[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53750-53751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 collections of information 
associated with the guidance issued January 30, 2008, and titled 
``Recommendations: Clinical Laboratory Improvement Amendments of 1988 
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic 
Devices''.

DATES: Submit written or electronic comments on the collection of 
information by December 21, 2009.

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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 of 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.

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

[[Page 53751]]

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.
    FDA estimates the burden of this collection 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.

    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 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 Sec.  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.

    Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25177 Filed 10-19-09; 8:45 am]
BILLING CODE 4160-01-S