[NCBDDD] The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Living with Muscular Dystrophy Survey

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Women Living with Muscular Dystrophy Survey (telephone interview)	Form and Instruction	New	Repair queued
Women Living with Muscular Dystrophy Survey (screen shot of intro to the web-based form)	Form and Instruction	New	Available
Women Living with Muscular Dystrophy Survey (paper)	Form and Instruction	New	Available
MD STARnet Women Living with Muscular Dystrophy Survey	Form and Instruction	New	Repair queued
Men Living with Muscular Dystrophy Survey (telephone interview)	Form and Instruction	New	Available
Men Living with Muscular Dystrophy Survey (screen shot of intro to the web-based form)	Form and Instruction	New	Available
Men Living with Muscular Dystrophy Survey (paper)	Form and Instruction	New	Available
MD STARnet Men Living with Muscular Dystrophy Survey	Form and Instruction	New	Repair queued
Attachment Ra-i_RecruitmentandFollow-upCommunication.docx	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment Q_Study Flowchart.docx	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment P_MD STARnet Survey Research Determination.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment O_VCU IRB Approval MDSTARnet Survey.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment N_UUtah IRB Approval MDSTARnet Survey.docx	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment M_SCDHEC IRB Approval MDSTARnet Survey.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment L_NYSDOH IRB Exemption MDSTARnet Survey.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment K_RTI IRB Exemption MDSTARnet Survey.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment J_UIowa IRB Approval MDSTARnet Survey.rtf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment I_UFlorida IRB Approval MDSTARnet Survey.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment H_MD_STARnet_CaseDefinitions_8.6.2021.docx	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment G_60 Day Federal Register Notice.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment B_MD CARE Act of 2001.pdf	Supplementary Document	Uploaded 2023-02-24	Repair queued
Attachment A_Public Health Service Act.docx	Supplementary Document	Uploaded 2023-02-24	Repair queued
2023 2 13 SSA MDSTARnet_Survey.docx	Supporting Statement A	Uploaded 2023-02-24	Repair queued
2023 2 13 SSB MDSTARnet_Survey.docx	Supporting Statement B	Uploaded 2023-02-24	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
258573	MD STARnet Women Living with Muscular Dystrophy Survey	Form and Instruction	New	Women Living with Muscular Dystrophy Survey (telephone interview)
258573	MD STARnet Women Living with Muscular Dystrophy Survey	Form and Instruction	New	Women Living with Muscular Dystrophy Survey (screen shot of intro to the web-based form)
258573	MD STARnet Women Living with Muscular Dystrophy Survey	Form and Instruction	New	Women Living with Muscular Dystrophy Survey (paper)
258573	MD STARnet Women Living with Muscular Dystrophy Survey	Form and Instruction	New
258572	MD STARnet Men Living with Muscular Dystrophy Survey	Form and Instruction	New	Men Living with Muscular Dystrophy Survey (telephone interview)
258572	MD STARnet Men Living with Muscular Dystrophy Survey	Form and Instruction	New	Men Living with Muscular Dystrophy Survey (screen shot of intro to the web-based form)
258572	MD STARnet Men Living with Muscular Dystrophy Survey	Form and Instruction	New	Men Living with Muscular Dystrophy Survey (paper)
258572	MD STARnet Men Living with Muscular Dystrophy Survey	Form and Instruction	New

ICR Details

OMB Control No: 0920-1405	ICR Reference No: 202302-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22IV
Title: [NCBDDD] The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Living with Muscular Dystrophy Survey
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/01/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/08/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2025	24 Months From Approved
Responses	1,010	0	0
Time Burden (Hours)	292	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: MD STARnet is a population-based surveillance system that aims to identify and collect clinical data on individuals with muscular dystrophy in select surveillance areas. Although surveillance data primarily collected through medical record abstraction have been instrumental in estimating prevalence and increasing our understanding about the natural history and treatment received by people with muscular dystrophy, other methods of data collection are necessary to address important gaps in knowledge. This study proposes to evaluate 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 MD STARnet. Respondents may participate by completing a paper questionnaire, a web-based survey, or a telephone interview.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act
   PL: Pub.L. 107 - 84 4 Name of Law: Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 58095	09/23/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 13824	03/06/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
MD STARnet Men Living with Muscular Dystrophy Survey	None, None, None	Men Living with Muscular Dystrophy Survey (paper) ,   Men Living with Muscular Dystrophy Survey (screen shot of intro to the web-based form) ,   Men Living with Muscular Dystrophy Survey (telephone interview)
MD STARnet Women Living with Muscular Dystrophy Survey	None, None, None	Women Living with Muscular Dystrophy Survey (paper) ,   Women Living with Muscular Dystrophy Survey (screen shot of intro to the web-based form) ,   Women Living with Muscular Dystrophy Survey (telephone interview)

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,010	0	0	1,010	0	0
Annual Time Burden (Hours)	292	0	0	292	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $24,850

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 03/08/2023

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