[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]


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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.

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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
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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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
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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