Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification, 89705-89706 [2023-28594]
Download as PDF
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices
compliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28675 Filed 12–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0039]
Electronic Submissions; Update to the
Specifications for Preparing and
Submitting Postmarket Individual Case
Safety Reports for Vaccines; Technical
Specification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) Center
for Biologics Evaluation and Research
(CBER) is announcing the availability of
version 2.3 of the Specifications for
Preparing and Submitting Postmarket
Individual Case Safety Reports (ICSRS)
for Vaccines (Specifications). The
version update is not applicable to
CBER-regulated drug products marketed
for human use with approved New Drug
Applications (NDAs) and Abbreviated
New Drug Applications (ANDAs);
CBER-regulated therapeutic biological
products marketed for human use with
approved Biologic License Applications
(BLAs); Whole Blood or blood
components; and human cells, tissues,
and cellular and tissue-based products
(HCT/Ps) regulated solely under the
Public Health Service Act.
ADDRESSES: You may submit either
electronic or written comments at any
time as follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD 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,
VerDate Sep<11>2014
20:14 Dec 27, 2023
Jkt 262001
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–
2021–N–0039 for ‘‘Electronic
Submissions; Update to the
Specifications for Preparing and
Submitting Postmarket Individual Case
Safety Reports for Vaccines; Technical
Specification’’. 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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
89705
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 laws.
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.
FOR FURTHER INFORMATION CONTACT:
Victoria Wagman, Center for Biologics
Evaluation and Research, Food and
Drug Administration, Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
Background
CBER is announcing the availability
of version 2.3 of the Specifications for
Preparing and Submitting Postmarket
ICSRs for Vaccines (available at https://
www.fda.gov/industry/about-esg/cbervaccine-icsr-implementation). The
version update has been prepared to
provide updated specifications on
submitting re-challenge information, to
correct values for the ‘Vaccination
Facility Type’ (FDA.G.k.4.r.14.8), and to
record modifications to the ‘Attachment
File Name’ (FDA.C.1.6.1.r.3) as well as
various document formatting
refinements. In addition, version 2.3
includes updated business rules
(Appendix I of the Specifications)
which provide details on data field
specifications. The version update is not
applicable to CBER-regulated drug
products marketed for human use with
approved NDAs and ANDAs; CBERregulated therapeutic biological
products marketed for human use with
approved BLAs; Whole Blood or blood
components; and HCT/Ps regulated
solely under section 361 of the Public
Health Service Act (42 U.S.C. 264).
At this time, all existing eVAERS
submitters (vaccine manufacturers and
others responsible for reporting ICSRs
for vaccines) have successfully
transitioned to reporting in version 2.2.
E:\FR\FM\28DEN1.SGM
28DEN1
89706
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices
All eVAERS submitters are expected to
transition from version 2.2 to the
current version 2.3 as soon as possible.
Additional information about
electronically submitting postmarket
individual case safety reports (ICSRs)
for vaccines to VAERS is available at
https://www.fda.gov/industry/aboutesg/cber-vaccine-icsr-implementation.
Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28594 Filed 12–27–23; 8:45 am]
Electronic Submissions
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4177]
Quality Considerations for Topical
Ophthalmic Drug Products; Revised
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 revised
draft guidance for industry entitled
‘‘Quality Considerations for Topical
Ophthalmic Drug Products.’’ This
revised draft guidance discusses certain
quality considerations for ophthalmic
drug products (i.e., gels, ointments,
creams, and liquid formulations such as
solutions, suspensions, and emulsions)
intended for topical delivery in and
around the eye. Specifically, this
revised draft guidance discusses
microbiological considerations;
approaches to evaluating visible
particulate matter, extractables and
leachables, and impurities and
degradation products; use of in vitro
drug release/dissolution testing as an
optional quality control strategy for
certain ophthalmic dosage forms;
recommendations for design and
delivery and dispensing features of
container closure systems; and
recommendations for stability studies.
The revised draft guidance applies to
marketed products including
ophthalmic drug products approved
under new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), and biologics license
applications (BLAs), as well as to overthe-counter (OTC) monograph drugs,
drugs compounded by outsourcing
facilities, and the drug or biological
product constituent part of a
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:14 Dec 27, 2023
Jkt 262001
combination product. This guidance
revises the draft guidance for industry of
the same name issued in October 2023.
DATES: Submit either electronic or
written comments on the revised draft
guidance by February 26, 2024 to ensure
that the Agency considers your
comment on this revised 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:
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–
2023–D–4177 for ‘‘Quality
Considerations for Topical Ophthalmic
Drug Products.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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 revised draft 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 revised draft guidance
document.
E:\FR\FM\28DEN1.SGM
28DEN1
Agencies
[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Notices]
[Pages 89705-89706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28594]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0039]
Electronic Submissions; Update to the Specifications for
Preparing and Submitting Postmarket Individual Case Safety Reports for
Vaccines; Technical Specification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) Center for
Biologics Evaluation and Research (CBER) is announcing the availability
of version 2.3 of the Specifications for Preparing and Submitting
Postmarket Individual Case Safety Reports (ICSRS) for Vaccines
(Specifications). The version update is not applicable to CBER-
regulated drug products marketed for human use with approved New Drug
Applications (NDAs) and Abbreviated New Drug Applications (ANDAs);
CBER-regulated therapeutic biological products marketed for human use
with approved Biologic License Applications (BLAs); Whole Blood or
blood components; and human cells, tissues, and cellular and tissue-
based products (HCT/Ps) regulated solely under the Public Health
Service Act.
ADDRESSES: You may submit either electronic or written comments 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-2021-N-0039 for ``Electronic Submissions; Update to the
Specifications for Preparing and Submitting Postmarket Individual Case
Safety Reports for Vaccines; Technical Specification''. 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 laws. 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.
FOR FURTHER INFORMATION CONTACT: Victoria Wagman, Center for Biologics
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
Background
CBER is announcing the availability of version 2.3 of the
Specifications for Preparing and Submitting Postmarket ICSRs for
Vaccines (available at https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation). The version update has been prepared to
provide updated specifications on submitting re-challenge information,
to correct values for the `Vaccination Facility Type'
(FDA.G.k.4.r.14.8), and to record modifications to the `Attachment File
Name' (FDA.C.1.6.1.r.3) as well as various document formatting
refinements. In addition, version 2.3 includes updated business rules
(Appendix I of the Specifications) which provide details on data field
specifications. The version update is not applicable to CBER-regulated
drug products marketed for human use with approved NDAs and ANDAs;
CBER-regulated therapeutic biological products marketed for human use
with approved BLAs; Whole Blood or blood components; and HCT/Ps
regulated solely under section 361 of the Public Health Service Act (42
U.S.C. 264).
At this time, all existing eVAERS submitters (vaccine manufacturers
and others responsible for reporting ICSRs for vaccines) have
successfully transitioned to reporting in version 2.2.
[[Page 89706]]
All eVAERS submitters are expected to transition from version 2.2 to
the current version 2.3 as soon as possible.
Additional information about electronically submitting postmarket
individual case safety reports (ICSRs) for vaccines to VAERS is
available at https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation.
Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28594 Filed 12-27-23; 8:45 am]
BILLING CODE 4164-01-P