[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47151-47152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15463]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 www.reginfo.gov/public/do/PRAMain. 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 [email protected] 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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
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)...
                                 -------------------------------------------------------------------------------
    Total.......................             171  ..............  ..............  ..............        1,374.84
----------------------------------------------------------------------------------------------------------------


Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-15463 Filed 7-20-23; 8:45 am]
BILLING CODE 4165-15-P