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OMB Control No: 0910-0841	ICR Reference No: 201612-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute - Sponsored Transfusion-Transmissible Infections Monitoring System - Risk Factor Elicitation
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: 07/12/2017
	Date Received in OIRA: 01/18/2017
Terms of Clearance: OMB encourages FDA to monitor breakoff closely to help ensure adequate data quality.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved
Responses	600	0	0
Time Burden (Hours)	450	0	0
Cost Burden (Dollars)	0	0	0

Abstract: FDA intends to interview blood donors to collect risk factor information associated with testing positive for transfusion-transmissible infections (TTI). This collection of information is part of a larger initiative called Transfusion-Transmissible Infections Monitoring System (TTIMS), which is a collaborative project funded by FDA, the NHLBI of the National Institutes of Health (NIH), and the Department of Health and Human Services (HHS) Office of the Assistant Secretary of Health with input from other agencies in HHS including the Centers for Disease Control and Prevention (CDC). FDA will use these scientific data collected through such interview-based risk factor elicitation of blood donors to monitor and help ensure the safety of the United States blood supply. FDA issued a document entitled ‘‘Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, Guidance for Industry’’ dated December 2015, which changed the blood donor criterion for men who have sex with men (MSM) from an indefinite (permanent) deferral to a 12-month deferral since last MSM contact. The impact of this change in the deferral criteria requires a national monitoring effort as part of TTIMS to assess if the relative proportions of risk factors for infection in blood donors have changed following the adoption of the 12-month donor deferral for MSM. TTIMS will use similar procedures as the ones used in previous OMB approved information collection “Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance” (OMB control number 0925-0630) to monitor and evaluate risk factors among human immunodeficiency virus (HIV)-positive donors and recently Hepatitis C virus (HCV) or Hepatitis B virus (HBV) infected donors as well as controls. The study will help identify the specific risk factors for TTI and their prevalence in blood donors, and help inform FDA on the proportion of incident (new) infections among all HIV positive blood donors. Donations with incident infections have the greatest potential transmission risk because they could be missed during routine blood screening. The study will help FDA evaluate the effectiveness of screening strategies in reducing the risk of HIV transmission from at-risk donors and to evaluate if there are unexpected consequences associated with the recent change in donor deferral policy such as an increase in HIV incidence among donors. These data also will inform FDA regarding future blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments, and to inform the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options.

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 67358	09/30/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 89949	12/13/2016
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Cases and Controls

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	600	600
Annual Time Burden (Hours)	450	450
Annual Cost Burden (Dollars)	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.

Annual Cost to Federal Government: $846,597

Does this IC contain surveys, censuses, or employ statistical methods? No

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

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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