Study To Assess Hepatitis Risk (STAHR)

Forms and Documents

Document Name	Status
Form 2 Study to Assess Hepatitis Risk: Behavioral Risk Assessment Form Form and Instruction	New
Form 1 Study to Assess Hepatitis Risk (STAHR): Screener Form Form and Instruction	New
OMB response.doc Supplementary Document	2009-02-05
STAHR UCSD IRB Protocol 11-10-08 [amended_Bold].doc Supplementary Document	2009-02-05
STAHR UCSD Consent_incentive language.doc Supplementary Document	2009-02-05
Attach_4_CoreQuestionnaire.doc Supplementary Document	2009-02-05
Attach_3_EligibilityScreener.doc Supplementary Document	2009-02-05
Amendment approval letter 12_02_2008.pdf Supplementary Document	2009-02-05
SuppStat_B_StatMethods.doc Supporting Statement B	2009-02-05
Attach7.doc Supplementary Document	2008-07-07
Attach6.doc Supplementary Document	2008-07-07
Attach5.pdf Supplementary Document	2008-07-04
Attach1.doc Supplementary Document	2008-07-03
Attach2.doc Supplementary Document	2008-07-03
SuppStat_A.doc Supporting Statement A	2009-02-05

IC Document Collections

IC ID	Document Title	Status
185972	Study to Assess Hepatitis Risk: Behavioral Risk Assessment Form Form and Instruction	New
185971	Study to Assess Hepatitis Risk (STAHR): Screener Form Form and Instruction	New

ICR Details

OMB Control No: 0920-0804	ICR Reference No: 200808-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Study To Assess Hepatitis Risk (STAHR)
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: 02/10/2009
	Date Received in OIRA: 08/01/2008
Terms of Clearance: Approved consistent with updates included in the 02/05/2009 uploaded documents. Prior to approval of the larger surveillance project, CDC will provide justification for each item included in the questionnaire based on the findings of this pilot project. CDC is encouraged to include power calculations, as appropriate, in future submissions.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2012	24 Months From Approved
Responses	1,800	0	0
Time Burden (Hours)	816	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the United States. The most common risk factor for hepatitis C is injection drug use, particularly among persons 18 to 30 years of age. Injection drug users (IDUs), who are the primary risk group for acute hepatitis C (60-70% of identified acute cases), have additional barriers to health care access and/or utilization resulting in the potential for a further underestimation of overall incidence. The purpose of this study is to pilot test three methods of recruiting 18-30 year old IDUs in San Diego for a behavioral risk assessment interview and serologic testing for hepatitis C virus (HCV) infection in order to determine the optimal method for ongoing national hepatitis C surveillance.

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Authorizing Statute(s): US Code: 3 USC 301 Name of Law: (241) Research and Investigations
  

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:
	72 FR 42413	08/02/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 39702	07/10/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Study to Assess Hepatitis Risk (STAHR): Screener Form	1	Study to Assess Hepatitis Risk (STAHR): Screener Form
Study to Assess Hepatitis Risk: Behavioral Risk Assessment Form	2	Study to Assess Hepatitis Risk: Behavioral Risk Assessment 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	1,800	0	0	1,800	0	0
Annual Time Burden (Hours)	816	0	0	816	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: New ICR

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Annual Cost to Federal Government: $356,675

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)? 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: 08/01/2008

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