Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92941 

Elements and Drug Price Negotiation 

Process for Initial Price Applicability 

Year 2027 under sections 11001 and 

11002 of the Inflation Reduction Act 

Information Collection Request (ICR) 

(CMS–10849, OMB 0938–1452); Use: 

Under the authority in sections 11001 

and 11002 of the Inflation Reduction 

Act of 2022 (Pub. L. 117–169), the 

Centers for Medicare & Medicaid 

Services (CMS) is implementing the 

Medicare Drug Price Negotiation 

Program, codified in sections 1191 

through 1198 of the Social Security Act 

(‘‘the Act’’). The Act establishes the 

Negotiation Program to negotiate 

maximum fair prices (‘‘MFPs’’), defined 

at 1191(c)(3) of the Act, for certain high 

expenditure, single source selected 

drugs covered under Medicare Part B 

and Part D. For the second year of the 

Negotiation Program, the Secretary of 

Health and Human Services (the 

‘‘Secretary’’) will select up to 15 high 

expenditure, single source drugs 

covered under Part D for negotiation. 

Negotiation Data Elements: The 

statute requires that CMS consider 

certain data from Primary 

Manufacturers as part of the negotiation 

process. To the extent that more than 

one entity meets the statutory definition 

of manufacturer (specified in section 

1193(a)(1) of the Act) for a selected drug 

for purposes of initial price applicability 

year 2027, CMS will designate the entity 

that holds the New Drug Application(s) 

(NDA(s))/Biologics License 

Application(s) (BLA(s)) for the selected 

drug to be ‘‘the manufacturer’’ of the 

selected drug (hereinafter the ‘‘Primary 

Manufacturer’’). The Primary 

Manufacturer’s data submissions 

include non-FAMP and related data for 

selected drugs for the purpose of 

establishing a ceiling price, as outlined 

in section 1193(a)(4)(A) of the Act, and 

the negotiation factors outlined in 

section 1194(e)(1) of the Act for the 

purpose of formulating offers and 

counteroffers process pursuant to 

section 1193(a)(4)(B) of the Act. Some of 

these data are held by the Primary 

Manufacturer and are not currently 

available to CMS. Data described in 

sections 1194(e)(1) and 1193(a)(4) of the 

Act must be submitted by the Primary 

Manufacturer. 

Section 1194(e)(2) of the Act requires 

CMS to consider certain data on 

selected drugs and their alternative 

treatments. Because the statute does not 

specify where these data come from, 

CMS will allow for optional submission 

from Primary Manufacturers and the 

public. CMS will additionally review 

existing literature, conduct internal 

analyses, and consult subject matter and 

clinical experts on the factors listed in 

section 1194(e)(2) of the Act. Primary 

Manufacturers may optionally submit 

this information as part of their 

Negotiation Data Elements Information 

Collection Request Form. The public 

may also optionally submit evidence 

about the selected drugs and their 

alternative treatments. 

Drug Price Negotiation Process: Any 

MFPs that are negotiated for the drugs 

selected for the second year of the 

Negotiation Program will apply 

beginning in initial price applicability 

year 2027. For initial price applicability 

year 2027, the negotiation period begins 

on the earlier of the date that the 

Primary Manufacturer enters into a 

Medicare Drug Price Negotiation 

Program Agreement or February 28, 

2025. 

Section 1194(b)(2)(C) of the Act 

provides that if the Primary 

Manufacturer does not accept CMS’ 

written initial offer, the Primary 

Manufacturer may submit an optional 

written counteroffer no later than 30 

days after the date of receipt of CMS’ 

written initial offer. If the Primary 

Manufacturer chooses to develop and 

submit a written counteroffer to CMS’ 

written initial offer during the drug 

price negotiation process for initial 

price applicability year 2027 in 

accordance with section 1194(b)(2)(C) of 

the Act, the Primary Manufacturer must 

submit the Statutory Written 

Counteroffer Form. Form Number: 

CMS–10849 (OMB control number: 

0938–1452); Frequency: Once; Affected 

Public: Private sector, Business or other 

for-profit; Number of Respondents: 340; 

Total Annual Responses: 340; Total 

Annual Hours: 23,764 (For policy 

questions regarding this collection 

contact Elisabeth Daniel at 667–290– 

8793.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–27490 Filed 11–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity: Services Provided to 

Unaccompanied Children (Office of 

Management and Budget #: 0970–0553) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Refugee 

Resettlement (ORR), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services, is inviting public comments 

on the proposed information collection, 

including proposed changes. The 

request consists of several forms that 

will allow the Unaccompanied Children 

(UC) Bureau to continue providing 

statutorily mandated services to 

unaccompanied children in ORR care. 

DATES: Comments due January 24, 2025. 

In compliance with the requirements of 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described in this notice. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: ORR has undertaken a 

reorganization of its information 

collections to promote operational 

efficiency. The reorganization will 

result in more collections that contain 

fewer forms under a single Office of 

Management and Budget number. This 

information collection currently 

contains 22 unique forms (33 including 

alternative versions). Under the 

reorganization, ORR proposes to 

discontinue the use of six forms; 

transfer 10 forms to new information 

collections associated with Assessments 

and Home Studies/Post-Release 

Services; and revise five existing forms. 

The UC Bureau is requesting to 

discontinue the use of six forms created 

for the UC Path case management 

system, which was never implemented. 

Except where indicated below, the UC 

Path versions of these forms contain 

features and/or logic not replicated in 

the UC Portal, and have never been 

used, thus maintaining these forms is 

unnecessary. These forms include: 

• Long Term Foster Care Travel 

Request (Form S–14)—UC Path version 

only. UC Bureau plans to revise and 

continue using the UC Portal version. 

• Home Study/Post-Release Service 

(HS/PRS) Provider Entity (Form S–21A). 

• Home Study/Post-Release Service 

(HS/PRS) Subcontractor Entity (Form S– 

21B). 

• Home Study/Post-Release Service 

(HS/PRS) Primary Provider Profile 

(Form S–21C). 

• Home Study/Post-Release Service 

(HS/PRS) Subcontractor Profile (Form 

S–21D). 


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92942 Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 

• Sponsor Application (Form S–24). 

Additionally, the following forms 

currently approved under this collection 

will be transferred to two new 

information collections proposed 

separately. The proposed new 

collections will encompass forms 

pertaining to Assessments and Home 

Study/Post-Release Services (HS/PRS). 

These forms include: 

• Assessments Information Collection 

Æ Sponsor Assessment (Form S–5) 

Æ Adult Contact Profile (Form S–7) 

Æ Initial Intakes Assessment (Form S– 

8) 

Æ Assessment for Risk (Form S–9) 

Æ UC Assessment (Form S–11) 

Æ UC Case Review (Form S–12) 

Æ Individual Service Plan (Form S– 

13) 

• Home Study/Post-Release Services 

Information Collection 

Æ Home Study Assessment (Form S– 

6) 

Æ Post-Release Service (PRS) Referral 

(Form S–19) 

Æ Post-Release Service (PRS) Report 

(Form S–22) 

Æ Home Study Referral (Form S–26) 

Finally, the UC Bureau plans to keep 

the following forms in this information 

collection and make revisions as noted 

below. These forms are completed by 

foster parents or case managers or 

clinicians at care provider facilities to 

request approval for a child to travel 

outside the local community with their 

foster parent; to update the child’s 

biographic information and admit them 

into the program; to authorize and 

document the child’s contact with 

others outside the program; to document 

outreach performed on the child’s 

behalf by care providers; and, to capture 

high-level milestones in the child’s case. 

These forms are documentary in nature 

and a critical component of the child’s 

case file. ORR funded care providers 

must always remain compliant with 

ORR and state licensing requirements 

per the Unaccompanied Children 

Program Foundational Rule, 45 CFR 

410.1302(a); proposed revisions that 

remove or simplify form fields attesting 

to or documenting program compliance 

do not exempt programs from satisfying 

these requirements. The following 

revisions are currently proposed for 

each form: 

• Foster Care Travel Request (Form 

S–14): 

Æ Remove ‘‘Long-term’’ from the 

form’s title to clarify this form may be 

used for children in all foster care 

settings. 

Æ Add ‘‘physical location of the 

child’’ field to the UC Basic Information 

section, consistent with changes made 

to the UC Case Status (S–27) form; this 

field will auto-populate data from the 

UC Portal Discharge Tab. 

Æ Clarify that the name of the 

individual with whom the child is 

traveling must be an adult. 

Æ Remove Personal Vehicle 

information section from the form to 

align UC travel request data collection 

with domestic child welfare practices. 

Æ Add Health Safety Travel Plan 

section to the form to document how the 

child’s health conditions, if applicable, 

may be effectively managed while 

traveling with their foster family, and 

plan for how the foster family will 

handle any health-related emergencies 

which may occur during travel. 

Æ Simplify the Travel Request 

Approval section by removing the 

following fields: 

D Reason Travel Request is being 

submitted to ORR/DCS for approval: 

D Is the travel request in accordance 

with state guidelines? 

D Purpose of travel and trip summary: 

D Are there any identified safety 

concerns in this child’s background? 

D Is there any indication of flight risk? 

Æ Add a summary approval field with 

an open text comment space for 

approving officials to document their 

rationale for denial. 

Æ Adjust the burden estimate to 

account for an increase in the number 

of care provider facilities completing the 

form (form now used for children in all 

foster care settings, not just long-term 

foster care) and number of children 

placed in ORR care, and to reflect a 

decrease in the overall number of fields 

the respondent will need to complete. 

The annual number of respondents 

increased from 30 to 138, the annual 

number of responses per response 

increased from 8 to 178, and the average 

burden hours per response decreased 

from 0.33 hours to 0.25 hours. 

• Admission (Form S–18): 

Æ Replace ‘‘UAC’’ with ‘‘UC’’ 

throughout the form to conform with UC 

Bureau standard terminology as 

established in UC Program Foundational 

Rule, 45 CFR 410. 

Æ Add ‘‘Nonbinary’’ to dropdown 

menu options for Gender. 

Æ Add ‘‘physical location of the 

child’’ filed to the UC Basic Information 

section, consistent with changes made 

to the UC Case Status (S–27) form; this 

field will auto-populate data from the 

UC Portal Discharge Tab. 

Æ Adjust the burden estimate to 

account for an increase in the number 

of care provider facilities and number of 

children placed in ORR care. The 

annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response increased from 278 to 327. 

• UC Authorized/Restricted Call List 

and Call Log (Form S–20): 

Æ Replace ‘‘UAC’’ with ‘‘UC’’ 

throughout the form to conform with UC 

Bureau standard terminology as 

established in UC Bureau Foundational 

Rule. 

Æ Add ‘‘Call Supervision Required?’’ 

field to the Authorized Contacts List; 

content will auto-populate on the call 

logs display tab and reference the 

corresponding field in the Family/ 

Friend contact profile. When entering 

this data, respondents will select from a 

‘‘Yes/No’’ dropdown menu to indicate if 

contact between the child and named 

individual must be supervised by care 

provider staff. 

Æ Add the following fields to the UC 

Call Log to support data tracking related 

to UC Bureau Policy Guide Section 

3.3.10 Calls, Visitation, Mail and Email: 

D ‘‘Call Duration’’ with an open text 

field for the care provider staff to 

document the length of the call. 

D ‘‘Supervision Required?’’ which 

will auto-populate ‘‘Yes’’ or ‘‘No’’ based 

on the corresponding field in the 

contact profile. 

D ‘‘Supervised By:’’ with an open text 

field for the care provider to identify 

which staff member supervised the call. 

D Call Method with dropdown 

options to specify if the contact was 

made by phone or video call. 

Æ Adjust the burden estimate to 

account for an increase in the number 

of care provider facilities and number of 

children placed in ORR care, as well as 

revisions to policies on phone calls in 

UC Bureau Policy Guide Section 3.3.10– 

Calls, Visitation, Mail and Email. The 

annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response increased from 6,981 to 

15,711. 

• Case Manager Call Log and Case 

Notes (Form S–23): 

Æ Replace ‘‘UAC’’ with ‘‘UC’’ 

throughout the form to conform with UC 

Bureau standard terminology as 

established in UC Program Foundational 

Rule. 

Æ Adjust the burden estimate to 

account for an increase in the number 

of care provider facilities and number of 

children placed in ORR care. The 

annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response decreased from 8,426 to 8,183. 

• UC Case Status (Form S–27): 

Æ Assigned a tracking number to the 

form (S–27). 

Æ Add ‘‘Physical Location of the 

Child’’ Field to the UC Basic 

Information Section. This will autopopulate with data sourced from the UC 


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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92943 

Portal Discharge Tab, presented as an 

appendix to the form. 

Æ Add ‘‘Concurrent Planning: 

Additional Potential Sponsors’’ segment 

to Family Reunification Section with 

the following fields (which will autopopulate from the Sponsor Assessment 

(Form S–5, currently approved under 

this information collection): 

D Potential Sponsor Name. 

D Relationship to Child. 

D Sponsor Category. 

Æ Split the ‘‘Know Your Rights 

Presentation and Legal Screening’’ into 

two distinct fields to capture the 

completion date for each more 

accurately, acknowledging that they 

typically are not completed on the same 

day. 

Æ Add ‘‘Back-Up Case Manager’’ 

segment to Case Manager Information 

Section to designate an alternative Case 

Manager who may take actions on 

behalf of the primary Case Manager 

when they are unavailable. The 

corresponding fields mirror those for 

primary case manager and will either be 

system-generated or auto-populate with 

user account data already entered the 

system. The fields include: 

D Back-up Case Manager Name. 

D Back-up Case Manager Email 

Address. 

D Back-up Case Manager Phone 

Number. 

D Back-up Case Manager 

Organization. 

D Assigned on (MM/DD/YYYY). 

Æ Adjust the burden estimate to 

account for an increase in the number 

of care provider facilities and number of 

children placed in ORR care, as well as 

the addition of the above listed new 

segments and fields. The annual number 

of respondents increased from 216 to 

300, the annual number of responses per 

respondent increased from 278 to 327, 

and the average burden hours per 

response increased from 0.08 hours to 

0.25 hours. 

Respondents: ORR grantee and 

contractor staff. 

Annual Burden Estimates: 

ANNUAL BURDEN ESTIMATE FOR RESPONDENTS

Form 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual total 

burden hours 

Foster Care Travel Req. Form (S–14) ............................................................ 138 178 0.25 6,141 

Admission (S–18) ............................................................................................ 300 327 0.33 32,373

UC Authorized/Restricted Call List and Call Log (S–20) ................................ 300 15,711 0.08 377,064 

Case Manager Call Log and Case Notes (S–23) ........................................... 300 8,183 0.08 196,392 

UC Case Status (S–27) ................................................................................... 300 327 0.25 24,525 

Estimated Annual Burden Hours Total ..................................................... ........................ ........................ ........................ 636,495 

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: 6 U.S.C. 279; 8 U.S.C. 

1232. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–27505 Filed 11–22–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0180] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for the Collection of Quantitative Data 

on Tobacco Products and 

Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by December 

26, 2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0810. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Generic Clearance for the Collection of 

Quantitative Data on Tobacco Products 

and Communications 

OMB Control Number 0910–0810— 

Extension 

This information collection supports 

FDA programs. Under section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)), FDA is authorized to 

conduct educational and public 

information programs. Under this 

umbrella, FDA’s Center for Tobacco 

Products (CTP) conducts research and 

uses a variety of media to inform and 


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