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 

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 

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 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: 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 / Notices 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; Reform of Requirements for Long-Term Care Facilities; Final rule 

(CMS–3260–F) Published October 4, 2016.

81 FR 68688 .. All ICRs, except as 

noted below. 

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.

85 FR 54820 .. Section 483.80(h)— 

COVID–19 Testing. 

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.

86 FR 26306 .. Sections 483.80(d)(3)— 

COVID–19 immunizations and (g)(1)(viii)– 

(x). 

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.

86 FR 62240 .. Section 483.80(g). 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
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. 

ACTION: Notice of availability; reopening 

of the comment period. 

SUMMARY: 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 

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. 

• 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-2015- 

09-18/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 


khammond on DSKJM1Z7X2PROD with NOTICES