Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals, 28857-28858 [2017-13248]
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Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
participants and entered into RAPTER;
and (7) Video recordings of coaching
sessions: Collection of data on the
interaction between the coaches and
participants.
A second follow-up survey will be
administered approximately 21 months
after random assignment. This data
collection activity will be included
under a separate OMB submission.
Respondents: Program staff and
individuals enrolled in the Evaluation
of Employment Coaching for TANF and
Other Low-Income Populations.
Program staff may include coaches, case
managers, workshop instructors, job
developers, supervisors, and managers.
All participants will be able to opt out
of participating in the data collection
activities.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
sradovich on DSK3GMQ082PROD with NOTICES
Baseline data collection—study participants .......................
Baseline data collection—staff .............................................
First follow-up survey ...........................................................
Semi-structured staff interviews ...........................................
Staff survey ..........................................................................
In-depth participant interviews .............................................
Staff reports of program service receipt ..............................
Video recordings of coaching sessions ...............................
Annual
number of
respondents
6,000
60
2,400
66
48
24
30
27
2,000
20
800
22
16
8
10
9
Estimated Total Annual Burden
Hours: 3,754.
In compliance with the requirements
of section 3506(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: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary Jones,
ACF/OPRE Certifying Officer.
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
[FR Doc. 2017–13288 Filed 6–23–17; 8:45 am]
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Jkt 241001
Food and Drug Administration
[Docket No. FDA–2016–N–4620]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Reports of Corrections and Removals
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 July 26,
2017.
SUMMARY:
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 0910–0359. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
1
100
1
1
1
1
5,200
10
Average
burden hours
per response
Annual
burden hours
0.33
0.33
1
1.5
0.75
2.5
0.03
0.10
660
660
800
33
12
20
1,560
9
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:
Medical Devices; Reports of Corrections
and Removals—21 CFR Part 806
OMB Control Number 0910–0359—
Extension
FDA is requesting approval for the
collection of information regarding
reports of corrections and removals
required under part 806 (21 CFR part
806), which implements section 519(g)
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360i(g)),
as amended by the Food and Drug
Modernization Act of 1997 (FDAMA)
(Pub. L. 105–115). A description of the
information collection requirements are
provided as follows:
Under § 806.10 (21 CFR 806.10),
within 10 working days of initiating any
action to correct or remove a device to
reduce a risk to health posed by the
device or to remedy a violation of the
FD&C Act caused by the device that may
present a risk to health, device
manufacturers or importers must submit
a written report to FDA of the correction
or removal.
Under § 806.20(a), device
manufacturers or importers that initiate
a correction or removal that is not
required to be reported to FDA must
keep a record of the correction or
removal.
The information collected in the
reports of corrections and removals will
be used by FDA to identify marketed
devices that have serious problems and
E:\FR\FM\26JNN1.SGM
26JNN1
28858
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
to ensure that defective devices are
removed from the market. This will
assure that FDA has current and
complete information regarding these
corrections and removals to determine
whether recall action is adequate.
Failure to collect this information
would prevent FDA from receiving
timely information about devices that
may have a serious effect on the health
of users of the devices.
Reports of corrections and removals
may be submitted to FDA via mail or
using FDA’s Electronic Submission
Gateway (ESG). We estimate that
approximately 99 percent of submitters
will use the ESG. Our estimate of the
reporting and recordkeeping burden is
based on Agency records and our
experience with this program, as well as
similar programs that utilize FDA’s ESG.
For respondents who submit
corrections and removals using the
electronic process, the operating and
maintenance costs associated with this
information collection are
approximately $30 per year to purchase
a digital verification certificate
(certificate must be valid for 1 to 3
years). This burden may be minimized
if the respondent has already purchased
a verification certificate for other
electronic submissions to FDA.
However, FDA is assuming that all
respondents who submit corrections
and removals using the electronic
process will be establishing a new
WebTrader account and purchasing a
digital verification certificate. We
therefore estimate the total operating
and maintenance costs to be $30,660
annually (1,022 respondents × $30).
In the Federal Register of March 20,
2017 (82 FR 14367), 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
(21 CFR part)
Number of
respondents
Electronic process setup 3 .............
Submission of corrections and removals (part 806) .......................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours 2
Total operating and
maintenance costs
1,022
1
1,022
3.08
3,148
$30,660
1,033
1
1,033
10
10,330
..................................
1 There
are no capital costs associated with this collection of information.
may not sum due to rounding.
estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in
a total one-time burden of 9,454 hours for the setup of the electronic process.
2 Totals
3 We
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
(21 CFR part)
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Records of corrections and removals (part 806) .................
93
1
93
10
930
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13248 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
sradovich on DSK3GMQ082PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extralabel Drug
Use in Animals
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
SUMMARY:
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Jkt 241001
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the reporting
requirements associated with extralabel
drug use in animals.
DATES: Submit either electronic or
written comments on the collection of
information by August 25, 2017.
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 25,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 25, 2017.
Comments received by mail/hand
PO 00000
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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
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Agencies
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28857-28858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13248]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4620]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Reports of Corrections and Removals
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 July
26, 2017.
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 0910-0359.
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, 10A63, 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.
Medical Devices; Reports of Corrections and Removals--21 CFR Part 806
OMB Control Number 0910-0359--Extension
FDA is requesting approval for the collection of information
regarding reports of corrections and removals required under part 806
(21 CFR part 806), which implements section 519(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(g)), as amended
by the Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115). A description of the information collection requirements are
provided as follows:
Under Sec. 806.10 (21 CFR 806.10), within 10 working days of
initiating any action to correct or remove a device to reduce a risk to
health posed by the device or to remedy a violation of the FD&C Act
caused by the device that may present a risk to health, device
manufacturers or importers must submit a written report to FDA of the
correction or removal.
Under Sec. 806.20(a), device manufacturers or importers that
initiate a correction or removal that is not required to be reported to
FDA must keep a record of the correction or removal.
The information collected in the reports of corrections and
removals will be used by FDA to identify marketed devices that have
serious problems and
[[Page 28858]]
to ensure that defective devices are removed from the market. This will
assure that FDA has current and complete information regarding these
corrections and removals to determine whether recall action is
adequate. Failure to collect this information would prevent FDA from
receiving timely information about devices that may have a serious
effect on the health of users of the devices.
Reports of corrections and removals may be submitted to FDA via
mail or using FDA's Electronic Submission Gateway (ESG). We estimate
that approximately 99 percent of submitters will use the ESG. Our
estimate of the reporting and recordkeeping burden is based on Agency
records and our experience with this program, as well as similar
programs that utilize FDA's ESG.
For respondents who submit corrections and removals using the
electronic process, the operating and maintenance costs associated with
this information collection are approximately $30 per year to purchase
a digital verification certificate (certificate must be valid for 1 to
3 years). This burden may be minimized if the respondent has already
purchased a verification certificate for other electronic submissions
to FDA. However, FDA is assuming that all respondents who submit
corrections and removals using the electronic process will be
establishing a new WebTrader account and purchasing a digital
verification certificate. We therefore estimate the total operating and
maintenance costs to be $30,660 annually (1,022 respondents x $30).
In the Federal Register of March 20, 2017 (82 FR 14367), 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 Average
Activity (21 CFR part) Number of responses per Total annual burden per Total hours Total operating and
respondents respondent responses response \2\ maintenance costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic process setup \3\....................... 1,022 1 1,022 3.08 3,148 $30,660
Submission of corrections and removals (part 806).. 1,033 1 1,033 10 10,330 ...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
\3\ We estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours
for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and
Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in a total one-time
burden of 9,454 hours for the setup of the electronic process.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity (21 CFR part) Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of corrections and removals (part 806)..................... 93 1 93 10 930
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13248 Filed 6-23-17; 8:45 am]
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