SOLICITATION NOTICE
B -- Recall Root Cause Analysis Project (Subject Matter Expert)
- Notice Date
- 9/13/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- RFQ1035881
- Response Due
- 9/19/2007
- Archive Date
- 10/4/2007
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Part 13.501 and 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation, NAICS code 541990, Sampling services, statistical services, identified as RFQ1035266, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a total small, business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizzOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED: Voluntary recalls are initiated by firms to remove or correct marketed consumer products (including labeling and promotional literature) that violate the laws administered by the Food and Drug Administration (FDA). Manufacturers and/or distributors may initiate a recall at any time to protect the public from exposure to risks posed by defective products. Product defects arise from various sources, and most commonly these sources include poor manufacturing practices. Recalls are an essential part of public health protection and times may supplant for the need for resource intensive, less expeditious formal enforcement actions. Objectives of the Contract The objectives is to perform a robust analysis of the available drug product recall data utilizing knowledge of pharmaceutical manufacturing and statistical knowledge to identify important market trends. Recalls are classified as Class I and I1 and are considered to represent the highest risk to public safety. Over the past 5 years, CDER has classified a yearly average of 23 Class I and 185 Class I1 recalls. The current recalls system, known as the Recall Establishment System (RES), does not capture specific root cause information for each of these recalls. The contractor will conduct a retrospective data-based assessment of the drug industry through mining information for each recall through review of information from (1) Field Alert Reports (FARs); (2) Drug Quality Reporting System (DQRS) reports; (3) Biologic Product Deviation Reports; (4) Establishment Inspection Reports (EIRs); (5) Consumer/Industry complaints; and (6) Annual drug testing program. Review archived data and metadata for Class I, 11, and I1 drug recalls using the center records and file: Describe the time span and sampling frame for the data to be analyzed. Define the critical independent factors to be extracted from the archived records Define the critical dependent outcomes to be extracted from the archived records Develop and populate a data set using appropriate software Summarize data set to establish the scope and range of the data Perform statistical analysis and risk assessment to estimate potential cause and effect relationships Evaluate risk estimates and relationship to public health Perform a risk priority analysis for potential proactive intervention Report and present analysis and summary of findings Present related concepts and statistical-based training to staff. The research capabilities required for this contract includes training in statistics, experience with statistical software, data analysis, and extensive work experience in and knowledge of CGMP compliance and regulations. The contractor will have the capability to conduct a root cause evaluation, quality risk management and analysis, and provide risk estimates and their relationship to public health. Additionally, the contractor will provide training to FDA employees based on the results of this analysis. REPORTING REQUIREMENT: The contractor shall be required to submit a report every 2 months with supporting analysis, as deemed appropriate. Presentations and training to agency staff, a draft and final report are due at the conclusion of the project. Upon request by the Project Officer, the contractor shall submit any logs, data reports, data analysis, statistical methods used, project schedules, and process-related documents in performance of this agreement. PRICING: Principal Investigator - 1650 Hours @ Rate ______ Research Assistant - 100 Hours @ Rate ______ *** Labor rates should be fully burden*** OTHER DIRECT COSTS: Supplies Equipment Travel. PERIOD OF PERFORMANCE: September 24, 2007 through September 23, 2008. Base Year Option Year One Option Year Two EVALUATION: The Contractor, as a pharmaceutical consultant shall have adequate background in all of the following: Quality Assurance, Quality Control and Manufacturing, Statistical Data Analysis, CGMP Compliance, CGMP Regulations, Root Cause Analysis, Method Validations, Out-of-Specification (OOS) Analysis, Validations Related to Drug Manufacturing, Quality by Design, Process Analytical Technology, Quality Systems, and training in manufacturing of pharmaceutical, biopharmaceutical, biologics and medical device. Understanding the Problem (10 Points) -Demonstrates familiarity working with the various sources of information used in assessing regulatory compliance, including, but not limited to statistics, reports and other information. Technical Approach/Knowledge (30 Points) - Demonstrate extensive knowledge of and experience working in the area of Current Good Manufacturing Practices (CGMP) statistics and its application to regulatory requirements. Demonstrate knowledge of utilizing statistical tools in support of quality risk management and analysis, applied statistics and experimental design in support of pharmaceutical and biopharmaceutical development, quality assurance, and concepts of Quality by Design. Demonstrates experience in testing methodologies that have qualitative and quantitative components. Corporate Experience/Past Performance (30 Points) - Demonstrate past work and/or expertise in the following areas: statistical data analysis, CGMP compliance, CGMP regulations, root cause evaluation and analysis, and the risk estimates and their relationship to public health. Demonstrates experience and/or is familiar with the FDA 21st Century CGMP Initiative Demonstrates access to, and/or experience working with the pharmaceutical industry. Feasibility of Completion (20 Points) - Potential bidders must provide milestones or work plan for timely project completion. Anticipates potential `road blocks? and provides for potential solutions. Staffing (10 Points) ? Principal Investigator must have a degree in Statistics and demonstrates appropriate technical and professional work experience. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Duns & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to patricia.pemberton@fda.hhs.gov no later than September 14, 2007, 2:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: patricia.pemberton@fda.hhs.gov, no later than 2:00pm, EST on Thursday, September 19, 2007. ANTICIPATED AWARD DATE: The anticipated award date is on or about September 21, 2007; however, all dates in this announcement are subject to change. PROVISIONS and CLAUSES: FAR Part 52.217-8 Option to Extend Services and FAR 52.217-9 Option to Extend the Term of the Contract. 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. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. 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, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to patricia.pemberton@fda.hhs.gov. No phone calls will be accepted.
- Place of Performance
- Address: 11919 Rockville Pike, HFD-320
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01405355-W 20070915/070913220544 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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