[Federal Register Volume 65, Number 222 (Thursday, November 16, 2000)]
[Notices]
[Page 69314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29326]



[[Page 69314]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1604]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for over-the-counter (OTC) test sample collection systems 
for drugs of abuse testing.

DATES: Submit written or electronic comments on the collection of 
information by January 16, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All documents should be identified 
with the docket number found in brackets in the heading of this 
document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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

    FDA has reclassified 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).
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                         No. of        Annual frequency     Total annual        Hours per
  21 CFR section      respondents        per response        responses           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: November 9, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29326 Filed 11-15-00; 8:45 am]
BILLING CODE 4160-01-F