[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
[Notices]
[Pages 22152-22154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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.

[[Page 22154]]

 
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