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 VerDate Mar<15>2010 13:22 Apr 29, 2013 Jkt 229001 25277 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 [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 ...... VerDate Mar<15>2010 13:22 Apr 29, 2013 Jkt 229001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 VerDate Mar<15>2010 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 http:// 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. PO 00000 Frm 00028 Fmt 4703 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