Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices 87433 

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

*1. Sullivan, H.W., K.J. Aikin, and L.B. 

Squiers, ‘‘Quantitative Information on 

Oncology Prescription Drug websites,’’ 

Journal of Cancer Education, vol. 33, 

Issue 2, pp. 371–374, 2018. (https://

www.ncbi.nlm.nih.gov/pmc/articles/

PMC5334459) 

2. Dillman, D.A., J.D. Smyth, and L.M. 

Christian, internet, Phone, Mail, and 

Mixed-Mode Surveys: The Tailored 

Design Method, 4th ed., John Wiley & 

Sons, Inc.: Hoboken, NJ, 2014. 

*3. Cheung, Y.T.D., X. Weng, M.P. Wang, et 

al., ‘‘Effect of Prepaid and Promised 

Financial Incentive on Follow-Up 

Survey Response in Cigarette Smokers: A 

Randomized Controlled Trial,’’ BMC 

Medical Research Methodology, vol. 19, 

Article 138, 2019. (https://link.

springer.com/article/10.1186/s12874- 

019-0786-9) 

4. Mercer, A., A. Caporaso, D. Cantor, et al., 

‘‘How Much Gets You How Much? 

Monetary Incentives and Response Rates 

in Household Surveys,’’ Public Opinion 

Quarterly, vol. 79, pp. 105–129, 2015. 

5. Sun, H., J. Newsome, J. McNulty, et al., 

‘‘What Works, What Doesn’t? Three 

Studies Designed to Improve Survey 

Response,’’ Field Methods, vol. 32, Issue 

3, pp. 235–252, 2020. (https://doi.org/ 

10.1177/1525822X20915464) 

6. Ellis, J., J. Charbonnier, C. Lowenstein, et 

al., ‘‘Assessing the Impacts of Different 

Incentives and Use of Postal Mail on 

Response Rates,’’ American Association 

for Public Opinion Research (AAPOR) 

Conference, Chicago, IL, 2022, May. 

*7. Yu, S., H.E. Alper, A.M. Nguyen, et al., 

‘‘The Effectiveness of a Monetary 

Incentive Offer on Survey Response 

Rates and Response Completeness in a 

Longitudinal Study,’’ BMC Medical 

Research Methodology, vol. 17, Article 

77, 2017. (https://bmcmedresmethodol.

biomedcentral.com/articles/10.1186/ 

s12874-017-0353-1) 

Dated: December 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27652 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–5323] 

Hoffmann-La Roche, Inc., et al.; 

Withdrawal of Approval of Two New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of two new drug 

applications (NDAs) from multiple 

applicants. The applicants notified the 

Agency in writing that the drug 

products were no longer marketed and 

requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

January 17, 2024. 

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: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application under § 314.150(c) is 

without prejudice to refiling. 

Application No. Drug Applicant 

NDA 021455 ...... Boniva (ibandronate sodium) Tablets, equivalent to (EQ) 2.5 

milligrams (mg) base and EQ 150 mg base.

Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, 

South San Francisco, CA 94080–4990. 

NDA 022424 ...... Flowtuss (guaifenesin 200 mg/5 milliliters (mL) and 

hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution.

Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 

10920. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 17, 

2024. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in the table without an approved 

NDA violates sections 505(a) and 301(d) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(a) and 331(d)). Drug 

products that are listed in the table that 

are in inventory on January 17, 2024 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: December 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27661 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–D–3740] 

Priority Zoonotic Animal Drug 

Designation and Review Process; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry (GFI) #283 

entitled ‘‘Priority Zoonotic Animal Drug 

Designation and Review Process.’’ This 

draft guidance is intended to assist 

sponsors pursuing priority zoonotic 

animal drug (PZAD) designation for a 

new animal drug. This draft guidance is 

intended to provide the eligibility 

criteria for PZAD designation, the 

process for requesting PZAD 

designation, and enhancements in the 

FDA review process for PZADs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 16, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
87434 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked, and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–3740 for ‘‘Priority Zoonotic 

Animal Drug Designation and Review 

Process.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Evgenij Evdokimov, Center for 

Veterinary Medicine (HFV–108), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–402– 

0712, evgenij.evdokimov@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

draft GFI #283 entitled ‘‘Priority 

Zoonotic Animal Drug Designation and 

Review Process.’’ The Coronavirus Aid, 

Relief, and Economic Security (CARES) 

Act (Pub. L. 116–136), signed into law 

on March 27, 2020, added section 512A 

‘‘Priority zoonotic animal drugs’’ to the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b–1), which provides for 

the designation of a new animal drug as 

a PZAD. This legislation is intended to 

expedite the development and review of 

certain new animal drugs that have the 

potential to prevent or treat a zoonotic 

disease in animals, including a vectorborne disease, that has the potential to 

cause serious adverse health 

consequences for, or serious or lifethreatening diseases in, humans. 

This draft guidance is intended to 

assist sponsors pursuing designation of 

a new animal drug as a PZAD. This draft 

guidance proposes the eligibility criteria 

a new animal drug should meet to 

obtain PZAD designation and describes 

the process sponsors may use to request 

such designation. In addition, this draft 

guidance identifies the enhancements 

FDA intends to implement to expedite 

the PZAD review process. 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on ‘‘Priority Zoonotic 

Animal Drug Designation and Review 

Process.’’ It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR 514 have been 

approved under OMB control number 

0910–0032; 21 CFR 511.1 have been 

approved under OMB control number 

0910–0117. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 


khammond on DSKJM1Z7X2PROD with NOTICES
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. 


khammond on DSKJM1Z7X2PROD with NOTICES