Document ID: FDA-2010-N-0199-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Posted Date: 2010-05-04T04:00Z

[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]               
[Page 23781-23782]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my10-94]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0199]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Procedures for the Clinical Laboratory 
Improvement Amendments of 1988 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 of an existing collection of 
information, and to allow 60 days for public comment in 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 July 6, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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 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 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 (OMB 
Control Number 0910-0607-Extension)

    A guidance document entitled ``Guidance for Administrative 
Procedures for CLIA Categorization'' was released on May 7, 2008. 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 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.
    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                          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               $46,800
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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 $52 per hour (52 x 900) totaling $46,800. This includes 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. The burden hours are based on FDA familiarity with the types of 
documentation typically included in a sponsor's categorization 
requests, and costs for basic office supplies (e.g. paper). The costs 
have been updated based on the Bureau of Labor Statistics estimates of 
inflation.

[[Page 23782]]

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10358 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S