Use Agreement (DUA) Limited Data Set (LDS) Forms Research Identifiable Files (FIF) Forms (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	Modified
Form CMS-R-235 Limited Data Set Data Use Agreement (DUA) Form and Instruction	Modified
Form CMS-R-235 Forms used to update the DUA Information Form and Instruction	Modified
CMS-R-235_Supporting Statement A.docx Supporting Statement A	2025-05-29
Change Crosswalk.pdf Supplementary Document	2025-05-27

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	Modified
253070	Limited Data Set Data Use Agreement (DUA) Form and Instruction	Modified
253069	Forms used to update the DUA Information Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0734	ICR Reference No: 202505-0938-012
Status: Received in OIRA	Previous ICR Reference No: 202204-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Use Agreement (DUA) Limited Data Set (LDS) Forms Research Identifiable Files (FIF) Forms (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: 06/17/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2025
Responses	7,755	9,655
Time Burden (Hours)	3,810	3,876
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:
	90 FR 3220	01/14/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 22490	05/28/2025
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, CMS-R-235	DUA Certificate of Disposition ,   QE DUA Signature Addendum ,   NDTR DUA Signature Addendum ,   Contractor DUA Signature Addendum
Limited Data Set Data Use Agreement (DUA)	CMS-R-235, CMS-R-235, CMS-R-235	Limited Data Set Data Use Agreement (DUA) ,   LDS DUA Signature Addendum_ ,   LDS DUA Request Application
RIF Request Packet	CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235	RIF Request Application ,   State Agency Supplement ,   Innovator Supplement ,   Collaborator Supplement ,   Key Personnel Supplement ,   Amendment Request Form ,   RIF Extenstion Request Form ,   RIF DUA Signature Addendum

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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	7,755	9,655	0	-1,900	0	0
Annual Time Burden (Hours)	3,810	3,876	0	-66	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: Burden has decreased due to the growth in DUA forms to include the forms in the research request packet that provide CMS with information pertaining to the research study. The language in the LDS DUA has been revised to clarify CMS data release policies, rules, regulations, and updated data security requirements. Second, this package includes the addition of six (6) new forms: Signature Addendums for all five (5) types of DUAs, and the Attachment A - LDS DUA Request Application. The new Signature Addendums will be used in place of the soon-to-be discontinued general DUA Signature Addendum. The new addendums were created and tailored to accompany specific types of DUAs, versus a general version used for all DUAs. Each type of DUA requires different forms, and not all forms in this package will be used when a respondent submits a DUA request. The burden to respondents has increased from 3,876 to 3,809 which is an decrease of 66 hours.

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Annual Cost to Federal Government: $10,814

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: 06/17/2025

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