Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3301 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–P–0015A and 

CMS–10394] 

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 

March 22, 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: lll, 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.html. 

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–P–0015A Medicare Current 

Beneficiary Survey (MCBS) 

CMS–10394 Application and Triennial 

Re-application to Be a Qualified 

Entity to Receive Medicare Data for 

Performance Measurement 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare 

Current Beneficiary Survey (MCBS); 

Use: CMS is the largest single payer of 

health care in the United States. The 

agency plays a direct or indirect role in 

administering health insurance coverage 

for more than 120 million people across 

the Medicare, Medicaid, CHIP, and 

Exchange populations. A critical aim for 

CMS is to be an effective steward, major 

force, and trustworthy partner in 

supporting innovative approaches to 

improving quality, accessibility, and 

affordability in healthcare. CMS also 

aims to put patients first in the delivery 

of their health care needs. 

The Medicare Current Beneficiary 

Survey (MCBS) is the most 

comprehensive and complete survey 

available on the Medicare population 

and is essential in capturing data not 

otherwise collected through our 

operations. The MCBS is a nationallyrepresentative, longitudinal survey of 

Medicare beneficiaries that we sponsor 

and is directed by the Office of 

Enterprise Data and Analytics (OEDA). 

MCBS data collection includes both inperson and phone interviewing. The 

survey captures beneficiary information 

whether aged or disabled, living in the 

community or facility, or serviced by 

managed care or fee-for-service. Data 

produced as part of the MCBS are 

enhanced with our administrative data 

(e.g., fee-for-service claims, prescription 

drug event data, enrollment, etc.) to 

provide users with more accurate and 

complete estimates of total health care 

costs and utilization. The MCBS has 

been continuously fielded for more than 

30 years, encompassing over 1.2 million 

interviews and more than 140,000 

survey participants. Respondents 

participate in up to 11 interviews over 

a four-year period. This gives a 

comprehensive picture of health care 

costs and utilization over a period of 

time. 

The MCBS continues to provide 

unique insight into the Medicare 

program and helps CMS and our 

external stakeholders better understand 

and evaluate the impact of existing 

programs and significant new policy 

initiatives. In the past, MCBS data have 

been used to assess potential changes to 

the Medicare program. For example, the 

MCBS was instrumental in supporting 

the development and implementation of 

the Medicare prescription drug benefit 

by providing a means to evaluate 

prescription drug costs and out-ofpocket burden for these drugs to 

Medicare beneficiaries. Beginning in 

2023, this proposed revision to the 

clearance will add a few new measures 

to existing questionnaire sections and 

will remove COVID–19-related content 

that is no longer relevant for 

administration. New respondent 

materials are also included in this 

request. The revisions will result in a 

net decrease in respondent burden as 

compared to the current clearance due 

to the removal of COVID–19 items. 

Form Number: CMS–P–0015A (OMB: 

0938–0568); Frequency: Occasionally; 

Affected Public: Business or other forprofits and Not-for-profit institutions; 

Number of Respondents: 13,656; Total 

Annual Responses: 35,998; Total 


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3302 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

Annual Hours: 46,575. (For policy 

questions regarding this collection 

contact William Long at 410–786–7927.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Application and 

Triennial Re-application to Be a 

Qualified Entity to Receive Medicare 

Data for Performance Measurement; 

Use: The Patient Protection and 

Affordable Care Act (ACA) was enacted 

on March 23, 2010 (Pub. L. 111–148). 

ACA amends section 1874 of the Social 

Security Act by adding a new 

subsection (e) to make standardized 

extracts of Medicare claims data under 

Parts A, B, and D available to qualified 

entities to evaluate the performance of 

providers of services and suppliers. This 

is the application needed to determine 

an organization’s eligibility as a 

qualified entity. The information from 

the collection is used by CMS to 

determine whether an organization 

meets the criteria required to be 

considered a qualified entity to receive 

Medicare claims data under ACA 

Section 10332. CMS evaluates the 

organization’s eligibility in terms of 

organizational and governance 

capabilities, addition of claims data 

from other sources, and data privacy 

and security. This collection covers the 

application through which 

organizations provide information to 

CMS to determine whether they will be 

approved as a qualified entity. This 

collection also covers the triennial reapplication (CMS–10596; 0938–1317) 

through which organizations provide 

information to CMS to determine 

whether they are approved to continue 

as a qualified entity. Form Number: 

CMS–10394 (OMB control number: 

0938–1144); Frequency: Occasionally; 

Affected Public: Not-for-profits 

institutions and Business or other forprofits; Number of Respondents: 30; 

Total Annual Responses: 30; Total 

Annual Hours: 3,800. (For policy 

questions regarding this collection 

contact Kari A. Gaare at 410–786–8612.) 

Dated: January 18, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–01183 Filed 1–20–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0593] 

Collecting and Providing 702(b) 

Portions of Food and Drug 

Administration Official Samples— 

Questions and Answers; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry and FDA staff 

entitled ‘‘Collecting and Providing 

702(b) Portions of FDA Official 

Samples—Questions and Answers.’’ 

This draft guidance is intended to assist 

industry and FDA staff with issues and 

questions related to the requirements for 

FDA to collect and provide a part of an 

official sample of an article to any 

person named on the label of the article, 

or the owner thereof, or his attorney or 

agent. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 22, 2022 to ensure that we 

consider your comment on this draft 

guidance before we begin 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– 

2021–D–0593 for ‘‘Collecting and 

Providing 702(b) Portions and of FDA 

Official Samples—Questions and 

Answers.’’ 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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. 


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