Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 80725 

notices. The scope of the April 2021 

umbrella accounts for Medicaid and 

CHIP State plan amendments, waivers, 

demonstrations, and reporting. This 

Federal Register notice seeks public 

comment on one or more of our 

collection of information requests that 

we believe are generic and fall within 

the scope of the umbrella. Interested 

persons are invited to submit 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 

December 4, 2023. 

ADDRESSES: When commenting, please 

reference the applicable form number 

(see below) and the OMB control 

number (0938–1148). 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: CMS–10398 (#37)/OMB 

control number: 0938–1148, 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: Following 

is a summary of the use and burden 

associated with the subject information 

collection(s). More detailed information 

can be found in the collection’s 

supporting statement and associated 

materials (see ADDRESSES). 

Generic Information Collections 

1. Title of Information Collection: 

Managed Care Rate Setting Guidance; 

Type of Information Collection Request: 

Revision of an active collection of 

information request; Use: In accordance 

with 42 CFR 438.7, states must submit 

to CMS for review and approval all rate 

certifications for managed care 

organizations (MCOs), prepaid inpatient 

health plans (PIHPs), and prepaid 

ambulatory health plans (PAHPs). The 

rate certification itself is prepared by a 

state’s actuary who certifies the 

managed care program’s capitation rates 

as actuarially sound for a specific time 

period, and documents the rate 

development process and final certified 

capitation rates. 

Our Medicaid Managed Care Rate 

Development Guide (otherwise referred 

to as the ‘‘rate guide’’) outlines the rate 

development standards and CMS’ 

expectations for documentation 

included in rate certifications such as 

descriptions of base data used, trend 

factors to base data, projected benefit 

and non-benefit costs, and any other 

considerations or adjustments used 

when setting capitation rates. The 

information outlined in the rate guide 

must be included within the rate 

certification in adequate detail to allow 

CMS to determine compliance with 

applicable provisions of 42 CFR part 

438, including that the data, 

assumptions, and methodologies used 

for rate development are consistent with 

generally accepted actuarial principles 

and practices and that the capitation 

rates are appropriate for the populations 

and services to be covered. There is no 

required template that states’ actuaries 

must utilize for the rate certification, but 

the guidance outlined in the rate guide 

serves as a resource for states and their 

actuaries. Adherence by states and their 

actuaries to the rate development 

standards and documentation 

expectations outlined in the rate guide, 

will aid in ensuring compliance with 

the regulations and support CMS’s 

review and approval of actuarially 

sound capitation rates and associated 

federal financial participation. Form 

Number: CMS–10398 (#37) (OMB 

control number: 0938–1148); Frequency: 

Annual; Affected Public: State, Local, or 

Tribal Governments; Number of 

Respondents: 47; Total Annual 

Responses: 137; Total Annual Hours: 

753. For policy questions regarding this 

collection contact Rebecca Burch-Mack 

at 303–844–7355. 

Dated: November 15, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–25631 Filed 11–17–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Financing for Early Care and 

Education: Quality and Access for All 

(New Collection) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, United States 

Department of Health and Human 

Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) at the U.S. 

Department of Health and Human 

Services seeks approval to collect 

information to explore the role of Head 

Start in the early care and education 

(ECE) financing landscape, as well as 

how the use of multiple funding sources 

within a single Head Start program may 

be associated with the provision of Head 

Start’s comprehensive services and with 

state-level differences in ECE funding. 

Survey data will be collected from Head 

Start program directors and state 

government administrators. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The proposed data 

collection seeks to better understand 


ddrumheller on DSK120RN23PROD with NOTICES1
80726 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 

Head Start’s participation in or use of 

coordinated funding, defined as the 

piecing together or combining of 

multiple funding sources. The data 

collection effort will consist of two 

surveys: (1) a census survey of Head 

Start program directors (of any grant 

recipient with a Head Start grant, Early 

Head Start grant, or both, or one of their 

delegate programs), and (2) a census 

survey of three state government 

administrative positions in each of the 

50 states and Washington, DC (the Head 

Start Collaboration Office Director, the 

administrator of state pre-kindergarten 

funds, and the administrator of the 

federal Child Care and Development 

Fund [CCDF]). The surveys will identify 

the most common approaches to 

coordinated funding; examine how 

these approaches relate to the provision 

of high-quality, comprehensive ECE 

services in Head Start programs; 

understand policy levers and conditions 

that influence Head Start programs’ 

decisions around and ability to 

coordinate funding; and document how 

participation in coordinated funding 

relates to Head Start’s engagement with 

other ECE programs and system efforts. 

The resulting insights will inform ACF 

about the prevalence of coordinated 

funding in Head Start, facilitators and 

challenges of coordinated funding for 

Head Start programs, and potential 

associations with program quality. They 

will also inform future case studies. 

Respondents: Head Start Program 

Directors, state-based Head Start 

Collaboration Office Directors, state 

administrators of state pre-kindergarten 

funds, and state-based administrators of 

federal CCDF. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Program Director Survey (Head Start Program Directors or financial administrators) ....................................................................................................... 1,642 1 .83 1,363 

ECE State Administrator Survey (State-based Head Start Collaboration Office Directors, administrators of state pre-kindergarten funds, state-based 

administrators of federal CCDF) .................................................................. 138 1 .67 93 

Estimated Total Annual Burden 

Hours: 1,456. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 9835; 42 U.S.C. 

9844. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–25607 Filed 11–17–23; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4806] 

Implementing Interoperable Systems 

and Processes for Enhanced Drug 

Distribution Security Requirements 

Under Section 582(g)(1) of the Federal 

Food, Drug, and Cosmetic Act; 

Establishment of a Public Docket; 

Request for Information and 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for information 

and comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

publishing this request for information 

to better understand the status of trading 

partners’ interoperable systems and 

processes for enhanced drug 

distribution security as required by the 

Food, Drug and Cosmetic Act (FD&C 

Act). 

DATES: Although you can comment at 

any time, submit either electronic or 

written information and comments by 

February 20, 2024 to ensure that the 

Agency considers your comments for 

potential future actions. 

ADDRESSES: You may submit 

information and comments 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’’). 


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