[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Notices]
[Pages 26760-26762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10618]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-0904]
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 No. 0920-0904, exp. 11/30/
2014)--Revision--National Center for Chronic Disease Prevention and
Health
[[Page 26761]]
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. 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 clinical 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. In Phases 1 and 2, the clinical centers and a data
coordinating center were funded through cooperative agreements. The
information collected at that time was not provided directly to CDC.
Phase 3 (2011-present) builds upon previous efforts. Five clinical
sites collect patient-level information that is compiled by a data
coordinating center. CDC obtained OMB approval to receive the
information in 2011 (SEARCH for Diabetes in Youth, OMB No. 0920-0904,
exp. 11/30/2014). Phase 3 includes a case registry of youth <20 years
of age who have been diagnosed with diabetes, and a longitudinal cohort
research study about SEARCH cases whose diabetes was incident in 2002
or later. To date, SEARCH Phase 3 has identified an average of 1,361
incident cases of diabetes among youth under 20 years each year of the
study and has completed an average of 1,088 participant surveys each
year (80% participation rate among registry study participants). As of
November 2013, SEARCH Phase 3 has completed visits for 1,839 cohort
study participants.
CDC plans to continue information collection for two additional
years, with minor changes. Participants in the registry study will
continue to complete a Medication Inventory and an Initial Participant
Survey; however, the in-person study examination will be discontinued.
This change will result in a decrease in burden per respondent. CDC
estimates that each clinical site will identify and register an average
of 255 cases per year, for a total 1,275 cases across all sites.
No data collection changes are planned for the cohort study. CDC
estimates that each clinical site will conduct follow-up on an average
of 142 cases per year, for a total of 710 cases across all sites. The
items collected for each case include a Health Questionnaire (Youth
version), an additional Health Questionnaire (Parent version), Center
for Epidemiologic Study-Depression, Quality of Care, Pediatric Quality
of Life Survey (Peds QL), SEARCH Michigan Neuropathy Screening
Instrument, Diabetes Eating Survey, Low Blood Sugar Survey,
Supplemental Survey, Tanner Stage, Retinal Photo, Family Conflict
Survey, Pediatric Diabetes Quality of Life Scale, Physical Exam,
Specimen Collection, and Food Frequency Questionnaire.
Findings from the registry study will be used to estimate the
incidence of diabetes in youth in the U.S. Findings from the cohort
study will be used to estimate the prevalence and incidence of risk
factors and complications associated with diabetes in youth, including
chronic microvascular complications (retinopathy, nephropathy, and
autonomic neuropathy) and selected markers of macrovascular
complications (hypertension, arterial stiffness) of diabetes.
Participation is voluntary and there are no costs to respondents
other than their time. The total estimated annualized burden hours are
4,248.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hr)
----------------------------------------------------------------------------------------------------------------
SEARCH Registry Study Participants.... Medication Inventory.... 1,275 1 5/60
Initial Participant 1,275 1 10/60
Survey.
SEARCH Cohort Study Participants...... Health Questionnaire- 710 1 15/60
Youth.
Health Questionnaire- 710 1 15/60
Parent.
CES-Depression.......... 710 1 4/60
Quality of Care......... 710 1 13/60
Peds QL................. 710 1 5/60
SEARCH MNSI Neuropathy.. 710 1 10/60
Diabetes Eating Survey.. 710 1 5/60
Low Blood Sugar Survey.. 710 1 5/60
Supplemental Survey..... 710 1 10/60
Tanner Stage............ 710 1 5/60
Retinal Photo........... 710 1 15/60
Family Conflict Survey.. 710 1 5/60
Pediatric Diabetes QOL 710 1 5/60
Scale.
Physical Exam........... 710 1 3
Specimen Collection..... 710 1 20/60
Food Frequency 710 1 20/60
Questionnaire.
----------------------------------------------------------------------------------------------------------------
[[Page 26762]]
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. 2014-10618 Filed 5-8-14; 8:45 am]
BILLING CODE 4163-18-P