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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-0734
ICR Reference No:
201409-0938-011
Status:
Historical Active
Previous ICR Reference No:
201107-0938-005
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CMS-R-235
Title:
Data Use Agreement Information Collection Requirements, Model Language, and Supporting Regulations in 45 CFR Section 5b
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/19/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/18/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2017
36 Months From Approved
12/31/2014
Responses
9,240
0
2,200
Time Burden (Hours)
2,742
0
1,100
Cost Burden (Dollars)
0
0
0
Abstract:
he Privacy Act of 1976, ?552a requires the Centers for Medicare & Medicaid Services (CMS) to track all disclosures of the agency's Personally Identifiable Information (PII) and the exceptions for these data releases. CMS is also required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Federal Information Security Management Act (FISMA) of 2002 to properly protect all PII data maintained by the agency. When entities request CMS PII data, they enter into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the recipient of CMS PII data must properly protect the data according to FISMA and also provide for its appropriate destruction at the completion of the project/study or the expiration date of the DUA. The DUA form enables the data recipient and CMS to document the request and approval for release of CMS PII data. The form requires the submitter to provide the Requestor's organization; project/study name; CMS contract number (if applicable); data descriptions and the years of the data; retention date; attachments to the agreement; name, title, contact information to include address, city, state, zip code, phone, e-mail, signature and date signed by the requester and custodian; disclosure provision; name of Federal Agency sponsor; Federal Representative name, title, contact information, signature, date; CMS representative name, title, contact information, signature and date; and concurrence/non-concurrence signatures and dates from 3 CMS System Manager or Business Owners. While the data elements collected are not subject to change, the individualized clauses that are incorporated into any specific DUA are subject to change based on a specific case or situation such as disclosures to states, oversight agencies or DUAs for disproportionate share hospital (DSH) data requests as well as updates to DUAs with additional data descriptions, changes to the requestor or adding custodians to current DUAs.
Authorizing Statute(s):
US Code:
5 USC 552(a)
Name of Law: The Privacy Act of 1974
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
79 FR 36516
06/27/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 53067
09/05/2014
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Data Use Agreement Information Collection Requirements, Model Language, and Supporting Regulations in 45 CFR Section 5b
CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235, CMS-R-235
CMS-R-235.Tab_2a
,
CMS-R-235.Tab_2b
,
CMS-R-235.Tab_2e
,
CMS-R-235.Tab_2i
,
CMS-R-235.Tab_2j
,
CMS-R-235.Tab_2f
ICR Summary 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
9,240
2,200
0
7,040
0
0
Annual Time Burden (Hours)
2,742
1,100
0
1,642
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:
The burden has increased due to numerous new CMS sponsored programs which are aimed at getting data out to the health care community to encourage innovative changes to reduce the cost of health care for Medicare and Medicaid beneficiaries. These new programs have increased our work load for new data use agreements with corresponding increases to the number of data use agreement addendums and updates.
Annual Cost to Federal Government:
$313,488
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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?
Uncollected
Agency Contact:
Kayla Williams 410 786-5887 kayla.williams@cms.hhs.gov
Common Form ICR:
No
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:
11/18/2014
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