[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]


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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 [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
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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]
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