[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35798-35799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: 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-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 Regulations.gov.
    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: 
[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

[[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.
                                                 ---------------------------------------------------------------
    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