Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications, 46693-46694 [2016-16886]
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Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices
employees in ORR with access to the
database, and a limited number of
employees in other HHS offices, e.g.,
CDC and SAMHSA, receiving data from
ORR) who are advised of the
confidentiality of the records and the
civil and criminal penalties for misuse.
Personnel with authorized access to the
system are provided privacy and
security training for electronically
stored information. The records are
processed and stored in a secure
environment. All records are stored in
an area that is physically safe from
access by unauthorized persons at all
times. Safeguards conform to the HHS
Information Security Program, https://
www.hhs.gov/ocio/securityprivacy/
index.html.
RETENTION AND DISPOSAL:
The records will be retained
indefinitely pending scheduling with
the National Archives and Records
Administration (NARA). Because the
records will have continuing value for
epidemiological purposes, the retention
period proposed to NARA may be 100
years or longer.
SYSTEM MANAGER AND ADDRESS:
Director, Division of Refugee Health,
Office of Refugee Resettlement,
Administration for Children and
Families, Mary E. Switzer Building, 330
C Street SW., Washington, DC 20201.
NOTIFICATION PROCEDURE:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Individuals seeking to determine
whether this system of records contains
information about them should address
written inquiries to the System
Manager. The request should include
the alien number, age, telephone
number, and/or email address of the
individual data subject. The request
must be signed by the requester.
Verification of identity as described in
the Department’s Privacy Act
regulations may be required (see 45 CFR
5b.5). If the individual data subject is a
minor or is legally incompetent, the
individual’s legal representative (parent
or court-appointed guardian) may
request notification on the individual’s
behalf. The representative must provide
verification of identity and competent
evidence of the parent or guardian
relationship.
RECORD ACCESS PROCEDURES:
Individuals seeking access to a record
about them in this system of records
should address written inquiries to the
System Manager. The request should
include the alien number, age,
telephone number, and/or email address
of the individual. The request must be
signed by the individual to whom such
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46693
information pertains. Verification of
identity as described in the
Department’s Privacy Act regulations
may be required (see 45 CFR 5b.5). If the
individual data subject is a minor or is
legally incompetent, the individual’s
legal representative (parent or courtappointed guardian) may request access
on the individual’s behalf. The
representative must provide verification
of identity and competent evidence of
the parent or guardian relationship.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CONTESTING RECORD PROCEDURES:
AGENCY:
Individuals seeking to amend a record
about them in this system of records
should address the request for
amendment to the System Manager. The
request should:
• Include the alien number, age,
telephone number, and/or email address
of the individual, and should be signed
by the individual to whom such
information pertains;
• identify the system of records that
the individual believes includes his or
her records or otherwise provide enough
information to enable the identification
of the individual’s record;
• identify the information that the
individual believes is not accurate,
relevant, timely or complete;
• indicate what corrective action is
sought; and
• include supporting justification or
documentation for the requested
amendment.
Verification of identity as described in
the Department’s Privacy Act
regulations may be required (see 45 CFR
5b.5). If the individual data subject is a
minor or is legally incompetent, the
individual’s legal representative (parent
or court-appointed guardian) may make
an amendment request on the
individual’s behalf. The representative
must provide verification of identity
and competent evidence of the parent or
guardian relationship.
RECORD SOURCE CATEGORIES:
The information maintained in the
system is provided by states and other
resettlement organizations when they
report a suicide attempt using the
Refugee Suicide and Report Form. The
State Refugee Coordinator and State
Refugee Health Coordinator will be
primarily responsible for reporting this
information. They will collect the
information from various sources within
the state including refugee resettlement
agencies, public health departments,
ethnic-based community organizations,
and refugee community leaders.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
[FR Doc. 2016–16812 Filed 7–15–16; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2008–D–0031]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Clinical Laboratory
Improvement Amendments Act of 1988
Waiver Applications
Food and Drug Administration,
HHS.
ACTION:
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 August 17,
2016.
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.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@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.
FOR FURTHER INFORMATION CONTACT:
CLIA Waiver Applications—OMB
Control Number 0910–0598—Extension
Congress passed the 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
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18JYN1
46694
Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices
‘‘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.
In the Federal Register of April 1,
2016 (81 FR 18858), 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
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The total number of reporting and
recordkeeping hours is 160,000 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
1,200 hours per waiver application for
a total of 48,000 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 $350,000.
This cost is largely attributed to clinical
study costs incurred, which include site
selection and qualification, protocol
review, and study execution (initiation,
monitoring, closeout, and clinical site/
subject compensation—including
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specimen collection for study as well as
shipping and supplies).
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16886 Filed 7–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Refurbishing, Reconditioning,
Rebuilding, Remarketing,
Remanufacturing, and Servicing of
Medical Devices Performed by ThirdParty Entities and Original Equipment
Manufacturers; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Refurbishing, Reconditioning,
Rebuilding, Remarketing,
SUMMARY:
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Remanufacturing, and Servicing of
Medical Devices Performed by ThirdParty Entities and Original Equipment
Manufacturers.’’ The topics to be
discussed are the current regulatory
environment for these activities, the
definitions of the various terms FDA
proposed in the prior Federal Register
notice on this subject, and whether
these activities should appropriately be
regulated by FDA or a nongovernmental organization.
DATES: The public workshop will be
held on October 27, 2016, from 8:30
a.m. to 5 p.m. and October 28, 2016,
from 8:30 a.m. to 4 p.m.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46693-46694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16886]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0031]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Clinical Laboratory
Improvement Amendments Act of 1988 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 August
17, 2016.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@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.
CLIA Waiver Applications--OMB Control Number 0910-0598--Extension
Congress passed the 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
[[Page 46694]]
``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.
In the Federal Register of April 1, 2016 (81 FR 18858), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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.
The total number of reporting and recordkeeping hours is 160,000
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 1,200 hours per waiver application for a total of 48,000 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 $350,000. This cost is largely attributed
to clinical study costs incurred, which include site selection and
qualification, protocol review, and study execution (initiation,
monitoring, closeout, and clinical site/subject compensation--including
specimen collection for study as well as shipping and supplies).
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16886 Filed 7-15-16; 8:45 am]
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