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
5550 Federal Register / Vol. 89, No. 19 / Monday, January 29, 2024 / Notices 

were realigned to their respective 

divisions. 

The OPQ retitled four of its suboffices 

and retitled the majority of its divisions. 

The OPQ will establish the Office of 

Quality Assurance and within it 

established the Quality Assurance Staff, 

Learning and Professional Staff, and the 

Project Management Staff. 

FDA, CDER, OPQ has been 

restructured as follows: 

DCDL. ORGANIZATION. The Office 

of Pharmaceutical Quality is headed by 

the Director of Pharmaceutical Quality 

and includes the following 

organizational units: 

Office of Pharmaceutical Quality 

(DCDL) 

Office of Product Quality Assessment I 

(DCDLH) 

Division of Product Quality 

Assessment I (DCDLHA) 

Division of Product Quality 

Assessment II (DCDLHB) 

Division of Product Quality 

Assessment III (DCDLHC) 

Division of Product Quality 

Assessment IV (DCDLHD) 

Division of Product Quality 

Assessment V (DCDLHE) 

Division of Product Quality 

Assessment VI (DCDLHF) 

Office of Product Quality Assessment II 

(DCDLB) 

Division of Product Quality 

Assessment VII (DCDLBA) 

Division of Product Quality 

Assessment VIII (DCDLBB) 

Division of Product Quality 

Assessment IX (DCDLBC) 

Division of Product Quality 

Assessment X (DCDLBD) 

Division of Product Quality 

Assessment XI (DCDLBE) 

Division of Product Quality 

Assessment XII (DCDLBF) 

Office of Product Quality Assessment III 

(DCDLA) 

Division of Product Quality 

Assessment XIII (DCDLAA) 

Division of Product Quality 

Assessment XIV (DCDLAB) 

Division of Product Quality 

Assessment XV (DCDLAC) 

Division of Product Quality 

Assessment XVI (DCDLAD) 

Division of Product Quality 

Assessment XVII (DCDLAE) 

Division of Product Quality 

Assessment XVIII (DCDLAF) 

Division of Product Quality 

Assessment XIX (DCDLAG) 

Office of Pharmaceutical Manufacturing 

Assessment (DCDLD) 

Division of Pharmaceutical 

Manufacturing Assessment I 

(DCDLDA) 

Division of Pharmaceutical 

Manufacturing Assessment II 

(DCDLDB) 

Division of Pharmaceutical 

Manufacturing Assessment III 

(DCDLDC) 

Division of Pharmaceutical 

Manufacturing Assessment IV 

(DCDLDD) 

Division of Pharmaceutical 

Manufacturing Assessment V 

(DCDLDE) 

Division of Pharmaceutical 

Manufacturing Assessment VI 

(DCDLDF) 

Office of Program and Regulatory 

Operations (DCDLG) 

Division of Regulatory & Business 

Process Management I (DCDLGA) 

Division of Regulatory & Business 

Process Management II (DCDLGB) 

Division of Regulatory & Business 

Process Management III (DCDLGC) 

Division of Regulatory & Business 

Process Management IV (DCDLGD) 

Office of Pharmaceutical Quality 

Research (DCDLF) 

Division of Pharmaceutical Quality 

Research I (DCDLFA) 

Division of Pharmaceutical Quality 

Research II (DCDLFB) 

Division of Pharmaceutical Quality 

Research III (DCDLFC) 

Division of Pharmaceutical Quality 

Research IV (DCDLFD) 

Division of Pharmaceutical Quality 

Research V (DCDLFE) 

Division of Pharmaceutical Quality 

Research VI (DCDLFF) 

Office of Policy for Pharmaceutical 

Quality (DCDLC) 

Compendial Operations and 

Standards Staff (DCDLCA) 

Division of Regulations and Guidance 

(DCDLCB) 

Division of Internal Policy and 

Communication (DCDLCC) 

Division of Editorial and Project 

Management (DCDLCD) 

Office of Quality Assurance (DCDLJ) 

Quality Assurance Staff (DCDLJ1) 

Learning and Professional 

Development Staff (DCDLJ2) 

Enterprise Project Management Staff 

(DCDLJ3) 

Office of Quality Surveillance (DCDLE) 

Division of Quality Intelligence I 

(DCDLEB) 

Division of Quality Intelligence II 

(DCDLEC) 

Division of Quality Intelligence III 

(DCDLED) 

Office of Administrative Operations 

(DCDLI) 

Administrative Analysis Staff 

(DCDLI1) 

Administrative Operations Staff 1 

(DCDLI2) 

Administrative Operations Staff 2 

(DCDLI3) 

Administrative Operations Staff 3 

(DCDLI4) 

Administrative Operations Staff 4 

(DCDLI5) 

Financial Services Staff (DCDLI6) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

This reorganization is reflected in 

FDA’s Staff Manual Guide (SMG). 

Persons interested in seeing the 

complete SMG can find it on FDA’s 

website at: http://www.fda.gov/ 

AboutFDA/ReportsManualsForms/ 

StaffManualGuides/default.htm. 

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

Xavier Becerra, 

Secretary of Health and Human Services. 

[FR Doc. 2024–01613 Filed 1–26–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request 

Collection of Grants and Contracts 

Data the Historically Black Colleges and 

Universities (HBCUs) and Small 

Businesses May Be Interested in 

Pursuing (Office of the Director) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH), 

Office of the Director, Office of 

Acquisitions and Logistics Management 

(OALM), Small Business Program Office 

(SBPO), has submitted to the Office of 

Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 


ddrumheller on DSK120RN23PROD with NOTICES1