94732 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

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 

of a previously approved collection; 

Title: Medicare Program: Procedures for 

Making National Coverage Decisions; 

Use: This collection is required by a 

notice (78 FR 48164–69) published on 

August 7, 2013 which delineates the 

process for making a national coverage 

determination (NCD) including 

information for external parties to 

submit a formal request for a new NCD 

or a reconsideration of an existing NCD. 

An NCD is defined in 1862(l) of the 

Social Security Act (the Act) as ‘‘a 

determination by the Secretary with 

respect to whether or not a particular 

item or service is covered nationally 

under this title.’’ This information 

collection will assist us in obtaining the 

information we require to make a 

national coverage determination in a 

timely manner and ensuring that the 

Medicare program continues to meet the 

needs of its beneficiaries. Form Number: 

CMS–R–290 (OMB control number: 

0938–0776); Frequency: Annual; 

Affected Public: Private Sector: Business 

or other for-profits; Number of 

Respondents: 30; Total Annual 

Responses: 30; Total Annual Hours: 

1,200. (For policy questions regarding 

this collection contact Lori M. Ashby at 

410–786–6322.) 

2. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection: 

Title of Information Collection: 

Transcatheter Valve Therapy (TVT) 

Registry; Use: The data collection is 

required by the Centers for Medicare 

and Medicaid Services (CMS) National 

Coverage Determination (NCD) entitled, 

‘‘Transcatheter Aortic Valve 

Replacement (TAVR)’’. The TAVR 

device is only covered when specific 

conditions are met including that the 

heart team and hospital are submitting 

data in a prospective, national, audited 

registry. The data includes patient, 

practitioner and facility level variables 

that predict outcomes such as all cause 

mortality and quality of life. CMS finds 

that the Society of Thoracic Surgery/ 

American College of Cardiology 

Transcatheter Valve Therapy (STS/ACC 

TVT) Registry, one registry overseen by 

the National Cardiovascular Data 

Registry, meets the requirements 

specified in the NCD on TAVR. The 

TVT Registry will support a national 

surveillance system to monitor the 

safety and efficacy of the TAVR 

technologies for the treatment of aortic 

stenosis. 

The data will also include the 

variables on the eight item Kansas City 

Cardiomyopathy Questionnaire (KCCQ– 

10) to assess heath status, functioning 

and quality of life. In the KCCQ, an 

overall summary score can be derived 

from the physical function, symptoms 

(frequency and severity), social function 

and quality of life domains. For each 

domain, the validity, reproducibility, 

responsiveness and interpretability have 

been independently established. Scores 

are transformed to a range of 0–100, in 

which higher scores reflect better health 

status. 

The conduct of the STS/ACC TVT 

Registry and the KCCQ–10 is in 

accordance with Section 1142 of the 

Social Security Act (the Act) that 

describes the authority of the Agency for 

Healthcare Research and Quality 

(AHRQ). Under section 1142, research 

may be conducted and supported on the 

outcomes, effectiveness, and 

appropriateness of health care services 

and procedures to identify the manner 

in which disease, disorders, and other 

health conditions can be prevented, 

diagnosed, treated, and managed 

clinically. Section 1862(a)(1)(E) of the 

Act allows Medicare to cover under 

coverage with evidence development 

(CED) certain items or services for 

which the evidence is not adequate to 

support coverage under section 

1862(a)(1)(A) and where additional data 

gathered in the context of a clinical 

setting would further clarify the impact 

of these items and services on the health 

of beneficiaries. 

The data collected and analyzed in 

the TVT Registry will be used by CMS 

to determine if the TAVR is reasonable 

and necessary (e.g., improves health 

outcomes) for Medicare beneficiaries 

under Section 1862(a)(1)(A) of the Act. 

Furthermore, data from the Registry will 

assist the medical device industry and 

the Food and Drug Administration 

(FDA) in surveillance of the quality, 

safety and efficacy of new medical 

devices to treat aortic stenosis. For 

purposes of the TAVR NCD, the TVT 

Registry has contracted with the Data 

Analytic Centers to conduct the 

analyses. In addition, data will be made 

available for research purposes under 

the terms of a data use agreement that 

only provides de-identified datasets. 

Form Number: CMS–10443 (OMB 

control number: 0938–1202); Frequency: 

Annual; Affected Public: Individuals, 

Households and Private Sector; Number 

of Respondents: 49,704; Total Annual 

Responses: 198,816; Total Annual 

Hours: 63,790. (For policy questions 

regarding this collection contact Nina 

Arya at 667–290–9456). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–28077 Filed 11–27–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request; Centers for 

Independent Living Program 

Performance Report (0985–0061) 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

an opportunity for the public to 

comment on the proposed collection of 

information listed above. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This proposed revision of a 

currently approved information 

collection request (ICR Rev) solicits 

comments on the information collection 

requirements related to the Centers for 

Independent Living (CILs) under the 

Rehabilitation Act of 1973, 29 U.S.C. 

701, et seq. (the Act). 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 94733 

DATES: Comments on the collection of 

information must be submitted 

electronically by 11:59 p.m. (ET) or 

postmarked by January 28, 2025. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: Peter Nye at 

OILPPRAComments@acl.hhs.gov. 

Submit written comments on the 

collection of information to 

Administration for Community Living, 

Washington, DC 20201, Attention: Peter 

Nye. 

FOR FURTHER INFORMATION CONTACT: 

Peter Nye, Administration for 

Community Living, Washington, DC 

20024, (202) 795–7606 or 

OILPPRAComments@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to 

Office of Management and Budget for 

approval. To comply with this 

requirement, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following collection 

of information, ACL invites comments 

on our burden estimates or any other 

aspect of this collection of information, 

including: 

(1) whether the proposed collection of 

information is necessary for the proper 

performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) ways to minimize the burden of 

the collection of information on 

respondents, including through the use 

of automated collection techniques 

when appropriate, and other forms of 

information technology. 

Independent living (IL) programs, 

including CILs, are authorized by the 

Act to ‘‘promote a philosophy of 

independent living including a 

philosophy of consumer control, peer 

support, self-help, self-determination, 

equal access, and individual and system 

advocacy, in order to maximize the 

leadership, empowerment, 

independence, and productivity of 

individuals with disabilities, and the 

integration and full inclusion of 

individuals with disabilities into the 

mainstream of American society’’ (Title 

VII, chapter 1). This request is for the 

CIL Program Performance Report (PPR), 

which is submitted annually by all CILs 

receiving IL Subchapter C funds. The 

PPRs are used by ACL to assess 

grantees’ compliance with title VII of 

the Act, with 45 CFR part 1329 of the 

Code of Federal Regulations, and with 

applicable provisions of the HHS 

Regulations at 45 CFR part 75. The PPR 

serves as the primary basis for ACL’s 

monitoring activities in fulfillment of its 

responsibilities under sections 706 and 

722 of the Act. The PPR is also used by 

ACL to design CIL and Statewide 

Independent Living Council training 

and technical assistance programs 

authorized by sections 711A and 721 of 

the Act. 

This revision adds the collection of 

sexual-orientation and gender-identity 

(SOGI) data elements consistent with 

Executive Orders: 13985 Advancing 

Racial Equity and Support for 

Underserved Communities Through the 

Federal Government; 13988 Preventing 

and Combating Discrimination on the 

Basis of Gender Identity and Sexual 

Orientation and 14075 Advancing 

Equality for Lesbian, Gay, Bisexual, 

Transgender, Queer, and Intersex 

Individuals. ACL will adhere to best 

practices for collection of all 

demographic information in accordance 

with Office of Management and Budget 

(OMB) guidance—including, but not 

limited to guidance specific to the 

collection of SOGI. In addition, 

measures were added around the nature 

of CIL board governance and number of 

full-time equivalent positions filled by 

individuals with significant disabilities 

to affirm adherence to statutory 

requirements. Additional measures were 

also added to allow CILs to report 

carryover funding and to count the total 

number of services provided by 

consumer, as well as to describe their 

collaborations. These measures were 

added based on the request of 

stakeholders to yield more precise data 

that show impact. With the addition of 

these four measures, eleven other 

measures are suggested to be removed to 

increase efficiency and remove 

redundancy and unnecessary 

information. The revised CIL PPR 

instrument is expected to take less time 

than the prior instrument. 

The proposed data collection tool may 

be found on the ACL website for review 

at https://www.acl.gov/about-acl/publicinput. 

Estimated Program Burden 

ACL estimates the burden for new 

measures added as follows: 351 CILs 

completing one CIL PPR annually, 

taking an estimated time of 36 hours per 

CIL for total of 12,708 annual burden 

hours. This burden estimate is based 

partly on OILP’s estimates of how long 

CILs take to complete the PPRs as well 

as feedback gathered from CILs to ACL. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual burden 

hours 

CIL ................................................................................................................... 351 1 36 12,636 


khammond on DSK9W7S144PROD with NOTICES
94734 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

Dated: November 25, 2024. 

Maura Calsyn, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2024–28052 Filed 11–27–24; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4731] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

administrative detention and banned 

medical devices. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

January 28, 2025 

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 

January 28, 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–4731 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Administrative Detention and Banned 

Medical Devices.’’ 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 


khammond on DSK9W7S144PROD with NOTICES