32030 Federal Register / Vol. 87, No. 102 / Thursday, May 26, 2022 / Notices 

eligible organization or its plan. Eligible 

organizations are required to self-certify 

that they are eligible for this 

accommodation and provide a copy of 

such self-certification to their third 

party administrators. The final rules 

also set forth processes and standards to 

fund the payments for the contraceptive 

services that are provided for 

participants and beneficiaries in selfinsured plans of eligible organizations 

under the accommodation described 

previously, through an adjustment in 

the FFE user fee payable by an issuer 

participating in an FFE. 

CMS will use the data collections 

from participating issuers and third 

party administrators to verify the total 

dollar amount for such payments for 

contraceptive services provided under 

this accommodation for the purpose of 

determining a participating issuer’s user 

fee adjustment. The attestation that the 

payments for contraceptive services 

were made in compliance with 26 CFR 

54.9815–2713A(b)(2) or 29 CFR 

2590.715–2713A(b)(2) will help ensure 

that the user fee adjustment is being 

utilized to provide contraceptive 

services for the self-insured plans in 

accordance with the previously noted 

accommodation. Form Number: CMS– 

10492 (OMB control number: 0938– 

1285); Frequency: Annually; Affected 

Public: Private sector (Business or other 

for-profits and Not-for-profit 

institutions); Number of Respondents: 

861; Total Annual Responses: 861; Total 

Annual Hours: 12,930. (For policy 

questions regarding this collection 

contact Jacqueline Wilson at 

jacqueline.wilson1@cms.hhs.gov.) 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–11301 Filed 5–25–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Sexual Risk Avoidance 

Education National Evaluation: 

Nationwide Study of the National 

Descriptive Study (New Collection) 

AGENCY: Office of Planning, Research 

and Evaluation; Administration for 

Children and Families; HHS. 

ACTION: Request for public comment. 

SUMMARY: The Office of Planning, 

Research and Evaluation (OPRE), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), 

proposes survey and focus group data 

collection activities for the Sexual Risk 

Avoidance Education National 

Evaluation (SRAENE) Nationwide Study 

(NWS) of the National Descriptive 

Study. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

Paperwork Reduction Act of 1995, ACF 

is soliciting public comment on the 

specific aspects of the information 

collection described above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: OPRE/ACF/HHS 

proposes to conduct the NWS, a substudy under the National Descriptive 

Study (NDS) of the SRAENE, to learn 

about Sexual Risk Avoidance Education 

(SRAE) program implementation 

experiences and outcomes of the SRAE 

grant program. The NWS builds on the 

Early Implementation Study, the first 

sub-study of the NDS, which was 

designed to tell the story about SRAE 

grant program plans (OMB Control 

#0970–0530). The NWS, which supports 

Congress’s reauthorization in February 

2018 of title V, section 510 of the Social 

Security Act (Pub. L. 115–123) and 

extended by the Coronavirus Aid, 

Relief, and Economic Security (CARES) 

ACT of 2020 (Pub. L. 116–136), will use 

a mixed-methods approach of surveys 

and focus groups to tell the story of the 

SRAE grant program, collecting detailed 

information on grantee program 

implementation experiences from grant 

recipients, SRAE program providers and 

facilitators, and youth program 

recipients. The NWS will also make use 

of extant data from grant-recipient 

performance measures on program 

outputs and outcomes. Combined with 

data on program implementation, the 

NWS will examine associations between 

implementation, outputs, and outcomes. 

The survey and focus group data are key 

to fully understanding program 

implementation experiences from all 

levels that bring the SRAE programs to 

youth-from grant administrators to 

program supervisors to the facilitators 

who interact directly with the youth 

themselves. 

The study is being undertaken by ACF 

and its contractor Mathematica. The 

study research questions driving the 

need for data collection are as follows: 

1. What are grant recipients’ and 

providers’ experiences with delivering 

SRAE curricular content? What are 

youth’s experiences with receiving the 

SRAE curricular content? 

2. How did grant recipients and 

providers interpret, understand, and 

address the A to F topics in the SRAE 

legislation? 

3. Are some features of 

implementation more strongly 

associated with youth outcomes than 

others? 

4. What provider characteristics are 

associated with a greater number of 

youth served and with youth outcomes? 

To support these efforts, ACF 

proposes the following data collection 

activities: (1) A web-based survey of all 

grant recipient Directors who are not 

also providers, (2) a web-based survey of 

all SRAE program providers, (3) a webbased survey of all SRAE program 

facilitators, and (4) in-person (or virtual 

if necessary) focus groups with youth 

recipients of SRAE programming across 

five geographic regions of the United 

States. 

Respondents: Respondents to the 

surveys will be SRAE program grant 

Directors, SRAE program providers, and 

SRAE program facilitators. Focus group 

participants will be youth recipients of 

SRAE programming. The focus group 

participants will be recruited from 

middle and high school across five U.S. 

Geographic regions: West, Midwest, 

Southwest, Southeast, and Northeast. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 102 / Thursday, May 26, 2022 / Notices 32031 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

(1) NWS Grantee Survey ................................................................................. 40 1 .17 7 

(2) NWS Provider Survey ................................................................................ 500 1 .75 375 

(3) NWS Facilitator Survey .............................................................................. 1,600 1 .5 800 

(4)SRAE Program Youth Focus Group Discussion Guide .............................. 200 1 .75 150 

Estimated Total Annual Burden 

Hours: 1,332. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: The Title V Competitive 

SRAE Program was authorized and 

funded by section 510 of the Social 

Security Act (42 U.S.C. 710), as 

amended by section 50502 of the 

Bipartisan Budget Act of 2018 (Pub. L. 

115–123) and extended by the CARES 

Act of 2020 (Pub. L. 116–136). 

See https://www.ssa.gov/OP_Home/ 

ssact/title05/0510.htm. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–11364 Filed 5–25–22; 8:45 am] 

BILLING CODE 4184–83–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0850] 

Gilead Sciences, Inc.; Withdrawal of 

Approval of Indications for Relapsed 

Follicular Lymphoma and Relapsed 

Small Lymphocytic Lymphoma for 

ZYDELIG (Idelalisib) Tablets 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that it is withdrawing 

approval of the indications for relapsed 

follicular lymphoma and relapsed small 

lymphocytic lymphoma for ZYDELIG 

(idelalisib) Tablets, approved under new 

drug application (NDA) 205858, held by 

Gilead Sciences, Inc., 333 Lakeside Dr., 

Foster City, CA 94404 (Gilead). Gilead 

voluntarily requested that the Agency 

withdraw approval of these indications 

and waived its opportunity for a 

hearing. 

DATES: Approval is withdrawn as of 

May 26, 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: On July 

23, 2014, FDA approved NDA 205858 

for ZYDELIG (idelalisib) Tablets for the 

treatment of patients with relapsed 

follicular B-cell non-Hodgkin 

lymphoma in patients who have 

received at least two prior systemic 

therapies (the follicular lymphoma 

indication). On that same day, FDA also 

approved NDA 205858 for ZYDELIG 

(idelalisib) Tablets for the treatment of 

patients with relapsed small 

lymphocytic lymphoma in patients who 

have received at least two prior systemic 

therapies (the SLL indication). FDA 

approved both the follicular lymphoma 

indication and the SLL indication under 

the Agency’s accelerated approval 

regulations, 21 CFR part 314, subpart H. 

As a condition of accelerated approval 

of ZYDELIG (idelalisib) Tablets for the 

follicular lymphoma indication and the 

SLL indication, the applicant was 

required to conduct postmarketing trials 

to verify the clinical benefit of idelalisib 

for the follicular lymphoma and SLL 

indications. 

On November 22, 2021, FDA met with 

Gilead to discuss the status of ZYDELIG 

(idelalisib) Tablet’s accelerated approval 

for the follicular lymphoma indication 

and the SLL indication, including the 

continued need for postmarketing trials 

intended to verify clinical benefit in 

follicular lymphoma and small 

lymphocytic lymphoma. FDA raised 

withdrawal of approval during this 

discussion, explaining its intent to 

consult the Oncologic Drugs Advisory 

Committee (ODAC) on whether FDA 

should pursue withdrawal of the 

follicular lymphoma indication and the 

SLL indication. Subsequently, on 

December 17, 2021, following further 

communication with Gilead, FDA 

advised Gilead that voluntary 

withdrawal of approval for these 

indications would be appropriate under 

§ 314.150(d) (21 CFR 314.150(d)). On 

January 10, 2022, Gilead submitted a 

letter requesting withdrawal of the 

follicular lymphoma indication and the 

SLL indication for ZYDELIG (idelalisib) 

Tablets and waiving its opportunity for 

a hearing. Gilead subsequently clarified, 

on February 23, 2022, that they were 

requesting the Agency withdraw 

approval of the follicular lymphoma 

indication and the SLL indication 

pursuant to § 314.150(d). 

Therefore, under § 314.150(d), 

approvals of the follicular lymphoma 

indication and the SLL indication for 

ZYDELIG (idelalisib) Tablets are 

withdrawn as of May 26, 2022. 

Withdrawal of approval of these 

indications does not affect any other 

approved indication for ZYDELIG 

(idelalisib) Tablets. 

Dated: May 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11277 Filed 5–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Integrative Health; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


khammond on DSKJM1Z7X2PROD with NOTICES