SOURCES SOUGHT
A -- Identification, Adaptation, Development, Evaluation and Implementation of Advanced Methods and Tools
- Notice Date
- 5/8/2008
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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
- REQ1041514
- Point of Contact
- Monifa N Coleman,, Phone: 301-827-7164
- E-Mail Address
-
monifa.coleman@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any sources with capabilities or prior experience that can provide support Applying Pattern Recognition, Statistical Process Control, Operations Research, & Other Methods, to Optimize Effectiveness of Regulatory Oversight in accordance with the following statement of work. This is a potential Indefinite Delivery Indefinite Quantity (IDIQ), Task Order oriented, firm-fixed price contract with a base period and four option years. OBJECTIVE: FDA wishes to engage expert consultants to provide technical assistance in identifying, developing, applying, testing, validating or otherwise evaluating methods for advanced data mining, signal detection and signal management, pattern recognition, optimal estimation theory, and statistical process/quality control, and other appropriate analytic methods and approaches, to better identify and manage risks, and to optimize the effectiveness of FDA regulatory oversight of human drugs. STATMENT OF WORK: The contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described below. The contractor shall be prepared to develop a response to individual tasks as they are assigned. This contract may be used for awarding tasks for analytic studies, methodology development, testing and implementation support projects, and technical assistance. The scope of this contract covers all aspects of data identification and access, analysis and modeling, evaluation and reporting, and other tasks determined to be necessary to conduct the specified tasks. The contractor shall specify the methods it will employ in accomplishing the key tasks in each task order. The contractor shall specify the methods it will employ in accomplishing the key tasks of each task order. The contractor shall demonstrate the ability to do the following: 1)Provide technical assistance in identifying, developing, enhancing, applying, validating or otherwise evaluating, and implementing advanced analytic methods to address the specific issues, challenges, and objectives outlined for each task. 2)Develop a study design and plan, applying principles and methods that include, but are not limited to, advanced statistical methods including both Classical and Bayesian statistics, statistical process control, operations research, risk analysis, sensor systems and signal processing, artificial intelligence, modeling and simulation, and other mathematical, statistical or engineering methods as appropriate for each task. 3)Conduct sophisticated modeling and analysis, or develop new methods and models, applying principles and methods that include, but are not limited to, advanced statistics including both Classical and Bayesian statistics, statistical process control, operations research, risk analysis, sensor systems and signal processing, artificial intelligence, modeling and simulation, and other mathematical, statistical or engineering methods as appropriate for each task. 4)Develop data identification and access plans that includes the kinds, and availability of, data necessary to complete the specified analytic task and related evaluation. 5)Conduct survey and analysis of existing literature and other sources of information relevant to identified characteristics of information, decision making, operations issues, regulatory activities, system performance, or other factors pertinent to the specified task. 6)Conduct reviews of relevant primary data, focusing on information characteristics of the data, including non-clinical and clinical data collected in clinical studies, if required for the specific task. 7)Depending on the focus of the specified task, identify and analyze potential advantages and disadvantages of existing/proposed methods for data extraction, signal detection, pattern recognition, application of optimal estimation theory, statistical process/quality control, or other specified methods, to specified regulatory activities. 8)Provide regular briefings to the agency on draft deliverables and findings, e.g., following literature reviews, proposed approaches to analysis, the findings of conducted analyses, and other tasks, to obtain agency input. 9)Provide technical assistance to support not only the development and evaluation of the potential application of these advanced methods, but also support the piloting and full-scale implementation of these methods in FDA regulatory operations, as appropriate, and required by FDA for a given task. Examples of tasks of interest that might be awarded under this task order contract would include but not be limited to: 1)Develop and apply advanced mathematical approaches to analysis of data related to drug safety and effectiveness from all available sources at each stage of the drug life cycle 2)Apply new signal detection technologies and methodologies to safety analysis of clinical trial data and post-market observational data 3)Apply engineering and systems dynamics approaches to problem-solving, safety issue prioritization, workload management, and other regulatory operations issues. 4)Develop and apply advanced pattern-recognition algorithms to enhance post-market safety surveillance and signal detection, including analysis of patterns of medical care associated with safe use versus safety problems. 5)Develop and apply algorithms for analysis of health care delivery system and drug product design features associated with safe use versus safety problems 6)Develop an automated Center- or Agency-wide system for identifying companies engaged in false and deceptive marketing of drugs in vast sources of electronic information (the web) through manipulation of information extraction and natural language processing and thus minimize the impact to public health of these products. 7)Identify, access and evaluate available data on the supply chain, manufacture, and quality assurance of imported drug ingredients, intermediates, and finished drug products, to improve understanding of commercial trends, enable risk-based prioritization of oversight and surveillance activities, including development of portable analytical technology to rapidly screen suspicious imported ingredients. 8)Identify or develop risk assessment and management tools to facilitate reviews, inspections related to the implementation of new process and analytical technologies. 9)Improve quality of data sources on post-market product defects, and algorithms to detect emerging risks. Analyze data on product defects and adverse events to facilitate development of cause/effect relationships which may reveal common manufacturing failure modes and product defects that are ultimately linked to adverse events. Develop risk models and feed the acquired information into risk models to enhance the scientific basis for review and inspection decisions related to product safety/quality risk mitigation decisions, and prioritize oversight activities. 10) Risk-Based Prioritization for Inspections; program assistance and other technical services for both program development and analysis of outcomes. 1.Work with designated FDA experts to identify and characterize quantitatively-scaled criteria for risk-based prioritization of inspections in various CDER product areas, including clinical trials. 2.Work with designated FDA experts to characterize measurable, risk-based outcomes for reporting and validation studies. 3.Assist with development, project management and delivery of risk-based prioritization tools for prioritizing several different classes of compliance surveillance and pre-approval inspections 11) Develop training materials and provide training to FDA staff to ensure that staff have a full understanding, proficiency and confidence in the application and interpretation of the data and findings resulting from application of the advanced methods and models developed under a given contractor task. PLACE OF PERFORMANCE: Work shall be performed at the Contractor's normal place of business, or as specified in the individual task order. Companies are encouraged to respond if they have the capability and capacity to provide the identified services with little or no disruption of services to the current users at the FDA. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above wile in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541712 with size limitation standards of 500 employees and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 2:00pm, Eastern Time, May 16, 2008. The capabilities response shall be e-mailed to: Monifa.Coleman@fda.hhs.gov. All information received in response to this notice that is marked Proprietary will be handled accordingly. Responses to the notice will not be returned, nor will there be any ensuing discussions or debriefings of any responses. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. The FDA will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. FDA reserves the right to contact any respondent to this notice for the sole purpose of enhancing FDA's understanding of the notice submission. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=1d13eba652fce080bc56a07c29ae6ad7&tab=core&_cview=1)
- Place of Performance
- Address: 5630 Fishers Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01568805-W 20080510/080508215241-1d13eba652fce080bc56a07c29ae6ad7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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