Accession Number : ADA290251

Title :   FDA Regulations: Sustained Management Attention Needed To Improve Timely Issuance.

Corporate Author : GENERAL ACCOUNTING OFFICE WASHINGTON DC HUMAN RESOURCES DIV

PDF Url : ADA290251

Report Date : 21 FEB 1992

Pagination or Media Count : 26

Abstract : Over the years, FDA has experienced major delays in the development of regulations and publication of its final regulations. As of April 1991, when FDA released agencywide data, 388 regulations were in process that the agency had begun to develop but had not completed or published in the Federal Register as final regulations. Of 301 regulations published as proposed rules to obtain public comment, 217 (72 percent) had been in pending status for more than 5 years. Some have been pending much longer; two have been pending for 29 years. Further, certain regulations required by federal statute had been in process an average of 4 years. At the time of our review, 45 such regulations were in process within FDA. Because FDA's management of regulation development and issuance has been generally ineffective, we support the agency's August 1991 establishment of a Regulations Council to oversee and, when needed, direct the management of the rulemaking process. In addition, we believe a single automated tracking system that encompasses agency-wide regulation activities is needed to improve management's oversight of the rulemaking process. JMD

Descriptors :   *PUBLIC HEALTH, *REGULATIONS, *FEDERAL LAW, CONTROL, AUTOMATION, MANAGEMENT, ATTENTION, AUTOMATIC TRACKING.

Subject Categories : Biochemistry
      Information Science
      Medicine and Medical Research

Distribution Statement : APPROVED FOR PUBLIC RELEASE