[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24308-24309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10141, CMS-R-235 and CMS-10515]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

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

ACTION: Notice.

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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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by May 25, 2022.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

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

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Prescription Drug Benefit Program; Use: Plan sponsor and State 
information is used by CMS to approve contract applications, monitor 
compliance with contract requirements, make proper payment to plans, 
and ensure that correct information is disclosed to potential and 
current enrollees. Form Number: CMS-10141 (OMB control number: 0938-
0964); Frequency: Annually; Affected Public: Private Sector and 
Business or other for-profit institutions; Number of Respondents: 
11,771,497; Total Annual Responses: 675,231,213; Total Annual Hours: 
9,261,354. (For policy questions regarding this collection contact Chad 
D. Buskirk at 410-786-1630.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Use 
Agreement (DUA) Form, Research Identifiable Files Request Packet, and 
Data Management Plan; Use: CMS is permitted to disclose data files for 
approved research purposes in compliance with 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.

[[Page 24309]]

    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. Form Number: CMS-R-235 
(OMB control number: 0938-0734); Frequency: Occasionally; Affected 
Public: Private Sector, State, Local, or Tribal Governments, Federal 
Government (Business or for-profits and Not-for-profit institutions); 
Number of Respondents: 9,655; Total Annual Responses: 9,655; Total 
Annual Hours: 3,875. (For policy questions regarding this collection, 
contact Kari A. Gaare at 410-786-8612.)
    3. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Payment Collections Operations Contingency Plan; Use: Under sections 
1401, 1411, and 1412 of the Patient Protection and Affordable Care Act 
(PPACA) and 45 CFR part 155 subpart D, an Exchange makes an advance 
determination of tax credit eligibility for individuals who enroll in 
QHP coverage through the Exchange and seek financial assistance. Using 
information available at the time of enrollment, the Exchange 
determines whether the individual meets the income and other 
requirements for advance payments and the amount of the advance 
payments that can be used to pay premiums. Advance payments are made 
periodically under section 1412 of the PPACA to the issuer of the QHP 
in which the individual enrolls. Section 1402 of the PPACA provides for 
the reduction of cost sharing for certain individuals enrolled in a QHP 
through an Exchange, and section 1412 of the PPACA provides for the 
advance payment of these reductions to issuers. The statute directs 
issuers to reduce cost sharing for essential health benefits for 
individuals with household incomes between 100 and 400 percent of the 
Federal poverty level (FPL) who are enrolled in a silver level QHP 
through an individual market Exchange and are eligible for advance 
payments of the premium tax credit. Until January 2016, HHS collected 
data required to meet these statutory requirements via a manual system 
in which issuers submitted data. HHS now has an automated system that 
does not require issuer data submission for FFE issuers. The data 
collection has been used by HHS to make payments or collect charges 
from SBE issuers under the following programs: Advance payments of the 
premium tax credit, advanced cost-sharing reductions, and Exchange user 
fees. The workbook template was used to make payments in January 2014 
and will continue for issuers in states transitioning to a State-Based 
Exchange, as may be required based on HHS's operational progress. Form 
Number: CMS-10515 (OMB Control Number: 0938-1217); Frequency: 
Occasionally; Affected Public: Private Sector--Business or other for-
profits and not-for-profit institutions; Number of Respondents: 50; 
Total Annual Responses: 600; Total Annual Hours: 3,051. (For policy 
questions regarding this collection contact Christelle Jang at 410-786-
8438.)

     Dated: April 19, 2022.
William N. Parham III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-08683 Filed 4-22-22; 8:45 am]
BILLING CODE 4120-01-P