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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