5548 Federal Register / Vol. 89, No. 19 / Monday, January 29, 2024 / Notices 

• Delete item (5) of the Office of 

Business Integrity and Strategic 

Management (CAJTB) functional 

statement and renumber the remaining 

items accordingly. 

Delegations of Authority 

All delegations and redelegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegation, provided they are 

consistent with this reorganization. 

(Authority: 44 U.S.C. 3101) 

Dia Taylor, 

Acting Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–01708 Filed 1–26–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10858, CMS– 

10215 and CMS–10394] 

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 

March 29, 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–10858 Rebate Reduction 

Requests under Sections 11101 and 

11102 of the Inflation Reduction 

Act 

CMS–10215 Identifying Medicaid 

Payment for Physician 

Administered Drugs 

CMS–10394 Application To Be a 

Qualified Entity to Receive 

Medicare Data for Performance 

Measurement/Reapplication/ 

Annual Report Worksheet 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Rebate 

Reduction Requests under Sections 

11101 and 11102 of the Inflation 

Reduction Act; Use: Under the authority 

in sections 11101 and 11102 of the 

Inflation Reduction Act of 2022 (Pub. L. 

117–169), the Centers for Medicare & 

Medicaid Services (CMS) is 

implementing the Medicare Part B Drug 

Inflation Rebate Program and the 

Medicare Part D Drug Inflation Rebate 

Program codified in section 1847A(i) 

and section 1860D–14B of the Social 

Security Act (‘‘the Act’’), respectively. 

In accordance with section 1847A(i) of 

the Act, for calendar quarters beginning 

January 1, 2023, a manufacturer of a Part 

B rebatable drug will owe a rebate, to be 

deposited in the Federal Supplementary 

Medical Insurance Trust Fund, if the 

amount specified in section 

1847A(i)(3)(A)(ii)(I) of the Act exceeds 

the inflation-adjusted payment amount, 

which is calculated as set forth in 

section 1847A(i)(3)(C) of the Act. A 

‘‘Part B rebatable drug’’ means a singlesource drug or biological product (as 

defined section 1847A(c)(6)(D) of the 

Act), including a biosimilar biological 

product (as defined section 

1847A(c)(6)(H) of the Act) but excluding 

a qualifying biosimilar biological 

product (as defined section 

1847A(b)(8)(B)(iii) of the Act), for which 

payment is made under Medicare Part 

B, except such term shall not include 

such a drug or biological product if, as 

determined by the Secretary, the average 

total allowed charges for such drug or 

biological product under Part B for a 

year per individual that uses such a 

drug or biological product are less than 

the applicable threshold; or that is a 

vaccine described in subparagraph (A) 

or (B) of section 1861(s)(10) of the Act. 

In accordance with Section 1860D–14B 

of the Act, for each 12-month applicable 

period, starting with the applicable 

period beginning October 1, 2022, a 

manufacturer of a Part D rebatable drug 

will owe a rebate, to be deposited in the 

Federal Supplementary Medical 

Insurance Trust Fund, if the annual 


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Federal Register / Vol. 89, No. 19 / Monday, January 29, 2024 / Notices 5549 

manufacturer price exceeds the 

inflation-adjusted payment amount. 

Section 1860D–14B(g)(1)(A) of the Act 

defines a ‘‘Part D rebatable drug,’’ in 

part, as a drug or biological described at 

section 1860D–14B(g)(1)(C) that is a 

‘‘covered Part D drug’’ as that term is 

defined in section 1860D–2(e) of the 

Act. The definition of a Part D rebatable 

drug includes generic drugs that meet 

certain statutory criteria (effectively sole 

source generics). The definition of a Part 

D rebatable drug does not include a drug 

or biological if, as determined by the 

Secretary, the ‘‘average annual total 

cost’’ for such drug or biological under 

Part D for a year per individual that uses 

such a drug or biological is less than the 

applicable threshold. 

Sections 1847A(i)(3)(G)(ii) and 

1860D–14B(b)(1)(C)(ii) of the Act 

require that CMS reduce or waive the 

inflation rebate amount owed (if any) for 

a Part B rebatable biosimilar biological 

product and generic Part D rebatable 

drug or biosimilar when CMS 

determines there is a severe supply 

chain disruption during a calendar 

quarter or applicable period, 

respectively, such as that caused by a 

natural disaster or other unique or 

unexpected event. CMS must also 

reduce or waive the inflation rebate 

amount owed (if any) for a generic Part 

D rebatable drug if CMS determines that 

without such reduction or waiver, the 

drug is likely to be in shortage in a 

subsequent applicable period, as 

required by section 1860D– 

14B(b)(1)(C)(iii) of the Act. 

CMS does not have information 

necessary to determine whether 

manufacturers of Part B and Part D 

rebatable drugs should have their rebate 

amount reduced due to either a severe 

supply chain disruption or a likely 

shortage as required by sections 

1847A(i)(3)(G)(ii), 1860D– 

14B(b)(1)(C)(ii), and 1860D– 

14B(b)(1)(C)(iii) of the Act. Some of the 

information and supporting 

documentation needed for CMS to make 

a determination regarding a severe 

supply chain disruption and the 

likelihood of a future shortage are held 

by manufacturers and are not available 

to CMS. As such, for CMS to determine 

whether there is a severe supply chain 

disruption or likelihood of future 

shortage, in accordance with sections 

1847A(i)(3)(G)(ii), 1860D– 

14B(b)(1)(C)(ii), and 1860D– 

14B(b)(1)(C)(iii) of the Act, a 

manufacturer must submit to CMS a 

request for a rebate reduction along with 

supporting documentation. Form 

Number: CMS–10858 (OMB control 

number: 0938–New); Frequency: Once; 

Affected Public: Private sector and 

business or other for-profits; Number of 

Respondents: 10; Total Annual 

Responses: 20; Total Annual Hours: 

620. (For policy questions regarding this 

collection contact Elisabeth Daniel at 

667–290–8793.) 

2. Type of Information Collection 

Request: Extension of currently 

approved collection; Title of 

Information Collection: Identifying 

Medicaid Payment for Physician 

Administered Drugs; Use: States are 

required to provide for the collection 

and submission of utilization data for 

certain physician-administered drugs in 

order to receive Federal financial 

participation for these drugs. 

Physicians, serving as respondents to 

States, submit National Drug Code 

numbers and utilization information for 

‘‘J’’ code physician-administered drugs 

so that the States will have sufficient 

information to collect drug rebate 

dollars. Form Number: CMS–10215 

(OMB control number: 0938–1026); 

Frequency: Weekly; Affected Public: 

Business or other for-profits and not-forprofit institutions); Number of 

Respondents: 26,000; Total Annual 

Responses: 39,053,932; Total Annual 

Hours: 162,074. (For policy questions 

regarding this collection contact 

Michael Forman at 410–786–2666.) 

2. Type of Information Collection 

Request: Revision with change of a 

currently approved collection; Title of 

Information Collection: Application to 

be a Qualified Entity to Receive 

Medicare Data for Performance 

Measurement/Reapplication/Annual 

Report Worksheet; Use: The Patient 

Protection and Affordable Care Act 

(ACA) was enacted on March 23, 2010 

(Pub. L. 111–148). ACA amends section 

1874 of the Social Security Act by 

adding a new subsection (e) to make 

standardized extracts of Medicare 

claims data under Parts A, B, and D 

available to QEs to evaluate the 

performance of providers of services 

and suppliers. This is the Application, 

Reapplication, and ARW which 

provides CMS with the information it 

needs to determine whether an 

organization earns approval and 

continues as a QE. 

CMS established the Qualified Entity 

Certification Program (QECP) to 

evaluate an organization’s eligibility 

across three areas: (1) organizational and 

governance capabilities, (2) addition of 

claims data from other sources (as 

required in the statute), and (3) data 

privacy and security. QE certification 

lasts for 3 years. Organizations that are 

interested in remaining in the QE 

program must submit a Reapplication 

that is reviewed and approved by QECP. 

In addition, each year QEs must submit 

an annual report to QECP that provides 

information required by statute. Form 

Number: CMS–10394 (OMB control 

number: 0938–1144); Frequency: Yearly; 

Affected Public: Business or other forprofits; Number of Respondents: 40; 

Total Annual Responses: 210; Total 

Annual Hours: 17,400. (For policy 

questions regarding this collection 

contact Kari Gaare at kari.gaare@

cms.hhs.gov). 

Dated: January 24, 2024. 

William N. Parham, III 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–01723 Filed 1–26–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for Drug 

Evaluation and Research (CDER), Office 

of Pharmaceutical Quality (OPQ) has 

modified its organizational structure. 

This new structure was approved by the 

Secretary of Health and Human Services 

on August 10, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Michael Kopcha, Director, Office of 

Pharmaceutical Quality, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 240–402–2461. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

amended to reflect reorganization of 

CDER, OPQ. 

This reorganization changed the OPQ 

organizational structure from an office 

with nine suboffices to 10 suboffices. 

The former offices with divisions and 

branches had their branches abolished 

and the branch functions and resources 


ddrumheller on DSK120RN23PROD with NOTICES1