[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Pages 27573-27574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0041]


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

AGENCY: Food and Drug Administration, HHS.

[[Page 27574]]


ACTION: Notice.

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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 June 
15, 2007.

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: 202-395-6974. All comments should be identified with the OMB 
Control Number 0910-NEW and the title ``Administrative Procedures for 
the Clinical Laboratory Improvement Amendments of 1988 
Categorization.'' Also include the FDA 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: 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 (42 CFR 493.17)

    A draft guidance document entitled ``Guidance for Administrative 
Procedures for Clinical Laboratory Improvement Amendments of 1988 
Categorization'' (CLIA) 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 premarket approval (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.
    In the Federal Register of February 14, 2007 (72 FR 7043), FDA 
published a 60-day notice soliciting public comment on the proposed 
collection of information requirements. In response to that notice, no 
comments were received.
    The likely respondents for this collection are Investigational New 
Drug Application sponsors.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                                                       Total Operating &
            42 CFR Section                    No. of        Annual Frequency     Total Annual        Hours per         Total Hours         Maintenance
                                           Respondents        per Response        Responses           Response                               Costs
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493.17                                                 60                 15                900                  1                900            $45,000
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Total                                                  60                 15                900                  1                900            $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. 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.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9435 Filed 5-15-07; 8:45 am]
BILLING CODE 4160-01-S