Notice2021-14437
Proposed Data Collection Submitted for Public Comment and Recommendations
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
July 7, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Muscular Dystrophy Questionnaire: Understanding the impact of COVID-19, flu, pain, fatigue, pregnancy and infertility, on adults with muscular dystrophy. 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 muscular dystrophy who are identified through the Muscular Dystrophy Surveillance Tracking and Research Network (MD STARnet). Information will be used to develop interventions that improve the lives of people with muscular dystrophy and their families.
Full Text
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<title>Federal Register, Volume 86 Issue 127 (Wednesday, July 7, 2021)</title>
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[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35798-35799]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14437]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-21-21FS; Docket No. CDC-2021-0059]
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 and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled The Muscular Dystrophy
Surveillance, Tracking, and Research Network (MD STARnet) Muscular
Dystrophy Questionnaire: Understanding the impact of COVID-19, flu,
pain, fatigue, pregnancy and infertility, on adults with muscular
dystrophy. 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 muscular dystrophy
who are identified through the Muscular Dystrophy Surveillance Tracking
and Research Network (MD STARnet). Information will be used to develop
interventions that improve the lives of people with muscular dystrophy
and their families.
DATES: CDC must receive written comments on or before September 7,
2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0059 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://Regulations.gov">Regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (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-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email:
<a href="/cdn-cgi/l/email-protection#ff90929dbf9c9b9cd1989089"><span class="__cf_email__" data-cfemail="0a6567684a696e69246d657c">[email protected]</span></a>.
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
[[Page 35799]]
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
The Muscular Dystrophy Surveillance, Tracking, and Research Network
(MD STARnet) Muscular Dystrophy Questionnaire: Understanding the impact
of COVID-19, flu, pain, fatigue, pregnancy and infertility, on adults
with muscular dystrophy--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 cases at
sources including healthcare facilities where patients with MD receive
care, and administrative datasets such as vital records and hospital
discharge data. While 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 muscular dystrophy (DMD), Becker muscular
dystrophy (BMD), myotonic dystrophy (DM), facioscapulohumeral muscular
dystrophy (FSHD), limb-girdle muscular dystrophy (LGMD), Congenital
muscular dystrophy (CMD), Emery-Dreifuss muscular dystrophy (EDMD), and
distal muscular dystrophy. 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 people and their families living with
MD. Individuals with MDs frequently report pain and fatigue, but
studies have largely been conducted in clinic-based populations and
included the three most common MDs. 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 muscular dystrophy who are
identified through the Muscular Dystrophy Surveillance Tracking and
Research Network (MD STARnet).
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
muscular dystrophy on pregnancy and fertility on adults living with
muscular dystrophy. Ultimately, this information can be used by
stakeholders to develop interventions that improve the lives of people
with muscular dystrophy and their families.
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) hours
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Adult males 18 and over....... MD STARnet male 1,794 1 15/60 449
questionnaire.
Adult females 18 and over..... MD STARnet 1,574 1 20/60 525
female
questionnaire.
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Total..................... ................ .............. .............. .............. 974
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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. 2021-14437 Filed 7-6-21; 8:45 am]
BILLING CODE 4163-18-P
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