[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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Draft Guidance for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 This draft
guidance is intended to assist industry in preparing premarket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 The draft
guidance also provides recommendations regarding the labeling of these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 This draft guidance is neither final nor is it in effect at this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diskette of the draft guidance document entitled ``Draft Guidance for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