Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1, 43139-43141 [2019-17877]
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Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
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Dated: August 14, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–17879 Filed 8–19–19; 8:45 am]
Food and Drug Administration
Food and Drug Administration,
HHS.
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 8, 2011. The document
announced the withdrawal of approval
of 70 new drug applications (NDAs) and
97 abbreviated new drug applications
from multiple applicants, effective July
8, 2011. The document contained the
incorrect applicant information for NDA
018380. The correct applicant for NDA
018380 is Hospira, Inc. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, June 8,
2011 (76 FR 33310), appearing on page
33310 in FR Doc. 2011–14164, the
following correction is made:
On page 33311, in table 1, in the
‘‘Applicant’’ column for NDA 018380,
correct the entry ‘‘Do.’’ to read ‘‘Hospira,
Inc., 275 North Field Dr., Bldg. H2, Lake
Forest, IL 60045–5046.’’
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17933 Filed 8–19–19; 8:45 am]
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Food and Drug Administration,
HHS.
Bristol-Myers Squibb Co. et al.;
Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated
New Drug Applications; Correction
VerDate Sep<11>2014
Food and Drug Administration
AGENCY:
[Docket No. FDA–2011–N–0411]
ACTION:
acceptance receipt is on or before that
date.
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide: Version 3.1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2019–N–3500]
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing that it intends to conduct a
Fit for Use (FFU) pilot program to test
the processing and analysis of
nonclinical study data provided
electronically for the Clinical Data
Interchange Standards Consortium
(CDISC) for Standard for Exchange of
Nonclinical Data (SEND)
Implementation Guide (IG): Version 3.1
(SEND 3.1). The Agency’s Center for
Drug Evaluation and Research (CDER)
will test the processing and analysis of
nonclinical study data provided
electronically in SEND 3.1 format. FDA
is inviting individual firms that wish to
participate in this pilot program to
submit participation requests via email
or in writing.
DATES: To be considered for
participation in the pilot program,
submit electronic or written requests by
September 19, 2019. See the ADDRESSES
section for participation request
instructions.
ADDRESSES: Submit electronic requests
to participate in the pilot and comments
regarding this pilot project to https://
www.regulations.gov. Submit written
requests to participate in the pilot and
comments regarding the pilot to Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
by September 19, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
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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–
2019–N–3500 for ‘‘Fit for Use Pilot
Program Invitation for the Clinical Data
Interchange Standards Consortium for
Standard for Exchange of Nonclinical
Data Implementation Guide: Version
3.1.’’ Received comments, those filed in
a timely manner (see ADDRESSES), will
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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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
Isaac Chang, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–7501, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Data standards help FDA receive,
process, review, and archive submission
data more efficiently and effectively.
Study data standards describe a
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standard way to exchange clinical and
nonclinical research data between
computer systems. These standards
provide a consistent general framework
for organizing study data, including
templates for datasets, standard names
for variables, and standard ways of
doing calculations with common
variables. Study data standards are
required for study data submitted to
FDA’s Center for Drug Evaluation and
Research (CDER) per the published
guidance.1
CDISC is an open, multidisciplinary,
nonprofit organization that has
established worldwide industry
standards to support the electronic
acquisition and submission of study
data and metadata for medical and
biopharmaceutical product
development.2 CDISC is currently
facilitating and testing the extension of
the SEND 3.1 standard for nonclinical
toxicology data.
CDER completed a pilot project
evaluating SEND 3.0 using SENDformatted sample toxicology datasets.
Phase 1 of the pilot supported the
development of a SEND Implementation
Guide (SENDIG) describing the process
for formatting data from single and
repeat-dose animal toxicity and
carcinogenicity studies for submission
purposes. During Phase 2 of the pilot,
CDER evaluated submission of SEND
formatted datasets and evaluated data
validation and analysis tools
capabilities. The outcomes of this pilot
resulted in improvements to the
SENDIG 3.0.3
Based on published guidance 4 studies
initiated after December 17, 2016, must
be submitted with data formatted in
accordance with the data standards
listed in the FDA Data Standards
Catalog for new drug applications
(NDAs), biologics license applications
(BLAs), and abbreviated new drug
applications (ANDAs). For
investigational new drug applications
(INDs), the requirement 5 applies to
studies initiated after December 17,
2017. SEND 3.1 is included in the Data
Standards Catalog, and the submission
of SEND nonclinical datasets is
1 See the guidance Providing Regulatory
Submissions in Electronic Format—Standardized
Study Data: Guidance for Industry (PDF—136KB)
(Dec. 2014) at https://www.fda.gov/media/82716/
download.
2 See the CDISC website at https://www.cdisc.org.
3 The updated guide can be found at https://
www.cdisc.org/. FDA has verified the website
address, but the Agency is not responsible for any
subsequent changes to the website address after this
document publishes in the Federal Register.
4 See the Technical Rejection Criteria for Study
Data at https://www.fda.gov/media/100743/
download.
5 See footnote 4.
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expected to continue to increase in the
future. This pilot will evaluate the
compliance of sample SEND 3.1 datasets
submitted to CDER. As part of this
evaluation and in anticipation of FDA
receiving datasets for regulatory review,
the CDISC SEND team, in collaboration
with CDER and available pilot
participants, will update the SENDIG
3.1 as needed to include specific data
elements and terms.
II. Project Participation
CDER is seeking a maximum of five
participants in this pilot. The Center
will use its discretion in choosing
participants based on the completeness
of the submission per the guidelines
below. CDER requests participants to
submit a nonclinical study package
containing the following materials:
• SEND 3.1 datasets 6
• Sample related study report 7 (PDF
format)
• Nonclinical Study Data Reviewers
Guide 8
• Define.xml (v2.0) 9
• Sample standardized study
protocol.
CDER will prioritize nonclinical
packages that highlight the most
significant changes from SENDIG 3.0 to
SENDIG 3.1 and therefore, the studies
that meet as many of the following
criteria as possible:
1. Toxicology studies with safety
pharmacology data that demonstrate
appropriate use of:
a. Continuous data typically included
in these safety pharmacology studies:
(i) Cardiovascular data represented in
the Electrocardiogram (ECG) Test
Results Domain, Electrocardiogram
Domain (EG), and the Cardiovascular
Test Results Domain (CV).
(ii) Respiratory data in the Respiratory
Test Results Domain (RE).
b. Timing variables for Planned Start
of Assessment Interval (—STINT), and
Planned End of Assessment Interval
(—ENINT) (in the use of timing
variables in the EG domain).
c. Unscheduled Flag, (—USCHFL)
variable.
d. Nominal Study Day for
Tabulations, (—NOMDY), Label for
Nominal Study Day, (—NOMLBL)
variable to group and label data for
reporting purposes.
e. Study data from a study or studies
using the Latin Square design.
6 See the FDA Study Data Resources web page,
available at https://www.fda.gov/ForIndustry/
DataStandards/StudyDataStandards/default.htm.
7 See Footnote 6.
8 See the PhUSE Wiki web page, available at
https://www.phusewiki.org/wiki/index.php?
title=Nonclinical_Study_Data_Reviewers_Guide.
9 See Footnote 6.
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2. Toxicology studies including
Pharmacokinetic Concentrations
Domain (PC) and Pharmacokinetics
Parameters Domain (PP) domains.
3. Toxicology studies with study data
using controlled terminology (version
2018–03–30 or later) for:
a. Severity.
b. Non-neoplasm (NONNEO) using
codelist NONNEO and Microscopic
Domain (MI).
Please indicate in your request for
participation the extent to which your
submission will meet the above listed
criteria.
This pilot is intended to inform on the
readiness of the SEND 3.1 standard and
support improvements to the SENDIG
3.1 that will benefit FDA and
submitters. Pilot participants commit to
publicly share lessons learned with the
CDISC SEND team to ensure that the
CDISC SEND standard is improved for
the community. Participants may redact
any sensitive information as needed to
enable sharing FDA feedback with the
CDISC SEND team.
III. Requests for Participation
Requests to participate in the SENDIG
3.1 FFU pilot are to be identified with
the docket number found in brackets in
the heading of this document. Interested
persons should include the following
information in the request: Contact
name, contact phone number, email
address, name of the sponsor, address,
and license number, as well as the
description of criteria met, addressing
each of the items in the II. Project
Participation section.
Once requests for participation are
received, CDER will contact interested
sponsors to discuss the pilot project and
clarify requirements and expectations.
The elapsed time duration of the pilot
is expected to be approximately 6
months but may be extended as needed.
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17877 Filed 8–19–19; 8:45 am]
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HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2019–N–0573]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Blood Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Blood Products Advisory
Committee (the Committee) in the
Center for Biologics Evaluation and
Research. Nominations will be accepted
for upcoming vacancies effective with
this notice. FDA seeks to include the
views of women and men, members of
all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before October 21, 2019 will be given
first consideration for membership on
the Blood Products Advisory
Committee. Nominations received after
October 21, 2019 will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
factrsportal/factrs/index.cfm.
Information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s website at
https://www.fda.gov/advisorycommittees.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268,
Silver Spring, MD 20993–0002, 240–
402–8054, Fax: 301–595–1309, email:
Christina.Vert@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the Blood Products Advisory
Committee.
I. General Description of the Committee
Duties
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and appropriate use of
blood, products derived from blood and
serum or biotechnology which are
intended for use in the diagnosis,
prevention, or treatment of human
diseases, and, as required, any other
product for which FDA has regulatory
responsibility, and advises the
Commissioner of Food and Drugs (the
Commissioner) of its findings regarding
screening and testing (to determine
eligibility) of donors and labeling of the
products, on clinical and laboratory
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43141
studies involving such products, on the
affirmation or revocation of biological
products licenses, and on the quality
and relevance of FDA’s research
program which provides the scientific
support for regulating these agents. The
Committee will function at times as a
medical device panel under the Federal
Food, Drug, and Cosmetic Act Medical
Device Amendments of 1976. As such,
the Committee recommends
classification of devices subject to its
review into regulatory categories;
recommends the assignment of a
priority for the application of regulatory
requirements for devices classified in
the standards or premarket approval
category; advises on formulation of
product development protocols and
reviews premarket approval
applications for those devices to
recommend changes in classification as
appropriate; recommends exemption of
certain devices from the application of
portions of the Act; advises on the
necessity to ban a device; and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices.
II. Criteria for Voting Members
The Committee consists of a core of
17 voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry, engineering,
biological and physical sciences,
biotechnology, computer technology,
statistics, epidemiology, sociology/
ethics, and other related professions.
Almost all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address, telephone number,
and email address if available and a
signed copy of the Acknowledgement
and Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES). Nominations must specify
the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
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]]>Agencies
[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43139-43141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17877]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3500]
Fit for Use Pilot Program Invitation for the Clinical Data
Interchange Standards Consortium for Standard for Exchange of
Nonclinical Data Implementation Guide: Version 3.1
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it intends to conduct a Fit for Use (FFU) pilot program to test
the processing and analysis of nonclinical study data provided
electronically for the Clinical Data Interchange Standards Consortium
(CDISC) for Standard for Exchange of Nonclinical Data (SEND)
Implementation Guide (IG): Version 3.1 (SEND 3.1). The Agency's Center
for Drug Evaluation and Research (CDER) will test the processing and
analysis of nonclinical study data provided electronically in SEND 3.1
format. FDA is inviting individual firms that wish to participate in
this pilot program to submit participation requests via email or in
writing.
DATES: To be considered for participation in the pilot program, submit
electronic or written requests by September 19, 2019. See the ADDRESSES
section for participation request instructions.
ADDRESSES: Submit electronic requests to participate in the pilot and
comments regarding this pilot project to https://www.regulations.gov.
Submit written requests to participate in the pilot and comments
regarding the pilot to Dockets Management Staff (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time by September 19, 2019. 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-2019-N-3500 for ``Fit for Use Pilot Program Invitation for the
Clinical Data Interchange Standards Consortium for Standard for
Exchange of Nonclinical Data Implementation Guide: Version 3.1.''
Received comments, those filed in a timely manner (see ADDRESSES), will
[[Page 43140]]
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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Isaac Chang, Office of Computational
Science, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
402-7501, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Data standards help FDA receive, process, review, and archive
submission data more efficiently and effectively. Study data standards
describe a standard way to exchange clinical and nonclinical research
data between computer systems. These standards provide a consistent
general framework for organizing study data, including templates for
datasets, standard names for variables, and standard ways of doing
calculations with common variables. Study data standards are required
for study data submitted to FDA's Center for Drug Evaluation and
Research (CDER) per the published guidance.\1\
---------------------------------------------------------------------------
\1\ See the guidance Providing Regulatory Submissions in
Electronic Format--Standardized Study Data: Guidance for Industry
(PDF--136KB) (Dec. 2014) at https://www.fda.gov/media/82716/download.
---------------------------------------------------------------------------
CDISC is an open, multidisciplinary, nonprofit organization that
has established worldwide industry standards to support the electronic
acquisition and submission of study data and metadata for medical and
biopharmaceutical product development.\2\ CDISC is currently
facilitating and testing the extension of the SEND 3.1 standard for
nonclinical toxicology data.
---------------------------------------------------------------------------
\2\ See the CDISC website at https://www.cdisc.org.
---------------------------------------------------------------------------
CDER completed a pilot project evaluating SEND 3.0 using SEND-
formatted sample toxicology datasets. Phase 1 of the pilot supported
the development of a SEND Implementation Guide (SENDIG) describing the
process for formatting data from single and repeat-dose animal toxicity
and carcinogenicity studies for submission purposes. During Phase 2 of
the pilot, CDER evaluated submission of SEND formatted datasets and
evaluated data validation and analysis tools capabilities. The outcomes
of this pilot resulted in improvements to the SENDIG 3.0.\3\
---------------------------------------------------------------------------
\3\ The updated guide can be found at https://www.cdisc.org/. FDA
has verified the website address, but the Agency is not responsible
for any subsequent changes to the website address after this
document publishes in the Federal Register.
---------------------------------------------------------------------------
Based on published guidance \4\ studies initiated after December
17, 2016, must be submitted with data formatted in accordance with the
data standards listed in the FDA Data Standards Catalog for new drug
applications (NDAs), biologics license applications (BLAs), and
abbreviated new drug applications (ANDAs). For investigational new drug
applications (INDs), the requirement \5\ applies to studies initiated
after December 17, 2017. SEND 3.1 is included in the Data Standards
Catalog, and the submission of SEND nonclinical datasets is expected to
continue to increase in the future. This pilot will evaluate the
compliance of sample SEND 3.1 datasets submitted to CDER. As part of
this evaluation and in anticipation of FDA receiving datasets for
regulatory review, the CDISC SEND team, in collaboration with CDER and
available pilot participants, will update the SENDIG 3.1 as needed to
include specific data elements and terms.
---------------------------------------------------------------------------
\4\ See the Technical Rejection Criteria for Study Data at
https://www.fda.gov/media/100743/download.
\5\ See footnote 4.
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II. Project Participation
CDER is seeking a maximum of five participants in this pilot. The
Center will use its discretion in choosing participants based on the
completeness of the submission per the guidelines below. CDER requests
participants to submit a nonclinical study package containing the
following materials:
SEND 3.1 datasets \6\
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\6\ See the FDA Study Data Resources web page, available at
https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm.
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Sample related study report \7\ (PDF format)
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\7\ See Footnote 6.
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Nonclinical Study Data Reviewers Guide \8\
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\8\ See the PhUSE Wiki web page, available at https://www.phusewiki.org/wiki/index.php?title=Nonclinical_Study_Data_Reviewers_Guide.
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Define.xml (v2.0) \9\
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\9\ See Footnote 6.
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Sample standardized study protocol.
CDER will prioritize nonclinical packages that highlight the most
significant changes from SENDIG 3.0 to SENDIG 3.1 and therefore, the
studies that meet as many of the following criteria as possible:
1. Toxicology studies with safety pharmacology data that
demonstrate appropriate use of:
a. Continuous data typically included in these safety pharmacology
studies:
(i) Cardiovascular data represented in the Electrocardiogram (ECG)
Test Results Domain, Electrocardiogram Domain (EG), and the
Cardiovascular Test Results Domain (CV).
(ii) Respiratory data in the Respiratory Test Results Domain (RE).
b. Timing variables for Planned Start of Assessment Interval (--
STINT), and Planned End of Assessment Interval (--ENINT) (in the use of
timing variables in the EG domain).
c. Unscheduled Flag, (--USCHFL) variable.
d. Nominal Study Day for Tabulations, (--NOMDY), Label for Nominal
Study Day, (--NOMLBL) variable to group and label data for reporting
purposes.
e. Study data from a study or studies using the Latin Square
design.
[[Page 43141]]
2. Toxicology studies including Pharmacokinetic Concentrations
Domain (PC) and Pharmacokinetics Parameters Domain (PP) domains.
3. Toxicology studies with study data using controlled terminology
(version 2018-03-30 or later) for:
a. Severity.
b. Non-neoplasm (NONNEO) using codelist NONNEO and Microscopic
Domain (MI).
Please indicate in your request for participation the extent to
which your submission will meet the above listed criteria.
This pilot is intended to inform on the readiness of the SEND 3.1
standard and support improvements to the SENDIG 3.1 that will benefit
FDA and submitters. Pilot participants commit to publicly share lessons
learned with the CDISC SEND team to ensure that the CDISC SEND standard
is improved for the community. Participants may redact any sensitive
information as needed to enable sharing FDA feedback with the CDISC
SEND team.
III. Requests for Participation
Requests to participate in the SENDIG 3.1 FFU pilot are to be
identified with the docket number found in brackets in the heading of
this document. Interested persons should include the following
information in the request: Contact name, contact phone number, email
address, name of the sponsor, address, and license number, as well as
the description of criteria met, addressing each of the items in the
II. Project Participation section.
Once requests for participation are received, CDER will contact
interested sponsors to discuss the pilot project and clarify
requirements and expectations. The elapsed time duration of the pilot
is expected to be approximately 6 months but may be extended as needed.
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17877 Filed 8-19-19; 8:45 am]
BILLING CODE 4164-01-P
