Agency Information Collection Activities: Proposed Collection; Comment Request, 3301-3302 [2022-01183]

Download as PDF Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 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 Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 https:// 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. jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 3301 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 E:\FR\FM\21JAN1.SGM 21JAN1 3302 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices jspears on DSK121TN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 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. 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: SUMMARY: 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 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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-201509-18/pdf/2015-23389.pdf. E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3301-3302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01183]



[[Page 3301]]

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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 
https://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: ___, 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/PRA-Listing.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 nationally-representative, 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 in-person 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-of-pocket 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 for-profits 
and Not-for-profit institutions; Number of Respondents: 13,656; Total 
Annual Responses: 35,998; Total

[[Page 3302]]

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 re-application (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 for-profits; 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

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