HIV Study in Blood Donors from Five Chinese Regions (NHLBI)

Forms and Documents

Document Name	Status
Form 1 HIV Risk Factor Questionnaire Blood donors Control Peripheral Sites Form and Instruction	New
Form 1 HIV Risk Factor Questionnaire Blood donors Control Primary Sites Form and Instruction	New
Form 1 HIV Risk Factor Questionnaire Blood donors Case Peripheral Sites Sites Form and Instruction	New
Form 1 HIV Risk Factor Questionnaire Blood donors Case Primary Sites Form and Instruction	New
Form 1.2 HBV and HCV Risk Factor Form and Instruction	Removed
Form 1.1 HIV Risk Factor Form and Instruction	Removed
Attachment_6.1_ China HIV Study Protocol_050914.docx Supplementary Document	2014-11-05
Attachment_5.4_HIV_China_Steering_Committee_4_2014_V_2.0.docx Supplementary Document	2014-11-05
Attachment_5.3_HIV_IAC_Advisory_Committee_1_2014_V_1.0.docx Supplementary Document	2014-11-05
Attachment_5.2_Survey_Questionaire_Justification_4_2014_6.0.docx Supplementary Document	2014-11-05
Attachment_5.1_HIV__OSMB_Members_1_2014_V_1.0.docx Supplementary Document	2014-11-05
Attachment_4_Follow-up call_11_2014_V_4.0.docx Supplementary Document	2014-11-05
Attachment_3_Introduction over phone_8_2013_V_4 0 (2).docx Supplementary Document	2014-11-05
Attachment_1.2_HIV_Risk_Factor_Q_Web_Screen_Shots_11_2014_v_4.0.docx Supplementary Document	2014-11-05
Supporting_Statment_B_HIV_China_7_2014_V_9.0.docx Supporting Statement B	2014-11-05
Supporting Statement A_HIV_China_11_2014_V_20.0.docx Supporting Statement A	2014-11-05

IC Document Collections

IC ID	Document Title	Status
213750	HIV Risk Factor Questionnaire Blood donors Control Peripheral Sites Form and Instruction	New
213749	HIV Risk Factor Questionnaire Blood donors Control Primary Sites Form and Instruction	New
213748	HIV Risk Factor Questionnaire Blood donors Case Peripheral Sites Sites Form and Instruction	New
213747	HIV Risk Factor Questionnaire Blood donors Case Primary Sites Form and Instruction	New
187041	HBV and HCV Risk Factor Form and Instruction	Removed
187040	HIV Risk Factor Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0596	ICR Reference No: 201411-0925-001
Status: Historical Active	Previous ICR Reference No: 200810-0925-007
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: HIV Study in Blood Donors from Five Chinese Regions (NHLBI)
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: 12/19/2014
	Date Received in OIRA: 11/14/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	01/31/2012
Responses	1,350	0	3,920
Time Burden (Hours)	450	0	1,294
Cost Burden (Dollars)	0	0	0

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Abstract: To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). The major objectives of the study will be to evaluate the proportion of blood donors in China who were tested positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV-1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status (http://www.unaids.org.cn/pics/20130521161757.pdf). The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad cross-section of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, as suggested by recent HBV and HCV data from US CDC (http://www.cdc.gov/immigrantrefugeehealth/guidelines/domestic/hepatitis-screening-guidelines.html), the study objectives have direct relevance for HIV control in the US and globally.

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Authorizing Statute(s): US Code: 42 USC Chapter 6A, subchapter III, 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:
	79 FR 33764	06/12/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 67176	11/12/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
HIV Risk Factor	1.1	HIV
HBV and HCV Risk Factor	1.2	HBV HCV
HIV Risk Factor Questionnaire Blood donors Case Primary Sites	1, 2	HIV Risk Factor Questionnaire English ,   HIV Questionaire Informed Consent
HIV Risk Factor Questionnaire Blood donors Case Peripheral Sites Sites	2, 1	HIV Risk Factor Questionnaire English ,   HIV Questionaire Informed Consent
HIV Risk Factor Questionnaire Blood donors Control Primary Sites	1, 2	HIV Risk Factor Questionnaire English ,   HIV Questionaire Informed Consent
HIV Risk Factor Questionnaire Blood donors Control Peripheral Sites	1, 2	HIV Risk Factor Questionnaire English ,   HIV Questionaire Informed Consent

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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	1,350	3,920	0	-2,570	0	0
Annual Time Burden (Hours)	450	1,294	0	-844	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This HIV Risk Factor Survey constitutes a request for a reinstatement with change of a previous collection of information (OMB Number: 0925-0596 expiration date, January 31, 2012). Compared with the previous study, there are three changes: 1. Increased number of study sites from four to five: the previous study was conducted with blood donors at four blood centers (Kunming, Luoyang, Mianyang and Urumqi), while the current study collects data from a larger number of blood centers (Chongqing, Guangxi, Luoyang, Mianyang and Urumqi) thus increasing the study's geographic representation. 2. New survey questions to examine recently HIV infected donors: the questionnaire includes new questions about potential risk factors that may be associated with recently-acquired HIV infections and new questions probing detailed risks associated with increasing HIV prevalence in high risk groups. With this information captured and linked to the HIV test data and donor demographic characteristics, the study aims to establish the profiles of recently HIV infected donors and possibly identify new strategies to prevent window period blood donations. 3. Decrease amount of incentive for survey participants from 200 RMB to 100 RMB: based on the data collection team's experience with conducting similar surveys with this population in these regions in China, it was decided that this study does not need 200 RMB incentive.

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Annual Cost to Federal Government: $203,999

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: 11/14/2014

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