Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry; Availability, 83886-83887 [2024-24098]
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Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
TAVIST (clemastine fumarate) tablet,
2.68 mg, is the subject of NDA 017661,
held by Novartis Pharmaceuticals Corp.
and initially approved on February 25,
1977. TAVIST (clemastine fumarate)
tablet, 2.68 mg, is indicated for the relief
of symptoms associated with allergic
rhinitis such as sneezing, rhinorrhea,
pruritus, and lacrimation. It is also
indicated for the relief of mild,
uncomplicated allergic skin
manifestations of urticaria and
angioedema.
TAVIST (clemastine fumarate) tablet,
2.68 mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In a letter
dated February 13, 2004, Novartis
Consumer Health, Inc., requested
withdrawal of NDA 017661 for TAVIST
(clemastine fumarate). In the Federal
Register of March 4, 2005 (70 FR
10651), FDA announced that it was
withdrawing approval of NDA 017661,
effective April 4, 2005.
Pharmobedient Consulting, LLC,
submitted a citizen petition dated
February 21, 2024 (Docket No. FDA–
2024–P–0761), under 21 CFR 10.30,
requesting that the Agency determine
whether TAVIST (clemastine fumarate)
tablet, 2.68 mg, was withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that TAVIST (clemastine
fumarate) tablet, 2.68 mg, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that TAVIST (clemastine
fumarate) tablet, 2.68 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of TAVIST
(clemastine fumarate) tablet, 2.68 mg,
from sale. We have also independently
VerDate Sep<11>2014
16:48 Oct 17, 2024
Jkt 265001
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list TAVIST (clemastine
fumarate) tablet, 2.68 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24103 Filed 10–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–2732]
Recommendations for the
Development of Blood Collection,
Processing, and Storage Systems for
the Manufacture of Blood Components
Using the Buffy Coat Method; 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 ‘‘Recommendations
for the Development of Blood
Collection, Processing, and Storage
Systems for the Manufacture of Blood
Components Using the Buffy Coat
Method.’’ The draft guidance document
provides recommendations on the
development of blood collection,
processing, and storage systems (e.g.,
blood bags with anticoagulant and
additive solutions, empty bags for
platelet pooling) used for the
manufacture of blood and blood
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
components intended for transfusion
using the buffy coat (BC) method. This
guidance is intended for manufacturers
of blood collection, processing, and
storage systems.
DATES: Submit either electronic or
written comments on the draft guidance
by December 17, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance 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–
2024–D–2732 for ‘‘Recommendations
for the Development of Blood
Collection, Processing, and Storage
Systems for the Manufacture of Blood
Components Using the Buffy Coat
E:\FR\FM\18OCN1.SGM
18OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices
Method.’’ 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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 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
VerDate Sep<11>2014
16:48 Oct 17, 2024
Jkt 265001
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
‘‘Recommendations for the
Development of Blood Collection,
Processing, and Storage Systems for the
Manufacture of Blood Components
Using the Buffy Coat Method.’’ This
guidance provides recommendations on
the development of blood collection,
processing, and storage systems (e.g.,
blood bags with anticoagulant and
additive solutions, empty bags for
platelet pooling) used for the
manufacture of blood and blood
components intended for transfusion
using the BC method. This guidance is
intended for manufacturers of blood
collection, processing, and storage
systems.
Blood and blood components must be
prepared in a manner consistent with
the instructions provided by the
manufacturer (21 CFR 606.65(e)),
including the directions provided in the
instructions for use of the approved or
cleared collection, processing, and
storage system. To prepare blood
components using the BC method, blood
establishments must use blood
collection, processing and storage
systems approved or cleared for such
use. However, blood collection,
processing, and storage systems
currently marketed in the United States
are only approved or cleared for the
preparation of blood components from
Whole Blood (WB) using the platelet
rich plasma method, and none are yet
approved or cleared for the preparation
of blood components using the BC
method.
This guidance provides
recommendations to manufacturers who
wish to obtain FDA approval or
clearance to market blood collection,
processing, and storage systems
intended for the manufacture of blood
components using the BC method. With
the availability of such systems, blood
establishments in the United States
would have the option of manufacturing
WB-derived blood components using
the BC method.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
83887
This 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 ‘‘Recommendations for the
Development of Blood Collection,
Processing, and Storage Systems for the
Manufacture of Blood Components
Using the Buffy Coat Method.’’ 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
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 11, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24098 Filed 10–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2061]
Review of Drug Master Files in
Advance of Certain Abbreviated New
Drug Application Submissions Under
Generic Drug User Fee Amendments;
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 final
guidance for industry entitled ‘‘Review
of Drug Master Files in Advance of
Certain ANDA Submissions Under
GDUFA.’’ This guidance provides
information and recommendations on
the Generic Drug User Fee Amendments
(GDUFA) III program enhancements
agreed upon by the Agency and industry
in ‘‘GDUFA Reauthorization
SUMMARY:
E:\FR\FM\18OCN1.SGM
18OCN1
]]>Agencies
[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83886-83887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-2732]
Recommendations for the Development of Blood Collection,
Processing, and Storage Systems for the Manufacture of Blood Components
Using the Buffy Coat Method; 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 ``Recommendations for the
Development of Blood Collection, Processing, and Storage Systems for
the Manufacture of Blood Components Using the Buffy Coat Method.'' The
draft guidance document provides recommendations on the development of
blood collection, processing, and storage systems (e.g., blood bags
with anticoagulant and additive solutions, empty bags for platelet
pooling) used for the manufacture of blood and blood components
intended for transfusion using the buffy coat (BC) method. This
guidance is intended for manufacturers of blood collection, processing,
and storage systems.
DATES: Submit either electronic or written comments on the draft
guidance by December 17, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2024-D-2732 for ``Recommendations for the Development of Blood
Collection, Processing, and Storage Systems for the Manufacture of
Blood Components Using the Buffy Coat
[[Page 83887]]
Method.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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 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
``Recommendations for the Development of Blood Collection, Processing,
and Storage Systems for the Manufacture of Blood Components Using the
Buffy Coat Method.'' This guidance provides recommendations on the
development of blood collection, processing, and storage systems (e.g.,
blood bags with anticoagulant and additive solutions, empty bags for
platelet pooling) used for the manufacture of blood and blood
components intended for transfusion using the BC method. This guidance
is intended for manufacturers of blood collection, processing, and
storage systems.
Blood and blood components must be prepared in a manner consistent
with the instructions provided by the manufacturer (21 CFR 606.65(e)),
including the directions provided in the instructions for use of the
approved or cleared collection, processing, and storage system. To
prepare blood components using the BC method, blood establishments must
use blood collection, processing and storage systems approved or
cleared for such use. However, blood collection, processing, and
storage systems currently marketed in the United States are only
approved or cleared for the preparation of blood components from Whole
Blood (WB) using the platelet rich plasma method, and none are yet
approved or cleared for the preparation of blood components using the
BC method.
This guidance provides recommendations to manufacturers who wish to
obtain FDA approval or clearance to market blood collection,
processing, and storage systems intended for the manufacture of blood
components using the BC method. With the availability of such systems,
blood establishments in the United States would have the option of
manufacturing WB-derived blood components using the BC method.
This 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
``Recommendations for the Development of Blood Collection, Processing,
and Storage Systems for the Manufacture of Blood Components Using the
Buffy Coat Method.'' 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
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: October 11, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24098 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P
