Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications, 18858-18860 [2016-07365]
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18858
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
LIHEAP Leveraging Report .............................................................................
70
1
38
2,660
Estimated Total Annual Burden
Hours: 2,660.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–07359 Filed 3–31–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2015–N–2489]
Receipt of Notice That a Patent
Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
SUMMARY:
FDA has received notice of the
following complaint under section
351(l)(6)(C) of the PHS Act:
Amgen, Inc., v. Apotex, Inc., 15–cv–
61631 (consolidated with 15–cv–62081,
S.D. Fla., filed October 2, 2015).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act, and does not perform a
substantive review of the complaint.
Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07364 Filed 3–31–16; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6208, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required, under section
351(l)(6)(C) of the PHS Act, to provide
the FDA with notice and a copy of the
complaint within 30 days of service.
FDA is required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
SUPPLEMENTARY INFORMATION:
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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 Act 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
Amendments of 1988 (CLIA) waiver
applications.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 31, 2016.
DATES:
ADDRESSES:
You may submit comments
as follows:
E:\FR\FM\01APN1.SGM
01APN1
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; CLIA
Waiver Applications.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management 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
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19:10 Mar 31, 2016
Jkt 238001
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
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18859
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
‘‘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
E:\FR\FM\01APN1.SGM
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Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
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
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
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 ...........................
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07365 Filed 3–31–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Arthritis
Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Arthritis Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Arthritis Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 5, 2018.
DATES: Authority for the Arthritis
Advisory Committee will expire on
April 5, 2018, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, AAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
SUMMARY:
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FDA is announcing the renewal of the
Arthritis Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility. The
Committee reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases, and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of arthritis,
rheumatology, orthopedics,
epidemiology or statistics, analgesics,
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
E:\FR\FM\01APN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18858-18860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07365]
-----------------------------------------------------------------------
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 Act 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
(CLIA) waiver applications.
DATES: Submit either electronic or written comments on the collection
of information by May 31, 2016.
ADDRESSES: You may submit comments as follows:
[[Page 18859]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; CLIA Waiver Applications.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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
``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
[[Page 18860]]
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........................... 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: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07365 Filed 3-31-16; 8:45 am]
BILLING CODE 4164-01-P
