SOURCES SOUGHT
A -- Professional Services Support for the Operation of CDRN Certifications and Inspection Programs
- Notice Date
- 5/19/2009
- 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
- HHS-FDA-SS-09-1055777
- Archive Date
- 6/10/2009
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Description: Professional Services Support for the Operation of CDRN Certifications and Inspection Programs 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 woman-owned small businesses) for Professional Services for Communication, Education, and Radiation Programs pertaining to the evaluation and risk of the Physical Parameters Associated with Medical Devices, Electronic Products and Radiation programs; nationally and internationally. This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. No telephone inquiries will be accepted. Objectives: The ultimate goal of this project to provide CDRH with the required resources to properly address critical scientific issues within the time constraints imposed by regulatory requirements nationally and internationally. As it determines its changing needs, CDRH will obtain a commensurate level of data, analytical procedures, or specialized instrumentation sufficient for the generation of meaningful data to facilitate the assessment of the safety and effectiveness of medical devices and electronic products that emit radiation in a regulatory environment. Draft Scope of Work: The requirement shall consist of personnel to accomplish all aspects of the following specific tasks, including hardware, software development and training fabrication, data acquisition, interfacing development, supply processing, and experimentation. Tasks may include: 1. Provision for performance of systems analysis, software design, system development, and testing in support of medical device programs; electronic product review, testing and research. Performance of computer hardware and network equipment analysis, performance monitoring, and trouble shooting in support of medical device and electronic product review, testing and research. 2. Provision of data entry support for inspection related activities. 3. Provision of technical support for the MQSA Calibration Facility. 4. Provision of audiovisual support for presentations and seminars. 5. Provision of Information Technology training support services, web development, web based training development, system support, related to medical device and radiation data system programs. 6. Provision of consumer safety support services for medical devices, small manufacturing, and benefit analysis related to reviews, approvals, and instrumentation of medical devices and radiation programs. 7. Provision of project management, development of public communication, risk communication, and public outreach services in the identification, analysis and/or use of medical devices and radiation health and safety device practices. We may anticipate a labor hour type contract with a base year plus four one year options. Viable parties shall provide the following: Part A. Capabilities and Technical Experience – Provide a capability statement describing how your company would provide professional services listed in the Draft Scope of Work. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm’s status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest for professional services for Communication, Education, and Radiation Programs pertaining to the evaluation and risk of the Physical Parameters Associated with Medical Devices, Electronic Products and Radiation programs; nationally and internationally. Part D. Cost Estimate - Provide a cost estimate for the services (i.e. hourly rates, hours/days) and the number of hours for professional services for Communication, Education, and Radiation Programs pertaining to the evaluation and risk of the Physical Parameters Associated with Medical Devices, Electronic Products and Radiation programs; nationally and internationally. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation on Subcontracting. Responses shall be: -identified with the Sources Sought number -no more than ten (10) pages in length; -not submit marketing materials; -submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-SS-09-1055777/listing.html)
- Record
- SN01822257-W 20090521/090520001207-f85ad51af28fda13a4c8c00b169fed8b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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