[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]
BILLING CODE 4160-01-F
