Federal Register / Vol. 86, No. 39 / Tuesday, March 2, 2021 / Notices 12193 

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 

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 

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 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice; withdrawal. 

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 


jbell on DSKJLSW7X2PROD with NOTICES
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 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health. 

ACTION: Notice. 

SUMMARY: 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 http://

www.dhhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

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/index.html. 

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. 

SUPPLEMENTARY INFORMATION: 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 http://www.dhhs.gov/ohrp/sachrpcommittee/meetings/index.html. 

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 

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. 


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