Submission for OMB Review; Comment Request, 55051-55052 [E9-25259]
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55051
Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices
• Press release announcing the
effective date of the cigarette flavor ban,
• Flavored tobacco products fact
sheet, and
• Flavored tobacco products parental
advisory.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
Activity and Form
FDA 3734
No. of
Respondents
Reporting violations of section 907(a)(1)(A) of the
FDCA
Annual Frequency
per Response
1,700
Dated: October 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25604 Filed 10–23–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Total Annual
Responses
1
Minutes per
Response
1,700
Title: Community Services Block
Grant (CSBG) Program Model Plan
Application.
OMB No.: New collection.
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
Total Hours
10
283
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
approval 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
mstockstill on DSKH9S0YB1PROD with NOTICES
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 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
VerDate Nov<24>2008
18:16 Oct 23, 2009
Jkt 220001
Dated: October 21, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–25650 Filed 10–23–09; 8:45 am]
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Average burden hours per
response
1
1
10
10
56
30
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.
BILLING CODE 4184–01–P
Number of responses per
respondent
Total burden
hours
560
300
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Cross-Site Evaluation of the
Children’s Bureau Grantee Cluster:
Supporting Evidence-Based Home
Visiting Programs to Prevent Child
Maltreatment (EBHV).
OMB No.: New collection.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing this crosssite evaluation data collection activity to
identify successful strategies for
adopting, implementing, and sustaining
high-quality home visitation programs
to prevent child maltreatment. An
evaluation study will address four
domains: (1) Systems change to develop
infrastructure, (2) fidelity to evidence-
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26OCN1
55052
Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices
based models, (3) costs of home visiting
programs, and (4) family and child
outcomes (via a review of grantee
analysis reports). A process study will
focus on the broader grant initiative to
understand how programs plan and
develop the infrastructure needed to
support home visitation services and
how they ensure service quality.
Information will be collected through
biennial site visits, web-based data
entry, a data quality progress table, a
relationship questionnaire completed by
participants and home visitors, and a
grantee-partner network survey. In
particular, site visits will include
interviews with key grantee staff and
stakeholders involved in the execution
of the grant and in the efforts to make
system changes. Grantees will complete
systems web-based data entry on goals
and operations every six months while
agencies implementing home visiting
programs associated with the grantee
will utilize the fidelity/cost web-based
data entry to provide EBHV program,
provider, and participant characteristics
along with yearly data on costs of home
visiting programs.
Respondents: EBHV grantee and key
staff (evaluators, home visitors and
supervisors), partners, implementing
agencies, home visiting participants,
and home visitors.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hour
per response
Estimated
annual burden
hours
EBHV grantee and key staff-partner interview guide ......................................
EBHV grantee systems web-based data entry ...............................................
EBHV agency fidelity/cost web-based data entry ...........................................
EBHV grantee data quality progress table ......................................................
Participant-home visitor relationship questionnaire .........................................
Home visitor-participant relationship questionnaire .........................................
EBHV grantee-partner network survey ............................................................
249
17
50
17
4,716
4,716
142
2
2
12
4
2
2
2
1.60
1.00
9.00
4.25
0.25
0.25
0.42
797
34
5,400
289
2,358
2,358
119
Estimated Total Burden Hours .................................................................
........................
........................
........................
11,355
mstockstill on DSKH9S0YB1PROD with NOTICES
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: October 14, 2009.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. E9–25259 Filed 10–23–09; 8:45 am]
BILLING CODE 4184–01–M
VerDate Nov<24>2008
15:19 Oct 23, 2009
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0307 (formerly
Docket No. 2007–D–0173)]
Guidance for Industry on Investigator
Responsibilities—Protecting the
Rights, Safety, and Welfare of Study
Subjects; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Investigator Responsibilities—
Protecting the Rights, Safety, and
Welfare of Study Subjects.’’ This
guidance is intended to assist
investigators in meeting their
responsibilities with respect to
protecting human subjects and ensuring
the integrity of data in the conduct of
clinical investigations. The guidance
also clarifies FDA’s expectations
concerning the investigator’s
responsibility for supervising a clinical
study in which some study tasks are
delegated to employees of the
investigator or to outside parties.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
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Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Joseph Griffin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204,
Silver Spring, MD 20993, 301–796–
2270, Joseph.Griffin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Investigator Responsibilities—
Protecting the Rights, Safety, and
Welfare of Study Subjects.’’ Under the
regulations in part 312 (21 CFR part
312) (Investigational New Drug
Application) and part 812 (21 CFR part
812) (Investigational Device
Exemptions), an investigator is
responsible for ensuring that a clinical
investigation is conducted according to
the signed investigator statement, the
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]]>Agencies
[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55051-55052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25259]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Cross-Site Evaluation of the Children's Bureau Grantee
Cluster: Supporting Evidence-Based Home Visiting Programs to Prevent
Child Maltreatment (EBHV).
OMB No.: New collection.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services (HHS), is proposing this
cross-site evaluation data collection activity to identify successful
strategies for adopting, implementing, and sustaining high-quality home
visitation programs to prevent child maltreatment. An evaluation study
will address four domains: (1) Systems change to develop
infrastructure, (2) fidelity to evidence-
[[Page 55052]]
based models, (3) costs of home visiting programs, and (4) family and
child outcomes (via a review of grantee analysis reports). A process
study will focus on the broader grant initiative to understand how
programs plan and develop the infrastructure needed to support home
visitation services and how they ensure service quality.
Information will be collected through biennial site visits, web-
based data entry, a data quality progress table, a relationship
questionnaire completed by participants and home visitors, and a
grantee-partner network survey. In particular, site visits will include
interviews with key grantee staff and stakeholders involved in the
execution of the grant and in the efforts to make system changes.
Grantees will complete systems web-based data entry on goals and
operations every six months while agencies implementing home visiting
programs associated with the grantee will utilize the fidelity/cost
web-based data entry to provide EBHV program, provider, and participant
characteristics along with yearly data on costs of home visiting
programs.
Respondents: EBHV grantee and key staff (evaluators, home visitors
and supervisors), partners, implementing agencies, home visiting
participants, and home visitors.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average Estimated
Instrument of responses per burden hour annual burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
EBHV grantee and key staff-partner interview 249 2 1.60 797
guide..........................................
EBHV grantee systems web-based data entry....... 17 2 1.00 34
EBHV agency fidelity/cost web-based data entry.. 50 12 9.00 5,400
EBHV grantee data quality progress table........ 17 4 4.25 289
Participant-home visitor relationship 4,716 2 0.25 2,358
questionnaire..................................
Home visitor-participant relationship 4,716 2 0.25 2,358
questionnaire..................................
EBHV grantee-partner network survey............. 142 2 0.42 119
---------------------------------------------------------------
Estimated Total Burden Hours................ .............. .............. .............. 11,355
----------------------------------------------------------------------------------------------------------------
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. E-mail address: OPREinfocollection@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-
6974, Attn: Desk Officer for the Administration for Children and
Families.
Dated: October 14, 2009.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. E9-25259 Filed 10-23-09; 8:45 am]
BILLING CODE 4184-01-M
