Document ID: FDA-2016-D-4308-0020
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Draft Guidance for
Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing
Results
Posted Date: 2018-10-22T04:00Z

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53275-53276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22959]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4308]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry: Labeling of Red Blood Cell Units With Historical Antigen 
Typing Results

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, or Agency) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 21, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Draft Guidance for Industry: Labeling of Red Blood Cell Units 
with Historical Antigen Typing Results.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Labeling of Red Blood Cell Units With Historical Antigen Typing 
Results, OMB Control Number 0910-NEW

    The draft guidance document provides establishments that collect 
blood and blood components for transfusion with recommendations for 
labeling RBC units with non-ABO/Rh(D) antigen typing results obtained 
from previous donations (historical antigen typing results). The draft 
guidance provides recommendations to transfusion services for managing 
RBC units labeled with historical antigen typing results. The guidance 
also provides licensed blood collection establishments that choose to 
implement labeling of RBC units with historical antigen typing results 
instructions regarding how to report the manufacturing and labeling 
changes under 21 CFR 601.12.
    Description of Respondents: Establishments that collect blood and 
blood components intended for transfusion.
    Burden Estimate: We believe that the information collection 
provisions in the draft guidance do not create a new burden for 
respondents and are part of usual and customary business practices. 
According to the 30th edition of the AABB Standards for Blood Banks and 
Transfusion Services, RBC units may be labeled as RBC antigen negative 
without testing the current donation if two previous separate donations 
were tested by the collection facility and results of RBC typing were 
found to be concordant. The standards indicate that facilities have the 
option to put the non-ABO/Rh(D) historical antigen typing results on a 
tie-tag or directly on the container label.
    The guidance also recommends establishments that collect blood and 
blood components for transfusion should convey to transfusion services 
the practices for repeating historical RBC typing results on current 
donations and for labeling RBC units with historical RBC antigen typing 
results.
    We believe that collection establishments have already developed 
standard operating procedures 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.
    In the Federal Register of January 3, 2017 (82 FR 130), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received six comments on the guidance; 
however, no comments were related to the collection of information.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR 601.12 have been approved under OMB control number 0910-0338; 
and the collections of information in 21 CFR

[[Page 53276]]

part 606 have been approved under OMB control number 0910-116.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22959 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P