SPECIAL NOTICE
B -- Professional Services Support
- Notice Date
- 1/4/2010
- Notice Type
- Special Notice
- 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-RFI-10-001
- Archive Date
- 1/30/2010
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams,
- 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 RFI 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: This requirement is to provide CDRH with the required resources to properly address critical scientific issues within the time constraints imposed by regulatory requirements: As it determines its changing needs, CDRH will obtain from the Contractor 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. Draft Scope of Work: General Work Requirement 1. Laboratory activities in physical sciences, computer science, biological sciences and general engineering disciplines. 2. Research and engineering studies related to the safety and effectiveness of medical devices and electronic products; development and implementation of measurement methods, instrumentation, calibration capabilities, and analytical procedures to characterize and promote the improvement of such devices and products. 3. Research and development relating to the emissions and interactions with matter of electromagnetic, optical and acoustic energy emitted from electronic products; development, testing, and evaluation of effectiveness or optimizing human exposure from such devices. 4. Administrative assistance supporting the projects and programs associated with these general areas of work. 5. Audiovisual support services for presentations and seminars on current issues related to medical devices and radiation health and safety. 6. Intra-Inter National Consumer Safety Officer support services related to medical devices and radiation health and safety. 7. Information Technology technicians for term projects related to radiation and medical device data system programs in the collection, analysis and effectiveness; positions will include but are not limited to web based training developers, system engineers, training specialists, help desk, and administrative system support staff. 8. Project Management, communication, risk assessment, benefit analysis, and consumer outreach services in the identification, analyze related to medical devices and radiation health and safety. Task Order Processing Tasks include but are not limited to the following items: 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. Additional Tasks may be requested for: ADMINISTRATIVE SERVICES BUSINESS SERVICES CLIENT RELATIONSHIP MANAGEMENT DATA/CONFIGURATION MANAGEMENT EDUCATION AND TRAINING RISK INFORMATION ASSURANCE OPERATIONS/NETWORK SUPPORT QUALITY ASSURANCE SCIENTIFIC/BUSINESS/ENGINEER TECHNICAL TEST/HARDWARE ENGINEERING WEB DEVELOPMENT PROGRAM MANAGEMENT For Scope of Work tasks (1) through (7), the anticipated seven individual team members whose primary specialized experiences are in the areas listed respectively below: Team Member 1 Biomedical Technician: Associates degree or equivalent experience in biomedical equipment maintenance and repair. Specific experience in radiographic film processing, and troubleshooting, maintenance, and repair of radiographic film processors is required. Team Member 2 Junior Level Computer Technician: Associates degree or equivalent experience in Computer Science, or experience as an Administrative Assistant with demonstrable skills in database management and utilization. Team Member 3 Health Physicist: B.S. or higher in Physics, or related degree that includes experience in Medical Physics or Radiation Science, and computer literacy in statistical software packages. Team Member 4 Audiovisual Technician: Demonstrated proficiency in utilizing audiovisual equipment for presentations and training, to include use of computer projectors, audio systems, and stationary HD cameras. Experience and ability in techniques of web cast design and development for the requirement for training implementation. Team Member 5 Information Technology professionals and technicians for incremental projects related to radiation and medical device data system programs in the design, development, collection, analysis and effectiveness; positions will include but are not limited to database design and developers, web based training developers, e-Learning designers and developers, game and simulation designers and developers, system engineers, training specialists, help desk, and administrative system support staff. Qualifications range per position and can be complex. Examples of needs for Information Technology Computer engineering positions typically include a thorough understanding and demonstrated experience with Object Orient Programming based on recognized industry standards. Positions will require a professional knowledge of electronics engineering theories and principles. Experience using Object Orient Programming, SMS (Sequel Messaging Service), MS SQL Server and Oracle DB Server; PHP, Java, Ruby on Rails, and MS.NET application framework; and both Apache and MS IIS web servers. Experience with engineering of computer hardware and software (e.g., advanced component technologies, software tools and methods, and digital theory). Ability to conduct analysis of system requirements to establish functional requirements and identify and perform hardware/software trade-offs. Ability to develop conceptual design of computer systems through analysis of computer hardware, interface hardware, software requirements, and network architectures as elements of total system design. Demonstrated ability to formulate and conduct demonstrations to validate design concepts and to provide a basis for full-scale engineering development and subsequent production of project. Ability to apply state-of-the-art computer engineering methodologies to implement computer systems designs. Demonstrated ability to design computer hardware and software systems including modifications to existing systems. The ability to prepare hardware and software specifications for contract work, evaluation of contract work, and establishment of test requirements and validation procedures to measure performance quality and reliability. Ability to write and coordinate execution of a variety of implementation plans to include those associated with web based training. Implementation plans will include Ops, Systems Administration, Clients, and systems architectures by coordinating with other subject matter experts. Team Member 6 Consumer safety intra-inter national support: B.S. or higher degree or related equivalent experience which includes at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provide knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics or course work that includes the principles, theory, or practical application of computers or computer programming. Team Member 7 Communication risk strategist for public communication and project management support. BA, BS or higher degree of education in public affairs, advertising, health communication or equivalent experience which includes, but not limited to: Change management, strategic and improvement subject area of business planning, development of leadership/management skills, organizational design, benchmarking, consumer analysis, information management, process modeling and analysis, performance measurement, and business process reengineering methodologies experience preferred. We may anticipate an IDIQ 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, as follows: Factor 1-Scientific Experience Scientific experience associated with the safety and effectiveness of medical devices, and electronic products; development and implementation of measurement methods, instrumentation, calibration capabilities, and analytical procedures to characterize and promote the improvement of such devices and products. Factor 2-Information Technology 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. Factor 3-Project Management Project Management, communication, risk assessment, benefit analysis, and consumer outreach services in the identification, analyze related to medical devices and radiation health and safety. 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 RFI number ; *no more than ten (20) 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-RFI-10-001/listing.html)
- Record
- SN02034275-W 20100106/100104235404-24b304a5bf84578acc6e457d66584e23 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |