Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components; Agency Guidance

ICR 201811-0910-003

OMB: 0910-0681

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2018-12-05
Supplementary Document
2018-12-05
Supplementary Document
2018-12-05
Supplementary Document
2018-12-05
Supplementary Document
2018-12-05
Supplementary Document
2018-12-05
Supplementary Document
2018-12-05
Supporting Statement A
2017-04-18
ICR Details
0910-0681 201811-0910-003
Historical Active 201704-0910-004
HHS/FDA CBER
Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components; Agency Guidance
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/07/2018
Retrieve Notice of Action (NOA) 12/06/2018
  Inventory as of this Action Requested Previously Approved
06/30/2020 06/30/2020 06/30/2020
1 0 1
1 0 1
0 0 0

The information collection supports agency guidance. The guidance document implements the donor screening recommendations for the FDA - approved serological test systems for the detection of antibodies to T. cruzi. The use of the donor screening tests are to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of Whole Blood and blood components intended for transfusion.

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

  81 FR 78170 11/07/2016
82 FR 19062 04/25/2017
No

  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
Uncollected
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.
12/06/2018


© 2024 OMB.report | Privacy Policy