Submission for OMB Review; Comment Request, 24887-24888 [2011-10410]
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srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 85 / Tuesday, May 3, 2011 / Notices
improves the management and
functionality of public health
laboratories in partner countries by
supporting laboratory systems quality
improvement, biosafety, and
implementation of international
laboratory standards and guidelines;
(5) develops models for continuous
tracking and improvement of critical
outputs and outcomes from the
programs around the world that the
division supports (monitoring and
evaluating function); (6) implements
and coordinates CDC’s support to
WHO’S Integrated Disease Surveillance
and Response strategy and directly
supports the implementation of the
International Health Regulations at the
country level; (7) enhances the skills,
knowledge, and capacity of the human
resources for surveillance by merging
those efforts with IT solutions that allow
the surveillance workforce to function at
a high level of timeliness and reliability;
(8) works with partner countries to
establish human resource information
systems to better track the public health
workforce within ministries of health;
(9) mobilizes expertise from across the
agency and from partners throughout
the USG and internationally to provide
technical assistance for countries
interested in building their own
dedicated public health institutions
(‘‘national CDCs’’); (10) plans, directs,
supports, implements, and coordinates
public health leadership and
management development and
organizational excellence efforts; (11)
provides leadership and technical
assistance for reconstruction and
stabilization efforts aimed at rebuilding
or strengthening severely disrupted
public health systems in countries in
crisis or emerging from crisis (‘‘fragile
states’’); and (12) coordinates and works
closely with the Field and Applied
Epidemiology Training Programs
Branch in areas of assessments and
workforce development to meet system
needs and overall strategies.
Delete in its entirety the function
statement for the Office of the Director
(CWJ1), Division of Global Disease
Detection and Emergency Response
(CWJ), and insert the following:
Office of the Director (CWJ1). (1)
Provides leadership, oversight,
evaluation and overall direction and
management for the activities of the
division; (2) develops the division
overall strategy and the division policies
on planning, evaluation, management,
and operations; (3) plans, allocates, and
monitors resources; (4) provides liaison
with other CDC organizations, other
Federal agencies, national ministries of
health, international organizations, nongovernmental organizations, private
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20:39 May 02, 2011
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sector, and others that CDC cooperates
with in global health programs and
activities; (5) promotes high standards
in science and ethics among CDC’s
international activities; (6) maintains
staff in the CDC Emergency Operations
Center to manage, direct, coordinate and
evaluate biosurveillance data from
domestic and international networks
and serve as a central focus for global
outbreak and incident response
activities; and (7) maintains and
supports the Health Systems
Reconstruction Office in its efforts to
coordinate the implementation of
training/capacity building initiatives
within Haiti and other impacted
countries.
Delete in its entirety item (8) of the
functional statement for the Global
Disease Detection Branch (CWJB).
Delete item (2) and insert the following:
(2) provides program support, resources
and technical assistance to the Global
Disease Detection (GDD) Centers around
the world;
Delete items (3), (4), (6), and (7) of the
functional statement for the Global
Health Security Branch (CWJC) and
insert the following accordingly: (3)
provides support and coordination at
HHS/OGHA regarding the development
of policies and priorities on
international influenza; (4) serves as
liaison with HHS and technical agency
(CDC, NIH, FDA) representatives for
international pandemic preparedness
related to budget formulation, program
development, strategic planning, and
global health security policy
development; (6) provides technical
assistance through training, and
capacity building in supporting efforts
to reduce the public health threat from
chemical, biological, and nuclear
disasters that are either natural or manmade; (7) provides liaison with the DoS
Biosecurity Engagement Program and
DoD Defense Threat Reduction Agency
to coordinate on global biological threat
reduction;
Dated: April 19, 2011.
James D. Seligman,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–10639 Filed 5–2–11; 8:45 am]
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24887
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Project LAUNCH Cross-Site
Evaluation.
OMB No.: 0970–0373.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services, is planning to collect data as
part of a cross-site evaluation of a new
initiative called Project LAUNCH
(Linking Actions for Unmet Needs in
Children’s Health). Project LAUNCH is
intended to promote the healthy
development and wellness of children
ages birth to eight years. A total of 24
Project LAUNCH grantees are funded to
improve coordination among childserving systems, build infrastructure,
and improve methods for providing
services. Grantees will also implement a
range of public health strategies to
support young child wellness in a
designated locality.
Data for the cross-site evaluation of
Project LAUNCH will be collected
through: (1) interviews conducted either
via telephone or during site-visits to
Project LAUNCH grantees, and (2) semiannual reports that will be submitted
electronically on a web-based data-entry
system. Information will be collected
from all Project LAUNCH grantees.
During either telephone interviews or
the site visits, researchers will conduct
interviews with Project LAUNCH
service providers and collaborators in
States/Tribes and local communities of
focus. Interviewers will ask program
administrators questions about all
Project LAUNCH activities, including:
infrastructure development;
collaboration and coordination among
partner agencies, organizations, and
service providers; and development,
implementation, and refinement of
service strategies.
As part of the proposed data
collection, Project LAUNCH staff will be
asked to submit semi-annual electronic
reports on State/Tribal and local
systems development and on services
that children and families receive. The
electronic data reports also will collect
data about other Project LAUNCHfunded service enhancements, such as
trainings, Project LAUNCH systems
change activities, and changes in
provider settings. Information provided
in these reports will be aggregated on a
quarterly basis, and reported semiannually.
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24888
Federal Register / Vol. 76, No. 85 / Tuesday, May 3, 2011 / Notices
Respondents: State/Tribal Child
Wellness Coordinator, State/Tribal
Wellness Council Members, State ECCS
Project Director, Local Child Wellness
Coordinator, Local Wellness Council
Members, Local Evaluator, and Local
Service Providers.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Telephone or Site Visit Interview Guide ..........................................................
Electronic Data Reporting: Systems Measures ...............................................
Electronic Data Reporting: Services Measures ...............................................
Estimated Total Annual Burden
Hours: 876.
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, submit comments on or
before June 2, 2011. 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: April 25, 2011.
Seth F. Chamberlain,
OPRE Reports Clearance, Officer.
[FR Doc. 2011–10410 Filed 5–2–11; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
srobinson on DSKHWCL6B1PROD with NOTICES
[Docket No. FDA–2011–N–0044]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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24
24
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 under the Paperwork
Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 2,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that the written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer. Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0673. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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: Information
Request Regarding Guidance for
Industry and FDA Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products—
(OMB Control Number 0910–0673)—
Extension.
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new chapter
granting FDA important new authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
SUMMARY:
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Number of
responses per
respondent
1
2
2
Average
burden hours
per response
1.25
4
8
Total annual
burden hours
300
192
384
Section 905(j)(1) of the FD&C Act
authorizes FDA to establish the form
and manner for the submission of
information related to substantial
equivalence (21 U.S.C. 387e(j)(1)). In a
level 1 guidance document issued under
the Good Guidances Practices regulation
(21 CFR 10.115), FDA provides
recommendations intended to assist
persons submitting reports under
section 905(j) of the FD&C Act, and
explains, among other things, FDA’s
interpretation of the statutory sections
related to substantial equivalence (see
‘‘Guidance for Industry and FDA Staff—
Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products’’ (January 6, 2011, 76 FR 789).)
In the Federal Register of January 24,
2011 (76 FR 4116), FDA published a 60day notice requesting public comment
on the proposed information collection.
FDA received one comment in
response to the 60-day notice. The
commenter indicated that the
substantial equivalence requirements
were ‘‘burdensome to industry in the
extreme,’’ that FDA’s estimation of the
number of reports to be received was too
low, and that the current burden hours
to complete each report was unrealistic.
Although the commenter asserted that
the burden hours were too low and
unrealistic, no alternative estimates
were provided.
The recommendations in the
‘‘Guidance for Industry and FDA Staff—
Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products’’ are the information that FDA
suggests a manufacturer include in a
report submitted under section
905(j)(1)(A)(i) of the FD&C Act. The
recommendations reflect the
information FDA believes is necessary
for it to make the required findings
under section 910(a) of the FD&C Act
(21 U.S.C. 387j(a)). FDA has also
articulated current enforcement policies
in its guidances that are intended to
address some of the burden associated
with premarket requirements for new
tobacco products (manufacturers and
interested parties may refer to FDA’s
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]]>Agencies
[Federal Register Volume 76, Number 85 (Tuesday, May 3, 2011)]
[Notices]
[Pages 24887-24888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10410]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Project LAUNCH Cross-Site Evaluation.
OMB No.: 0970-0373.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services, is planning to collect
data as part of a cross-site evaluation of a new initiative called
Project LAUNCH (Linking Actions for Unmet Needs in Children's Health).
Project LAUNCH is intended to promote the healthy development and
wellness of children ages birth to eight years. A total of 24 Project
LAUNCH grantees are funded to improve coordination among child-serving
systems, build infrastructure, and improve methods for providing
services. Grantees will also implement a range of public health
strategies to support young child wellness in a designated locality.
Data for the cross-site evaluation of Project LAUNCH will be
collected through: (1) interviews conducted either via telephone or
during site-visits to Project LAUNCH grantees, and (2) semi-annual
reports that will be submitted electronically on a web-based data-entry
system. Information will be collected from all Project LAUNCH grantees.
During either telephone interviews or the site visits, researchers
will conduct interviews with Project LAUNCH service providers and
collaborators in States/Tribes and local communities of focus.
Interviewers will ask program administrators questions about all
Project LAUNCH activities, including: infrastructure development;
collaboration and coordination among partner agencies, organizations,
and service providers; and development, implementation, and refinement
of service strategies.
As part of the proposed data collection, Project LAUNCH staff will
be asked to submit semi-annual electronic reports on State/Tribal and
local systems development and on services that children and families
receive. The electronic data reports also will collect data about other
Project LAUNCH-funded service enhancements, such as trainings, Project
LAUNCH systems change activities, and changes in provider settings.
Information provided in these reports will be aggregated on a quarterly
basis, and reported semi-annually.
[[Page 24888]]
Respondents: State/Tribal Child Wellness Coordinator, State/Tribal
Wellness Council Members, State ECCS Project Director, Local Child
Wellness Coordinator, Local Wellness Council Members, Local Evaluator,
and Local Service Providers.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average
Instrument of responses per burden hours Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Telephone or Site Visit Interview Guide......... 240 1 1.25 300
Electronic Data Reporting: Systems Measures..... 24 2 4 192
Electronic Data Reporting: Services Measures.... 24 2 8 384
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 876.
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, submit comments on or
before June 2, 2011. 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: April 25, 2011.
Seth F. Chamberlain,
OPRE Reports Clearance, Officer.
[FR Doc. 2011-10410 Filed 5-2-11; 8:45 am]
BILLING CODE 4184-22-M
