9156 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices 

services are consistent with efficiency, 

economy, and quality of care. CMS will 

collect this data to ensure that VBP 

programs adopted by States continue to 

meet these standards. Form Number: 

CMS–10722 (OMB control number: 

0938–1385); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

51; Total Annual Responses: 51; Total 

Annual Hours: 306. (For policy 

questions regarding this collection 

contact Abraham Weinschneider at 410– 

786–5688.) 

4. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Limitations on 

Provider Related Donations and Health 

Care Related Taxes, Medicaid and 

Supporting Regulations in 42 CFR 

433.68 through 433.74; Use: States may 

elect to submit a waiver to CMS for the 

broad based and/or uniformity 

requirements for any health care related 

tax program which does not conform to 

the broad based and uniformity 

requirements. It is also the 

responsibility of each State to 

demonstrate that their tax program(s) do 

not violate the hold harmless provision. 

For a waiver to be approved and a 

determination that the hold harmless 

provision is not violated, States must 

submit written documentation which 

satisfies the regulatory requirements. 

Without this information, the amount of 

FFP (Federal financial participation) 

payable to a State cannot be correctly 

determined. Form Number: CMS–R–148 

(OMB control number: 0938–0618); 

Frequency: Quarterly and occasionally; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

50; Total Annual Responses: 40; Total 

Annual Hours: 3,200. (For policy 

questions regarding this collection 

contact Stuart Goldstein at 410–786– 

0694.) 

William N. Parham, III 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–02662 Filed 2–8–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–P–4279] 

Determination That QMIIZ (Meloxicam) 

Orally Disintegrating Tablets, 7.5 

Milligrams and 15 Milligrams, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that QMIIZ (meloxicam) 

Orally Disintegrating Tablets, 7.5 

milligrams (mg) and 15 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for QMIIZ 

(meloxicam) Orally Disintegrating 

Tablets, 7.5 mg and 15 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6280, 

Silver Spring, MD 20993–0002, 301– 

796–3507, Nicole.Mueller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

QMIIZ (meloxicam) Orally 

Disintegrating Tablets, 7.5 mg and 15 

mg, are the subject of NDA 211210, held 

by TerSera Therapeutics LLC (TerSera), 

and initially approved on October 19, 

2018. QMIIZ is a non-steroidal antiinflammatory indicated for 

osteoarthritis in adults, rheumatoid 

arthritis in adults, and pauciarticular or 

polyarticular course juvenile 

rheumatoid arthritis in pediatric 

patients who weigh greater than or 

equal to 60 kilograms. 

In a letter dated March 24, 2021, 

TeraSera notified FDA that QMIIZ 

(meloxicam) Orally Disintegrating 

Tablets, 7.5 mg and 15 mg, were being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Pharmobedient Consulting submitted 

a citizen petition dated September 27, 

2023 (Docket No. FDA–2023–P–4279), 

under 21 CFR 10.30, requesting that the 

Agency determine whether QMIIZ 

(meloxicam) Orally Disintegrating 

Tablets, 7.5 mg and 15 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that QMIIZ (meloxicam) 

Orally Disintegrating Tablets, 7.5 mg 

and 15 mg, were not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that QMIIZ 

(meloxicam) Orally Disintegrating 

Tablets, 7.5 mg and 15 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of QMIIZ 

(meloxicam) Orally Disintegrating 

Tablets, 7.5 mg and 15 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices 9157 

not withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list QMIIZ (meloxicam) 

Orally Disintegrating Tablets, 7.5 mg 

and 15 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to QMIIZ (meloxicam) 

Orally Disintegrating Tablets, 7.5 mg 

and 15 mg, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02710 Filed 2–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0014] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC). The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. This meeting will be 

held to discuss and make 

recommendations on the selection of 

strains to be included in the influenza 

virus vaccines for the 2024 to 2025 

influenza season. The meeting will be 

open to the public. 

DATES: The meeting will be held 

virtually on March 5, 2024, from 9 a.m. 

to 3:30 p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://

youtube.com/live/Wf0aE32DPKc. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. FDA is establishing a 

docket for public comment on this 

meeting. The docket number is FDA– 

2024–N–0014. The docket will close on 

March 4, 2024. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 4, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Comments received on or before 

February 26, 2024, will be provided to 

the committee. Comments received on 

or after February 26, 2024, and by 

March 4, 2024, will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

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– 

2024–N–0014 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC); Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 


ddrumheller on DSK120RN23PROD with NOTICES1