Proposed Information Collection Activity; Comment Request, 66846-66847 [2012-27101]
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66846
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices
OMB No.: 0970–0382.
Description: Sections 676 and 677 of
the Community Services Block Grant
Act require States, including the District
of Columbia and the Commonwealth of
Puerto Rico, Tribes, Tribal organizations
and U.S. territories applying for
Community Services Block Grant
(CSBG) funds to submit an application
and plan (Model Application Plan). The
application plan must meet statutory
requirements prior to being funded with
CSBG funds. Applicants have the option
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Community Services Block
Grant (CSBG) Program Model Plan
Application.
to submit a detailed application
annually or biannually. Entities that
submit a biannual application must
provide an abbreviated application the
following year if substantial changes to
the initial application will occur. OMB
renewal is being sought.
Respondents: State Governments,
including the District of Columbia and
the Commonwealth of Puerto Rico,
Tribal Governments, Tribal
Organizations, and U.S. territories.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Model State CSBG Application .......................................................................
Model Indian Tribes & Tribal Organizations CSBG Application ......................
Estimated Total Annual Burden
Hours: 860.
In compliance with the requirements
of Section 506(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, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@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
Number of
responses per
respondent
56
30
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–27104 Filed 11–6–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Average
burden hours
per response
1
1
Total burden
hours
10
10
560
300
OMB No.: 0970–0207.
Description: The Office of Head Start
is proposing to renew, without changes,
the Head Start Grant Application and
Budget Instrument, which standardizes
the grant application information that is
requested from all Head Start and Early
Head Start grantees applying for
continuation grants. The application
and budget forms are available in a
password-protected, web-based system.
Completed applications can be
transmitted electronically to Regional
and Central Offices. The Administration
for Children and Families believes that
this application form makes the process
of applying for Head Start program
grants more efficient for applicants.
Respondents: Head Start and Early
Head Start grantees.
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Head Start Grant Application
and Budget Instruments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
HS grant and budget instrument .....................................................................
pmangrum on DSK3VPTVN1PROD with NOTICES
Instrument
1,600
1
33
52,800
Estimated Total Annual Burden
Hours: 52,800.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
VerDate Mar<15>2010
15:43 Nov 06, 2012
Jkt 229001
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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.
Email address:
E:\FR\FM\07NON1.SGM
07NON1
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices
infocollection@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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–27101 Filed 11–6–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
pmangrum on DSK3VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Circulatory
System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 5 and 6, 2012, from
8 a.m. to 6 p.m.
Location: Holiday Inn, Grand
Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD. The hotel phone
number is 301–948–8900.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993 301–796–3063, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
VerDate Mar<15>2010
15:43 Nov 06, 2012
Jkt 229001
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On December 5, 2012, during
session I, the committee will discuss
and make recommendations regarding
the 515(i) order issued by FDA on April
9, 2009 [Docket No. FDA–2009–M–
0101], for the external counter-pulsating
(ECP) devices, one of the remaining preAmendment Class III devices. These
systems typically consist of a treatment
table, pressure cuffs and a controller.
They are intended to provide
noninvasive circulatory support by
applying external pressure to the lower
extremities during diastole to increase
coronary perfusion pressure, and
releasing external pressure during
systole to reduce left ventricular
workload.
On March 9, 1979 (44 FR 13426), FDA
published a proposed rule for
classification of ECP devices as class III
requiring premarket approval. The
Cardiovascular Device Classification
Panel (the Panel) recommended class III
because the device is life supporting
and potentially hazardous to life or
health even when used properly. In
addition, the Panel believed that
sufficient information did not exist to
determine the adequacy of general
controls or to establish standards to
provide a reasonable assurance of the
safety and effectiveness of the device.
Subsequent to the proposed rule, in
1980, FDA classified external counterpulsating devices into class III after
receiving no comments on the proposed
rule (45 FR 7966, February 5, 1980). In
1987, FDA published a clarification by
inserting language in the codified
language stating that no effective date
had been established for the
requirement for premarket approval for
ECP devices (52 FR 17737, May 11,
1987).
The discussion at the panel meeting
will involve making recommendations
regarding regulatory classification to
either reconfirm to class III (subject to
premarket approval application [PMA])
or reclassify to class I or class II (subject
to premarket notification [510(k)]), as
directed by section 515(i) of the Federal
Food, Drug and Cosmetic Act.
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Fmt 4703
Sfmt 4703
66847
On December 5, 2012, during session
II, the committee will discuss and make
recommendations regarding the 515(i)
order issued by FDA on April 9, 2009
[Docket No. FDA–2009–M–0101], for
Intra-aortic balloon and control systems,
one of the remaining pre-Amendment
Class III devices. Intra-aortic balloon
pump (IABP) systems consist of an
inflatable balloon and a console which
inflates in synchronization with the
cardiac cycle. During diastole, the
balloon will inflate, creating a rise in
pressure in the aorta, thus increasing
blood flow to the coronary arteries and
increasing myocardial oxygen supply.
During systole, deflation of the balloon
causes a fall in pressure in the aorta,
which assists the left ventricle by
reducing the pressure that needs to be
generated to achieve ejection through
the aortic valve.
On March 9, 1979 (44 FR 13369), FDA
published a proposed rule for
classification of IABP devices as class III
requiring premarket approval. The Panel
recommended class III because the
device is life supporting and because
the Panel believed that insufficient
medical and scientific information
existed to establish a standard to assure
the safety and effectiveness of the
device. The Panel also stated that
controversy exists as to whether the
device is beneficial in many situations
in which it is used, and that it is
difficult to use the device safely and
effectively. Subsequent to the proposed
rule, in 1980, FDA classified IABP
devices into class III after receiving no
comments on the proposed rule (45 FR
7939, February 5, 1980). In 1987, FDA
published a clarification by inserting
language in the codified language
stating that no effective date had been
established for the requirement for
premarket approval for IABP devices (52
FR 17736, May 11, 1987).
The discussion at the panel meeting
will involve making recommendations
regarding regulatory classification to
either reconfirm to class III (subject to
premarket approval application [PMA])
or reclassify to class I or class II (subject
to premarket notification [510(k)]), as
directed by section 515(i) of the Federal
Food, Drug and Cosmetic Act.
On December 6, 2012, the committee
will discuss and make
recommendations regarding the 515(i)
order issued by FDA on April 9, 2009
[Docket No. FDA–2009–M–0101], for
Nonroller-type cardiopulmonary bypass
blood pumps, one of the remaining preAmendment Class III devices. A
nonroller-type cardiopulmonary bypass
blood pump is a device that uses a
method other than revolving rollers to
pump blood. There are two types of
E:\FR\FM\07NON1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66846-66847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27101]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Head Start Grant Application and Budget Instruments.
OMB No.: 0970-0207.
Description: The Office of Head Start is proposing to renew,
without changes, the Head Start Grant Application and Budget
Instrument, which standardizes the grant application information that
is requested from all Head Start and Early Head Start grantees applying
for continuation grants. The application and budget forms are available
in a password-protected, web-based system. Completed applications can
be transmitted electronically to Regional and Central Offices. The
Administration for Children and Families believes that this application
form makes the process of applying for Head Start program grants more
efficient for applicants.
Respondents: Head Start and Early Head Start grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
HS grant and budget instrument.............. 1,600 1 33 52,800
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 52,800.
In compliance with the requirements of Section 506(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, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address:
[[Page 66847]]
infocollection@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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-27101 Filed 11-6-12; 8:45 am]
BILLING CODE 4184-01-P
