Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 31717 

Management Specialist, Centers for 

Disease Control and Prevention, 

National Center for Immunization and 

Respiratory Diseases, 1600 Clifton Road 

NE, MS–H24–8, Atlanta, Georgia 30329– 

4027; Telephone: (404) 639–8367; 

Email: ACIP@cdc.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with 41 CFR 102–3.150(b), 

less than 15 calendar days’ notice is 

being given for this meeting due to the 

exceptional circumstances of the 

COVID–19 pandemic and rapidly 

evolving COVID–19 vaccine 

development and regulatory processes. 

The Secretary of Health and Human 

Services has determined that COVID–19 

is a Public Health Emergency. A notice 

of this ACIP meeting has also been 

posted on CDC’s ACIP website at: http:// 

www.cdc.gov/vaccines/acip/index.html. 

In addition, CDC has sent notice of this 

ACIP meeting by email to those who 

subscribe to receive email updates about 

ACIP. 

Purpose: The committee is charged 

with advising the Director, CDC, on the 

use of immunizing agents. In addition, 

under 42 U.S.C. 1396s, the committee is 

mandated to establish and periodically 

review and, as appropriate, revise the 

list of vaccines for administration to 

vaccine-eligible children through the 

Vaccines for Children (VFC) program, 

along with schedules regarding dosing 

interval, dosage, and contraindications 

to administration of vaccines. Further, 

under provisions of the Affordable Care 

Act, section 2713 of the Public Health 

Service Act, immunization 

recommendations of the ACIP that have 

been approved by the Director of the 

Centers for Disease Control and 

Prevention and appear on CDC 

immunization schedules must be 

covered by applicable health plans. 

Matters To Be Considered: The agenda 

will include discussions on COVID–19 

vaccine safety and booster doses. 

Agenda items are subject to change as 

priorities dictate. For more information 

on the meeting agenda visit https://

www.cdc.gov/vaccines/acip/meetings/ 

meetings-info.html. 

Meeting Information: The meeting 

will be webcast live via the World Wide 

Web; for more information on ACIP 

please visit the ACIP website: http://

www.cdc.gov/vaccines/acip/index.html. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials, are part of 

the public record and are subject to 

public disclosure. Comments will be 

posted on https://www.regulations.gov. 

Therefore, do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

Written Public Comment: Written 

comments must be received on or before 

June 18, 2021. 

Oral Public Comment: This meeting 

will include time for members of the 

public to make an oral comment. Oral 

public comment will occur before any 

scheduled votes including all votes 

relevant to the ACIP’s Affordable Care 

Act and Vaccines for Children Program 

roles. Priority will be given to 

individuals who submit a request to 

make an oral public comment before the 

meeting according to the procedures 

below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the June 18, 2021, 

ACIP meeting must submit a request at 

http://www.cdc.gov/vaccines/acip/ 

meetings/ no later than 11:59 p.m., EDT, 

June 16, 2021, according to the 

instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

by 12:00 p.m., EDT, June 17, 2021. To 

accommodate the significant interest in 

participation in the oral public 

comment session of ACIP meetings, 

each speaker will be limited to 3 

minutes, and each speaker may only 

speak once per meeting. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–12578 Filed 6–11–21; 11:15 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1757–N] 

Medicare Program; Virtual Public 

Meetings in July 2021 for New 

Revisions to the Healthcare Common 

Procedure Coding System (HCPCS) 

Code Set 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

dates and times of virtual Healthcare 

Common Procedure Coding System 

(HCPCS) public meetings to be held in 

July 2021 to discuss our preliminary 

coding recommendations for new 

revisions to the HCPCS Level II code set. 

DATES: Virtual Meeting Dates: 

Wednesday, July 7, 2021, 9 a.m. to 5 

p.m., eastern daylight time (e.d.t.), 

Thursday, July 8, 2021, 9 a.m. to 5 p.m., 

e.d.t., and Friday, July 9, 2021, 9 a.m. 

to 5 p.m. e.d.t. 

Deadline for Primary Speaker 

Registration and Presentation Materials: 

The deadline for registering to be a 

primary speaker, and submitting 

materials that will be used in support of 

an oral presentation is 5 p.m., e.d.t., 

Friday, June 25, 2021. 

Deadline for 5-Minute Speakers 

Registration: The deadline for 

registering to be a 5-Minute speaker is 

5 p.m., e.d.t., Friday, June 25 2021. 

Deadline for Registration for all Other 

Attendees: All individuals who plan to 

attend the virtual public meetings to 

listen, but are not registering as a 

primary or 5-minute speaker, may 

simply join the virtual meeting on the 

date that they plan to attend, using the 

meeting link specified for that meeting 

date. A ‘‘raise your hand’’ feature will 

be available to ask questions. A meeting 

link for each public meeting date will be 

posted in advance of the public 

meetings on CMS’ HCPCS website at 

https://www.cms.gov/Medicare/Coding/ 

MedHCPCSGenInfo. 

Deadline for Requesting Special 

Accommodations: Individuals who plan 


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31718 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 

1https://www.whitehouse.gov/briefing-room/ 

presidential-actions/2021/02/24/notice-on-thecontinuation-of-the-national-emergencyconcerning-the-coronavirus-disease-2019-covid-19- 

pandemic/. 

to participate in the virtual public 

meetings and require special assistance 

must request these services by 5 p.m., 

e.d.t., Friday, June 25, 2021. 

Deadline for Submission of Written 

Comments: To be considered in 

formulating a final coding decision, 

written comments and other 

documentation must be received by 5 

p.m., e.d.t., on the date of the virtual 

public meeting at which the applicable 

code request is scheduled for 

discussion. 

ADDRESSES: 

Virtual Meeting Location: The July 7 

through 9, 2021 HCPCS public meetings 

will be held virtually via Zoom only. 

Detailed information pertaining to 

registering to participate via Zoom, 

including dial-in information for 

primary speakers, 5-minute speakers, 

and all other attendees, will be provided 

in a document posted prior to the 

HCPCS public meeting on CMS’ HCPCS 

website at https://www.cms.gov/ 

Medicare/Coding/MedHCPCSGenInfo/ 

HCPCSPublicMeetings. 

Written Comments: As part of CMS’ 

response to the COVID–19 public health 

emergency (PHE), written comments 

from the general public and meeting 

registrants will only be accepted when 

emailed to HCPCS_Level_II_Code_

Applications@cms.hhs.gov before 5 

p.m., e.d.t., on the date of the virtual 

public meeting at which a request is 

discussed. 

FOR FURTHER INFORMATION CONTACT: Irina 

Akelaitis, (410) 786–4602, or 

Irina.Akelaitis@cms.hhs.gov; Felicia 

Kyeremeh, (410) 786–1898, or 

Felicia.Kyeremeh@cms.hhs.gov; Sundus 

Ashar, (410) 786–0750, or 

Sundus.Ashar1@cms.hhs.gov; William 

Walker, (410) 786–5023, or 

William.Walker@cms.hhs.gov; 

Constantine Markos, (410) 786–0911, 

Constantine.Markos@cms.hhs.gov; or 

HCPCS_Level_II_Code_Applications@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Guidelines for Presentation Materials 

and Primary Speakers: There is a 10- 

page submission limit for any 

presentation materials. All registered 

primary speakers will be emailed a 

participant ID for their individual use to 

join the meeting, in advance of the 

virtual meeting. Detailed information 

pertaining to registering to participate 

via Zoom, including dial-in information 

for primary speakers, will be provided 

in a document posted on CMS’ HCPCS 

website at https://www.cms.gov/ 

Medicare/Coding/MedHCPCSGenInfo/ 

HCPCSPublicMeetings prior to the 

HCPCS public meeting. We encourage 

all speakers to follow the protocols for 

participation as a speaker in CMS’ 

HCPCS public meetings as detailed in 

this document. 

Guidelines for 5-Minute Speakers: All 

registered 5-minute speakers will be 

emailed a participant ID for their 

individual use to join the meeting, in 

advance of the virtual meeting. Detailed 

information pertaining to registering to 

participate via Zoom, including dial-in 

information for 5-minute speakers, will 

be provided in a document posted on 

CMS’ HCPCS website at https://

www.cms.gov/Medicare/Coding/ 

MedHCPCSGenInfo/HCPCSPublic

Meetings prior to the HCPCS public 

meeting. We encourage all speakers to 

follow the protocols for participation as 

a speaker in CMS’ HCPCS public 

meetings as detailed in this document. 

Guidelines for All Other Attendees: A 

‘‘raise your hand’’ feature will be 

available to ask questions. A meeting 

link for each public meeting date will be 

posted in advance of the public 

meetings on CMS’ HCPCS website at 

https://www.cms.gov/Medicare/Coding/ 

MedHCPCSGenInfo. 

I. Background 

On December 21, 2000, Congress 

passed the Medicare, Medicaid, and 

SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA) (Pub. L. 

106–554). Section 531(b) of BIPA 

mandated that we establish procedures 

that permit public consultation for 

coding and payment determinations for 

new durable medical equipment (DME) 

under Medicare Part B of title XVIII of 

the Social Security Act (the Act). In the 

November 23, 2001 Federal Register (66 

FR 58743), we published a notice 

providing information regarding the 

establishment of the public meeting 

process for DME. The procedures and 

public meetings announced in that 

notice for new DME were in response to 

the mandate of section 531(b) of BIPA. 

As of 2020, we implemented changes 

to our HCPCS coding procedures that 

enable quarterly coding cycles for drugs 

and biological products, and bi-annual 

coding cycles for non-drug and nonbiological items and services. To 

achieve the time savings necessary to 

implement coding for the vast majority 

of drugs and biological products on a 

quarterly cycle, as a general matter, we 

will not be conducting public meetings 

for coding decisions on drugs and 

biological products. For the 2021 coding 

cycles, for drug and biological code 

applicants who are dissatisfied with 

CMS’ coding decision in a quarterly 

coding cycle, we provide them an 

opportunity to resubmit their 

application in a subsequent quarterly 

cycle. 

II. Virtual Meeting Registration 

Due to the ‘‘Notice of the 

Continuation of the National Emergency 

Concerning the Coronavirus Disease 

2019 (COVID–19) Pandemic’’ 1 issued 

on February 24, 2021 there will not be 

an in-person meeting. The July 7 

through July 9, 2021 HCPCS public 

meetings will be virtual and available 

for remote audio attendance and 

participation only via Zoom. 

A. Required Information for Registration 

The following information must be 

provided when registering online to 

attend: 

• Name. 

• Company name and address. 

• Direct-dial telephone. 

• Email address. 

• Any special accommodation 

requests. 

A CMS staff member will confirm 

your registration by email. 

B. Registration Process 

1. Primary Speakers 

Individuals must also indicate 

whether they are the ‘‘primary speaker’’ 

for an agenda item. Primary speakers 

must be designated by the entity that 

submitted the HCPCS coding request. 

When registering, primary speakers 

must provide a brief written statement 

regarding the nature of the information 

they intend to provide and regarding 

any needs for audio/visual support and 

email it to HCPCS_Level_II_Code_

Applications@cms.hhs.gov. Speaker 

PowerPoint files are tested and arranged 

in speaker sequence well in advance of 

the meeting. We will accept emailed 

PowerPoint files that are received by the 

deadline for submissions of presentation 

materials as specified in the DATES

section of this notice. Materials will 

only be accepted when emailed to 

HCPCS_Level_II_Code_Applications@

cms.hhs.gov. Due to the timeframe for 

planning and coordination of the 

HCPCS public meetings under CMS’ 

shorter and more frequent coding cycles 

that started in 2020, late submissions 

and updates of materials after our 

deadline cannot be accommodated. 

All presentation materials and 

additional supporting documentation 

should not exceed 10 pages (each side 

of a page counts as 1 page). An 

exception will be made to the 10-page 


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Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 31719 

limit only for relevant studies newly 

published between the application 

deadline and the virtual public meeting 

date, in which case, we request a copy 

of the complete publication be emailed 

as soon as possible to HCPCS_Level_II_

Code_Applications@cms.hhs.gov. This 

exception applies only to the page limit 

and not the submission deadline. 

Fifteen minutes is the total time 

interval for the presentation. In 

establishing the public meeting agenda, 

we may group multiple, related requests 

under the same agenda item. In that 

case, we will decide whether additional 

time will be allotted, and may opt to 

increase the amount of time allotted to 

the primary speaker. 

Every primary speaker must declare at 

the beginning of their presentation at 

the meeting, as well as in their written 

summary, whether they have any 

financial involvement with the 

manufacturers or competitors of any 

items being discussed; this includes any 

payment, salary, remuneration, or 

benefit provided to that speaker by the 

manufacturer or the manufacturer’s 

representatives. 

On the day of the virtual meeting, 

before the end of the meeting, all 

primary speakers must email a brief 

written summary of their comments and 

conclusions to HCPCS_Level_II_Code_

Applications@cms.hhs.gov. 

2. 5-Minute Speakers 

The deadline for registering to be a 5- 

minute speaker is noted in the DATES

section of this notice. Individuals must 

provide their name, company name and 

address, and contact information as 

specified in the instructions for remote 

participation, and identify the specific 

agenda item that they will address. 

Based on the number of items on the 

agenda and the progress of the meeting, 

a determination will be made by the 

meeting coordinator and the meeting 

moderator regarding how many 5- 

minute speakers can be accommodated 

and whether the 5-minute allocation 

would be reduced to accommodate the 

number of speakers. 

Every 5-minute speaker must declare 

at the beginning of their presentation at 

the meeting, as well as in their written 

summary, whether they have any 

financial involvement with the 

manufacturers or competitors of any 

items being discussed; this includes any 

payment, salary, remuneration, or 

benefit provided to that speaker by the 

manufacturer or the manufacturer’s 

representatives. 

On the day of the virtual meeting, 

before the end of the meeting, all 5- 

minute speakers must email a brief 

written summary of their comments and 

conclusions to HCPCS_Level_II_Code_

Applications@cms.hhs.gov. 

C. Additional Virtual Meeting/ 

Registration Information 

Prior to registering to attend a virtual 

public meeting, all participants are 

advised to review the public meeting 

agendas at https://www.cms.gov/ 

Medicare/Coding/MedHCPCSGenInfo/ 

HCPCSPublicMeetings which identify 

our preliminary coding 

recommendations, and the dates each 

item will be discussed. All participants 

and other stakeholders are encouraged 

to regularly check CMS’ official HCPCS 

website at https://www.cms.gov/ 

Medicare/Coding/MedHCPCSGenInfo/ 

HCPCSPublicMeetings for publication of 

draft agendas, including a summary of 

each request and our preliminary 

recommendations. 

CMS’ official HCPCS website will 

include additional details regarding the 

public meeting process for new 

revisions to the HCPCS code set, 

including information on how to join 

the meeting remotely, and guidelines for 

an effective presentation. Individuals 

who intend to provide a presentation at 

a virtual public meeting are encouraged 

to familiarize themselves with the 

HCPCS website and the valuable 

information it provides to prospective 

registrants. The HCPCS website also 

contains a document titled ‘‘Healthcare 

Common Procedure Coding System 

(HCPCS) Level II Coding Procedures,’’ 

which is a description of the HCPCS 

coding process, including a detailed 

explanation of the procedures CMS uses 

to make coding determinations for the 

items and services that are coded in the 

HCPCS. 

III. Written Comments From Meeting 

Attendees 

As part of CMS’ response to the 

COVID–19 PHE, written comments from 

the general public and meeting 

registrants will only be accepted when 

emailed to HCPCS_Level_II_Code_

Applications@cms.hhs.gov before 5 

p.m., e.d.t., on the date of the virtual 

public meeting at which a request is 

discussed. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: June 9, 2021. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2021–12453 Filed 6–11–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Tribal Maternal, Infant, and 

Early Childhood Home Visiting 

Program: Guidance for Submitting an 

Annual Report to the Secretary (OMB 

#0970–0409) 

AGENCY: Office of Child Care, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF), Office of 

Child Care (OCC) is requesting a 3-year 

extension of the Tribal Maternal, Infant, 

and Early Childhood Home Visiting 

(MIECHV) Program: Guidance for 

Submitting an Annual Report to the 

Secretary (OMB #0970–0409; expiration 

9/30/2021). There are minor updates to 

the annual guidance which reflects a 

change in timing for the due date of the 

final report. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing infocollection@

acf.hhs.gov. Alternatively, copies can 

also be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation (OPRE), 330 C Street 

SW, Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: Section 511(e)(8)(A) of Title 

V of the Social Security Act requires 

that grantees under the MIECHV 

program for states and jurisdictions 

submit an annual report to the Secretary 

of Health and Human Services regarding 

the program and activities carried out 

under the program, including such data 

and information as the Secretary shall 

require. Section 511(h)(2)(A) further 


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