SOURCES SOUGHT
B -- Decision & Social Science Outcome Research, & Other Disciplines to Support Decision Making
- Notice Date
- 3/31/2008
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting 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
- 20857-0001
- Solicitation Number
- FDA-SOL-08-00579
- Response Due
- 4/9/2008
- Archive Date
- 4/24/2008
- Point of Contact
- Dominique Malone, Contract Specialist, Phone (301) 827-7227, Fax (301) 827-7101, - Leonard Grant, Contracting Officer, Phone (301) 827-7173, Fax (301) 827-7101
- E-Mail Address
-
dominique.malone@fda.hhs.gov, leonard.grant@fda.hhs.gov
- Description
- A. General Information: In accordance with FAR 15.201(e), this request is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in the announcement. This is a Sources Sought regarding potential sources. 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) to provide The Food and Drug Administration (FDA) with expert consultants to provide technical assistance in identifying, developing, enhancing, applying or evaluating a wide range of quantitative and qualitative methods drawn from decision science, risk analysis, social science, health outcomes research, health economics and other analytic disciplines. B. Objectives: FDA wishes to engage expert consultants to provide technical assistance in identifying, developing, enhancing, applying or evaluating a wide range of quantitative and qualitative methods drawn from decision science, risk analysis, social science, health outcomes research, health economics and other analytic disciplines. These methods will be applied in a variety of projects to enable FDA to use more comprehensive and rigorous methods of analysis, measures of effectiveness, measures of quality, and measures of value and other impact on consumers, on public health, health care, regulated industry and other stakeholders. In general, the contractor will produce estimates of benefit, risk, or other impact obtained from the application of such methods and metrics. In addition, the contractor may be required to evaluate the performance of such methods and metrics in providing net-new information value to center decision makers. C. Statement of Work: The contractor shall be prepared to develop a response to individual tasks as they are assigned. 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. This contract could be used for one or more analytic studies and technical assistance. The scope of this contract will cover all aspects of data collection, analysis and modeling, evaluation and reporting, and other tasks determined to be necessary to conduct the specified studies. 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 and evaluating more formalized approaches to center analysis and impact assessment. 2) Develop a study design and plan, including decision science, social science, risk analysis economic, mathematical and statistical, or other methods of analysis as appropriate for each task. 3) Develop data identification and access plans that include the kinds, and availability of, data necessary to complete the specified analytic task and related evaluation. 4) Conduct survey and analysis of medical literature relevant to the identified dimensions of risk, benefit, quality, effectiveness or other impact analysis for the specified task. 5) Conduct reviews of FDA-provided relevant primary data, including non-clinical data and clinical data collected in clinical studies, if required for the specific task. 6) Identify and analyze potential advantages and disadvantages of existing and available methods to quantify risk, benefit, quality, effectiveness, or other dimensions of impact relevant to the specified task. 7) Conduct sophisticated modeling and analysis methods drawing from the literature and current best practice in decision analysis, risk analysis, economics, including pharmacoeconomics, and medical outcomes research. 8) Develop new methods and models applying appropriate mathematical and statistical techniques to account for the features of specific health impact questions, issues and related needs for analysis and decision support. 9) Analyze program parameters as appropriate using FDA data systems, to assess the applicability and performance of more formalized methods in the actual operational context of center decision making processes. 10) Provide frequent 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. Examples of specific tasks of interest, that might be ordered under this task order contract, would include, but not be limited to: 1) Provide technical assistance in identifying, applying and evaluating more formalized approaches to risk benefit analysis for selected drug case studies. 2) Conduct reviews of relevant literature and other information sources and perform data analytic tasks as needed to support regulatory initiatives related to risks and other regulatory issues concerning marketed unapproved drugs. 3) Develop measures and estimates of the expected impact of regulatory qualification of specified biomarkers on related drug development, including clinical trials. 4) Develop and apply measures of effectiveness of the postmarket study protocols used to address specified safety issues. 5) Develop and apply measures of effectiveness of agency-specified or provided information for health care professionals and patients, in informing and supporting decisions about safe drug use. 6) Develop definitions and measures of ?quality? in the context of clinical trials, including clinical trial data and the conduct of clinical research. 7) Develop a model and measures for estimating the health, economic and other impacts of regulatory compliance actions based on FDA clinical trial site investigations 8) Conduct a quantitative and qualitative analysis of health impact and costs of specified human drug recalls. 9) Develop and evaluate new ways to measure the benefit and other impacts of maintaining acceptable compliance of the industry by proactively identifying problematic FDA inspection findings in ongoing surveillance programs to identify and prevent emerging problems that would otherwise lead to substandard product quality. 10) 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 methods and models developed under a given contractor task. D. Project Background: The mission of the FDA Center for Drug Evaluation and Research (CDER) is to assure that safe and effective drugs are available to the American people. CDER promotes, protects and enhances the health of the public through drug development, evaluation and continued safety monitoring throughout the drug life cycle. CDER must accomplish its mission and address the increasing complexity of its operating environment by applying information and analytic strategies that will enable success even in the face of potentially quite-limited resources. FDA/CDER is interested in exploring, applying and evaluating more formalized and comprehensive approaches to analysis and impact assessment that could inform and enhance center strategies, actions and decisions. E. Contract performance The place of performance with be the contractor's site and FDA's site located at 5600 Fishers Lane, Rockville, MD 20857. F. Procurement/Contract Strategy: It is anticipated that a indefinite delivery, indefinite quantity task order contract with anticipated firm fixed price task orders will be awarded. The contract will have a period of performance of 1 base year with 4 option years. This is a new requirement. The NAICS Code is 541690, with a size standard of $6.5 mil. G. Capability Statement Requirements: 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 while 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. Respondents must address their capability, experience and knowledge directly correlated to the Statement of Work. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 4:00pm, Eastern Time, April 9, 2008. The capabilities response shall be e-mailed to: Dominique.Malone@fda.hhs.gov. Responses to the notice will not be returned. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. H. Additional Requirements/ Instructions for Submitting SOURCES SOUGHT Responses to FDA: 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 541690, size standard $ 6.5 mil and status, if qualified as an 8(a) firm (must be certified by 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, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (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 in Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should 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. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request 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 request. The Government will 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 announcement. a. Responses to this notice must be received by the Contract Specialist, Dominique.Malone@fda.hhs.gov on or before April 9, 2008 by 4:00 PM (noon) eastern standard time. b. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government?s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. c. All transmitted information marked proprietary shall be treated as such. Therefore, businesses should identify any proprietary information in their SOURCES SOUGHT response. Proprietary materials will neither be distributed, nor discussed with, any other organization. Information submitted in response to this SOURCES SOUGHT will be used at the discretion of the Government. Further, the information submitted will remain confidential insofar as permitted by law, including the Freedom of Information and Privacy Acts. I. Other Information: 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 announcement. Any responses received will not be used as a proposal. FDA does reserve the right to utilize any non-proprietary technical information in the anticipated SOW or solicitation. Information received will be considered solely to make informed decisions regarding a potential procurement. Responses to the SOURCES SOUGHT will not be returned and will not be accepted after the due date. All communications shall be by email. Respondents will not be notified of the results of the review of the responses. On behalf of the Food and Drug Administration, thank you for your interest. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (31-MAR-2008); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-08-00579/listing.html)
- Place of Performance
- Address: Contractor's Site and 5630 Fishers Lane Rockville, MD
- Zip Code: 20857
- Country: UNITED STATES
- Zip Code: 20857
- Record
- SN01545629-F 20080402/080401073210 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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