[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Draft Guidance for Premarket Submissions for Kits for Screening 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availability of the draft guidance entitled ``Guidance for Premarket 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 This draft guidance addresses screening devices sold over-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DATES: Written comments concerning this draft guidance must be received 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diskette of the draft guidance entitled ``Guidance for Premarket 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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electronic access to the draft guidance.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draft guidance document entitled ``Points to Consider for Approval of 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