Multi-site HIV Testing in Community Mental Health Settings Serving African Americans

Forms and Documents

Document Name	Status
Form No number Core Questionnaire Form	New
Form no number Consent Questionnaire Form	New
Form no number Eligibility Screener Form	New
OMB Response_Comments_MultiSiteHIV_113009.doc Supplementary Document	2009-12-04
OMB Response_ICR_MultiSiteHIV_113009_clean.doc Supplementary Document	2009-12-04
92008BL-OMB Supporting Statement B_ 042009.doc Supporting Statement B	2009-05-06
Att 9 References.doc Supplementary Document	2009-05-06
Att 8 Model Consent.doc Supplementary Document	2009-05-06
Att 7 Restrictions on Release of Data.doc Supplementary Document	2009-05-06
Att 6 Assurance of Confidentiality.doc Supplementary Document	2009-05-06
Att 5E Sheppard Pratt IRB_Baltimore.doc Supplementary Document	2009-05-06
Att 5D University of Pennsylvania IRB.pdf Supplementary Document	2009-05-06
Att 5C University of Maryland IRB.pdf Supplementary Document	2009-05-06
Att 5B Philadelphia City IRB.pdf Supplementary Document	2009-05-06
Att 5A CDC IRB Approval.doc Supplementary Document	2009-05-06
Att 4 Consultants.doc Supplementary Document	2009-05-06
Att 2d Comment to Revised FRN_2008.doc Supplementary Document	2009-05-06
Att 2c Revised 60-Day FRN_2008.pdf Supplementary Document	2009-05-06
Att 2b Comment to FRN.doc Supplementary Document	2009-05-06
Att 2a Initial 60-Day FRN.pdf Supplementary Document	2009-05-06
Att 1 PHSA.pdf Supplementary Document	2009-05-06
OMB Response_ICR_MultiSiteHIV_113009_marked.doc Supporting Statement A	2009-12-07

IC Document Collections

IC ID	Document Title	Status
189385	Core Questionnaire Form	New
189384	Consent Questionnaire Form	New
189383	Eligibility Screener Form	New

ICR Details

OMB Control No: 0920-0833	ICR Reference No: 200905-0920-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Multi-site HIV Testing in Community Mental Health Settings Serving African Americans
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: 12/08/2009
	Date Received in OIRA: 05/29/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	24 Months From Approved
Responses	1,856	0	0
Time Burden (Hours)	313	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: People with severe mental illness (SMI) are at increased risk of HIV infection compared with the general population. Despite the risk of comorbidity, persons with SMI are often not included when planning and implementing HIV programs and interventions by health agencies. Mental health care settings are important for HIV testing and promoting prevention efforts. This project will implement HIV testing programs in 6 mental health settings in Balitmore and Philadelphia. Testing and linkage to treatment services will be offered to those receiving mental health services in a hospital psychiatry inpatient unit; a community-based outpatient clinic, and outreach program. Approximately 1200 clients will be enrolled over 2 years. The data wil help inform the development of HIV testing and prevention programs in settings that serve persons with SMI.

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Authorizing Statute(s): US Code: 42 USC 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:
	73 FR 45226	08/04/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 21810	05/11/2009
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Eligibility Screener	no number	Eligibility Screener
Consent Questionnaire	no number	Consent questionnaire
Core Questionnaire	No number	Core questionnaire

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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	1,856	0	0	1,856	0	0
Annual Time Burden (Hours)	313	0	0	313	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: $353,998

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? Yes

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: 05/29/2009

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