Rapid HIV Testing Clinical Information Form for Minority AIDS Initiative (MAI) for Ethnic Racial Minorities at Risk for Substance Use and HIV/AIDS

Forms and Documents

Document Name	Status
Form Attachment A - HIV HIV/AID Rapid Testing Clinical Information Form Form and Instruction	Modified
0295-SS-B-10 18 12 Final doc.doc Supporting Statement B	2012-10-17
Attachment D- RHT Consent Form.doc Supplementary Document	2012-06-12
Attachment C - List of MAITCE Grantees.doc Supplementary Document	2012-06-12
Attachment B-List of RHT Grantees.pdf Supplementary Document	2012-06-12
0295-SS-A-10_18_12_Final_doc[1].doc Supporting Statement A	2012-10-23

IC Document Collections

IC ID	Document Title	Status
185896	HIV/AID Rapid Testing Clinical Information Form Form and Instruction	Modified

ICR Details

OMB Control No: 0930-0295	ICR Reference No: 201206-0930-001
Status: Historical Active	Previous ICR Reference No: 200906-0930-004
Agency/Subagency: HHS/SAMHSA	Agency Tracking No:
Title: Rapid HIV Testing Clinical Information Form for Minority AIDS Initiative (MAI) for Ethnic Racial Minorities at Risk for Substance Use and HIV/AIDS
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/21/2012
	Date Received in OIRA: 06/22/2012
Terms of Clearance: As shown by the changes made to this collection, SAMHSA shall accurately account for burden estimates and detail its plans for dealing with missing data.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	36 Months From Approved	11/30/2012
Responses	64,000	0	20,000
Time Burden (Hours)	9,576	0	3,192
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.

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Authorizing Statute(s): US Code: 42 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:
	77 FR 21984	04/12/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 34960	06/12/2012
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	Attachment A - HIV Form	Attachment A - HIV 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	64,000	20,000	0	44,000	0	0
Annual Time Burden (Hours)	9,576	3,192	0	6,384	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: Currently there are 3,192 burden hours in the OMB inventory. SAMHSA is now requesting to increase this ceiling to 9,576 total burden hours. The increase of 6,384 hours is due to the following: 1) The inclusion of both clinicians and clients in our "respondent" calculations; 2) The program adjustment of 20,000 respondents/2,660 burden hours is due to a recalculation of the actual number of respondents receiving a rapid HIV test and the inclusion of 1,333 retested respondents/532 burden hours. The 1,333 retested respondents and 532 burden hours reflects one third of the re-test population; 3) The program change of 40,000 respondents/5,320 burden hours is due to the addition of eleven 2011 MAI-TCE grantees and a program change increase of 2,667 respondents/1,064 burden hours to be retested for the 11 new grantees. The 2,667 retested respondents and 1,064 burden hours reflects two-thirds of the re-test population highlighted; and 4) 4000 respondents, on average, per year will be retested to ensure that a read of this submission is transparently clear.

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Annual Cost to Federal Government: $460,330

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]? 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: 06/22/2012

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