Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 89701 

by using the search function. By mail to 

the Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Bldg., 725 17th St. NW, Rm. 10235, 

Washington, DC 20503, Attn: OMB Desk 

Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Delaney Roach, Administration for 

Community Living, evaluation@

acl.hhs.gov, (202) 795–7316. 

SUPPLEMENTARY INFORMATION: In 

compliance with the Paperwork 

Reduction Act, the Administration for 

Community Living (ACL) has submitted 

the following proposed collection of 

information to OMB for review and 

clearance. A Program Performance 

Report on activities under title VI of the 

Older Americans Act (OAA) is 

necessary for ACL to monitor Federal 

funds effectively and to be informed as 

to the progress of the programs. 

Grantees are required to submit an 

annual Program Performance Report to 

allow for efficient Federal monitoring. 

The OAA states that the tribal 

organization (applicant) for a grant 

under title VI part A, Indian Program, 

report data for ACL to comply with 

requirements under the OAA. The OAA 

also states that an applicant under title 

VI part B, Native Hawaiian Program, 

provide that the organization will report 

information for the agency Assistant 

Secretary to reasonably require, and 

comply with such requirements. An 

applicant for a grant under title VI part 

C, Native American Caregiver Support 

Program must also prepare and submit 

reports on the data and records, 

including information on the services 

funded by ACL. A combined Program 

Performance Report form is used for 

reporting by grantees under Parts A, B 

and C. The regulations require grantees 

to submit annual performance reports 

unless ACL requires quarterly or 

semiannual reports. 

The Program Performance Report 

provides a data base for ACL to: (1) 

monitor program achievement of 

performance objectives; (2) establish 

program policy and direction; and (3) 

prepare responses to Congress, the 

OMB, other Federal departments, and 

public and private agencies as required 

by the OAA. If ACL did not collect the 

program data herein requested, it would 

not be able to monitor and manage total 

program progress as expected, nor 

develop program policy options 

directed toward assuring the most 

effective use of limited title VI funds. 

Comments in Response to the 60-Day 

Federal Register Notice 

A 60-day FRN published in the FR on 

October 25, 2023, at 88 FR 73344– 

73345. ACL did not receive any public 

comments during the 60-day FRN 

public comment period. 

Estimated Program Burden: The 

burden estimate is specific to the type 

of work done by the grantees that use 

this reporting format; ACL estimates it 

takes 3.5 hours to complete the title VI 

PPR. With 282 respondents taking 3.5 

hours per performance report, annual 

burden hour totals 987 hours. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual burden 

hours 

Title VI PPR ..................................................................................................... 282 1 3.5 987 

Total .......................................................................................................... ........................ ........................ ........................ 987 

Dated: December 21, 2023. 

Alison Barkoff, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging 

[FR Doc. 2023–28577 Filed 12–27–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

State Health Insurance Assistance 

Program (SHIP) Client Contact Forms 

OMB Control Number 0985–0040 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living is announcing that 

the proposed collection of information 

listed above has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance as 

required under the Paperwork 

Reduction Act of 1995. This 30-day 

notice collects comments on the 

information collection requirements 

related to the proposed revision for the 

information collection requirements 

related to the State Health Insurance 

Assistance Program (SHIP) Client 

Contact Forms OMB Control Number 

0985–0040. 

DATES: Comments on the collection of 

information must be submitted 

electronically by 11:59 p.m. (EST) or 

postmarked by January 29, 2024. 

ADDRESSES: Submit written comments 

and recommendations for the proposed 

information collection within 30 days of 

publication of this notice to 

www.reginfo.gov/public/do/PRAMain. 

Find the information collection by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. By mail to 

the Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Bldg., 725 17th St. NW, Rm. 10235, 

Washington, DC 20503, Attn: OMB Desk 

Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Glendening, Administration 

for Community Living, 

Katherine.Glendening@acl.hhs.gov, 

(202) 795–7350. 

SUPPLEMENTARY INFORMATION: In 

compliance with the Paperwork 

Reduction Act (44 U.S.C. 3507), the 

Administration for Community Living 

(ACL) has submitted the following 

proposed collection of information to 

OMB for review and clearance. The 

purpose of this data collection is to 

collect performance data from grantees, 

grantee team members and partners. 

Congress requires this data collection 

for program monitoring and 

Government Performance Results Act 

(GPRA) (31 U.S.C. 1115) purposes. This 

data collection allows ACL to 

communicate with Congress and the 

public on the SHIP, the Senior Medicare 

Patrol (SMP) program, and the Medicare 

Improvements for Patients & Providers 

Act (MIPPA) program, in addition to the 

SHIP Data Performance Reports and 

Information Collection under OMB 

0985–0040. The SHIP, SMP, and MIPPA 

programs are in each of the 50 states, the 

District of Columbia, Puerto Rico, 

Guam, and the U.S. Virgin Islands. To 

ensure that grantees report activity 

accurately and consistently it is 

imperative that these data collection 

tools remain active. The respondents for 


khammond on DSKJM1Z7X2PROD with NOTICES
89702 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 

this data collection are grantees, grantee 

team members, and partners who meet 

with Medicare beneficiaries and older 

adults in-group settings and in one-onone sessions to educate them on 

Medicare enrollment, Medicare benefits 

and subsidy programs, the importance 

of being aware of Medicare fraud, error, 

and abuse, and having the knowledge to 

protect the Medicare system. 

Authorizing Legislation: The Omnibus 

Budget Reconciliation Act of 1990 

created the State Health Insurance 

Assistance Program (SHIP) (U.S.C. 

1395b–4) and requires the Secretary to 

provide a series of reports to the U.S. 

Congress on the performance of the 

SHIP program annually. The law also 

requires ACL to report on the program’s 

impact on beneficiaries and to obtain 

important feedback from beneficiaries. 

This tool captures the information and 

data necessary for ACL to meet these 

Congressional requirements, as well as, 

capturing performance data on 

individual grantees providing ACL with 

essential insight for monitoring and 

technical assistance purposes. In 

addition, MIPPA (42 U.S.C. 1935b–3 

notes), provided targeted funding for the 

SHIPs, area agencies on aging, and 

Aging and Disability Resource Centers 

to conduct enrollment assistance to 

Medicare beneficiaries for the Limited 

Income Subsidy and Medicare Savings 

Program. These activities have been 

funded nearly annually through a series 

of funding or extenders bills. This tool 

also collects performance and outcome 

data on the MIPPA Program providing 

ACL necessary information for 

monitoring and oversight. 

Under Public Law 104–208, the 

Omnibus Consolidated Appropriations 

Act of 1997, Congress established the 

Senior Medicare Patrol Projects to 

further curb losses to the Medicare 

program. The Senate Committee noted 

that retired professionals, with 

appropriate training, could serve as 

educators and resources to assist 

Medicare beneficiaries and others to 

detect and report errors, fraud, and 

abuse. 

Among other requirements, it directed 

ACL to work with the Department of 

Health and Human Services, Office of 

Inspector General (HHS/OIG) and the 

Government Accountability Office 

(GAO), to assess the performance of the 

program. ACL employs this tool to 

collect performance and outcome data 

on the SMP Program, necessary 

information for monitoring and 

oversight. ACL has shared this data and 

worked with HHS/OIG to develop SMP 

performance measures. 

The HHS/OIG has collected SMP 

performance data and issued SMP 

performance reports since 1997. The 

information from the current collection 

is reported by the HHS/OIG to Congress 

and the public. This information is also 

used by ACL as the primary method for 

monitoring the SMP Projects. 

This data collection will also support 

ACL in tracking performance outcomes 

and efficiency measures with respect to 

annual and long-term performance 

targets established in the GPRA. 

This information collection collects 

demographic data from people receiving 

programs and services funded by ACL. 

ACL will adhere to best practices for 

collection of all demographic 

information when this information is 

collected for the programs listed in 

accordance with OMB guidance. 

This includes, but is not limited to, 

guidance specific to the collection of 

sexual orientation and gender identity 

(SOGI) items that align with Executive 

Order 13985 on Advancing Racial 

Equity and Support for Underserved 

Communities Through the Federal 

Government, Executive Order 14075 on 

Advancing Equality for Lesbian, Gay, 

Bisexual, Transgender, Queer, and 

Intersex Individuals, and Executive 

Order 13988 on Preventing and 

Combating Discrimination on the Basis 

of Gender Identity and Sexual 

Orientation. Understanding these 

disparities can and should lead to 

improved service delivery for ACL’s 

programs and populations served. 

Comments in Response to the 60-Day 

Federal Register Notice 

ACL published a 60-day FRN on 

October 25, 2023, at 88 FR 73345. ACL 

did not receive any public comments 

during the 60-day FRN. 

Estimated Program Burden: ACL 

estimates the respondent burden hours 

to prepare and complete all reports 

associated with this collection as 

329,294 annual burden hours. This 

estimate is based on the current data 

system’s aggregate data and reports. 

Modifying several forms, ACL has 

reduced the overall burden hours 

associated with this information 

collection along with grantees no longer 

generating reports outside of the data 

system. 

Form name Estimated time in minutes Fraction of an 

hour 

SMP Media Outreach & Education ............................................ 4 .................................................................................................. 0.0667 

SMP Group Outreach & Education ............................................ 4 .................................................................................................. 0.0667 

SMP Individual Interaction .......................................................... 5 .................................................................................................. 0.0833 

SMP Team Member Activity ....................................................... 5 .................................................................................................. 0.0833 

SMP Interaction .......................................................................... 5 .................................................................................................. 0.0833 

SMP Team Member ................................................................... 7 .................................................................................................. 0.1166 

SHIP Media Outreach & Education ............................................ 4 .................................................................................................. 0.0667 

SHIP Group Outreach & Education ........................................... 4 .................................................................................................. 0.0667 

SHIP Team Member ................................................................... 7 .................................................................................................. 0.1166 

SHIP Beneficiary Contact ........................................................... 5 .................................................................................................. 0.0833 

SHIP Training Form .................................................................... 6 .................................................................................................. 0.10 

SHIP Team Member Activity ...................................................... 7 .................................................................................................. 0.1166 

SHIP Training ............................................................................. 4 .................................................................................................. 0.0667 

Estimated Annualized Burden Hours 

Grantee respondent type Form/report name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in minutes) 

Total burden 

hours 

SMP .................................................. Media Outreach & Education ........... 216 46 4 662.4 

SMP .................................................. Group Outreach & Education ........... 6,935 4 4 1,849.33 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 89703 

Grantee respondent type Form/report name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in minutes) 

Total burden 

hours 

SMP .................................................. Individual Interaction ........................ 6,935 41 5 23,694.58 

SMP .................................................. Team Member .................................. 216 31 5 558 

SMP .................................................. SIRS Team Member Activity ............ 216 31 5 558 

*SMP ................................................. OIG Report ....................................... * 0 0 0 0 

*SMP ................................................. Time Spent Report ........................... * 0 0 0 0 

SHIP/MIPPA ...................................... Media Outreach & Education ........... 3,750 15 4 3,750 

SHIP/MIPPA ...................................... Group Outreach & Education ........... 3,750 15 4 3,750 

SHIP/MIPPA ...................................... STARS Team Member ..................... 216 75 5 1,350 

SHIP/MIPPA ...................................... Beneficiary Contact .......................... 15,000 233 5 291,250 

*SHIP/MIPPA .................................... SHIP Performance Report ............... * 0 0 0 0 

*SHIP/MIPPA .................................... Resource Report .............................. * 0 0 0 0 

*SHIP/MIPPA .................................... MIPPA Performance Report ............ * 0 0 0 0 

SHIP/MIPPA ...................................... SHIP Team Member Activity ............ 216 40 7 1,008 

SHIP/MIPPA ...................................... Team Member Training .................... 216 40 6 864 

*SHIP/SMP/MIPPA ........................... Summary Reports ............................ * 0 0 0 0 

*SHIP/MIPPA .................................... Part D Enrollment Outcomes Report * 0 0 0 0 

Totals ......................................... ........................................................... 37,666 571 ........................ 329,294.31 

* This data collection activity is an automated task in the system and does not compute to an estimate of time for burden. 

Dated: December 21, 2023. 

Alison Barkoff, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2023–28623 Filed 12–27–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–5408] 

Reformulating Drug Products That 

Contain Carbomers Manufactured With 

Benzene; 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 final 

guidance for industry entitled 

‘‘Reformulating Drug Products That 

Contain Carbomers Manufactured With 

Benzene.’’ The purpose of this guidance 

is to provide recommendations to 

applicants and manufacturers on what 

tests should be performed and what 

documentation should be submitted or 

available to support the reformulation of 

drug products that use carbomers 

manufactured with benzene. Certain 

United States Pharmacopeia (USP) 

carbomer monographs currently allow 

for unacceptable levels of benzene, 

which raises safety concerns. FDA has 

requested that the USP omit (or remove) 

these monographs, and applicants and 

manufacturers may need to reformulate 

their drug products to avoid use of these 

carbomers. This guidance provides 

recommendations for tests and 

documentation related to reformulation 

based on various routes of 

administration and dosage forms of 

affected drug products, and provides 

recommendations for application 

holders on the appropriate submission 

types to notify the Agency of 

reformulation changes. The intended 

effect of this guidance is to, as 

appropriate, provide a less burdensome 

risk-based approach to reformulation 

submissions relative to existing 

guidances on scale-up and postapproval changes (SUPAC), and address 

the immediate public health need to 

expedite the discontinuation of the use 

of carbomers manufactured with high 

levels of benzene in drug products. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 28, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–5408 for ‘‘Reformulating Drug 

Products That Contain Carbomers 

Manufactured With Benzene; Guidance 

for Industry.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 


khammond on DSKJM1Z7X2PROD with NOTICES