Agency Information Collection Activities: Submission for OMB Review; Comment Request, 77514-77515 [2024-21631]
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77514
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
FEE SCHEDULE FOR EACH VESSEL SIZE—Continued
Operational
inspection 2 fee
(US$)
Vessel size (GT 1)
Tier 4 (>180,001 GT) ...................................................................................................................................
64,584
Construction and
renovation
inspection 3 fee
(US$)
129,168
1 Gross
tonnage in cubic feet, as shown in Lloyd’s Register of Shipping (https://www.lr.org/en/).
2 Operations 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
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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16:57 Sep 20, 2024
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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.
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\23SEN1.SGM
23SEN1
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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.
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
SUMMARY:
77515
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.
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.
SUPPLEMENTARY INFORMATION:
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
NDA 004652 .....
ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg).
WINSTEROID (stanozolol) Tablets, 2 mg ................................
Copper T Model TCu 200B (copper) Intrauterine Device ........
NDA 013268 .....
NDA 017455 .....
khammond on DSKJM1Z7X2PROD with NOTICES
NDA 205003 .....
Holder
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.
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.
Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA
90212.
Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016.
Duramed Research, Inc., 425 Privet Rd., Horsham, PA
19044.
Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest,
NC 27588.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21680 Filed 9–20–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3112]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Experience Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
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23SEN1
Agencies
[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77514-77515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21631]
-----------------------------------------------------------------------
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/PRA-Listing.
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 [email protected].)
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 Sec. 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.
[[Page 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
[email protected].)
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