[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Notices]
[Pages 20888-20890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-23DV; Docket No. CDC-2023-0023]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a proposed information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Focus groups among adults with or caring for individuals with
congenital heart
[[Page 20889]]
defects (CHD), muscular dystrophy (MD), and spina bifida (SB). The
purpose of this project is to conduct focus groups to obtain firsthand
perspectives from individuals with CHD, MD, and SB.
DATES: CDC must receive written comments on or before June 6, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0023 by either of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.regulations.gov) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
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. Due to
advances in diagnosis and medical interventions, CHD mortality has
decreased over the past few decades. Therefore, more individuals are
living into adulthood with CHD, a lifelong condition, that can increase
the need for specialist care and clinical interventions due to the
higher risk of CHD related long-term sequelae.
There is limited data on adults living with CHD who have fallen out
of cardiac care, and the available information is strictly among those
who returned to care. Currently, there is no information on adults with
CHD who remain out of care and what might bring them back into cardiac
care. Understanding what may bring adults with CHD back into care,
aside from an urgent cardiac need, would help in developing
interventions, as well as improving access and retention to cardiac
care, ultimately improving long-term health and wellbeing.
Focus group participants with CHD will be recruited from adults
that participated in the Congenital Heart Survey to Recognize Outcomes,
Needs and well-beinG (CH STRONG). Between 2016 and 2019, CH STRONG was
administered to adults ages 19-38 with a confirmed CHD diagnosis, born
in Arizona, Arkansas, and 5-county Metro- Atlanta, Georgia. CH STRONG
assessed many factors, including access to care and healthcare
utilization. Through survey responses we will identify a subpopulation
of respondents whose last cardiology encounter was >=3 years before
survey completion, creating a unique opportunity to better understand
this population not typically available to researchers.
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
[[Page 20890]]
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 project is to conduct virtual focus groups
among adults with or caring for individuals with CHD, MD, and SB with a
special focus on: receipt of and access to medical care (including
specialist care), and barriers and facilitators to accessing,
receiving, or reengaging care; the journey to diagnosis; and the
transition period 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 perspectives that may be shared with clinicians and
inform clinical care.
CDC requests OMB approval for an estimated 533 annual burden hours.
There is no cost 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 Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Adults with a CHD that have CHD Screening 410 1 10/60 68
been out of cardiac care for Questionnaire.
>=3.
Adults with a CHD that have CHD Focus Group 80 1 90/60 120
been out of cardiac care for Guide.
>=3.
Adults with MD or adult MD Screening 215 1 10/60 36
caregivers of individuals Tool.
with MD.
Adults with MD or adult MD Focus Group 135 1 90/60 203
caregivers of individuals Guide.
with MD.
Adults with SB or adult SB Screening 95 1 10/60 16
caregivers of individuals Tool.
with SB.
Adults with SB or adult SB Focus Group 60 1 90/60 90
caregivers of individuals Guide.
with SB.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 533
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2023-07348 Filed 4-6-23; 8:45 am]
BILLING CODE 4163-18-P