[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Pages 23568-23569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09180]



Food and Drug Administration

[Docket No. FDA-2012-N-0937]

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

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 May 20, 

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 emailed 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.

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.

Clinical Laboratory Improvement Amendments Waiver Applications--(OMB 
Control Number 0910-0598)--Extension

    Congress passed the Clinical Laboratory Improvement Amendments 
(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(d)(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).
    On January 30, 2008, FDA published a guidance document entitled 
``Guidance for Industry and FDA Staff: Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm). 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.
    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 
maintaining the record for a total of 112,000 hours. The total 
operating and maintenance cost associated with the

[[Page 23569]]

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).
    In the Federal Register of September 14, 2012 (77 FR 56846), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one PRA-related comment.
    The comment asserts that the amount of time per response and the 
cost associated with a waiver application are underestimated. FDA has 
revised its estimates based on the comment received on the 60-day 
Federal Register notice. As shown below, FDA is increasing the hours 
per response from 780 to 1,200 hours. FDA is also increasing the 
estimated operating and maintenance cost burden from $66,200 to 
    The Center for Devices and Radiological Health (including both the 
Office of In Vitro Diagnostics and the Division of Biostatistics) 
maintains dialogue with industry representatives (the Advanced Medical 
Technology Association), regarding development of additional options 
regarding study design and data analysis approaches for certain devices 
to demonstrate they are suitable candidates for waiver.
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                  Number of
                  Activity                       Number of      responses per     Total annual    Average burden    Total hours     Total operating and
                                                respondents       respondent       responses       per response                      maintenance costs
CLIA waiver application.....................              40                1               40            1,200           48,000               $350,000
\1\ There are no capital costs associated with this collection of information.

                                                    Table 2--Estimated Annual Recordkeeping Burden \1\
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
CLIA waiver records................................................              40                1               40            2,800          112,000
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09180 Filed 4-18-13; 8:45 am]