Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 96653 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments received are subject to 

public disclosure. In general, comments 

received will be made available without 

change and will not be modified to 

remove personal or business 

information including confidential, 

contact, or other identifying 

information. Comments should not 

include any information such as 

confidential information that would not 

be appropriate for public disclosure. 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than January 6, 2025. 

A. Federal Reserve Bank of Richmond 

(Brent B. Hassell, Assistant Vice 

President) P.O. Box 27622, Richmond, 

Virginia 23261. Comments can also be 

sent electronically to 

Comments.applications@rich.frb.org: 

1. Atlantic Union Bankshares 

Corporation, Richmond, Virginia; to 

acquire Sandy Spring Bancorp, Inc., and 

thereby indirectly acquire Sandy Spring 

Bank, both of Olney, Maryland. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Associate Secretary of the Board. 

[FR Doc. 2024–28465 Filed 12–4–24; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–906] 

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 

February 3, 2025. 

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 906 Fiscal Soundness Reporting 

Requirements (FSRR) 

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 Collections 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Fiscal 

Soundness Reporting Requirements 

(FSRR); Use: Title 18, section 

1857(d)(4)(A)(i) requires that contracting 

organizations such as Medicare Health 

Plans (including Medicare Advantage 

(MA) organizations, Medicare-Medicaid 

Capitated Financial Alignment 

Demonstrations (MMPs)) and 1876 Cost 

Plans), Prescription Drug Plan sponsors 


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96654 Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 

(PDPs), and Programs of All-Inclusive 

Care for the Elderly (PACE) 

organizations report financial 

information demonstrating the 

organization has a fiscally sound 

operation. The FSRR is designed to 

capture financial data of these 

contracting entities. The Division of 

Finance and Benefits (DFB) within the 

Medicare Advantage Contract 

Administration Group (MCAG) of CMS 

is assigned the responsibility of 

reviewing ongoing financial 

performance of the contracting entities. 

All contracting organizations must 

submit audited annual financial 

statements one time per year. In 

addition to the audited annual 

submission, Health Plans with a 

negative net worth and/or a net loss and 

the amount of that loss is greater than 

one-half of the organization’s total net 

worth submit quarterly financial 

statements for fiscal soundness 

monitoring. Part D organizations are 

required to submit three (3) quarterly 

financial statements. Lastly, PACE 

organizations are required to file four (4) 

quarterly financial statements for the 

first three (3) years in the program. After 

the first three (3) years, PACE 

organizations with a negative net worth 

and/or a net loss and the amount of that 

loss is greater than one-half of the 

organization’s total net worth must 

submit quarterly financial statements for 

fiscal soundness monitoring. Form 

Number: CMS–906 (OMB control 

number: 0938–0496); Frequency: 

Quarterly and Yearly; Affected Public: 

Private Sector (Business or other forprofits, Not-for-Profit Institutions); 

Number of Respondents: 251; Total 

Annual Responses: 1,004; Total Annual 

Hours: 335. (For policy questions 

regarding this collection contact Christa 

M. Zalewski at (410) 786–1971.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–28458 Filed 12–4–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5354] 

Determination That Bentyl Preservative 

Free (Dicyclomine Hydrochloride) 

Injection, 10 Milligrams/Milliliters, and 

Other Drug Products 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 the drug products listed 

in this document were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@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 generally known 

as the ‘‘Orange Book.’’ Under FDA 

regulations, a drug is 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). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) before an ANDA that 

refers to that listed drug may be 

approved, (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved, and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for safety or 

effectiveness reasons, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table are no longer 

being marketed. 

TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

Application No. Drug name Active ingredient(s) Dosage form/route Strength(s) Applicant 

NDA 008370 ............ BENTYL PRESERVATIVE 

FREE.

Dicyclomine Hydrochloride Injectable; Injection .......... 10 Milligrams (mg)/Milliliters (mL).AbbVie. 

NDA 012104 ............ KENALOG ........................ Triamcinolone Acetonide Spray; Topical .................. 0.147 mg/Gram (g) .......... Sun Pharmaceutical Industries Limited. 

NDA 017806 ............ THALLOUS CHLORIDE 

TL 201.

Thallous Chloride TL–201 Injectable; Intravenous ..... 1 Millicurie (mCi)/mL; 2 

mCi/mL.

Lantheus. 

NDA 017823 ............ HALOG ............................. Halcinonide ...................... Solution; Topical .............. 0.10% ............................... Sun Pharmaceutical Industries Limited. 

NDA 018849 ............ LIDEX ............................... Fluocinonide ..................... Solution; Topical .............. 0.05% ............................... Alvogen. 

NDA 020551 ............ NIMBEX ........................... Cisatracurium Besylate .... Injectable; Injection .......... Equivalent to (EQ) 2 mg 

Base/mL.

AbbVie. 

NDA 020551 ............ NIMBEX PRESERVATIVE 

FREE.

Cisatracurium Besylate .... Injectable; Injection .......... EQ 2 mg Base/mL; EQ 10 

mg Base/mL.

AbbVie. 


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