[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Pages 78855-78856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26859]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10733]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by February 5, 2021.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number _____, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10733 Data Management Plan Self-Attestation Questionnaire (DMP SAQ)

    Under the 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. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Data 
Management Plan Self-Attestation Questionnaire (DMP SAQ); Use: The 
Privacy Act of 1974 allows for discretionary releases of data 
maintained in Privacy Act protected systems of records under Sec.  
552a(b) (Conditions of Disclosure). The mandate to account for 
disclosures of data under the Privacy Act is found at Sec.  
552a(c)(Accounting of Certain Disclosures). This section states that 
certain information must be maintained regarding disclosures made by 
each agency. This information is: Date, Nature, Purpose, and Name/
Address of Recipient. Section 552a(e) sets the overall Agency 
Requirements that each agency must meet in order to maintain records 
under the Privacy Act. The Data Use Agreement (DUA) form is needed as 
part of the review of each CMS data request to ensure compliance with 
the requirements of the Privacy Act for disclosures that contain PII.
    The DUA legally binds the user to the Agreement's terms. The user 
must agree to all the terms and sign off on them prior to the release 
or access to data files containing protected health information, and 
individual identifiers. The DMP SAQ is a technical, evidence-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.

[[Page 78856]]

Form Number: CMS-10733 (OMB control number: 0938-New); Frequency: 
Annually; Affected Public: Private Sector, State, Local, or Tribal 
Governments, Federal Government, Business or other for-profits, Not-
for-profits institutions; Number of Respondents: 1,000; Total Annual 
Responses: 1,000; Total Annual Hours: 1,500. (For policy questions 
regarding this collection contact James Krometis at 410-786-0340.)

    Dated: December 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-26859 Filed 12-4-20; 8:45 am]
BILLING CODE 4120-01-P