82 FR 130 - Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 1 (January 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 1 (January 3, 2017)
| Page Range | 130-132 | |
| FR Document | 2016-31771 |
[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)] [Notices] [Pages 130-132] From the Federal Register Online [www.thefederalregister.org] [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Administration [Docket No. FDA-2016-D-4308] Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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of a draft document entitled ``Labeling of Red [[Page 131]] Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry.'' The draft guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with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 The draft guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 3, 2017.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: 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 [email protected]. 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
![130 Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
made publicly available, you can section 503B(a) of the FD&C Act are information the outsourcing facility
provide this information on the cover satisfied, a drug compounded by or should submit to FDA, including the
sheet and not in the body of your under the direct supervision of a appropriate format of the NDC code; (2)
comments and you must identify this licensed pharmacist in an outsourcing clarified what information submitted as
information as ‘‘confidential.’’ Any facility is exempt from certain sections part of a product report will be made
information marked as ‘‘confidential’’ of the FD&C Act, including section public; and (3) made grammatical and
will not be disclosed except in 502(f)(1) (21 U.S.C. 352(f)(1)) other minor editorial changes for clarity.
accordance with 21 CFR 10.20 and other (concerning the labeling of drugs with In some cases, comments raised issues
applicable disclosure law. For more adequate directions for use) and section that were not directly pertinent to the
information about FDA’s posting of 505 (21 U.S.C. 355) (concerning the topics addressed in the revised draft
comments to public dockets, see 80 FR approval of human drug products under guidance.
56469, September 18, 2015, or access new drug applications or abbreviated This guidance is being issued
the information at: http://www.fda.gov/ new drug applications). Drugs consistent with FDA’s good guidance
regulatoryinformation/dockets/ compounded in outsourcing facilities practices regulation (21 CFR 10.115).
default.htm. are not exempt from the requirements of The guidance represents the current
Docket: For access to the docket to section 501(a)(2)(B) of the FD&C Act (21 thinking of FDA on ‘‘Electronic Drug
read background documents or the U.S.C. 351(a)(2)(B)) (concerning current Product Reporting for Human Drug
electronic and written/paper comments good manufacturing practice for drugs). Compounding Outsourcing Facilities
received, go to https:// Under section 503B, an outsourcing Under Section 503B of the Federal
www.regulations.gov and insert the facility must, at the time of initial Food, Drug, and Cosmetic Act.’’ It does
docket number, found in brackets in the registration and twice each year, in June not establish any rights for any person
heading of this document, into the and December, submit to FDA a report and is not binding on FDA or the public.
‘‘Search’’ box and follow the prompts identifying the drugs compounded by You can use an alternative approach if
and/or go to the Division of Dockets the facility during the previous 6-month it satisfies the requirements of the
Management, 5630 Fishers Lane, Rm. period. For each identified drug, the applicable statutes and regulations.
1061, Rockville, MD 20852. outsourcing facility must report the
II. Paperwork Reduction Act of 1995
Submit written requests for single following information to FDA for each
copies of this guidance to the Division product that it compounds: This guidance contains collections of
of Drug Information, Center for Drug • The active ingredient and strength information that are subject to review by
Evaluation and Research, Food and of active ingredient per unit; the Office of Management and Budget
Drug Administration, 10001 New • the source of the active ingredient (OMB) under the Paperwork Reduction
Hampshire Ave., Hillandale Building, (bulk or finished drug); Act of 1995 (44 U.S.C. 3501–3520). The
4th Floor, Silver Spring, MD 20993– • the National Drug Code (NDC) collections of information have been
0002. Send one self-addressed adhesive number of the source drug or bulk active approved under OMB control number
label to assist that office in processing ingredient, if available; 0910–0827.
your requests. See the SUPPLEMENTARY • the dosage form and route of
administration; III. Electronic Access
INFORMATION section for electronic
access to the guidance document. • the package description; Persons with access to the Internet
• the number of individual units may obtain the document at either
FOR FURTHER INFORMATION CONTACT: produced; and http://www.fda.gov/Drugs/Guidance
Lysette Deshields, Center for Drug • the NDC number of the final ComplianceRegulatoryInformation/
Evaluation and Research Food and Drug product, if assigned.1 Guidances/default.htm or https://
Administration, 10903 New Hampshire This final guidance explains that www.regulations.gov.
Ave., Silver Spring, MD 20993 301– registered outsourcing facilities must
796–3100. Dated: December 28, 2016.
provide reports to FDA on compounded
Leslie Kux,
SUPPLEMENTARY INFORMATION: drugs in SPL format using FDA’s
electronic submissions system unless Associate Commissioner for Policy.
I. Background [FR Doc. 2016–31789 Filed 12–30–16; 8:45 am]
FDA grants a request for a waiver of
FDA is announcing the availability of such requirement because use of BILLING CODE 4164–01–P
a guidance for industry entitled electronic means is not reasonable for
‘‘Electronic Drug Product Reporting for the person requesting the waiver. It
Human Drug Compounding Outsourcing supersedes the revised draft guidance DEPARTMENT OF HEALTH AND
Facilities Under Section 503B of the entitled ‘‘Electronic Drug Product HUMAN SERVICES
Federal Food, Drug, and Cosmetic Act.’’ Reporting for Human Drug Food and Drug Administration
In the Federal Register of November 24, Compounding Outsourcing Facilities
2014 (79 FR 69857), FDA announced the Under Section 503B of the Federal [Docket No. FDA–2016–D–4308]
availability of a revised draft guidance Food, Drug, and Cosmetic Act.’’
for industry entitled ‘‘Electronic Drug The comment period for the revised Labeling of Red Blood Cell Units With
Product Reporting for Human Drug draft guidance ended on January 23, Historical Antigen Typing Results;
Compounding Outsourcing Facilities 2015. FDA received three comments on Draft Guidance for Industry;
Under Section 503B of the Federal the draft. In response to received Availability
Food, Drug, and Cosmetic Act.’’ On
sradovich on DSK3GMQ082PROD with NOTICES
comments or on its own initiative, FDA AGENCY: Food and Drug Administration,
November 27, 2013, President Obama made the following changes and HHS.
signed the DQSA into law (Pub. L. 113– updates in the final guidance: (1) ACTION: Notice of availability.
54). The DQSA added a new section Clarified FDA’s definition of the source
503B to the FD&C Act (21 U.S.C. 353b). of the active ingredient used to SUMMARY: The Food and Drug
Under section 503B(b), a compounder compound the final product and the Administration (FDA or Agency) is
can register as an outsourcing facility announcing the availability of a draft
with FDA. If the conditions outlined in 1 Section 503B(b)(2)(A)(ii) of the FD&C Act. document entitled ‘‘Labeling of Red
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![Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices 131
Blood Cell Units with Historical manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Antigen Typing Results; Draft Guidance Submissions’’ and ‘‘Instructions’’). read background documents or the
for Industry.’’ The draft guidance electronic and written/paper comments
Written/Paper Submissions
document provides establishments that received, go to http://
collect blood and blood components for Submit written/paper submissions as www.regulations.gov and insert the
transfusion with recommendations for follows: docket number, found in brackets in the
labeling Red Blood Cell (RBC) units • Mail/Hand delivery/Courier (for heading of this document, into the
with non-ABO/Rh(D) antigen typing written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
results obtained from previous Dockets Management (HFA–305), Food and/or go to the Division of Dockets
donations (historical antigen typing and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
results). The draft guidance provides Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
recommendations to transfusion • For written/paper comments Submit comments on information
services for managing RBC units labeled submitted to the Division of Dockets collection issues to the Office of
with historical antigen typing results. Management, FDA will post your Management and Budget in the
comment, as well as any attachments, following ways:
The guidance also provides licensed
except for information submitted, • Fax to the Office of Information and
blood collection establishments that
marked and identified, as confidential, Regulatory Affairs, OMB, Attn: FDA
choose to implement labeling of RBC
if submitted as detailed in Desk Officer, FAX: 202–395–7285, or
units with historical antigen typing
‘‘Instructions.’’ email to oira_ubmission@omb.eop.gov.
results instructions regarding how to Instructions: All submissions received
report the manufacturing and labeling All comments should be identified with
must include the Docket No. [Insert
changes under the biologics regulations. the title, Labeling of Red Blood Cell
docket number xxxxx] for ‘‘Labeling of
The guidance does not apply to test Red Blood Cell Units with Historical Units with Historical Antigen Typing
results for ABO and Rh(D) antigens. Antigen Typing Results; Draft Guidance Results; Draft Guidance for Industry.
DATES: Although you can comment on for Industry.’’ Received comments will Submit written requests for single
any guidance at any time (see 21 CFR be placed in the docket and, except for copies of the draft guidance to the Office
10.115(g)(5)), to ensure that the Agency those submitted as ‘‘Confidential of Communication, Outreach and
considers your comment on this draft Submissions,’’ publicly viewable at Development, Center for Biologics
guidance before it begins work on the http://www.regulations.gov or at the Evaluation and Research (CBER), Food
final version of the guidance, submit Division of Dockets Management and Drug Administration, 10903 New
either electronic or written comments between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 71, Rm. 3128,
on the draft guidance by April 3, 2017. through Friday. Silver Spring, MD 20993–0002. Send
Submit electronic or written comments • Confidential Submissions—To one self-addressed adhesive label to
on the information collection issues submit a comment with confidential assist the office in processing your
under the Paperwork Reduction Act of information that you do not wish to be requests. The draft guidance may also be
1995 by March 6, 2017. made publicly available, submit your obtained by mail by calling CBER at 1–
comments only as a written/paper 800–835–4709 or 240–402–8010. See
ADDRESSES: You may submit comments submission. You should submit two the SUPPLEMENTARY INFORMATION section
as follows: copies total. One copy will include the for electronic access to the draft
Electronic Submissions information you claim to be confidential guidance document.
with a heading or cover note that states FOR FURTHER INFORMATION CONTACT:
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Melissa Segal, Center for Biologics
following way: CONFIDENTIAL INFORMATION.’’ The Evaluation and Research, Food and
• Federal eRulemaking Portal: http:// Agency will review this copy, including Drug Administration, 10903 New
www.regulations.gov. Follow the the claimed confidential information, in Hampshire Ave., Bldg. 71, Rm. 7301,
instructions for submitting comments. its consideration of comments. The Silver Spring, MD 20993–0002, 240–
Comments submitted electronically, second copy, which will have the 402–7911.
including attachments, to http:// claimed confidential information SUPPLEMENTARY INFORMATION:
www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http:// I. Background
comment will be made public, you are www.regulations.gov. Submit both FDA is announcing the availability of
solely responsible for ensuring that your copies to the Division of Dockets a draft document entitled ‘‘Labeling of
comment does not include any Management. If you do not wish your Red Blood Cell Units with Historical
confidential information that you or a name and contact information to be Antigen Typing Results; Draft Guidance
third party may not wish to be posted, made publicly available, you can for Industry.’’ The draft guidance
such as medical information, your or provide this information on the cover document provides establishments that
anyone else’s Social Security number, or sheet and not in the body of your collect blood and blood components for
confidential business information, such comments and you must identify this transfusion with recommendations for
as a manufacturing process. Please note information as ‘‘confidential.’’ Any labeling RBC units with historical
that if you include your name, contact information marked as ‘‘confidential’’ antigen typing results. The guidance
information, or other information that will not be disclosed except in provides recommendations to
identifies you in the body of your accordance with 21 CFR 10.20 and other transfusion services for managing RBC
sradovich on DSK3GMQ082PROD with NOTICES
comments, that information will be applicable disclosure law. For more units labeled with historical antigen
posted on http://www.regulations.gov. information about FDA’s posting of typing results. This guidance also
• If you want to submit a comment comments to public dockets, see 80 FR provides licensed blood collection
with confidential information that you 56469, September 18, 2015, or access establishments that choose to
do not wish to be made available to the the information at: http://www.fda.gov/ implement labeling of RBC units with
public, submit the comment as a regulatoryinformation/dockets/ historical antigen typing results
written/paper submission and in the default.htm. instructions regarding how to report the
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![132 Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices
manufacturing and labeling changes information to a third party. Section previous separate donations were tested
under 21 CFR 601.12. The guidance 3506(c)(2)(A) of the PRA (44 U.S.C. by the collection facility and results of
does not apply to test results for ABO 3506(c)(2)(A)) requires Federal Agencies RBC typing were found to be
and Rh(D) antigens. For ABO and Rh(D) to provide a 60-day notice in the concordant. The standards indicate that
antigens, establishments must follow Federal Register concerning each facilities have the option to put the non-
FDA requirements in 21 CFR 640.5(b), proposed collection of information ABO/Rh(D) historical antigen typing
640.5(c), and 606.121(c)(9) and (13), as before submitting the collection to OMB results on a tie-tag or directly on the
well as all other applicable for approval. To comply with this container label.
requirements. requirement, FDA is publishing notice We believe that facilities have already
At the AABB–FDA Liaison Meeting of the proposed collection of developed standard operating
held on April 12, 2012, AABB stated information set forth in this document. procedures for putting the non-ABO/
that it is the practice of some blood With respect to the following Rh(D) historical antigen typing results
collection establishments to provide collection of information, FDA invites on a tie-tag or directly on the container
historical RBC antigen typing results to comments on these topics: (1) Whether label.
transfusion services using a tie-tag the proposed collection of information The draft guidance also refers to
attached to the RBC unit. AABB asked is necessary for the proper performance previously approved collections of
for recommendations from FDA of FDA’s functions, including whether information found in FDA regulations.
regarding labeling of RBC units with the information will have practical The collections of information in 21
historical RBC antigen typing results. utility; (2) the accuracy of FDA’s CFR 601.12 have been approved under
FDA’s Blood Products Advisory estimate of the burden of the proposed OMB control number 0910–0338; and
Committee discussed this topic on collection of information, including the the collections of information in 21 CFR
December 4, 2012, and supported the validity of the methodology and 606.100, 606.121, 606.160, 606.171 have
concept of using historical RBC antigen assumptions used; (3) ways to enhance been approved under OMB control
typing results to label RBC units. the quality, utility, and clarity of the number 0910–116, 0910–0795 and
AABB has revised its standards to information to be collected; and (4) 0910–0458.
include accommodations for labeling ways to minimize the burden of the
RBC units with historical RBC typing collection of information on III. Electronic Access
results. According to the 30th edition of respondents, including through the use Persons with access to the Internet
the AABB Standards for Blood Banks of automated collection techniques, may obtain the draft guidance at either
and Transfusion Services, RBC units when appropriate, and other forms of http://www.fda.gov/BiologicsBlood
may be labeled as RBC antigen negative information technology. Vaccines/GuidanceCompliance
without testing the current donation if Labeling of Red Blood Cell Units with RegulatoryInformation/Guidances/
two previous separate donations were Historical Antigen Typing Results; Draft default.htm or http://
tested by the collection facility and Guidance for Industry; OMB Control No. www.regulations.gov.
results of RBC typing were found to be 0910–NEW
Dated: December 27, 2016.
concordant. The standards indicate that The draft guidance document
facilities have the option to put the non- provides establishments that collect Leslie Kux,
ABO/Rh(D) historical antigen typing blood and blood components for Associate Commissioner for Policy.
results on a tie-tag or directly on the transfusion with recommendations for [FR Doc. 2016–31771 Filed 12–30–16; 8:45 am]
container label. labeling RBC units with non-ABO/Rh(D) BILLING CODE 4164–01–P
The draft guidance is being issued antigen typing results obtained from
consistent with FDA’s good guidance previous donations (historical antigen
practices regulation (21 CFR 10.115). typing results). The draft guidance DEPARTMENT OF HEALTH AND
The draft guidance, when finalized, will provides recommendations to HUMAN SERVICES
represent the current thinking of FDA transfusion services for managing RBC
on labeling of red blood cell units with units labeled with historical antigen National Institutes of Health
historical antigen typing results. It does typing results. The guidance also
Prospective Grant of Exclusive
not establish any rights for any person provides licensed blood collection
License: Development, Manufacture
and is not binding on FDA or the public. establishments that choose to
and Commercialization of Gene
You can use an alternative approach if implement labeling of RBC units with
Therapy Products for Human Gene
it satisfies the requirements of the historical antigen typing results
Therapy Use To Treat and/or Prevent
applicable statutes and regulations. instructions regarding how to report the
Methylmalonic Acidemia (MMA)
manufacturing and labeling changes
II. Paperwork Reduction Act of 1995
under 21 CFR 601.12. AGENCY: National Institutes of Health
The draft guidance document Description of Respondents: (NIH).
contains information collection Establishments that collect blood and ACTION: Notice.
provisions that are subject to review by blood components for transfusion,
the Office of Management and Budget transfusion services, and licensed blood SUMMARY: The National Human Genome
(OMB) under the Paperwork Reduction collection establishments. Research Institute (NHGRI), an institute
Act of 1995 (the PRA) (44 U.S.C. 3501– Burden Estimate: We believe that the of the National Institutes of Health,
3520). Under the PRA, Federal Agencies information collection provisions in the Department of Health and Human
must obtain approval from OMB for draft guidance do not create a new Services, is contemplating the grant of
sradovich on DSK3GMQ082PROD with NOTICES
each collection of information they burden for respondents and are part of an exclusive commercialization patent
conduct or sponsor. ‘‘Collection of usual and customary business practices. license to practice the inventions
information’’ is defined in 44 U.S.C. According to the 30th edition of the embodied in the Patent Applications
3502(3) and 5 CFR 1320.3(c) and AABB Standards for Blood Banks and listed in the Supplementary Information
includes Agency requests or Transfusion Services, RBC units may be section of this notice License to Selecta
requirements that members of the public labeled as RBC antigen negative without Biosciences (‘‘Selecta’’) located in
submit reports, keep records, or provide testing the current donation if two Watertown, Massachusetts.
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Document Created: 2018-02-01 14:44:27
Document Modified: 2018-02-01 14:44:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 130 |
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