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FDA CENTERS SHOULD HOLD REGULAR MEETINGS ON REGULATIONS DEVELOPMENT

This article was originally published in The Gray Sheet

Executive Summary

FDA CENTERS SHOULD HOLD REGULAR MEETINGS ON REGULATIONS DEVELOPMENT, the agency's regulations streamlining task force recommends in a report issued on Jan. 15. "Centers should institute monthly (or at least quarterly) planning and priority meetings with" FDA's regulations policy and management staff, the task force recommends. Center representatives as well as officials from the office of general counsel, the economic staff, and the paperwork reduction staff should attend the meetings, the group says. According to the task force, the focus of the meetings would be to: set monthly goals; review time frames for significant Federal Register notices; set priorities for documents to be sent to the Office of Management and Budget; evaluate issues outside the regulations development process that impact on specific Federal Register documents; and resolve any current logjams in the development of regs. The report makes a total of eight recommendations on how FDA could streamline regulations development. The task force was established in August 1991 by Deputy Commissioner for Policy Michael Taylor in response to criticisms that FDA fails to issue regs in a timely manner. The task force report identifies several deficiencies that are responsible for "many of the delays" in the regulations development process. The group says that FDA lacks an agency-wide automated tracking system for Federal Register documents, as well as sustained leadership in agency planning and priority setting related to regulations. The regulations process also is hindered by requests for extensive economic studies and extensions of comment periods on most proposed rules. In addition to suggesting meetings on regulations development, the task force report recommends that FDA establish an agency-wide electronic tracking system for Federal Register documents that would allow the agency: "to monitor the progress being made on all regulations under development within the agency including the five FDA centers; generate recurring reports for top agency officials and center directors about the regulations planned and under way; and maintain a basis for learning about delays in issuing regulations and initiating appropriate actions to overcome internal delays." Noting that the recommendation for an automated tracking system has been made "at least twice" in previous studies of the regulations process, the task force states that it considers the recommendation to be "the most efficient way to improve FDA's regulations development process quickly." The task force calls for "immediate" implementation of the recommendation. The task force further recommends that each center appoint a "senior regulations liaison" to the center director's office. The liaison would "have the knowledge and authority to make decisions for, and on behalf of, the center director for all issues involving regulations development and processing." The liaison also would aid regulation writers in "obtaining necessary clearances of the regulations documents in a timely manner," the report states. The task force notes that two centers have already appointed regulations liaisons: the Center for Biologics Evaluation and Research and the Center for Food Safety and Nutrition. The task force says that FDA should establish a policy for reviewing and acting upon requests for extensions of comment periods. The group notes three suggestions made by the American Bar Association on the issue, including developing "boiler plate" language for proposed rules that states that FDA is obligated to publish a final rule by a specific date; incorporating longer comment periods in proposed rules for which FDA believes extension requests are likely; and establishing a policy that requests for extensions will not be considered if the request is received less than 10 days before the original comment period closes. The groups final recommendations are: that no Federal Register documents should be accepted for processing by the office of policy's regulations editorial staff until after the document has received initial general counsel clearance; that the commissioner appoint someone from his office or the office of general counsel to oversee development of regulations that involve more than one center's jurisdiction; that the centers assess the need for addressing economic issues or paperwork requirements during the preliminary drafting phase of the reg; and that the agency develop standard operating procedures for processing Federal Register documents. In a Federal Register notice to be published on Jan. 19, FDA is announcing its intent to withdraw 10 proposed rules in its continuing effort to reduce the agency's backlog of regulations. In December 1991, the agency withdrew 89 proposed rules that it considered of low priority or unnecessary. Interested parties have 60 days to comment on the proposed withdrawals. The proposed rules to be withdrawn include a rule that invited comments on revision of the investigational device exemption regulation. The agency says that its existing regulations are "adequate." Proposed rules related to the development of performance standards for vascular graft prostheses of 6 mm and greater diameter, central nervous system fluid shunts and components, and continuous ventilators and ventilator tubing are being withdrawn due to procedural changes made by the Safe Medical Devices Act of 1990. FDA said that it will publish a single notice of proposed rulemaking "for the establishment, amendment, or revocation of a performance standard."
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