Notice2023-09823
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
Primary source
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Published
May 9, 2023
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 89 (Tuesday, May 9, 2023)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09823]
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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.
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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 <a href="/cdn-cgi/l/email-protection#e49485948196938b968fa48c969785ca838b92"><span class="__cf_email__" data-cfemail="5c2c3d2c392e2b332e371c342e2f3d723b332a">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#ee9e8f9e8b9c99819c85ae869c9d8fc0898198"><span class="__cf_email__" data-cfemail="f48495849186839b869fb49c868795da939b82">[email protected]</span></a> 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
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Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
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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)...
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Total....................... 171 .............. .............. .............. 1,955.1
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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]
BILLING CODE 4165-15-P
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