FY 2005 OCER Annual Report - Appendix

 OCER Staffing and Organization

OCER includes the Office of the Director, two Staffs, and four Divisions.

Office of the Director

• Provides overall leadership and direction.
• Provides administrative support to all OCER programs

Sherrie Appel Nancy Bennaugh Karen Brown Malcolm Dennis Clifford Evans Udina Frett Stefan Gagne

Heather Howell Renee Lapp David Racine Lynne Rice* John McCrohan Kimberly Vitale Cynthia Whittington

 

Staff College

• Develops and delivers training programs, courses, seminars, and lectures.
• Provides satellite telecasts and distance learning programs on a variety of topics

 

Marjory Brier Renee Brotman* Sharon Burdette Simon Choi Kamilah Cooper Diane Gausman Mary Hanna Bernadette Kawaley

Susan Kornspan Toni Morch Elizabeth Moten Steven Nesseler Laura Stewart Parbodh Tohan Jacqueline Woodard

 

Regulations Staff

• Develops and advises on the preparation of Federal Register documents, including proposed and final regulations and notices.
• Coordinates the preparation, review and processing of responses to citizen petitions.

 

Domini Cassis Ruth Fischer Rosa Gilmore

Myrna Hanna Bernice Noland Philip Desjardins

 

Division of Mammography Quality and Radiation Programs

• Implements the Mammography Quality Standards Act, including the certification and annual inspection of all mammography facilities
• Supports collaborative activities that help protect the public from unnecessary exposure to electronic product radiation
• Administers the CDRH Radiation Safety Office

 

Scott Abernethy Catherine Akey Fiad Ali Helen Barr* Stephanie Belella Penny Boyce Sean Boyd Henry Chan Kaye Chesemore Pamela Chissler Joanne Choy Daryl Crutchfield Sharon Davis Jerome Dennis La Netta Dietrichson Michael Divine

Charles Finder Kathleen Franke Wesley Friend Timothy Haran Thomas Jakub Vickie Jernigan Richard Kaczmarek Manuel Karos Daniel Kassiday George Kraus Charles Lively Frank Mackison Tommy Mosely Walid Mourad Albert Moyal

Michael Noska Thomas Ohlhaber Ellyce Ratskoff Denise Robinson Heyward Rourk Petro Shandruk Kathleen Sheridan Dale Smith Dave Spelic Stan Stern Dan Trammell Cory Tylka Evelyn Wandell Stella Wei Nancy Wynne

 

Division of Device User Programs and Systems Analysis

• Provides human factors and systems analysis to reduce use error by evaluating device design, instructions for use, and patient labeling in premarket and postmarket reviews
• Conducts and advises on qualitative research to help construct risk messages and analyze internal processes.
• Develops information and outreach for health professionals and consumers

 

Harriet Albersheim Robert Cangelosi Peter Carstensen Carol Clayton Ron Kaye Jack McCracken Susan Meadows Kristine Mejia Laurel Mendelson Michael Mendelson Mary Lou Pijar

Jay Rachlin* Walter Scott Edie Seligson Paula Silberberg Sharon Snider Alvin Thomas Margaret Tolbert Tammy Wallace Alicia Witters Mary Ann Wollerton

 

Division of Communication Media

• Produces videotapes and teleconferences – from script development to completed program – using in-house resources
• Delivers satellite productions to CDRH, FDA, and national audiences to promote the mission and messages of CDRH and FDA.

 

David Bailey Bruce Butler Kenton Frederick Katherine Gray Robert McCleary* Stefan Monica

Barbara Richards Stanley Rose Glenn Scimonelli Laurie Silverman Michael Sobola Jeanine Vinson

 

Division of Small Manufacturers, International and Consumer Assistance

• Educates industry and helps them comply with FDA regulations.
• Educates consumers on medical devices and radiation emitting product issues and problems
• Educates foreign governments on the U.S. regulatory process
• Supports global harmonization and Mutual Recognition Agreement (MRA) activities

 

Bonnie Alderton Gene Allen Tom Cardamone Geoffrey Clark Connie Daly Carol Fedorchak Cynthia Garris Nancy Leonard Marie Nelson Yung Pak Lisa Pritchard

Joseph Puleo Joyce Raines Anthony Rodgers Walter Snesko Barbara Stellar John Stigi* William Sutton Tawana Taylor Crystal Watts Arthur Yellin

 

An asterisk at the end of the name denotes the Director of each Staff or Division.

 OCER Organization Chart

 

Text description of OCER Organization Chart:

Office of the Director: Lynne Rice
Deputy Director: John McCrohan
Special Assistant to the Director: Heather Howell
Assistant Director for Program Operations: Clifford Evans
Regulations Staff: Director, Vacant
Staff College: Director, Renee Brotman
Division of Communication Media: Director, Robert McCleary
Division of Device User Programs and Systems Analysis:

Director, Vacant
Deputy Director, Margaret Tolbert
Labeling Research and Policy Development Staff Chief, Vacant
Human Factors Engineering Branch Chief, Robert Cangelosi
Outreach and Public Participation Branch Chief, Alvin Thomas

Division of Mammography Quality and Radiation Programs:

Director, Helen Barr
Deputy Director, Thomas Ohlhaber
Associate Director for Administration, Kathleen Sheridan
Associate Director for Policy and Clinical Affairs, Charles Binder
Inspection and Compliance Branch Acting Chief, Mike Devine
Information Management Branch Chief, Timothy Haran
Radiation Programs Branch Chief, Pete Shandruk
Accreditation and Certification Branch Chief, Kathleen Franke
Electronic Product Devices Branch Chief, Sean Boyd
Diagnostic Devices Branch Chief, Tom Jakub

Division of Small Manufacturers, International and Consumer Assistance:

Director, John Stigi
Deputy Director, William Sutton
Technical Assistance Branch Chief, Joseph Puleo
Regulatory Assistance Branch Chief, Thomas Cardamone