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FY 2007 and 2006 ODE Annual Report - Part 6 - Program Support

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Freedom of Information Requests

ODE staff received 39 FOI requests during FY 06, a decrease from 706 in the last fiscal year. During FY 06, the number of FOI requests closed was 573 compared to 637 in FY 05. The total number of FOI requests pending in ODE at the end of FY 06 is 34 compared to 422 in FY 05. In FY 07, ODE staff received 1 FOI request and closed 558 requests. The FOI requests pending in ODE at the end of FY 07 is 4. The decrease in FOI requests for FY 06 and FY 07 is due to the FOI centralization piloted in 2005-2006 and fully implemented in October 2006.

Congressional Inquiries

Staff from ODE responded to Congressional inquiries and participated in briefings on the following topics – breast implants, electromagnetic treatment devices, digital mammography, ankle implant devices, sterility issues, reuse and single-use devices. ODE also participated in hearings of Congressional committees and briefings of Congressional staff during FY 06 and FY 07.  These dealt primarily with FDA’s budget and MDUFMA.

Publications

During FY 06 and FY 07, ODE staff authored 46 manuscripts for publication in professional and scientific journals and delivered 300 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.

ODE Vendor Day

ODE coordinated the Ventilators Vendor Day which was held on November 16, 2005.  The Vendor Day is an educational interaction between device manufacturers and ODE employees that highlights the scientific basis for a product line with the goal that this interaction will benefit both the manufacturers and attendees.  Representatives from Tyco Healthcare, Newport Medical Instruments, Inc., Draeger Medical Inc., Hamilton Medical Inc., Pulmonetic Systems, Inc., Maquet Inc., Viasys Respiratory Care, GE Healthcare, and Respironics California, Inc. participated.  There were over 125 attendees. On November 15, 2006 ODE coordinated a Ventricular Assist Devices Vendor Day. Representatives from Abiomed, Inc., Jarvik Heart, Inc., Levtronix, LLC, Thoratec Corporation, Syncardia Systems, LVAD Technologies, and Ventracor, Inc. participated.

Mentoring Program

ODE’s mentoring program is designed to orient new employees to their job responsibilities and their workplace. The program matches a new employee with a mentor who is expected to provide technical, informational and career guidance to the employee in an effort to enable employee assimilation into the workforce and to ensure appropriate employee development. The ODE PMO Office has served as an informal mentoring agent for minorities. Forty-two employees completed the formal program in 2006 and 64 in 2007.

Recruitment

To enhance the Center’s effort to increase the hiring of minorities and those with a disability, ODE participated and partnered with the Agency’s EEO/Diversity Management Office to support the 2006 and the 2007 National Medical Association Career Fair, the 2006 Society for Advancement of Chicanos & Native Americans in Science Conference and Career Fair and the 2006 and 2007 Biomedical Symposium.

Other Than Hiring to Expand/Enhance Resources (OTHER) Program

In an effort to enhance and expand resources for the Office of Device Evaluation, the Program Management Office continues to use a variety of methods through the OTHER initiative. Some of the OTHER programs that were utilized in FY 2006 and 2007 include:

  • ORISE – Oak Ridge Institute for Science and Education – provides educational appointments for students, faculty, teachers, and post graduates at various FDA-approved host facilities.
  • ODE Employee Exchange – useful for bringing employees from other FDA and CDRH offices into ODE for short periods. Several Office and Center employees participate in this on-going program.
  • Experts/Consultants - intermittent temporary services of highly qualified people who possess unique professional, scientific, or technical expertise that is not available within the regular workforce.
  • Contracts - arrangements that can be used to acquire services not available in the existing workforce and for short-term needs that require specific skills.
  • ODE Intern Program - a no-cost program that brings students and professionals to ODE for short-term work experience; ODE Employee Share Program - an employee from one division works part-time or full-time for a limited period of time in another division within ODE or at another Office within the Center.
     

Device Evaluation Web Home Page

ODE continues to provide information on the web that can be downloaded and searched through the ODE home page at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115879.htm.  Information on Premarket Approval Applications (PMAs) and Premarket Notifications (510(k)s) can be found on the ODE home page. Information about recent device approvals in ODE can be found on the ODE home page under Medical Device Approvals.

Consumer Information

The Consumer Staff in FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (DSMICA) also provides information to consumers regarding medical devices and radiation-emitting products to enhance users ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

Website: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm

E-Mail: dsmica@fda.hhs.gov

Phone: Toll Free 1-800-638-2041 or 240-276-3103 directly between the hours of

8:00 a.m. – 4:30 p.m. EST

Fax: 240-276-3101

Mail: Consumer Staff, CDRH/FDA, 1 350 Piccard Drive, HFZ-210, Rockville, MD 20850