Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 94731 

Semistandard Supplies; and FAR 

52.216–4, Economic Price Adjustment— 

Labor and Material. These clauses 

require contractors on contracts that 

provide for economic price adjustments 

to promptly notify the contracting 

officer of any increases or decreases to 

established prices or labor rates 

(including fringe) because of certain 

contingencies, such as increases or 

decreases to established catalog or 

market prices or changes to cost indexes 

for labor or materials. 

The contracting officer uses the 

information provided by the contractor 

to negotiate price adjustments under the 

contract due to the contingency 

specified in the contract. 

• FAR 52.216–5, Price 

Redetermination-Prospective. Paragraph 

(c) of this clause requires a contractor on 

a fixed-price contract with prospective 

price redetermination to submit to the 

Government (within an agreed upon 

timeframe) a statement of costs incurred 

for the most recent period of 

performance, the proposed prices for the 

upcoming contract period, and any 

supporting or relevant documentation. 

Per paragraph (h) of this clause, during 

periods where firm prices have not been 

established, the contractor must also 

submit quarterly statements that 

includes a breakdown of total contract 

prices, costs, and profit incurred and all 

invoices accepted for delivered items or 

services for which final prices have not 

been established. 

The contracting officer uses the 

information to negotiate/redetermine 

fair and reasonable prices for supplies 

and services that may be delivered or 

performed under the contract in the 

period following the effective date of 

price redetermination. 

• FAR 52.216–6, Price 

Redetermination—Retroactive. 

Paragraph (c) of this clause requires a 

contractor on a fixed-ceiling-price 

contract with retroactive price 

redetermination to submit to the 

Government (within an agreed upon 

timeframe after completion of the 

contract) the proposed prices, all costs 

incurred in performing the contract, and 

any supporting or relevant 

documentation. Per paragraph (g) of this 

clause, until final price redetermination 

has been completed, the contractor must 

also submit a quarterly statement that 

includes a breakdown of total contract 

prices, costs, and interim profit incurred 

and all invoices accepted for delivered 

items. 

The contracting officer uses the 

information provided by the contractor 

to negotiate/redetermine fair and 

reasonable prices for supplies and 

services that have already been 

delivered or performed under the 

contract. 

• FAR 52.216–16, Incentive Price 

Revision—Firm Target; and FAR 

52.216–17, Incentive Price Revision— 

Successive Targets. These clauses 

require contractors on fixed price 

incentive (firm or successive target) 

contracts to submit to the Government 

on a quarterly basis a statement 

regarding total contract prices, costs, 

portions of interim profit, and amounts 

of invoices or vouchers for completed 

work that is cumulative from the 

beginning of the contract (see 52.216– 

16(g) and 52.216–17(i)). Upon final 

delivery of supplies or completion of 

services for covered line items, the 

contractor is required to submit a 

detailed statement of all costs incurred 

up to the end of that month in 

performing all work under the items; an 

estimate of costs of further performance, 

if any, that may be necessary to 

complete performance of all work under 

the items; a list of all residual inventory 

and an estimate of its value; and any 

other relevant data that the Contracting 

Officer may reasonably require (see 

52.216–16(c) and 52.216–17(e)). 

Paragraph (c) of 52.216–17 also requires 

submission of data for establishing the 

firm fixed price or a final profit 

adjustment formula. 

The contracting officer uses the 

information provided by the contractor 

to evaluate the contractor’s performance 

in meeting the incentive target and to 

negotiate the final prices of incentiverelated items and services. 

C. Annual Burden 

Respondents: 2,710. 

Total Annual Responses: 45,260. 

Total Burden Hours: 71,192. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0067, Certain Federal 

Acquisition Regulation Part 16 Contract 

Pricing Requirements. 

William Clark, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2024–28053 Filed 11–27–24; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–290 and 

CMS–10443] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. 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 or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

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 December 30, 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. 


khammond on DSK9W7S144PROD with NOTICES
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