Notice2023-04492
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 6, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 43 (Monday, March 6, 2023)</title>
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[Federal Register Volume 88, Number 43 (Monday, March 6, 2023)]
[Notices]
[Pages 13824-13825]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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
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
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