Ryan White HIV/AIDS Program Mpox Vaccine Distribution

Forms and Documents

Document Name	Status
Form 3 Wastage Upload Report Form	New
Form 2 Therapeutic Courses (Administered and Available) Form	New
Form 1 RWHAP MPx Vaccine Distribution Request Table Form	New
Supporting Statement Mpox 11.28.23_Clean.docx Supporting Statement A	2023-11-28

IC Document Collections

IC ID	Document Title	Status
261185	Wastage Upload Report Form	New
261184	Therapeutic Courses (Administered and Available) Form	New
261183	RWHAP MPx Vaccine Distribution Request Table Form	New

ICR Details

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

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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.

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

Citations for New Statutory Requirements: None

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

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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

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

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

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	5,985	0	0	5,985	0	0
Annual Time Burden (Hours)	1,375	0	0	1,375	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/21/2023

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