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 Department of Health and Human Services Centers for Disease Control and Prevention [60Day-21-21FS; Docket No. CDC-2021-0059]
 AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
 ACTION: Notice with comment period.
 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 STAR *net*) 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 STAR *net*). 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: *omb@cdc.gov.*


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 ( print 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 STAR *net*) 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 STAR *net* 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 STAR *net* 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 STAR *net* 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 STAR *net* 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 STAR *net*). 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
Type of respondents
Form name
Number of respondents
Number of responses per 
               respondent
Average burden per 
               response 
               (in hours)
Total burden hoursAdult males 18 and over
MD STAR *net* male questionnaire
1,794
1
15/60
449Adult females 18 and over
MD STAR *net* female questionnaire
1,574
1
20/60
525Total




974
 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