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pdfFederal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
202497, MARQIBO (vincristine sulfate
LIPOSOME injection) for intravenous
infusion, submitted by Acrotech
Biopharma LLC, indicated for the
treatment of adult patients with
Philadelphia chromosome negative
(Ph-) acute lymphoblastic leukemia in
second or greater relapse or whose
disease has progressed following two or
more anti-leukemia therapies.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see ADDRESSES) on or before
November 18, 2021, will be provided to
the committee. Oral presentations from
the public will be scheduled between
approximately 11:15 a.m. to 11:45 a.m.
and 3:45 p.m. to 4:15 p.m. Eastern Time.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before November 8, 2021. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 9, 2021.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
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16:50 Sep 23, 2021
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If you require accommodations due to a
disability, please contact She-Chia Chen
and Rhea Bhatt (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20740 Filed 9–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Bureau of
Health Workforce Performance Data
Collection, OMB No. 0915–0061—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than November 23,
2021.
SUMMARY:
Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
ADDRESSES:
PO 00000
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53069
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Bureau of Health Workforce
Performance Data Collection, OMB No.
0915–0061—Revision.
Abstract: Over 40 Bureau of Health
Workforce (BHW) programs award
grants to health professions schools and
training programs across the United
States to develop, expand, and enhance
training, and to strengthen the
distribution of the health workforce.
These programs are governed by the
Public Health Service Act (42 U.S.C. 201
et seq.), specifically Titles III, VII, and
VIII. Performance information is
collected in the HRSA Performance
Report for Grants and Cooperative
Agreements. Data collection activities
consisting of an annual progress and
annual performance report satisfy
statutory and programmatic
requirements for performance
measurement and evaluation (including
specific Title III, VII and VIII
requirements), as well as Government
Performance and Results Act of 1993
and the Government Performance and
Results Act Modernization Act of 2010
requirements. The performance
measures were last revised in 2019 to
ensure they addressed programmatic
changes, met evolving program
management needs, and responded to
emerging workforce concerns. As these
changes were successful, BHW will
continue with its current performance
management strategy and make only
minor changes that reduce burden,
simplify reporting, and reflect new
Department of Health and Human
Services and HRSA priorities as well as
elements to enable longitudinal analysis
of program performance. An Excel
upload feature will be implemented for
a majority of programs, disciplinerelated questions will be split into two
parts to make it easier for respondents
to find the appropriate answer, COVIDrelated questions are being added,
additional information is being
collected for telehealth, and additional
loan repayment questions are being
added.
Need and Proposed Use of the
Information: The purpose of the
proposed data collection is to continue
analysis and reporting of grantee
training activities and education,
identify intended practice locations, and
report outcomes of funded initiatives.
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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices
Data collected from these grant
programs will also provide a description
of the program activities of
approximately 1,630 reporting grantees
to inform policymakers on the barriers,
opportunities, and outcomes involved
in health care workforce development.
The proposed measures focus on five
key outcomes:
(1) Increasing the workforce supply of
diverse well-educated practitioners in
needed professions,
(2) increasing the number of
practitioners that practice in
underserved and rural areas,
(3) enhancing the quality of
education,
(4) increasing the recruitment,
training, and placement of underrepresented groups in the health
workforce, and
(5) supporting educational
infrastructure to increase the capacity to
train more health professionals in high
demand areas.
Likely Respondents: Respondents are
awardees of BHW health professions
grant programs.
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; to
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; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
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
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Direct Financial Support Program .......................................
Infrastructure Program .........................................................
Multipurpose or Hybrid Program ..........................................
699
142
789
1
1
1
699
142
789
2.7
6.2
3.4
1887.3
880.4
2682.6
Total ..............................................................................
1630
........................
1630
........................
5450.3
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.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Centers for Disease Control and
Prevention (CDC)/HRSA Advisory
SUMMARY:
16:50 Sep 23, 2021
This meeting will be held
virtually by webinar. Advance
registration is required to attend. Please
visit the meeting website above to
register. The registration deadline is
Friday, October 29, 2021, at 12:00 p.m.
Prior to the meeting, each individual
registrant will receive a registration
confirmation along with an access link
to the virtual meeting location.
• Meeting website link: https://
www.chacfall2021.org/.
FOR FURTHER INFORMATION CONTACT:
Theresa Jumento, Senior Public Health
Advisor, HIV/AIDS Bureau, HRSA,
(301) 443–5807; or [email protected].
SUPPLEMENTARY INFORMATION: CHAC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
matters of significance concerning the
activities under Section 222 of the
Public Health Service (PHS) Act, 42
U.S.C. 217a.
ADDRESSES:
[FR Doc. 2021–20650 Filed 9–23–21; 8:45 am]
VerDate Sep<11>2014
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment (CHAC)
has scheduled a public meeting.
Information about CHAC and the agenda
for this meeting can be found on the
CHAC website at https://www.cdc.gov/
maso/facm/facmCHACHSPT.html and
the meeting website at https://
www.chacfall2021.org/.
DATES: November 3, 2021, 12:30 p.m.–
5:00 p.m. Eastern Time and November
4, 2021, 12:30 p.m.–5:00 p.m. Eastern
Time.
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The purpose of CHAC is to advise the
Secretary of HHS, the Director of CDC,
and the HRSA Administrator regarding
objectives, strategies, policies, and
priorities for HIV, viral hepatitis, and
other STDs; prevention and treatment
efforts, including surveillance of HIV
infection, viral hepatitis, and other
STDs, and related behaviors;
epidemiologic, behavioral, health
services, and laboratory research on
HIV, viral hepatitis, and other STDs;
identification of policy issues related to
HIV/viral hepatitis/STD professional
education, patient health care delivery,
and prevention services; agency policies
about prevention of HIV, viral hepatitis
and other STDs; treatment, health care
delivery, and research and training;
strategic issues influencing the ability of
CDC and HRSA to fulfill their missions
of providing prevention and treatment
services; programmatic efforts to
prevent and treat HIV, viral hepatitis,
and other STDs; and support to the CDC
and HRSA in their developoment of
responses to emerging health needs
related to HIV, viral hepatitis, and other
STDs.
During the November 3–4, 2021
meeting, CHAC will discuss issues
related to engagement in care among
people living with HIV using
telemedicine; improving STI screenings
in people with HIV through the Ryan
White HIV/AIDS program; providing
housing services at the intersection of
substance use disorder, mental health
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File Type | application/pdf |
File Modified | 2021-09-24 |
File Created | 2021-09-24 |