81418 Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 

notice appears in the Federal Register, 

and the Commission requests that 

comments be submitted within 7 days 

on agreements that request expedited 

review. Copies of agreements are 

available through the Commission’s 

website (www.fmc.gov) or by contacting 

the Office of Agreements at (202) 523– 

5793 or tradeanalysis@fmc.gov. 

Agreement No.: 201307–001. 

Agreement Name: Crowley/Sealand 

Space Charter Agreement. 

Parties: Crowley Latin America 

Services, LLC; Maersk A/S DBA 

Sealand. 

Filing Party: Wayne Rohde; Cozen 

O’Connor. 

Synopsis: The amendment deletes 

Haiti from the geographic scope of the 

agreement and adjusts the amount of 

space being chartered. 

Proposed Effective Date: 11/16/2023. 

Location: https://www2.fmc.gov/

FMC.Agreements.Web/Public/

AgreementHistory/22408. 

Dated: November 17, 2023. 

Carl Savoy, 

Federal Register Alternate Liaison Officer. 

[FR Doc. 2023–25815 Filed 11–21–23; 8:45 am] 

BILLING CODE 6730–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10418] 

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 (the 

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 our burden estimates or any 

other aspect of this collection of 

information, including any of the 

following subjects: 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 

the OMB desk officer by December 22, 

2023. 

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 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: Annual MLR 

and Rebate Calculation Report and MLR 

Rebate Notices; Use: Under section 2718 

of the Affordable Care Act and 

implementing regulation at 45 CFR part 

158, a health insurance issuer (issuer) 

offering group or individual health 

insurance coverage must submit a report 

to the Secretary concerning the amount 

the issuer spends each year on claims, 

quality improvement expenses, nonclaims costs, Federal and State taxes 

and licensing and regulatory fees, the 

amount of earned premium, and 

beginning with the 2014 reporting year, 

the amounts related to the transitional 

reinsurance and risk adjustment 

programs established under sections 

1341 and 1343, respectively, of the 

Affordable Care Act. An issuer must 

provide an annual rebate if the amount 

it spends on certain costs compared to 

its premium revenue (excluding Federal 

and States taxes and licensing and 

regulatory fees) does not meet a certain 

ratio, referred to as the medical loss 

ratio (MLR). Each issuer is required to 

submit annually MLR data, including 

information about any rebates it must 

provide, on a form prescribed by CMS, 

for each State in which the issuer 

conducts business. Each issuer is also 

required to provide a rebate notice to 

each policyholder that is owed a rebate 

and each subscriber of policyholders 

that are owed a rebate for any given 

MLR reporting year. Additionally, each 

issuer is required to maintain for a 

period of seven years all documents, 

records and other evidence that support 

the data included in each issuer’s 

annual report to the Secretary. 

Based upon CMS’ experience in the 

MLR data collection and evaluation 

process, CMS is updating its annual 

burden hour estimates to reflect the 

actual numbers of submissions, rebates 

and rebate notices. 

The 2022 MLR Reporting Form and 

Instructions reflect changes for the 2020 

reporting year and beyond. For 2022, it 

is expected that issuers will submit 

fewer reports and on average, send 

fewer notices and rebate checks in the 

mail to policyholders and subscribers, 

which will reduce burden on issuers. 

Form Number: CMS–10418 (OMB 

control number: 0938–1164); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 480; Number of 

Responses: 1,677; Total Annual Hours: 

170,091. For policy questions regarding 

this collection contact Jiyun Lim at 667– 

290–9650. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 81419 

Dated: November 17, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–25861 Filed 11–21–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–P–4223] 

Determination That BUPRENEX 

(Buprenorphine Hydrochloride) 

Injection, 0.3 Milligram/Milliliter, Was 

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, the Agency, or 

we) has determined that BUPRENEX 

(buprenorphine hydrochloride) 

Injection, 0.3 milligram (mg)/milliliter 

(mL), was 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 this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Caitlin Callahan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6269, 

Silver Spring, MD 20993–0002, 301– 

796–3600, Caitlin.Callahan@

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. 

BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, is 

the subject of NDA 018401, held by 

Indivior, Inc., and initially approved on 

December 29, 1981. BUPRENEX is 

indicated for the management of pain 

severe enough to require an opioid 

analgesic and for which alternate 

treatments are inadequate. 

BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. Odin Pharmaceuticals LLC 

submitted a citizen petition dated 

September 27, 2023 (Docket No. FDA– 

2023–P–4223), under 21 CFR 10.30, 

requesting that the Agency determine 

whether BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, 

was 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 BUPRENEX 

(buprenorphine hydrochloride) 

Injection, 0.3 mg/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

BUPRENEX (buprenorphine 

hydrochloride) Injection, 0.3 mg/mL, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list BUPRENEX 

(buprenorphine hydrochloride) 

Injection, 0.3 mg/mL, 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. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also 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: November 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25857 Filed 11–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4719] 

Translation of Good Laboratory 

Practice Study Reports: Questions and 

Answers; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Translation of GLP Study Reports: 

Questions and Answers.’’ This guidance 

provides information to sponsors and 

nonclinical laboratories regarding the 

translation of study reports for studies 

conducted in compliance with good 

laboratory practice (GLP) regulations. 

GLP studies are nonclinical safety 

studies that include, but are not limited 

to nonclinical toxicology studies, safety 

pharmacology studies, and device safety 

studies. When study reports of GLP 

studies are translated from the original 

language into English, adequate 

documentation is critical to ensure 


khammond on DSKJM1Z7X2PROD with NOTICES