Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority, 13586-13588 [2015-05868]
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13586
Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Jingsheng Tuo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5207,
Bethesda, MD 20892, 301–451–8754, tuoj@
nei.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 10, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05824 Filed 3–13–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child Care Quarterly Case
Record Report—ACF–801.
OMB No.: 0970–0167.
Description: Section 658K of the Child
Care and Development Block Grant Act
(42 U.S.C. 9858) requires that States and
Territories submit monthly case-level
data on the children and families
receiving direct services under the Child
Care and Development Fund (CCDF).
The implementing regulations for the
statutorily required reporting are at 45
CFR 98.70. Case-level reports, submitted
quarterly or monthly (at grantee option),
include monthly sample or full
population case-level data. The data
elements to be included in these reports
are represented in the ACF–801. ACF
uses disaggregate data to determine
program and participant characteristics
as well as costs and levels of child care
services provided. This provides ACF
with the information necessary to make
reports to Congress, address national
child care needs, offer technical
assistance to grantees, meet performance
measures, and conduct research. On
November 19, 2014, the President
signed the Child Care and Development
Block Grant Act of 2014 (Pub. L. 113–
86) which reauthorized the CCDF
program and made some changes to
ACF–801 reporting requirements.
Owing to the need to consult with CCDF
administrators and other interested
parties on these changes, and a limited
amount of time before the current ACF–
801 form expires, ACF is not proposing
changes to the ACF–801 at this time. We
request to extend the ACF–801 without
changes in order to ensure the form does
not expire. In the near future, ACF plans
to initiate a new clearance process
under the Paperwork Reduction Act to
implement the data reporting changes in
the newly-reauthorized law.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
ACF–801 ..........................................................................................................
56
4
25
5,600
........................
........................
........................
5,600
Rmajette on DSK2VPTVN1PROD with NOTICES
Estimated total annual burden hour .........................................................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
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Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–05918 Filed 3–13–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0793]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Recall Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
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Total burden
hours
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
the information collection requirements
for medical device recall authority.
DATES: Submit either electronic or
written comments on the collection of
information by May 15, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices
docket number found in brackets in the
heading of this document.
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.
Medical Device Recall Authority—21
CFR 810 (OMB Control Number 0910–
0432)—Extension
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360h(e)) and part
810 (21 CFR part 810), medical device
recall authority provisions. Section
518(e) of the FD&C Act provides FDA
with the authority to issue an order
requiring an appropriate person,
including manufacturers, importers,
distributors, and retailers of a device, if
FDA finds that there is reasonable
probability that the device intended for
human use would cause serious adverse
health consequences or death, to: (1)
Immediately cease distribution of such
device; (2) immediately notify health
professionals and device-user facilities
of the order; and (3) instruct such
professionals and facilities to cease use
of such device.
Further, the provisions under section
518(e) of the FD&C Act set out the
following three-step procedure for
issuance of a mandatory device recall
order:
• If there is a reasonable probability
that a device intended for human use
would cause serious, adverse health
consequences or death, FDA may issue
a cease distribution and notification
order requiring the appropriate person
to immediately:
Æ Cease distribution of the device,
Æ notify health professionals and
device user facilities of the order, and
Æ instruct those professionals and
facilities to cease use of the device;
• FDA will provide the person named
in the cease distribution and
notification order with the opportunity
for an informal hearing on whether the
order should be modified, vacated, or
amended to require a mandatory recall
of the device; and
• after providing the opportunity for
an informal hearing, FDA may issue a
mandatory recall order if the Agency
determines that such an order is
necessary.
The information collected under the
recall authority provisions will be used
by FDA to do the following: (1) Ensure
that all devices entering the market are
safe and effective; (2) accurately and
immediately detect serious problems
with medical devices; and (3) remove
dangerous and defective devices from
the market.
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
Collection activity—21 CFR section
Average
burden per
response
Total annual
responses
Total hours
Collections Specified in the Order—810.10(d) ....................
Request for Regulatory Hearing—810.11(a) .......................
Written Request for Review—810.12(a–b) ..........................
Mandatory Recall Strategy—810.14 ....................................
Periodic Status Reports—810.16(a–b) ................................
Termination Request—810.17(a) .........................................
2
1
1
2
2
2
1
1
1
1
12
1
2
1
1
2
24
2
8
8
8
16
40
8
16
8
8
32
960
16
Total hours ....................................................................
........................
........................
........................
........................
1,040
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Rmajette on DSK2VPTVN1PROD with NOTICES
Collection activity—21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
Documentation of Notifications to Recipients—810.15(b) ...
2
1
1
8
8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 80, No. 50 / Monday, March 16, 2015 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Collection activity—21 CFR section
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Notification to Recipients—810.15(a)–(c) ............................
Notification to Recipients; Followup—810.15(d) ..................
Notification of Consignees by Recipients—810.15(e) .........
2
2
10
1
1
1
2
2
10
12
4
1
24
8
10
Total ..............................................................................
........................
........................
........................
........................
42
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05868 Filed 3–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2015–0001]
Final Flood Hazard Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Final notice.
AGENCY:
Flood hazard determinations,
which may include additions or
modifications of Base Flood Elevations
(BFEs), base flood depths, Special Flood
Hazard Area (SFHA) boundaries or zone
designations, or regulatory floodways on
the Flood Insurance Rate Maps (FIRMs)
and where applicable, in the supporting
Flood Insurance Study (FIS) reports
have been made final for the
communities listed in the table below.
The FIRM and FIS report are the basis
of the floodplain management measures
that a community is required either to
adopt or to show evidence of having in
effect in order to qualify or remain
qualified for participation in the Federal
Emergency Management Agency’s
SUMMARY:
(FEMA’s) National Flood Insurance
Program (NFIP). In addition, the FIRM
and FIS report are used by insurance
agents and others to calculate
appropriate flood insurance premium
rates for buildings and the contents of
those buildings.
DATES: The effective date of January 7,
2015 which has been established for the
FIRM and, where applicable, the
supporting FIS report showing the new
or modified flood hazard information
for each community.
ADDRESSES: The FIRM, and if
applicable, the FIS report containing the
final flood hazard information for each
community is available for inspection at
the respective Community Map
Repository address listed in the tables
below and will be available online
through the FEMA Map Service Center
at www.msc.fema.gov by the effective
date indicated above.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, FEMA,
500 C Street SW., Washington, DC
20472, (202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov; or visit
the FEMA Map Information eXchange
(FMIX) online at
www.floodmaps.fema.gov/fhm/fmx_
main.html.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) makes the final determinations
Community
listed below for the new or modified
flood hazard information for each
community listed. Notification of these
changes has been published in
newspapers of local circulation and 90
days have elapsed since that
publication. The Deputy Associate
Adminstrator for Mitigation has
resolved any appeals resulting from this
notification.
This final notice is issued in
accordance with section 110 of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4104, and 44 CFR part 67.
FEMA has developed criteria for
floodplain management in floodprone
areas in accordance with 44 CFR part
60.
Interested lessees and owners of real
property are encouraged to review the
new or revised FIRM and FIS report
available at the address cited below for
each community or online through the
FEMA Map Service Center at
www.msc.fema.gov.
The flood hazard determinations are
made final in the watersheds and/or
communities listed in the table below.
(Catalog of Federal Domestic Assistance No.
97.022, ‘‘Flood Insurance.’’)
Dated: February 23, 2015.
Roy E. Wright,
Deputy Associate Administrator for
Mitigation, Department of Homeland
Security, Federal Emergency Management
Agency.
Community map repository address
Floyd County, Iowa and Incorporated Areas
Docket No.: FEMA–B–1342
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City of Charles City ..................................................................................
Unincorporated Areas of Floyd County ....................................................
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City Hall, 105 Milwaukee Mall, Charles City, IA 50616.
Floyd County Courthouse, 101 South Main Street, Suite 108, Charles
City, IA 50616.
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]]>Agencies
[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13586-13588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05868]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0793]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority
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 the information collection
requirements for medical device recall authority.
DATES: Submit either electronic or written comments on the collection
of information by May 15, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the
[[Page 13587]]
docket number found in brackets in the heading of this document.
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.
Medical Device Recall Authority--21 CFR 810 (OMB Control Number 0910-
0432)--Extension
This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), medical device recall authority provisions.
Section 518(e) of the FD&C Act provides FDA with the authority to issue
an order requiring an appropriate person, including manufacturers,
importers, distributors, and retailers of a device, if FDA finds that
there is reasonable probability that the device intended for human use
would cause serious adverse health consequences or death, to: (1)
Immediately cease distribution of such device; (2) immediately notify
health professionals and device-user facilities of the order; and (3)
instruct such professionals and facilities to cease use of such device.
Further, the provisions under section 518(e) of the FD&C Act set
out the following three-step procedure for issuance of a mandatory
device recall order:
If there is a reasonable probability that a device
intended for human use would cause serious, adverse health consequences
or death, FDA may issue a cease distribution and notification order
requiring the appropriate person to immediately:
[cir] Cease distribution of the device,
[cir] notify health professionals and device user facilities of the
order, and
[cir] instruct those professionals and facilities to cease use of
the device;
FDA will provide the person named in the cease
distribution and notification order with the opportunity for an
informal hearing on whether the order should be modified, vacated, or
amended to require a mandatory recall of the device; and
after providing the opportunity for an informal hearing,
FDA may issue a mandatory recall order if the Agency determines that
such an order is necessary.
The information collected under the recall authority provisions
will be used by FDA to do the following: (1) Ensure that all devices
entering the market are safe and effective; (2) accurately and
immediately detect serious problems with medical devices; and (3)
remove dangerous and defective devices from the market.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Collection activity--21 CFR Number of responses per Total annual burden per Total hours
section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the 2 1 2 8 16
Order--810.10(d)...............
Request for Regulatory Hearing-- 1 1 1 8 8
810.11(a)......................
Written Request for Review-- 1 1 1 8 8
810.12(a-b)....................
Mandatory Recall Strategy-- 2 1 2 16 32
810.14.........................
Periodic Status Reports-- 2 12 24 40 960
810.16(a-b)....................
Termination Request--810.17(a).. 2 1 2 8 16
-------------------------------------------------------------------------------
Total hours................. .............. .............. .............. .............. 1,040
----------------------------------------------------------------------------------------------------------------
\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 Average burden
Collection activity--21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Notifications to Recipients--810.15(b)............ 2 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 13588]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Collection activity--21 CFR Number of disclosures Total annual Average
section respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients-- 2 1 2 12 24
810.15(a)-(c)..................
Notification to Recipients; 2 1 2 4 8
Followup--810.15(d)............
Notification of Consignees by 10 1 10 1 10
Recipients--810.15(e)..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05868 Filed 3-13-15; 8:45 am]
BILLING CODE 4164-01-P
