Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 89709 

approved under OMB control number 

0910–0014; the collections of 

information in 21 CFR 600.14 have been 

approved under OMB control number 

0910–0458; and the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at https:// 

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, http://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28596 Filed 12–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Advanced 

Nursing Education Program Specific 

Form OMB No. 0915–0375—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 26, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Advanced Nursing Education (ANE) 

Program Specific Form OMB No. 0915– 

0375—Revision 

Abstract: HRSA provides advanced 

nursing education grants to educational 

institutions to increase the supply, 

distribution, quality of, and access to 

advanced education nurses through the 

ANE Programs. The ANE Programs are 

authorized by section 811 of the Public 

Health Service Act (42 U.S.C. 296j), as 

amended. This clearance request is for 

continued approval of the information 

collection OMB No. 0915–0375 with 

revisions. This revision request seeks to 

add the Advanced Nursing EducationNurse Practitioner Residency and 

Fellowship (ANE–NPRF) Program and 

the Maternity Care Nursing Workforce 

Expansion Program to the ANE Program 

Specific Form, and to remove programs 

that have closed, which include the 

Advanced Nursing Education-Nurse 

Practitioner Residency (ANE–NPR) 

Program and the Advanced Nursing 

Education-Nurse Practitioner Residency 

Integration Program. The activities 

previously supported under the ANE– 

NPR and the Advanced Nursing 

Education-Nurse Practitioner Residency 

Integration Program are now supported 

under the ANE–NPRF Program. 

Need and Proposed Use of the 

Information: Section 811 of the Public 

Health Service Act provides the 

Secretary of Health and Human Services 

with the authority to award grants to 

and enter into contracts with eligible 

entities to meet the costs of: (1) projects 

that support the enhancement of 

advanced nursing education and 

practice; and (2) traineeships for 

individuals in advanced nursing 

education programs. Under this section, 

HRSA makes awards to entities who 

train and support nurses characterized 

as ‘‘advanced education nurses.’’ In 

awarding such grants, funding 

preference is given to applicants with 

projects that will substantially benefit 

rural or underserved populations or 

help meet public health nursing needs 

in state or local health departments; 

special consideration is given to an 

eligible entity that agrees to extend the 

award to train advanced education 

nurses who will practice in designated 

Health Professional Shortage Areas. 

The ANE Program Specific Form 

allows HRSA to effectively target 

funding and measure the impact of the 

ANE Programs in meeting the legislative 

intent and program goals of supporting 

the enhancement of advanced nursing 

education and creating opportunities for 

individuals in advanced nursing 

education programs to increase the 

number of advanced practice nurses, 

especially in rural and underserved 

areas. Additionally, collecting this data 

assists HRSA in carrying out the most 

impactful program and ensuring 

resources are used responsibly. The 

proposed updates to this information 

collection are to accurately list the 

current ANE Programs. 

Likely Respondents: Likely 

respondents will be current ANE 

Programs awardees and new applicants 

to ANE Programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

(includes the ANE program specific tables and attachments) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Advanced Nursing Education Workforce ............................. 156 1 156 7 1,092 

Nurse Anesthetist Traineeship ............................................. 64 1 64 7 448 


khammond on DSKJM1Z7X2PROD with NOTICES
89710 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name 

(includes the ANE program specific tables and attachments) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Advanced Nursing Education Sexual Assault Nurse Examiners .................................................................................. 54 1 54 7 378 

ANE–NPRF .......................................................................... 64 1 64 7 448 

Maternity Care Nursing Workforce Expansion .................... 10 1 10 7 70 

Total .............................................................................. 348 ........................ 348 ........................ 2,436 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–28664 Filed 12–27–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[OMHA–2302–N] 

Medicare Program; Administrative Law 

Judge Hearing Program for Medicare 

Claim and Entitlement Appeals; 

Quarterly Listing of Program 

Issuances—July Through September 

2023 

AGENCY: Office of Medicare Hearings 

and Appeals (OMHA), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists the 

OMHA Case Processing Manual (OCPM) 

instructions that were published from 

July through September 2023. This 

manual standardizes the day-to-day 

procedures for carrying out adjudicative 

functions, in accordance with 

applicable statutes, regulations, and 

OMHA directives, and gives OMHA 

staff direction for processing appeals at 

the OMHA level of adjudication. 

FOR FURTHER INFORMATION CONTACT: Jon 

Dorman, by telephone at (571) 457– 

7220, or by email at jon.dorman@

hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Office of Medicare Hearings and 

Appeals (OMHA), a staff division within 

the Office of the Secretary within the 

U.S. Department of Health and Human 

Services (HHS), administers the 

nationwide Administrative Law Judge 

hearing program for Medicare claim; 

organization, coverage, and at-risk 

determination; and entitlement appeals 

under sections 1869, 1155, 

1876(c)(5)(B), 1852(g)(5), and 1860D– 

4(h) of the Social Security Act (the Act). 

OMHA ensures that Medicare 

beneficiaries and the providers and 

suppliers that furnish items or services 

to Medicare beneficiaries, as well as 

Medicare Advantage organizations 

(MAOs), Medicaid State agencies, and 

applicable plans, have a fair and 

impartial forum to address 

disagreements with Medicare coverage 

and payment determinations made by 

Medicare contractors, MAOs, or Part D 

plan sponsors (PDPSs), and 

determinations related to Medicare 

eligibility and entitlement, Part B late 

enrollment penalty, and income-related 

monthly adjustment amounts (IRMAA) 

made by the Social Security 

Administration (SSA). 

The Medicare claim, organization 

determination, coverage determination, 

and at-risk determination appeals 

processes consist of four levels of 

administrative review, and a fifth level 

of review with the Federal district 

courts after administrative remedies 

under HHS regulations have been 

exhausted. The first two levels of review 

are administered by the Centers for 

Medicare & Medicaid Services (CMS) 

and conducted by Medicare contractors 

for claim appeals, by MAOs and an 

Independent Review Entity (IRE) for 

Part C organization determination 

appeals, or by PDPSs and an IRE for Part 

D coverage determination and at-risk 

determination appeals. The third level 

of review is administered by OMHA and 

conducted by Administrative Law 

Judges and attorney adjudicators. The 

fourth level of review is administered by 

the HHS Departmental Appeals Board 

(DAB) and conducted by the Medicare 

Appeals Council (Council). In addition, 

OMHA and the DAB administer the 

second and third levels of appeal, 

respectively, for Medicare eligibility, 

entitlement, Part B late enrollment 

penalty, and IRMAA reconsiderations 

made by SSA; a fourth level of review 

with the Federal district courts is 

available after administrative remedies 

within SSA and HHS have been 

exhausted. 

Sections 1869, 1155, 1876(c)(5)(B), 

1852(g)(5), and 1860D–4(h) of the Act 

are implemented through the 

regulations at 42 CFR part 405 subparts 

I and J; part 417, subpart Q; part 422, 

subpart M; part 423, subparts M and U; 

and part 478, subpart B. As noted above, 

OMHA administers the nationwide 

Administrative Law Judge hearing 

program in accordance with these 

statutes and applicable regulations. To 

help ensure nationwide consistency in 

that effort, OMHA established a manual, 

the OCPM. Through the OCPM, the 

OMHA Chief Administrative Law Judge 

establishes the day-to-day procedures 

for carrying out adjudicative functions, 

in accordance with applicable statutes, 

regulations, and OMHA directives. The 

OCPM provides direction for processing 

appeals at the OMHA level of 

adjudication for Medicare Part A and B 

claims; Part C organization 

determinations; Part D coverage 

determinations and at-risk 

determinations; and SSA eligibility and 

entitlement, Part B late enrollment 

penalty, and IRMAA determinations. 

Section 1871(c) of the Act requires 

that the Secretary publish a list of all 

Medicare manual instructions, 

interpretive rules, statements of policy, 

and guidelines of general applicability 

not issued as regulations at least every 

three months in the Federal Register. 

II. Format for the Quarterly Issuance 

Notices 

This quarterly notice provides the 

specific updates to the OCPM that have 

occurred in the three-month period of 

July through September 2023. A 

hyperlink to the available chapters on 

the OMHA website is provided below. 

The OMHA website contains the most 

current, up-to-date chapters and 

revisions to chapters, and will be 


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