Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices, 62540-62541 [2019-24803]
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62540
Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
downloadable materials through FDA’s
‘‘This is Our Watch’’ Program, to assist
retailers in complying with the
requirements under the law. FDA
estimates the burden of this collection
of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Develop training program ....................................................
Develop written policy against sales to minors and employee acknowledgement .................................................
Develop internal compliance check program ......................
273,900
1
273,900
16
4,382,400
273,900
273,900
1
1
273,900
273,900
1
8
273,900
2,191,200
Total ..............................................................................
........................
........................
........................
........................
6,847,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeper
Total hours
Training program ............................................................
Written policy against sales to minors and employee
acknowledgement.
Internal compliance check program ...............................
273,900
273,900
4
4
1,095,600
1,095,600
0.25 (15 minutes)
0.10 (6 minutes) ..
273,900
109,560
273,900
2
547,800
0.5 (30 minutes) ..
273,900
Total ........................................................................
........................
........................
........................
.............................
657,360
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents in tables 1 and 2 is based
on data reported to the U.S. Department
of Health and Human Services
Substance Abuse and Mental Health
Services Administration. According to
the fiscal year 2009 Annual Synar
Report, there are 372,677 total retail
tobacco outlets in the 50 States, District
of Columbia, and 8 U.S. territories that
are accessible to youth (meaning that
there is no State law restricting access
to these outlets to individuals older than
age 18). Inflating this number by about
10 percent to account for outlets in
States that sell tobacco but are, by law,
inaccessible to minors, results in an
estimated total number of tobacco
outlets of 410,000. We assume that 75
percent of tobacco retailers already have
some sort of training program for age
and identification verification. We
expect that some of those retailer
training programs already meet the
elements in the guidance, some retailers
would update their training program to
meet the elements in the guidance, and
other retailers would develop a training
program for the first time. Thus, we
estimate that two-thirds of tobacco
retailers would develop a training
program that meets the elements in the
guidance (66% of 410,000 = 270,600).
FDA estimates that the total burden
for this collection will be 7,504,860
hours (6,847,500 reporting + 657,360
recordkeeping).
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We also estimate that there are
approximately 5,000 to 10,000 vape
shops; we assume that 66 percent of
them, or 3,300 (66% × 5,000) of the low
estimate, currently engage in retailing
activities (Ref. 1).
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
II. Reference
The following reference is on display
with the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is not available electronically at https://
www.regulations.gov as this reference is
copyright protected. It may be available
at the website address, if listed. FDA has
verified the website addresses, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
1. Burke, D., ‘‘Trends & Insights in the
Nicotine Delivery Category.’’ Management
Science Associates, Inc. Presentation at
NATO Show, April 23, 2015.
Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24785 Filed 11–14–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Q-Submission
Program for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
16, 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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0756. Also
include the FDA docket number found
SUMMARY:
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62541
Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
in brackets in the heading of this
document.
Q-Submission Program for Medical
Devices
FOR FURTHER INFORMATION CONTACT:
OMB Control Number 0910–0756—
Extension
The guidance entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ (https://www.fda.gov/media/
114034/download) provides an
overview of the mechanisms available to
submitters through which they can
request feedback from or a meeting with
FDA regarding certain potential or
planned medical device submissions
reviewed by the Center for Devices and
Radiological Health (CDRH) and the
Center for Biologics Evaluation and
Research (CBER). The guidance
provides recommendations regarding
certain types of Q-Submissions, such as
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Pre-Submissions, Submission Issue
Requests, Study Risk Determinations,
Informational Meetings, and other QSubmissions Types and other uses of
the Q-Submission Program.
For clarity and consistency with the
guidance that describes the program, we
are requesting that the title of the
information collection request, OMB
control number 0910–0756, be changed
to ‘‘Q-Submission Program for Medical
Devices.’’
In the Federal Register of August 13,
2019 (84 FR 40069), 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
respondents
FDA Center
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
CDRH ...................................................................................
CBER ...................................................................................
3,502
91
1
1
3,502
91
137
137
479,774
12,467
Total ..............................................................................
........................
........................
........................
........................
492,241
1 There
are no capital costs or operating and maintenance cost associated with this of information.
Respondents are medical device
manufacturers subject to FDA’s laws
and regulations. FDA’s annual estimate
of 3,593 submissions is based on
experienced recent trends. FDA’s
administrative and technical staffs, who
are familiar with Q-Submissions,
estimate that an average of 137 hours is
required to prepare a Q-Submission.
Our estimated burden for the
information collection reflects an
overall increase of 143,713 hours. We
attribute this adjustment to an increase
in the number of submissions we
received based on FY18 data.
Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24803 Filed 11–14–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0796]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
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 communication
studies involving medical devices and
radiation-emitting products regulated by
FDA. This information will be used to
explore concepts of interest and assist in
SUMMARY:
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the development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
DATES: Submit either electronic or
written comments on the collection of
information by January 14, 2020.
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 January 14,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 14, 2020.
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
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]]>Agencies
[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62540-62541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24803]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Q-Submission Program
for Medical Devices
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
December 16, 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 0910-0756.
Also include the FDA docket number found
[[Page 62541]]
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.
Q-Submission Program for Medical Devices
OMB Control Number 0910-0756--Extension
The guidance entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (https://www.fda.gov/media/114034/download) provides an overview of the
mechanisms available to submitters through which they can request
feedback from or a meeting with FDA regarding certain potential or
planned medical device submissions reviewed by the Center for Devices
and Radiological Health (CDRH) and the Center for Biologics Evaluation
and Research (CBER). The guidance provides recommendations regarding
certain types of Q-Submissions, such as Pre-Submissions, Submission
Issue Requests, Study Risk Determinations, Informational Meetings, and
other Q-Submissions Types and other uses of the Q-Submission Program.
For clarity and consistency with the guidance that describes the
program, we are requesting that the title of the information collection
request, OMB control number 0910-0756, be changed to ``Q-Submission
Program for Medical Devices.''
In the Federal Register of August 13, 2019 (84 FR 40069), 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\
----------------------------------------------------------------------------------------------------------------
Annual
FDA Center Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
CDRH............................ 3,502 1 3,502 137 479,774
CBER............................ 91 1 91 137 12,467
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 492,241
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance cost associated with this of information.
Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA's annual estimate of 3,593 submissions is based on
experienced recent trends. FDA's administrative and technical staffs,
who are familiar with Q-Submissions, estimate that an average of 137
hours is required to prepare a Q-Submission.
Our estimated burden for the information collection reflects an
overall increase of 143,713 hours. We attribute this adjustment to an
increase in the number of submissions we received based on FY18 data.
Dated: November 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24803 Filed 11-14-19; 8:45 am]
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