Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices 87435 

Dated: December 11, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27655 Filed 12–15–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5344] 

Pharmacyclics LLC.; Withdrawal of 

Approval of Indications for Mantle Cell 

Lymphoma and Marginal Zone 

Lymphoma for IMBRUVICA (ibrutinib) 

Capsules and 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 mantle 

cell lymphoma (MCL) and marginal 

zone lymphoma (MZL) for IMBRUVICA 

(ibrutinib) Capsules and Tablets 

approved, respectively, under new drug 

applications (NDAs) 205552 and 

210563. These NDAs are held by 

Pharmacyclics LLC, 1000 Gateway 

Blvd., South San Francisco, CA 94080 

(Pharmacyclics). Pharmacyclics 

voluntarily requested that the Agency 

withdraw approval of these indications 

and waived its opportunity for a 

hearing. 

DATES: Approval is withdrawn as of 

December 18, 2023. 

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 

November 13, 2013, FDA approved 

NDA 205552 for IMBRUVICA (ibrutinib) 

Capsules for the treatment of adult 

patients with MCL who have received at 

least one prior therapy (the MCL 

indication). On January 18, 2017, FDA 

approved a prior approval supplement 

for NDA 205552 for IMBRUVICA 

(ibrutinib) Capsules for the treatment of 

adult patients with MZL who require 

systemic therapy and have received at 

least one prior anti-CD20-based therapy 

(the MZL indication). On February 16, 

2018, FDA approved NDA 210563 for 

IMBRUVICA (ibrutinib) Tablets, a new 

dosage form of IMBRUVICA (ibrutinib), 

for the MCL and MZL indications. FDA 

approved the MCL and MZL indications 

for both products under the Agency’s 

accelerated approval regulations, 21 

CFR part 314, subpart H. As a condition 

of accelerated approval of IMBRUVICA 

(ibrutinib) Capsules and Tablets for the 

MCL and MZL indications, the 

applicant was required to conduct 

postmarketing trials to verify the 

clinical benefit of ibrutinib for the MCL 

and MZL indications. 

On February 8, 2023, FDA met with 

Pharmacyclics to inform the applicant 

of the plans to convene the Oncologic 

Drugs Advisory Committee regarding 

the accelerated approvals for the MCL 

and MZL indications because the 

required postmarketing trials did not 

verify the clinical benefit of ibrutinib for 

these indications. On March 21, 2023, 

FDA met with Pharmacyclics to discuss 

the applicant’s request to voluntarily 

withdraw approval of the MCL and MZL 

indications for IMBRUVICA (ibrutinib) 

Capsules and Tablets. On April 6, 2023, 

Pharmacyclics submitted a letter 

requesting withdrawal of the MCL and 

MZL indications for IMBRUVICA 

(ibrutinib) Capsules and Tablets 

pursuant to § 314.150(d) (21 CFR 

314.150(d)) and waiving its opportunity 

for a hearing. 

Therefore, under § 314.150(d), 

approvals of the MCL and MZL 

indications for IMBRUVICA (ibrutinib) 

Capsules and Tablets are withdrawn as 

of December 18, 2023. Withdrawal of 

approval of these indications does not 

affect any other approved indication for 

IMBRUVICA (ibrutinib) Capsules and 

Tablets. 

Dated: December 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27662 Filed 12–15–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Funding Opportunity for the 

Community Opioid Intervention 

Prevention Program 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2024–IHS–COIPP–0001. 

Assistance Listing (Catalog of Federal 

Domestic Assistance or CFDA) Number: 

93.654. 

Key Dates 

Application Deadline Date: February 

7, 2024. 

Earliest Anticipated Start Date: April 

1, 2024. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS), 

Office of Clinical and Preventive 

Services, Division of Behavioral Health 

(DBH) is accepting applications for 

grants for the Community Opioid 

Intervention Prevention Program 

(COIPP). This program is authorized 

under the Snyder Act, 25 U.S.C. 13, and 

the Transfer Act, 42 U.S.C. 2001(a). 

Funding for this program is provided in 

the Consolidated Appropriations Act, 

2023, Public Law 117–328, 136 Stat. 

4459, 4808 (2022). The Assistance 

Listings section of SAM.gov (https://

sam.gov/content/home) describes this 

program under 93.654. 

Background 

The initial opioid prevention 

program, called the Community Opioid 

Intervention Pilot Project, was first 

established in Fiscal Year (FY) 2019, 

pursuant to Congressional instruction to 

better combat the opioid epidemic. The 

goal was to create a pilot program to 

address the opioid epidemic in Indian 

Country and award grants that 

supported the development, 

documentation, and sharing of locally 

designed and culturally appropriate 

prevention, treatment, recovery, and 

aftercare services for opioid use 

disorders in the American Indian and 

Alaska Native (AI/AN) communities. 

Evidence-based activities are available 

for reference at https://www.ihs.gov/ 

asap/coipp/. A total of 35 grants were 

awarded to Tribal and Urban Indian 

communities in the pilot phase. Based 

on evaluation results from the pilot 

project, this funding opportunity will 

continue to provide grant support to 

Tribal and Urban Indian communities to 

continue efforts to combat the opioid 

epidemic and develop strategies that 

align with the Department of Health and 

Human Services Overdose Prevention 

Strategy. 

The Centers for Disease Control and 

Prevention (CDC) reported that the AI/ 

AN population had the highest drug 

overdose death rates in both 2020 and 

2021, at rates of 42.5 and 56.6 deaths 

per 100,000 persons, respectively. The 

AI/AN population also experienced a 33 

percent increase in drug overdose 

deaths from 2020 through 2021. 

Overdose deaths among AI/AN have 

continued to increase over the last 20 

years. The CDC reported from 2019 to 

2020, overdose death rates increased 39 

percent for the non-Hispanic AI/AN 

population and drug overdose death 

rates were highest for AI/AN people 

compared to other racial and ethnic 

groups. 


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