[Federal Register Volume 66, Number 27 (Thursday, February 8, 2001)]
[Notices]
[Page 9586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1604]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; OTC Test Sample Collection Systems for Drugs 
of Abuse Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
March 12, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

OTC Test Sample Collection Systems for Drugs of Abuse Testing--21 
CFR Part 809 (OMB Control Number 0910-0368)--Extension

    FDA has reclassified over-the-counter (OTC) test sample collection 
systems for drugs of abuse testing from class III (premarket approval) 
into class I (general controls) subject to restrictions established in 
accordance with section 520(e) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j)(e).
    The labeling requirements for certain in vitro diagnostic products 
require that manufacturers of OTC test sample collection systems for 
drugs of abuse testing provide certain information to consumers for the 
proper use of the test sample collection system and for interpreting 
the results. The purpose of this regulation is to ensure that lay 
persons collecting samples for testing have adequate instructions for 
sample collection and handling and for receiving and understanding the 
test results reported by laboratories performing the analyses.
    The most likely respondents to this information collection will be 
manufacturers of over-the-counter drugs of abuse test kits.
    In the Federal Register of November 16, 2000 (65 FR 69314), the 
agency requested comments on the proposed collection of information. No 
comments were received.
     FDA estimates the burden of this collection of information as 
follows:

                                 Table1.--Estimated Annual Reporting Burden \1\
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                                    Annual frequency     Total annual
21 CFR Section  No. of respondents    per response         responses      Hours per response      Total Hours
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809.10                 20                  1                 20                 100               2,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based upon submissions to the agency (premarket notifications, 
premarket approval applications, registration and listing), FDA 
estimates that there will be about 20 manufacturers of these devices.
    FDA estimates, based upon discussions with manufacturers of similar 
devices required to comply with 21 CFR 809.10, that it will take 
approximately 40 hours to gather the information required by the rule, 
40 hours to design and prepare the labeling, and an additional 20 hours 
per year to review and revise the labeling as necessary.

    Dated: February 2, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-3322 Filed 2-7-01; 8:45 am]
BILLING CODE 4160-01-S