Labeling of Red Blood Cell Units with Historical Antigen Typing Results

ICR 201810-0910-010

OMB: 0910-0862

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
233624
New
ICR Details
0910-0862 201810-0910-010
Active
HHS/FDA CBER
Labeling of Red Blood Cell Units with Historical Antigen Typing Results
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 11/26/2018
Retrieve Notice of Action (NOA) 10/23/2018
  Inventory as of this Action Requested Previously Approved
11/30/2021 36 Months From Approved
1 0 0
1 0 0
0 0 0

The information collection provisions found in the guidance include FDA recommendations for including the non-ABO/Rh(D) historical antigen typing results on a tie-tag or directly on the container label, and for conveying any change in their antigen typing or labeling practices to their consignees, including practices for repeating historical RBC typing results on current donations and for labeling RBC units with historical RBC antigen typing results.

US Code: 42 USC 262 Name of Law: null
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 130 01/03/2017
83 FR 53275 10/22/2018
No

1
IC Title Form No. Form Name
Historical Antigen Typing Results

  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 0 0 1 0 0
Annual Time Burden (Hours) 1 0 0 1 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Agency guidance being issued that discusses implementation of labeling provisions for certain blood/biologics under existing FDA regulations.

$0
No
    No
    No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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.
10/23/2018


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