[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23781-23782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10358]
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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,
[email protected].
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