Assessing Client Factors Associated with Detectable HIV Viral Loads; and Models of Care the Ryan White HIV/AIDS Program

Forms and Documents

Document Name	Status
Attachment G - NOA RW Outcomes.pdf Supplementary Document	2017-11-09
Attachment F - IRB Approval Letters.pdf Supplementary Document	2017-11-09
Supporting Statement B_11-1-17.doc Supporting Statement B	2017-11-09
Supporting Statement A_11-1-2017.doc Supporting Statement A	2017-11-09

IC Document Collections

IC ID	Document Title	Status
228991	Assessing Client Factors Associated with Detectable HIV Viral Loads; and Models of Care the Ryan White HIV/AIDS Program Other-Interview	New

ICR Details

OMB Control No: 0906-0033	ICR Reference No: 201711-0906-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Assessing Client Factors Associated with Detectable HIV Viral Loads; and Models of Care the Ryan White HIV/AIDS Program
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 without change	Conclusion Date: 12/14/2017
	Date Received in OIRA: 11/13/2017
Terms of Clearance: Approved consistent with the understanding that the scope of the 2 studies is limited to only those clients receiving services and sites receiving funding through the Ryan White HIV/AIDS Program. Outcomes from the studies are not generalizable to broader populations of patients with or providers serving those with HIV/AIDS. Any publications, reports, or presentations describing the outcomes of the studies will clearly communicate the study methodology and limitations affecting interpretation of conclusions

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved
Responses	1,340	0	0
Time Burden (Hours)	1,510	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: One study will identify characteristics of RWHAP clients and health facilities that are associated with the ability to achieve and sustain an undetectable viral load. This study will enable the development of better targeted interventions for improved viral suppression rates. The second study will compare HIV and primary health outcomes across various models of care to determine which are most effective in responding to HIV as a chronic disease.

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Authorizing Statute(s): US Code: 42 USC 6A, Section 301 Name of Law: Public Health Service Act
  

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:
	82 FR 22838	05/18/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 52309	11/13/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Assessing Client Factors Associated with Detectable HIV Viral Loads; and Models of Care the Ryan White HIV/AIDS Program

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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	1,340	0	0	1,340	0	0
Annual Time Burden (Hours)	1,510	0	0	1,510	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 ICR, so burden increases from zero (0).

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Annual Cost to Federal Government: $980,042

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? Uncollected

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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: 11/13/2017

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