Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization, 30127-30129 [2019-13561]
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Federal Register / Vol. 84, No. 123 / Wednesday, June 26, 2019 / Notices
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
812 ..............................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff‘‘.
50, 56 ..........................................................................................
Premarket notification .................................................................
Investigational Device Exemption ..............................................
De Novo classification process ..................................................
0910–0120
0910–0078
0910–0844
Q-submissions ............................................................................
0910–0756
Protection of Human Subjects: Informed Consent; Institutional
Review Boards.
Institutional Review Boards ........................................................
0910–0755
56 ................................................................................................
Dated: June 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13554 Filed 6–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0514]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Procedures for Clinical Laboratory
Improvement Amendments
Categorization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 administrative
procedures for Clinical Laboratory
Improvement Amendments of 1988
(CLIA) categorization of certain in vitro
diagnostic tests.
DATES: Submit either electronic or
written comments on the collection of
information by August 26, 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 August 26,
SUMMARY:
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30127
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2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 26, 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.
PO 00000
Frm 00046
Fmt 4703
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0910–0130
• 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–
2013–N–0514 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Administrative Procedures for Clinical
Laboratory Improvement Amendments
Categorization.’’ 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
E:\FR\FM\26JNN1.SGM
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30128
Federal Register / Vol. 84, No. 123 / Wednesday, June 26, 2019 / Notices
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.
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.
Administrative Procedures for CLIA
Categorization—42 CFR 493.17
describes procedures FDA uses to assign
the complexity category to a device,
which affects what type of CLIA
certificate the laboratory obtains.
Typically, FDA assigns complexity
categorizations to devices at the time of
clearance or approval of the device. In
some cases, however, a manufacturer
may request CLIA categorization even if
FDA is not simultaneously reviewing a
510(k) or PMA. One example is when a
manufacturer requests that FDA assign
CLIA categorization to a previously
cleared device that has changed names
since the original CLIA categorization.
Another example is when a device is
exempt from premarket review. In such
cases, the guidance recommends that
manufacturers provide FDA with a copy
of the package insert for the device and
a cover letter indicating why the
manufacturer is requesting a
categorization (e.g., name change,
exempt from 510(k) review). The
guidance recommends that in the
correspondence to FDA the
manufacturer should identify the
product code and classification as well
as reference to the original 510(k) when
this is available.
FDA estimates the burden of this
collection of information as follows:
OMB Control Number 0910–0607—
Extension
FDA’s ‘‘Guidance for Administrative
Procedures for CLIA Categorization’’ 1
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
Request for CLIA categorization ..............
80
5
400
1
400
$2,000
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1 There
are no capital costs associated with this collection of information.
Based on recent receipt data for
requests for CLIA categorization
separate from a product application, the
number of respondents is approximately
80. On average, each respondent
requests such categorizations five times
per year.
The cost, not including personnel, is
estimated at $5 per submission (5 ×
400), totaling $2,000. This includes the
cost of copying and mailing copies of
package inserts and a cover letter. The
burden hours are based on FDA
familiarity with the types of
documentation typically included in a
sponsor’s categorization requests, and
costs for basic office supplies (e.g.,
paper). Upon review of this information
collection, we have adjusted the
estimated cost per submission
(previously $52). Because the
submissions are typically only a few
pages per package insert and copying or
printing and postage for a few pages is
not expected to be more than $5, we
believe this is a more appropriate cost
burden estimate.
Our estimated burden for the
information collection reflects an
overall decrease of 500 hours. We
attribute this adjustment to a decrease in
the number of submissions we received
over the last few years. Also, upon
review of this information collection,
we believe the previous estimate may
have included requests for
categorization associated with a
premarket submission, the burden
estimate of which is included under the
OMB approval for the applicable
premarket submission. We have
therefore revised the number of
respondents/responses to include only
those that are separate from a product
application, consistent with the scope of
this information collection.
1 Available at https://www.fda.gov/media/71065/
download.
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Federal Register / Vol. 84, No. 123 / Wednesday, June 26, 2019 / Notices
Dated: June 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13561 Filed 6–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[CMS–3365–N]
Secretarial Review and Publication of
the National Quality Forum 2018
Activities Report to Congress and the
Secretary of the Department of Health
and Human Services
Office of the Secretary of
Health and Human Services, HHS.
ACTION: Notice.
AGENCY:
This notice acknowledges the
Secretary of the Department of Health
and Human Services’ (the Secretary)
receipt and review of the National
Quality Forum 2018 Annual Activities
Report to Congress and the Secretary
submitted by the consensus-based entity
under contract with the Secretary in
accordance with the Social Security Act.
The Secretary has reviewed and is
publishing the report in the Federal
Register together with the Secretary’s
comments on the report not later than
6 months after receiving the report in
accordance with section 1890(b)(5)(B) of
the Social Security Act.
FOR FURTHER INFORMATION CONTACT:
Sophia Chan, (410) 786–5050.
SUPPLEMENTARY INFORMATION:
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
I. Background
The United States Department of
Health and Human Services (HHS) has
long recognized that a high functioning
health care system that provides higher
quality care requires accurate, valid, and
reliable measurements of quality and
efficiency. The Medicare Improvements
for Patients and Providers Act of 2008
(MIPPA) (Pub. L. 110–275) added
section 1890 of the Social Security Act
(the Act), which requires the Secretary
to contract with the consensus-based
entity (CBE) to perform multiple duties
designed to help improve performance
measurement. Section 3014 of the
Patient Protection and Affordable Care
Act (the Affordable Care Act) (Pub. L.
111–148) expanded the duties of the
CBE to help in the identification of gaps
in available measures and to improve
the selection of measures used in health
care programs.
HHS awarded a competitive contract
to the National Quality Forum (NQF) in
January 2009 to fulfill the requirements
of section 1890 of the Act. A second,
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multi-year contract was awarded to NQF
after an open competition in 2012. A
third, multi-year contract was awarded
again to NQF after an open competition
in 2017. Section 1890(b) of the Act
requires the following:
Priority Setting Process: Formulation
of a National Strategy and Priorities for
Health Care Performance Measurement.
The CBE must synthesize evidence and
convene key stakeholders to make
recommendations on an integrated
national strategy and priorities for
health care performance measurement
in all applicable settings. In doing so,
the CBE is to give priority to measures
that: (1) Address the health care
provided to patients with prevalent,
high-cost chronic diseases; (2) have the
greatest potential for improving quality,
efficiency, and patient-centered health
care; and (3) may be implemented
rapidly due to existing evidence,
standards of care, or other reasons.
Additionally, the CBE must take into
account measures that: (1) May assist
consumers and patients in making
informed health care decisions; (2)
address health disparities across groups
and areas; and (3) address the
continuum of care across multiple
providers, practitioners and settings.
Endorsement of Measures: The CBE
must provide for the endorsement of
standardized health care performance
measures. This process must consider
whether measures are evidence-based,
reliable, valid, verifiable, relevant to
enhanced health outcomes, actionable at
the caregiver level, feasible to collect
and report, responsive to variations in
patient characteristics such as health
status, language capabilities, race or
ethnicity, and income level, and are
consistent across types of health care
providers, including hospitals and
physicians.
Maintenance of CBE Endorsed
Measures: The CBE is required to
establish and implement a process to
ensure that endorsed measures are
updated (or retired if obsolete) as new
evidence is developed.
Review and Endorsement of an
Episode Grouper Under the Physician
Feedback Program: The CBE must
provide for the review and, as
appropriate, the endorsement of the
episode grouper developed by the
Secretary on an expedited basis.
Convening Multi-Stakeholder Groups:
The CBE must convene multistakeholder groups to provide input on:
(1) The selection of certain categories of
quality and efficiency measures, from
among such measures that have been
endorsed by the entity; (2) such
measures that have not been considered
for endorsement by such entity but are
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30129
used or proposed to be used by the
Secretary for the collection or reporting
of quality and efficiency measures; and
(3) national priorities for improvement
in population health and in the delivery
of health care services for consideration
under the national strategy. The CBE
provides input on measures for use in
certain specific Medicare programs, for
use in programs that report performance
information to the public, and for use in
health care programs that are not
included under the Act. The multistakeholder groups provide input on
quality and efficiency measures for
various federal health care quality
reporting and quality improvement
programs including those that address
certain Medicare services provided
through hospices, hospital inpatient and
outpatient facilities, physician offices,
cancer hospitals, end stage renal disease
(ESRD) facilities, inpatient
rehabilitation facilities, long-term care
hospitals, psychiatric hospitals, and
home health care programs.
Transmission of Multi-Stakeholder
Input: Not later than February 1 of each
year, the CBE must transmit to the
Secretary the input of multi-stakeholder
groups.
Annual Report to Congress and the
Secretary: Not later than March 1 of
each year, the CBE is required to submit
to Congress and the Secretary an annual
report. The report must describe:
• The implementation of quality and
efficiency measurement initiatives and
the coordination of such initiatives with
quality and efficiency initiatives
implemented by other payers;
• Recommendations on an integrated
national strategy and priorities for
health care performance measurement;
• Performance of the CBE’s duties
required under its contract with the
Secretary;
• Gaps in endorsed quality and
efficiency measures, including measures
that are within priority areas identified
by the Secretary under the national
strategy established under section
399HH of the Public Health Service Act
(National Quality Strategy), and where
quality and efficiency measures are
unavailable or inadequate to identify or
address such gaps;
• Areas in which evidence is
insufficient to support endorsement of
quality and efficiency measures in
priority areas identified by the Secretary
under the National Quality Strategy, and
where targeted research may address
such gaps; and
• The convening of multi-stakeholder
groups to provide input on: (1) The
selection of quality and efficiency
measures from among such measures
that have been endorsed by the CBE and
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]]>Agencies
[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Pages 30127-30129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0514]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Procedures for Clinical Laboratory
Improvement Amendments Categorization
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 administrative procedures for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) categorization of
certain in vitro diagnostic tests.
DATES: Submit either electronic or written comments on the collection
of information by August 26, 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 August 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 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-2013-N-0514 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Administrative Procedures for
Clinical Laboratory Improvement Amendments Categorization.'' 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
[[Page 30128]]
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.
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: 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.
Administrative Procedures for CLIA Categorization--42 CFR 493.17
OMB Control Number 0910-0607--Extension
FDA's ``Guidance for Administrative Procedures for CLIA
Categorization'' \1\ describes procedures FDA uses to assign the
complexity category to a device, which affects what type of CLIA
certificate the laboratory obtains. Typically, FDA assigns complexity
categorizations to devices at the time of clearance or approval of the
device. In some cases, however, a manufacturer may request CLIA
categorization even if FDA is not simultaneously reviewing a 510(k) or
PMA. One example is when a manufacturer requests that FDA assign CLIA
categorization to a previously cleared device that has changed names
since the original CLIA categorization. Another example is when a
device is exempt from premarket review. In such cases, the guidance
recommends that manufacturers provide FDA with a copy of the package
insert for the device and a cover letter indicating why the
manufacturer is requesting a categorization (e.g., name change, exempt
from 510(k) review). The guidance recommends that in the correspondence
to FDA the manufacturer should identify the product code and
classification as well as reference to the original 510(k) when this is
available.
---------------------------------------------------------------------------
\1\ Available at https://www.fda.gov/media/71065/download.
---------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for CLIA categorization................... 80 5 400 1 400 $2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Based on recent receipt data for requests for CLIA categorization
separate from a product application, the number of respondents is
approximately 80. On average, each respondent requests such
categorizations five times per year.
The cost, not including personnel, is estimated at $5 per
submission (5 x 400), totaling $2,000. This includes the cost of
copying and mailing copies of package inserts and a cover letter. The
burden hours are based on FDA familiarity with the types of
documentation typically included in a sponsor's categorization
requests, and costs for basic office supplies (e.g., paper). Upon
review of this information collection, we have adjusted the estimated
cost per submission (previously $52). Because the submissions are
typically only a few pages per package insert and copying or printing
and postage for a few pages is not expected to be more than $5, we
believe this is a more appropriate cost burden estimate.
Our estimated burden for the information collection reflects an
overall decrease of 500 hours. We attribute this adjustment to a
decrease in the number of submissions we received over the last few
years. Also, upon review of this information collection, we believe the
previous estimate may have included requests for categorization
associated with a premarket submission, the burden estimate of which is
included under the OMB approval for the applicable premarket
submission. We have therefore revised the number of respondents/
responses to include only those that are separate from a product
application, consistent with the scope of this information collection.
[[Page 30129]]
Dated: June 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13561 Filed 6-25-19; 8:45 am]
BILLING CODE 4164-01-P
