Minority AIDS Initiative for Collaboration for Prevention and Treatment Improvement for AIANs at Risk for Substance Use and HIV/AID, (MIA) Rapid HIV Testing Clinical Information Form

Forms and Documents

Document Name	Status
Form HIV-AIAN/RHTI Data HIV/AID Rapid Testing Clinical Information Form Form	New
MAI RHT FINAL SS 07-29-08.doc Supporting Statement B	2008-07-29
CDC PEMS Form as of 2 2 08.pdf Supplementary Document	2008-07-24
MAI RHT FINAL SS 07-29-08.doc Supporting Statement A	2008-07-29

IC Document Collections

IC ID	Document Title	Status
185896	HIV/AID Rapid Testing Clinical Information Form Form	New

ICR Details

OMB Control No: 0930-0295	ICR Reference No: 200807-0930-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/SAMHSA	Agency Tracking No:
Title: Minority AIDS Initiative for Collaboration for Prevention and Treatment Improvement for AIANs at Risk for Substance Use and HIV/AID, (MIA) Rapid HIV Testing Clinical Information Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 08/28/2008
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/19/2008
	Date Received in OIRA: 07/29/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2009	6 Months From Approved
Responses	50,000	0	0
Time Burden (Hours)	8,350	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The data on the MAI Rapid HIV Testing Clinical Information Form will be used to collect clinical information that can be used for quality assurance, quality performance, and product monitoring. The form does not require patient specific information to be collected from parties participating in the MAI program. The form is designed to inform SAMHSA that the HIV Rapid Test Kits are reaching their intended audience, as many communities have expressed an interest in acquiring these no cost test kits to assist them in informing and protecting their citizens. The information that we require, will also serve to justify the use of Federal funds to benefit the American Indian/Alaska Native community.

Emergency Justfication: It was originally thought that the clinical information to be collected using the MAI HIV Rapid Testing Clinical Information Form was clinical exempt information associated with the testing of biological fluids. As a result, almost 20,000 test kits were received in June 2008 with a 6 month expiration date. It has now been determined that the MAI HIV Rapid Testing Clinical Information Form requires OMB approval. In order to provide American Indian and Alaska Native communities immediate access to these critical Rapid HIV tests, which are inextricably linked to status determination, and to avoid future loss to the government of the almost 20,000 previously purchased Rapid Test Kits, SAMHSA is requesting an emergency approval of the MAI HIV Rapid Testing Clinical Information Form. Given the history, SAMHSA could not have anticipated the need for this information any earlier. Even with an emergency OMB clearance, the timeline is extremely short for completing the information gathering and taking all other needed steps to provide approximately 50,000 no cost Rapid HIV Test to American Indian and Alaska Native communities.

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Authorizing Statute(s): US Code: 5 USC 505 Name of Law: Data Collection
  

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:
	73 FR 43945	07/29/2008
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
HIV/AID Rapid Testing Clinical Information Form	HIV-AIAN/RHTI Data Collection Form	HIV-AIAN/RHTI Data Collection Form

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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	50,000	0	0	50,000	0	0
Annual Time Burden (Hours)	8,350	0	0	8,350	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 data collection.

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Annual Cost to Federal Government: $201,788

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 07/29/2008

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