Blood Donation Rules Opinion Study (Blood DROPS)

ICR 201309-0925-007

OMB: 0925-0669

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2013-09-23
Supplementary Document
2013-01-18
Supplementary Document
2013-01-18
Supplementary Document
2012-08-15
ICR Details
0925-0669 201309-0925-007
Historical Active 201208-0925-001
HHS/NIH 20587
Blood Donation Rules Opinion Study (Blood DROPS)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/30/2013
Retrieve Notice of Action (NOA) 09/30/2013
  Inventory as of this Action Requested Previously Approved
01/31/2014 01/31/2014 01/31/2014
6,904 0 6,884
1,920 0 1,900
0 0 0

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.

US Code: 42 USC 285b Name of Law: NHLBI Legislative Authority
  
None

Not associated with rulemaking

Yes

  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
No
No
Seeking approval to increase the number of Aim 3 telephone interview respondents from 20 to 40.

$380,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Saleda Perryman

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/30/2013


© 2024 OMB.report | Privacy Policy