Proposed Information Collection Activity; Comment Request Proposed Projects, 10646-10647 [05-4236]
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10646
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
• Medicare Modernization Act:
Outreach and education strategies.
• Public comment.
• Listening session with CMS
leadership.
• Next steps.
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to Lynne
Johnson, Health Insurance Specialist,
Division of Partnership Development,
Center for Beneficiary Choices, Centers
for Medicare & Medicaid Services, 7500
Security Boulevard, Mail stop S2–23–
05, Baltimore, MD 21244–1850 or by email at ljohnson3@cms.hhs.gov no later
than 12 noon, e.s.t., March 15, 2005.
The number of oral presentations may
be limited by the time available.
Individuals not wishing to make a
presentation may submit written
comments to Ms. Johnson by 12 noon,
e.s.t., March 15, 2005. The meeting is
open to the public, but attendance is
limited to the space available.
Special Accommodation: Individuals
requiring sign language interpretation or
other special accommodations should
contact Ms. Johnson at least 15 days
before the meeting.
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)
and 41 CFR 102–3).
Dated: March 1, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–4272 Filed 3–3–05; 8:45 am]
BILLING CODE 4120–01–U
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request Proposed
Projects
Title: Evaluation of the Improving
Child Welfare Outcome through
Systems of Care Grant Program.
OMB No. New Collection
Description: The 1994 Amendments
to the Social Security Act (SSA)
authorize the U.S. Department of Health
and Human Services to review State
child and family service programs to
ensure conformance with the
requirements in titles IV–B and IV–E of
SSA. Under the final Rule, which took
effect March 25, 2000, States are
assessed for substantial conformity with
certain Federal requirements for childwelfare services. The Child and Family
Service Reviews (CFSR), administered
by the Children’s Bureau, are designed
to ensure conformity with Federal childwelfare requirements and, ultimately, to
help States improve child-welfare
services and outcomes, specifically
safety, permanency and well-being
outcomes for child-welfare-involved
children and their families. States
determined not to have achieved
substantial conformity in any of the
areas assessed are required to develop
and implement Program Improvement
Plans (PIP) addressing the areas of
nonconformity.
The Systems of Care grant cluster,
from which these data are proposed to
be collected, is designed to encourage
public child-welfare agencies to address
the issues identified in their State’s
CFSR. Although Systems of Care has
shown promise in working with various
at-risk and family populations, it has
not been applied to a child-welfare
target population. The data collected
from these demonstration sites will
allow the Children’s Bureau to test
whether this approach can help States
reach the goals stated in their PIP and
explore how child-welfare can benefit
from being part of a system of care. Data
will be collected via interviews, forms
completed by project staff, surveys,
focus groups and case-file reviews. Data
also will be collected to determine the
extent to which the Technical
Assistance (A) provided, brokered or
contracted by the TA and Evaluation
Center is meeting the needs of the
grantees, and how.
Respondents: Systems of Care Project
Directors (members of the Systems of
Care collaborative may include
representatives from mental health,
juvenile justice, education, health,
among others); child-welfare agency
supervisors and caseworkers; partner
agency caseworkers, and families who
have been involved with the childwelfare system.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Average
burden hours
per response
(minutes)
Number of
responses per
respondent
Total burden
hours
Stakeholder Survey ....................................................................................
Child-Welfare Agency Survey .....................................................................
Supervisor Interviews .................................................................................
Interviews with family members ..................................................................
Stakeholder Interviews ...............................................................................
Project Director Interviews ..........................................................................
Child-Welfare agency and Partner agency focus groups ...........................
Community Description Form .....................................................................
Organizational Structure Form ....................................................................
Collaborative Membership Form .................................................................
Major Activities Form ..................................................................................
Policy Changes Form .................................................................................
Other Training and Technical Assistance Form .........................................
Training and Technical Assistance Participant Feedback Forms ..............
Technical Assistance Follow-up Survey .....................................................
240
1440
140
140
140
30
700
20
20
20
20
20
20
1080
518
51 items ............
72 items ............
5 questions .......
5 questions .......
5 questions .......
21 questions .....
6 questions .......
14 items ............
7 items ..............
7 items ..............
7 items ..............
7 items ..............
4 items ..............
37 items ............
15 .....................
.29
.29
5
5
5
14
6
2
4
2
6
6
5
.56
.29
59
501
58
58
58
42
420
9
9
5
14
14
7
373
38
Total estimated total annual burden hours ..........................................
........................
...........................
..........................
1,665
1 One
hour for entire interview.
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10647
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
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 Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
grjohnson@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.
Dated: February 28, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–4236 Filed 3–3–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Reports of Corrections and Removals—
21 CFR Part 806 (OMB Control Number
0910–0359)—Extension
Food and Drug Administration
The collection of information required
under the reports of corrections and
removals, part 806 (21 CFR part 806),
implements section 519(f) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360i(f)), as amended by the
Food and Drug Administration
Modernization Act of 1997 (FDAMA)
(21 U.S.C. 301) (Public Law 105–115).
Each device manufacturer or importer
under § 806.10 shall submit a written
report to FDA of any action initiated to
correct or remove a device to reduce a
risk to health posed by the device, or to
remedy a violation of the act caused by
the device which may present a risk to
health, within 10 working days of
initiating such correction or removal.
Each device manufacturer or importer
of a device who initiates a correction or
removal of a device that is not required
to be reported to FDA under § 806.20
shall keep a record of such 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
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 and to
determine whether recall action is
adequate.
In the Federal Register of December
14, 2004 (69 FR 74527), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Respondents to this collection of
information are manufacturers and
importers of medical devices.
FDA estimates the burden of this
collection of information as follows:
[Docket No. 2004N–0525]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 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 April 4,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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.
ADDRESSES:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
806.10
Annual Frequency per
Response
482
Total Annual
Responses
1
482
Hours per
Respondent
10
Totals
1There
Total Hours
4,820
4,820
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
21 CFR Section
806.20
Annual Frequency per
Record
143
Total Annual
Records
1
143
Totals
1There
Hours per
Recordkeeper
10
Total Hours
1,430
1,430
are no capital costs or operating and maintenance costs associated with this collection of information.
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Agencies
[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10646-10647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Evaluation of the Improving Child Welfare Outcome through
Systems of Care Grant Program.
OMB No. New Collection
Description: The 1994 Amendments to the Social Security Act (SSA)
authorize the U.S. Department of Health and Human Services to review
State child and family service programs to ensure conformance with the
requirements in titles IV-B and IV-E of SSA. Under the final Rule,
which took effect March 25, 2000, States are assessed for substantial
conformity with certain Federal requirements for child-welfare
services. The Child and Family Service Reviews (CFSR), administered by
the Children's Bureau, are designed to ensure conformity with Federal
child-welfare requirements and, ultimately, to help States improve
child-welfare services and outcomes, specifically safety, permanency
and well-being outcomes for child-welfare-involved children and their
families. States determined not to have achieved substantial conformity
in any of the areas assessed are required to develop and implement
Program Improvement Plans (PIP) addressing the areas of nonconformity.
The Systems of Care grant cluster, from which these data are
proposed to be collected, is designed to encourage public child-welfare
agencies to address the issues identified in their State's CFSR.
Although Systems of Care has shown promise in working with various at-
risk and family populations, it has not been applied to a child-welfare
target population. The data collected from these demonstration sites
will allow the Children's Bureau to test whether this approach can help
States reach the goals stated in their PIP and explore how child-
welfare can benefit from being part of a system of care. Data will be
collected via interviews, forms completed by project staff, surveys,
focus groups and case-file reviews. Data also will be collected to
determine the extent to which the Technical Assistance (A) provided,
brokered or contracted by the TA and Evaluation Center is meeting the
needs of the grantees, and how.
Respondents: Systems of Care Project Directors (members of the
Systems of Care collaborative may include representatives from mental
health, juvenile justice, education, health, among others); child-
welfare agency supervisors and caseworkers; partner agency caseworkers,
and families who have been involved with the child-welfare system.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of responses per burden hours Total burden
Instrument respondents respondent per response hours
(minutes)
----------------------------------------------------------------------------------------------------------------
Stakeholder Survey.................. 240 51 items.................. .29 59
Child-Welfare Agency Survey......... 1440 72 items.................. .29 501
Supervisor Interviews............... 140 5 questions............... 5 58
Interviews with family members...... 140 5 questions............... 5 58
Stakeholder Interviews.............. 140 5 questions............... 5 58
Project Director Interviews......... 30 21 questions.............. \1\4 42
Child-Welfare agency and Partner 700 6 questions............... 6 420
agency focus groups.
Community Description Form.......... 20 14 items.................. 2 9
Organizational Structure Form....... 20 7 items................... 4 9
Collaborative Membership Form....... 20 7 items................... 2 5
Major Activities Form............... 20 7 items................... 6 14
Policy Changes Form................. 20 7 items................... 6 14
Other Training and Technical 20 4 items................... 5 7
Assistance Form.
Training and Technical Assistance 1080 37 items.................. .56 373
Participant Feedback Forms.
Technical Assistance Follow-up 518 15........................ .29 38
Survey.
---------------
Total estimated total annual .............. .......................... .............. 1,665
burden hours.
----------------------------------------------------------------------------------------------------------------
\1\ One hour for entire interview.
[[Page 10647]]
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
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: grjohnson@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.
Dated: February 28, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05-4236 Filed 3-3-05; 8:45 am]
BILLING CODE 4184-01-M