[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6206-6207]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe10-62]
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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 oira_submission@omb.eop.gov. 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,
Daniel.Gittleson@fda.hhs.gov.
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