68628 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 

teleconferencing and/or video 

conferencing platform. 

The Committee will receive updates 

on the accelerated approval program in 

oncology and two new drug 

applications (NDAs) approved under 21 

CFR 314.500 (subpart H, accelerated 

approval regulations) that have not met 

their agreed-upon milestones for 

completion of confirmatory trial(s). 

Confirmatory trials are postmarketing 

studies to verify and describe the 

clinical benefit of a drug after it receives 

accelerated approval. These updates 

will provide information on the status of 

all accelerated approvals granted in 

oncology, including products with 

delayed confirmatory trials, and the 

status of confirmatory trials for the 

specific NDAs to be discussed, 

including any ongoing and planned 

trials. 

The two products to be discussed are: 

(1) FOLOTYN (pralatrexate), NDA 

022468 submitted by Acrotech 

Biopharma Inc, indicated for the 

treatment of patients with relapsed or 

refractory peripheral T-cell lymphoma 

(PTCL), and (2) BELEODAQ (belinostat), 

NDA 206256 submitted by Acrotech 

Biopharma Inc, indicated for the 

treatment of patients with relapsed or 

refractory PTCL. Based on the updates 

provided, the Committee will have a 

general discussion about delayed 

confirmatory trials as well as a focused 

discussion on next steps for the two 

products, FOLOTYN (pralatrexate) and 

BELEODAQ (belinostat), approved for 

PTCL. The overall goal will be the 

continued optimization of the 

accelerated approval process with a 

focus on decreasing the amount of time 

to verify (or fail to verify) clinical 

benefit, while continuing to provide 

early availability of promising oncology 

products. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https:// 

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. 

The meeting will include slide 

presentations with audio and video 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before November 1, 

2023, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 11:30 a.m. and 12:30 

p.m. eastern time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

24, 2023. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 25, 2023. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Moon Hee V. 

Choi (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/ucm111462.

htm for procedures on public conduct 

during advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and the ends of justice will 

be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21984 Filed 10–3–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3859] 

Dr. Reddy’s Laboratories, Inc.; 

Withdrawal of Approval of 11 

Abbreviated 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 11 abbreviated 

new drug applications (ANDAs) from 

Dr. Reddy’s Laboratories, Inc. The 

applicant 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 

November 3, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicant listed in the table has 

informed FDA that these drug products 

are no longer marketed and has 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicant has also, by 

their request, waived the opportunity 

for a hearing. Withdrawal of approval of 

an application or abbreviated 

application under § 314.150(c) is 

without prejudice to refiling. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 68629 

Application No. Drug Applicant 

ANDA 090177 ....... Oxycodone and Acetaminophen Tablets, 3.25 milligrams 

(mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 

mg, 500 mg; 7.5 mg, 650 mg; 10 mg.

Dr. Reddy’s Laboratories, Inc., U.S. Agent for Dr. Reddy’s 

Laboratories SA, 107 College Rd. East, Princeton NJ 

08540. 

ANDA 091313 ....... Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 

mg, 20 mg, 30 mg.

Do. 

ANDA 091670 ....... Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mg ............ Do. 

ANDA 203107 ....... Oxycodone HCl Capsules, 5 mg ............................................ Do. 

ANDA 203335 ....... Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mg.Do. 

ANDA 203807 ....... Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mg .............. Do. 

ANDA 204092 ....... Oxycodone HCl Oral Solution 100 mg/5 milliliters ................. Do. 

ANDA 205386 ....... Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, 

60 mg, 100 mg.

Do. 

ANDA 206329 ....... Fentanyl Citrate Tablets, Equivalent to (EQ) 0.1 mg base, 

EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ 

0.6 mg base, EQ 0.8 mg base.

Do. 

ANDA 206953 ....... Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg 

base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg base.

Do. 

ANDA 207270 ....... Morphine Sulfate Tablets, 15 mg, 30 mg ............................... Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of November 3, 

2023. 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 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

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

Drug products that are listed in the table 

that are in inventory on November 3, 

2023 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: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21992 Filed 10–3–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders Meeting and 

Solicitation for Written Comments 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Intergovernmental and 

External Affairs, White House Initiative 

on Asian Americans, Native Hawaiians, 

and Pacific Islanders. 

ACTION: Notice of meeting and 

solicitation for written comments. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

announces the next meeting of the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders (Commission) and 

the solicitation of written comments 

regarding the advancement of equity, 

justice, and opportunity for Asian 

American, Native Hawaiian, and Pacific 

Islander (AA and NHPI) communities. 

The meeting is open to the public and 

will be held in Washington, DC on 

October 25 and October 26, 2023. 

Virtual attendance will be available 

through livestream. The Commission is 

working to accomplish its mission to 

provide independent advice and 

recommendations to the President on 

ways to advance equity, justice, and 

opportunity for AA and NHPI 

communities. 

DATES: The Commission will meet on 

October 25, 2023, from 9:00 a.m. Eastern 

Time (ET) to 4:30 p.m. ET and October 

26, 2023, from 9:00 a.m. ET to 2:00 p.m. 

ET. The final location and agenda will 

be posted on the website for the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders: https:// 

www.hhs.gov/about/whiaanhpi/ 

commission/index.html when this 

information becomes available. 

ADDRESSES: Members of the public may 

attend virtually. Registration is required 

through the following link: https:// 

www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-tickets-715434733547?aff=

oddtdtcreator. 

FOR FURTHER INFORMATION CONTACT: 

Viviane Chao, Designated Federal 

Officer, President’s Advisory 

Commission on Asian Americans, 

Native Hawaiians, and Pacific Islanders, 

U.S. Department of Health and Human 

Services, Office of the Secretary, Office 

of Intergovernmental and External 

Affairs, Hubert H. Humphrey Building, 

Room 620E, 200 Independence Ave. 

SW, Washington, DC 20201; email: 

AANHPICommission@hhs.gov; 

telephone: (202) 690–6060. 

SUPPLEMENTARY INFORMATION: The 

meeting is the seventh in a series of 

Federal advisory committee meetings 

regarding the development of 

recommendations to advance equity, 

justice, and opportunity for AA and 

NHPI communities. The meeting is open 

to the public and will be live streamed. 

The Commission, co-chaired by HHS 

Secretary Xavier Becerra and the U.S. 

Trade Representative Ambassador 

Katherine Tai, advises the President on: 

the development, monitoring, and 

coordination of executive branch efforts 

to advance equity, justice, and 

opportunity for AA and NHPI 

communities in the United States, 

including efforts to close gaps in health, 

socioeconomic, employment, and 

educational outcomes; policies to 

address and end anti-Asian bias, 

xenophobia, racism, and nativism, and 

opportunities for the executive branch 

to advance inclusion, belonging, and 

public awareness of the diversity and 

accomplishments of AA and NHPI 

people, cultures, and histories; policies, 

programs, and initiatives to prevent, 

report, respond to, and track anti-Asian 

hate crimes and hate incidents; ways in 

which the Federal Government can 

build on the capacity and contributions 

of AA and NHPI communities through 

equitable Federal funding, grantmaking, 

and employment opportunities; policies 

and practices to improve research and 

equitable data disaggregation regarding 

AA and NHPI communities; policies 

and practices to improve language 


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