PRESOL | U | Certification Materials for Office of Regulatory Affairs (ORA)

FBO DAILY ISSUE OF MAY 26, 2010 FBO #3105
SOLICITATION NOTICE

U -- Certification Materials for Office of Regulatory Affairs (ORA)

Notice Date: 5/24/2010
Notice Type: Combined Synopsis/Solicitation
NAICS: 813920 — Professional Organizations
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: REQ1074049
Point of Contact: Vida - Niles,
E-Mail Address: vida.niles@fda.hhs.gov
(vida.niles@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: REQ 1074049 The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant firm fixed price purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-34. NAICS Code 813920 Project Title: Certification for ORA's newly hired Quality System Managers (QSMs) prepare for their American Society Quality (ASQ)/Certified Manager of Quality/Organizational Excellence (CMQ/OE) exam Materials. Background FDA's Office of Regulatory Affairs (ORA) Quality Management System The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement and executes FDA's Import Strategy and Food Protection Plans. The scope and complexity of ORA's mission is getting increasingly broader. Some examples are: the food outbreaks from the past few years; new food legislation on the horizon that will greatly expand our workload and the way the organization does its' work; innovations and new complexities in drugs, biologics, devices and veterinary medicines; exponential growth in imports; as well as a large increase in our staffing leading to additional administrative burdens. These examples are all proof that ORA needs to be as aligned, efficient, and effective as possible. In order to accomplish these objectives ORA's Senior Management Team (SMT) determined that a systematic implementation of a Quality Management System (QMS) would equip ORA with the tools to be better able to tackle the challenges of today and beyond. ORA has already begun to implement the QMS. This effort, stemming from the vitalization initiative was designed through a highly collaborative process involving a cross-section of employees from all areas of ORA, as well as the Centers. Technical Specifications: Certified Manager of Quality/Organizational Excellence Certification Materials Material Quantity The Certified Manager of Quality/Organizational Excellence Handbook (3rd Edition. ISBN: 978-0-87389-678-8) Quantity 10 ASQ Certified Manager of Quality/Organizational Excellence Exam Question Bank Quantity 20 ASQ Certified Manager of Quality/Organizational Excellence Exam Online Training Module Quantity 26 ASQ Certification Exam Fee for Certified Manager of Quality/Organizational excellence certification Exam Quantity 42 Deliverables: The contractor shall deliver within 30 days after receipt of order. CCR: Vendor must be registered in the Central Contractor Register (CCR) prior to the award of the contract. You may register by going to www.ccr.gov. You will need to your Tax ID, Duns Number, Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Vida.Niles@fda.hhs.gov, no later June 1 2010, 10:00 am, EST. QUOTATIONS DUE: All quotations are due to: Vida.Niles@fda.hhs.gov, no later than 10:00 am, EST on June 8, 2010. PROVISIONS and CLAUSES: The provision subpart 39.201-Electronic and Information Tehnology (a) this subpart implements Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), and the Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards (36 CFR Part 1194); (b) Further information on Section 508 is available via the internet at http://www.section508.gov. The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.232-33, FAR 52.246-9 and FAR 52.246-18. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice shall be sent via email to Vida.Niles@fda.hhs.gov, Telephone calls will not be accepted. Evaluation Factors Factor 1 Technical The evaluation factors used for this solicitation shall be the offeror's ability to meet the technical specifications. Factor 2 Relevant Experience The contractor shall describe their relevant experience in fulfilling this requirement. Identify other organizations with which you have acted as a contractor while participating in the same or similar efforts. Include the degree of your involvement, the size and complexity of the organization and other information describing your experience. Vendors shall submit the names of three agencies that are currently using the materials that can be contacted for experienced opinions on the use of their materials. Factor 3 Price The vendor shall provide a price in accordance with the requirements of the technical specifications. Evaluation for Award: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical 2) Experience and 3) Price. Technical and Experience is more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 12.6, Simplified Acquisition Procedures.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/REQ1074049/listing.html)
Place of Performance: Address: Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN02158137-W 20100526/100524234504-695826586b6233237ad37d92432456ae (fbodaily.com)
Source: FedBizOpps Link to This Notice
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U -- Certification Materials for Office of Regulatory Affairs (ORA)