Chart Abstraction of Ryan White HIV/AIDS Program Recipient Data

Forms and Documents

Document Name	Status
Form 3 Pre-Site Visit Interview Form	New
Form 2 Site Screening Interview Form	New
Form 1 Medical Record Data Abstraction Form	New
Proposed Timeline for Chart Abstraction Client Level Data Collection.docx Supplementary Document	2020-04-07
Data dictionary.pdf Supplementary Document	2019-12-02
IRB Approval.pdf Supplementary Document	2019-12-02
Legislation.pdf Supplementary Document	2019-12-02
Privacy Impact Assessment.pdf Supplementary Document	2019-12-02
Supporting Statement B Feb 2020.docx Supporting Statement B	2020-04-07
Supporting Statement A March 2020.docx Supporting Statement A	2020-04-07

IC Document Collections

IC ID	Document Title	Status
238735	Pre-Site Visit Interview Form	New
238734	Site Screening Interview Form	New
238732	Medical Record Data Abstraction Form	New

ICR Details

OMB Control No: 0906-0050	ICR Reference No: 201912-0906-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Chart Abstraction of Ryan White HIV/AIDS Program Recipient Data
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: 04/08/2020
	Date Received in OIRA: 12/03/2019
Terms of Clearance: This one-time information collection is approved for a period of three years consistent with the understanding that this will serve as a bridge period for HRSA to address the technical issues in the Ryan White HIV/AIDS Program Services Report (RSR, OMB Control No. 0906-0039) and other related Ryan White HIV/AIDS Program information collection systems. HRSA will identify ways to reduce burden on grantees during this period and will consider methods of collecting required information through standard reporting systems utilized by all grant recipients. HRSA will continue to work with OMB over the coming years on ways to continue to integrate and harmonize data collection within the Ryan White HIV/AIDS Program.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	36 Months From Approved
Responses	200	0	0
Time Burden (Hours)	225	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Health Resources and Services Administration is required to assess the quality of care provided by Ryan White HIV/AIDS Program recipients. HHS guidelines and U.S. Preventative Services Task Force guidelines serve as the basis for assessing the quality of care within the RWHAP. HRSA will collect patient level clinical information from a representative sample of 50 RWHAP recipients or subrecipients annually for three years. The information collected will be used to assess the quality of care provided through the RWHAP.

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Authorizing Statute(s): PL: Pub.L. 111 - 87 Title XXVI Name of Law: PHSA, as amended by the RW HIV/AIDS Treatment Extension Act of 2009
  

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:
	84 FR 20638	05/10/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 63664	11/18/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Medical Record Data Abstraction	1	Medical Record Data Abstraction Screenshots.pdf
Site Screening Interview	2	Medical Record Data Abstraction Screenshots.pdf
Pre-Site Visit Interview	3	Pre-Site Site Interview Form.docx

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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	200	0	0	200	0	0
Annual Time Burden (Hours)	225	0	0	225	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: $1,203,756

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.     Yes

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.     Yes

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: 12/03/2019

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