[Federal Register: December 2, 2003 (Volume 68, Number 231)]
[Notices]               
[Page 67460-67461]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de03-77]                         


[[Page 67460]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0522]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; Premarket Submissions and Labeling Recommendations for Drugs of 
Abuse Screening Tests; 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availability of the draft guidance entitled ``Draft Guidance for 
Industry and FDA Staff; Premarket Submission and Labeling 
Recommendations for Drugs of Abuse Screening Tests.'' This draft 
guidance is intended to assist industry in preparing premarket 
notification submissions for drugs of abuse screening tests. The draft 
guidance also provides recommendations regarding the labeling of these 
tests. This draft guidance is neither final nor is it in effect at this 
time.

DATES: Submit written or electronic comments on this guidance by March 
1, 2004.


ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Draft Guidance for 
Industry and FDA Staff; Premarket Submission and Labeling 
Recommendations for Drugs of Abuse Screening Tests'' to the Division of 
Small Manufacturers, International, and Consumer 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. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jean 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

    On November 14, 2000, FDA issued two draft guidance documents 
entitled ``Over the Counter (OTC) Screening Tests for Drugs of Abuse: 
Guidance for Premarket Notifications'' and ``Guidance for Prescription 
Use Drugs of Abuse Assays Premarket Notifications'' (docket nos. 1999D-
1020 and 2000D-1587). This draft guidance replaces those documents and 
is intended to address concerns about those documents, including 
concerns regarding a recommendation that the cost of confirmatory 
testing be bundled with the cost of screening tests. Among other 
changes, the draft guidance FDA is issuing today recognizes that 
measures other than bundling the cost of confirmatory testing may help 
mitigate the risk of inaccurate results. The new draft guidance also 
clarifies that premarket submissions for drugs of abuse screening tests 
used in workplace and other repetitive testing sites may not require 
the same types of data as submissions for screening tests that are 
intended for sale directly to untrained users. The draft guidance is 
intended to assist manufacturers in preparing premarket submissions for 
drugs of abuse tests used in any setting, including hospital, 
workplace, sports, insurance, and home settings. The draft guidance 
also provides recommendations on labeling drugs of abuse screening 
tests.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on premarket submissions and 
labeling of drugs of abuse screening tests. 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 requirements of the applicable statute and regulations.

III. Electronic Access

    To receive ``Draft Guidance for Industry and FDA Staff; Premarket 
Submissions and Labeling Recommendations for Drugs of Abuse Screening 
Tests'' by 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 (152) followed by the pound sign ([numsign]). 
Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. 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 Internet 
access. Updated on a regular basis, the CDRH home page includes device 
safety alerts, Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturer's assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. The CDRH Web site may be 
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.

guidance.html. Guidance documents are also available on the Division of 
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E) (OMB control number 0910-0120). The labeling provisions addressed in 
the guidance have been approved by OMB under the PRA under OMB control 
number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this document 
at any time. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit two paper copies of any mailed 
comments, 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. Comments received may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.


[[Page 67461]]


    Dated: November 13, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29855 Filed 12-01-03; 8:45 am]

BILLING CODE 4160-01-S