Notice2023-15463
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Mpox Vaccine Distribution Request Forms, OMB No. 0915-xxxx-New
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 21, 2023
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with of the Paperwork Reduction Act of 1995, HRSA 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.
Full Text
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<title>Federal Register, Volume 88 Issue 139 (Friday, July 21, 2023)</title>
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[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47151-47152]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15463]
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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; 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 of the Paperwork Reduction Act of 1995,
HRSA 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 August 21,
2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#384859485d4a4f574a5378504a4b59165f574e"><span class="__cf_email__" data-cfemail="413120312433362e332a01293332206f262e37">[email protected]</span></a> or call
(301) 443-3093.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: 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 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 of 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),
[[Page 47152]]
a system HHS uses to quickly distribute vaccines to HHS health
partners. 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 their 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 December 31, 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.
A 60-day notice was published in the Federal Register on May 9,
2023, vol. 88, no. 89, pp. 29909-10. There was one comment received.
There are no changes made to the information collection since the
comment received is outside the scope of this information request.
Need and Proposed Use of the Information: HRSA will use the
information collected to (1) assess and improve its response to the
mpox outbreak 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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Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
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Vaccine Distribution Report..... 57 1 57 0.20 11.40
Wastage Upload Report........... 57 52 2,964 0.23 681.72
Therapeutic Courses 57 52 2,964 0.23 681.72
(Administered and Available)...
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Total....................... 171 .............. .............. .............. 1,374.84
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-15463 Filed 7-20-23; 8:45 am]
BILLING CODE 4165-15-P
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