[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Proposed Rules]
[Page 29174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 809 and 864

[Docket No. 97N-0135]


Medical 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.

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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 filed by 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. 98-14048 Filed 5-27-98; 8:45 am]
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