Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute - Sponsored Transfusion-Transmissible Infections Monitoring System - Risk Factor Elicitation

Forms and Documents

Document Name	Status
Protocol - TTIMS.pdf Supplementary Document	2020-07-16
Cert of Confidentiality - TTIMS.pdf Supplementary Document	2020-07-16
0841Supporting Statement Part B 2020 - TTIMS.docx Supporting Statement B	2020-07-16
0841 Supporting Statement Part A 2020.docx Supporting Statement A	2020-07-16

IC Document Collections

IC ID	Document Title	Status
224801	Cases and Controls Other-Survey	Modified

ICR Details

OMB Control No: 0910-0841	ICR Reference No: 202007-0910-008
Status: Active	Previous ICR Reference No: 201612-0910-007
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/24/2020
	Date Received in OIRA: 07/17/2020
Terms of Clearance: Previous terms continue: OMB encourages FDA to monitor breakoff closely to help ensure adequate data quality.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	600	0	600
Time Burden (Hours)	300	0	450
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): None

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:
	85 FR 922	01/08/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 42001	07/13/2020
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Cases and Controls

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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	600	600	0	0	0	0
Annual Time Burden (Hours)	300	450	0	0	-150	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: FDA has adjusted our burden estimate, which has resulted in a decrease to the currently approved burden of 300 hours. Based on experience with this survey, we decreased the average burden per response from 45 to 30 minutes resulting in a change from the previous 450 hours to 300 total hours which is a decrease of 150 hours. We also made several changes to the questionnaire, described in section 1 of this supporting statement.

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Annual Cost to Federal Government: $846,597

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? Yes

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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: 07/17/2020

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