42484 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10511, CMS– 

10788, CMS–10052, CMS–460 and CMS– 

10105] 

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 August 15, 2022. 

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, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing 

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; 

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: 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Prescription 

Drug and Health Care Spending; Use: 

On December 27, 2020, the 

Consolidated Appropriations Act, 2021 

(CAA) was signed into law. Section 204 

of Title II of Division BB of the CAA 

added parallel provisions at section 

9825 of the Internal Revenue Code (the 

Code), section 725 of the Employee 

Retirement Income Security Act 

(ERISA), and section 2799A–10 of the 

Public Health Service Act (PHS Act) 

that require group health plans and 

health insurance issuers offering group 

or individual health insurance coverage 

to annually report to the Department of 

the Treasury, the Department of Labor 

(DOL), and the Department of Health 

and Human Services (HHS) 

(collectively, ‘‘the Departments’’) certain 

information about prescription drug and 

health care spending, premiums, and 

enrollment under the plan or coverage. 

This information will support the 

development of public reports that will 

be published by the Departments on 

prescription drug reimbursements for 

plans and coverage, prescription drug 

pricing trends, and the role of 

prescription drug costs in contributing 

to premium increases or decreases 

under the plans or coverage. The 2021 

interim final rules, ‘‘Prescription Drug 

and Health Care Spending’’ issued by 

the Departments and the Office of 

Personnel Management (OPM) 

implement the provisions of section 

9825 of the Code, section 725 of ERISA, 

and section 2799A–10 of the PHS Act, 

as enacted by section 204 of Title II of 

Division BB of the CAA. OPM joined the 

Departments in issuing the 2021 interim 

final rules, requiring Federal Employees 

Health Benefits (FEHB) carriers to report 

information about prescription drug and 

health care spending, premiums, and 

plan enrollment in the same manner as 

a group health plan or health insurance 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42485 

issuer offering group or individual 

health insurance coverage. Form 

Number: CMS–10788 (OMB control 

number: 0938–1405); Frequency: 

Annual; Affected Public: Private Sector; 

Number of Respondents: 356; Total 

Annual Responses: 356; Total Annual 

Hours: 1,684,080. (For policy questions 

regarding this collection, contact 

Christina Whitefield at 301–492–4172.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Recognition of 

Pass-Through Payment for Additional 

(New) Categories of Devices under the 

Outpatient Prospective Payment System 

and Supporting Regulations; Use: The 

transitional pass-through provision 

provides a way for ensuring appropriate 

payment for new technologies whose 

use and costs are not adequately 

represented in the base year claims data 

on which the outpatient PPS is 

constructed as required by law. 

Categories of medical devices will 

receive transitional pass-through 

payments for 2 to 3 years from the date 

payments are initiated for the category. 

However, the underlying provision is 

permanent and provides an on-going 

mechanism for reflecting timely 

introduction of new items into the 

payment structure. 

Interested parties such as hospitals, 

device manufacturers, pharmaceutical 

companies, and physicians apply for 

transitional pass-through payment for 

certain items used with services covered 

in the outpatient PPS. After we receive 

all requested information, we evaluate 

the information to determine if the 

creation of an additional category of 

medical devices for transitional passthrough payments is justified. We may 

request additional information related to 

the proposed new device category, as 

needed. We advise the applicant of our 

decision, and update the outpatient PPS 

during its next scheduled quarterly 

payment update cycle to reflect any 

newly approved device categories. We 

list below the information that we 

require from all applicants. The 

following information is required to 

process requests for additional 

categories of medical devices for 

transitional pass-through payments. 

Form Number: CMS–10052 (OMB 

control number: 0938–0857); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profits; 

Number of Respondents: 10; Number of 

Responses: 10; Total Annual Hours: 

160. (For questions regarding this 

collection contact Kimberly A. 

Campbell at 410–786–2289.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection: Title of 

Information Collection: Medicare 

Participating Physician or Supplier 

Agreement; Use: Form CMS–460 is the 

agreement a physician, supplier, or their 

authorized official signs to become a 

participating provider in Medicare Part 

B. By signing the agreement to 

participate in Medicare, the physician, 

supplier, or their authorized official 

agrees to accept the Medicaredetermined payment for Medicare 

covered services as payment in full and 

to charge the Medicare Part B 

beneficiary no more than the applicable 

deductible or coinsurance for the 

covered services. For purposes of this 

explanation, the term ‘‘supplier’’ means 

certain other persons or entities, other 

than physicians, that may bill Medicare 

for Part B services (e.g., suppliers of 

diagnostic tests, suppliers of radiology 

services, durable medical suppliers 

(DME) suppliers, nurse practitioners, 

clinical social workers, physician 

assistants). Institutions that render Part 

B services in their outpatient 

department are not considered 

‘‘suppliers’’ for purposes of this 

agreement. Form Number: CMS–460 

(OMB control number: 0938–0373); 

Frequency: Annually; Affected Public: 

Private Sector, Business or other forprofits; Number of Respondents: 36,000; 

Number of Responses: 36,000; Total 

Annual Hours: 9,000. (For questions 

regarding this collection contact Mark 

G. Baldwin at 410–786–8139.) 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: National 

Implementation of the In-Center 

Hemodialysis CAHPS Survey; Use: The 

national implementation of the ICH 

CAHPS Survey is designed to allow 

third-party, CMS-approved survey 

vendors to administer the ICH CAHPS 

Survey using mail-only, telephone-only, 

or mixed (mail with telephone followup) modes of survey administration. 

Experience from previous CAHPS 

surveys shows that mail, telephone, and 

mail with telephone follow-up data 

collection modes work well for 

respondents, vendors, and health care 

providers. Any additional forms of 

information technology, such as web 

surveys, is under investigation as a 

potential survey option in this 

population. 

Data collected in the national 

implementation of the ICH CAHPS 

Survey are used for the following 

purposes: 

• To provide a source of information 

from which selected measures can be 

publicly reported to beneficiaries as a 

decision aid for dialysis facility 

selection. 

• To aid facilities with their internal 

quality improvement efforts and 

external benchmarking with other 

facilities. 

• To provide CMS with information 

for monitoring and public reporting 

purposes. 

• To support the ESRD Quality 

Improvement Program. 

Form Number: CMS–10105 (OMB 

control number: 0938–0926); Frequency: 

Semi Annually; Affected Public: 

Individuals and Households; Number of 

Respondents: 103,500; Total Annual 

Responses: 621,000; Total Annual 

Hours: 55,890. (For policy questions 

regarding this collection contact Israel 

H. Cross at 410–786–0619.) 

Dated: July 12, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–15175 Filed 7–14–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–1615] 

Instructions for Use—Patient Labeling 

for Human Prescription Drug and 

Biological Products—Content and 

Format; 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 final 

guidance for industry entitled 

‘‘Instructions for Use—Patient Labeling 

for Human Prescription Drug and 

Biological Products—Content and 

Format.’’ This guidance provides 

recommendations for developing the 

content and format of an Instructions for 

Use (IFU) document for human 

prescription drug and biological 

products, as well as drug-led or 

biologic-led combination products 

submitted under a new drug application 

(NDA) or a biologics license application 

(BLA). The IFU is written for patients 

(or their caregivers) who use drug 

products that have complicated or 

detailed patient-use instructions. The 

recommendations in this guidance are 

intended to help ensure that patients 

receive clear and concise information 

that is easily understood for the safe and 


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