Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 52689 

amount of available operating reserves 

would be phased in over the first 3 years 

of BsUFA III (33 weeks in fiscal year 

2023, 27 weeks in fiscal year 2024, and 

21 weeks in fiscal year 2025). BsUFA III 

also proposes to add a strategic hiring 

and retention adjustment to ensure FDA 

has the funding necessary to provide for 

the costs of retaining and hiring highly 

qualified scientific and technical staff 

for the process for the review of 

biosimilar biological product 

applications under BsUFA. This 

strategic hiring and retention 

adjustment would add $150,000 to the 

base revenue amount each fiscal year 

during BsUFA III. 

K. Impact of BsUFA III Enhancements 

on User Fee Revenue 

To implement the proposed 

enhancements for BsUFA III, funding 

for a cumulative total of 15 FTE staff is 

proposed to be phased in over the 

course of BsUFA III. The new funding 

would be phased in as follows: 

• $4,428,886 for fiscal year 2023 

• $320,569 for fiscal year 2024 

IV. Public Meeting Information 

A. Purpose and Scope of the Meeting 

The virtual public meeting will 

include a presentation by FDA and an 

industry panel. For members of the 

public who would like to make verbal 

comments on the proposed 

enhancements, there will be a public 

comment period at the end of the 

meeting (see instructions below). We 

will also provide an opportunity for 

individuals to submit written comments 

to the docket before and after the 

meeting. 

B. Participating in the Public Meeting 

Registration: Registration is optional 

and not required to attend this virtual 

public meeting. However, registering 

will allow FDA to provide you with 

email updates if any meeting details 

change. If you wish to register, you can 

do so at https://bsufaiii-finalpublic

meeting.eventbrite.com. 

Opportunity for Verbal Public 

Comment: Those who register online 

will receive a confirmation email that 

includes a link to a request form to 

make a verbal public comment at the 

meeting. If you wish to speak during the 

public comment session, follow the 

instructions in the notification and 

identify which topic(s) you wish to 

address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

October 19, 2021, 11:59 p.m. Eastern 

Time. Depending on the number of 

requests, we will determine the amount 

of time allotted to each commenter, the 

approximate time each comment is to 

begin, and will select and notify 

participants by October 26, 2021. No 

commercial or promotional material 

will be permitted to be presented at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: The Zoom Webinar ID for this 

public meeting is 161 047 8285. The 

webcast link for this public meeting can 

be found here: https://fda.zoomgov.

com/j/1610478285?pwd=MG1lN2hr

YzBVTGhsd1F2eVhwZG1DQT09. The 

link above should allow you to enter the 

webinar directly. If Zoom asks for a 

passcode, please use the case-sensitive 

passcode below. 

Case-Sensitive Passcode for Zoom 

Webinar: S9d&fx 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). Transcripts of the 

meeting will be available on the FDA 

web page https://www.fda.gov/industry/ 

biosimilar-user-fee-amendments/bsufaiii-fiscal-years-2023-2027 approximately 

30 days after the meeting. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20432 Filed 9–21–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Information Collection 

Request Title: Bureau of Primary 

Health Care—Program Management 

Resource Compendium, 0906–XXXX, 

New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than October 22, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

9094. 

SUPPLEMENTARY INFORMATION:

Information Collection Request Title: 

Bureau of Primary Health Care— 

Program Management Resource 

Compendium, OMB No. 0906–XXXX, 

New. 

Abstract: The Program Management 

Resource Compendium project will 

encompass an historical analysis of 

HRSA’s Bureau of Primary Health Care 

(BPHC), as well as a historical analysis 

of the Health Center Program, performed 

by federal contractors. Dating from the 

founding of the initial community 

health centers in the mid-1960s up to 

the present time, the analysis will 

consider the evolution and critical 

milestones of BPHC and the Health 

Center Program based on documentary 

research and interviews with 

individuals with historical knowledge 

of the Health Center Program and the 

health center movement. 

A 60-day notice published in the 

Federal Register (86 FR 30962 (June 10, 

2021). There were no public comments. 

Need and Proposed Use of the 

Information: The information gathered 

through interviews will be combined 

with information drawn from 

documentary research to inform the 

historical analysis. The results of the 

analysis will be presented in 

communication products for an internal 

audience, as well as products for an 

external audience. The goals of the 

project are to increase awareness of the 

Health Center Program management 

52690 Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 

within the government and among the 

general public, as well as to inform 

BPHC’s future development by 

analyzing and drawing lessons from its 

earlier administration of the Health 

Center Program. 

Likely Respondents: Interviews are 

expected with current and former BPHC 

employees, as well as representatives of 

the National Association of Community 

Health Centers, other national 

organizations, state and regional 

Primary Care Associations, and HRSAfunded health centers. A list of possible 

interviewees has been compiled with 

input by current and former HRSA 

leadership and staff. A total of 35–50 

interviews are expected. 

Interviews will be conducted virtually 

by a trained moderator and note taker, 

using a structured in-depth interview 

guide. Each interview is expected to last 

approximately one hour. It is also 

anticipated that interviewees may spend 

up to 15 minutes preparing for their 

interviews, for example by reviewing 

historical files. Signed consent forms 

regarding participation and the use of 

recording devices during the interview 

will be obtained from each participant 

prior to their participation in the 

interviews. The in-depth interview 

guide is available upon request. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to: Review instructions; 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; train 

personnel and to be able to respond to 

a collection of information; search data 

sources; complete and review the 

collection of information; and transmit 

or otherwise disclose the information. 

The total annual burden hours 

estimated for this ICR are summarized 

in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Historical interview ............................................................... 50 1 50 1.25 62.5 

Total .............................................................................. 50 ........................ 50 ........................ 62.5 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–20524 Filed 9–21–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Opportunity To 

Become an Office on Women’s Health 

(OWH) Self-Measured Blood Pressure 

(SMBP) Program Partner; Notice by the 

U.S. Department of Health and Human 

Services 

AGENCY: Office on Women’s Health, 

Office of the Assistant Secretary for 

Health, Office of the Secretary, U.S. 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services’ (HHS) 

Office on Women’s Health (OWH) 

invites public and private sector 

organizations to apply to become an 

OWH Self-Measured Blood Pressure 

(SMBP) Partner. This ongoing 

partnership opportunity engages 

support from partner organizations to 

promote SMBP and encourages women 

to maintain healthy blood pressure 

levels at every age and stage of their 

lives. Through the OWH SMBP 

Partnership Program (‘‘SMBP 

Program’’), OWH seeks to increase 

knowledge and access to SMBP 

information and resources, as well as 

encourage organizations to address heart 

health disparities, prevent hypertension, 

promote self-measured blood pressure, 

and improve health equity on a 

community level. The SMBP Program 

will launch during the 2nd annual 

observance of National Women’s Blood 

Pressure Awareness Week (NWBPAW), 

October 17–23, 2021. The SMBP 

Program will build on momentum 

generated by NWBPAW, which 

emphasizes the importance of blood 

pressure control and empowers women 

to improve their heart health through 

simple, everyday actions. 

Eligibility: Any organization may 

apply to be a SMBP Program partner. 

The selected SMBP Program partners 

may be recognized for their commitment 

and their work toward achieving the 

goals of the program. 

SMBP Program partners can be public 

and private organizations such as those 

at the state, local, county, and tribal 

levels, non-governmental organizations, 

non-profit organizations, businesses, 

academic organizations, organizations 

that impact health outcomes, 

philanthropic organizations, and tribal 

organizations that identify themselves 

as being aligned with or promoting the 

goals of the program. 

Organizations that work in areas such 

as fitness, nutrition, housing, health 

education, and those working to 

improve health outcomes in women 

may apply. Social organizations that 

work with, or have access to large 

populations of women, organizations 

promoting women in sports, and childcare facilities may apply. Organizations 

that have a defibrillator accessible 

onsite and are willing to make a selfmeasured blood pressure cuff accessible 

onsite, and organizations that identify 

themselves as being aligned with, or 

promoting blood pressure control are 

encouraged to apply. 

All organizations may apply. 

Individuals are not eligible to become 

an SMBP Program partner. 

Applicants shall submit a letter of 

interest and identify how they support 

or plan to support the SMBP Program 

goals. Applicants will be considered 

according to the organization’s 

commitment to support those goals. 

SMBP Program partners may receive 

recognition from OWH on 

womenshealth.gov, girlshealth.gov, or 

OWH Social Media platforms. They may 

also receive SMBP information and 

resources for dissemination. 

The following activities may be 

considered as an organization’s