Federal Register / Vol. 87, No. 66 / Wednesday, April 6, 2022 / Notices 19957 

for a 2-year period through March 22, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Rashaun Roberts, Ph.D., Designated 

Federal Officer, National Institute for 

Occupational Safety and Health, CDC, 

1090 Tusculum Avenue, Mailstop C–24, 

Cincinnati, Ohio 45226, Telephone: 

(513) 533–6800, Email: ocas@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–07241 Filed 4–5–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10511 and CMS– 

10440] 

Agency Information Collection 

Activities: Proposed Collection; 

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 (the 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

June 6, 2022. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10511 Medicare Coverage of 

Items and Services in FDA 

Investigational Device Exemption 

Clinical Studies—Revision of 

Medicare Coverage 

CMS–10440 Data Collection to 

Support Eligibility Determinations for 

Insurance Affordability Programs and 

Enrollment through Health Insurance 

Marketplaces, Medicaid and 

Children’s Health Insurance Program 

Agencies 

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. 

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 

requires federal agencies to publish a 

60-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. 

Information Collection 

1. Type of Information Collection 

Request: Reinstatement without change; 

Title of Information Collection: 

Medicare Coverage of Items and 

Services in FDA Investigational Device 

Exemption Clinical Studies—Revision 

of Medicare Coverage; Use: Section 

1862(m) of the Social Security Act (and 

regulations at 42 CFR Subpart B 

(sections 405.201–405.215) allows for 

payment of the routine costs of care 

furnished to Medicare beneficiaries in a 

Category A investigational device 

exemption (IDE) study and authorizes 

the Secretary to establish criteria to 

ensure that Category A IDE trials 

conform to appropriate scientific and 

ethical standards. Medicare does not 

cover the Category A device itself 

because Category A (Experimental) 

devices do not satisfy the statutory 

requirement that Medicare pay for 

devices determined to be reasonable and 

necessary. Medicare may cover Category 

B (Non-experimental) devices, and 

associated routine costs of care, if they 

are considered reasonable and necessary 

and if all other applicable Medicare 

coverage requirements are met. 

Under the current centralized review 

process, interested parties (such as 

study sponsors) that wish to seek 

Medicare coverage related to Category A 

or B IDE studies have a centralized 

point of contact for submission, review 

and determination of Medicare coverage 

IDE study requests. In order for CMS (or 

its designated entity) to determine if the 

Medicare coverage criteria are met, as 

described in our regulations, CMS (or its 

designated entity) must review 

documents submitted by interested 

parties or study sponsors. Such 

information submitted will be a FDA 

IDE approval letter, IDE study protocol, 

IRB approval letter, National Clinical 

Trials (NCT) number, and Supporting 

materials as needed. Form Number: 

CMS–10511 (OMB control number: 


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19958 Federal Register / Vol. 87, No. 66 / Wednesday, April 6, 2022 / Notices 

0938–1250); Frequency: Yearly; Affected 

Public: Private Sector (Business or other 

for-profits, Not-for-Profit Institutions); 

Number of Respondents: 116; Total 

Annual Responses: 116; Total Annual 

Hours: 232. (For policy questions 

regarding this collection contact Xiufen 

Sui at 410–786–3136.) 

2. Type of Information Collection 

Request: Reinstatement without change; 

Title of Information Collection: 

Medicare Coverage of Items and 

Services in FDA Investigational Device 

Exemption Clinical Studies—Revision 

of Medicare Coverage; Use: Section 1413 

of the Affordable Care Act directs the 

Secretary of Health and Human Services 

to develop and provide to each state a 

single, streamlined application form 

that may be used to apply for coverage 

through a Marketplace and for APTC/ 

CSR, Medicaid, and CHIP (which we 

refer to collectively as insurance 

affordability programs). The application 

must be structured to maximize an 

applicant’s ability to complete the form 

satisfactorily, taking into account the 

characteristics of individuals who may 

qualify for the programs by developing 

materials at appropriate literacy levels 

and ensuring accessibility. 

45 CFR 155.405(a) provides more 

detail about the application that must be 

used by Marketplaces to determine 

eligibility and to collect information 

necessary for enrollment. Eligibility 

standards for the Marketplace are set 

forth in 45 CFR 155.305. The 

information will be required of each 

applicant upon initial application, with 

some subsequent information 

collections for the purposes of 

confirming accuracy of previous 

submissions and for changes in an 

applicant’s circumstances. 42 CFR 

435.907 and 457.330 establish the 

standards for state Medicaid and CHIP 

agencies related to the use of the 

application. CMS has designed a 

dynamic electronic application that will 

tailor the amount of data required from 

an applicant based on the applicant’s 

circumstances and responses to 

particular questions in the FFM (please 

note SBM implementations may vary 

but the essence of the data collection 

must adhere to the same parameters). 

The paper version of the application 

will not be tailored in the same way but 

will require only the data necessary to 

determine eligibility. 

Information collected by the 

Marketplace, Medicaid or CHIP agency 

will be used to determine eligibility for 

coverage through the Marketplace and 

insurance affordability programs (i.e., 

Medicaid, CHIP, and APTC), and assist 

consumers in enrolling in a QHP if 

eligible. Applicants include anyone who 

may be eligible for coverage through any 

of these programs. Form Number: CMS– 

10440 (OMB control number: 0938– 

1191); Frequency: Annually; Affected 

Public: Private Sector (Business or other 

for-profits, Not-for-Profit Institutions); 

Number of Respondents: 4,884,000; 

Total Annual Responses: 4,884,000; 

Total Annual Hours: 2,205,614. 

(For policy questions regarding this 

collection contact Anne Pesto at 410–786– 

3492.) 

Dated: April 1, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–07314 Filed 4–5–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Migrant Health 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

National Advisory Council on Migrant 

Health (NACMH) has scheduled a 

public meeting. Information about 

NACMH and the agenda for this meeting 

can be found on the NACMH website at: 

https://bphc.hrsa.gov/quality

improvement/strategicpartnerships/ 

nacmh. 

DATES: May 31–June 3, 2022, 12:30–4:30 

p.m. Eastern Time each day. 

ADDRESSES: This meeting will be held 

virtually by webinar. Instructions for 

joining the meeting will be posted on 

the NACMH website 30 business days 

before the meeting date. 

FOR FURTHER INFORMATION CONTACT: 

Esther Paul, NACMH, Designated 

Federal Official (DFO), Strategic 

Initiatives, Office of Policy and Program 

Development, Bureau of Primary Health 

Care, HRSA, 5600 Fishers Lane, 

Rockville, Maryland 20857; 301–594– 

4300; or epaul@hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACMH 

advises, consults with, and makes 

recommendations to the Secretary of 

Health and Human Services on policy, 

program development, and other 

matters of significance concerning the 

activities under section 217 of the 

Public Health Service Act, as amended 

(42 U.S.C. 218). Specifically, NACMH 

provides recommendations concerning 

policy related to the organization, 

operation, selection, and funding of 

migrant health centers, and other 

entities under grants and contracts 

under section 330 of the Public Health 

Service Act (42 U.S.C. 254b). NACMH 

meets twice each calendar year, or at the 

discretion of the DFO in consultation 

with the NACMH Chair. 

During the May 31–June 3, 2022, 

meeting, NACMH will discuss topics 

and issues related to migratory and 

seasonal agricultural worker health. 

Agenda items are subject to change as 

priorities dictate. Refer to the NACMH 

website listed above for any updated 

information concerning the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to NACMH 

should be sent to Esther Paul, DFO, 

using the contact information above at 

least three business days prior to the 

meeting. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Esther Paul at the address and 

phone number listed above at least 10 

business days prior to the meeting. 

Registration is required to attend the 

meeting. Registration and meeting 

attendance instructions will be posted 

on the NACMH website 30 business 

days prior to the meeting date. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–07313 Filed 4–5–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 


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