Recommendations to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components

ICR 202006-0910-011

OMB: 0910-0681

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-06-23
IC Document Collections
ICR Details
0910-0681 202006-0910-011
Active 201811-0910-003
HHS/FDA CBER
Recommendations to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components
Revision of a currently approved collection   No
Regular
Approved without change 07/27/2020
Retrieve Notice of Action (NOA) 06/23/2020
  Inventory as of this Action Requested Previously Approved
07/31/2023 36 Months From Approved 07/31/2020
1 0 1
1 0 1
0 0 0

The information collection supports agency guidance documents. The guidance documents include recommendations regarding notification practices that are intended to reduce the transmission of infection in whole blood and blood components. Although we believe such notification practices are usual and customary, we have developed Relevant Transfusion-Transmitted Infection specific guidance documents consistent with 21 CFR 630.3.

US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act
   US Code: 42 USC 262 Name of Law: PHS Act
  
None

Not associated with rulemaking

  85 FR 716 01/07/2020
85 FR 18983 04/03/2020
No

1
IC Title Form No. Form Name
Reducing Risk of Relevant Transfusion-Transmitted Infection

  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 1 1 0 0 0 0
Annual Time Burden (Hours) 1 1 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
Yes
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
06/23/2020


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