Submission for OMB Review; Comment Request, 47306-47307 [2010-19268]
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47306
Federal Register / Vol. 75, No. 150 / Thursday, August 5, 2010 / Notices
You may
call 202–452–3206 beginning at
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
SUPPLEMENTARY INFORMATION:
Board of Governors of the Federal Reserve
System, August 3, 2010.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2010–19471 Filed 8–3–10; 4:15 pm]
BILLING CODE 6210–01–S
Intermediary licenses have been
reissued by the Federal Maritime
Commission pursuant to section 19 of
the Shipping Act of 1984 (46 U.S.C.
chapter 409) and the regulations of the
Commission pertaining to the licensing
of Ocean Transportation Intermediaries,
46 CFR part 515.
FEDERAL MARITIME COMMISSION
Ocean Transportation Intermediary
License Reissuance
Notice is hereby given that the
following Ocean Transportation
License No.
Name/address
015941N ............
18547N ..............
020151NF ..........
Cargo Plus, Inc., 8333 Wessex Drive, Pennsauken, NJ 08109 .........................................................
Pallets in Motion, 426 W. Florence Avenue, Inglewood, CA 90301 ..................................................
United Global Logistics, LLC, 1139 East Jersey Street, Suite 417, Elizabeth, NJ 07201. ................
Sandra L. Kusumoto,
Director, Bureau of Certification and
Licensing.
Date reissued
[FR Doc. 2010–19146 Filed 8–4–10; 8:45 am]
Dated: July 30, 2010.
Sherry Glied,
Assistant Secretary for Planning and
Evaluation.
BILLING CODE P
[FR Doc. 2010–19211 Filed 8–2–10; 4:15 pm]
BILLING CODE 4151–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Administration for Children and
Families
Office of the Assistant Secretary for
Planning and Evaluation; Technical
Review Panel on the Medicare
Trustees Reports
Submission for OMB Review;
Comment Request
Department of Health and
Human Services, Office of the Assistant
Secretary for Planning and Evaluation.
ACTION: Notice; correction.
AGENCY:
This document corrects the
fax number and adds an e-mail address
for Marian Robinson found in the
Federal Register (FR) on July 30, 2010,
entitled ‘‘Technical Review Panel on the
Medicare Trustees Reports’’. The FR
notice should have the corrected fax
number of 202–260–2524 and should
include the e-mail address for Marian
Robinson (marian.robinson@hhs.gov).
Applicability Date: The corrections in
this notice are applicable on and after
August 2, 2010.
SUMMARY:
Title: Case Plan Requirement, Title
IV–E of the Social Security Act.
OMB No.: 0980–0140.
Description: Under section 471(a)(16)
of title IV–E of the Social Security Act
(the Act), to be eligible for payments,
states must have an approved title IV–
E plan that provides for the
development of a case plan for each
child for whom the State receives foster
care maintenance payments and that
provides a case review system that
meets the requirements in section 475(5)
and 475(6) of the Act. The Fostering
Connections to Success and Increasing
Adoptions Act of 2008 (Pub. L. 110–
351) added a new section 479B to the
Act providing authority at 479B(b) for
an Indian Tribe, tribal organization or
tribal consortia (hereafter ‘‘Tribe’’) to
June 23, 2010.
June 26, 2010.
May 27, 2010.
elect to operate a title IV–E program
with an approved title IV–E plan. Tribes
are to operate a program in the same
manner as states and must provide for
a case plan for each child and for a case
review system.
The case review system assures that
each child has a case plan designed to
achieve placement in a safe setting that
is the least restrictive (most family-like)
setting available and in close proximity
to the child’s parental home, consistent
with the best interest and special needs
of the child. Through these
requirements, States and Tribes also
comply, in part, with title IV–B section
422(b) of the Act, which assures certain
protections for children in foster care.
The case plan is a written document
that provides a narrative description of
the child-specific program of care.
Federal regulations at 45 CFR 1356.21(g)
and section 475(1) of the Act delineate
the specific information that should be
addressed in the case plan. The
Administration for Children and
Families (ACF) does not specify a
recordkeeping format for the case plan
nor does ACF require submission of the
document to the Federal government.
Case plan information is recorded in a
format developed and maintained by the
State or Tribal child welfare agency.
Respondents: State and Tribe title IV–
B and title IV–E agencies
mstockstill on DSKH9S0YB1PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Case Plan ........................................................................................
VerDate Mar<15>2010
17:52 Aug 04, 2010
Jkt 220001
Number of
responses per
respondent
Number of
respondents
Instrument
PO 00000
Frm 00049
Fmt 4703
603,453
Sfmt 4703
E:\FR\FM\05AUN1.SGM
Average
burden hours
per response
1
4.79
05AUN1
Total burden
hours
2,890,539.87
Federal Register / Vol. 75, No. 150 / Thursday, August 5, 2010 / Notices
Estimated Total Annual Burden
Hours: 2,890,539.87
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 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. E-mail 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, Fax: 202–395–7285,
E-mail: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Dated: August 2, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–19268 Filed 8–4–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0348]
Center for Devices and Radiological
Health 510(k) Working Group
Preliminary Report and
Recommendations, and Task Force on
the Utilization of Science in Regulatory
Decision Making Preliminary Report
and Recommendations; Availability;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comment.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of a
two-volume set of documents entitled
‘‘Center for Devices and Radiological
Health Preliminary Internal
Evaluations,’’ which is comprised of the
preliminary reports of two internal
committees: The 510(k) Working Group
and the Task Force on the Utilization of
Science in Regulatory Decision Making.
Volume I is entitled ‘‘510(k) Working
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:52 Aug 04, 2010
Jkt 220001
Group Preliminary Report and
Recommendations.’’ Volume II is
entitled ‘‘Task Force on the Utilization
of Science in Regulatory Decision
Making Preliminary Report and
Recommendations.’’ The
recommendations contained in these
reports are preliminary. FDA has not
made any decisions on specific changes
to pursue. FDA is soliciting public input
on the recommendations discussed in
these reports, including the feasibility of
implementation and potential
alternatives. Once its assessment of
public input and other necessary
reviews are completed, FDA will
announce which improvements it will
implement, as well as projected
timelines for implementation.
DATES: Submit either electronic or
written comments on the preliminary
report by October 4, 2010.
ADDRESSES: See the SUPPLEMENTARY
INFORMATION section for electronic
access to the document.
Submit electronic comments on the
preliminary report to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5447, Silver Spring,
MD 20993–0002, 301–796–5678.
SUPPLEMENTARY INFORMATION:
I. Background
A. 510(k) Working Group
The premarket notification (510(k))
process for the review of medical
devices was established in 1976, under
the Medical Device Amendments to the
Federal Food, Drug, and Cosmetic Act
(FDCA). With the exception of certain
low-risk devices that are exempt from
premarket submission requirements, a
medical device that is first introduced
into the market after May 28, 1976 (a
postamendment device) may be legally
marketed without an approved
premarket approval application (PMA)
if FDA concludes through review of a
510(k) submission that the device meets
the comparative standard of ‘‘substantial
equivalence’’ to a ‘‘predicate’’ device.
Substantial equivalence may be
determined by a comparison to a device
that was legally marketed prior to May
28, 1976 (a preamendment device), to a
device that has been reclassified from
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
47307
class III (high-risk) to class II or class I
(medium- to low-risk), or to a device
that has previously been cleared
through the 510(k) process.
Since its inception, the 510(k) process
has undergone a number of statutory
changes. In addition, FDA has modified
its implementation of the process to
adapt to changing circumstances and
accommodate the evolving medical
device landscape. The current 510(k)
program reflects the current statutory
framework and FDA’s implementation
of that framework through regulation,
guidance, and administrative practice.
The 510(k) program, as it currently
exists, is intended to support FDA’s
public health mission by meeting two
important goals: making available to
consumers devices that are safe and
effective, and fostering innovation in the
medical device industry. In recent years,
concerns have been raised within and
outside of FDA about whether the
current 510(k) program optimally
achieves these goals.
In September 2009, CDRH convened
an internal 510(k) Working Group as
part of a two-pronged, comprehensive
assessment of the 510(k) process. The
other component of this assessment is
an ongoing independent study by the
Institute of Medicine, which is expected
to conclude in the summer of 2011. The
510(k) Working Group was charged to
evaluate the 510(k) program and explore
actions CDRH could take to strengthen
the program and improve the
consistency of its decision making, with
a principal focus on actions the Center
could take in the short term under its
existing statutory authority.
B. Task Force on the Utilization of
Science in Regulatory Decision Making
CDRH uses science to guide its
regulatory decision making across the
total product life cycle of medical
devices and radiation-emitting products.
At any stage of that life cycle, CDRH
may encounter new, unfamiliar, or
unexpected information that may
influence its thinking, expectations, and
actions. To fulfill its mission to protect
and promote the public health, CDRH
must strike a balance between the
ability to adapt its approach as
necessary as new science emerges, and
the desire to provide predictable
regulatory pathways that foster
innovation.
In September 2009, CDRH convened
an internal Task Force on the Utilization
of Science in Regulatory Decision
Making to review how CDRH uses
science in its regulatory decision
making, and to make recommendations
on how the Center can quickly
incorporate new science—including
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 75, Number 150 (Thursday, August 5, 2010)]
[Notices]
[Pages 47306-47307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Case Plan Requirement, Title IV-E of the Social Security
Act.
OMB No.: 0980-0140.
Description: Under section 471(a)(16) of title IV-E of the Social
Security Act (the Act), to be eligible for payments, states must have
an approved title IV-E plan that provides for the development of a case
plan for each child for whom the State receives foster care maintenance
payments and that provides a case review system that meets the
requirements in section 475(5) and 475(6) of the Act. The Fostering
Connections to Success and Increasing Adoptions Act of 2008 (Pub. L.
110-351) added a new section 479B to the Act providing authority at
479B(b) for an Indian Tribe, tribal organization or tribal consortia
(hereafter ``Tribe'') to elect to operate a title IV-E program with an
approved title IV-E plan. Tribes are to operate a program in the same
manner as states and must provide for a case plan for each child and
for a case review system.
The case review system assures that each child has a case plan
designed to achieve placement in a safe setting that is the least
restrictive (most family-like) setting available and in close proximity
to the child's parental home, consistent with the best interest and
special needs of the child. Through these requirements, States and
Tribes also comply, in part, with title IV-B section 422(b) of the Act,
which assures certain protections for children in foster care.
The case plan is a written document that provides a narrative
description of the child-specific program of care. Federal regulations
at 45 CFR 1356.21(g) and section 475(1) of the Act delineate the
specific information that should be addressed in the case plan. The
Administration for Children and Families (ACF) does not specify a
recordkeeping format for the case plan nor does ACF require submission
of the document to the Federal government. Case plan information is
recorded in a format developed and maintained by the State or Tribal
child welfare agency.
Respondents: State and Tribe title IV-B and title IV-E agencies
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Case Plan............................... 603,453 1 4.79 2,890,539.87
----------------------------------------------------------------------------------------------------------------
[[Page 47307]]
Estimated Total Annual Burden Hours: 2,890,539.87
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Administration, Office of Information Services, 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. E-mail 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, Fax: 202-395-
7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Dated: August 2, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-19268 Filed 8-4-10; 8:45 am]
BILLING CODE 4184-01-P
