Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79613 

data collections include online and 

onsite training session evaluations. 

CMS uses information from the data 

collection activities to determine the 

extent to which the goals of each 

training and support session were 

achieved and to help CMS make 

improvements for future training and 

support sessions. The collected data 

helps CMS address its Government 

Performance and Results Act (GPRA) 

requirements, as well as CMS and HHS 

goals for support for, and open dialogue 

with, stakeholders. 

The Affordable Care Act (ACA) was 

enacted to assist millions of Americans 

in obtaining affordable health care 

services and to allow more employers to 

offer insurance coverage to their 

employees in a cost-effective manner. 

Since the implementation of ACA in 

2014, individuals and small businesses 

have been able to purchase private 

health insurance through competitive 

marketplaces called the ‘‘Health 

Insurance Marketplace’’ (Marketplace). 

CMS issued regulations for the 

establishment and practices of 

Marketplaces in States. The cooperation 

and coordination of States, health 

insurance issuers, the Federal 

Government and other key stakeholders 

is essential to the continued success of 

the Marketplace. 

The Consolidated Appropriations Act 

(CAA) of 2021 became law on December 

27, 2020. It is a $1.4 trillion omnibus 

spending agreement that encompasses 

many different provisions. Two (2) acts 

within the law apply to the Centers for 

Medicare and Medicaid Services (CMS) 

Center for Consumer Information and 

Insurance Oversight (CCIIO): Title I, 

‘‘No Surprises Act’’ and Title II, 

‘‘Transparency’’ (NST). Beginning in 

2022, new protections through the No 

Surprises Act are in place to shield 

millions of consumers from surprise 

medical bills. 

CMS is strongly committed to 

providing training, outreach, and 

technical assistance to stakeholders 

participating in the Marketplace and/or 

programs mandated by the ACA or NST. 

In addition, CMS recognizes that the 

success of Marketplaces and associated 

programs relies on the cooperation and 

coordination of States, issuers, 

Assisters, self-insured health plans, 

third-party administrators (TPA) of selfinsured health plans, agents and 

brokers, Providers/Facilities, and other 

stakeholders. Therefore, CMS expects to 

design and conduct various consumer 

satisfaction and feedback surveys, 

usability tests, and focus groups for 

these respondents to complete. Form 

Number: CMS–10598 (OMB Control 

Number: 0938–1331); Frequency: 

Annually; Affected Public: Individuals 

and Households, Private Sector, State, 

Local, and Tribal Governments, Federal 

Government, Business or other forprofit, and not-for-profit institutions; 

Number of Respondents: 9,588; Number 

of Responses: 9,588 Total Annual 

Hours: 2,397 hours. (For policy 

questions regarding this collection 

contact Sonia Henderson at 301–492– 

4320.) 

2. Type of Information Collection 

Request: Extension without change of a 

previously approved collection; Title of 

Information Collection: Federally 

Qualified Health Center Cost Report 

Form; Use: The Form CMS–224–14 cost 

report is needed to determine a 

provider’s reasonable cost incurred in 

furnishing medical services to Medicare 

beneficiaries and to calculate the FQHC 

settlement amount. These providers, 

paid under the FQHC prospective 

payment system (PPS), may receive 

reimbursement outside of the PPS for 

Medicare reimbursable bad debts, 

pneumococcal, influenza, and COVID– 

19 vaccines, and monoclonal antibody 

products. CMS uses the Form CMS– 

224–14 for rate setting; payment 

refinement activities, including 

developing a FQHC market basket; 

Medicare Trust Fund projections; and to 

support program operations. 

Additionally, the Medicare Payment 

Advisory Commission (MedPAC) uses 

the FQHC Medicare cost report data to 

calculate Medicare margins; to 

formulate recommendations to Congress 

regarding the FQHC PPS; and to 

conduct additional analysis of the 

FQHC PPS. Form Number: CMS–224–14 

(OMB control number: 0938–1298); 

Frequency: Yearly; Affected Public: 

Private Sector, State, Local, or Tribal 

Governments, Federal Government, 

Business or other for-profits, Not-forProfit Institutions; Number of 

Respondents: 2,967; Total Annual 

Responses: 2,967; Total Annual Hours: 

172,086. (For policy questions regarding 

this collection contact LuAnn Piccione 

at 410–786–5423.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–22355 Filed 9–27–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10516] 

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 October 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. 


ddrumheller on DSK120RN23PROD with NOTICES1
79614 Federal Register / Vol. 89, No. 189 / Monday, September 30, 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. Title of Information Collection: 

Program Integrity II; Type of 

Information Collection Request: 

Extension without change of a currently 

approved collection; Use: On March 23, 

2010, the Patient Protection and 

Affordable Care Act (PPACA; Pub. L. 

111–148) was signed into law and on 

March 30, 2010, the Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111–152) was signed into law. 

The two laws implement various health 

insurance policies. On June 19, 2013, 

the Department of Health and Human 

Services (HHS) published proposed rule 

CMS–9957–P: Program Integrity: 

Exchanges, SHOP, Premium 

Stabilization Programs, and Market 

Standards (78 FR 37302) (Program 

Integrity Proposed Rule) which, among 

other things, contained third party 

disclosure requirements and data 

collections that supported the oversight 

of premium stabilization programs, 

State Exchanges, and qualified health 

plan (QHP) issuers in Federallyfacilitated Exchanges (FFEs). Parts of the 

proposed rule were finalized as Patient 

Protection and Affordable Care Act; 

Program Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014; Final Rule 

(Program Integrity Final Rule II), 78 FR 

25326 (October 24, 2013). This 

information collection request relates to 

a portion of the information collection 

requirements set forth in the final rule. 

Form Number: CMS–10516 (OMB 

control number: 0938–1277); Frequency: 

Annually; Affected Public: Private 

Sector, State, Local, or Tribal 

Governments; Business or other forprofits, and Not-for Profits; Number of 

Respondents: 457; Number of 

Responses: 457; Total Annual Hours: 

42,771. (For questions regarding this 

collection, contact Andrea Honig at 

(301) 492–4147.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–22345 Filed 9–27–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–D–0598] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Safety of Residues of 

Veterinary Drugs in Human Food: 

Genotoxicity Testing (Revision 2); 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

revised guidance for industry (GFI) #116 

(VICH GL23) entitled ‘‘Studies to 

Evaluate the Safety of Residues of 

Veterinary Drugs in Human Food: 

Genotoxicity Testing (Revision 2).’’ This 

draft guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). This draft guidance 

recommends a Standard Battery of Tests 

that can be used for the evaluation of 

the genotoxicity of veterinary drug 

residues in food. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 29, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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– 

2000–D–0598 for ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: Genotoxicity 

Testing (Revision 2).’’ Received 

comments 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 


ddrumheller on DSK120RN23PROD with NOTICES1