Blood Donation Rules Opinion Study (Blood DROPS)

Forms and Documents

Document Name	Status
Form 1 Aim 3 Telephone Questionnaire Form and Instruction	Modified
Form 1 Aim 2.2 Web-based Screener and QUESTIONNAIRE Form and Instruction	Modified
Form 1 Aim 2.1 Web-based SCREENER and Questionnaire Form and Instruction	Modified
Form 1 Aim 1 Focus Group Screener and Topic Guide Form and Instruction	Modified
Change Request REDS-III Blood Drops[1].doc Justification for No Material/Nonsubstantive Change	2013-09-23
MSM_OMB_Attach_2_Web-based_Screener_and_Q_8Jan2013_clean_V_4_0.docx Supplementary Document	2013-01-18
MSM_OMB_Attach_2_Web-based_Screener_and_Q_8Jan2013_clean_V_4_0.docx Supplementary Document	2013-01-18
MSM_OMB_Attach_2_Web_based_Screener_Q_5_2102_V_3 0 pdf.pdf Supplementary Document	2012-08-15

IC Document Collections

IC ID	Document Title	Status
203732	Aim 3 Telephone Questionnaire Form and Instruction	Modified
203731	Aim 2.2 Web-based Screener and QUESTIONNAIRE Form and Instruction	Modified
203730	Aim 2.1 Web-based SCREENER and Questionnaire Form and Instruction	Modified
203729	Aim 1 Focus Group Screener and Topic Guide Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0669	ICR Reference No: 201309-0925-007
Status: Historical Active	Previous ICR Reference No: 201208-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 20587
Title: Blood Donation Rules Opinion Study (Blood DROPS)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/30/2013
	Date Received in OIRA: 09/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	01/31/2014	01/31/2014
Responses	6,904	0	6,884
Time Burden (Hours)	1,920	0	1,900
Cost Burden (Dollars)	0	0	0

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Abstract: The current policy for blood donation in the US with respect to men who have sex with men (MSM) is that any man who discloses having had sex with another man since 1977 (MSM77) is deferred indefinitely from donating. Any potential change to the MSM policy for blood donation requires additional data that is not currently available. One study from Sweden sought to directly assess the MSM and blood donation by surveying the MSM population. In this 2007 study, 19% of 334 MSM who responded reported donating blood at some time since 1985.Another study conducted in 2009-2010 from the UK reported that 10.6% of 1028 MSM who completed a survey had donated blood even though they were ineligible according to the existing lifetime deferral policy in the UK, and 2.5% of sexually active MSM had donated within the previous year. The UK policy has now been changed and a 1-year deferral for sexually active MSM has been adopted. In the US, motivating factors and compliance or not with the current policy are unstudied aspects of the larger issue. In the proposed study, data directly relevant to this issue will be collected through the assessment of motivations for blood donation in the MSM population using focus group participants as key informants. Surveys of MSM and of male blood donors in the communities where Recipient Epidemiology and Donor Evaluation Study (REDS-III) blood centers are located will be conducted to estimate the prevalence of compliance and non-compliance with the current policy using web-based surveys, and to assess intended compliance with a potentially modified MSM policy. A final component of the project will seek to conduct telephone interviews of persons who report both MSM and blood donation to determine primary drivers for MSM who actually do donate blood. These studies will provide a currently unavailable assessment of this topic in the US and can also help to guide improved communication strategies with potential donors.

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Authorizing Statute(s): US Code: 42 USC 285b Name of Law: NHLBI Legislative Authority
  

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

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
Aim 1 Focus Group Screener and Topic Guide	1	Focus Goup Topic Guide Q
Aim 2.1 Web-based SCREENER and Questionnaire	1	Web-based Screener
Aim 2.2 Web-based Screener and QUESTIONNAIRE	1	Web-based Survey
Aim 3 Telephone Questionnaire	1	Telephone Questionaire

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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	6,904	6,884	0	0	20	0
Annual Time Burden (Hours)	1,920	1,900	0	0	20	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Seeking approval to increase the number of Aim 3 telephone interview respondents from 20 to 40.

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Annual Cost to Federal Government: $380,000

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: 09/30/2013

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