QUALITY ASSURANCE SUPPORT FOR CONDUCT OF AUDITS AND INSPECTIONS

RELEASE DATE:  May 30, 2003

NOTICE: NOT-ES-03-010

National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/dert/rcb/rfp.htm)

The purpose of this notice is to announce a Request for Proposal 
(RFP NIH-03-03) for a contract to obtain independent quality assurance 
monitoring and retrospective auditing support resources.  Through these 
support resources, the National Toxicology Program (NTP) will be better 
informed to take action to assure the high quality of studies, 
ascertain areas of vulnerabilities in the conduct and documentation of 
studies, and develop acceptance standards for the performance of high 
quality studies.  The tasks will be carried out based on priorities 
established by the Project Officer.  The base contract will provide 
NIEHS with a resource for auditing various materials and reports from 
toxicological and Carcinogenicity studies. The base contract will 
encompass 4 tasks and two options: Task 1- Audit of NTP Technical 
Report: Toxicity (A/TxR) or Technical (A/TR); Task 2 - Audit of Reports 
Submitted by an NTP Testing Laboratory: Laboratory Report for Standard 
Toxicity Study (A/LR) or Report for Other Toxicity Study (A/OR); Task 3 
- Audit of Pathology Tables (A/PT); Task 4 - Audit of Internet 
Information (A/II); Option 1 - Tasks 1 to 4. Additional Audits beyond 
Base-Contract Projections, and Option 2 - Task 5 - QA Site Visit 
Support for Monitoring Work in Progress.  Two options will expand the 
effort in the contract pending the need for additional assessments and 
the availability of funds.  Option 1, which may be exercised once per 
contract year will provide support for additional Task 1 - 4 audits, 
for up to 40% of the level projected in the base contract.  Option 2, 
which may be exercised once per contract year, will provide support for 
site visit inspections at two designed laboratory facilities.  All work 
will be handled confidentially and reported for review to the Project 
Officer or as otherwise directed by the Project Officer.  Award of one 
cost-reimbursement, performance based, term form, level of effort type 
of contract with an estimated period of performance of two years with 
options up to an additional eight years for a total of ten years is 
contemplated as a result of this solicitation.  This is a 100% set 
aside for Small Business.  The Government estimates that the project 
will require approximately 1,530 senior professional hours, 5,712 
technical hours, and 1,120 clerical hours for a total of 8,362 labor 
hours on an annual basis for this award.  Option Number One is 
estimated at a total of 2,258 labor hours and Option Two is 344 labor 
hours on an annual basis.  Interested organizations should telefax a 
request for RFP NIH-ES-03-03 to the attention of Mr. David Sedgley, 
Procurement Technician at (919) 541-4027 or send an e-mail at: 
[email protected].  The electronic version of the FedBizOps 
synopsis is available at: http://www.niehs.nih.gov/dert/rcb/rfp.htm.   
An electronic copy of the RFP will be posted to this site on or about 
June 6, 2003.  All responsible sources may submit a proposal, which 
shall be considered by the Agency.  Expected release date of the RFP is 
June 6, 2003 with proposals due July 8, 2003.    This requirement is 
100% set aside for Small Business.  The NAICS is 541710.

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