[Federal Register: December 21, 1999 (Volume 64, Number 244)]
[Notices]
[Page 71461-71462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de99-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-5125]


Draft Guidance on the Labeling for Over-the-Counter Sample
Collection Systems for Drugs of Abuse Testing; 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availability of the draft guidance entitled ``Guidance on Labeling for
Over-the-Counter Sample Collection Systems for Drugs of Abuse
Testing.'' This guidance is neither final nor is it in effect at this
time. This guidance provides labeling recommendations for over-the-
counter sample collection systems for drugs of abuse testing and is
being issued as a result of FDA's proposed reclassification of over-
the-counter sample collection systems for drugs of abuse testing as
class I restricted devices.

DATES: Submit written comments concerning this draft guidance by March
22, 2000.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance. Submit written requests for
single copies on a 3.5'' diskette of the draft guidance document
entitled ``Guidance on Labeling for Over-the-Counter Sample Collection
Systems for Drugs of Abuse Testing'' 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    Submit written comments on this draft guidance to the Dockets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.

FOR FURTHER INFORMATION CONTACT: Joseph Hackett, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 5, 1998 (63 FR 10792), FDA
published a proposed rule that would reclassify over-the-counter (OTC)
sample collection systems for drugs of abuse testing from class III
(premarket approval) to class I (general controls),

[[Page 71462]]

and would exempt them from the premarket notification (510(k)) and
current good manufacturing practice (CGMP) requirements. The proposal
would also restrict these devices under section 520(e) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(e)) to require
the following: (1) The laboratory test(s) incorporated into these
systems would be required to have been cleared, approved, or otherwise
recognized by FDA as accurate and reliable for laboratory use; (2) the
laboratory performing the underlying test(s) must be able to reliably
perform the necessary screening and confirmatory tests; and (3) the
samples must be adequately identified to avoid mix-ups and the test
sample collection system must be accurately labeled so that consumers
can readily use it. The draft guidance will help manufacturers meet
this third criterion if the regulation becomes final and also can be
used by manufacturers currently marketing these products under FDA's
Interim Policy regarding ``Parents' Access to Tests for Drugs of
Abuse.'' This draft guidance also addresses the need to provide
consumers with access to professional assistance in interpreting/
understanding test results and counseling referrals.

II. Significance of Guidance

    This draft guidance document represents the agency's current
thinking on labeling of over-the-counter sample collection systems for
drugs of abuse testing. 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), 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 the draft guidance entitled ``Guidance on
Labeling for Over-the-Counter Sample Collection Systems for Drugs of
Abuse Testing'' via your fax machine; call the CDRH Facts-On-Demand
(FOD) 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 (1154)
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 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. Updated on a regular basis,
the CDRH home page includes the draft guidance entitled ``Guidance on
Labeling for Over-the-Counter Sample Collection Systems for Drugs of
Abuse Testing,'' 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. ``Guidance on Labeling for Over-the-Counter Sample Collection
Systems for Drugs of Abuse Testing'' will be available at http://
www.fda.gov/cdrh/ggpmain.html#docs.

IV. Paperwork Reduction Act of 1995

    The information collection provisions referred to in this guidance
have been approved under OMB control number 0910-0368. This approval
expires April 30, 2001. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

V. Comments

    Interested persons may, on or before March 22, 2000, submit to
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 guidance document and received comments may be seen
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: December 10, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-33002 Filed 12-20-99; 8:45 am]
BILLING CODE 4160-01-F