Notice2024-06754
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 29, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 62 (Friday, March 29, 2024)</title>
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[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
[Notices]
[Pages 22152-22154]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06754]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-23DV]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Focus groups among adults with or caring
for individuals with congenital heart defects (CHD), muscular dystrophy
(MD), and spina bifida (SB)'' to the Office of Management and budget
(OMB) for review and approval. CDC previously published a ``Proposed
Data Collection Submitted for Public Comment and Recommendations''
notice on April 7, 2023 to obtain comments from the public and affected
agencies. CDC received one public comment related to this notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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,
[[Page 22153]]
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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Focus Groups Among Adults with or Caring for Individuals with
Congenital Heart Defects (CHD), Muscular Dystrophy (MD), and Spina
Bifida (SB)--New--National Center on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Congenital heart defects (CHD) are the most common type of
structural birth defects in the United States, affecting approximately
one in 110 live-born children, and are a leading cause of birth defect-
associated infant mortality, morbidity, and healthcare costs. CHD
mortality has decreased over the past few decades due to advances in
diagnosis and medical interventions. As a result, more individuals are
living into adulthood with CHD, a lifelong condition that can result in
an increasing need for specialist care and clinical interventions over
time. There is a lack of information on adults that are lost to cardiac
care since most data sources only have access to patients that have
been hospitalized or that are currently in cardiac care. A better
understanding of the factors that contribute to adults not remaining in
or seeking cardiac care will fill an important knowledge gap and could
help shape future interventions to bring this population back to
cardiac care.
Muscular dystrophies (MD) are a group of rare inherited disorders
characterized by progressive and irreversible muscle weakness and
wasting. The nine major types of MD (Duchenne and Becker [DBMD],
myotonic dystrophy [DM], congenital [CMD], limb girdle [LGMD], Emory-
Dreifuss [EDMD], facioscapulohumeral [FSHD], distal, and
oculopharyngeal [OPMD]) vary by age of onset, muscle groups affected,
genes involved, severity, and progression of disease. In 2002, CDC
implemented the Muscular Dystrophy Surveillance, Tracking, and Research
Network (MD STARnet [DD-19-002]). Now in its fourth funding cycle,
MDSTARnet has conducted surveillance and collected epidemiologic and
clinical data on people with DBMD, DM, FSHD, LGMD, CMD, OPMD, EDMD, and
distal MD and has published numerous articles in scientific journals.
However, qualitative data on the experiences of individuals with
certain types of MD (DBMD, DM, FSHD, LGMD, and CMD) or their caregivers
are limited. The MD portion of this collection will focus on gathering
qualitative information to better understand the personal experiences
of adults (>=18 years) with DBMD, FSHD, DM, and LGMD as well as adult
caregivers of youth (<18 years) with DBMD, congenital or juvenile onset
DM, and CMD. Specifically, qualitative data on barriers to accessing
and receiving care, the journey to diagnosis, and for those diagnosed
early in life the transition into adulthood will help to address a gap
in the literature and inform future research and surveillance efforts.
Spina bifida (SB) is among the most common disabling birth defects
in the United States. Based on national data from 2010-2014, the
estimated birth prevalence for spina bifida is 3.9 per 10,000 live
births. SB impacts different organ systems, resulting in the need for
various types of clinical specialists. In 2008, CDC implemented the
National Spina Bifida Patient Registry (NSBPR; [DD-19-001]) with SB
clinics across the United States. In 2014, CDC funded a subset of NSBPR
clinics to establish and implement the ``Urologic Management to
Preserve Initial Renal Function Protocol for Young Children with Spina
Bifida'' (UMPIRE Protocol; [DD-14-002]). NSBPR and UMPIRE have
generated numerous publications on clinical interventions, health
outcomes, and lessons learned. However, increases in survival for
individuals with SB have prompted the need for greater understanding of
the complexities involved in their clinical and psychological care.
Qualitative data on individual and caregiver experiences with SB,
including barriers to accessing specialty care, managing one's skin
health and bowel and bladder function, and the transition from
childhood to adulthood (for those with MD diagnosed prior to adulthood)
are needed to guide future SB surveillance and research projects as
well as the care of those aging into adulthood.
The purpose of this Information Collection Request (ICR) is to
recruit individuals for virtual focus groups and gather qualitative
data from adults with or caring for individuals with congenital heart
defects (CHD), muscular dystrophies (MD), and spina bifida (SB). This
data will be collected by KRC Research, a contracted research firm,
over the course of the study and will provide firsthand perspectives on
the types of care individuals receive with a special focus on receipt
of and access to medical care and barriers and facilitators to
accessing, receiving, or reengaging care; the journey to diagnosis; and
the transition from pediatric to adult care (for persons diagnosed
during childhood). This information may be used to address gaps in
knowledge, inform future surveillance, research, and data collection,
and gather patient and caregiver perspectives that may be shared with
clinicians and inform clinical care.
The total estimated annualized burden for all audiences is 603
hours. There are no costs to respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Adults with a CHD that have been out CHD Screening 410 1 10/60
of cardiac care. Questionnaire.
Adults with a CHD that have been out CHD Focus Group Guide... 80 1 105/60
of cardiac care.
Adults with MD or adult caregivers of MD Screening Tool....... 210 1 10/60
individuals with MD.
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Adults with MD or adult caregivers of MD Focus Group Guide.... 137 1 105/60
individuals with MD.
Adults with SB or adult caregivers of SB Screening Tool....... 90 1 10/60
individuals with SB.
Adults with SB or adult caregivers of SB Focus Group Guide.... 60 1 105/60
individuals with SB.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-06754 Filed 3-28-24; 8:45 am]
BILLING CODE 4163-18-P
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