a Request for Proposal (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-10. The acquisition is set-aside for Woman-own Business. The associated NAICS code is 541618 and small business size standard is $6.5 Millions. BACKGROUND: Quality Assurance as defined by the International Conference on Harmonization?s (ICH) Guidance for Industry E6 Good Clinical Practice (GCP): Consolidated Guidance is: ?All those planned and systematic actions that are established to ensure that the (clinical) trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s). FDA has developed a Quality Assurance Program for FDA-sponsored human subject research. It has developed procedures for implementing an agency-wide assurance program to oversee the quality of FDA-sponsored research involving human subjects. This program is designed to monitor and provide feedback to the Commissioner and agency managers on adherence to applicable regulations and acceptable standards for the conduct of human subject research. The underlying objective of the program is to assure the quality and integrity of human subject research and to ensure that human subjects of FDA-sponsored research are protected. FDA-sponsored human research falls under the jurisdiction of 45 CFR 46. These regulations govern all federally funded human subject research. FDA-sponsored research that is within the scope of the agency quality assurance program includes: Research sponsored, funded or supported by FDA. Research conducted by or under the direction of any employee or agent of FDA in connection with his or her official responsibilities. Research conducted by or under the direction of any employee or agent of FDA using any property or facility of FDA. Research involving the use of FDA?s non-public information to identify or contact human research subjects or prospective subjects. Good Clinical Practice Guidelines dictate that studies involving human subjects require oversight by an Institutional Review Board (IRB) and periodic monitoring by qualified individuals. CFSAN personnel who are conducting (as Principle Investigators) or collaborating on studies involving human subjects obtain approval and have oversight of their study(s) from the FDA?s Research Involving Human Subjects Committee (RIHSC). Each Center at FDA is required to develop and implement a Quality Assurance Program for monitoring of ongoing studies and recordkeeping. Purpose: The purpose of the monitoring of studies involving human subjects is to verify that: the rights and well-being of human subjects are protected; the reported trial/study/focus group/survey data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with currently approved protocol/amendment(s) with Good Clinical Practice Guidelines. - Personnel Requirements- The contract must provide trained-personnel with scientific and clinical knowledge who have monitored and audited research studies involving human subjects. Personnel shall be thoroughly familiar with such areas as clinical trial design, human subject protection issues as they relate to research studies, essential elements of informed consent, etc. Personnel need to have had experience auditing studies involving human subjects both clinical studies and social science studies. They must also be familiar with assessing QA of contractors who are conducting studies for principle investigator(s). Scope of Work: The contractor shall: Provide personnel to assist CFSAN Human Subject Protection Lead -in determining if its quality assurance research program has adequate procedures in place. Assess CFSAN?s current QA program related to studies involving human subjects including monitoring and recordkeeping before, during and after completion of studies involving human subjects. Provide recommendations for modifications and further development of this program. At any given time, there are a few clinical trials being conducted by CFSAN personnel. But most of the studies conducted by CFSAN employees utilize outside contractors to develop and to facilitate the actual focus groups, surveys, etc. Therefore QA procedures are needed for both CFSAN internal study activities and for collaborating with outside contractors/institutions. Period of Performance: August 14, 2006 to August 13, 2007. OFFEROR MUST COMPLETE AND SUBMIT WITH ITS PROPOSAL, FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS ? COMMERCIAL ITEMS (MAR 2005), WHICH ARE AVAILABLE ELECTRONICALLY AT: http://www.arnet.gov/far/current/html/52_212_213.html. The clause at FAR 52.212-4, Contract Terms and Conditions ? Commercial, FAR 52.212-5, Contract Terms and, Conditions required to Implement Statutes or Executive Orders ? Commercial Items, applies to this acquisition, and FAR 52.212-1 Instructions to Offerors-Commercial Items. The additional FAR clauses cited in the clause are applicable to the acquisition: (1) 52.203-6 Restrictions on Subcontractor Sales to the Government, with Alternate I (JUL 1995), (2) 52.219-8, Utilization of Small Business Concerns (Oct 2000), (3) 52.219-14, Limitations on Subcontracting (DEC 1996), (4) 52.222-21 Prohibition of Segregated Facilities (FEB 1999), (5) 52.222-26 Equal Opportunity (APR2002), (6) 52.222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (DEC 2001), (7) 52.222-36 Affirmative Action for Workers and Disabilities (JUN 1998), (8) 52.222-37 Employment Reports on Special Disabled Veterans, Veterans on the Vietnam Era, and Other Eligible Veterans (DEC 2001) (9) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (SEP 2002) (10) 52.225-13 Restrictions on Certain Foreign Purchases (JUL 2000) (11) 52.232-33 Payment by Electronic Funds Transfer. 52.204-7 Central Contractor Registration (OCT 2003). Quotation shall be no more than 25 pages. Award will be made to the offeror providing best value to the Government in consideration of cost and technical and cost quotation. The Government reserves the right to make an award without discussion. The Contract Specialist must receive questions no later than July 31, 2006, 12:30 pm, EST via-e-mail. The closing date for receipt of all quotations is August 10, 2006 at 12:30pm EST via-email. An original and 3 copy of the offerors cost and technical proposal shall be received at Food and Drug Administration 5630 Fishers Lane, Room 2081, Rockville, MD 20857. For information regarding this solicitation, please contact Patricia Pemberton, at Fax 301-827-7106, or email: patricia.pemberton@fda.hhs.gov See notes 22.
- Place of Performance
- Address: 5100 Paint Branch, College Park
- Zip Code: 20740
- Country: UNITED STATES
- Zip Code: 20740
- Record
- SN01092482-W 20060721/060719220554 (fbodaily.com)
- Source
-
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