Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices 36751 

• An opportunity for public comment 

• Meeting summary, review of 

recommendations, and next steps 

Individuals or organizations that wish 

to make a 5-minute oral presentation on 

an agenda topic should submit a written 

copy of the oral presentation to the DFO 

at the address listed in the ADDRESSES

section of this notice by the date listed 

in the DATES section of this notice. The 

number of oral presentations may be 

limited by the time available. 

Individuals not wishing to make an oral 

presentation may submit written 

comments to the DFO at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

III. Meeting Participation 

The meeting is open to the public, but 

attendance is limited to registered 

participants. Persons wishing to attend 

this meeting must register at the website 

https://www.eventbrite.com/e/apoe-july28-2021-virtual-meeting-tickets151112584809 or contact the DFO at the 

address or number listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice by the date specified in the 

DATES section of this notice. This 

meeting will be held virtually. 

Individuals who are not registered in 

advance will be unable to attend the 

meeting. 

IV. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: June 30, 2021. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2021–14830 Filed 7–12–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–2567] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is requesting 

that this information collection request 

(ICR), for revisions to the form CMS– 

2567 be processed under the emergency 

Paperwork Reduction Act of 1995 (PRA) 

clearance process. 

DATES: Comments must be received by 

August 12, 2021. 

ADDRESSES: When commenting, please 

reference the document identifier 

(CMS–2567) or OMB control number 

(0938–0391). 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: CMS–R–39/OMB Control 

Number 0938–0365, 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 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

FOR FURTHER INFORMATION CONTACT: 

William Parham, Reports Clearance 

Office at (410) 786–1326. 

SUPPLEMENTARY INFORMATION: In 

December, 2020, Congress passed the 

Consolidated Appropriations Act, 2021 

(CAA, 2021). Section 407 of CAA, 2021, 

amended Part A of Title XVIII of the 

Social Security Act (the Act) at section 

1822 establishing hospice program 

survey and enforcement requirements. 

This amendment, in part, now requires 

the Accrediting Organizations (AOs) 

that accredit hospice programs to 

include the form CMS–2567 to 

document the findings of their hospice 

program surveys beginning on October 

1, 2021. Public harm is reasonably likely 

to ensue if the normal, non-emergency 

clearance procedures are followed. CMS 

would miss the statutorily mandated 

deadline of October 1, 2021 for 

Accrediting Organizations (AOs), with a 

hospice program, to begin using the 

form CMS–2567. AOs will not have the 

revised form to include in their current 

survey documentation systems and 

processes and will not meet the 

deadline of October 1, 2021 for 

beginning use. If CMS misses the 

deadline, it will jeopardize another 

CAA, 2021 mandated provision 

deadline for public posting of these AO 

hospice program survey reports on our 

website. The purpose of this 

requirement is for public transparency 

of survey and certification information. 

This statutory provision requires that 

the hospice program survey reports be 

posted by no later than October 1, 2022. 

Additionally, the public may not have 

all the information necessary to make an 

informed decision regarding where they 

seek high quality, safe care hospice 

program organizations for themselves or 

loved ones. Beneficiaries and the public 

at large utilize survey findings when 

evaluating whether to receive care from 

certain facilities. 

Under the PRA, federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed ICR. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this ICR including the necessity and 

utility of the proposed ICR 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. 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following ICR. More detailed 

information can be found in the 

collection’s supporting statement and 

associated materials (see ADDRESSES). 

CMS–2567 Statement of Deficiency 

and Plan of Correction 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 


jbell on DSKJLSW7X2PROD with NOTICES
36752 Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices 

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. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Statement of 

Deficiency and Plan of Correction Use: 

The form CMS–2567 is the means by 

which State and CMS surveyors 

document findings of compliance or 

noncompliance (deficiencies) resulting 

from inspection of Medicare, Medicaid, 

and Clinical Laboratory Improvement 

Amendments (CLIA) laboratories. The 

form CMS–2567 is the legal, 

documentary basis for CMS’ 

certification of a facility’s compliance or 

noncompliance with the Medicare/ 

Medicaid Conditions of Participation or 

Coverage, and the requirements for 

Nursing Home participation and CLIA 

certification. 

In December, 2020, Congress passed 

the Consolidated Appropriations Act, 

2021 (CAA, 2021). Section 407 of CAA, 

2021, amended Part A of Title XVIII of 

the Social Security Act (the Act) at 

section 1822 establishing hospice 

program survey and enforcement 

requirements. This amendment, in part, 

now requires the Accrediting 

Organizations (AOs) that accredit 

hospice programs to include the form 

CMS–2567 to document the findings of 

their hospice program surveys 

beginning on October 1, 2021. As of 

June 2021, there are three AOs with 

CMS-approved hospice accreditation 

programs. The AOs survey 

approximately half of the over 5,000 

Medicare-certified hospice programs, 

while the SAs survey the remaining 

half. 

To enable AOs to use the form CMS– 

2567, we must revise it by adding fields 

for the AO name. Also, the instructions 

must be updated to include AOs as 

another group which utilizes the form 

CMS–2567. We have also included the 

burden calculations from CMS–1747–P 

(Medicare and Medicaid Programs; CY 

2022 Home Health Prospective Payment 

System Rate Update), related to the onetime update needed to each of AO’s 

proprietary electronic systems in order 

to use the form CMS–2567 as directed 

by the CAA, 2021. Form Numbers: 

CMS–2567 (OMB control number: 

0938–0391); Frequency: Yearly and 

Occasionally; Affected Public: Private 

Sector (Business or for-profits and Notfor-profit institutions); Number of 

Respondents: 65,948; Total Annual 

Responses: 65,948; Total Annual Hours: 

1,210,376. (For policy questions 

regarding this collection contact 

Caroline Gallaher at 410–786–8705.) 

Dated: July 8, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–14866 Filed 7–12–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0895] 

Issuance of Priority Review Voucher; 

Material Threat Medical 

Countermeasure Product 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a material threat medical 

countermeasure (MCM) product 

application. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that 

STRATAGRAFT (allogeneic cultured 

keratinocytes and dermal fibroblasts in 

murine collagen—dsat), manufactured 

by Stratatech, a Mallinckrodt Company, 

meets the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Shruti Modi, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a material 

threat MCM priority review voucher to 

the sponsor of an approved material 

threat MCM product application. Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a), which was added by the 

Cures Act (Pub. L. 114–255), FDA will 

award priority review vouchers to 

sponsors of approved material threat 

MCM product applications that meet 

certain criteria upon approval of those 

applications. FDA has determined that 

STRATAGRAFT (allogeneic cultured 

keratinocytes and dermal fibroblasts in 

murine collagen—dsat), manufactured 

by Stratatech, a Mallinckrodt Company, 

meets the criteria for a material threat 

MCM priority review voucher. 

STRATAGRAFT is indicated for the 

treatment of adults with thermal burns 

containing intact dermal elements for 

which surgical intervention is clinically 

indicated (deep partial-thickness burns). 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further 

information about STRATAGRAFT 

(allogeneic cultured keratinocytes and 

dermal fibroblasts in murine collagen— 

dsat), go to the Center for Biologics 

Evaluation and Research Approved 

Cellular and Gene Therapy Products 

website at https://www.fda.gov/ 

vaccines-blood-biologics/cellular-genetherapy-products/approved-cellularand-gene-therapy-products. 

Dated: July 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14779 Filed 7–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1048] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

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, 


jbell on DSKJLSW7X2PROD with NOTICES