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 


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