Agency Information Collection Activities: Proposed Collection; Comment Request, 12193-12194 [2021-04296]

Download as PDF Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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: Extension of a currently approved collection; Title of Information Collection: New Technology Services for Ambulatory Payment Classifications under the Outpatient Prospective Payment System; Use: Section 1833(t)(6) of the Social Security Act (the Act) states, ‘‘The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services).’’ In accordance with the Act, CMS needs to keep pace with emerging new technologies and make them accessible to Medicare beneficiaries in a timely manner. It is necessary that we continue to collect appropriate information from interested parties such as hospitals, medical device manufacturers, pharmaceutical companies and others that bring to our attention specific services that they wish us to evaluate for New Technology Ambulatory Payment Classifications (APC) payment. The information that we seek to continue to collect is necessary to determine whether certain new services are eligible for payment in New Technology APCs, to determine appropriate coding and to set an appropriate payment rate for the new technology service. The intent of these provisions is to ensure timely beneficiary access to new and appropriate technologies. Both the New Technology APC provision and the transitional passthrough provisions provide ways for ensuring appropriate payment for new technologies for which the use and costs are not adequately represented in the base year claims data on which the VerDate Sep<11>2014 17:11 Mar 01, 2021 Jkt 253001 outpatient PPS is constructed. Although individual drugs and biologicals and categories of medical devices will receive transitional pass-through payments for 2 to 3 years from the date payment is initiated for the specific item or category, the underlying statutory provision is permanent and provides an on-going mechanism for reflecting the introduction of new items into the payment structure in a timely manner. New Technology APCs are designed to allow appropriate payment for new technology services that are not covered by the transitional pass-through provisions. Form Number: CMS–10054 (OMB control number: 0938–0272); Frequency: Yearly; Affected Public: Private Sector, Business or other forprofits; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. (For policy questions regarding this collection contact Allison Bramlett at 410–786– 6556.) 2. Type of Information Collection Request: Reinstatement with change; Title of Information Collection: Evaluating Coverage to Care in Communities; Use: The purpose of this study is to extend our understanding from RAND Corporation’s prior study of how C2C materials are used. This will be accomplished by assessing what materials best serve partners in their efforts to activate, engage, and empower consumers and how consumers engage with or respond to C2C materials. These data collection efforts will also serve the goals of informing future consumer messaging and creating a long-term feedback loop for maintaining a relevant, successful, and engaging C2C initiative. Initial survey results will be available in early 2022, which may help to fine-tune the strategy for the 2022 relaunch of C2C and will influence strategies and techniques going forward. Further, this study opens the door for a feedback loop that may include future consumer testing to adjust and improve C2C outreach strategies to meet the changing needs of various targeted populations. The C2C Logic Model serves as the basis of this package. The goal of C2C is to improve the health of all populations, especially vulnerable and newly insured populations, by helping consumers understand their health insurance coverage and connecting individuals to primary care and preventive services. The urgency of achieving this goal is underscored by the COVID–19 pandemic, which has discouraged patients from seeking preventive care and hampered patients from properly managing chronic conditions at a time when preserving PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 12193 emergency room and hospital bed capacity is paramount. There are three main paths of information dissemination covered by the C2C Logic Model (see Exhibit 1): (a) A direct path to the consumer, (b) a path to the consumer through a partner, and (c) a role for performance measurement in improving performance (i.e., desired effect and how C2C can improve). The partner and consumer surveys in the present evaluation build upon RAND’s earlier study by adapting their questions to the C2C Logic Model and using similar survey methodologies in three to four targeted geographic areas known to have received a high volume of C2C materials and messages. These research questions and sub-questions correspond to the short-term and intermediate-term outcomes on the C2C Logic Model. Thus, the foregoing is a reformulation of questions answered by RAND and a consideration of additional questions. Form Number: CMS–10632 (OMB control number: 0938–1342); Frequency: Yearly; Affected Public: Individuals and Households, Business or other forprofits, Not-for-profits institutions; Number of Respondents: 460; Total Annual Responses: 460; Total Annual Hours: 152. (For policy questions regarding this collection contact Ashley Peddicord-Auston at 410–786–0757.) Dated: February 25, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–04303 Filed 3–1–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–372(S)] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice; withdrawal. AGENCY: On Thursday, February 25, 2021, the Centers for Medicare & Medicaid Services (CMS) published a 60-day notice entitled, ‘‘Agency Information Collection Activities: Proposed Collection; Comment Request.’’ That notice invited public comments on the following information collection request: Title: Annual Report on Home and Community Based Services Waivers E:\FR\FM\02MRN1.SGM 02MRN1 12194 Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices and Supporting Regulations; Form Number: CMS–372(S); and OMB Control Number: 0938–0272. Through the publication of this document we are withdrawing that notice (FR document: 2021–03916) in its entirety. While the notice published in error, it will be resubmitted for publication and public comment when ready. Dated: February 25, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–04296 Filed 3–1–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice. AGENCY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https:// www.dhhs.gov/ohrp/sachrp-committee/ meetings/. DATES: The meeting will be held on Tuesday, March 23rd, 2021, from 11:00 a.m. until 4:30 p.m., and Wednesday, March 24, 2021, from 11:00 a.m. until 4:30 p.m. (times are tentative and subject to change). The confirmed times and agenda will be posted on the SACHRP website when this information becomes available. ADDRESSES: This meeting will be held via webcast. Members of the public may also attend the meeting via webcast. Instructions for attending via webcast will be posted one week prior to the meeting at https://www.hhs.gov/ohrp/ sachrp-committee/meetings/. FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240–453– 8141; fax: 240–453–6909; email address: SACHRP@hhs.gov. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:11 Mar 01, 2021 Jkt 253001 Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The Subpart A Subcommittee (SAS) was established by SACHRP in October 2006 and is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment. The Subcommittee on Harmonization (SOH) was established by SACHRP at its July 2009 meeting and charged with identifying and prioritizing areas in which regulations or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification or coordination. The SACHRP meeting will open to the public at 11:00 a.m., on Tuesday, March 23, 2021, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The meeting will begin with presentation of recommendations on Justice as an Ethical Concept in 45 CFR 46, followed by an expert panel discussion of draft recommendations on Mandatory Exploratory Biopsies in Research. The day will conclude with discussion of a new SACHRP topic, IRB Authority to Restrict Use of Data in Research. March 24th will include presentation of Interactions between Sponsors, Clinical Trial Sites, and Research Subjects, and lastly, Consideration of Risks to Bystanders in Research. Other topics may be added; for the full and updated meeting agenda, see https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/. The public will have an opportunity to send comments to SACHRP during the meeting’s public comment session or to submit written public comments in advance. Persons who wish to provide public comments should review instructions at https://www.hhs.gov/ ohrp/sachrp-committee/meetings/ index.html and respond by midnight Wednesday, March 18th, 2021, ET. Individuals submitting written statements as public comment should submit their comments to SACHRP at SACHRP@hhs.gov. Comments are limited to three minutes each. Time will be allotted for public comment on both days. Note that public SUPPLEMENTARY INFORMATION: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 comment must be relevant to topics currently being addressed by SACHRP. Dated: February 22, 2021. Julia G. Gorey, Executive Director, SACHRP, Office for Human Research Protections. [FR Doc. 2021–04244 Filed 3–1–21; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings 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 property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA– L Conflict SEP. Date: March 25, 2021 Time: 11:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue Bethesda, MD 20892 (Virtual Meeting). Contact Person: Preethy Nayar, Ph.D. Scientific Review Officer Scientific Review Branch National Institute on Drug Abuse, NIH 301 North Stonestreet Avenue Bethesda, MD 20892, 301–443–4577, nayarp2@ csr.nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Implementing the HIV Service Cascade for Justice-Involved Populations (U01—Clinical Trial Optional). Date: March 30, 2021. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue Bethesda, MD 20892, (Virtual Meeting). Contact Person: Sheila Pirooznia, Ph.D.; Scientific Review Officer, Division of Extramural Review, Scientific Review Branch, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue Bethesda, MD 20892, (301) 496–9350 sheila.pirooznia@ nih.gov. E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12193-12194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-372(S)]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice; withdrawal.

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    On Thursday, February 25, 2021, the Centers for Medicare & Medicaid 
Services (CMS) published a 60-day notice entitled, ``Agency Information 
Collection Activities: Proposed Collection; Comment Request.'' That 
notice invited public comments on the following information collection 
request: Title: Annual Report on Home and Community Based Services 
Waivers

[[Page 12194]]

and Supporting Regulations; Form Number: CMS-372(S); and OMB Control 
Number: 0938-0272. Through the publication of this document we are 
withdrawing that notice (FR document: 2021-03916) in its entirety. 
While the notice published in error, it will be resubmitted for 
publication and public comment when ready.

    Dated: February 25, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-04296 Filed 3-1-21; 8:45 am]
BILLING CODE 4120-01-P
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