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 Form HIV/AID Rapid Testing Clinical Information Form Form and Instruction	Modified
SAMHSA MAI RHTI- SS-6-4-09.doc Supporting Statement B	2009-06-22
SAMHSA MAI RHTI- SS-6-4-09.doc Supporting Statement A	2009-06-22

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: 200906-0930-004
Status: Historical Active	Previous ICR Reference No: 200807-0930-002
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/14/2009
	Date Received in OIRA: 06/29/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved
Responses	20,000	0	0
Time Burden (Hours)	3,192	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.

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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:
	74 FR 8802	02/26/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 29494	06/22/2009
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	Form	Information 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	20,000	0	0	20,000	0	0
Annual Time Burden (Hours)	3,192	0	0	3,192	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: Previously 8,350 burden hours were estimated in the OMB inventory. CSAT is now requesting 3,192 total burden hours which is a decrease of 5,158 hours in burden from the earlier estimate. The previous estimate of 50,000 respondents has been modified to reflect a more realistic number of respondents of 20,000.

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Annual Cost to Federal Government: $371,788

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)? 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: 06/29/2009

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