SOURCES SOUGHT
A -- Data Analysis & Evaluation
- Notice Date
- 5/24/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- Reference-Number-J-FDA-07-052307-2
- Response Due
- 6/13/2007
- Archive Date
- 6/28/2007
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance (FDA/CDER/OC) is conducting a Sources Sought Synopses; this is not a request for proposals. No Solicitation is available at this time. This request for information does not commit the Government to pay any cost incurred in preparation or any submission to this Sources Sought Notice or to a contract for services. The capability statements received in response to this Source Sought Notice will be used to determine the feasibility of soliciting an acquisition. BACKGROUND: FDA/CDER/OC seeks capability statements from interested and qualified potential sources to conduct an evaluation and analysis of available drug product recall data. The FDA/CDER/OC will provide parameters of the review period to be analyzed, but recommends that the data set be large enough to identify manufacturing trends with significant confidence that are most problematic. Initially, recall data from several fiscal years will be extracted from various data stores that FDA currently maintains. The evaluation and coordination of the evaluation will be performed independently by the contractor, in collaboration with the agency. The contractor will be responsible also for compiling a report that synthesizes the results of the evaluation and identify areas in which the root cause(s) of manufacturing issues result in product being recalled from the market. QUALIFICATIONS: The contractor must have the following qualifications: a. The contractor must demonstrate extensive knowledge of and experience working in the area of Current Good Manufacturing Practices (CGMP) statistics and its application to regulatory requirements. b. In particular, the contractor must 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. c. The contractor must demonstrate familiarity working with the various sources of information used in assessing regulatory compliance, including, but not limited to statistics, reports and other information. d. The contractor must be familiar with the FDA 21st Century CGMP Initiative e. The contractor must 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. The contractor must demonstrate experience in testing methodologies that have qualitative and quantitative components. g. The contractor must demonstrate access to, and/or experience working with the pharmaceutical industry. All companies responding to this synopsis must demonstrate their experience and/or capability by submitting qualification statements, including references directly related to the subject requirement. Qualification statements should be sent to the above address from any SMALL BUSINESS. Qualification statements must include references and provide: (1) The referenced contract numbers; (2) The type of contract and dollar amount; (3) a description of the work performed and end products produced; (4) For whom performed and personal point of contact (name, title, address, and telephone number); (5) Performance period and location; and (6) Number and type of personnel employed on the specified contract. Firms responding to this request for qualification statements should indicate whether they are, or are not, certified by the Small Business Administration as small business. The applicable North American Industry Classification Code is 541710 and small business size standard is $ 500.0 Millions. Qualification statements are due 20 days after publication of this notice and should reference Sources Sought No. J-FDA-07-052307-2.
- Place of Performance
- Address: 11919 Rockville Pike, Rockville, MD
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01302304-W 20070526/070524220520 (fbodaily.com)
- Source
-
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