Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model; Clarification to Food and Drug Administration Data Standards, 12951-12952 [2021-04609]
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Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
Application No.
Drug
ANDA 090732 ........
ANDA 203161 ........
Anastrozole Tablets, 1 mg .....................................................
Irbesartan Tablets, 75 mg, 150 mg, and 300 mg ..................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 5, 2021.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on April 5, 2021 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04520 Filed 3–4–21; 8:45 am]
BILLING CODE 4164–01–P
Do.
Do.
Consortium (CDISC) Study Data
Tabulation Model (SDTM) and the dates
when such new standard and version
update will be required in certain
submissions. The Agency will update
the FDA Data Standards Catalog
(Catalog) to reflect these changes. An
additional note is added to the Catalog
clarifying the requirements for the
submission of a simplified trial
summary dataset to determine a study
start date at the point of submission at
the electronic gateway.
Support for version 1.1 of the
CDISC SENDIG–DART and version 1.6
of the CDISC SDTM will begin on March
15, 2021. The requirement for electronic
submissions to be submitted using
version 1.1 of the CDISC SENDIG–DART
will begin March 15, 2023, for new drug
applications (NDAs), abbreviated new
drug applications (ANDAs), and certain
biologics license applications (BLAs),
and March 15, 2024, for certain
investigational new drug applications
(INDs). The requirement for electronic
submissions to be submitted using
version 1.6 of the CDISC SDTM will
begin on March 15, 2022.
DATES:
ADDRESSES:
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2020–N–2354]
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
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is announcing the date that
support will begin for version 1.1 of the
Clinical Data Interchange Standards
Consortium (CDISC) Standard for
Exchange of Nonclinical Data
Developmental and Reproductive
Toxicology Implementation Guide
(SENDIG–DART) and version 1.6 of the
Clinical Data Interchange Standards
SUMMARY:
VerDate Sep<11>2014
20:30 Mar 04, 2021
Jkt 253001
You may submit comments
as follows.
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
Applicant
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Data Standards; Requirement Begins
for the Clinical Data Interchange
Standards Consortium Version 1.1 of
the Standard for Exchange of
Nonclinical Data Developmental and
Reproductive Toxicology
Implementation Guide and Version 1.6
of the Study Data Tabulation Model;
Clarification to Food and Drug
Administration Data Standards
PO 00000
Frm 00052
12951
Fmt 4703
Sfmt 4703
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–
2020–N–235 for ‘‘Data Standards;
Requirements Begin for the Clinical
Data Interchange Standards Consortium
Version 1.1 of the Standard for
Exchange of Nonclinical Data
Developmental and Reproductive
Toxicology Implementation Guide and
Version 1.6 of the Study Data
Tabulation Model. Clarification to the
FDA Data Standards Catalog.’’ 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
E:\FR\FM\05MRN1.SGM
05MRN1
jbell on DSKJLSW7X2PROD with NOTICES
12952
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
‘‘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.
FOR FURTHER INFORMATION CONTACT:
Bryan Spells, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1117, Silver Spring,
MD 20993–0002, 240–402–6511, email:
cderdatastandards@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA’s
CDER is issuing this Federal Register
notice to announce the date that support
will begin for version 1.1 of the CDISC
SENDIG–DART and version 1.6 of the
CDISC SDTM and the dates when such
new standard and version update will
be required in certain submissions. The
FDA guidance for industry ‘‘Providing
Regulatory Submissions in Electronic
Format—Standardized Study Data’’
(October 2020) (eStudy Data guidance),
posted on FDA’s Study Data Standards
Resources web page at https://
www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm, implements the electronic
submission requirements of section
745A(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379k–1(a)) for
study data contained in NDAs, ANDAs,
certain BLAs, and certain INDs
submitted to CDER or the Center for
Biologics Evaluation and Research by
specifying the format for electronic
submissions. The eStudy Data guidance
states that a Federal Register notice will
specify any new standards and version
updates to FDA-supported study data
standards that will be added to the
Catalog, when the support for such
standards and version updates begins or
ends, and when the requirement to use
such standards and version updates in
submissions begins or ends.
Support for version 1.1 of the CDISC
SENDIG–DART and version 1.6 of the
CDISC SDTM will begin on March 15,
2021, the transition date. The
requirement for electronic submissions
VerDate Sep<11>2014
20:30 Mar 04, 2021
Jkt 253001
to be submitted using version 1.1 of the
CDISC SENDIG–DART will begin March
15, 2023, for NDAs, ANDAs and certain
BLAs, and March 15, 2024, for certain
INDs. The requirement for electronic
submissions to be submitted using
version 1.6 of the CDISC SDTM will
begin on March 15, 2022.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04609 Filed 3–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0180]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Quantitative Data
on Tobacco Products and
Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the generic
clearance for the collection of
quantitative data on tobacco products
and communications.
DATES: Submit either electronic or
written comments on the collection of
information by May 4, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 4, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 4, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
acceptance receipt is on or before that
date.
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–
2018–N–0180 for ‘‘Generic Clearance for
the Collection of Quantitative Data on
Tobacco Products and
Communications.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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
E:\FR\FM\05MRN1.SGM
05MRN1
Agencies
[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12951-12952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2354]
Data Standards; Requirement Begins for the Clinical Data
Interchange Standards Consortium Version 1.1 of the Standard for
Exchange of Nonclinical Data Developmental and Reproductive Toxicology
Implementation Guide and Version 1.6 of the Study Data Tabulation
Model; Clarification to Food and Drug Administration Data Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is announcing the date that support
will begin for version 1.1 of the Clinical Data Interchange Standards
Consortium (CDISC) Standard for Exchange of Nonclinical Data
Developmental and Reproductive Toxicology Implementation Guide (SENDIG-
DART) and version 1.6 of the Clinical Data Interchange Standards
Consortium (CDISC) Study Data Tabulation Model (SDTM) and the dates
when such new standard and version update will be required in certain
submissions. The Agency will update the FDA Data Standards Catalog
(Catalog) to reflect these changes. An additional note is added to the
Catalog clarifying the requirements for the submission of a simplified
trial summary dataset to determine a study start date at the point of
submission at the electronic gateway.
DATES: Support for version 1.1 of the CDISC SENDIG-DART and version 1.6
of the CDISC SDTM will begin on March 15, 2021. The requirement for
electronic submissions to be submitted using version 1.1 of the CDISC
SENDIG-DART will begin March 15, 2023, for new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and certain
biologics license applications (BLAs), and March 15, 2024, for certain
investigational new drug applications (INDs). The requirement for
electronic submissions to be submitted using version 1.6 of the CDISC
SDTM will begin on March 15, 2022.
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): 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-2020-N-235 for ``Data Standards; Requirements Begin for the
Clinical Data Interchange Standards Consortium Version 1.1 of the
Standard for Exchange of Nonclinical Data Developmental and
Reproductive Toxicology Implementation Guide and Version 1.6 of the
Study Data Tabulation Model. Clarification to the FDA Data Standards
Catalog.'' 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
[[Page 12952]]
``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.
FOR FURTHER INFORMATION CONTACT: Bryan Spells, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 240-
402-6511, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA's CDER is issuing this Federal Register
notice to announce the date that support will begin for version 1.1 of
the CDISC SENDIG-DART and version 1.6 of the CDISC SDTM and the dates
when such new standard and version update will be required in certain
submissions. The FDA guidance for industry ``Providing Regulatory
Submissions in Electronic Format--Standardized Study Data'' (October
2020) (eStudy Data guidance), posted on FDA's Study Data Standards
Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm, implements the electronic submission
requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379k-1(a)) for study data contained in NDAs, ANDAs,
certain BLAs, and certain INDs submitted to CDER or the Center for
Biologics Evaluation and Research by specifying the format for
electronic submissions. The eStudy Data guidance states that a Federal
Register notice will specify any new standards and version updates to
FDA-supported study data standards that will be added to the Catalog,
when the support for such standards and version updates begins or ends,
and when the requirement to use such standards and version updates in
submissions begins or ends.
Support for version 1.1 of the CDISC SENDIG-DART and version 1.6 of
the CDISC SDTM will begin on March 15, 2021, the transition date. The
requirement for electronic submissions to be submitted using version
1.1 of the CDISC SENDIG-DART will begin March 15, 2023, for NDAs, ANDAs
and certain BLAs, and March 15, 2024, for certain INDs. The requirement
for electronic submissions to be submitted using version 1.6 of the
CDISC SDTM will begin on March 15, 2022.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04609 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P