Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability, 130-132 [2016-31771]
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130
Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
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.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 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Lysette Deshields, Center for Drug
Evaluation and Research Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993 301–
796–3100.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
In the Federal Register of November 24,
2014 (79 FR 69857), FDA announced the
availability of a revised draft guidance
for industry entitled ‘‘Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ On
November 27, 2013, President Obama
signed the DQSA into law (Pub. L. 113–
54). The DQSA added a new section
503B to the FD&C Act (21 U.S.C. 353b).
Under section 503B(b), a compounder
can register as an outsourcing facility
with FDA. If the conditions outlined in
VerDate Sep<11>2014
22:14 Dec 30, 2016
Jkt 241001
section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or
under the direct supervision of a
licensed pharmacist in an outsourcing
facility is exempt from certain sections
of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use) and section
505 (21 U.S.C. 355) (concerning the
approval of human drug products under
new drug applications or abbreviated
new drug applications). Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
Under section 503B, an outsourcing
facility must, at the time of initial
registration and twice each year, in June
and December, submit to FDA a report
identifying the drugs compounded by
the facility during the previous 6-month
period. For each identified drug, the
outsourcing facility must report the
following information to FDA for each
product that it compounds:
• The active ingredient and strength
of active ingredient per unit;
• the source of the active ingredient
(bulk or finished drug);
• the National Drug Code (NDC)
number of the source drug or bulk active
ingredient, if available;
• the dosage form and route of
administration;
• the package description;
• the number of individual units
produced; and
• the NDC number of the final
product, if assigned.1
This final guidance explains that
registered outsourcing facilities must
provide reports to FDA on compounded
drugs in SPL format using FDA’s
electronic submissions system unless
FDA grants a request for a waiver of
such requirement because use of
electronic means is not reasonable for
the person requesting the waiver. It
supersedes the revised draft guidance
entitled ‘‘Electronic Drug Product
Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
The comment period for the revised
draft guidance ended on January 23,
2015. FDA received three comments on
the draft. In response to received
comments or on its own initiative, FDA
made the following changes and
updates in the final guidance: (1)
Clarified FDA’s definition of the source
of the active ingredient used to
compound the final product and the
1 Section
PO 00000
503B(b)(2)(A)(ii) of the FD&C Act.
Frm 00049
Fmt 4703
Sfmt 4703
information the outsourcing facility
should submit to FDA, including the
appropriate format of the NDC code; (2)
clarified what information submitted as
part of a product report will be made
public; and (3) made grammatical and
other minor editorial changes for clarity.
In some cases, comments raised issues
that were not directly pertinent to the
topics addressed in the revised draft
guidance.
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 ‘‘Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ 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
This guidance contains collections of
information 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
collections of information have been
approved under OMB control number
0910–0827.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31789 Filed 12–30–16; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Labeling of Red
SUMMARY:
E:\FR\FM\03JAN1.SGM
03JAN1
Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
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.
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.
DATES:
ADDRESSES:
You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
22:14 Dec 30, 2016
Jkt 241001
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
https://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 https://
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: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
131
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 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
E:\FR\FM\03JAN1.SGM
03JAN1
132
Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 nonABO/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
VerDate Sep<11>2014
22:14 Dec 30, 2016
Jkt 241001
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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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 nonABO/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
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development, Manufacture
and Commercialization of Gene
Therapy Products for Human Gene
Therapy Use To Treat and/or Prevent
Methylmalonic Acidemia (MMA)
AGENCY:
National Institutes of Health
(NIH).
ACTION:
Notice.
The National Human Genome
Research Institute (NHGRI), an institute
of the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive commercialization patent
license to practice the inventions
embodied in the Patent Applications
listed in the Supplementary Information
section of this notice License to Selecta
Biosciences (‘‘Selecta’’) located in
Watertown, Massachusetts.
SUMMARY:
E:\FR\FM\03JAN1.SGM
03JAN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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): 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 https://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 https://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: https://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 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 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 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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