Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program: Mpox Vaccine Distribution Request Forms, OMB No. 0915-xxxx-New, 29909-29910 [2023-09823]
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Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment for the
NCHA PSO
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
AGENCY:
The Patient Safety and
Quality Improvement Final Rule
(Patient Safety Rule) authorizes AHRQ,
on behalf of the Secretary of HHS, to list
as a patient safety organization (PSO) an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety and Quality Improvement Act of
2005 (Patient Safety Act) and Patient
Safety Rule, when a PSO chooses to
voluntarily relinquish its status as a
PSO for any reason, or when a PSO’s
listing expires. AHRQ accepted a
notification of proposed voluntary
relinquishment from the NCHA PSO,
PSO number P0025, of its status as a
PSO, and has delisted the PSO
accordingly.
SUMMARY:
The delisting was effective at
12:00 Midnight ET (2400) on April 30,
2023.
ADDRESSES: The directories for both
listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. Both
directories can be accessed
electronically at the following HHS
website: https://www.pso.ahrq.gov/listed.
FOR FURTHER INFORMATION CONTACT:
Cathryn Bach, Center for Quality
Improvement and Patient Safety, AHRQ,
5600 Fishers Lane, MS 06N100B,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
ddrumheller on DSK120RN23PROD with NOTICES1
Background
The Patient Safety Act, 42 U.S.C.
299b–21 to 299b–26, and the related
Patient Safety Rule, 42 CFR part 3,
published in the Federal Register on
November 21, 2008 (73 FR 70732–
70814), establish a framework by which
individuals and entities that meet the
definition of provider in the Patient
Safety Rule may voluntarily report
information to PSOs listed by AHRQ, on
a privileged and confidential basis, for
VerDate Sep<11>2014
19:27 May 08, 2023
Jkt 259001
the aggregation and analysis of patient
safety work product.
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
PSOs.
AHRQ has accepted a notification of
proposed voluntary relinquishment
from the NCHA PSO to voluntarily
relinquish its status as a PSO.
Accordingly, the NCHA PSO, PSO
number P0025, was delisted effective at
12:00 Midnight ET (2400) on April 30,
2023.
NCHA PSO has patient safety work
product (PSWP) in its possession. The
PSO will meet the requirements of
section 3.108(c)(2)(i) of the Patient
Safety Rule regarding notification to
providers that have reported to the PSO
and of section 3.108(c)(2)(ii) regarding
disposition of PSWP consistent with
section 3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO has 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at https://www.pso.ahrq.gov.
Dated: May 3, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–09771 Filed 5–8–23; 8:45 am]
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29909
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Ryan White
HIV/AIDS Program: Mpox Vaccine
Distribution Request Forms, OMB No.
0915–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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 July 10, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 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 paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at 301–594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Ryan White HIV/AIDS Program: Mpox
Vaccine Distribution Request Forms—
OMB No. 0915–xxxx–New.
Abstract: On August 4, 2022, the
mpox outbreak was declared a public
health emergency (PHE) in the United
States. From the outset, HRSA engaged
with federal partners across HHS to
provide resources to combat the spread
of mpox; assist health care providers
who are treating people who have
mpox; and ensure those who are most
at risk are the focus of vaccine response
efforts.
HHS authorized HRSA to receive
allotments of the JYNNEOS vaccine for
mpox for rapid distribution to Ryan
SUMMARY:
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29910
Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Notices
White HIV/AIDS Program (RWHAP)
recipients. HRSA was identified as a
distribution partner due to the health
care services provided to individuals
with HIV and the number of uninsured
and underinsured persons seen in
RWHAP and Health Center Programs.
The allotments were meant to
supplement, not replace, vaccine efforts
at jurisdictional levels.
To expedite dispensing the vaccine,
HRSA provided the vaccine to dually
funded RWHAP Part C and Health
Center providers that care for at-risk
populations. Most of the identified
providers already had access to the
Health Partner Ordering Portal (HPOP),
a system HHS uses to quickly distribute
the vaccines to clients. For providers
who elected to receive the vaccine but
did not have access to HPOP, HRSA
registered them in the HPOP system.
HRSA made 73 shipments to 57 (53
dually funded and four Part C only)
RWHAP recipients who elected to
receive and distribute the mpox vaccine.
RWHAP recipients that receive
shipments of the JYNNEOS vaccine are
required to upload administration and
inventory/wastage data into HPOP on a
weekly basis. The information collected
includes federal or state PIN, contact, lot
number, description, number of vials,
expiration date, courses/doses/bottles
administered, bottles available, wastage,
reason, and date reported.
RWHAP recipients who accept
JYNNEOS vaccine from HRSA are also
asked to submit data with information
necessary for HRSA to assess the
quantity of mpox vaccines requested
and its distribution status. The
information collected includes grant
number; recipient name, point of
contact, and phone number; shipping
address; shipping point of contact,
email address, and phone number; and
number of boxes of mpox vaccine
requested.
As a result of the PHE for mpox, the
Assistant Secretary for Planning and
Evaluation issued a Paperwork
Reduction Act waiver for collection of
these data. Since the PHE ended on
January 31, 2023, HRSA is proposing to
continue collecting these data until the
end of 2025. This action will help to
improve HRSA’s ability to provide
additional resources and assistance to
RWHAP recipients, which may result in
increased prevention of mpox among
RWHAP clients.
Need and Proposed Use of the
Information: HRSA will use the
information collected to (1) assess and
improve its response to the mpox
pandemic and (2) improve HRSA’s
ability to provide resources and
assistance to RWHAP recipients in
future public health emergencies.
Likely Respondents: Dually funded
RWHAP Part C and Health Center
recipients who accepted at least one
shipment of mpox vaccine from HRSA.
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
Average
burden per
response
(in hours)
Total
responses
Total
burden hours
Vaccine Distribution Report .................................................
Wastage Upload Report ......................................................
Therapeutic Courses (Administered and Available) ............
57
57
57
1
1
1
57
57
57
0.5
23.4
10.4
28.5
1,333.8
592.8
Total ..............................................................................
171
........................
........................
........................
1,955.1
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.
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–09823 Filed 5–8–23; 8:45 am]
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Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Research Study Section.
Date: June 22–23, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F58,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Mario Cerritelli, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F58, Rockville, MD
20892, 240–669–5199, cerritem@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
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[Federal Register Volume 88, Number 89 (Tuesday, May 9, 2023)]
[Notices]
[Pages 29909-29910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Ryan
White HIV/AIDS Program: Mpox Vaccine Distribution Request Forms, OMB
No. 0915-xxxx-New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 July 10,
2023.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 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] or call Samantha Miller,
the acting HRSA Information Collection Clearance Officer, at 301-594-
4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Ryan White HIV/AIDS Program:
Mpox Vaccine Distribution Request Forms--OMB No. 0915-xxxx-New.
Abstract: On August 4, 2022, the mpox outbreak was declared a
public health emergency (PHE) in the United States. From the outset,
HRSA engaged with federal partners across HHS to provide resources to
combat the spread of mpox; assist health care providers who are
treating people who have mpox; and ensure those who are most at risk
are the focus of vaccine response efforts.
HHS authorized HRSA to receive allotments of the JYNNEOS vaccine
for mpox for rapid distribution to Ryan
[[Page 29910]]
White HIV/AIDS Program (RWHAP) recipients. HRSA was identified as a
distribution partner due to the health care services provided to
individuals with HIV and the number of uninsured and underinsured
persons seen in RWHAP and Health Center Programs. The allotments were
meant to supplement, not replace, vaccine efforts at jurisdictional
levels.
To expedite dispensing the vaccine, HRSA provided the vaccine to
dually funded RWHAP Part C and Health Center providers that care for
at-risk populations. Most of the identified providers already had
access to the Health Partner Ordering Portal (HPOP), a system HHS uses
to quickly distribute the vaccines to clients. For providers who
elected to receive the vaccine but did not have access to HPOP, HRSA
registered them in the HPOP system. HRSA made 73 shipments to 57 (53
dually funded and four Part C only) RWHAP recipients who elected to
receive and distribute the mpox vaccine.
RWHAP recipients that receive shipments of the JYNNEOS vaccine are
required to upload administration and inventory/wastage data into HPOP
on a weekly basis. The information collected includes federal or state
PIN, contact, lot number, description, number of vials, expiration
date, courses/doses/bottles administered, bottles available, wastage,
reason, and date reported.
RWHAP recipients who accept JYNNEOS vaccine from HRSA are also
asked to submit data with information necessary for HRSA to assess the
quantity of mpox vaccines requested and its distribution status. The
information collected includes grant number; recipient name, point of
contact, and phone number; shipping address; shipping point of contact,
email address, and phone number; and number of boxes of mpox vaccine
requested.
As a result of the PHE for mpox, the Assistant Secretary for
Planning and Evaluation issued a Paperwork Reduction Act waiver for
collection of these data. Since the PHE ended on January 31, 2023, HRSA
is proposing to continue collecting these data until the end of 2025.
This action will help to improve HRSA's ability to provide additional
resources and assistance to RWHAP recipients, which may result in
increased prevention of mpox among RWHAP clients.
Need and Proposed Use of the Information: HRSA will use the
information collected to (1) assess and improve its response to the
mpox pandemic and (2) improve HRSA's ability to provide resources and
assistance to RWHAP recipients in future public health emergencies.
Likely Respondents: Dually funded RWHAP Part C and Health Center
recipients who accepted at least one shipment of mpox vaccine from
HRSA.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Vaccine Distribution Report..... 57 1 57 0.5 28.5
Wastage Upload Report........... 57 1 57 23.4 1,333.8
Therapeutic Courses 57 1 57 10.4 592.8
(Administered and Available)...
-------------------------------------------------------------------------------
Total....................... 171 .............. .............. .............. 1,955.1
----------------------------------------------------------------------------------------------------------------
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. 2023-09823 Filed 5-8-23; 8:45 am]
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