[Federal Register Volume 65, Number 220 (Tuesday, November 14, 2000)]
[Notices]
[Pages 68151-68152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29109]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-1020]


Medical Devices Draft Guidance on Over the Counter (OTC) 
Screening Tests for Drugs of Abuse: Guidance for Premarket 
Notifications; 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availability of the draft guidance entitled ``Over the Counter (OTC) 
Screening Tests for Drugs of Abuse: Guidance for Premarket 
Notifications.'' FDA is issuing this draft guidance to provide 
information about studies and labeling considerations applicable to OTC 
screening tests that use urine as the clinical specimen for any 
combination of one or more of these drugs: Amphetamine (and, or 
methamphetamine), cocaine, cannabinoids, opiates, and phencyclidine. 
This draft guidance defines OTC use for the purposes of this document 
as use in home, workplace, insurance, and sports settings, and includes 
requests for comments on confirmatory testing and OTC alcohol testing. 
This draft guidance is neither final nor in effect at this time.

DATES: Submit written comments on the draft guidance by February 12, 
2001.

ADDRESSES: Submit written requests for single copies on a 3.5 " 
diskette of the draft guidance entitled ``Over the Counter (OTC) 
Screening Tests for Drugs of Abuse: Guidance for Premarket 
Notifications,'' 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

[[Page 68152]]

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 Submit written comments on the draft guidance to the 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. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 30, 1998 (63 FR 71932), FDA 
announced the availability for comment of a draft guidance entitled 
``Guidance for Premarket Submissions for Tests for Screening Drugs of 
Abuse to Be Used By The Consumer.'' FDA invited interested persons to 
comment on the draft guidance by March 30, 1999. FDA is replacing that 
draft guidance document with a new draft guidance entitled ``Over the 
Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for 
Premarket Notifications.'' This second draft guidance provides more 
detailed recommendations on what to include in a premarket notification 
for this device, and includes new information addressing the relevant 
least burdensome provisions of the Food and Drug Administration 
Modernization Act of 1997.
    The draft guidance recommends including in the premarket 
notification:
     OTC studies showing correct results at concentrations 50 
percent above and 50 percent below the cutoff;
     Description of the patient reporting format;
     Studies on the stability of the device; and
     The confirmatory laboratory's credentials.
    The draft guidance also seeks public comment on premarket review of 
OTC alcohol tests.
    The draft guidance also addresses labeling for these devices.
    As part of its efforts to ensure that FDA considers the least 
burdensome path to market, the agency has drafted the guidance to:
     Clarify that OTC screening tests for drugs of abuse 
ordinarily will be reviewed as a premarket notification;
     Suggest the use of spiked urine samples instead of urine 
obtained from individuals using drugs; and
     Suggest combining drugs in these spiked urine samples in 
order to reduce the number of samples tested.

II. Significance of Guidance

    This draft guidance represents the agency's current thinking on 
submissions for OTC screening tests for drugs of abuse. 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.
    The agency has adopted good guidance practices (GGP's), and 
published the final rule, which set forth the agency's policies and 
procedures for the development, issuance, and use of guidance documents 
(65 FR 56468, September 19, 2000). This guidance document is issued as 
a Level 1 guidance consistent with the GGP's.

III. Electronic Access

    In order to receive the draft guidance entitled ``Over the Counter 
(OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket 
Notifications'' via your fax machine, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system. At the second voice prompt press 1 to 
order a document. Enter the document number (2209) followed by the 
pound sign (#). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. The Center for Devices and Radiological Health 
(CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the Internet. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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. ``Over the Counter (OTC) Screening Tests for Drugs of Abuse: 
Guidance for Premarket Notifications'' is available at http://www.fda.gov/cdrh/ode/guidance/2209.pdf.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by February 12, 
2001. 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: November 2, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29109 Filed 11-8-00; 4:21 pm]
BILLING CODE 4160-01-F