SOURCES SOUGHT
R -- Technology Assessment Data
- Notice Date
- 5/4/2009
- Notice Type
- Sources Sought
- 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- SS-09-1056050
- Point of Contact
- Zetherine Gore ,, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- Technology Assessment Data to Aid in Risk Assessment of Medical Devices “This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.” Background During the premarket review process, sponsors provide the Food and Drug Administration, Center for Devices and Radiological Health(CDRH) with detailed information to support clearance or approval of their medical device for a specific indication for use. The premarket submission includes bench top study results, animal studies as well as clinical data. In the post-market area CDRH has MDR information as well as registry information to support post market decision making. To supplement what CDRH has, additional information is needed. The Risk based post market decision making project requires volumes of information about a wide array of medical technologies which can be retrieved quickly and efficiently. CDRH will use the information as a supplement to the data it already has to evaluate the impact of a particular medical device on patient outcomes, healthcare utilization, and the quality of healthcare and risks of treatment. Statement of Need CDRH needs comprehensive health technology assessments of a wide range of new and emerging health technologies, existing technologies for which there is new or conflicting evidence of safety or efficacy, and existing technologies that are being used for new applications. These assessments should be independent, unbiased and evidence-based. They need to cover medical devices in all product areas (e.g. imaging equipment, surgical implants, medical devices, diagnostic tests, combination products and biologics). The information available should be kept current. For each medical device and indication for use CDRH requires the following information: •purpose of the technology; •medical background; •related drugs, treatment and devices; •diagnosis to which the treatment applies; •clinical evidence; •publication history; and •future potential products. Information included on each clinical trial should include the authors and publications, the study population, the study treatment and outcome measures, the study results and the limitations. CDRH requires updated information including scientific reports, and policy announcements from government agencies such as the CDC, NIH, and CMS as well as information on new guidelines and recommendations from health organizations and medical associations. The detailed information should include a wide range of devices and indications, for example: •Acupuncture and Acupressure for the Treatment of Nausea and Vomiting •Cochlear Implantation •Deep Brain Stimulation for Treatment of Dystonia •Drug-Eluting Stents for Treatment of Coronary Artery Disease •Endometrial Cryoablation •Implanted Cardioverter Defibrillators for Primary Prevention of Sudden Cardiac •Laparoscopic Bariatric Surgery: Roux-en-Y Gastric Bypass, Vertical Banded Gastroplasty and Adjustable Gastric Banding •Low Level Light Therapy for Joint Pain •Magnetic Resonance Imaging for Breast Cancer Screening in Women at High Risk •Magnetic Resonance Imaging for Breast Cancer Screening in Women at High Risk Anticipated Period of Performance: The period of performance for this data will be for one (1) year with the option to purchase up to 4 additional years. Capability Statement/Information Sought: Sources interested in this requirement must a provide statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met. Responses should provide a description of the services which can be provided by its firm. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=17015b942b2a4c945a6eabae400158b3&tab=core&_cview=1)
- Record
- SN01808199-W 20090506/090504220343-17015b942b2a4c945a6eabae400158b3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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