Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices 9155 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–02683 Filed 2–8–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10291, CMS– 

10529, CMS–10722, and CMS–R–148] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

April 9, 2024. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10291 State Collection and 

Reporting of Dental Provider and 

Benefit Package Information on the 

Insure Kids Now! Website and 

Hotline 

CMS–10529 Quarterly Medicaid and 

CHIP Budget and Expenditure 

Reporting for the Medical 

Assistance Program, Administration 

and CHIP 

CMS–10722 Annual State Report on 

CMS Value Based Purchasing 

Arrangements (VBP) Supplemental 

Rebate Agreements 

CMS–R–148 Limitations on Provider 

Related Donations and Health Care 

Related Taxes, Medicaid and 

Supporting Regulations in 42 CFR 

433.68 through 433.74 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: State Collection 

and Reporting of Dental Provider and 

Benefit Package Information on the 

Insure Kids Now! Website and Hotline; 

Use: On the Insure Kids Now (IKN) 

website, the Secretary is required to post 

a current and accurate list of dentists 

and providers that provide dental 

services to children enrolled in the State 

plan (or waiver) under Medicaid or the 

State child health plan (or waiver) 

under CHIP. States collect the 

information pertaining to their Medicaid 

and CHIP dental benefits. Form 

Number: CMS–10291 (OMB control 

number: 0938–1065); Frequency: Yearly 

and quarterly; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 51; Total Annual 

Responses: 255; Total Annual Hours: 

11,781. (For policy questions regarding 

this collection contact Andrew Snyder 

at 410–786–1274.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Quarterly 

Medicaid and CHIP Budget and 

Expenditure Reporting for the Medical 

Assistance Program, Administration and 

CHIP; Use: The Medicaid and CHIP 

Financial System is a financial reporting 

system that produces budget estimate 

statements for Forms CMS–37 and 

CMS–21B. The Medicaid and CHIP 

Budget and Expenditure System is a 

financial reporting system that produces 

expenditure statements for Forms CMS– 

64 and CMS–21. All forms are to be 

filed on a quarterly basis and need to be 

certified by the States. Form Number: 

CMS–10529 (OMB control number: 

0938–1265); Frequency: Quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 672; Total 

Annual Hours: 18,144. (For policy 

questions regarding this collection 

contact Robert Lane at 410–786–2015.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Annual State 

Report on CMS Value Based Purchasing 

Arrangements (VBP) Supplemental 

Rebate Agreements; Use: The reported 

data is being collected to safeguard 

against unnecessary utilization of such 

care and services and to assure that 

State payments to providers of Medicaid 


ddrumheller on DSK120RN23PROD with NOTICES1
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 


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