Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications, 11307-11309 [2019-05759]
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Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
The guidance represents the current
thinking of FDA on ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014;
the collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
Electronic Submissions
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05760 Filed 3–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Clinical Laboratory
Improvement Amendments Waiver
Applications
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSK30RV082PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
VerDate Sep<11>2014
17:54 Mar 25, 2019
Jkt 247001
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 (CLIA) waiver applications.
DATES: Submit either electronic or
written comments on the collection of
information by May 28, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 28, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 28, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
PO 00000
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11307
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–D–0031 for ‘‘CLIA Waiver
Applications.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
E:\FR\FM\26MRN1.SGM
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11308
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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.
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
‘‘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
‘‘Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic
Devices—Guidance for Industry and
FDA Staff’’ (https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
ucm079632.htm). This guidance
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.
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 ..........................
13
1
13
1,200
15,600
$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 ..........................................................
13
1
13
2,800
36,400
jbell on DSK30RV082PROD 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 52,000 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 13
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
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application, including the time needed
to assemble supporting data, averages
1,200 hours per waiver application for
a total of 15,600 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
36,400 hours.
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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).
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Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
Our estimated burden for the
information collection reflects a
decrease of 27 responses and 27 records,
and a corresponding overall decrease of
108,000 hours. We attribute this
adjustment to a decrease in the average
number of submissions we received
over the last few years.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05759 Filed 3–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0297]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prevention of
Salmonella Enteritidis in Shell Eggs
During Production; Recordkeeping and
Registration Provisions
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSK30RV082PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 information
collection provisions of FDA’s
recordkeeping and registration
requirements for shell egg producers.
DATES: Submit either electronic or
written comments on the collection of
information by May 28, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 28, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 28, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
VerDate Sep<11>2014
17:54 Mar 25, 2019
Jkt 247001
Electronic Submissions
11309
comments only as a written/paper
submission. You should submit two
Submit electronic comments in the
copies total. One copy will include the
following way:
• Federal eRulemaking Portal: https:// information you claim to be confidential
with a heading or cover note that states
www.regulations.gov. Follow the
‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments.
CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically,
Agency will review this copy, including
including attachments, to https://
the claimed confidential information, in
www.regulations.gov will be posted to
its consideration of comments. The
the docket unchanged. Because your
second copy, which will have the
comment will be made public, you are
claimed confidential information
solely responsible for ensuring that your
redacted/blacked out, will be available
comment does not include any
for public viewing and posted on
confidential information that you or a
https://www.regulations.gov. Submit
third party may not wish to be posted,
both copies to the Dockets Management
such as medical information, your or
Staff. If you do not wish your name and
anyone else’s Social Security number, or
contact information to be made publicly
confidential business information, such
available, you can provide this
as a manufacturing process. Please note
information on the cover sheet and not
that if you include your name, contact
in the body of your comments and you
information, or other information that
must identify this information as
identifies you in the body of your
‘‘confidential.’’ Any information marked
comments, that information will be
as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov.
except in accordance with 21 CFR 10.20
• If you want to submit a comment
and other applicable disclosure law. For
with confidential information that you
more information about FDA’s posting
do not wish to be made available to the
of comments to public dockets, see 80
public, submit the comment as a
FR 56469, September 18, 2015, or access
written/paper submission and in the
the information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper
fdsys/pkg/FR-2015-09-18/pdf/2015Submissions’’ and ‘‘Instructions’’).
23389.pdf.
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
follows:
received, go to https://
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
written/paper submissions): Dockets
docket number, found in brackets in the
Management Staff (HFA–305), Food and
heading of this document, into the
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Dockets Management
• For written/paper comments
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management
Rockville, MD 20852.
Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
well as any attachments, except for
Domini Bean, Office of Operations,
information submitted, marked and
Food and Drug Administration, Three
identified, as confidential, if submitted
White Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Instructions: All submissions received Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
must include the Docket No. FDA–
fda.hhs.gov.
2013–N–0297 for ‘‘Agency Information
SUPPLEMENTARY INFORMATION: Under the
Collection Activities; Proposed
PRA (44 U.S.C. 3501–3520), Federal
Collection; Comment Request;
Agencies must obtain approval from the
Prevention of Salmonella Enteritidis in
Office of Management and Budget
Shell Eggs During Production;
(OMB) for each collection of
Recordkeeping and Registration
information they conduct or sponsor.
Provisions.’’ Received comments, those
‘‘Collection of information’’ is defined
filed in a timely manner (see
ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
and, except for those submitted as
or requirements that members of the
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov public submit reports, keep records, or
provide information to a third party.
or at the Dockets Management Staff
Section 3506(c)(2)(A) of the PRA (44
between 9 a.m. and 4 p.m., Monday
U.S.C. 3506(c)(2)(A)) requires Federal
through Friday.
Agencies to provide a 60-day notice in
• Confidential Submissions—To
the Federal Register concerning each
submit a comment with confidential
proposed collection of information,
information that you do not wish to be
including each proposed extension of an
made publicly available, submit your
PO 00000
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E:\FR\FM\26MRN1.SGM
26MRN1
]]>Agencies
[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11307-11309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0031]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Clinical Laboratory Improvement Amendments Waiver
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 (CLIA) waiver
applications.
DATES: Submit either electronic or written comments on the collection
of information by May 28, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 28, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2008-D-0031 for ``CLIA Waiver Applications.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
[[Page 11308]]
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@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.
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
``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
``Recommendations for Clinical Laboratory Improvement Amendments of
1988 (CLIA) Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices--Guidance for Industry and FDA Staff'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm). This guidance 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.
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........................... 13 1 13 1,200 15,600 $350,000
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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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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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CLIA Waiver Records................................................ 13 1 13 2,800 36,400
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\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 52,000
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 13 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 15,600 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 36,400 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).
[[Page 11309]]
Our estimated burden for the information collection reflects a
decrease of 27 responses and 27 records, and a corresponding overall
decrease of 108,000 hours. We attribute this adjustment to a decrease
in the average number of submissions we received over the last few
years.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05759 Filed 3-25-19; 8:45 am]
BILLING CODE 4164-01-P
