Federal Register / Vol. 87, No. 71 / Wednesday, April 13, 2022 / Notices 21887 

April 22, at 5 p.m. Eastern Time. 

Members of the public are encouraged 

to submit registration requests via email 

in advance of the deadline. Seating for 

members of the public is limited and 

will be available on a first-come, firstserved basis for those who register in 

advance. We will note when the limit of 

in-person attendees has been reached. If 

you have accessibility concerns and 

require assistance, contact secretary@

fmc.gov. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Dylan Richmond, Designated Federal 

Officer of the National Shipper 

Advisory Committee, phone: (202) 523– 

5810; email: drichmond@fmc.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The National Shipper 

Advisory Committee is a federal 

advisory committee. It operates under 

the provisions of the Federal Advisory 

Committee Act, 5 U.S.C. app., and 46 

U.S.C. chapter 425. The Committee was 

established on January 1, 2021, when 

the National Defense Authorization Act 

for Fiscal Year 2021 became law. Public 

Law 116–283, section 8604, 134 stat. 

3388 (2021). The Committee will 

provide information, insight, and 

expertise pertaining to conditions in the 

ocean freight delivery system to the 

Commission. Specifically, the 

Committee will advise the Federal 

Maritime Commission on policies 

relating to the competitiveness, 

reliability, integrity, and fairness of the 

international ocean freight delivery 

system. 46 U.S.C. 42502(b). 

The Committee will hear from 

Commissioner Bentzel for an update on 

the Maritime Transportation Data 

Initiative. They will also receive 

updates from each of its subcommittees. 

The Committee will receive proposals 

for recommendations to the Federal 

Maritime Commission and may vote on 

these recommendations. These 

recommendations will also be available 

for the public to view in advance of the 

meeting on the NSAC’s website, https:// 

www.fmc.gov/industry-oversight/ 

national-shipper-advisory-committee/. 

Public Comments: Members of the 

public may submit written comments to 

NSAC at any time. Comments should be 

addressed to NSAC, c/o Dylan 

Richmond, Federal Maritime 

Commission, 800 North Capitol St NW, 

Washington, DC 20573 or nsac@

fmc.gov. 

The Committee will also take public 

comment at its meeting. If attending the 

meeting and providing comments, 

please note that in the registration 

request. Comments are most helpful if 

they address the Committee’s objectives 

or their proposed recommendations. 

Comments at the meeting will be 

limited to 3 minutes each. 

A copy of all meeting documentation, 

including meeting minutes, will be 

available at www.fmc.gov following the 

meeting. 

By the Commission. 

Dated: April 8, 2022. 

William Cody, 

Secretary. 

[FR Doc. 2022–07896 Filed 4–12–22; 8:45 am] 

BILLING CODE 6730–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10680 and 

CMS–10692] 

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 

June 13, 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: ll, 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 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

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–10680 Electronic Visit Verification 

Compliance Survey 

CMS–10692 Home and Community 

Based Services (HCBS) Incident 

Management Survey 

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. Title of Information Collection: 

Electronic Visit Verification Compliance 


jspears on DSK121TN23PROD with NOTICES1
21888 Federal Register / Vol. 87, No. 71 / Wednesday, April 13, 2022 / Notices 

Survey; Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Use: The 

web-based survey will allow states to 

self-report their progress in 

implementing electronic visit 

verification (EVV) for personal care 

services (PCS) and home health care 

services (HHCS), as required by section 

1903(l) of the Social Security Act. CMS 

will use the survey data to assess states’ 

compliance with section 1903(l) of the 

Act and levy Federal Medical 

Assistance Percentage (FMAP) 

reductions where necessary as required 

by 1903(l) of the Act. 

The survey will be disseminated to all 

51 state Medicaid agencies (including 

the District of Columbia) and the 

Medicaid agencies of five US territories. 

States will be required to complete the 

survey in order to demonstrate that they 

are complaint with Section 1903(l) of 

the Act by reporting on their EVV 

implementation status for PCS provided 

under sections 1905(a)(24), 1915(c), 

1915(i), 1915(j), 1915(k), and Section 

1115 of the Act; and HHCS provided 

under 1905(a)(7) of the Act or under a 

demonstration project or waiver (e.g., 

1915(c) or 1115 of the Act). 

The survey will be a live form, 

meaning states will have the ability to 

update their 1903(l) compliance status 

on a continuous basis. As FMAP 

reductions are assigned quarterly per 

1903(l) of the Act, states who are not in 

compliance will be asked to review their 

survey information on a quarterly basis 

to ensure it is up-to-date and to update 

their survey responses as needed until 

they come into compliance. Form 

Number: CMS–10680 (OMB control 

number: 0938–1360); Frequency: On 

occasion; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 56; Number of Responses: 

336; Total Annual Hours: 504. (For 

questions regarding this collection 

contact Ryan Shannahan at 410–786– 

0295.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Home and 

Community Based Services (HCBS) 

Incident Management Survey; Use: The 

Survey will be disseminated to all 51 

state Medicaid agencies (including the 

District of Columbia) to assess incident 

management systems in 1915(c) 

waivers. States will be surveyed to 

identify methods and promising 

practices for identifying, reporting, 

tracking, and resolving incidents of 

abuse, neglect, and exploitation. The 

survey results will also be used to 

review the strengths and weaknesses of 

each state’s incident management 

system and will inform guidance to help 

ensure compliance with sections 

1902(a)(30(A) and 1915(c)(2)(A) of the 

Social Security Act. Form Number: 

CMS–10692 (OMB control number: 

0938–1362); Frequency: Once and on 

occasion; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 51; Total Annual 

Responses: 102; Total Annual Hours: 

153. (For policy questions regarding this 

collection contact Ryan Shannahan at 

410–786–0295.) 

3. 

Dated: April 8, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–07917 Filed 4–12–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Request for Information: Technical 

Assistance Needs and Priorities on 

Implementation and Coordination of 

Early Childhood Development 

Programs in American Indian and 

Alaska Native Communities; 

Correction 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice; correction. 

SUMMARY: The Administration for 

Children and Families published a 

document in the Federal Register of 

March 22, 2022 concerning a request for 

information on technical assistance 

needs and priorities on implementation 

and coordination of early childhood 

development programs in American 

Indian and Alaska Native communities. 

The document contained incorrect 

dates. 

FOR FURTHER INFORMATION CONTACT: 

Moushumi Beltangady at 

Moushumi.beltangady@acf.hhs.gov or 

202–260–3613. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of March 22, 

2022, in FR Doc. 2022–05962 (Vol. 87, 

No. 55) on page 16195, in the first 

column, final line, correct the DATES

caption to read: 

DATES: Send comments on or before 

May 20, 2022. 

Kathleen D. Hamm, 

Deputy Assistant Secretary for Early 

Childhood Development, Administration for 

Children and Families, U.S. Department of 

Health and Human Services. 

[FR Doc. 2022–07840 Filed 4–12–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0529] 

Secura Bio, Inc.; Withdrawal of 

Approval of Relapsed or Refractory 

Follicular Lymphoma Indication for 

COPIKTRA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that it is withdrawing approval of the 

relapsed or refractory follicular 

lymphoma indication for COPIKTRA 

(duvelisib) Capsules, approved under 

new drug application 211155, held by 

Secura Bio, Inc., 1995 Village Center 

Circle, Suite 128, Las Vegas, NV 89134. 

Secura Bio, Inc. voluntarily requested 

that the Agency withdraw approval of 

this indication and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of 

April 13, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA 

approved COPIKTRA (duvelisib) 

Capsules for the treatment of adult 

patients with relapsed or refractory 

follicular lymphoma after at least two 

prior systemic therapies (the follicular 

lymphoma indication) on September 24, 

2018, under the Agency’s accelerated 

approval regulations, 21 CFR part 314, 

subpart H. As a condition of accelerated 

approval of COPIKTRA (duvelisib) 

Capsules for follicular lymphoma, the 

applicant was required to conduct a 

postmarketing trial to verify the clinical 

benefit of duvelisib for follicular 

lymphoma. 

On November 22, 2021, FDA met with 

Secura Bio, Inc., to discuss the 

company’s inability to conduct a 


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