Submission for OMB Review; Comment Request, 20321-20322 [E9-10020]
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Federal Register / Vol. 74, No. 83 / Friday, May 1, 2009 / Notices
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Mary Anne Bright,
Associate Director, Office of Public
Information and Resource Management,
Office of Communications and
Education, National Cancer Institute,
6116 Executive Blvd., Room 3049, MSC
8322, Bethesda, MD 20892–8322 or call
301–594–9048 or e-mail your request,
including your address, to:
brightma@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: April 23, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–10012 Filed 4–30–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10284 and CMS–
2567]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
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Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: New Collection; Title of
Information Collection: Children’s
Health Insurance Program
Reauthorization Act (CHIPRA) of 2009,
State Option Pre-print to Include
Pregnant Women in Title XXI; Use:
Section 111 of CHIPRA adds a new
section 2112 to the Social Security Act
which gives States the option of
providing necessary prenatal, delivery
and postpartum care to low-income
uninsured pregnant women through an
amendment to its State Child Health
Plan (CHIP plan). The purpose of this
draft State plan amendment template is
to provide States with the format
needed to enable a State to amend their
CHIP plan to reflect the coverage of
pregnant women. Form Number: CMS–
10284 (OMB#: 0938–NEW); Frequency:
Reporting—One-time and Occasionally;
Affected Public: State, Local or Tribal
Government; Number of Respondents:
40; Total Annual Responses: 40; Total
Annual Hours: 3,200. (For policy
questions regarding this collection
contact Meredith Robertson at 410–786–
6543. For all other issues call 410–786–
1326.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection:
Statement of Deficiencies and Plan of
Correction; Use: The information from
the CMS–2567 is used by the States and
CMS regional offices to document and
certify compliance. Form Number:
CMS–2567 (OMB#: 0938–0391);
Frequency: Reporting—Annually;
Affected Public: State, Local or Tribal
Government, Federal Government,
Business or other for-profits and Notfor-profit Institutions; Number of
Respondents: 60,000; Total Annual
Responses: 60,000; Total Annual Hours:
120,000. (For policy questions regarding
this collection contact Joanne Perry at
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20321
410–786–3336. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by June 30, 2009:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier/OMB Control
Number (CMS–10283), Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 23, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–9959 Filed 4–30–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Evaluation of the Transitional
Living Program (TLP).
OMB No.: New Collection.
Description: The Runaway and
Homeless Youth Act (RHYA), as
amended by Public Law 106–71 (42
U.S.C. 5701 et seq.), provides for the
Transitional Living Program (TLP), a
residential program lasting up to 18
months designed to prepare older
homeless youth ages 16–21 for a healthy
and self-sufficient adulthood. Section
119 of RHYA requires a study on the
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Federal Register / Vol. 74, No. 83 / Friday, May 1, 2009 / Notices
long-term housing outcomes of youth
after exiting the program. In addition to
collecting information on housing
outcomes, the study will also consider
the living, employment, education, and
family situation of the youth before and
after their time in the TLP. This
information will be used to better
understand the most effective practices
in improving long-term outcomes of
youth in an effort to guide program
improvements.
Respondents: (1) Youth ages 16–21
participating in Transitional Living
Programs and (2) the Executive Director
and Program Manager representing TLP
grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Grantee Survey ................................................................................................
Youth Baseline Survey ....................................................................................
Youth Exit Survey ............................................................................................
Youth 6-Month Follow Up ................................................................................
Youth 12-Month Follow Up ..............................................................................
Service Log ......................................................................................................
Estimated Total Annual Burden
Hours: 1,780.
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: 202–395–7245,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: April 28, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–10020 Filed 4–30–09; 8:45 am]
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760
760
760
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0181]
Draft Guidance for Industry on Label
Comprehension Studies for
Nonprescription Drug Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Label Comprehension
Studies for Nonprescription Drug
Products.’’ The draft guidance provides
recommendations on the design of label
comprehension studies, which can be
used to assess the extent to which
consumers understand the information
conveyed by proposed nonprescription
drug product labeling and then apply
that information when making
hypothetical drug product use
decisions.
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 July 30, 2009.
ADDRESSES: 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. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
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Number of
responses per
respondent
Average
burden hours
per response
1
1
1
1
1
1
1
0.50
0.50
0.50
0.50
0.25
Total burden
hours
70
380
380
380
380
190
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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Laura Shay, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 5466, Silver Spring,
MD 20993–0002, 301–796–0994.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Label Comprehension Studies for
Nonprescription Drug Products.’’ This
draft guidance is intended for
individuals or organizations involved in
the development of label
comprehension studies for
nonprescription drug products. This
draft guidance discusses general
concepts to be considered in the design
and conduct of a label comprehension
study. This draft guidance also
incorporates advice obtained from the
September 25, 2006, meeting of the
Nonprescription Drug Advisory
Committee that considered issues
related to the analysis and interpretation
of consumer behavior studies conducted
to support marketing of nonprescription
drug products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on label comprehension studies for
nonprescription drug products. It does
not create or confer any rights for or on
any person and does not operate to bind
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Agencies
[Federal Register Volume 74, Number 83 (Friday, May 1, 2009)]
[Notices]
[Pages 20321-20322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10020]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Evaluation of the Transitional Living Program (TLP).
OMB No.: New Collection.
Description: The Runaway and Homeless Youth Act (RHYA), as amended
by Public Law 106-71 (42 U.S.C. 5701 et seq.), provides for the
Transitional Living Program (TLP), a residential program lasting up to
18 months designed to prepare older homeless youth ages 16-21 for a
healthy and self-sufficient adulthood. Section 119 of RHYA requires a
study on the
[[Page 20322]]
long-term housing outcomes of youth after exiting the program. In
addition to collecting information on housing outcomes, the study will
also consider the living, employment, education, and family situation
of the youth before and after their time in the TLP. This information
will be used to better understand the most effective practices in
improving long-term outcomes of youth in an effort to guide program
improvements.
Respondents: (1) Youth ages 16-21 participating in Transitional
Living Programs and (2) the Executive Director and Program Manager
representing TLP grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Grantee Survey.................................. 70 1 1 70
Youth Baseline Survey........................... 760 1 0.50 380
Youth Exit Survey............................... 760 1 0.50 380
Youth 6-Month Follow Up......................... 760 1 0.50 380
Youth 12-Month Follow Up........................ 760 1 0.50 380
Service Log..................................... 760 1 0.25 190
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,780.
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: 202-395-7245,
Attn: Desk Officer for the Administration for Children and Families.
Dated: April 28, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-10020 Filed 4-30-09; 8:45 am]
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