Federal Register: May 28, 1998 (Volume 63, Number 102)Proposed RulesPage 29174From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr28my98-38

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 809 and 864

Docket No. 97N-0135Medical Devices; Hematology and Pathology Devices; Reclassification; Restricted Devices; OTC Test Sample Collection Systems for Drugs of Abuse Testing; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing on proposed rule.

SUMMARY: The Food and Drug Administration (FDA) is announcing a public hearing on a proposed rule to reclassify over-the-counter (OTC) test sample collection systems for drugs of abuse testing. The purpose of the public hearing is to solicit input on the proposed rule in addition to comments being submitted to the docket. The information obtained at the hearing will assist FDA in its preparation of a final rule. DATES: The public hearing will be held on June 19, 1998, from 9 a.m. to 5 p.m. Written notices of participation should be filedby June 8, 1998. Submit written comments by July 5, 1998.

ADDRESSES: The public hearing will be held at the Food and Drug Administration, 5600 Fishers Lane, conference rooms D and E, Rockville, MD 20857. Submit written notices of participation and written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Steven I. Gutman, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 5, 1998 (63 FR 10792), FDA published a proposed rule to reclassify OTC test sample collection systems for drugs of abuse testing. FDA has determined that a public hearing on the proposed rule is warranted. The hearing will be directed by William B. Schultz, Deputy Commissioner for Policy, FDA. To the extent possible, oral testimony should address the issues identified in the proposed rule (63 FR 10792). The procedures governing the hearing are those applicable to a public hearing before the Commissioner of Food and Drugs under 21 CFR part 15.

Interested persons who wish to participate may, on or before June 8, 1998, submit a notice of participation to the Dockets Management Branch (address above). All notices submitted should be identified with the docket number found in brackets in the heading of this document and should contain the name, address, telephone number, business affiliation of the person requesting to make a presentation, a brief summary of the presentation, and the approximate time requested for the presentation.

Individuals or groups having similar interests are requested to consolidate their comments and present them through a single representative. FDA will allocate the time available for the hearing among the persons who properly file a notice of appearance.

After reviewing the notice of participation and accompanying information, FDA will schedule each appearance and notify each participant by mail or telephone of the time allotted to the person and the approximate time the person's presentation is scheduled to begin. FDA may require joint presentations by persons with common interests. The schedule of the public hearing will be available at the hearing and it will be placed on file in the Dockets Management Branch following the hearing.

The administrative record of the proposed regulation will be open for 15 days after the hearing to allow comments on matters raised at the hearing. Persons who wish to provide additional materials for consideration are to file these materials with the Dockets Management Branch (address above) during that period.

The hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officers and panel members may question any person during or at the conclusion of their presentation.

Dated: May 20, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination.

FR Doc. 98-14048Filed5-27-98; 8:45 amBILLING CODE 4160-01-F