Data Use Agreement (DUA) Form, Research Identifiable Files Request Packet Packet, and Data Management Plan (CMS-R-235)

Forms and Documents

Document Name	Status
Form CMS-R-235 RIF Request Packet Form and Instruction	Modified
Form CMS-R-235 Data Management Plan Self-Attestation Questionnaire (DMP SAQ) Form and Instruction	New
Form CMS-R-235 Limited Data Set Data Use Agreement (DUA) Form and Instruction	New
Form CMS-R-235 Forms used to update the DUA Information Form and Instruction	New
CMS-R-235 Supporting_Statement.docx Supporting Statement A	2022-04-26
Change crosswalk 3-30.pdf Supplementary Document	2022-04-14

IC Document Collections

IC ID	Document Title	Status
8408	RIF Request Packet Form and Instruction	Modified
253071	Data Management Plan Self-Attestation Questionnaire (DMP SAQ) Form and Instruction	New
253070	Limited Data Set Data Use Agreement (DUA) Form and Instruction	New
253069	Forms used to update the DUA Information Form and Instruction	New

ICR Details

OMB Control No: 0938-0734	ICR Reference No: 202204-0938-004
Status: Received in OIRA	Previous ICR Reference No: 202005-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Data Use Agreement (DUA) Form, Research Identifiable Files Request Packet Packet, and Data Management Plan (CMS-R-235)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/27/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2023
Responses	9,655	9,200
Time Burden (Hours)	3,876	2,900
Cost Burden (Dollars)	0	0

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Abstract: CMS is permitted to disclose data files for approved research purposes in compliance with 45 45 CFR 164.512(i). Researchers requesting research identifiable files (RIF) must, as part of the request process, complete a research request packet that provides CMS with information pertaining to the research study, including describing how the research results/findings will be disseminated, as well as the data files being requested. Should CMS approve the research request, the data requestor enters into a Data Use Agreement (DUA). This data collection is necessary to ensure that disclosures of data for research purposes comply with federal laws and regulations as well as CMS policy. Researchers requesting RIF files also must complete a Data Management Plan Self-Attestation Questionnaire (DMP SAQ). A DMP SAQ is required each time a DUA is established. Both the DUA and the DMP SAQ forms are valid for one year from the date of approval and are renewable at expiration. If the environment described in a DMP SAQ is the same for multiple DUAs from a single organization, the same DMP SAQ can be used across the DUAs, provided it has not expired. The DMP SAQ is a technical, evidence basedevidence-based questionnaire that DUA users must complete as part of the data request packet. The DMP SAQ will enable CMS to evaluate researcher data systems to ensure that CMS data are adequately secured and appropriately protected, as per the Privacy Act and the HIPAA Privacy Rule. The DMP SAQ also allows CMS to measure compliance through the implementation of security and privacy controls as outlined in the National Institute of Standards and Technology (NIST) Special Publication 800-53 and the Centers for Medicare & Medicaid Services (CMS) Information Security and Acceptable Risk Safeguards (ARS). The second component of the DMP SAQ is to provide ongoing oversight. All organizations will be subject to routine audits of the environments used to store and process CMS data, as described in their organizational-level DMP SAQ.

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Authorizing Statute(s): US Code: 5 USC 552(a) Name of Law: The Privacy Act of 1974
  

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:
	86 FR 60245	11/01/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 24308	04/25/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Data Management Plan Self-Attestation Questionnaire (DMP SAQ)	CMS-R-235	Data Management Plans Self Attestation Questionnaire (DMP SAQ)
Forms used to update the DUA Information	CMS-R-235, CMS-R-235, CMS-R-235	Data Use Agreement (DUA) Signature Addendum ,   DUA Update to Existing Data Use Agreement ,   DUA Certificate of Disposition
Limited Data Set Data Use Agreement (DUA)	CMS-R-235	Limited Data Set Data Use Agreement (DUA)
RIF Request Packet	CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235	Data Use Agreement (DUA) ,   RIF Request Application ,   State Agency Supplement ,   Innovator Supplement ,   Collaborator Supplement ,   Key Personnel Supplement ,   Amendment Request Form

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ICR Summary of Burden

	Total Request	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	9,655	9,200	0	455	0	0
Annual Time Burden (Hours)	3,876	2,900	0	976	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: First, the number of DUA forms has increased to include the forms in the research request packet that provide CMS with information pertaining to the research study. The language in the DUA has been revised to clarify CMS data release policies and updated data security requirements. Second, this package also now includes the DMP SAQ that was previously approved in a separate PRA package. The DMP SAQ was updated to collect information on a second point of contact. Third, there has been a decrease in the number of requesters for LDS datasets and therefore the number of respondents using Form 0235l DUA has been reduced. There has also been a decrease in the use of the Form 0235 DUA as many of the CMS programs that have historically used the form have transitioned to program specific documents that are tailored to the uses and disclosures for a specific CMS program. The hourly burden estimates have been updated to include the forms used in the RIF research request packets and the DMP SAQ.

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Annual Cost to Federal Government: $2,904,800

Does this IC contain surveys, censuses, or employ statistical methods? No

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? No

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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: 04/27/2022

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