FY 2005 ODE Annual Report - Part 7 - Program Support
Freedom of Information Requests
ODE staff received 706 FOI requests during FY 05, a decrease from 972 in the last fiscal year. During FY 05, the number of FOI requests closed was 637 compared to 547 in FY 04. The total number of FOI requests pending in ODE at the end of FY 05 is 422 compared to 587 in FY 04.
Staff from ODE responded to Congressional inquiries and participated in briefings on the following topics – breast implants, electromagnetic treatment devices, spinal cord injuries, cervical discs, total joint prostheses, multiple artificial disc, hemostatic devices, automatic external defibrillators, carotid artery stenosis, and pacemakers. ODE also participated in hearings of Congressional committees and briefings of Congressional staff during FY 05. These dealt primarily with FDA’s budget and MDUFMA.
During FY 05, ODE staff authored 34 manuscripts for publication in professional and scientific journals and delivered 138 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.
ODE Vendor Day
ODE coordinated the Dental Implants Vendor Day which was held on June 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 3implant, Zimmer, Sterngold, and Dentsply participated. There were over 100 attendees.
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. Twenty-six employees completed the formal program.
To enhance the Center’s effort to increase the hiring of minorities and those with a disability, ODE participated in the 2005 Marriott Bridges Students with a Disabilities Program. In addition, ODE participated in the 2005 DHHGNTC Minority Career Fair, and we partnered with the Agency’s EEO/Diversity Management Office to support the Hispanic Employment Forum, the National Medical Association Career Fair, the Association of American Indian Physicians Conference, and the Society for Advancement of Chicanos & Native Americans in Science Conference and Career Fair.
Other Than Hiring to Expand/Enhance Resources Program (OTHER)
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 2005 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.
Medical Device 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.
CDRH has the ability to conduct Video Conferences with outside parties that have H.320 compliant systems, a standard for video conferencing over ISDN lines and other narrowband transmission media. In FY 05, ODE held 4 video conferences with industry and Federal agencies.
ODE installed medical/pharmaceutical/dental/biotech spell checking software on all of the ODE computers to assist in the preparation of review-related documents. ODE continued to install docking laptops to enable reviewers to use the same computer at work and at home with all files available at both locations. In addition, ODE increased the number of users working from home and continued to provide training and equipment for offsite access to the FDA network.
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.
Phone: Toll Free 1-800-638-2041 or 240-276-3103 directly between the hours of 8:00 a.m. – 5:00 p.m. EST