75598 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

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 

January 2, 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–10558 Machine Readable Data 

for Provider Network and 

Prescription Formulary Content for 

FFM QHPs 

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: Extension of currently 

approved collection; Title of 

Information Collection: Machine 

Readable Data for Provider Network and 

Prescription Formulary Content for FFM 

QHPs; Use: Under 45 CFR 

156.122(d)(1)(2), 156.230(b), and 

156.230(c), as finalized in the rule, the 

Patient Protection and Affordable Care 

Act; HHS Notice of Benefit and Payment 

Parameters for 2018 (CMS–9934–F), 

established standards for qualified 

health plan (QHP) issuers for the 

submission of provider and formulary 

data in a machine-readable format to the 

Department of Health and Human 

Services. (HHS) and for posting the data 

on issuer websites. These standards 

provide greater transparency for 

consumers, including by allowing 

software developers to access formulary 

and provider data to create innovative 

and informative tools. On September 30, 

2015, the Office of Management and 

Budget (OMB) granted approval to the 

data collection Information Collection 

for Machine Readable Data for Provider 

Network and Prescription Formulary 

Content for FFE QHPs under OMB 

control number 0938–1284. OMB 

approval was granted again on 

November 3, 2017 and March 22, 2021. 

The Centers for Medicare and Medicaid 

Services (CMS) is continuing that 

information collection request (ICR) in 

connection with these machine-readable 

standards. This ICR serves as a formal 

request for the renewal of the data 

collection clearance. The burden 

estimate for the ICR included in this 

package reflects the time and effort for 

QHP and SADP issuers to update and 

publish the appropriate data and submit 

it to CMS. Form Number: CMS–10558 

(OMB control number: 0938–1284); 

Frequency: Annually; Affected Public: 

Private Sector, State, Business, and Notfor Profits; Number of Respondents: 434; 

Number of Responses: 434; Total 

Annual Hours: 39,126. (For questions 

regarding this collection, contact Ana 

Alza at (667) 290–8569, ext. 70008569). 

Dated: October 31, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–24371 Filed 11–2–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

Assessment and Evaluation of ACL’s 

American Indian, Alaska Natives, and 

Native Hawaiian Programs Older 

Americans Act Title VI (OMB Control 

Number 0985–0059) 

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 Assessment and 

Evaluation of ACL’s American Indian, 

Alaska Natives, and Native Hawaiian 

Programs Older Americans Act Title VI 

(OMB Control Number 0985–0059). 

DATES: Submit written comments on the 

collection of information by December 

4, 2023. 

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: 

Amanda Cash at Amanda.Cash@

acl.hhs.gov or (202) 795–7369. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, the 

Administration for Community Living 

(ACL) has submitted the following 


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Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 75599 

proposed collection of information to 

OMB for review and clearance. 

The Administration for Community 

Living (ACL) is requesting approval for 

data collection associated with the 

Assessment and Evaluation of ACL’s 

American Indian, Alaska Natives, and 

Native Hawaiian Programs Older 

Americans Act Title VI (OMB Control 

Number 0985–0059). OAA Title VI 

establishes grants to Native Americans 

for nutrition services, supportive 

services, and family caregiver support 

services. 

The purpose of Title VI is ‘‘to promote 

the delivery of supportive services, 

including nutrition services, to 

American Indians, Alaskan Natives, and 

Native Hawaiians that are comparable to 

services provided under Title III’’ (42 

U.S.C. 3057), which provides nutrition, 

caregiver and supportive services to the 

broader U.S. population. Title VI is 

comprised of three parts; Part A 

provides nutrition and supportive 

services to American Indians and 

Alaska Natives, Part B provides 

nutrition and supportive services to 

Native Hawaiians, and Part C provides 

caregiver services to any programs that 

have Part A/B. 

The previous data collection for this 

project entailed a series of interviews 

and focus groups with Title VI program 

staff, elders, and caregivers. American 

Indian, Alaska Native, and Native 

Hawaiian (AI/AN/NH) populations 

experience significant health and 

socioeconomic disparities compared to 

the rest of the U.S. population. The AI/ 

AN population has the highest rate of 

disabilities and the lowest life 

expectancy compared to the averages for 

the overall population (Centers for 

Disease Control and Prevention [CDC], 

2008; Goins, Moss, Buchwald, & 

Guralnik, 2007). While 18% of the nonHispanic white population is 65 years or 

older, just 8% of Native Hawaiians and 

10% of the AI/AN population is 65 

years or older (AoA, 2015). However, as 

overall life expectancy increases, the 

proportion of older AI/AN adults is 

expected to increase. By 2050, the 

percentage of non-Hispanic white adults 

is expected to decrease by 20%, while 

the population of older minority 

population adults, including AI/AN/ 

NH, is expected to increase by 110% 

(AoA, 2015; CDC, 2013). For AI/AN 

populations, this translates to a 93% 

increase in the number of older adults. 

In addition, the population aged 75 and 

older needing long-term care is expected 

to double by the year 2030 (AoA, 2015; 

CDC 2013; Goins et al., 2007). 

In fiscal year 2023, ACL awarded 290 

Title VI three-year grants to tribes/tribal 

organizations elders for the provision of 

nutrition and supportive services, and a 

portion of awardees also received funds 

for the Native American Caregiver 

Support Program. The Assessment and 

Evaluation of the Title VI Programs will 

examine the effects of the program on: 

1. Older Indians, their families and 

caregivers 

2. Tribal communities 

3. Intergenerational connections in 

tribal communities 

4. Management of the Title VI program 

Additionally, the assessment will 

examine how using COVID 

supplemental funds impacted Title VI 

services provided to older adults. This 

work will help ACL better understand 

and document the impact of these 

funds, how service provision changed 

over time, and what gaps existed despite 

the additional funding. 

The Need for Assessment and 

Evaluation 

The Assessment and Evaluation of the 

Title VI Programs is authorized under 

Section 206(a, c) of Title II of the OAA, 

which directs ACL to ‘‘. . . measure and 

evaluate the impact of all programs 

authorized by this Act, their 

effectiveness in achieving stated goals in 

general, and in relation to their cost, 

their impact on related programs, their 

effectiveness in targeting for services 

under this Act unserved older 

individuals with greatest economic need 

(including low-income minority 

individuals and older individuals 

residing in rural areas) and unserved 

older individuals with greatest social 

need (including low-income minority 

individuals and older individuals 

residing in rural areas), and their 

structure and mechanisms for delivery 

of services, including, where 

appropriate, comparisons with 

appropriate control groups composed of 

persons who have not participated in 

such programs.’’ 

Consistent with requirements of the 

Government Performance Results 

Modernization Act (GPRMA), ACL’s 

Administration on Aging (AoA) 

integrates its strategic priorities and 

plans with performance measurement 

criteria. The AoA has three major 

performance measures: improve 

program efficiency, improve client 

outcomes, and improve effective 

targeting of vulnerable elders. Through 

program assessments, ACL seeks a better 

understanding of key programs, such as 

the programs under Title VI of the OAA 

for AI/AN/NH. Having completed most 

of the data collection, the Assessment 

and Evaluation of the Title VI Programs 

has an interest in adding a data 

collection activity to do a follow-up 

interview with grantees after they have 

completed the current evaluation cycle 

to understand which components of the 

technical assistance, they have received 

have been the most useful for them. 

Table 1 provides an overview of the 

Assessment and Evaluation of the Title 

VI Program data collection activity. 

Data Collection Activities 

TABLE 1 

Activity Purpose, respondents, method, and relevant study 

Title VI Program Staff Follow-up Interviews.The Program Staff Follow-up Interviews will assess how the Title VI Programs have been utilizing 

and implementing the Technical Assistance they have received from the contractor around the 

practice of evaluation. Data will include how evaluation practice is being implemented and on what 

occurring basis, as well as perceptions of met and unmet needs around evaluation; and barriers to 

using evaluation. Up to 2 local staff (e.g., program director and evaluation staff person) will participate in each interview. The interviews will be conducted via telephone in Year 4 with up to 12 evaluation grantees, for a maximum of 24 participants, and will take 60 minutes to complete. See Attachment A (Title VI Program Staff Consent Form and Interview Guide). 

Use of Information Collected 

ACL’s strategic priorities are to 

empower older people and their 

families to (1) make informed decisions 

about, and easily access, health and 

long-term care options and (2) enable 

seniors to remain in their own homes 

through the provision of home and 

community-based services. 

Central to these priorities is the 

pursuit of consistent and effective 

approaches to support older adults in 

their own homes and communities, and 

to coordinate the provision of 


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75600 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

supportive services to seniors and their 

caregivers in an integrated system of 

long-term care. Information gathered 

through the Assessment and Evaluation 

of the Title VI Programs will inform 

ACL and its partners, other Federal 

agencies and administrators, current 

grantees, policymakers, and the field 

about ways to improve service delivery 

for elders and their caregivers and 

helping them to remain in their homes 

for as long as possible. For example, 

information gathered through the 

evaluation will be used to identify gaps 

and challenges in service delivery, as 

well as areas of further need. 

Without this assessment and 

evaluation, Federal and local officials 

will not be able to determine whether 

the Title VI Programs are having the 

intended impact on AI/AN/NH elders 

and whether the grantees are meeting 

the individual goals of the programs. 

The new proposed data collection with 

further allow ACL to understand how 

successful the training and technical 

assistance provided to Title VI 

evaluation grantees was for their 

practice of data collection and use. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice published in the Federal 

Register 88 FR 56633 on August 18, 

2023. There were no public comments 

received during the 60-day FRN. 

Estimated Program Burden: 

ESTIMATED PROGRAM BURDEN

Respondent type Form name 

Number of 

annual 

respondents 

Number of 

responses per 

respondent 

Average burden 

(in hours) 

per response 

Annual burden 

hours 

Program director ........... Program staff follow-up interview guide ............. 12 1 1 12 

Dated: October 30, 2023. 

Alison Barkoff, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the duties of the Administrator 

and the Assistant Secretary for Aging. 

[FR Doc. 2023–24255 Filed 11–2–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4372] 

Enforcement Policy for Clinical 

Electronic Thermometers; Guidance 

for Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Enforcement Policy 

for Clinical Electronic Thermometers.’’ 

This guidance applies to clinical 

electronic thermometers, which are 

regulated as class II devices. This 

guidance has been implemented 

without prior comment, but it remains 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 3, 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–N–4372 for ‘‘Enforcement Policy 

for Clinical Electronic Thermometers.’’ 

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. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 


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