Agency Information Collection Activities: Proposed Collection; Comment Request, 14536-14538 [2022-05360]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 14536 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices patient-centeredness of laboratory services; revisions to the standards under which clinical laboratories are regulated; the impact of proposed revisions to the standards on medical and laboratory practice; and the modification of the standards and provision of non-regulatory guidelines to accommodate technological advances, such as new test methods, the electronic transmission of laboratory information, and mechanisms to improve the integration of public health and clinical laboratory practices. Matters To Be Considered: The agenda will include agency updates from CDC, CMS, and FDA. In addition to the general updates, an update will be provided on the ongoing CLIAC workgroups. Presentations and CLIAC discussion will focus on the future of laboratory medicine, especially testing in non-traditional sites. There will be an extended public comment session focusing on anticipated changes in testing practices, personnel issues, and emerging technologies used in nontraditional testing sites. Agenda items are subject to change as priorities dictate. It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments pertinent to agenda items. Public comment periods for each agenda item are scheduled immediately prior to the Committee discussion period for that item. In general, each individual or group requesting to present an oral comment will be limited to a total time of five minutes (unless otherwise indicated). Speakers should email CLIAC@cdc.gov or notify the contact person at least five business days prior to the meeting date. For individuals or groups unable to attend the meeting, CLIAC accepts written comments until the date of the meeting (unless otherwise stated). However, it is requested that comments be submitted at least five business days prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. All written comments will be included in the meeting Summary Report posted on the CLIAC website. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and VerDate Sep<11>2014 21:10 Mar 14, 2022 Jkt 256001 Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2022–05430 Filed 3–14–22; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10573 and CMS– 10106] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 May 16, 2022. 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 https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection SUMMARY: PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 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: llll, 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-andGuidance/Legislation/Paperwork ReductionActof1995/PRA-Listing. 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–10573 Reform of Requirements for Long-Term Care Facilities CMS–10106 Medicare Authorization to Disclose Personal Health Information 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: Revision of a currently approved collection; Title of Information Collection: Reform of Requirements for Long-Term Care Facilities; Use: According to our data, as of April 2, 2021, there were 15,372 LTC E:\FR\FM\15MRN1.SGM 15MRN1 14537 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices facilities in the United States. These facilities are currently caring for 1,290,290 residents. Since the number of LTC facilities and residents varies yearly, for the purposes of this analysis, we utilized estimates of 15,600 for LTC facilities and 1.3 million residents. LTC facilities include skilled nursing facilities (SNFs) as defined in section 1819(a) of the Social Security Act in the Medicare program and nursing facilities (NFs) as defined in 1919(a) of the Act in the Medicaid program. SNFs and NFs provide skilled nursing care and related services for residents who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. In addition, NFs provide health-related care and services to individuals who because of their mental or physical condition require care and services (above the level of room and board) which can be made available to them only through institutional facilities, and is not primarily for the care and treatment of mental diseases. SNFs and NFs must care for their residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident and must provide to residents services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care, which describes the medical, nursing, and psychosocial needs of the resident and how such needs will be met and is updated periodically. Under the authority of sections 1819 and 1919 of the Act, the Secretary proposed to reform the requirements that SNFs and NFs must meet to participate in the Medicare & Medicaid programs. These requirements would be set forth in 42 CFR 483 subpart B as Requirements for LTC Care Facilities. The requirements apply to an LTC facility as an entity as well as the services furnished to each individual under the care of the LTC facility, unless a requirement is specifically limited to Medicare or to Medicaid beneficiaries. To implement these requirements, State survey agencies generally conduct surveys of LTC facilities to determine whether or not they are complying with the requirements. Ordinarily, we would be required to estimate the public reporting burden for information collection requirements (ICRs) for these regulations in accordance with chapter 35 of title 44, United States Code. However, sections 4204(b) and 4214(d) of Omnibus Budget Reconciliation Act of 1987, Public Law 100–203 (OBRA ’87) provide for a waiver of Paperwork Reduction Act (PRA) requirements for some regulations. At the time that the 2016 LTC final rule (81 FR 68688) published, we believed that this waiver still applied to those updates we made to existing requirements in part 483 subpart B that were set forth by OBRA 87. However, we acknowledged that the 2016 final rule also extensively revised many of the existing requirements in part 483 subpart B and recognized that the revisions likely created new burdens for facilities. In addition, we noted that the 2016 final rule implemented several new requirements set forth by the Affordable Care Act, which were not included in the PRA waiver. Therefore, we provided burden estimates for the new ICRs finalized in the 2016 LTC final rule set forth by the Affordable Care Act, as well as those revisions to existing requirements in part 483 subpart B that were so extensive they could be considered new ICRs in concept. For the current or 2022 information collection request (ICR), we have provided updates to the burden in the 2019 ICR, as well as provided burden estimates for all of the new ICs finalized since 2016 that were in effect as of May 2021. The ICRs and the rules they were finalized in are indicated in table below. khammond on DSKJM1Z7X2PROD with NOTICES ICRS ASSOCIATED WITH EACH RULE Rule name and publication date FR citation Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; Final rule (CMS–3260–F) Published October 4, 2016. Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency; IFC (CMS–3401–IFC) Published September 2, 2020. Medicare and Medicaid Programs; COVID–19 Vaccine Requirements for Long Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs–IID) Residents, Clients, and Staff); IFC (CMS–3414–IFC) (May 2021 Vaccination IFC) Published May 13, 2021. Medicare and Medicaid Programs: CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID–19 Reporting Requirements for Long-Term Care Facilities (86 FR 62240) (CMS–1747–F and CMS–5531–F). Published November 9, 2021. 81 FR 68688 .. The primary users of this information will be State agency surveyors, CMS, and the LTC facilities for the purposes of ensuring compliance with Medicare and Medicaid requirements as well as ensuring the quality of care provided to LTC facility residents. The ICs specified in the regulations may be used as a basis for determining whether a LTC is meeting the requirements to participate in the Medicare program. In addition, the information collected for purposes of ensuring compliance may be used to VerDate Sep<11>2014 21:10 Mar 14, 2022 Jkt 256001 inform the data provided on CMS’ Nursing Home Compare website and as such used by the public in considering nursing home selections for services. Form Number: CMS–10573 (OMB control number: 0938–1363); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profit and not-for-profit institutions; Number of Respondents: 15,600; Total Annual Responses: 18,658,854; Total Annual Hours: 29,935,899. (For policy questions PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 85 FR 54820 .. 86 FR 26306 .. 86 FR 62240 .. ICRs All ICRs, except as noted below. Section 483.80(h)— COVID–19 Testing. Sections 483.80(d)(3)— COVID–19 immunizations and (g)(1)(viii)– (x). Section 483.80(g). regarding this collection contact Diane Corning at 410–786–8486.) 2. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Medicare Authorization to Disclose Personal Health Information; Use: The ‘‘Medicare Authorization to Disclose Personal Health Information’’ will be used by Medicare beneficiaries to authorize Medicare to disclose their protected health information to a third E:\FR\FM\15MRN1.SGM 15MRN1 14538 Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices party. Medicare beneficiaries can submit the Medicare Authorization to Disclose Personal Health Information electronically at Medicare.gov. Beneficiaries may also submit the Medicare Authorization to Disclose Personal Health Information by mailing a complete and valid authorization form to Medicare. Beneficiaries can submit the Medicare Authorization to Disclose Personal Health Information verbally over the phone by calling Medicare. Form Number: CMS–10106 (OMB control number: 0938–0930); Frequency: Occasionally; Affected Public: Individuals or households; Number of Respondents: 1,000,000; Total Annual Responses: 1,000,000; Total Annual Hours: 250,000. (For policy questions regarding this collection contact Sam Jenkins at 410–786–3261.) Dated: March 9, 2022. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2022–05360 Filed 3–14–22; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0367] Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-Forming Fish and Fishery Products— Decomposition and Histamine; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or we) is reopening the comment period for the draft Compliance Policy Guide entitled ‘‘Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine’’ that published in the Federal Register of December 27, 2021. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to develop and submit data, other information, and comments before FDA begins work on the final guidance. DATES: FDA is reopening the comment period for the draft Compliance Policy Guide announced in the Federal Register on December 27, 2021 (86 FR 73295). Submit either electronic or khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:10 Mar 14, 2022 Jkt 256001 written comments on the draft guidance by April 14, 2022, to ensure that we consider your comments before we begin work on the final guidance. ADDRESSES: You may submit comments on any guidance at any time as follows. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–D–0367 for ‘‘Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and Histamine.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Division of Seafood Safety (HFS–325), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–5316, email: Steven.Bloodgood@fda.hhs.gov; or Jessica Larkin, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. SUPPLEMENTARY INFORMATION: In the Federal Register of December 27, 2021 (86 FR 73295), we published a notice announcing the availability of a draft Compliance Policy Guide (CPG) entitled ‘‘Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products—Decomposition and E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14536-14538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05360]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10573 and CMS-10106]


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 May 16, 2022.

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 
https://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.

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-10573 Reform of Requirements for Long-Term Care Facilities
CMS-10106 Medicare Authorization to Disclose Personal Health 
Information

    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: Revision of a currently 
approved collection; Title of Information Collection: Reform of 
Requirements for Long-Term Care Facilities; Use: According to our data, 
as of April 2, 2021, there were 15,372 LTC

[[Page 14537]]

facilities in the United States. These facilities are currently caring 
for 1,290,290 residents. Since the number of LTC facilities and 
residents varies yearly, for the purposes of this analysis, we utilized 
estimates of 15,600 for LTC facilities and 1.3 million residents. LTC 
facilities include skilled nursing facilities (SNFs) as defined in 
section 1819(a) of the Social Security Act in the Medicare program and 
nursing facilities (NFs) as defined in 1919(a) of the Act in the 
Medicaid program. SNFs and NFs provide skilled nursing care and related 
services for residents who require medical or nursing care, or 
rehabilitation services for the rehabilitation of injured, disabled, or 
sick persons. In addition, NFs provide health-related care and services 
to individuals who because of their mental or physical condition 
require care and services (above the level of room and board) which can 
be made available to them only through institutional facilities, and is 
not primarily for the care and treatment of mental diseases. SNFs and 
NFs must care for their residents in such a manner and in such an 
environment as will promote maintenance or enhancement of the quality 
of life of each resident and must provide to residents services to 
attain or maintain the highest practicable physical, mental, and 
psychosocial well-being of each resident, in accordance with a written 
plan of care, which describes the medical, nursing, and psychosocial 
needs of the resident and how such needs will be met and is updated 
periodically.
    Under the authority of sections 1819 and 1919 of the Act, the 
Secretary proposed to reform the requirements that SNFs and NFs must 
meet to participate in the Medicare & Medicaid programs. These 
requirements would be set forth in 42 CFR 483 subpart B as Requirements 
for LTC Care Facilities. The requirements apply to an LTC facility as 
an entity as well as the services furnished to each individual under 
the care of the LTC facility, unless a requirement is specifically 
limited to Medicare or to Medicaid beneficiaries. To implement these 
requirements, State survey agencies generally conduct surveys of LTC 
facilities to determine whether or not they are complying with the 
requirements.
    Ordinarily, we would be required to estimate the public reporting 
burden for information collection requirements (ICRs) for these 
regulations in accordance with chapter 35 of title 44, United States 
Code. However, sections 4204(b) and 4214(d) of Omnibus Budget 
Reconciliation Act of 1987, Public Law 100-203 (OBRA '87) provide for a 
waiver of Paperwork Reduction Act (PRA) requirements for some 
regulations. At the time that the 2016 LTC final rule (81 FR 68688) 
published, we believed that this waiver still applied to those updates 
we made to existing requirements in part 483 subpart B that were set 
forth by OBRA 87. However, we acknowledged that the 2016 final rule 
also extensively revised many of the existing requirements in part 483 
subpart B and recognized that the revisions likely created new burdens 
for facilities. In addition, we noted that the 2016 final rule 
implemented several new requirements set forth by the Affordable Care 
Act, which were not included in the PRA waiver. Therefore, we provided 
burden estimates for the new ICRs finalized in the 2016 LTC final rule 
set forth by the Affordable Care Act, as well as those revisions to 
existing requirements in part 483 subpart B that were so extensive they 
could be considered new ICRs in concept. For the current or 2022 
information collection request (ICR), we have provided updates to the 
burden in the 2019 ICR, as well as provided burden estimates for all of 
the new ICs finalized since 2016 that were in effect as of May 2021. 
The ICRs and the rules they were finalized in are indicated in table 
below.

                     ICRs Associated With Each Rule
------------------------------------------------------------------------
 Rule name and publication date       FR citation             ICRs
------------------------------------------------------------------------
Medicare and Medicaid Programs;  81 FR 68688.........  All ICRs, except
 Reform of Requirements for                             as noted below.
 Long-Term Care Facilities;
 Final rule (CMS-3260-F)
 Published October 4, 2016.
Medicare and Medicaid Programs,  85 FR 54820.........  Section
 Clinical Laboratory                                    483.80(h)--COVID
 Improvement Amendments (CLIA),                         -19 Testing.
 and Patient Protection and
 Affordable Care Act;
 Additional Policy and
 Regulatory Revisions in
 Response to the COVID-19
 Public Health Emergency; IFC
 (CMS-3401-IFC) Published
 September 2, 2020.
Medicare and Medicaid Programs;  86 FR 26306.........  Sections
 COVID-19 Vaccine Requirements                          483.80(d)(3)--CO
 for Long Term Care (LTC)                               VID-19
 Facilities and Intermediate                            immunizations
 Care Facilities for                                    and (g)(1)(viii)-
 Individuals with Intellectual                          (x).
 Disabilities (ICFs-IID)
 Residents, Clients, and
 Staff); IFC (CMS-3414-IFC)
 (May 2021 Vaccination IFC)
 Published May 13, 2021.
Medicare and Medicaid Programs:  86 FR 62240.........  Section
 CY 2022 Home Health                                    483.80(g).
 Prospective Payment System
 Rate Update; Home Health Value-
 Based Purchasing Model
 Requirements and Model
 Expansion; Home Health and
 Other Quality Reporting
 Program Requirements; Home
 Infusion Therapy Services
 Requirements; Survey and
 Enforcement Requirements for
 Hospice Programs; Medicare
 Provider Enrollment
 Requirements; and COVID-19
 Reporting Requirements for
 Long-Term Care Facilities (86
 FR 62240) (CMS-1747-F and CMS-
 5531-F). Published November 9,
 2021.
------------------------------------------------------------------------

    The primary users of this information will be State agency 
surveyors, CMS, and the LTC facilities for the purposes of ensuring 
compliance with Medicare and Medicaid requirements as well as ensuring 
the quality of care provided to LTC facility residents. The ICs 
specified in the regulations may be used as a basis for determining 
whether a LTC is meeting the requirements to participate in the 
Medicare program. In addition, the information collected for purposes 
of ensuring compliance may be used to inform the data provided on CMS' 
Nursing Home Compare website and as such used by the public in 
considering nursing home selections for services. Form Number: CMS-
10573 (OMB control number: 0938-1363); Frequency: Occasionally; 
Affected Public: Private Sector: Business or other for-profit and not-
for-profit institutions; Number of Respondents: 15,600; Total Annual 
Responses: 18,658,854; Total Annual Hours: 29,935,899. (For policy 
questions regarding this collection contact Diane Corning at 410-786-
8486.)
    2. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Medicare Authorization to Disclose Personal Health 
Information; Use: The ``Medicare Authorization to Disclose Personal 
Health Information'' will be used by Medicare beneficiaries to 
authorize Medicare to disclose their protected health information to a 
third

[[Page 14538]]

party. Medicare beneficiaries can submit the Medicare Authorization to 
Disclose Personal Health Information electronically at Medicare.gov. 
Beneficiaries may also submit the Medicare Authorization to Disclose 
Personal Health Information by mailing a complete and valid 
authorization form to Medicare. Beneficiaries can submit the Medicare 
Authorization to Disclose Personal Health Information verbally over the 
phone by calling Medicare. Form Number: CMS-10106 (OMB control number: 
0938-0930); Frequency: Occasionally; Affected Public: Individuals or 
households; Number of Respondents: 1,000,000; Total Annual Responses: 
1,000,000; Total Annual Hours: 250,000. (For policy questions regarding 
this collection contact Sam Jenkins at 410-786-3261.)

    Dated: March 9, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-05360 Filed 3-14-22; 8:45 am]
BILLING CODE P
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