[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7043-7044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0041]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Procedures for the Clinical Laboratory 
Improvement Amendments of 1998 Categorization

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 for an existing collection of 
information and to allow 60 days for public commein response to the 
notice. This notice solicits comments on administrative procedures for 
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
categorization.

DATES:  Submit written or electronic comments on the collection of 
information by April 16, 2007.

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

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-827-1472.

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 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 these topics: (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.

Administrative Procedures for CLIA Categorization (42 CFR 493.17)

    A draft guidance document entitled ``Guidance for Administrative 
Procedures for CLIA Categorization'' was released for comment on August 
14, 2000. The document describes procedures FDA will use to assign the 
complexity category to a device. Typically, FDA assigns complexity 
categorizations to devices at the time of clearance or approval of the 
device. In this way, no additional burden is incurred by the 
manufacturer since the labeling (including operating instructions) is 
included in the 510(k) or PMA. In some cases, however, a manufacturer 
may request CLIA categorization even if FDA is not simultaneously 
reviewing a 510(k) or PMA. One example is when a manufacturer requests 
that FDA assign CLIA categorization to a previously cleared device that 
has changed names since the original CLIA categorization. Another 
example is when a device is exempt from premarket review. In such 
cases, the guidance recommends that manufacturers provide FDA with a 
copy of the package insert for the device and a cover letter indicating 
why the manufacturer is requesting a categorization (e.g. name change, 
exempt from 510(k) review). The draft guidance recommends that in the 
correspondence to FDA the manufacturer should identify the product code 
and classification as well as reference to the original 510(k) when 
this is available.
    A previous 60-day notice that published August 14, 2000 (65 FR 
49582) announced the availability of a draft guidance and did not 
include a Paperwork Analysis Section. This 60-day notice for public 
comment supersedes that notice and is correcting that error.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7044]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                               No. of       Annual Frequency     Total Annual        Hours per                         Total Operating &
               CFR Section                   Respondents      per Response        Responses          Responses         Total Hours     Maintenance Costs
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42 CFR 493.17                                          60                 15                900               1 hr             900 hr            $45,000
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Total                                                  60                 15                900               1 hr             900 hr            $45,000
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\1\ There are no capital costs associated with this collection of information.

    The number of respondents is approximately 60. On average, each 
respondent will request categorizations (independent of a 510(k) or 
PMA) 15 times per year. The cost, not including personnel, is estimated 
at $50. Thisincludes the cost of copying and mailing copies of package 
inserts and a cover letter, which includes a statement of the reason 
for the request and reference to the original 510(k) numbers, including 
regulation numbers and product codes.

    Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2468 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S