Proposed Information Collection Activity; Comment Request, 1619-1620 [2011-332]
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Federal Register / Vol. 76, No. 7 / Tuesday, January 11, 2011 / Notices
distribution of materials, professional
development and individualized
technical assistance on health
promotion programs and environmental
approaches to Physical Activity,
Nutrition and Tobacco (PANT).
The asthma management
questionnaire includes questions about
planning and improving projects; joint
activities of the Local Education Agency
and Local Health Agency (LHA);
policies; asthma-related education;
health promotion and environmental
approaches to asthma management;
provision of health services;
collaboration with external partners;
SEAs, TEAs, and TGs; (2) assess the
extent to which programmatic
adjustments are indicated; (3) provide
descriptive and process information
about program activities; and (4)
provide greater accountability for use of
public funds.
Participation in the information
collection is required for programs that
receive funding through DASH. Each
Web-based questionnaire will be
completed annually by the program
coordinator for the activity. There are no
costs to respondents other than their
time.
reducing disparities among populations
of youth at disproportionate risk; and
information about additional program
activities. The sections on policies,
asthma-related education, health
services and health promotion and
environmental approaches to asthma
management include questions that
address the development and
distribution of materials, professional
development, and individualized
technical assistance.
Information gathered will: (1) Provide
standardized information about how
HIV prevention, CSHP, and asthma
management funds are used by LEAs,
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Avg. burden
per response
(in hrs)
Total burden
(in hrs)
Type of respondents
Form name
Local Education Agency Officials .....
Indicators for School Health Programs: HIV Prevention (LEA).
Indicators for School Health Programs:
Asthma
Management
(LEA).
Indicators for School Health Programs: HIV Prevention (SEA).
16
1
7
112
10
1
7
70
57
1
7
399
Indicators for School Health Programs:
Coordinated
School
Health Programs.
23
1
10
230
...........................................................
........................
........................
........................
811
State and Territorial Education
Agency and Tribal Government
Officials.
Total ...........................................
Dated: January 5, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–328 Filed 1–10–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0159]
Proposed Information Collection
Activity; Comment Request
mstockstill on DSKH9S0YB1PROD with NOTICES
Proposed Projects
Title: Statewide Automated Child
Welfare Information System (SACWIS)
Assessment Review Guide.
Description: The Department of
Health and Human Services is
authorized under section 474 of the
Social Security Act to provide funding
to state title IV–E agencies for
information systems that support the
provision of services to the nation’s
foster care and adoption populations.
The Act authorizes funding for the
planning, design, development, or
VerDate Mar<15>2010
17:33 Jan 10, 2011
Jkt 223001
installation of statewide automated
child welfare systems (SACWIS). The
data from these systems allows the
Department to report accurate,
meaningful and reliable information to
Congress about the extent of problems
facing these children and the
effectiveness of assistance provided to
this population.
Currently, SACWIS enable State
efforts to meet the following Federal
reporting requirements: The Adoption
and Foster Care Analysis and Reporting
System (AFCARS) required by section
479(b)(2) of the Social Security Act; the
National Child Abuse and Neglect Data
System (NCANDS); Child Abuse
Prevention and Treatment Act (CAPTA);
and the Chafee Independent Living
Program National Youth in Transition
Database (NYTD). SACWIS systems also
support States’ efforts to provide the
information to conduct the Child and
Family Service Reviews. Currently, 40
States and the District of Columbia have
developed, or are developing, a SACWIS
with Federal financial participation.
The SACWIS Assessment Reviews
validate that all aspects of the project,
as described in the approved Advance
Planning Document, have been
adequately completed, and conform to
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
applicable regulations and policies.
States use the SACWIS Assessment
Review Guide (SARG) to document
system components and functioning;
each State’s submission is unique and
State-specific. These reviews are usually
initiated by the State; however, ACF
reserves the right to initiate SACWIS
Assessment Reviews, at any time in the
system life cycle. Submission of the
SACWIS SARG and other supporting
documentation by States, completed at
the point that they have completed
system development and the system is
operational statewide, initiates a
SACWIS Assessment Review. The
additional supporting documentation
submitted as part of the review process
should be readily available to States as
a result of their routine good project
management practices. The SARG and
supporting documentation may be
submitted electronically.
The information collected in the
SACWIS Assessment Review Guide will
allow State and Federal officials to
determine if the State’s SACWIS meets
the requirements of title IV–E Federal
Financial Participation (FFP) defined at
45 CFR 1355.50. Additionally, other
States will be able to use the
documentation provided as part of this
E:\FR\FM\11JAN1.SGM
11JAN1
1620
Federal Register / Vol. 76, No. 7 / Tuesday, January 11, 2011 / Notices
review process to inform their own
system development efforts.
No small businesses will be involved
in this data collection effort.
Respondents: Title IV–E Agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
SACWIS Assessment Review Guide (SARG) .................................................
3
1
250
750
Estimated Total Annual Burden
Hours: 750.
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:
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. 2011–332 Filed 1–10–11; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
BILLING CODE 4184–01–P
VerDate Mar<15>2010
17:33 Jan 10, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0637]
Trials to Verify and Describe Clinical
Benefit of Midodrine Hydrochloride;
Establishment of Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
opening of a public docket to provide a
forum to facilitate communication
regarding the conduct of clinical trials
needed to verify and describe the
clinical benefit of midodrine
hydrochloride (HCl) when used to treat
symptomatic orthostatic hypotension.
DATES: Submit either electronic or
written comments by July 11, 2011.
ADDRESSES: Submit electronic
comments 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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Wei
Lu, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6196, Silver Spring,
MD 20993–0002, e-mail:
Wei.Lu@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA
approved PROAMATINE (midodrine
HCl) for marketing under its accelerated
approval regulations, 21 CFR part 314,
subpart H, on September 6, 1996, to
treat patients with symptomatic
orthostatic hypotension. Since that time,
FDA has approved five generic versions
of this product. Orthostatic hypotension
is a condition in which patients are
unable to maintain blood pressure in the
upright position and become dizzy or
faint upon standing. Subpart H allows
approval of drugs to treat serious or lifethreatening illnesses based on adequate
SUMMARY:
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Fmt 4703
Sfmt 4703
and well-controlled clinical trials
establishing that the drug has an effect
on a surrogate endpoint that is
reasonably likely to predict clinical
benefit or based on a clinical endpoint
other than survival or irreversible
morbidity. Approval of PROAMATINE
was based on trials demonstrating that
PROAMATINE increased 1-minute
standing systolic blood pressure, a
surrogate marker considered likely to
correspond to a clinical benefit,
principally relief of symptoms of
orthostatic hypotension and improved
ability to perform life activities.
The subpart H regulations specify that
approvals based upon surrogate
endpoints are ‘‘subject to the
requirement that the applicant study the
drug further to verify and describe its
clinical benefit’’ in postmarketing
studies. The postmarketing study
requirement for midodrine HCl was
described in the new drug application
(NDA) submission seeking its approval
and referenced in the Agency’s 1996
approval letter. In the time since
PROAMATINE was approved, the NDA
holder has sponsored clinical trials and
information regarding the drug’s
efficacy has been published, but data
submitted to the Agency have not
verified the drug’s clinical benefit to
FDA’s satisfaction. Accordingly, on
August 16, 2010, FDA issued a notice of
opportunity for a hearing (NOOH) on a
proposal to withdraw approval of the
NDA for midodrine HCl.
Although the NOOH process is
proceeding on a separate track, FDA
recognizes that existing and potential
sponsors may wish to conduct the
clinical trials needed to support
continued marketing authorization of
midodrine HCl. To assist sponsors in
planning and designing such trials, we
are placing in the docket a brief
description of a recommended clinical
trial design. We are also inviting
interested parties to submit information
to the docket such as any existing
controlled studies that verify the
clinical benefit of midodrine HCl when
used to treat orthostatic hypotension.
Physicians who treat orthostatic
hypotension and patient organizations
that would like to work with any
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 76, Number 7 (Tuesday, January 11, 2011)]
[Notices]
[Pages 1619-1620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No. 0970-0159]
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Statewide Automated Child Welfare Information System
(SACWIS) Assessment Review Guide.
Description: The Department of Health and Human Services is
authorized under section 474 of the Social Security Act to provide
funding to state title IV-E agencies for information systems that
support the provision of services to the nation's foster care and
adoption populations. The Act authorizes funding for the planning,
design, development, or installation of statewide automated child
welfare systems (SACWIS). The data from these systems allows the
Department to report accurate, meaningful and reliable information to
Congress about the extent of problems facing these children and the
effectiveness of assistance provided to this population.
Currently, SACWIS enable State efforts to meet the following
Federal reporting requirements: The Adoption and Foster Care Analysis
and Reporting System (AFCARS) required by section 479(b)(2) of the
Social Security Act; the National Child Abuse and Neglect Data System
(NCANDS); Child Abuse Prevention and Treatment Act (CAPTA); and the
Chafee Independent Living Program National Youth in Transition Database
(NYTD). SACWIS systems also support States' efforts to provide the
information to conduct the Child and Family Service Reviews. Currently,
40 States and the District of Columbia have developed, or are
developing, a SACWIS with Federal financial participation.
The SACWIS Assessment Reviews validate that all aspects of the
project, as described in the approved Advance Planning Document, have
been adequately completed, and conform to applicable regulations and
policies. States use the SACWIS Assessment Review Guide (SARG) to
document system components and functioning; each State's submission is
unique and State-specific. These reviews are usually initiated by the
State; however, ACF reserves the right to initiate SACWIS Assessment
Reviews, at any time in the system life cycle. Submission of the SACWIS
SARG and other supporting documentation by States, completed at the
point that they have completed system development and the system is
operational statewide, initiates a SACWIS Assessment Review. The
additional supporting documentation submitted as part of the review
process should be readily available to States as a result of their
routine good project management practices. The SARG and supporting
documentation may be submitted electronically.
The information collected in the SACWIS Assessment Review Guide
will allow State and Federal officials to determine if the State's
SACWIS meets the requirements of title IV-E Federal Financial
Participation (FFP) defined at 45 CFR 1355.50. Additionally, other
States will be able to use the documentation provided as part of this
[[Page 1620]]
review process to inform their own system development efforts.
No small businesses will be involved in this data collection
effort.
Respondents: Title IV-E Agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
SACWIS Assessment Review Guide (SARG)....... 3 1 250 750
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 750.
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: 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. 2011-332 Filed 1-10-11; 8:45 am]
BILLING CODE 4184-01-P
