[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6206-6207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0489]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recommendations for 
Clinical Laboratory Improvement Amendments of 1988 Waiver Applications

AGENCY: Food and Drug Administration, HHS.

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 March 
10, 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 0910-0598. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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.

Recommendations for Clinical Laboratory Improvement Amendments of 1988 
Waiver Applications--21 CFR Section 493 (OMB Control Number 0910-
0598)--Extension

    Congress passed the Clinical Laboratory Improvements Amendment 
(CLIA) (Public Law 100-578) in 1988 to establish quality standards for 
all laboratory testing. The purpose was to ensure the accuracy, 
reliability, and timeliness of patient test results regardless of where 
the test took place. CLIA requires that clinical laboratories obtain a 
certificate from the Secretary of Health and Human Services (the 
Secretary), before accepting materials derived from the human body for 
laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only 
tests that are ``simple'' and that have an ``insignificant risk of an 
erroneous result'' may obtain a certificate of waiver (42 U.S.C. 
263a(c)(2)). The Secretary has delegated to FDA the authority to 
determine whether particular tests (waived tests) are ``simple'' and 
have ``an insignificant risk of an erroneous result'' under CLIA (69 FR 
22849, April 27, 2004). This guidance document describes 
recommendations for device manufacturers submitting to FDA an 
application for determination that a cleared or approved device meets 
this CLIA standard (CLIA waiver application). The guidance recommends 
that CLIA waiver applications include a description of the features of 
the device that make it ``simple''; a report describing a hazard 
analysis that identifies potential sources of error, including a 
summary of the design and results of flex studies and conclusions drawn 
from the flex studies; a description of fail-safe and failure alert 
mechanisms and a description of the studies validating these 
mechanisms; a description of clinical tests that demonstrate the 
accuracy of the test in the hands of intended operators; and 
statistical analyses of clinical study results. Only new information 
collections not already approved are included in the estimate in the 
following table. Quick reference instructions are a short version of 
the instructions that are written in simple language and that can be 
posted.
    The total number of reporting and recordkeeping hours is 143,200 
hours. FDA bases the burden on an agency analysis of premarket 
submissions with clinical trials similar to the waived laboratory 
tests. Based on previous years' experience with CLIA waiver 
applications, FDA expects 40 manufacturers to submit one CLIA waiver 
application per year. The time required to prepare and submit a waiver 
application, including the time needed to assemble supporting data, 
averages 780 hours per waiver application for a total of 31,200 hours 
for reporting. Based on previous years experience with CLIA waiver 
applications, FDA expects that each manufacturer will spend 2,800 hours 
creating and

[[Page 6207]]

maintaining the record for a total of 112,000 hours. The total 
operating and maintenance cost associated with the waiver application 
is estimated at $66,200. The cost consists of specimen collection for 
the clinical study (estimated $23,500); laboratory supplies, reference 
testing and study oversight (estimated $26,700); shipping and office 
supplies (estimated $6,000); and educational materials, including quick 
reference instructions (estimated $10,000). This guidance also refers 
to previously approved collections of information found in FDA 
regulations. The collections of information in 21 CFR part 801 and 21 
CFR 809.10 have been approved under OMB control number 0910-0485 and 
the collections of information in 21 CFR part 803 have been approved 
under OMB control number 0910-0437.
    In the Federal Register of October 20, 2009 (74 FR 53750), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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  of   Total Annual      Hours per                        Operating and
              21 CFR Section                  Respondents           Response           Responses       Response       Total Hours     Maintenance Costs
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493.15(a) and (b)                                         40                     1              40             780          31,200               $50,200
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\1\ There are no capital costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                 No. of         Annual Frequency     Total Annual      Hours per                        Operating and
              21 CFR Section                 Recordkeepers      per Recordkeeping       Records         Record        Total Hours     Maintenance Costs
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493.15(a) and (b)                                         40                     1              40           2,800         112,000               $16,000
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\1\ There are no capital costs associated with this collection of information.


    Dated: January 25, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2598 Filed 2-5-10; 8:45 am]
BILLING CODE 4160-01-S