Department of Health and Human Services March 9, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a new Web-based system to electronically obtain a user fee payment identification number and to submit your Prescription Drug User Fee (PDUFA) cover sheet (FDA Form 3397) to the Office of Financial Management. The system will enable FDA to electronically track your company's application payments and will allow your organization to obtain the user fee payment identification number over the Web. By making the user fee payment identification number and the PDUFA cover sheet available on-line, we will be able to improve service, one of PDUFA's performance goals.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on September 28, 1993.

The CERHR announces the availability of the draft expert panel report for styrene on March 18, 2005, from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in printed text from the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on sections 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on June 1- 3, 2005, at the Holiday Inn Old Town Select in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the report on its Web site and solicit public comment on it through a Federal Register notice.