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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10545 and CMS-R-185]

# 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 (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 August 30, 2021.

# 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:*                     Outcome and Assessment Information Set (OASIS) OASIS-D;                     *Use:*                     Due to the COVID-19 related Public Health Emergency, the next version of the Outcome and Assessment Information Set (OASIS), version E planned for implementation January 1, 2021, was delayed. This request is for the Office of Management and Budget (OMB) approval to extend the current OASIS-D expiration date in order for home health agencies to continue data collection required for participation in the Medicare program. The current version of the OASIS-D, data item set was approved by OMB on December 6, 2018 and implemented on January 1, 2019. This request includes updated calculations using 2020 data for                           ( print page 40846)                        wages, number of home health agencies and number of OASIS assessments at each time point.                     *Form Number:*                     CMS-10545 (OMB control number: 0938-1279);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector (Business or other for-profit and Not-for-profit institutions);                     *Number of Respondents:*                     11,400;                     *Total Annual Responses:*                     17,932,166;                     *Total Annual Hours:*                     9,893,376. (For policy questions regarding this collection contact Joan Proctor at 410-786-0949).                

                    2.                     *Type of Information Collection Request:*                     Extension of currently approved collection;                     *Title of Information Collection:*                     Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs;                     *Use:*                     The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). If an accreditation organization is approved, the laboratories that it accredits are “deemed” to meet the CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements. The information collected will be used by HHS to: Determine comparability/equivalency of the accreditation organization standards and policies or State licensure program standards and policies to those of the CLIA program; to ensure the continued comparability/equivalency of the standards; and to fulfill certain statutory reporting requirements.                     *Form Number:*                     CMS-R-185 (OMB control number: 0938-0686);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector—Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     9;                     *Total Annual Responses:*                     9;                     *Total Annual Hours:*                     5,464. (For policy questions regarding this collection contact Arlene Lopez at 410-786-6782.)                

Dated: July 26, 2021.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. 

[FR Doc. 2021-16205 Filed 7-28-21; 8:45 am]

BILLING CODE 4120-01-P