322 Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices 

Lehman at 410–786–8929 or 

daniel.lehman@cms.hhs.gov.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Request for 

Termination of Medicare Premium Part 

A, Part B, or Part B Immunosuppressive 

Drug Coverage (Part B–ID) and 

Supporting Statute and Regulations; 

Use: Sections 1818(c)(5), 1818A(c)(2)(B) 

and 1838(b)(1) of the Act and 

corresponding regulations at 42 CFR 

406.28(a) and 407.27(c) require that a 

Medicare enrollee wishing to 

voluntarily terminate Part B or premium 

Part A coverage file a written request 

with CMS or SSA. Pursuant to 1838(h) 

of the Act and the corresponding 

regulation at 42 CFR 407.62(a), 

individuals wishing to terminate their 

Part B–ID coverage must notify SSA. 

The statute and regulations also specify 

when coverage ends based upon the 

date the request for termination is filed. 

The CMS–1763 is the form used by 

individuals who wish to terminate their 

Medicare Part A, Part B or Part B–ID. 

This 2024 iteration is a revision that 

does not propose any program changes. 

Per the Office of Communication’s plain 

language suggestion, the title has been 

updated to ‘‘Request for Termination of 

Medicare Premium Part A, Part B, or 

Part B Immunosuppressive Drug 

Coverage (Part B–ID).’’ The 2024 

submission saw an increase in the 

burden due to utilization of the form 

and improvement in the accuracy of the 

data exchanges between CMS and SSA. 

Updated wage information for a Federal 

Government employee is also 

responsible for part of the increase. 

Form Number: CMS–1763 (OMB control 

number 0938–0025); Frequency: 

Biennially; Affected Public: Private 

Sector—State, Local, or Tribal 

Governments; and Federal Government; 

Number of Respondents: 197,518; Total 

Annual Responses: 197,518; Total 

Annual Hours: 33,578. (For policy 

questions regarding this collection 

contact Tyrissa Woods at 410–786–0286 

or tyrissa.woods@cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–31567 Filed 1–2–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number(s): 93.645] 

Notice of Allotment Percentages to 

States for Child Welfare Services State 

Grants; Correction 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Notice; correction. 

SUMMARY: The Administration for 

Children and Families published a 

document in the Federal Register 

published Wednesday, December 4, 

2024, concerning notice of Allotment 

Percentages to States for Child Welfare 

Services State Grants. The formula used 

to calculate the allotment percentages 

for each state was not applied correctly. 

Although the percentage for the State of 

Alabama percentage was calculated 

correctly, the formula used to calculate 

the allotment percentages was not 

correctly applied to the remaining 

states. 

FOR FURTHER INFORMATION CONTACT: 

Sona Cook, 214–767–2973. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of December 4, 

2024, in FR Doc. 2024–28398, on page 

96256, in the second and third columns, 

the ALLOTMENT table contained an 

incorrect formula for the Allotment 

Percentages to States for Child Welfare 

Services State Grants. The updated 

ALLOTMENT table with the correct 

allotment percentage for each State is as 

follows: 

ALLOTMENT ** 

State Percentage 

Alabama ................................ 61.01 

Alaska * ................................. 48.58 

Arizona .................................. 55.49 

Arkansas ............................... 58.66 

California ............................... 41.38 

Colorado ............................... 43.03 

Connecticut ........................... 35.99 

Delaware ............................... 52.51 

District of Columbia 1 ............ 30.00 

Florida ................................... 51.25 

Georgia ................................. 56.80 

Hawaii * ................................. 52.67 

Idaho ..................................... 57.12 

Illinois .................................... 48.26 

Indiana .................................. 55.74 

Iowa ...................................... 54.48 

Kansas .................................. 53.25 

Kentucky ............................... 60.14 

Louisiana .............................. 57.73 

Maine .................................... 53.63 

ALLOTMENT **—Continued 

State Percentage 

Maryland ............................... 46.19 

Massachusetts ...................... 35.02 

Michigan ............................... 56.10 

Minnesota ............................. 47.65 

Mississippi ............................ 64.18 

Missouri ................................ 55.55 

Montana ................................ 53.73 

Nebraska .............................. 49.64 

Nevada ................................. 52.74 

New Hampshire .................... 43.28 

New Jersey ........................... 41.18 

New Mexico .......................... 60.32 

New York .............................. 41.19 

North Carolina ...................... 55.66 

North Dakota ........................ 47.82 

Ohio ...................................... 55.81 

Oklahoma ............................. 56.84 

Oregon .................................. 51.55 

Pennsylvania ........................ 50.59 

Rhode Island ........................ 51.41 

South Carolina ...................... 58.86 

South Dakota ........................ 47.83 

Tennessee ............................ 55.38 

Texas .................................... 52.76 

Utah ...................................... 54.33 

Vermont ................................ 52.28 

Virginia .................................. 47.50 

Washington ........................... 42.58 

West Virginia ........................ 62.16 

Wisconsin ............................. 53.26 

Wyoming ............................... 42.78 

America Samoa .................... 70.00 

Guam .................................... 70.00 

Puerto Rico ........................... 70.00 

N. Mariana Islands ............... 70.00 

Virgin Islands ........................ 70.00 

Anthony Petruccelli, 

Senior Grants Policy Specialist, Office of 

Grants Policy, Office of Administration. 

[FR Doc. 2024–31515 Filed 1–2–25; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5784] 

Interested Parties Meeting: 

Implementation of the Best 

Pharmaceuticals for Children Act and 

Pediatric Research Equity Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration’s (FDA, Agency, or we) 

Office of Pediatric Therapeutics, the 

Center for Drug Evaluation and 

Research, and the Center for Biologics 

Evaluation and Research are 

announcing a public meeting entitled 

‘‘Interested Parties Meeting: 


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Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices 323 

Implementation of the Best 

Pharmaceuticals for Children Act and 

Pediatric Research Equity Act.’’ The 

purpose of the public meeting is to seek 

input from interested parties, including 

patient/parent/caregiver groups, 

consumer groups, regulated industry, 

academia, and others. This input will 

enable FDA to obtain any 

recommendations or information 

relevant to the report to Congress that 

FDA is required to submit concerning 

pediatric drug and biologic 

development and labeling, as outlined 

in section 508 of the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA). 

DATES: The public meeting will be held 

on May 15, 2025, from 9 a.m. to 4:30 

p.m. Eastern Time. Regardless of 

attendance at the public meeting, you 

can submit electronic or written 

comments to the public docket. Either 

electronic or written comments on this 

public meeting must be submitted by 

June 13, 2025. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public meeting will be 

held in-person at the FDA White Oak 

Campus, 10903 New Hampshire Ave., 

Building 31 Conference Center, the 

White Oak Great Room, Silver Spring, 

MD 20993–0002 and virtually using the 

Zoom platform. Entrance for the inperson public meeting participants 

(non-FDA employees) is through 

Building 1 where routine security check 

procedures will be performed. For 

parking and security information, please 

refer to https://www.fda.gov/about-fda/ 

visitor-information. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 13, 2025. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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–2024– 

N–5784 for ‘‘Interested Parties Meeting: 

Implementation of the Best 

Pharmaceuticals for Children Act and 

Pediatric Research Equity Act.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Tworek, the Office of Pediatric 

Therapeutics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–9234, OPT@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the President signed 

into law the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144). 

Section 508 of FDASIA directs the 

Secretary of HHS to submit a report to 

Congress on the implementation of 

sections 505A and 505B of the Federal 

Food, Drug, and Cosmetic Act, which 

are commonly known as the Best 

Pharmaceuticals for Children Act 

(BPCA) and the Pediatric Research 

Equity Act (PREA), respectively. 

The first report was required to be 

submitted to Congress by July 9, 2016, 

and subsequent reports are required 

every 5 years thereafter, with the next 

report due to be submitted in July 2026. 

FDASIA also requires FDA to obtain, at 

least 180 days prior to submission of the 

report, input from interested parties, 

including: patient groups (including 

pediatric patient groups), consumer 

groups, regulated industry, academia, 

and any other interested parties to 

obtain any recommendations or 

information relevant to the report 

including suggestions for modifications 

that would improve pediatric drug 

research and pediatric labeling of drugs 

and biological products. In addition, on 

August 18, 2017, the FDA 

Reauthorization Act of 2017 (Pub. L. 


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324 Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Notices 

115–52) was signed into law, which 

outlined additional requirements to be 

included in the report. 

II. Topics for Discussion at the Public 

Meeting 

Some of the issues to be discussed at 

the meeting will include, but not be 

limited to: 

• Hearing from patients/parents/ 

caregivers and patient/parent/caregiver 

groups, consumer groups, industry, 

academia, and other interested parties 

about the public health impact that the 

pediatric legislation may have had on 

them or their communities, including 

treatment advances for children 

resulting from the legislation, as well as 

areas of continued unmet medical need. 

• Understanding the effects of the 

requirement of pediatric studies under 

PREA or the incentives under BPCA on 

drug/biologic development plans, 

including issues related to the balance 

of incentives and requirements and 

progress toward international alignment 

on pediatric drug development to the 

extent practicable. 

• Understanding if there are any 

barriers or resource issues preventing 

undertaking or completing studies 

under PREA and BPCA, including 

issues related to clinical trial 

infrastructure and enrollment and 

ensuring pediatric clinical trial 

populations reflect the diversity of 

children most likely to use and benefit 

from the therapeutic treatments. 

• Understanding successes and 

challenges with leveraging scientific 

advances in product development, 

including, but not limited to, use of 

pediatric extrapolation, adaptive trial 

designs, biomarkers as surrogates, and 

real-world data to facilitate more timely 

evidence-generation for pediatric 

populations. 

III. Participating in the Public Meeting 

Registration: For more information 

and to register for the public meeting, 

please visit: https://www.fda.gov/newsevents/fda-meetings-conferences-andworkshops/interested-parties-meetingimplementation-best-pharmaceuticalschildren-act-and-pediatric-research. 

Please provide complete contact 

information for each attendee, including 

name, email address, and affiliation. 

Registration is free and based on space 

availability for in-person attendance, 

with priority given to early registrants. 

Persons interested in attending this 

public meeting in-person must register 

by May 1, 2025, 11:59 p.m. Eastern 

Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 8 a.m. We will post a 

notice on the meeting web page if 

registration for in-person attendance 

closes before the day of the public 

meeting. 

If you need special accommodations 

due to a disability, please contact OPT@

fda.hhs.gov no later than May 8, 2025, 

11:59 p.m. Eastern Time. 

Requests for Oral Comment: During 

online registration you may indicate if 

you wish to present an oral comment 

during a public comment session, and 

which topic(s) you wish to address. We 

will do our best to accommodate 

requests to make oral comments. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

comments. All requests to make oral 

comments, for both virtual and inperson attendees, must be received by 

the close of in-person registration on 

May 1, 2025, 11:59 p.m. Eastern Time. 

Following the close of registration, we 

will determine the amount of time 

allotted to each presenter and the 

approximate time that the oral comment 

session is to begin, and will notify 

participants making an oral comment by 

May 5, 2025, 11:59 p.m. Eastern Time. 

If making an oral comment, any 

presentation materials must be emailed 

to OPT@fda.hhs.gov (see FOR FURTHER

INFORMATION CONTACT) no later than May 

9, 2025, 11:59 p.m. Eastern Time. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. The link to view the virtual 

Zoom webinar will be sent to registered 

participants prior to the meeting. The 

meeting web page link is: https://

www.fda.gov/news-events/fda-meetingsconferences-and-workshops/interestedparties-meeting-implementation-bestpharmaceuticals-children-act-andpediatric-research. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov, https://

www.fda.gov/news-events/fda-meetingsconferences-and-workshops/interestedparties-meeting-implementation-bestpharmaceuticals-children-act-andpediatric-research, or the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 9 

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

Friday, 240–402–7500. 

Notice of this meeting is given 

pursuant to 21 CFR 10.65. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31312 Filed 1–2–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine and Oral 

Fluid Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines) using 

Urine and the laboratories currently 

certified to meet the standards of the 

Mandatory Guidelines using Oral Fluid. 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Flanagan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Flanagan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) publishes a notice 

listing all HHS-certified laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) in the Federal Register during 

the first week of each month, in 

accordance with Section 9.19 of the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

Section 9.17 of the Mandatory 

Guidelines using Oral Fluid. If any 

laboratory or IITF certification is 

suspended or revoked, the laboratory or 

IITF will be omitted from subsequent 

lists until such time as it is restored to 

full certification under the Mandatory 

Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 


lotter on DSK11XQN23PROD with NOTICES1