Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications, 35871-35872 [2019-15787]
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35871
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
consistent with section 911(e) of the
FD&C Act, FDA is making the redacted
MRTPAs that are the subject of this
notice available electronically (see
section II).
II. Electronic Access
Persons with access to the internet
may obtain the documents at https://
www.fda.gov/tobacco-products/
advertising-and-promotion/22ndcentury-group-inc-modified-risktobacco-product-mrtp-applications.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15831 Filed 7–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Clinical Laboratory Improvement
Amendments Waiver Applications
[Docket No. FDA–2008–D–0031]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Clinical Laboratory
Improvement Amendments Waiver
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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 26,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
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).
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.
In the Federal Register of March 26,
2019 (84 FR 11307), 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 ..........................
13
1
13
1,200
15,600
$350,000
Average
burden per
recordkeeping
Total hours
1 There
are no capital costs associated with this collection of information.
jspears on DSK30JT082PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
CLIA Waiver Records ..........................................................
1 There
Number of
records per
recordkeeper
13
Total annual
records
1
13
are no capital costs or operating and maintenance costs associated with this collection of information.
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16:56 Jul 24, 2019
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2,800
36,400
35872
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
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).
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: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15787 Filed 7–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2775]
Food Safety Modernization Act
Domestic and Foreign Facility
Reinspection, Recall, and Importer
Reinspection Fee Rates for Fiscal Year
2020
jspears on DSK30JT082PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2020 fee rates for certain
domestic and foreign facility
reinspections, failures to comply with a
SUMMARY:
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16:56 Jul 24, 2019
Jkt 247001
recall order, and importer reinspections
that are authorized by the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA). These fees
are effective on October 1, 2019, and
will remain in effect through September
30, 2020.
FOR FURTHER INFORMATION CONTACT:
Tierra Ramsey, Office of Management,
Office of Regulatory Affairs, Food and
Drug Administration, 12420 Parklawn
Dr., Rockville, MD 20857, email:
oraomdfobudgetformbranch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 107 of FSMA (Pub. L. 111–
353) added section 743 to the FD&C Act
(21 U.S.C. 379j–31) to provide FDA with
the authority to assess and collect fees
from, in part: (1) The responsible party
for each domestic facility and the U.S.
agent for each foreign facility subject to
a reinspection, to cover reinspectionrelated costs; (2) the responsible party
for a domestic facility and an importer
who does not comply with a recall
order, to cover food 1 recall activities
associated with such order; and (3) each
importer subject to a reinspection to
cover reinspection-related costs
(sections 743(a)(1)(A), (B), and (D) of the
FD&C Act). Section 743 of the FD&C Act
directs FDA to establish fees for each of
these activities based on an estimate of
100 percent of the costs of each activity
for each year (sections 743(b)(2)(A)(i),
(ii), and (iv)), and these fees must be
made available solely to pay for the
costs of each activity for which the fee
was incurred (section 743(b)(3)). These
fees are effective on October 1, 2019,
and will remain in effect through
September 30, 2020. Section
743(b)(2)(B)(iii) of the FD&C Act directs
FDA to develop a proposed set of
guidelines in consideration of the
burden of fee amounts on small
businesses. As a first step in developing
these guidelines, FDA invited public
comment on the potential impact of the
fees authorized by section 743 of the
FD&C Act on small businesses (76 FR
45818, August 1, 2011). The comment
period for this request ended November
30, 2011. As stated in FDA’s September
2011 ‘‘Guidance for Industry:
Implementation of the Fee Provisions of
Section 107 of the FDA Food Safety
Modernization Act,’’ (https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-implementation-fee1 The term ‘‘food’’ for purposes of this document
has the same meaning as such term in section 201(f)
of the FD&C Act (21 U.S.C. 321(f)).
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
provisions-section-107-fda-food-safetymodernization-act), because FDA
recognizes that for small businesses the
full cost recovery of FDA reinspection
or recall oversight could impose severe
economic hardship, FDA intends to
consider reducing certain fees for those
firms. FDA does not intend to issue
invoices for reinspection or recall order
fees until FDA publishes a guidance
document outlining the process through
which firms may request a reduction in
fees.
In addition, FDA is in the process of
considering various issues associated
with the assessment and collection of
importer reinspection fees. The fee rates
set forth in this notice will be used to
determine any importer reinspection
fees assessed in FY 2020.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2020
FDA is required to estimate 100
percent of its costs for each activity in
order to establish fee rates for FY 2020.
In each year, the costs of salary (or
personnel compensation) and benefits
for FDA employees account for between
50 and 60 percent of the funds available
to, and used by, FDA. Almost all of the
remaining funds (operating funds)
available to FDA are used to support
FDA employees for paying rent, travel,
utility, information technology (IT), and
other operating costs.
A. Estimating the Full Cost per Direct
Work Hour in FY 2020
Full-time Equivalent (FTE) reflects the
total number of regular straight-time
hours—not including overtime or
holiday hours—worked by employees,
divided by the number of compensable
hours applicable to each fiscal year.
Annual leave, sick leave, compensatory
time off and other approved leave
categories are considered ‘‘hours
worked’’ for purposes of defining FTE
employment.
In general, the starting point for
estimating the full cost per direct work
hour is to estimate the cost of an FTE
or paid staff year. Calculating an
Agency-wide total cost per FTE requires
three primary cost elements: Payroll,
non-payroll, and rent.
We have used an average of past year
cost elements to predict the FY 2020
cost. The FY 2020 FDA-wide average
cost for payroll (salaries and benefits) is
$160,885; non-payroll—including
equipment, supplies, IT, general and
administrative overhead—is $92,828;
and rent, including cost allocation
analysis and adjustments for other rent
and rent-related costs, is $24,888 per
paid staff year, excluding travel costs.
E:\FR\FM\25JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35871-35872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15787]
-----------------------------------------------------------------------
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 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
26, 2019.
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 [email protected]. 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: 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,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Clinical Laboratory Improvement Amendments Waiver Applications
OMB Control Number 0910-0598--Extension
Congress passed the Clinical Laboratory Improvement Amendments
(CLIA) (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).
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.
In the Federal Register of March 26, 2019 (84 FR 11307), 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........................... 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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
CLIA Waiver Records............. 13 1 13 2,800 36,400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 35872]]
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).
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: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15787 Filed 7-24-19; 8:45 am]
BILLING CODE 4164-01-P
