Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 84155 

regarding the burden estimate 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 on the collection(s) of 

information must be received by the 

OMB desk officer by November 20, 

2024. 

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. 

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 Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement without change 

to a previously approved information 

collection; Title of Information 

Collection: National Provider Identifier 

(NPI) Application and Update Form and 

Supporting Regs in 45 CFR 142.408, 45 

CFR 162.408, 45 CFR 162.406; Use: The 

adoption by the Secretary of HHS of the 

standard unique health identifier for 

health care providers is a requirement of 

the Health Insurance Portability and 

Accountability Act of 1996 (HIPAA). 

The unique identifier is to be used on 

standard transactions and may be used 

for other lawful purposes in the health 

care system. The CMS Final Rule 

published on January 23, 2004, adopts 

the National Provider Identifier (NPI) as 

the standard unique health identifier for 

health care providers. Health care 

providers that are covered entities under 

HIPAA must apply for and use NPIs in 

standard transactions. Other health care 

providers are eligible for NPIs but are 

not required by regulation to apply for 

them or use them. Health care providers 

began applying for NPIs on May 23, 

2005. 

The National Provider Identifier 

Application and Update Form is used 

by health care providers to apply for 

NPIs and furnish updates to the 

information they supplied on their 

initial applications. The form is also 

used to deactivate their NPIs if 

necessary. The original application form 

was approved in February 2005 and has 

been in use since May 23, 2005. The 

form is available on paper or can be 

completed via a web-based process. 

Health care providers can mail a paper 

application, complete the application 

via the web-based process via the 

National Plan and Provider 

Enumeration System (NPPES), or have a 

trusted organization submit the 

application on their behalf via the 

Electronic File Interchange (EFI) 

process. The Enumerator uses the 

NPPES to process the application and 

generate the NPI. NPPES is the Medicare 

contractor tasked with issuing NPIs, and 

maintaining and storing NPI data. Form 

Number: CMS–10114 (OMB control 

number: 0938–0931); Frequency: 

Occasionally; Affected Public: Business 

or other for-profits, Not for-profits and 

Federal Government; Number of 

Respondents: 1,275,912; Number of 

Responses: 1,275,912; Total Annual 

Hours: 298,777. (For policy questions 

regarding this collection contact 

Da’Vona Boyd at 410–786–7483). 

2. Type of Information Collection 

Request: Revision of a currently 

approved information collection; Title 

of Information Collection: Medicare 

Drug Coverage and Your Rights; Use: 

Section 423.562(a)(3) and an associated 

regulatory provision at 

§ 423.128(b)(7)(iii) require that Part D 

plan sponsors’ network pharmacies 

provide Part D enrollees with a printed 

copy of our standardized pharmacy 

notice ‘‘Medicare Drug Coverage and 

Your Rights’’ (hereafter, ‘‘notice’’) if an 

enrollee’s prescription cannot be filled. 

The purpose of this notice is to 

provide enrollees with information 

about how to contact their Part D plans 

to request a coverage determination, 

including a request for an exception to 

the Part D plan’s formulary. The notice 

reminds enrollees about certain rights 

and protections related to their 

Medicare prescription drug benefits, 

including the right to receive a written 

explanation from the drug plan about 

why a prescription drug is not covered. 

Through delivery of this standardized 

notice, a Part D plan sponsor’s network 

pharmacies are in the best position to 

inform enrollees at point of sale about 

how to contact their Part D plan if the 

prescription cannot be filled. Form 

Number: CMS–10147 (OMB control 

number: 0938–0975); Frequency: Yearly; 

Affected Public: Private Sector, Business 

or other for-profits, Not for-profits; 

Number of Respondents: 72,900; 

Number of Responses: 55,215,940; Total 

Annual Hours: 919,898. (For policy 

questions regarding this collection 

contact Sabrina Edmonston at 410–786– 

3209 or Sabrina.edmonston@

cms.hhs.gov). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–24264 Filed 10–18–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Federal Tax Refund Offset, 

Administrative Offset, and Passport 

Denial 

AGENCY: Office of Child Support 

Services, Administration for Children 

and Families, U.S. Department of Health 

and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Child Support 

Services (OCSS), Administration for 

Children and Families (ACF), is 

requesting the federal Office of 

Management and Budget (OMB) to 

approve the Federal Tax Refund Offset, 

Administrative Offset, and Passport 

Denial with minor edits to change 


lotter on DSK11XQN23PROD with NOTICES1
84156 Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 

‘‘Office of Child Support Enforcement 

(OCSE)’’ to ‘‘Office of Child Support 

Services (OCSS)’’ and minor formatting 

enhancements. The current OMB 

approval expires on June 30, 2025. 

DATES: Comments due December 20, 

2024. 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 

above. 

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: The Federal Tax Refund 

Offset and Administrative Offset 

programs collect past-due child and 

spousal support by intercepting certain 

federal payments, including federal tax 

refunds, of parents who have been 

ordered to pay support and are 

delinquent. The Federal Offset Program 

is a cooperative effort among the 

Department of the Treasury’s Bureau of 

the Fiscal Service, OCSS, and state child 

support agencies (CSAs). The Passport 

Denial Program reports noncustodial 

parents who owe child and spousal 

support above a specified threshold to 

the Department of State, which will 

then deny passports to these 

individuals. State CSAs routinely 

submit the names, Social Security 

numbers, and the amount(s) of past-due 

child and spousal support of 

noncustodial parents who are 

delinquent in making payments to 

OCSS. 

Respondents: Child Support 

Agencies. 

ANNUAL BURDEN ESTIMATES

Information collection instrument Number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

annual 

burden 

hours per 

response 

Annual 

burden 

hours 

Input Record Specifications ..................................................................................... 54 52 .3 842.4 

Output Record Specifications .................................................................................. 54 52 .46 1,291.68 

Payment File (Charts 4–5) ...................................................................................... 54 52 .14 393.12

Annual Certification Letter ....................................................................................... 54 1 .4 21.6 

Child Support Portal Processing Screens ............................................................... 173 281 .01 486.13 

Estimated Total Annual Burden 

Hours: 3,034.93. 

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. 652(b); 42 U.S.C. 

664; 26 U.S.C. 6402(c); 31 CFR 285.3; 45 

CFR 302.60; 45 CFR 303.72; 31 U.S.C. 

3701 et seq.; 31 U.S.C. 3716(h); 31 CFR 

285.1; 42 U.S.C. 652(k); 42 U.S.C. 

654(31); 22 CFR 51.60; 42 U.S.C. 

654(31); 42 U.S.C. 664; 31 CFR 285.1; 

and 31 CFR 285.3. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–24228 Filed 10–18–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–E–3056] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Pascal Precision 

Transcatheter Valve Repair System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for PASCAL PRECISION 

TRANSCATHETER VALVE REPAIR 

SYSTEM and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of the U.S. 

Patent and Trademark Office (USPTO), 

Department of Commerce, for the 

extension of a patent which claims that 

medical device. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by December 20, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

April 21, 2025. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: 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 

December 20, 2024. 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 


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