Blood Donation Rules Opinion Study (Blood DROPS)

Forms and Documents

Document Name	Status
Form 1 Aim 2.2 Web-based Screener and QUESTIONNAIRE Form and Instruction	New
Form 1 Aim 2.1 Web-based SCREENER and Questionnaire Form and Instruction	New
MSM_OMB_Supporting Statement B_1_2013_V_9 0.docx Supporting Statement B	2013-01-11
MSM_OMB_Attach_4__Informed_Consents_1_2013_V_3.0.docx Supplementary Document	2013-01-11
MSM_OMB_Attach_5_OSMB_Members_5_2012_V_2.0.docx Supplementary Document	2013-01-11
MSM_OMB_Attach_6_Oversight_Committee_5_2012_V_2.0.docx Supplementary Document	2013-01-11
MSM_OMB_Attach_7_CoC_5_2012_V_2.0.docx Supplementary Document	2013-01-11
MSM_OMB_Attach_8_Protocol_1_2013_V_3.0.docx Supplementary Document	2013-01-11
MSM_OMB_Attach_9_Comments_Summary_5_2012_V_3.0.docx Supplementary Document	2013-01-11
MSM_OMB_Attach_2_Web-based_Screener_and_Q_1_2013_V_4_0.docx Supplementary Document	2013-01-11
MSM_OMB_Supporting Statement_A_1_2013_V_13 0.docx Supporting Statement A	2013-01-11

IC Document Collections

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

ICR Details

OMB Control No: 0925-0669	ICR Reference No: 201208-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Blood Donation Rules Opinion Study (Blood DROPS)
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: 01/25/2013
	Date Received in OIRA: 08/15/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved
Responses	6,884	0	0
Time Burden (Hours)	1,900	0	0
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. 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.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 10756	01/23/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 35408	06/13/2012
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
Aim 2.1 Web-based SCREENER and Questionnaire	1, 1	Web-based Screener
Aim 2.2 Web-based Screener and QUESTIONNAIRE	1, 1	Web-based Survey
Aim 3 Telephone Questionnaire	1

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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	6,884	0	0	6,884	0	0
Annual Time Burden (Hours)	1,900	0	0	1,900	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: $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: 08/15/2012

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