Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3, 40658-40659 [2020-14512]
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40658
Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
This is a new collection of
information whose total estimated
annual reporting burden is 9,198 hours.
The number of participants to be
included in each individual generic
submission under this collection of
information will vary, depending on the
nature of the compliance efforts and the
target audience.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14517 Filed 7–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1206]
Electronic Study Data Submission;
Data Standards; Support and
Requirement Begin for Study Data
Tabulation Model Version 1.7
Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) are
announcing the dates that support and
requirement will begin for version 1.7 of
the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data
Tabulation Model (SDTM)
Implementation Guide (IG) 3.3, as well
as for version 2.1 of the DefineExtensible Markup Language (DefineXML). CBER and CDER are also
announcing the date that support and
requirement will end for version 1.3 of
the CDISC SDTM IG 3.1.3. The Agency
will update the FDA Data Standards
Catalog (Catalog) to reflect these
changes.
SUMMARY:
You may submit either
electronic or written comments at any
time as follows:
ADDRESSES:
jbell on DSKJLSW7X2PROD 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://
VerDate Sep<11>2014
16:59 Jul 06, 2020
Jkt 250001
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–1206 for ‘‘Electronic Study
Data Submission; Data Standards;
Support and Requirement Begin for
Study Data Tabulation Model Version
1.7 Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3.’’
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993–
0002, 240–402–7911.
SUPPLEMENTARY INFORMATION: On
December 17, 2014, FDA published a
final guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Standardized Study
Data’’ (eStudy Data guidance), posted on
FDA’s Study Data Standards Resources
web page at https://www.fda.gov/
forindustry/datastandards/
studydatastandards/default.htm. The
eStudy Data guidance 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
new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), biologics license applications
(BLAs), and certain investigational new
drug applications (INDs) submitted to
E:\FR\FM\07JYN1.SGM
07JYN1
Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
CDER or CBER 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, when
the support begins or ends, and when
the requirement begins or ends, that will
be added to the Catalog. Support for
version 1.7 of the CDISC SDTM IG 3.3
and version 2.1 of the Define-XML will
begin on March 15, 2021, and the date
that the requirement begins will be on
March 15, 2022, for NDAs, ANDAs, and
certain BLAs. For noncommercial INDs,
the date that requirement begins will be
March 15, 2023. Support and
requirement ended for version 1.3 of the
CDISC SDTM IG 3.1.3 will end on
March 15, 2021.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14512 Filed 7–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1307]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Examination of
Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription
Drug Promotional Materials
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Examination of
Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription
Drug Promotional Materials.’’
DATES: Submit either electronic or
written comments on the collection of
information by September 8, 2020.
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 September 8,
2020. The https://www.regulations.gov
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:59 Jul 06, 2020
Jkt 250001
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 8, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service 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–
2020–N–1307 for ‘‘Examination of
Secondary Claim Disclosures and
Biosimilar Disclosures in Prescription
Drug Promotional Materials.’’ 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
40659
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the 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.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
For copies of the questionnaire
contact: Office of Prescription Drug
Promotion (OPDP) Research Team,
DTCresearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
E:\FR\FM\07JYN1.SGM
07JYN1
Agencies
[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40658-40659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1206]
Electronic Study Data Submission; Data Standards; Support and
Requirement Begin for Study Data Tabulation Model Version 1.7
Implementation Guide 3.3 and for Define-Extensible Markup Language
Version 2.1; Requirement Ends for Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Biologics Evaluation and Research (CBER) and Center for Drug Evaluation
and Research (CDER) are announcing the dates that support and
requirement will begin for version 1.7 of the Clinical Data Interchange
Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM)
Implementation Guide (IG) 3.3, as well as for version 2.1 of the
Define-Extensible Markup Language (Define-XML). CBER and CDER are also
announcing the date that support and requirement will end for version
1.3 of the CDISC SDTM IG 3.1.3. The Agency will update the FDA Data
Standards Catalog (Catalog) to reflect these changes.
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-2020-N-1206 for ``Electronic Study Data Submission; Data Standards;
Support and Requirement Begin for Study Data Tabulation Model Version
1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language
Version 2.1; Requirement Ends for Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3.'' 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.
FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION: On December 17, 2014, FDA published a final
guidance for industry entitled ``Providing Regulatory Submissions in
Electronic Format--Standardized Study Data'' (eStudy Data guidance),
posted on FDA's Study Data Standards Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
The eStudy Data guidance 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 new drug
applications (NDAs), abbreviated new drug applications (ANDAs),
biologics license applications (BLAs), and certain investigational new
drug applications (INDs) submitted to
[[Page 40659]]
CDER or CBER 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, when the support begins or ends,
and when the requirement begins or ends, that will be added to the
Catalog. Support for version 1.7 of the CDISC SDTM IG 3.3 and version
2.1 of the Define-XML will begin on March 15, 2021, and the date that
the requirement begins will be on March 15, 2022, for NDAs, ANDAs, and
certain BLAs. For noncommercial INDs, the date that requirement begins
will be March 15, 2023. Support and requirement ended for version 1.3
of the CDISC SDTM IG 3.1.3 will end on March 15, 2021.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14512 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P