[Federal Register Volume 63, Number 250 (Wednesday, December 30, 1998)]
[Notices]
[Pages 71932-71933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34346]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1020]
Draft Guidance for Premarket Submissions for Kits for Screening
Drugs of Abuse To Be Used by the Consumer; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Guidance for Premarket
Submissions for Kits for Screening Drugs of Abuse to Be Used By The
Consumer.'' This draft guidance addresses screening devices sold over-
the-counter for testing drugs of abuse. This type of device is intended
for use in the home setting as a screening test for any, or any
combination, of the following five substances in urine: Amphetamine/
methamphetamine, cocaine, cannabinoids, opiates, and phencyclidine.
DATES: Written comments concerning this draft guidance must be received
by March 30, 1999.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance entitled ``Guidance for Premarket
Submissions for Kits for Screening Drugs of Abuse to Be Used By The
Consumer'' to the Division of Small Manufacturers Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your
request, or fax your request to 301-443-8818. Submit written comments
on the draft guidance to the Dockets Management Branch (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Joseph L. Hackett, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-3084.
SUPPLEMENTARY INFORMATION:
I. Background
Over the last several years, FDA has worked to clarify the
regulation of products for use in the home setting intended to screen
for drugs of abuse. On September 17, 1997, FDA released for comment a
draft guidance document entitled ``Points to Consider for Approval of
Home Drugs of Abuse
[[Page 71933]]
Screening Kits.'' On September 25, 1997, FDA held an open public
meeting of the Clinical Chemistry and Clinical Toxicology Panel (the
Panel), an FDA advisory committee, in order to discuss and receive
comments on the September 1997 guidance. Based upon comments and
recommendations received at this meeting from the Panel, the public,
and manufacturers, FDA has revised the September 1997 guidance.
II. Significance of Guidance
This draft guidance represents the agency's current thinking on
drugs of abuse home screening kits. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the applicable statute, regulations, or both. This guidance is not
final nor is it in effect at this time. This draft guidance replaces
the September 17, 1997, guidance.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive ``Guidance for Premarket Submissions for Kits
for Screening Drugs of Abuse to Be Used By the Consumer'' via your fax
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. At the first voice prompt press 1
to access DSMA Facts, at second voice prompt press 2, and then enter
the document number 2209 followed by the pound sign (#). Then follow
the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the World Wide Web (WWW). CDRH maintains an entry on
the WWW for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with access to the
WWW. Updated on a regular basis, the CDRH home page includes ``Guidance
for Premarket Submissions for Kits for Screening Drugs of Abuse to Be
Used By the Consumer,'' device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''.
IV. Comments
Interested persons may, on or before March 30, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this draft guidance. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The draft guidance and received comments may be seen in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: December 15, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-34346 Filed 12-29-98; 8:45 am]
BILLING CODE 4160-01-F
