SOURCES SOUGHT
B -- Expert Consultants
- Notice Date
- 6/2/2008
- Notice Type
- Sources Sought
- 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
- FDA-SOL-08-00724
- Response Due
- 6/6/2008
- Archive Date
- 6/9/2008
- Point of Contact
- Dominique H Malone, Phone: (301) 827-7227, Patricia M Pemberton,, Phone: 301-827-1022
- E-Mail Address
-
dominique.malone@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- N/A
- 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: The main objectives of this study would be to: 1. Explore linking the STS clinical data to the CMS administrative claims data and/or other long-term clinical/administrative data. 2. Based on the demographic and clinical information from the STS Database (age, admission diagnosis, date of surgery, date of discharge, etc), match the database patient to the same patient in the administrative data set. 3. Use the STS Database to determine the device and clinical characteristics and severity-of-illness factors of a patient, and use the administrative data to determine the clinical course of that patient over the following years. Methods: Specific information to be collected by the STS database includes Demographic characteristics Device characteristics Pre-operative risk factors History of previous interventions Pre-operative cardiac status Pre-operative hemodynamics Operative procedure Post-operative medications Adverse events Discharge data Status at 30 days post-procedures Long-term outcomes (based on the CMS data) A statistical technique called “probabilistic matching” will enable STS to use administrative data to follow patients for an extended period of time. Demographic and clinical information on patients in the STS Database (age, admission diagnosis, date of surgery, date of discharge, etc) can be used in a well-accepted statistical technique to match the database patient to the same patient in the administrative data set. The probability of a correct match is in the range of 99%. With this matching process, it becomes possible to use the STS Database to determine the clinical characteristics and severity-of-illness factors of a patient, and use the administrative data to determine the clinical course of that patient over the following years. C. Statement 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. Please see that attached document which contains the Statement of Work and deliverables by Task order 1. D. Project Background: The Society of Thoracic Surgeons (STS) is a not-for-profit organization representing more than 5,400 surgeons, researchers, and other health professionals worldwide who are performing heart, lung, esophageal, and other surgical procedures for the chest. The mission of STS is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. The STS offers outcome programs in the areas of Adult Cardiac, General Thoracic and Congenital Heart-defect surgery. The STS National Database is a comprehensive national registry that collects information from over 600 participating hospitals on patients undergoing thoracic surgery. Since 2003, the Registry collected information on over 1,800,000 procedures. It is a confidential, voluntary, and national in scope. As an independent source of information on patients undergoing cardio-thoracic surgeries, this registry is superior to manufacturer initiated studies (both FDA mandated and voluntary). The analytical support for the STS National database is conducted by the Duke Clinical Research Institute (DCRI). Since 1994, there have been over 50 of publications in peer-reviewed journals resulting from the studies conducted through this Registry. The FDA in mid-1990s very successfully studied Transmyocardial Revascularization (TMR) devices in using the data from the STS registry to obtain valuable information that supplemented FDA postmarket surveillance programs. The Centers for Medicare and Medicaid Services (CMS) administrative claims data. contain long-term patient information that includes hospital admissions, admission diagnoses, and other information that can be used to determine clinical events over time. The Center for Devices and Radiological Health (CDRH) would like to collaborate with the STS in studying the experience of patients receiving various medical devices during cardio-thoracic procedures. E. Contract period of performance The study will begin in September 2008. The duration of the first task of this five- year contract will be two years. F. Procurement/Contract Strategy: It is anticipated that a contract indefinite delivery, indefinite quantity task order contract. 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 813920, with a small business 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 5:00pm, Eastern Time, Friday June 6, 2008. QUESTIONS WILL BE ACCEPTED UP TO WEDNESDAY, JUNE 4, 2008. The capabilities responses and questions 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 813920, 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 Friday June 6, 2008 by 5:00 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.
- Web Link
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FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=95dff701292e2ab90203098c09f8e23d&tab=core&_cview=1)
- Place of Performance
- Address: 1350 Piccard Dr., Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN01585154-W 20080604/080602220827-95dff701292e2ab90203098c09f8e23d (fbodaily.com)
- Source
-
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