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OMB Control No: 0906-0078	ICR Reference No: 202312-0906-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Ryan White HIV/AIDS Program Mpox Vaccine Distribution
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/07/2023
	Date Received in OIRA: 12/07/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2026	36 Months From Approved
Responses	5,985	0	0
Time Burden (Hours)	1,375	0	0
Cost Burden (Dollars)	0	0	0

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), 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.

Authorizing Statute(s): PL: Pub.L. 111 - 352 4 Name of Law: GPRA MODERNIZATION ACT OF 2010

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 29909	05/09/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 47151	07/21/2023
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
RWHAP MPx Vaccine Distribution Request Table	1
Therapeutic Courses (Administered and Available)	2
Wastage Upload Report	3

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	5,985	5,985
Annual Time Burden (Hours)	1,375	1,375
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new request.

Annual Cost to Federal Government: $16,802

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Laura Cooper 301 443-2126 lcooper@hrsa.gov

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