6118 Federal Register / Vol. 89, No. 21 / Wednesday, January 31, 2024 / Notices 

Frequency of response: Semiannual, 

annual. 

Total estimated burden: 1,800 hours 

(per year). Burden is defined at 5 CFR 

1320.3(b). 

Total estimated cost: $1,950,000 (per 

year), which includes $1,850,000 in 

annualized capital/startup and/or 

operation & maintenance costs. 

Changes in the Estimates: The 

increase in burden from the mostrecently approved ICR is due to an 

increase in the number of new or 

modified sources. There is also an 

increase in costs due to the use of 

updated labor rates. This ICR uses labor 

rates from the most-recent Bureau of 

Labor Statistics report (September 2022) 

to calculate respondent burden costs. 

This ICR also adjusts the capital/startup 

and operation and maintenance costs 

from 2008 to 2022 values using the 

CEPCI CE Index. 

Courtney Kerwin, 

Director, Regulatory Support Division. 

[FR Doc. 2024–01807 Filed 1–30–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10788] 

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 1, 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 ll: 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–10788 Prescription Drug and 

Health Care Spending 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Prescription 

Drug and Health Care Spending; Use: 

On December 27, 2020, the 

Consolidated Appropriations Act, 2021 

(CAA) was signed into law. Section 204 

of title II of division BB of the CAA 

added parallel provisions at section 

9825 of the Internal Revenue Code (the 

Code), section 725 of the Employee 

Retirement Income Security Act 

(ERISA), and section 2799A–10 of the 

Public Health Service Act (PHS Act) 

that require group health plans and 

health insurance issuers offering group 

or individual health insurance coverage 

to annually report to the Department of 

the Treasury, the Department of Labor 

(DOL), and the Department of Health 

and Human Services (HHS) 

(collectively, ‘‘the Departments’’) certain 

information about prescription drug and 

health care spending, premiums, and 

enrollment under the plan or coverage. 

This information will support the 

development of public reports that will 

be published by the Departments on 

prescription drug reimbursements for 

plans and coverage, prescription drug 

pricing trends, and the role of 

prescription drug costs in contributing 

to premium increases or decreases 

under the plans or coverage. The 2021 

interim final rules, ‘‘Prescription Drug 

and Health Care Spending’’ (2021 

interim final rules), issued by the 

Departments and the Office of Personnel 

Management (OPM) implement the 

provisions of section 9825 of the Code, 

section 725 of ERISA, and section 

2799A–10 of the PHS Act, as enacted by 

section 204 of title II of division BB of 

the CAA. OPM joined the Departments 

in issuing the 2021 interim final rules, 

requiring Federal Employees Health 

Benefits (FEHB) carriers to report 

information about prescription drug and 

health care spending, premiums, and 

plan enrollment in the same manner as 

a group health plan or health insurance 

issuer offering group or individual 

health insurance coverage. 

The 2023 Prescription Drug Data 

Collection (RxDC) Reporting 

Instructions reflect changes for the 2023 

reference year and beyond. As a result 

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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 21 / Wednesday, January 31, 2024 / Notices 6119 

year implementation costs and burdens 

that were incurred prior to 2024, it is 

estimated that there will be a decrease 

in total three-year average annual 

burden from 1,684,080 to 668,952. Form 

Number: CMS–10788 (OMB Control 

Number: 0938–1407); Frequency: 

Annually; Affected Public: Private 

Sector; Number of Respondents: 356; 

Number of Responses: 356 Total Annual 

Hours: 668,952. (For policy questions 

regarding this collection contact 

Christina Whitefield at 202–536–8676.) 

Dated: January 25, 2024. 

William N. Parham, III 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–01831 Filed 1–30–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–0361] 

Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2 for 

Emergency Use Authorization; 

Guidance for Industry; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on December 21, 2023. The 

document announced the availability of 

a final guidance for industry entitled 

‘‘Development of Monoclonal Antibody 

Products Targeting SARS–CoV–2 for 

Emergency Use Authorization.’’ The 

document was published with an 

incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Maria Clary, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4638, Silver Spring, 

MD 20993–0002, 240–402–8615. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 21, 2023 

(88 FR 88401), in FR Doc. 2023–28092, 

the following correction is made: 

1. On page 88401, in the first column 

in the header of the document, and in 

the ADDRESSES section, in the second 

and third lines of the first paragraph, the 

Docket No. is corrected to read ‘‘Docket 

No. FDA–2024–D–0361.’’ 

Dated: January 25, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01836 Filed 1–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National 

Institute of Diabetes and Digestive and 

Kidney Diseases Special Emphasis 

Panel NIDDK Application Review: 

RFA–DK–23–017 (U01) and RFA–DK– 

23–018 (U24) Continuation of the 

Childhood Liver Disease Research 

Network (ChiLDReN). 

Date: March 21, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

NIDDK, Democracy II, Suite 7000A, 

6707 Democracy Boulevard, Bethesda, 

MD 20892 (Virtual Meeting). 

Contact Person: Cheryl Nordstrom, 

Ph.D., M.Ph., Scientific Review Officer, 

NIDDK/Scientific Review Branch, 

National Institutes of Health, 6707 

Democracy Blvd., Room 7013, Bethesda, 

MD 20892, 301–402–6711, 

cheryl.nordstrom@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: January 25, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–01845 Filed 1–30–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK RC2 

Application Review. 

Date: March 1, 2024. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

NIDDK, Democracy II, Suite 7000A, 6707 

Democracy Boulevard, Bethesda, MD 

20892,(Virtual Meeting). 

Contact Person: Cheryl Nordstrom, Ph.D., 

M.Ph., Scientific Review Officer, NIDDK/ 

Scientific Review Branch, National Institutes 

of Health, 6707 Democracy Blvd., Room 

7013, Bethesda, MD 20892, 301–402–6711, 

cheryl.nordstrom@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: January 25, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–01849 Filed 1–30–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 


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