Evaluation of Risk Factors Associated with HIV, HBV and HCV in Chinese Donors (NHLBI)

Forms and Documents

Document Name	Status
Form 1.2 HBV and HCV Risk Factor Form and Instruction	New
Form 1.1 HIV Risk Factor Form and Instruction	New
Attachment 4 1_Study Protocol (3) (2).doc Supplementary Document	2009-01-26
Attachment 3 4_Enrollment Script (2) (2).doc Supplementary Document	2009-01-26
Attachment 2 3_Consent HBV (2).doc Supplementary Document	2009-01-26
Attachment 2 2_Consent Controls HIV (3).doc Supplementary Document	2009-01-26
Attachment 2 1_Consent Cases HIV (2) (3).doc Supplementary Document	2009-01-26
China Supporting Statement B.doc Supporting Statement B	2008-10-22
Attachment 3.4_Enrollment Script.doc Supplementary Document	2008-10-22
Attachment 3.2_Qx description.doc Supplementary Document	2008-10-22
Attachment 4.1_Study Protocol.doc Supplementary Document	2008-10-22
Attachment 3.3_SC Members.doc Supplementary Document	2008-10-22
Attachment 3.1_List of OSMB Members.doc Supplementary Document	2008-10-22
Attachment 2.3_Consent HBV.doc Supplementary Document	2008-10-22
Attachment 2.2_Consent Controls HIV.doc Supplementary Document	2008-10-22
Attachment 2.1_Consent Cases HIV.doc Supplementary Document	2008-10-22
China Supporting Statement A (8) (3).doc Supporting Statement A	2009-01-26

IC Document Collections

IC ID	Document Title	Status
187041	HBV and HCV Risk Factor Form and Instruction	New
187040	HIV Risk Factor Form and Instruction	New

ICR Details

OMB Control No: 0925-0596	ICR Reference No: 200810-0925-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Evaluation of Risk Factors Associated with HIV, HBV and HCV in Chinese Donors (NHLBI)
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: 01/30/2009
	Date Received in OIRA: 10/29/2008
Terms of Clearance: Approved consistent with with changes made and uploaded on 1/26/2009.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2012	36 Months From Approved
Responses	3,920	0	0
Time Burden (Hours)	1,294	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Understanding the risk factors associated with HIV, HBV and HCV infections in donors is essential for developing donor behavioral screening policies. Injection drug use, sexual transmissions, transfusion history, and medical injections are thought to be major routes of transmission in China but their relative importance in blood donors is unknown. In the U.S., risk factors have been better characterized but, questions still remain. Risk factors cannot be identified in 33% and 40% of persons with acute hepatitis B and C respectively, and risk factors may differ between the U.S. and China. This study will improve our understanding of potential transfusion transmitted viral risk factors that cannot be optimally studied in the U.S. because of their low prevalence.

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Authorizing Statute(s): US Code: 42 USC 241 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 44751	07/31/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 62514	10/21/2008
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
HIV Risk Factor	1.1	HIV
HBV and HCV Risk Factor	1.2	HBV HCV

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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	3,920	0	0	3,920	0	0
Annual Time Burden (Hours)	1,294	0	0	1,294	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 collection of information.

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Annual Cost to Federal Government: $240,042

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: 10/29/2008

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