Document ID: FDA-2016-D-4308-0001
Agency: fda
Document Type: Notice
Title: Labeling of Red Blood Cell Units With Historical Antigen Typing Results;
Draft Guidance for Industry; Availability
Posted Date: 2017-01-03T05:00Z

[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 130-132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31771]

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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Results; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Labeling of Red

[[Page 131]]

Blood Cell Units with Historical Antigen Typing Results; Draft Guidance 
for Industry.'' The draft guidance document provides establishments 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 The draft guidance provides 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 the biologics regulations. The guidance does not apply to 
test results for ABO and Rh(D) antigens.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 3, 2017. Submit electronic or written comments on the 
information collection issues under the Paperwork Reduction Act of 1995 
by March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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. 
[Insert docket number xxxxx] for ``Labeling of Red Blood Cell Units 
with Historical Antigen Typing Results; Draft Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of 
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
oira_ubmission@omb.eop.gov. All comments should be identified with the 
title, Labeling of Red Blood Cell Units with Historical Antigen Typing 
Results; Draft Guidance for Industry.
    Submit written requests for single copies of the draft 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 draft 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 draft 
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: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Labeling of Red Blood Cell Units with Historical Antigen Typing 
Results; Draft Guidance for Industry.'' The draft 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 
collection establishments that choose to implement labeling of RBC 
units with historical antigen typing results instructions regarding how 
to report the

[[Page 132]]

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), 640.5(c), and 606.121(c)(9) and (13), as well as all other 
applicable requirements.
    At the AABB-FDA Liaison Meeting held on April 12, 2012, AABB stated 
that it is the practice of some blood collection establishments to 
provide historical RBC antigen typing results to transfusion services 
using a tie-tag attached to the RBC unit. AABB asked for 
recommendations from FDA regarding labeling of RBC units with 
historical RBC antigen typing results. 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.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.

II. Paperwork Reduction Act of 1995

    The draft guidance document contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval 
from OMB for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Labeling of Red Blood Cell Units with Historical Antigen Typing 
Results; Draft Guidance for Industry; OMB Control No. 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 for transfusion, transfusion services, and licensed 
blood collection establishments.
    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.
    We believe that facilities have already developed standard 
operating procedures for putting the non-ABO/Rh(D) historical antigen 
typing results on a tie-tag or directly on the container label.
    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 606.100, 606.121, 606.160, 
606.171 have been approved under OMB control number 0910-116, 0910-0795 
and 0910-0458.

III. Electronic Access

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

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31771 Filed 12-30-16; 8:45 am]
 BILLING CODE 4164-01-P