[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28014-28015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10286 & CMS-10630]


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 June 9, 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: 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,

[[Page 28015]]

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: Extension of a currently 
approved collection; Title of Information Collection: Notice of 
Research Exception under the Genetic Information Nondiscrimination Act; 
Use: Under the Genetic Information Nondiscrimination Act of 2008 
(GINA), a plan or issuer may request (but not require) a genetic test 
in connection with certain research activities so long as such 
activities comply with specific requirements, including: (i) The 
research complies with 45 CFR part 46 or equivalent federal regulations 
and applicable State or local law or regulations for the protection of 
human subjects in research; (ii) the request for the participant or 
beneficiary (or in the case of a minor child, the legal guardian of 
such beneficiary) is made in writing and clearly indicates that 
compliance with the request is voluntary and that non-compliance will 
have no effect on eligibility for benefits or premium or contribution 
amounts; and (iii) no genetic information collected or acquired will be 
used for underwriting purposes. The Secretary of Labor or the Secretary 
of Health and Human Services is required to be notified if a group 
health plan or health insurance issuer intends to claim the research 
exception permitted under Title I of GINA. Nonfederal governmental 
group health plans and issuers solely in the individual health 
insurance market or Medigap market will be required to file with the 
Centers for Medicare & Medicaid Services (CMS). The Notice of Research 
Exception under the Genetic Information Nondiscrimination Act is a 
model notice that can be completed by group health plans and health 
insurance issuers and filed with either the Department of Labor or CMS 
to comply with the notification requirement. Form Number: CMS-10286, 
OMB control number: 0938-1077; Frequency: On Occasion; Affected Public: 
Private Sector; State, Local or Tribal governments; Number of 
Respondents: 2; Total Annual Responses: 2; Total Annual Hours: 1. (For 
policy questions regarding this collection contact Usree Bandyopadhyay 
at 410-786-6650)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: The PACE 
Organization (PO) Monitoring and Audit Process in 42 CFR part 460; Use: 
Sections 1894(e)(4) and 1934(e)(4) of the Act and the implementing 
regulations at 42 CFR 460.190 and 460.192 state that CMS, in 
conjunction with the State Administering Agency (SAA), must oversee a 
PACE organization's continued compliance with the requirements for a 
PACE organization.
    The data collected with the data request tools included in this 
package allow CMS to conduct a comprehensive review of PACE 
organizations' compliance in accordance with specific federal 
regulatory requirements. The information gathered during this audit 
will be used by the Medicare Parts C and D Oversight and Enforcement 
Group (MOEG) within the Center for Medicare (CM), as well as the SAA, 
to assess POs' compliance with PACE program requirements. If outliers 
or other data anomalies are detected, other offices within CMS will 
work in collaboration with MOEG for follow-up and resolution. 
Additionally, POs will receive the audit results, and will be required 
to implement corrective action to correct any identified deficiencies. 
Form Number: CMS-10630 (OMB control number: 0938-1327); Frequency: 
Annually; Affected Public: Private Sector, State, Local, or Tribal 
Governments and Business or other for-profit institutions; Number of 
Respondents: 40; Total Annual Responses: 40; Total Annual Hours: 
31,200. (For policy questions regarding this collection contact 
Kathleen Flannery at 410-786-6722.)

    Dated: May 5, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-10026 Filed 5-9-22; 8:45 am]
BILLING CODE 4120-01-P