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 


khammond on DSKJM1Z7X2PROD with NOTICES
31720 Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices 

states that the requirements for the 

MIECHV grants to tribes, tribal 

organizations, and urban Indian 

organizations are to be consistent, to the 

greatest extent practicable, with the 

requirements for grantees under the 

MIECHV program for states and 

jurisdictions. 

OCC, in collaboration with the Health 

Resources and Services Administration, 

Maternal and Child Health Bureau 

awarded grants for the Tribal MIECHV 

Program (Tribal Home Visiting) to 

support cooperative agreements to 

conduct community needs assessments; 

plan for and implement high-quality, 

culturally-relevant, evidence-based 

home visiting programs in at-risk tribal 

communities; establish, measure, and 

report on progress toward meeting 

performance measures in six 

legislatively-mandated benchmark 

areas; and conduct rigorous evaluation 

activities to build the knowledge base 

on home visiting among Native 

populations. 

After the first grant year, Tribal Home 

Visiting grantees must comply with the 

requirement to submit an Annual Report 

to the Secretary that should feature 

activities carried out under the program 

during the past reporting period, and a 

final report to the Secretary during the 

final year of their grant. To assist 

grantees with meeting these 

requirements, ACF created guidance for 

grantees to use when writing their 

reports. The guidance specifies that 

grantees must address the following: 

• Update on Home Visiting Program 

Goals and Objectives 

• Update on the Implementation of 

Home Visiting Program in Targeted 

Community(ies) 

• Progress toward Meeting Legislatively 

Mandated Benchmark Requirements 

• Update on Rigorous Evaluation 

Activities 

• Home Visiting Program Continuous 

Quality Improvement (CQI) Efforts 

• Update on dissemination activities 

• Administration of Home Visiting 

Program 

• Technical Assistance Needs 

Previously, the guidance included 

information about both the annual and 

the final reports from grantees. This 

extension request includes updates to 

the guidance to make it specific to just 

the annual reports. Guidance specific to 

the final report will be submitted for 

review and approval by OMB in the 

future. A comment period will 

accompany that request. 

Respondents: Tribal Home Visiting 

Managers (information collection does 

not include direct interaction with 

individuals or families that receive the 

services). 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual 

burden 

hours 

Annual Report to the Secretary ....................................................................... 23 1 25 575 

Estimated Total Annual Burden 

Hours: 575. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Title V of the Social Security 

Act, sections 511(e)(8)(A) and 511(h)(2)(A). 

John M. Sweet, Jr., 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–12464 Filed 6–14–21; 8:45 am] 

BILLING CODE 4184–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2319] 

Evaluation of Study Data Exchange 

Standards for Submission of Study 

Data to the Center for Veterinary 

Medicine; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is soliciting comments on the use of 

study data exchange standards from 

persons involved in study conduct, data 

collection, data management, and 

submission of animal study data 

intended to support the approval of new 

animal drug applications, abbreviated 

new animal drug applications, or 

applications for conditional approval. 

DATES: Submit either electronic or 

written comments on the notice by 

September 13, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 13, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 13, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES