00-28616. Report on FDA Plan for Statutory Compliance; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a report entitled “Report on FDA Plan for Statutory Compliance.” This report satisfies provisions of the FDA Modernization Act of 1997 (FDAMA), which charged FDA to develop a plan for meeting its statutory requirements, and to report on planned versus actual performance.

ADDRESSES:

Copies of the report may be obtained from the contact person at the address listed below. Persons with access to the Internet may obtain the report at http://www.fda.gov/​oc/​fdama/​fdamaplnresponse/​rptFY99.html.

FOR FURTHER INFORMATION CONTACT:

Bill J. Hagan, Office of Planning (HFP-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5212, FAX [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is announcing the availability of a report entitled “Report on FDA Plan for Statutory Compliance.” This report satisfies provisions outlined in section 406(b) of FDAMA, which charged FDA to develop a plan for meeting its statutory requirements, and to report on planned versus actual performance. The plan was published in November 1998. This report identifies accomplishments against that plan. As this report shows, in fiscal year 1999, FDA achieved significant gains in the six FDAMA objectives by combining the agency's traditional principles and practices with new approaches. In keeping with its traditional values, FDA continued providing a broad spectrum of consumer protections based on rigorous science-based standards. To strengthen its performance, FDA developed partnerships with stakeholders and stimulated cooperation and participation by making its activities more understandable and accessible to stakeholders. FDA's accomplishments include the following:

• New drugs and biological products are being reviewed and released to the public in record time,
• A nationwide food safety surveillance network has now been established which is helping to significantly reduce food-related illnesses and deaths, and
• Millions of consumers have wider and more timely access to information about their new medications.

FDA will continue working with Congress and our stakeholders to improve performance and to work towards meeting our statutory obligations under FDAMA.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.