[Federal Register Volume 88, Number 43 (Monday, March 6, 2023)]
[Notices]
[Pages 13824-13825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-22IV]


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 ``The Muscular Dystrophy Surveillance, 
Tracking, and Research Network (MD STARnet) Living with Muscular 
Dystrophy Questionnaire'' 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 
September 23, 2022 to obtain comments from the public and affected 
agencies. CDC did not receive comments related to the previous 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, 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

    The Muscular Dystrophy Surveillance, Tracking, and Research Network 
(MD STARnet) Living with Muscular Dystrophy Questionnaire--New--
National Center on Birth Defects and Developmental Disabilities 
(NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Since its establishment in 2002, the MD STARnet has been a 
population-based surveillance system that aims to identify and collect 
clinical data on individuals with muscular dystrophy (MD) in select 
surveillance areas. MD STARnet identifies and collects data on 
individuals with MD at sources including healthcare facilities where 
patients with MD receive care and administrative datasets such as vital 
records and hospital discharge data. Although MDs are rare genetic 
diseases with an estimated prevalence of 16.1/100,000, they have a high 
impact on affected individuals, their families, and society. MDs can be 
classified into nine major groups: Duchenne MD (DMD), Becker MD (BMD), 
myotonic dystrophy (DM), facioscapulohumeral muscular dystrophy (FSHD), 
limb-girdle MD (LGMD), Congenital MD (CMD), Emery-Dreifuss MD (EDMD), 
Oculopharyngeal MD (OPMD), and distal MD. A recent MD STARnet study has 
estimated the combined prevalence for DMD and BMD to be 1.92-2.48/
10,000 males age 5-9 years old. MD STARnet aims to improve 
understanding of MDs and ultimately the quality of life of individuals 
and their families living with MD.
    Individuals with MD frequently report pain and fatigue, but studies 
have primarily been conducted in single clinics and limited to the 
three most common MDs (DMD, DM, and FSHD).

[[Page 13825]]

Population-based studies are needed to describe the frequency and 
management of pain and fatigue and their impact on the lives of 
individuals with various types of MD. The purpose of the proposed study 
is to describe the epidemiology of COVID-19 and flu and the experience 
with pain, fatigue, pregnancy, and infertility for adults living with 
MD who are identified through MD STARnet. Information will be collected 
at the seven MD STARnet surveillance sites and will occur primarily via 
a survey of adult men and women with muscular dystrophy. The survey 
will primarily be web-based, but a paper version and phone interview 
will be provided to accommodate participant preferences. The estimated 
burden per response for the MD STARnet Men Living with Muscular 
Dystrophy Survey is 15 minutes. The MD STARnet Women Living with 
Muscular Dystrophy Survey includes additional questions about pregnancy 
and infertility, and the estimated burden per response is 20 minutes.
    Results generated from the study will provide a better 
understanding of: (1) the occurrence, testing, treatment and severity 
of COVID-19 in relation to MD; (2) vaccination status and reasons for 
not receiving COVID-19 and flu vaccinations; (3) the frequency, 
intensity, and management of pain and fatigue; and (4) the effect of 
having MD on pregnancy and fertility on adults living with MD. 
Ultimately, this information can be used to develop interventions that 
improve the lives of people with MD and their families.
    CDC requests OMB approval for two years. The total estimated 
annualized burden is 292 hours. Participation is voluntary and there 
are no costs to respondents other than their time.

                                        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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Adult Males 18 and over............  MD STARnet Men Living with              538               1           15/60
                                      Muscular Dystrophy Survey.
Adult Females 18 and over..........  MD STARnet Women Living                 472               1           20/60
                                      with Muscular Dystrophy
                                      Survey.
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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. 2023-04492 Filed 3-3-23; 8:45 am]
BILLING CODE 4163-18-P