Document ID: FDA-2016-D-4308-0021
Agency: fda
Document Type: Notice
Title: Labeling of Red Blood Cell Units With Historical Antigen Typing Results;
Guidance for Industry; Availability
Posted Date: 2018-12-21T05:00Z

[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65689-65690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27654]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Labeling of Red Blood Cell Units With Historical Antigen Typing 
Results; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Labeling of Red Blood 
Cell Units with Historical Antigen Typing Results; Guidance for 
Industry.'' The guidance document provides establishments that collect 
blood and blood components for transfusion with recommendations for 
labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing 
results obtained from previous donations (historical antigen typing 
results). The guidance provides recommendations to transfusion services 
for managing RBC units labeled with historical antigen typing results. 
The guidance also provides licensed blood 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 the biologics regulations. The guidance does not apply to 
test results for ABO and Rh(D) antigens. The guidance announced in this 
notice finalizes the draft guidance of the same title dated January 
2017.

DATES: The announcement of the guidance is published in the Federal 
Register on December 21, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA 2016-D-4308 for ``Labeling of Red Blood Cell Units with Historical 
Antigen Typing Results; Guidance for Industry.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

[[Page 65690]]

I. Background

    FDA is announcing the availability of a document entitled 
``Labeling of Red Blood Cell Units with Historical Antigen Typing 
Results; Guidance for Industry.'' The guidance document provides 
establishments that collect blood and blood components for transfusion 
with recommendations for labeling RBC units with historical antigen 
typing results. The guidance provides recommendations to transfusion 
services for managing RBC units labeled with historical antigen typing 
results. This guidance also provides licensed blood 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. The guidance does not apply 
to test results for ABO and Rh(D) antigens. For ABO and Rh(D) antigens, 
establishments must follow FDA requirements in 21 CFR 640.5(b) and (c), 
and 606.121(c)(9) and (13), as well as all other applicable 
requirements.
    FDA's Blood Products Advisory Committee discussed this topic on 
December 4, 2012, and supported the concept of using historical RBC 
antigen typing results to label RBC units. AABB has revised its 
standards to include accommodations for labeling RBC units with 
historical RBC typing results. 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.
    In the Federal Register of January 3, 2017 (82 FR 130), FDA 
announced the availability of the draft guidance of the same title 
dated January 2017. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated January 
2017.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on labeling of red blood cell units with 
historical antigen typing results. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The guidance 
refers to the collections of information for putting the non-ABO/Rh(D) 
historical antigen typing results on a tie-tag or directly on the 
container label. These collections of information have been approved 
under OMB control number 0910-0862. The guidance also refers to 
previously approved collections of information found in FDA 
regulations. The collections of information in 21 CFR part 601 and Form 
FDA 356h have been approved under OMB control number 0910-0338; and the 
collections of information in 21 CFR part 606 have been approved under 
OMB control number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27654 Filed 12-20-18; 8:45 am]
 BILLING CODE 4164-01-P