[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Pages 47601-47602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19358]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Administrative 
Procedures for the Clinical Laboratory Improvement Amendments of 1988 

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


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

DATES: Fax written comments on the collection of information by 
September 7, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0607. 
Also include the FDA docket number found in brackets in the heading of 
this document.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

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.

Administrative Procedures for the Clinical Laboratory Improvement 
Amendments of 1988 Categorization--(OMB Control Number 0910-0607; 

    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 Premarket Application. In some cases, however, a manufacturer may 
request CLIA categorization even if FDA is not

[[Page 47602]]

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. 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 
    In the Federal Register of May 4, 2010 (75 FR 23781), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                                                                                       Total Operating &
                42 CFR Section                       No. of       Annual Frequency    Total Annual      Hours per       Total Hours        Maintenance
                                                  Respondents       per Response       Responses        Responses                            Costs
42 CFR 493.17                                                60                 15              900                1              900            $46,800
\1\ There are no capital costs associated with this collection of information.

    Dated: August 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19358 Filed 8-5-10; 8:45 am]