Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications, 23568-23569 [2013-09180]
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23568
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2012–N–0937]
[Docket No. FDA–2012–N–0018]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Health Care Professional Survey of
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
On
October 12, 2012, the Agency submitted
a proposed collection of information
entitled ‘‘Health Care Professional
Survey of Prescription Drug Promotion’’
to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0730. The
approval expires on February 29, 2016.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09176 Filed 4–18–13; 8:45 am]
BILLING CODE 4160–01–P
17:11 Apr 18, 2013
Notice.
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,
2013.
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
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, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 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.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Health Care Professional Survey of
Prescription Drug Promotion’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
VerDate Mar<15>2010
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Clinical Laboratory
Improvement Amendments Waiver
Applications
Jkt 229001
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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’’ (https://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
E:\FR\FM\19APN1.SGM
19APN1
23569
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
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 PRArelated 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 $350,000.
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 follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Total operating and
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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
[FR Doc. 2013–09180 Filed 4–18–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2012–N–0324]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry, FDA Staff, and
Foreign Governments: Fiscal Year
2012 Medical Device User Fee Small
Business Qualification and
Certification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry, FDA Staff, and
Foreign Governments: Fiscal Year 2012
Medical Device User Fee Small Business
Qualification and Certification’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:11 Apr 18, 2013
Jkt 229001
On
January 31, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Guidance for Industry, FDA
Staff, and Foreign Governments: Fiscal
Year 2012 Medical Device User Fee
Small Business Qualification and
Certification’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0508. The
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09181 Filed 4–18–13; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0114]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Electronic Submission of Medical
Device Registration and Listing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Electronic Submission of Medical
Device Registration and Listing’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On August
06, 2012, the Agency submitted a
proposed collection of information
entitled ‘‘Electronic Submission of
Medical Device Registration and
Listing’’ to OMB for review and
SUMMARY:
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23568-23569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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,
2013.
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 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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 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.
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'' (https://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
$350,000.
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
follows:
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]
BILLING CODE 4160-01-P
