Office of Regulatory Affairs

Who are we?

In 1995, the Associate Commissioner for Regulatory Affairs (ACRA) established the ORA21 staff (now the Performance Results Staff), with Marie Urban as Staff Director, to help ORA adapt to anticipated changes in the federal government as a result of public pressure for a responsive government. Congress passed the Government Performance and Results Act of 1993, that held government agencies accountable and measured performance by the results and impacts aligned with the budgeting process. This law has a timeline for strategic planning and the reporting of performance results. In addition, the Administration issued a number of Executive Orders on Regulatory Reform and Customer Service initiatives. In response, the staff:

    designed a new database (CARS) to measure the impact of our field in achieving compliance within the regulated industry.

    designed and piloted a database that would measure the impact of our outreach activities on compliance. This effort was in response to direction from an ORA-wide Team, led by the Staff in developing a Strategic Plan for ORA.

    coordinated development of the FDA Customer Service Plan.

    coordinated development of the FDA Customer Service standards.

    brought together a cross-section of ORA employees to develop the ORA Strategic Plan.

    facilitates the Interagency Regulatory Reinvention Forum, which brings together regulatory agencies throughout the Federal Government to share lessons learned.   

    collected and compiled the FDA Conversations with America report for the Vice President's National Partnership for Reinventing Government (NPR).

    represents FDA with NPR in the areas of Customer Service and Reinvention.

    sets and reports on annual performance goals to measure ORA's impacts.

In November 1997, Congress passed the FDA Modernization Act, which furthered the reinvention initiatives for FDA.

The PRS facilitates changes in ORA to focus on:

    outcome measures

    outreach and grassroots initiatives

    partnerships

    customer service

    cutting red tape

The PRS serves as ORA's change catalyst, and also serves as the Agency lead for initiatives that are broader based such as customer service activities. The PRS has been extremely effective in getting ORA and FDA recognition on the successful results of the change initiatives. This office serves as a liaison to the Vice President's National Partnership for Reinventing Government on Hammer Awards and Customer Service activities including "Conversations with America," surveying customers, and developing standards for customer service.

Top of Page

Navigational Assist

Links to: ORA Home | FDA Home Page | FDA Site Index | FDA ORA Search Page | FDA Reader Comments |