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
| Published date | 22 September 2021 |
| Citation | 86 FR 52689 |
| Record Number | 2021-20524 |
| Section | Notices |
| Court | Health Resources And Services Administration |
52689
Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices
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/bsufa-
iii-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
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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 HRSA-
funded 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.
T
OTAL
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
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 child-
care facilities may apply. Organizations
that have a defibrillator accessible
onsite and are willing to make a self-
measured 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
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