82 FR 32702 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 135 (July 17, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 135 (July 17, 2017)
| Page Range | 32702-32703 | |
| FR Document | 2017-14913 |
[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)] [Notices] [Pages 32702-32703] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14913] [[Page 32702]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-0904] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project SEARCH for Diabetes in Youth Study (OMB Control Number 0920-0904, Expiration Date 08/31/2017)--Revision--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Diabetes is one of the most common chronic diseases among children in the United States. When diabetes strikes during childhood, it is routinely assumed to be type 1, or juvenile-onset, diabetes. Type 1 diabetes (T1D) develops when the body's immune system destroys pancreatic cells that make the hormone insulin. Type 2 diabetes begins when the body develops a resistance to insulin and no longer uses it properly. As the need for insulin rises, the pancreas gradually loses its ability to produce sufficient amounts of insulin to regulate blood sugar. Reports of increasing frequency of both type 1 and type 2 diabetes in youth have been among the most concerning aspects of the evolving diabetes epidemic. In response to this growing public health concern, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) funded the SEARCH for Diabetes in Youth Study. The SEARCH for Diabetes in Youth Study began in 2000 as a multi- center, epidemiological study, conducted in six geographically dispersed Study Centers that reflected the racial and ethnic diversity of the U.S. Phases 1 (2000-2005) and 2 (2005-2010) produced estimates of the prevalence and incidence of diabetes among youth age <20 years, according to diabetes type, age, sex, and race/ethnicity, and characterized selected acute and chronic complications of diabetes and their risk factors, as well as the quality of life and quality of health care. Phase 3 (2010-2015) built upon the activities in Phase 1 and 2 and added a cohort component to collect information on estimate the prevalence and incidence of risk factors and complications, including chronic microvascular (retinopathy, nephropathy, and autonomic neuropathy) and selected markers of macrovascular complications (hypertension, arterial stiffness) of diabetes. SEARCH Phase 4 (2015-2020) continues the activities of the SEARCH Registry Study via cooperative agreements with the clinical sites, data coordinating center, and CDC. Respondents will be youth <20 years of age who have been diagnosed with diabetes. Information will be collected from the study participants by five clinical sites and transmitted to the Coordinating Center for the study, each funded through a cooperative agreement. Information collection will support a case registry that can be used to estimate the incidence and prevalence of diabetes in youth in the U.S. The registry study will continue to collect information from participants related to diabetes diagnosis and will ask participants identified with incident diabetes in 2016 to complete an in-person study examination. CDC is no longer funding the cohort component of the SEARCH for Diabetes in Youth Study. SEARCH Phase 3 identified an average of 1,361 incident cases of diabetes among youth under 20 years each year of the study and completed an average of 1,088 participant surveys each year (80% participation rate among registry study participants). Respondents will be the Population-based Diabetes in Youth (SEARCH for Diabetes in Youth Phase 4) study participants. The information collection will include: 1. Incident diabetes cases:Collection of information on newly diagnosed incident diabetes cases in youth age <20 years. CDC estimates that each clinical site will identify and register an average of 302 to 303 cases per year, for a total of 1,511 cases across all sites. There are no changes for the Medication Inventory Form. The Initial Participant Survey form has been revised to eliminate questions that were not useful to the researchers and to improve readability and understanding for the participants. The overall burden for the form has not changed. The total estimated annualized burden for this information collection is 378 hours. Physical exam and specimen collection for the 2016 incident cases. CDC estimates that each clinical site will identify and register 1,511 cases during this incident year. Of these cases, CDC anticipants 80% will complete the Initial Participant Survey and be invited for an in-person visit. Of those, we anticipate a 65 to 70% response rate and complete 823 in-person visits. The Physical Exam Form has not changed. There was a change to the Specimen Collection Form since a spot urine sample will no longer be collected. The total estimated annualized burden for this information collection is 1,509 hours. 2. Prevalent diabetes cases: Collection of information on prevalent cases of diagnosed diabetes among youth <20 years. CDC estimates that the clinical sites will identify 776 cases. The items collected for each case include an Initial Participant Survey. The total estimated annualized burden for this information collection is 129 hours. This is a new data collection instrument. The estimated annualized burden per participant respondent is reduced by 3.2 hours since the CDC is no longer funding the cohort component. [[Page 32703]] The total annualized burden for this study is 2,016 hours. There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average Type of respondent Number of responses per Form name burden per respondents respondent response ---------------------------------------------------------------------------------------------------------------- Incident case......................... 1,511 1 Medical Inventory....... 5/60 1 Initial Participant 10/60 Survey Incident case (adult and parent). Incident case in 2016 who complete 823 1 Physical Exam........... 1.5 survey. 1 Specimen collection..... 20/60 Prevalent case........................ 776 1 Initial Participant 10/60 Survey, Prevalent case (adult and parent). ---------------------------------------------------------------------------------------------------------------- Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2017-14913 Filed 7-14-17; 8:45 am] BILLING CODE 4163-18-P
![32702 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices
DEPARTMENT OF HEALTH AND Background and Brief Description collect information from participants
HUMAN SERVICES Diabetes is one of the most common related to diabetes diagnosis and will
chronic diseases among children in the ask participants identified with incident
Centers for Disease Control and diabetes in 2016 to complete an in-
United States. When diabetes strikes
Prevention person study examination. CDC is no
during childhood, it is routinely
[30Day–17–0904] assumed to be type 1, or juvenile-onset, longer funding the cohort component of
diabetes. Type 1 diabetes (T1D) the SEARCH for Diabetes in Youth
Agency Forms Undergoing Paperwork develops when the body’s immune Study.
Reduction Act Review SEARCH Phase 3 identified an
system destroys pancreatic cells that
average of 1,361 incident cases of
The Centers for Disease Control and make the hormone insulin. Type 2
diabetes among youth under 20 years
Prevention (CDC) has submitted the diabetes begins when the body develops
each year of the study and completed an
following information collection request a resistance to insulin and no longer
average of 1,088 participant surveys
to the Office of Management and Budget uses it properly. As the need for insulin
each year (80% participation rate among
(OMB) for review and approval in rises, the pancreas gradually loses its
registry study participants).
accordance with the Paperwork ability to produce sufficient amounts of Respondents will be the Population-
Reduction Act of 1995. The notice for insulin to regulate blood sugar. Reports based Diabetes in Youth (SEARCH for
the proposed information collection is of increasing frequency of both type 1 Diabetes in Youth Phase 4) study
published to obtain comments from the and type 2 diabetes in youth have been participants. The information collection
public and affected agencies. among the most concerning aspects of will include:
Written comments and suggestions the evolving diabetes epidemic. In 1. Incident diabetes cases:
from the public and affected agencies response to this growing public health • Collection of information on newly
concerning the proposed collection of concern, the Centers for Disease Control diagnosed incident diabetes cases in
information are encouraged. Your and Prevention (CDC) and the National youth age <20 years. CDC estimates that
comments should address any of the Institutes of Health (NIH) funded the each clinical site will identify and
following: (a) Evaluate whether the SEARCH for Diabetes in Youth Study. register an average of 302 to 303 cases
proposed collection of information is The SEARCH for Diabetes in Youth per year, for a total of 1,511 cases across
necessary for the proper performance of Study began in 2000 as a multi-center, all sites. There are no changes for the
the functions of the agency, including epidemiological study, conducted in six Medication Inventory Form. The Initial
whether the information will have geographically dispersed Study Centers Participant Survey form has been
practical utility; (b) Evaluate the that reflected the racial and ethnic revised to eliminate questions that were
accuracy of the agencies estimate of the diversity of the U.S. Phases 1 (2000– not useful to the researchers and to
burden of the proposed collection of 2005) and 2 (2005–2010) produced improve readability and understanding
information, including the validity of estimates of the prevalence and for the participants. The overall burden
the methodology and assumptions used; incidence of diabetes among youth age for the form has not changed. The total
(c) Enhance the quality, utility, and <20 years, according to diabetes type, estimated annualized burden for this
clarity of the information to be age, sex, and race/ethnicity, and information collection is 378 hours.
collected; (d) Minimize the burden of characterized selected acute and chronic • Physical exam and specimen
the collection of information on those complications of diabetes and their risk collection for the 2016 incident cases.
who are to respond, including through factors, as well as the quality of life and CDC estimates that each clinical site
the use of appropriate automated, quality of health care. Phase 3 (2010– will identify and register 1,511 cases
electronic, mechanical, or other 2015) built upon the activities in Phase during this incident year. Of these cases,
technological collection techniques or 1 and 2 and added a cohort component CDC anticipants 80% will complete the
other forms of information technology, to collect information on estimate the Initial Participant Survey and be invited
e.g., permitting electronic submission of prevalence and incidence of risk factors for an in-person visit. Of those, we
responses; and (e) Assess information and complications, including chronic anticipate a 65 to 70% response rate and
collection costs. microvascular (retinopathy, complete 823 in-person visits. The
To request additional information on nephropathy, and autonomic Physical Exam Form has not changed.
the proposed project or to obtain a copy neuropathy) and selected markers of There was a change to the Specimen
of the information collection plan and macrovascular complications Collection Form since a spot urine
instruments, call (404) 639–7570 or (hypertension, arterial stiffness) of sample will no longer be collected. The
send an email to omb@cdc.gov. Written diabetes. total estimated annualized burden for
comments and/or suggestions regarding SEARCH Phase 4 (2015–2020) this information collection is 1,509
the items contained in this notice continues the activities of the SEARCH hours.
should be directed to the Attention: Registry Study via cooperative 2. Prevalent diabetes cases:
CDC Desk Officer, Office of Management agreements with the clinical sites, data • Collection of information on
and Budget, Washington, DC 20503 or coordinating center, and CDC. prevalent cases of diagnosed diabetes
by fax to (202) 395–5806. Written Respondents will be youth <20 years of among youth <20 years. CDC estimates
comments should be received within 30 age who have been diagnosed with that the clinical sites will identify 776
days of this notice. diabetes. Information will be collected cases. The items collected for each case
asabaliauskas on DSKBBXCHB2PROD with NOTICES
from the study participants by five include an Initial Participant Survey.
Proposed Project clinical sites and transmitted to the The total estimated annualized burden
SEARCH for Diabetes in Youth Study Coordinating Center for the study, each for this information collection is 129
(OMB Control Number 0920–0904, funded through a cooperative hours. This is a new data collection
Expiration Date 08/31/2017)— agreement. Information collection will instrument.
Revision—National Center for Chronic support a case registry that can be used The estimated annualized burden per
Disease Prevention and Health to estimate the incidence and participant respondent is reduced by 3.2
Promotion (NCCDPHP), Centers for prevalence of diabetes in youth in the hours since the CDC is no longer
Disease Control and Prevention (CDC). U.S. The registry study will continue to funding the cohort component.
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![Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices 32703
The total annualized burden for this
study is 2,016 hours. There are no costs
to respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of
Type of respondent responses per Form name burden
respondents respondent per response
Incident case ................................................... 1,511 1 Medical Inventory ........................................... 5/60
1 Initial Participant Survey Incident case (adult 10/60
and parent).
Incident case in 2016 who complete survey .. 823 1 Physical Exam ................................................ 1.5
1 Specimen collection ....................................... 20/60
Prevalent case ................................................ 776 1 Initial Participant Survey, Prevalent case 10/60
(adult and parent).
Leroy A. Richardson, electronic, mechanical, or other The research under this project will
Chief, Information Collection Review Office, technological collection techniques or survey companies who manufacture,
Office of Scientific Integrity, Office of the other forms of information technology, distribute, fabricate, formulate, use or
Associate Director for Science, Office of the e.g., permitting electronic submission of provide services related to engineered
Director, Centers for Disease Control and responses; and (e) Assess information nanomaterials. The analysis will
Prevention. collection costs. describe the survey sample, response
[FR Doc. 2017–14913 Filed 7–14–17; 8:45 am] To request additional information on rates, and types of company by industry
BILLING CODE 4163–18–P the proposed project or to obtain a copy and size. Further analysis will focus on
of the information collection plan and identifying the types of engineered
instruments, call (404) 639–7570 or nanomaterials being used in industry
DEPARTMENT OF HEALTH AND send an email to omb@cdc.gov. Written and the types of occupational safety and
HUMAN SERVICES comments and/or suggestions regarding health practices being implemented.
the items contained in this notice The analysis will be used to develop a
Centers for Disease Control and should be directed to the Attention:
Prevention final report which evaluates the
CDC Desk Officer, Office of Management influence of NIOSH products, services,
[30 Day–17–17NE] and Budget, Washington, DC 20503 or and outputs on industry occupational
by fax to (202) 395–5806. Written safety and health practices.
Agency Forms Undergoing Paperwork comments should be received within 30 Under this project, the following
Reduction Act Review days of this notice. activities and data collections will be
The Centers for Disease Control and Proposed Project conducted:
Prevention (CDC) has submitted the Survey of Engineered Nanomaterial (1) Company Pre-calls. Sampled
following information collection request Occupational Safety and Health companies will be contacted to identify
to the Office of Management and Budget Practices—New—National Institute for the person who will complete the
(OMB) for review and approval in Occupational Safety and Health survey and to ascertain whether or not
accordance with the Paperwork (NIOSH), Centers for Disease Control the company handles engineered
Reduction Act of 1995. The notice for and Prevention (CDC). nanomaterials.
the proposed information collection is (2) Survey. A web-based
published to obtain comments from the Background and Brief Description questionnaire, with a mail option, will
public and affected agencies. As mandated in the Occupational be administered to companies. The
Written comments and suggestions Safety and Health Act of 1970 (PL 91– purpose of the survey is to learn directly
from the public and affected agencies 596), NIOSH’s mission is to conduct from companies about their use of
concerning the proposed collection of research and investigations on work- NIOSH materials and their occupational
information are encouraged. Your related disease and injury and to safety and health practices concerning
comments should address any of the disseminate information for preventing engineered nanomaterials.
following: (a) Evaluate whether the identified workplace hazards (Sections A sample of 600 companies will be
proposed collection of information is 20 (a)(1) and (d)). This dual compiled from lists of industry
necessary for the proper performance of responsibility recognizes the need to associations, research reports, marketing
the functions of the agency, including translate research into workplace databases, and web-based searches. Of
whether the information will have application if it is to impact worker the 600 selected companies we
practical utility; (b) Evaluate the safety and well-being. The goal of this anticipate that 500 will complete the
accuracy of the agencies estimate of the project is to assess the relevance and survey within two years. The company
asabaliauskas on DSKBBXCHB2PROD with NOTICES
burden of the proposed collection of impact of NIOSH’s contribution to pre-call is expected to require five
information, including the validity of guidelines and risk mitigation practices minutes to complete. The survey is
the methodology and assumptions used; for safe handling of engineered expected to require 20 minutes to
(c) Enhance the quality, utility, and nanomaterials in the workplace. The complete; including the time it may take
clarity of the information to be intended use of this data is to inform respondents to look-up and retrieve
collected; (d) Minimize the burden of NIOSH’s research agenda to enhance its needed information. The estimated
the collection of information on those relevance and impact on worker safety annualized burden hours for the
who are to respond, including through and health in the context of engineered respondents’ time to participate in this
the use of appropriate automated, nanomaterials. information collection is 109 hours.
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Document Created: 2017-07-15 03:46:01
Document Modified: 2017-07-15 03:46:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 32702 |
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