Proposed Information Collection Activity; Comment Request, 7444-7445 [E9-3240]
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7444
Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Building Strong Families (BSF)
Demonstration and Evaluation—Impact
Study Second Follow-up.
OMB No.: 0970–0304.
Description: The Administration for
Children and Families (ACF),
U.S.Department of Health and Human
Services (HHS), anticipates continuing
data collection for the 15-month followup surveys of the Building Strong
Families (BSF) Demonstration and
Evaluation. Data collection will
continue for an additional 6 months
beyond the current date of expiration
(July 31, 2009).
This data collection is a part of the
BSF evaluation, which is an important
opportunity to learn if well-designed
interventions can help low-income
couples develop the knowledge and
relationship skills that research has
shown are associated with healthy
marriages. The BSF evaluation uses an
experimental design that randomly
assigns couples who volunteer to
participate in BSF programs to a
program or control group.
Materials for the original 15-month
data collection effort, previously
submitted to OMB, covered impact and
implementation data collections. Data
collection for the impact study is
complete. ACF anticipates collecting
data for an additional 6 months in order
to complete data collection for the entire
sample of participants.
Respondents: Couples enrolled in the
BSF evaluation, including program and
control groups.
ANNUAL BURDEN ESTIMATES
Annual number of respondents
Instrument
15-month telephone survey (female partner) ..................................................
15-month telephone survey (male partner) .....................................................
Total Burden Hours: 2,495
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research andEvaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPREReports 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 FederalRegister.
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: February 6, 2009.
Brendan C. Kelly,
Clearance Officer.
[FR Doc. E9–3053 Filed 2–13–09; 8:45 am]
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BILLING CODE 4184–01–M
VerDate Nov<24>2008
19:45 Feb 13, 2009
Jkt 217001
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Grant Application Data
Summary (GADS) Form.
OMB No.: 0970–0328.
Description: The purpose of this
request is to obtain emergency OMB
clearance of the Grant Application Data
Summary (GADS) form so information
collected from all FY09 ANA grant
applicants (in March 2009) is accurate.
The GADS collects information from
applicants seeking grants from the
Administration for Native Americans
(ANA). ANA awards annual grants in
nine competitive areas. Previously,
ANA collected information using the
GADS form for 4 competitive areas, not
9. The GADS form, which is part of the
ANA discretionary grant application
package, has been revised to comply
with required changes made to the ANA
FY09 Program Announcements (PAs).
The PAs were changed to comply with
a new policy established by ACF
requiring that subcategories within a PA
be broken down into a stand-alone PA.
On 12/5/08, ANA published nine PAs to
support this new requirement for
separate PAs, it was necessary for ANA
to change the GADS form to reflect the
new PAs. Below are the changes to the
GADS form: (please select relevant topic
under one heading)
Frm 00055
Fmt 4703
Sfmt 4703
Average burden hours per
response
Estimated annual burden
hours
1
1
.91
.83
1,305
1,190
1,434
1,434
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Number of responses per
respondent
(1) Special Initiative: Family
Preservation: Improving the Well-Being
of Children Planning
Curriculum Development; Community
Assessment; Develop a Family
Preservation Strategic Plan
Please choose all relevant topics from
the selection below:
Relationship and Marriage Education for
Adults; Relationship and Marriage
Education for Youth; Marriage
Enrichment activities and services;
Pre-marital education and marriage
skills; Relationships Skills;
Responsible Fatherhood or Parenting;
Family preservation activities offered
in a culturally appropriate and
traditional manner; Absentee parent
services, education and activities;
Reduce child/infant abuse and neglect
and family domestic violence; Needs
of grandparents raising grandchildren;
Foster Parent Training Family
strengthening services to individuals
with substance abuse issues; Public
Advertising Campaigns; Research
(2) Special Initiative: Family
Preservation: Improving the Well-Being
of Children Implementation
Relationship & Marriage Education for
Adults; Relationship & Marriage
Education for Youth; Marriage
Enrichment activities & services; Premarital education & marriage skills;
Relationships Skills; Responsible
Fatherhood; Parenting; Family
preservation activities in a culturally
appropriate & traditional manner;
Absentee parent services, education &
activities; Family Domestic Violence;
E:\FR\FM\17FEN1.SGM
17FEN1
Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices
Grandparents raising grandchildren;
Foster Parent Training; Family
strengthening services to individuals
with substance abuse issues; Public
Advertising Campaigns; Research
(3) Native Language Preservation &
Maintenance Assessment
Data Collection; Formal Language
Assessment; Informal Language
Assessment
(4) Native Language Preservation &
Maintenance Planning
Plan & design Master/Apprentice
programs; Plan & design
comprehensive Native language
immersion programs for a language
nest or survival school; Plan, design &
test curriculum for students, parents &
language instructors; Plan & design
teaching materials; Record, transcribe
& archive oral testimony; Plan &
design language resource materials
using recorded oral testimony; Plan &
design multi-media language learning
tools; Plan & design teacher
certification programs; Train teachers,
interpreters or translators of Native
languages
7445
teaching of Native American language
skills; Disseminate culturally relevant
materials to teach & enhance the use
of Native American languages;
Implement an immersion, mentor or
distance learning model; Produce,
distribute or participate in various
media forms to broadcast Native
languages; Implement an educational
site-based immersion project
(5) Native Language Preservation &
Maintenance Implementation
(6) Native Language Preservation &
Maintenance ImmersionLanguage Nest;
Language Survival School
Produce/disseminate culturally relevant
printed stories for children using the
Native language of the community;
Facilitate/encourage intergenerational
Respondents: Federally Recognized
Indian Tribes, Tribal Governments,
Native American Non-profits, Tribal
Colleges and Universities
ANNUAL BURDEN ESTIMATES
Number of respondents
Number of responses per
respondent
Average burden hours per
response
Total burden
hours
Grant Application Data Summary (GADS) ......................................................
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Instrument
500
1
0.50
250
Estimated Total Annual Burden
Hours: 250.
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
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.
VerDate Nov<24>2008
19:45 Feb 13, 2009
Jkt 217001
Dated: February 11, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–3240 Filed 2–13–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0006]
International Conference on
Harmonisation; Draft Guidance on S9
Nonclinical Evaluation for Anticancer
Pharmaceuticals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘S9 Nonclinical Evaluation for
Anticancer Pharmaceuticals.’’ The draft
guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance provides
recommendations for nonclinical
studies for the development of
pharmaceuticals, including both drugs
and biotechnology-derived products,
intended to treat patients with advanced
cancer. The recommendations describe
the type and timing of nonclinical
studies to support an investigational
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
new drug application (IND) and the
submission of a new drug application
(NDA) or biologics license application
(BLA). The draft guidance is intended to
provide information on internationally
accepted recommendations for
nonclinical studies to facilitate the
development of anticancer
pharmaceuticals.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by April 20, 2009.
ADDRESSES: Submit written comments
on the draft 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. Submit written
requests for single copies of the draft
guidance to the Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002; or the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. Send
two self-addressed adhesive labels to
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Agencies
[Federal Register Volume 74, Number 30 (Tuesday, February 17, 2009)]
[Notices]
[Pages 7444-7445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3240]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Grant Application Data Summary (GADS) Form.
OMB No.: 0970-0328.
Description: The purpose of this request is to obtain emergency OMB
clearance of the Grant Application Data Summary (GADS) form so
information collected from all FY09 ANA grant applicants (in March
2009) is accurate.
The GADS collects information from applicants seeking grants from
the Administration for Native Americans (ANA). ANA awards annual grants
in nine competitive areas. Previously, ANA collected information using
the GADS form for 4 competitive areas, not 9. The GADS form, which is
part of the ANA discretionary grant application package, has been
revised to comply with required changes made to the ANA FY09 Program
Announcements (PAs). The PAs were changed to comply with a new policy
established by ACF requiring that subcategories within a PA be broken
down into a stand-alone PA. On 12/5/08, ANA published nine PAs to
support this new requirement for separate PAs, it was necessary for ANA
to change the GADS form to reflect the new PAs. Below are the changes
to the GADS form: (please select relevant topic under one heading)
(1) Special Initiative: Family Preservation: Improving the Well-Being
of Children Planning
Curriculum Development; Community Assessment; Develop a Family
Preservation Strategic Plan
Please choose all relevant topics from the selection below:
Relationship and Marriage Education for Adults; Relationship and
Marriage Education for Youth; Marriage Enrichment activities and
services; Pre-marital education and marriage skills; Relationships
Skills; Responsible Fatherhood or Parenting; Family preservation
activities offered in a culturally appropriate and traditional manner;
Absentee parent services, education and activities; Reduce child/infant
abuse and neglect and family domestic violence; Needs of grandparents
raising grandchildren; Foster Parent Training Family strengthening
services to individuals with substance abuse issues; Public Advertising
Campaigns; Research
(2) Special Initiative: Family Preservation: Improving the Well-Being
of Children Implementation
Relationship & Marriage Education for Adults; Relationship & Marriage
Education for Youth; Marriage Enrichment activities & services; Pre-
marital education & marriage skills; Relationships Skills; Responsible
Fatherhood; Parenting; Family preservation activities in a culturally
appropriate & traditional manner; Absentee parent services, education &
activities; Family Domestic Violence;
[[Page 7445]]
Grandparents raising grandchildren; Foster Parent Training; Family
strengthening services to individuals with substance abuse issues;
Public Advertising Campaigns; Research
(3) Native Language Preservation & Maintenance Assessment
Data Collection; Formal Language Assessment; Informal Language
Assessment
(4) Native Language Preservation & Maintenance Planning
Plan & design Master/Apprentice programs; Plan & design comprehensive
Native language immersion programs for a language nest or survival
school; Plan, design & test curriculum for students, parents & language
instructors; Plan & design teaching materials; Record, transcribe &
archive oral testimony; Plan & design language resource materials using
recorded oral testimony; Plan & design multi-media language learning
tools; Plan & design teacher certification programs; Train teachers,
interpreters or translators of Native languages
(5) Native Language Preservation & Maintenance Implementation
Produce/disseminate culturally relevant printed stories for children
using the Native language of the community; Facilitate/encourage
intergenerational teaching of Native American language skills;
Disseminate culturally relevant materials to teach & enhance the use of
Native American languages; Implement an immersion, mentor or distance
learning model; Produce, distribute or participate in various media
forms to broadcast Native languages; Implement an educational site-
based immersion project
(6) Native Language Preservation & Maintenance ImmersionLanguage Nest;
Language Survival School
Respondents: Federally Recognized Indian Tribes, Tribal
Governments, Native American Non-profits, Tribal Colleges and
Universities
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Grant Application Data Summary (GADS)....... 500 1 0.50 250
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 250.
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 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 11, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-3240 Filed 2-13-09; 8:45 am]
BILLING CODE 4184-01-P