Submission for OMB Review; Comment Request, 71447-71448 [2010-29479]
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71447
Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR section
Number of
respondents
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
806.10 ..................................................................................
666
1
666
10
6,660
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Annual
frequency per
recordkeeping
Total annual
records
Hours per
record
Total hours
806.20 ..................................................................................
90
1
90
10
900
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are manufacturers and
importers of medical devices. FDA
reviewed reports of device corrections
and removals submitted to the Agency
for the previous 3 years as part of
responding to the current request for
approval of the information collection
requirements for §§ 806.10 and 806.20.
This information was obtained through
the Agency’s voluntary recall provisions
(i.e., 21 CFR part 7). The specific
information requested was the total
number of class I, II, and III recalls for
the last 3 years. This information was
obtained from the Agency’s Recall
Enterprise System—a database of all
recalls submitted to the Agency.
This information is relevant since a
§ 806.10 report is required for all class
I and II recalls. Although class III recalls
are not required to be submitted to FDA
(by § 806.10) a record must be kept in
the firm’s § 806.20 file. Therefore, the
number of class I and II recalls can be
used to estimate the maximum number
of reports that are required to be
submitted under § 806.10. Also, the
recordkeeping burden can be estimated
based upon the number of class III
recalls, which are not required to be
reported but must be retained in a
§ 806.20 file.
FDA has determined that estimates of
the reporting burden for § 806.10 should
be revised to reflect a projected 7.3
percent increase (from the last PRA
numbers) in reports submitted to FDA
as class I and II. FDA also estimates the
recordkeeping burden in § 806.20
should be revised to reflect a reduction
of 6.8 percent (from the last PRA
numbers) in records filed and
maintained under this section. The
estimates of time needed to collect part
806 information have not changed.
Dated: November 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–29520 Filed 11–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Assistance Program (LIHEAP) Model
Plan.
OMB No.: 0970–0075.
Description: States, including the
District of Columbia, Tribes, Tribal
Organizations and Territories applying
for LIHEAP block grant funds must
submit an annual application (Model
Plan) that meets the LIHEAP statutory
and regulatory requirements prior to
receiving Federal funds. A detailed
application must be submitted every
three years. Abbreviated applications
may be submitted in alternate years.
There have been no changes in the
Model Plan since the approval of the
addition of the LIHEAP Program
Integrity Assessment Supplement by the
Office of Management and Budget
earlier this year.
Respondents: State, Local or Tribal
Governments.
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Application Requirements for
the Low Income Home Energy
ANNUAL BURDEN ESTIMATES
Number of
respondents
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Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
LIHEAP Program Integrity Assessment and Plan ...........................................
Detailed Model Plan ........................................................................................
Abbreviated Model Plan ..................................................................................
216
72
144
1
1
1
1
1
.33
216
72
47.5
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
335.5
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71448
Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices
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: November 18, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–29479 Filed 11–22–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
Notice of Intent To Provide
Supplemental Funding
Notice of intent to provide
supplemental funding to the existing
cooperative agreement (90AM3204)
with the Administration on Aging and
a request for a supplemental
application.
ACTION:
The Administration on Aging
is announcing the availability of
supplemental grant funds for the
support of the Senior Medicare Program
(SMP). The goal of this supplemental is
a program expansion for one award to
include direct Medicare fraud
prevention intervention activities in
high risk areas.
Funding Opportunity Title/Program
Name: National Hispanic SMP
(NHSMP).
Announcement Type: Proposed
program expansion.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
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Funding Opportunity Number:
Program Announcement No. HHS–
2011–AoA–MP–1102.
Statutory Authority: HIPAA of 1996
(Pub. L. 104–191).
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.048
Discretionary Projects.
Key Dates: The deadline date for
comments under this Program
Announcement is December 23, 2010.
Other Important dates:
1. The supplemental application due
date is November 29, 2010.
2. The anticipated start date is
December 2010.
3. The opening date begins on the first
day of publication of this notice.
4. The expiration date is December 5,
2010.
DATES:
I. Funding Opportunity Description
Since September 2008 NHCOA has
operated the NHSMP providing
technical assistance to all SMP projects
nation-wide pertaining to Hispanic
community issues. The goal of the SMP
program is to prevent or reduce the
billions of dollars loss annually due to
Medicare/Medicaid fraud, error and
abuse. The Centers for Medicare &
Medicaid Services data has revealed
that Medicare fraud is rampant in the
Hispanic community. Hispanic older
adults are especially vulnerable to
Medicare fraud due to social isolation
from the general population due to a
combination of linguistic and cultural
factors. This goal of this program
expansion is to target direct intervention
activities in South Florida, especially
Miami and Dade counties. Intervention
activities must be relevant to the unique
characteristics of the older Hispanic
community designed to increase
awareness of the SMP program and
fraud prevention.
II. Award Information
A. Purpose of the Award: Health Care
Fraud Prevention Program Expansion.
B. Amount of the Award: $335,000.
C. Project Period: December 1, 2010–
May 31, 2011.
III. Eligible Applicant
The National Hispanic Council on
Aging.
IV. Evaluation Criteria
A. Purpose and Need for Assistance—
Weight: 20 Points
Does the proposed project clearly and
adequately describe the targeted
population and document the need for
intervention?
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B. Approach, Work Plan and
Activities—Weight: 30 Points
Does the proposal reflect a coherent
and feasible approach for successfully
addressing the identified problems? (10)
Is the project work plan clear and
comprehensive? (10)
Does the applicant demonstrate
experience in working with targeted
population? (10)
C. Project Outcomes, Evaluation and
Dissemination—Weight: 20 Points
Are the expected expansion benefits/
results clear and realistic? (10)
Does the project expansion contain an
evaluation component? (5)
Will results be disseminated to AoA
and other interested parties? (5)
D. Level of Effort—Weight: 30 Points
Does key staff have the background,
experience to carry out their designated
roles? (10)
Are budget line items clearly
delineated and consistent with work
plan objectives? (10)
Has the applicant demonstrated the
organization’s capacity to implement
the work plan? (10)
V. Application and Submission
Requirements
A. SF 424—Application for Federal
Assistance.
B. SF 424A—Budget Information.
C. Separate Budget Narrative/
Justification.
D. SF 424B—Assurances. Note: Be
sure to complete this form according to
instructions and have it signed and date
by the authorized representative (see
item 18d on the SF 424).
E. Lobbying Certification.
F. Program narrative no more than
five pages including the following
items:
• Summary/Abstract summary page
• Expansion Proposal
• Anticipated outcome(s)
G. Work Plan.
H. The application should be
submitted through grants.gov using the
funding opportunity #HHS–2011–AoA–
MP–1102.
VI. Application Review Information
Three Federal Reviewers external to
the Office of Elder Rights will score the
application.
VII. Agency Contact
Direct inquiries regarding
programmatic issues to U.S. Department
of Health and Human Services,
Administration on Aging, Office of
Elder Rights, Washington, DC 20201,
telephone: Barbara Dieker, (202) 357–
0139; e-mail
Barbara.Dieker@aoa.hhs.gov.
E:\FR\FM\23NON1.SGM
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Agencies
[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71447-71448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29479]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Application Requirements for the Low Income Home Energy
Assistance Program (LIHEAP) Model Plan.
OMB No.: 0970-0075.
Description: States, including the District of Columbia, Tribes,
Tribal Organizations and Territories applying for LIHEAP block grant
funds must submit an annual application (Model Plan) that meets the
LIHEAP statutory and regulatory requirements prior to receiving Federal
funds. A detailed application must be submitted every three years.
Abbreviated applications may be submitted in alternate years. There
have been no changes in the Model Plan since the approval of the
addition of the LIHEAP Program Integrity Assessment Supplement by the
Office of Management and Budget earlier this year.
Respondents: State, Local or Tribal Governments.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
LIHEAP Program Integrity Assessment and Plan.... 216 1 1 216
Detailed Model Plan............................. 72 1 1 72
Abbreviated Model Plan.......................... 144 1 .33 47.5
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 335.5
----------------------------------------------------------------------------------------------------------------
[[Page 71448]]
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: November 18, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-29479 Filed 11-22-10; 8:45 am]
BILLING CODE 4184-01-P