Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments of 1988 Waiver Applications, 56846-56847 [2012-22660]
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56846
Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Notices
The webcast will be
broadcast from the Centers for Disease
Control and Prevention facility, 1600
Clifton Rd. NE., Atlanta, GA 30329.
FOR FURTHER INFORMATION CONTACT:
CDC: LCDR. Jacinta Smith, Division of
Select Agents and Toxins, Office of
Public Health Preparedness and
Response, Centers for Disease Control
and Prevention, 1600 Clifton Road, NE.,
MS A–46, Atlanta, GA 30333;
lrsat@cdc.gov.
APHIS: Dr. Lidia Carrera, APHIS
Select Agent Program, APHIS, 4700
River Road, Unit 2, Riverdale, MD
20737; Lidia.Carrera@aphis.usda.gov
SUPPLEMENTARY INFORMATION: Title II of
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002, ‘‘Enhancing
Controls on Dangerous Biological
Agents and Toxins’’ (sections 201
through 231), provides for the regulation
of certain biological agents and toxins
by the Department of Health and Human
Services (subtitle A, sections 201–204)
and the Department of Agriculture
(subtitle B, sections 211–213).
Additionally, the statute provides for
interagency coordination between the
two departments regarding overlap
agents and toxins (subtitle C, section
221). For the Department of Health and
Human Services(HHS), the Centers for
Disease Control and Prevention (CDC)
oversees entities that possess, use or
transfer select agents and toxins that
have the potential to pose a severe
threat to public health and safety. The
U.S. Department of Agriculture’s
(USDA) Animal and Plant Health
Inspection Service (APHIS) has a
parallel program that oversees entities
that possess, use or transfer select agents
that have the potential to pose a severe
threat to animal or plant health, or to
animal or plant products . These two
programs constitute the Federal Select
Agent Program. The Federal Bureau of
Investigation’s (FBI) Criminal Justice
Information Services conducts security
risk assessments of (1) all individuals
and nongovernmental entities that
request to possess, use, or transfer select
agents and toxins, (2) all individuals
who need access to select agents and
toxins.
The webcast announced in this notice
is an opportunity for the regulated
community (i.e., registered entity
responsible officials, alternate
responsible officials, and entity owners)
and other interested individuals to
obtain specific regulatory guidance and
information on standards concerning
biosafety, biosecurity and incident
response issues related to the Federal
Select Agent Program. Representatives
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ADDRESSES:
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from HHS/CDC, USDA/APHIS, and the
FBI will be present during the webcast
to address questions and concerns from
the web participants.
Updates on the changes to the select
agent regulations; occupational health,
information and physical security;
personnel suitability; FD–961 form, and
changes to the APHIS/CDC Form 1 are
among the issues that will be discussed.
A question and answer session will take
place after each topic.
Registration instructions are found on
the Federal Select Agent Program Web
site https://www.selectagents.gov.
Registration ends on October 16, 2012.
This is a webcast only event and there
will be no on-site participation at the
HHS/CDC broadcast facility.
Registration is required for
participation. This is a 100% webcast;
therefore, in person participation cannot
be accommodated.
Participants will be able to submit
questions during the webcast at
selectagentwkshp@cdc.gov. Closedcaptioning services will be provided
during the webcast.
Dated: September 10, 2012.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2012–22653 Filed 9–13–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0937]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Clinical Laboratory
Improvement Amendments of 1988
Waiver Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 Clinical Laboratory Improvement
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Amendments of 1988 waiver
applications.
Submit either electronic or
written comments on the collection of
information by November 13, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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:
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: 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.
DATES:
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Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Notices
Clinical Laboratory Improvement
Amendments Waiver Applications—
(OMB Control Number 0910–0598)—
Extension
Congress passed the Clinical
Laboratory Improvement Amendments
(CLIA) (Pub. L. 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/Medical
Devices/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.
56847
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).
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
780
31,200
$66,200
1
There are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
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
Dated: August 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–22660 Filed 9–13–12; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0921]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Submission of Food and Drug
Administration Adverse Event Reports
and Other Safety Information Using the
Electronic Submission Gateway and
the Safety Reporting Portal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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16:39 Sep 13, 2012
Jkt 226001
PO 00000
Notice.
Frm 00040
Fmt 4703
Sfmt 4703
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
the use of the FDA Electronic
Submission Gateway (ESG) and the
Safety Reporting Portal (the SRP) to
collect adverse event reports and other
SUMMARY:
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]]>Agencies
[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56846-56847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22660]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0937]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Clinical Laboratory Improvement Amendments of 1988
Waiver Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Clinical Laboratory Improvement Amendments of 1988
waiver applications.
DATES: Submit either electronic or written comments on the collection
of information by November 13, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: 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: 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.
[[Page 56847]]
Clinical Laboratory Improvement Amendments Waiver Applications--(OMB
Control Number 0910-0598)--Extension
Congress passed the Clinical Laboratory Improvement Amendments
(CLIA) (Pub. L. 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 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).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total operating
Activity Number of responses per Total annual Average burden Total hours and maintenance
respondents respondent responses per response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLIA waiver application........................... 40 1 40 780 31,200 $66,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
operating
Activity Number of Number of records Total annual Average burden per Total hours and
recordkeepers per recordkeeper records recordkeeping maintenance
costs
--------------------------------------------------------------------------------------------------------------------------------------------- -------------
CLIA waiver records...................... 40 1 40 2,800 112,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: August 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22660 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P
