[Federal Register Volume 64, Number 244 (Tuesday, December 21, 1999)]
[Notices]
[Pages 71461-71462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33002]


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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Draft Guidance on the Labeling for Over-the-Counter Sample 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availability of the draft guidance entitled ``Guidance on Labeling for 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DATES: Submit written comments concerning this draft guidance by March 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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance document 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    Submit written comments on this draft guidance to the Dockets 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