Proposed Data Collections Submitted for Public Comment and Recommendations, 25277-25279 [2013-10130]
Download as PDF
Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices
FOR FURTHER INFORMATION CONTACT:
Yvonne Chow, Division of Nutrition
Research Coordination, National
Institute of Diabetes, Digestive and
Kidney Diseases, National Institutes of
Health; Room 624A, 6707 Democracy
Blvd., Bethesda, MD 20817; Telephone:
(301) 594–8821; Email:
DRInominations@hhs.gov.
The DRI
Subcommittee, in collaboration with its
Canadian counterpart, has been
responsible for prioritizing nutrients for
federally-funded DRI reviews that
establish nutrient reference values.
Given the completion in 2011 of the
most recent DRI review which was
conducted by the Institute of Medicine
at the National Academy of Sciences,
the DRI Subcommittee is now
considering future reviews. The
increasingly broad range of uses of the
DRIs warrants input to the DRI
Subcommittee concerning nutrients of
interest for such reviews. Input from all
interested parties is welcome and may
come from individuals and
organizations external to the federal
government as well as from federal
agencies.
The opportunity to provide
information is limited at this time to
new reviews for nutrients and food
components that have previously been
considered by Institute of Medicine DRI
committees. The nomination is to
include a cover letter and a literature
search. The requirements of the
nomination package and the nomination
procedures are specified in the Web site
identified above in the ADDRESSES
section, and interested persons should
access the Web site to obtain specific
instructions for the nomination. The
nomination will be regarded as
information for the DRI Subcommittee
and is intended to assist only in
informing planning activities; the
submission of a nomination does not
guarantee the initiation of a DRI review.
Further, the opportunity to provide
information should not be construed as
a funding opportunity or grant program.
Please note that proprietary or
confidential information cannot be
considered and should not be
submitted.
pmangrum on DSK3VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: April 24, 2013.
Howard K. Koh,
Assistant Secretary for Health.
[FR Doc. 2013–10054 Filed 4–29–13; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary; Office of the
Assistant Secretary for Preparedness
and Response; Statement of
Organization, Functions, and
Delegations of Authority
Centers for Disease Control and
Prevention
Part A, Office of the Secretary,
Statement of Organization, Functions,
and Delegations of Authority of the
Department of Health and Human
Services (HHS) is being amended at
Chapter AN, Office of the Assistant
Secretary for Preparedness and
Response (ASPR), as last amended at 78
FR 7784, dated February 4, 2013, and at
75 FR 35035–35038, dated June 21,
2010. This organizational change is to
rename the Office of Preparedness and
Emergency Operations (ANC), establish
five Divisions under the Office of
Preparedness and Emergency
Operations (ANC), and rename one
existing Division. The changes are as
follows.
I. Under Part A, Chapter AN, Section
AN.10, Organization, rename ‘‘Office of
Preparedness and Emergency
Operations’’ to ‘‘Office of Emergency
Management.’’
II. Under Part A, Chapter AN, Section
AN.20, Functions, Paragraph C, Office
of Preparedness and Emergency
Operations (ANC):
a. Replace all references to the ‘‘Office
of Preparedness and Emergency
Operations’’ and ‘‘OPEO’’ with the
‘‘Office of Emergency Management’’ and
‘‘OEM,’’ respectively.
b. Rename ‘‘Division of Mass Care
(ANC1)’’ as ‘‘Division of National
Hospital Preparedness (ANC1).’’
c. At the end of Paragraph C, add the
following sub-components:
• Division of Recovery (ANC7)
• Division of Regional Emergency
Coordinators (ANC8)
• Division of Logistics (ANC9)
• Division of Fusion (ANCA)
• Division of Tactical Programs (ANC5)
II. Delegations of Authority. All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegation, provided they are
consistent with this reorganization.
Dated: April 12, 2013.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2013–10056 Filed 4–29–13; 8:45 am]
BILLING CODE 4150–37–P
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[60Day–13–13RQ]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Kimberly S. Lane, 1600
Clifton Road, MS D–74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited 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)
ways to enhance 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Community Transformation Grants
(CTG) Context Scan Surveys—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Obesity currently affects more than
one-third of adults and approximately
17 percent of children in the United
States. Obese children and teens are
likely to remain so into adulthood, and
are at risk for developing severe health
conditions such as heart disease, type 2
diabetes, stroke, and certain cancers. As
one of the most dire and fastest growing
health-related problems, obesity
prevention has become a public health
priority.
Physical activity and dietary
behaviors are known to impact obesity.
Importantly, research has shown that
E:\FR\FM\30APN1.SGM
30APN1
pmangrum on DSK3VPTVN1PROD with NOTICES
25278
Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices
these behaviors are impacted by
community-level factors (social
determinants of health) such as place of
residence, access to healthy/unhealthy
food, availability of walkable
environments, and opportunities to be
physically active. Thus, one promising
strategy to address nutrition and
physical activity is through policy and
environmental improvements in settings
such as schools, childcare centers, and
workplaces.
Given the high proportion of children
enrolled, and the substantial amount of
time children spend in schools and
childcare centers, these settings are
natural targets for policy and
environment changes to improve
nutrition and physical activity. CDC and
others have recommended strategies to
decrease sedentary time, increase the
quantity and quality of physical activity,
improve nutrition standards, and
decrease the availability of less healthy
foods. Numerous governmental and
non-governmental initiatives are
underway to support improved policies
and environments, but little is known
about the barriers and facilitators to this
work, and the overall community
context in which these initiatives are
occurring.
In fiscal year 2011, the Patient
Protection and Affordable Care Act
(ACA) funded the Community
Transformation Grants (CTG) Program
(CDC–RFA–DP11–1103PPHF11) to
address the root causes of chronic
disease. CTG grants were awarded to
state and local governments, tribes and
territories, and nonprofit organizations
to help individuals lead healthier lives.
As mandated by the ACA, CDC is
conducting a national evaluation of the
CTG Program that includes the
following components: (1) Local
Evaluation, (2) Performance Monitoring,
(3) Population-level Surveillance, (4)
Enhanced Evaluation Studies, (5) Cost
Studies, (6) Simulation Modeling, and
(7) Context Scan (policy and community
characteristics).
The Context Scan will capture
information on social determinants
within communities, such as population
density, community resources for active
living and health eating, and nutrition
and physical activity policies and
environments in middle schools and
childcare centers. It will include (1)
Examining policies and environments in
school and childcare settings (including
review of school and childcare policies
and administration of the Context Scan
Surveys); (2) examining policies and
environments in the community
(including review of policies addressing
the nutrition and built environments
and observation of public food
environments such as grocery and
convenience stores) and (3) extraction of
data from the U.S. Bureau of the Census,
U.S. Department of Agriculture (USDA),
and other publically available data
sources.
The Context Scan Surveys will
employ longitudinal data collection to
document and monitor changes in
nutrition and physical activity policies
and environments in childcare centers
and middle schools over time. The
surveys will be implemented once per
year over a four-year period with
childcare center directors, middle
school principals, and school food
service personnel. A three-year Office of
Management and Budget (OMB)
clearance period is requested to support
the first three years of the data
collection.
The surveys include the (1) Childcare
Center Nutrition and Physical Activity
Survey (CCNPAS), (2) School Principal
Nutrition and Physical Activity Survey
(SPNPAS), and (3) School Food Service
Nutrition Survey (SFSNS). A mixedmode methodology will be used to
recruit respondents; schools and centers
will be identified from publically
available lists.
The specific aims of the Context Scan
Surveys, and related evaluation
questions, are as follows:
A. Document policies and
environments related to nutrition and
physical activity in middle schools and
childcare centers located in 20 CTG
awardees.
1. Evaluation Question 1: What are
the policies and environments related to
nutrition and physical activity in
middle schools?
2. Evaluation Question 2: What are
the policies and environments related to
nutrition and physical activity in
childcare centers?
B. Monitor changes in policies and
environments related to nutrition and
physical activity in childcare centers
and middle schools over time.
1. Evaluation Question 3: How do
policies and environments related to
Type of respondents
Form name
Childcare center directors ......................................................
Middle school principals .........................................................
Number of
respondents
CCNPAS .....
SANPAS ......
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nutrition and physical activity in
middle schools change over time within
and across awardees?
2. Evaluation Question 4: How do
policies and environments related to
nutrition and physical activity in
childcare centers change over time
within and across awardees?
The 20 CTG awardees selected for this
study were identified based on their
commitment to implementing
comprehensive active living and healthy
eating interventions and the diverse
geographic and demographic contexts
within their communities.
The study universe for these 20
communities includes 970 public
middle schools and 4,362 licensed
childcare centers in 871 intervention
area zip codes. The study design will
adopt implicit stratification coupled
with probability proportional to size
(PPS) systematic sampling with zip code
areas serving as primary sampling units.
The measure of size for PPS sampling
will be the number of childcare centers
in each zip code area and the resulting
sample size will consist of 120 zip
codes.
Participation in the surveys is
voluntary. There are no costs to
respondents other than time. The
surveys will be hosted by the secure
online survey-hosting site, Survey
Monkey. All surveys will be Web-based,
with paper options available as needed.
Data from the Context Scan Surveys will
provide the CDC with the ability to track
policy and environment change over
time across and within communities.
When combined with other Context
Scan and CTG national evaluation
datasets, the Context Scan Survey data
will provide a comprehensive
understanding of the community
environments in which CTG
interventions are occurring, an
evidence-base for policy and
environmental change strategies to
promote healthy eating and active
lifestyles, and an identification of the
factors that facilitate and inhibit policy
and environmental initiatives.
The estimated burden for each survey
response is 15 minutes. Pilot tests were
performed to inform burden estimates
and ensure relevance of questions to
respondents.
Estimated Annualized Burden Hours
Number of
responses per
respondent
760
738
E:\FR\FM\30APN1.SGM
1
1
30APN1
Avgerage
burden per
response
(in hrs)
15/60
15/60
Total burden
(in hrs)
190
185
25279
Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices
Number of
responses per
respondent
Number of
respondents
Avgerage
burden per
response
(in hrs)
Total burden
(in hrs)
Type of respondents
Form name
School food service personnel ...............................................
SFSNS ........
738
1
15/60
185
Total ................................................................................
.....................
........................
........................
........................
560
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
Prevention and the Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2013–10130 Filed 4–29–13; 8:45 am]
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
BILLING CODE 4163–18–P
[FR Doc. 2013–10064 Filed 4–29–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
pmangrum on DSK3VPTVN1PROD with NOTICES
The meeting announced below
concerns Evaluation of Treatments and
Services Provided to People with
Duchenne Muscular Dystrophy (DMD),
FOA DD13–002, initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 12:00 p.m.–2:00 p.m., May
30, 2013 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Evaluation of Treatments and
Services Provided to People with Duchenne
Muscular Dystrophy (DMD), FOA DD13–002,
initial review.’’
Contact Person for More Information: M.
Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F–46, Atlanta, Georgia 30341,
Telephone: (770) 488–3585, EEO6@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
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13:22 Apr 29, 2013
Jkt 229001
[Docket No. FDA–2013–N–0450]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Abbreviated New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the paperwork associated with
abbreviated new animal drug
applications submitted to the Center for
Veterinary Medicine, FDA.
DATES: Submit either electronic or
written comments on the collection of
information by July 1, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information 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.
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Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Information Management, Food and
Drug Administration, 1350 Piccard
Drive, PI50–400B, Rockville, MD 20850,
301–796–3794, Jonnalynn.capezzuto@
fda.hhs.gov.
Sfmt 4703
E:\FR\FM\30APN1.SGM
30APN1
Agencies
[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25277-25279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10130]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-13RQ]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Kimberly S. Lane, 1600 Clifton Road, MS D-74, Atlanta,
GA 30333 or send an email to omb@cdc.gov.
Comments are invited 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) ways to enhance 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. Written comments should be received
within 60 days of this notice.
Proposed Project
Community Transformation Grants (CTG) Context Scan Surveys--New--
National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Obesity currently affects more than one-third of adults and
approximately 17 percent of children in the United States. Obese
children and teens are likely to remain so into adulthood, and are at
risk for developing severe health conditions such as heart disease,
type 2 diabetes, stroke, and certain cancers. As one of the most dire
and fastest growing health-related problems, obesity prevention has
become a public health priority.
Physical activity and dietary behaviors are known to impact
obesity. Importantly, research has shown that
[[Page 25278]]
these behaviors are impacted by community-level factors (social
determinants of health) such as place of residence, access to healthy/
unhealthy food, availability of walkable environments, and
opportunities to be physically active. Thus, one promising strategy to
address nutrition and physical activity is through policy and
environmental improvements in settings such as schools, childcare
centers, and workplaces.
Given the high proportion of children enrolled, and the substantial
amount of time children spend in schools and childcare centers, these
settings are natural targets for policy and environment changes to
improve nutrition and physical activity. CDC and others have
recommended strategies to decrease sedentary time, increase the
quantity and quality of physical activity, improve nutrition standards,
and decrease the availability of less healthy foods. Numerous
governmental and non-governmental initiatives are underway to support
improved policies and environments, but little is known about the
barriers and facilitators to this work, and the overall community
context in which these initiatives are occurring.
In fiscal year 2011, the Patient Protection and Affordable Care Act
(ACA) funded the Community Transformation Grants (CTG) Program (CDC-
RFA-DP11-1103PPHF11) to address the root causes of chronic disease. CTG
grants were awarded to state and local governments, tribes and
territories, and nonprofit organizations to help individuals lead
healthier lives. As mandated by the ACA, CDC is conducting a national
evaluation of the CTG Program that includes the following components:
(1) Local Evaluation, (2) Performance Monitoring, (3) Population-level
Surveillance, (4) Enhanced Evaluation Studies, (5) Cost Studies, (6)
Simulation Modeling, and (7) Context Scan (policy and community
characteristics).
The Context Scan will capture information on social determinants
within communities, such as population density, community resources for
active living and health eating, and nutrition and physical activity
policies and environments in middle schools and childcare centers. It
will include (1) Examining policies and environments in school and
childcare settings (including review of school and childcare policies
and administration of the Context Scan Surveys); (2) examining policies
and environments in the community (including review of policies
addressing the nutrition and built environments and observation of
public food environments such as grocery and convenience stores) and
(3) extraction of data from the U.S. Bureau of the Census, U.S.
Department of Agriculture (USDA), and other publically available data
sources.
The Context Scan Surveys will employ longitudinal data collection
to document and monitor changes in nutrition and physical activity
policies and environments in childcare centers and middle schools over
time. The surveys will be implemented once per year over a four-year
period with childcare center directors, middle school principals, and
school food service personnel. A three-year Office of Management and
Budget (OMB) clearance period is requested to support the first three
years of the data collection.
The surveys include the (1) Childcare Center Nutrition and Physical
Activity Survey (CCNPAS), (2) School Principal Nutrition and Physical
Activity Survey (SPNPAS), and (3) School Food Service Nutrition Survey
(SFSNS). A mixed-mode methodology will be used to recruit respondents;
schools and centers will be identified from publically available lists.
The specific aims of the Context Scan Surveys, and related
evaluation questions, are as follows:
A. Document policies and environments related to nutrition and
physical activity in middle schools and childcare centers located in 20
CTG awardees.
1. Evaluation Question 1: What are the policies and environments
related to nutrition and physical activity in middle schools?
2. Evaluation Question 2: What are the policies and environments
related to nutrition and physical activity in childcare centers?
B. Monitor changes in policies and environments related to
nutrition and physical activity in childcare centers and middle schools
over time.
1. Evaluation Question 3: How do policies and environments related
to nutrition and physical activity in middle schools change over time
within and across awardees?
2. Evaluation Question 4: How do policies and environments related
to nutrition and physical activity in childcare centers change over
time within and across awardees?
The 20 CTG awardees selected for this study were identified based
on their commitment to implementing comprehensive active living and
healthy eating interventions and the diverse geographic and demographic
contexts within their communities.
The study universe for these 20 communities includes 970 public
middle schools and 4,362 licensed childcare centers in 871 intervention
area zip codes. The study design will adopt implicit stratification
coupled with probability proportional to size (PPS) systematic sampling
with zip code areas serving as primary sampling units. The measure of
size for PPS sampling will be the number of childcare centers in each
zip code area and the resulting sample size will consist of 120 zip
codes.
Participation in the surveys is voluntary. There are no costs to
respondents other than time. The surveys will be hosted by the secure
online survey-hosting site, Survey Monkey. All surveys will be Web-
based, with paper options available as needed. Data from the Context
Scan Surveys will provide the CDC with the ability to track policy and
environment change over time across and within communities. When
combined with other Context Scan and CTG national evaluation datasets,
the Context Scan Survey data will provide a comprehensive understanding
of the community environments in which CTG interventions are occurring,
an evidence-base for policy and environmental change strategies to
promote healthy eating and active lifestyles, and an identification of
the factors that facilitate and inhibit policy and environmental
initiatives.
The estimated burden for each survey response is 15 minutes. Pilot
tests were performed to inform burden estimates and ensure relevance of
questions to respondents.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Avgerage
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hrs)
respondent hrs)
----------------------------------------------------------------------------------------------------------------
Childcare center directors... CCNPAS........... 760 1 15/60 190
Middle school principals..... SANPAS........... 738 1 15/60 185
[[Page 25279]]
School food service personnel SFSNS............ 738 1 15/60 185
----------------------------------------------------------------------------------
Total.................... ................. .............. .............. .............. 560
----------------------------------------------------------------------------------------------------------------
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-10130 Filed 4-29-13; 8:45 am]
BILLING CODE 4163-18-P