77514 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

FEE SCHEDULE FOR EACH VESSEL SIZE—Continued 

Vessel size (GT 1) 

Operational 

inspection 2 fee 

(US$) 

Construction and 

renovation 

inspection 3 fee 

(US$) 

Tier 4 (>180,001 GT) ................................................................................................................................... 64,584 129,168 

1Gross tonnage in cubic feet, as shown in Lloyd’s Register of Shipping (https://www.lr.org/en/). 2Operations inspections and re-inspections involve the same procedures and require the same amount of time, so they are charged at the 

same rates. 3 Construction and renovation inspections require at least twice the amount of time as operations inspections, so they are charged double the 

rates. 

[FR Doc. 2024–21786 Filed 9–20–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10170 and 

CMS–10156] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate 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 on the collection(s) of 

information must be received by the 

OMB desk officer by October 23, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

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 Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Retiree Drug 

Subsidy Payment Request and 

Instructions; Use: Under the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 and 

implementing regulations at 42 CFR part 

423 subpart R plan sponsors (e.g., 

employers, unions) who offer 

prescription drug coverage meeting 

specified criteria to their qualified 

covered retirees are eligible to receive a 

28% subsidy for allowable drug costs, 

through the Retiree Drug Subsidy (RDS) 

Program. Section 423.886 describes the 

payment methods, including the 

provision of necessary information. The 

information provided in the payment 

request provides CMS with the 

information needed to pay RDS 

sponsors the subsidy. 

The application process for the RDS is 

a completely electronic process (100%). 

The basis for the decision for adopting 

this means of collection was to 

maximize efficiency. The only instance 

when hard copy/paper applications can 

be submitted is when the RDS Center is 

experiencing technical difficulties. The 

Plan Sponsor completes and submits the 

RDS application (including the Plan 

Sponsor’s Authorized Representative’s 

electronic signature) on-line, via the 

secure RDS Secure website, which is 

accessed at https://www.rds.cms.

hhs.gov. Form Number: CMS–10170 

(OMB control number: 0938–0977); 

Frequency: Yearly; Affected Public: 

Private; Business or other for-profits, 

and Not-for Profits; Number of 

Respondents: 1,245; Number of 

Responses: 1,245; Total Annual Hours: 

187,995. (For questions regarding this 

collection, contact Ivan Iveljic at 410– 

786–3312 or Ivan.iveljic@cms.hhs.gov.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Retiree Drug 

Subsidy (RDS) Application and 

Instructions ; Use: Under § 1860D–22 of 

the Social Security Act (Act), added by 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) and implementing 

regulations at 42 CFR part 423 subpart 

R, Plan Sponsors (e.g., employers or 

unions) who offer prescription drug 

coverage to their qualified covered 

retirees are eligible to receive a 28% 

subsidy for allowable drug costs. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77515 

CMS has contracted with an outside 

vendor to assist in the administration of 

the RDS program; this effort is called the 

RDS Center. Plan Sponsors will apply 

on-line for the retiree drug subsidy by 

logging on to the RDS Secure website. 

42 CFR 423.844 describes the 

requirement for qualified retiree 

prescription drug plans who want to 

receive the retiree drug subsidy. Once 

the Plan Sponsor submits the RDS 

application via the RDS Secure website 

(and a valid initial retiree list) CMS, 

using its contractor, will analyze the 

application to determine whether the 

Plan Sponsor qualifies for the RDS. To 

qualify for the subsidy, the Plan 

Sponsor must show that its coverage is 

as generous as, or more generous than, 

the defined standard coverage under the 

Medicare Part D prescription drug 

benefit. The information within the 

application includes sponsor account 

registration information, plan 

information, benefit options under the 

plan, actuary information and actuarial 

attestation. The RDS center has various 

checks within each section of the 

application. Applications can be denied 

if issues cannot be resolved. Form 

Number: CMS–10170 (OMB control 

number: 0938–0977); Frequency: Yearly; 

Affected Public: Private Sector; Business 

or other for-profits, and Not-for Profits; 

Number of Respondents: 1,245; Number 

of Responses: 1,245; Total Annual 

Hours: 79,680. (For questions regarding 

this collection, contact Ivan Iveljic at 

410–786–3312 or Ivan.iveljic@

cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–21631 Filed 9–20–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2219] 

Progynon Associates, et al.; 

Withdrawal of Approval of Four New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of four new drug applications 

(NDAs) from multiple holders of those 

NDAs. The basis for the withdrawal is 

that these NDA holders have repeatedly 

failed to file required annual reports for 

the identified NDAs. 

DATES: Approval is withdrawn as of 

September 23, 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 

holder of an approved application to 

market a new drug for human use is 

required to submit annual reports to 

FDA concerning its approved 

application in accordance with § 314.81 

(21 CFR 314.81). 

In the Federal Register of May 28, 

2024 (89 FR 46139), FDA published a 

notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of four NDAs 

because the holders of those NDAs had 

repeatedly failed to submit the required 

annual reports for those NDAs. The 

holders of those NDAs did not respond 

to the NOOH. Failure to file a written 

notice of participation and request for 

hearing as required by § 314.200 (21 

CFR 314.200) constitutes an election by 

those holders of the NDAs not to make 

use of the opportunity for a hearing 

concerning the proposal to withdraw 

approval of their NDAs and a waiver of 

any contentions concerning the legal 

status of the drug products. Therefore, 

FDA is withdrawing approval of the 

four applications listed in table 1 of this 

document. 

TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug Holder 

NDA 004652 ..... ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg).Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA 

90212. 

NDA 013268 ..... WINSTEROID (stanozolol) Tablets, 2 mg ................................ Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016. 

NDA 017455 ..... Copper T Model TCu 200B (copper) Intrauterine Device ........ Duramed Research, Inc., 425 Privet Rd., Horsham, PA 

19044. 

NDA 205003 ..... PRESTALIA (amlodipine besylate/perindopril arginine) Tablets, equivalent to (EQ) 2.5 mg base/3.5mg, EQ 5 mg base/ 

7 mg, and EQ 10 mg base/14 mg.

Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest, 

NC 27588. 

FDA finds that the holders of the 

NDAs listed in table 1 have repeatedly 

failed to submit reports required by 

§ 314.81. In addition, under § 314.200, 

FDA finds that the holders of the NDAs 

have waived any contentions 

concerning the legal status of the drug 

products. Therefore, under these 

findings, approval of the NDAs listed in 

table 1 and all amendments and 

supplements thereto are hereby 

withdrawn as of September 23, 2024. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21680 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3112] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarketing 

Adverse Experience Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 


khammond on DSKJM1Z7X2PROD with NOTICES