Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments, 31720-31722 [2021-12503]
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31720
Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices
states that the requirements for the
MIECHV grants to tribes, tribal
organizations, and urban Indian
organizations are to be consistent, to the
greatest extent practicable, with the
requirements for grantees under the
MIECHV program for states and
jurisdictions.
OCC, in collaboration with the Health
Resources and Services Administration,
Maternal and Child Health Bureau
awarded grants for the Tribal MIECHV
Program (Tribal Home Visiting) to
support cooperative agreements to
conduct community needs assessments;
plan for and implement high-quality,
culturally-relevant, evidence-based
home visiting programs in at-risk tribal
communities; establish, measure, and
report on progress toward meeting
performance measures in six
legislatively-mandated benchmark
areas; and conduct rigorous evaluation
activities to build the knowledge base
on home visiting among Native
populations.
After the first grant year, Tribal Home
Visiting grantees must comply with the
requirement to submit an Annual Report
to the Secretary that should feature
activities carried out under the program
during the past reporting period, and a
final report to the Secretary during the
final year of their grant. To assist
grantees with meeting these
requirements, ACF created guidance for
grantees to use when writing their
reports. The guidance specifies that
grantees must address the following:
• Update on Home Visiting Program
Goals and Objectives
• Update on the Implementation of
Home Visiting Program in Targeted
Community(ies)
• Progress toward Meeting Legislatively
Mandated Benchmark Requirements
• Update on Rigorous Evaluation
Activities
• Home Visiting Program Continuous
Quality Improvement (CQI) Efforts
• Update on dissemination activities
• Administration of Home Visiting
Program
• Technical Assistance Needs
Previously, the guidance included
information about both the annual and
the final reports from grantees. This
extension request includes updates to
the guidance to make it specific to just
the annual reports. Guidance specific to
the final report will be submitted for
review and approval by OMB in the
future. A comment period will
accompany that request.
Respondents: Tribal Home Visiting
Managers (information collection does
not include direct interaction with
individuals or families that receive the
services).
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden
hours per
response
Annual
burden
hours
Annual Report to the Secretary .......................................................................
23
1
25
575
Estimated Total Annual Burden
Hours: 575.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
khammond on DSKJM1Z7X2PROD with NOTICES
Authority: Title V of the Social Security
Act, sections 511(e)(8)(A) and 511(h)(2)(A).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–12464 Filed 6–14–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2319]
Evaluation of Study Data Exchange
Standards for Submission of Study
Data to the Center for Veterinary
Medicine; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA, the Agency, or
we) is soliciting comments on the use of
study data exchange standards from
persons involved in study conduct, data
collection, data management, and
submission of animal study data
intended to support the approval of new
animal drug applications, abbreviated
new animal drug applications, or
applications for conditional approval.
DATES: Submit either electronic or
written comments on the notice by
September 13, 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 September 13,
2021. The https://www.regulations.gov
SUMMARY:
PO 00000
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electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 13, 2021.
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.
E:\FR\FM\15JNN1.SGM
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Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
• 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. FDA2020–N–2319 for ‘‘Evaluation of Study
Data Exchange Standards for
Submission of Study Data to the Center
for Veterinary Medicine.’’ 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
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
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Jkt 253001
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:
Charles Andres, Center for Veterinary
Medicine (HFV–180), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–402–0653,
charles.andres@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
For new animal drug applications
(NADAs), the FDA requires full reports
of investigations that have been
conducted to show a new animal drug
is safe and effective for use (section
512(b)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360b(b)(1)(A))). Additionally, section
512(n)(1)(E) of the FD&C Act (21 U.S.C.
360b(n)(1)(E)) requires that abbreviated
applications for the approval of a new
animal drug (ANADAs) contain
information to show that the generic
new animal drug is bioequivalent to the
approved new animal drug. FDA also is
authorized to grant conditional approval
to certain new animal drugs. An
application for conditional approval
must contain full reports of
investigations that have been conducted
to show that the new animal drug is safe
and that there is a reasonable
expectation of effectiveness. (See
section 571(a)(2)(B) of the FD&C Act (21
U.S.C. 360ccc(a)(2)(B)).) 1 In addition to
the reports of animal studies conducted
to support the safety and effectiveness
of a new animal drug, copies of the
underlying study data are submitted to
FDA’s Center for Veterinary Medicine
(CVM).
1 Conditional approval allows a sponsor to begin
marketing a new animal drug after demonstrating
the safety of the product and that there is a
reasonable expectation of effectiveness, while the
sponsor continues to collect the evidence of
effectiveness needed for the product to receive full
approval under section 512 of the FD&C Act (21
U.S.C. 360b) (i.e., substantial evidence of
effectiveness). Conditional approval is valid for 1
year and can be renewed by FDA annually for up
to a total of 5 years, if the sponsor shows sufficient
progress towards demonstrating substantial
evidence of effectiveness.
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31721
As part of our continued effort to
modernize our information technology
systems and improve efficiency, we
have transitioned to an electronic data
format for submission of study data for
regulatory review. Currently, CVM does
not require or suggest study data
exchange standards for such
submissions. Study data standards are
sets of rules on how particular types of
data should be structured, defined,
formatted, or exchanged between
computer systems. The lack of
uniformity of submitted electronic data
files and the inconsistent use of
terminology across submissions
impedes efficiency and complicates our
efforts to display, evaluate, and validate
the data using advanced review and
analysis tools. The use of study data
exchange standards would improve the
clarity and consistency of our
expectations regarding submission of
electronic data files. Additionally, the
conformance to standardized study data
format is now being encouraged and
implemented in other parts of the FDA.2
Study data exchange standards
provide a consistent general framework
for organizing study data, including
templates for datasets, standard or
controlled terminology for variables,
and standard calculations for common
variables. The Clinical Data Interchange
Standards Consortium (CDISC) is an
open, multidisciplinary, nonprofit
organization that has established
worldwide industry standards to
support the electronic acquisition,
exchange, submission, and archiving of
clinical trial data and metadata for
medical and biopharmaceutical product
development.3 CDISC facilitates the
development of study data exchange
standards as part of a collaboration
involving multiple member
organizations, including FDA. Two
study data exchange standards
developed by CDISC that CVM is
exploring for potential use are the
Standard for Exchange of Nonclinical
Data (SEND), a data model developed to
support the exchange of nonclinical
tabulated datasets for toxicology studies
conducted in animals, and the Study
Data Tabulation Model (SDTM), a model
for exchange of human clinical study
data. FDA accepts both SEND and
SDTM study data exchange standards
for use in regulatory submissions.
We are inviting comments on the use
of study data exchange standards from
persons involved in study conduct, data
collection, data management, and
submission of animal study data
2 https://www.fda.gov/industry/fda-resourcesdata-standards.
3 https://www.cdisc.org.
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Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices
intended to support the approval of
NADAs, ANADAs, or applications for
conditional approval (for example,
animal drug sponsor, test facility,
developer, vendor, user of electronic
data capture (EDC) and data
visualization software, or study data
quality control (QC) and quality
assurance (QA) specialist).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0390]
Lederle Laboratories et al.; Withdrawal
of Approval of 12 Abbreviated New
Drug Applications; Correction
khammond on DSKJM1Z7X2PROD with NOTICES
II. Other Issues for Consideration
AGENCY:
CVM seeks to continuously enhance
review efficiency and interactions with
the animal health industry. As part of
our continued effort to engage with the
animal health industry, we are
interested in understanding more about
the experiences and familiarity of those
involved in animal drug development
with the use of data exchange standards.
We specifically request public comment
regarding the questions below. When
submitting comments, it would help us
if commenters would identify their
animal health industry sector (for
example, animal drug sponsor, test
facility, developer, vendor, user of EDC
and data visualization software, or study
data QC and QA specialist). We will
consider the comments as we evaluate
the potential use of study data exchange
standards for animal studies submitted
as part of the new animal drug approval
process.
1. Which study data exchange
standards are you currently using, if
any, for the submission of study data to
CVM; and which tools do you use to
review, analyze, or validate the study
data?
2. If study data exchange standards
are included as part of your study data
management process, when are they
incorporated (for example, in protocol
development, EDC database and case
report form development, post-study
processing)?
3. What are the potential benefits or
anticipated challenges to the animal
health industry of harmonizing CVM’s
data exchange standards expectations
with other FDA Centers’ expectations?
4. What can CVM do to help industry
to be more prepared for, or to reduce the
burden of implementing, the use of
study data exchange standards?
5. What other comments do you have
regarding the use of study data exchange
standards for submission of study data
to CVM?
Dated: June 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12503 Filed 6–14–21; 8:45 am]
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Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on May 12, 2021. The
document announced the withdrawal of
approval of 12 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of June 11,
2021. The document indicated that FDA
was withdrawing the approval of ANDA
060164, Nystatin Ointment, held by
Lederle Laboratories. However, the
document published with an incorrect
application number for this product.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, May 12,
2021 (86 FR 26058), appearing on page
26058 in FR Doc. 2021–09980, the
following correction is made:
On page 26058, in the first column, in
the first line in the table, the application
number ‘‘060164’’ is corrected to read
‘‘061064’’.
SUMMARY:
Dated: June 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12557 Filed 6–14–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0493]
Medical Devices; Exemption From
Premarket Notification: Powered
Patient Transport, All Other Powered
Patient Transport
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00030
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The Food and Drug
Administration (FDA or Agency) is
announcing that it has received a
petition requesting exemption from the
premarket notification requirements for
the generic device type, powered patient
transport, all other powered patient
transport. These devices are motorized
devices used to mitigate mobility
impairment caused by injury or other
disease by moving a person from one
location or level to another, such as up
and down flights of stairs. This device
type does not include motorized threewheeled vehicles or wheelchairs, and is
distinct from the device type, powered
patient transport, powered patient
stairway chair lifts, which is classified
separately within the same regulation.
FDA is publishing this notice to obtain
comments in accordance with
procedures established by the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
DATES: Submit either electronic or
written comments by August 16, 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 August 16,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 16, 2021.
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.
SUMMARY:
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
E:\FR\FM\15JNN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 113 (Tuesday, June 15, 2021)]
[Notices]
[Pages 31720-31722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12503]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2319]
Evaluation of Study Data Exchange Standards for Submission of
Study Data to the Center for Veterinary Medicine; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
soliciting comments on the use of study data exchange standards from
persons involved in study conduct, data collection, data management,
and submission of animal study data intended to support the approval of
new animal drug applications, abbreviated new animal drug applications,
or applications for conditional approval.
DATES: Submit either electronic or written comments on the notice by
September 13, 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 September 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 13, 2021. 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.
[[Page 31721]]
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-2319 for ``Evaluation of Study Data Exchange Standards for
Submission of Study Data to the Center for Veterinary Medicine.''
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 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: Charles Andres, Center for Veterinary
Medicine (HFV-180), Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855, 240-402-0653, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
For new animal drug applications (NADAs), the FDA requires full
reports of investigations that have been conducted to show a new animal
drug is safe and effective for use (section 512(b)(1)(A) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(b)(1)(A))).
Additionally, section 512(n)(1)(E) of the FD&C Act (21 U.S.C.
360b(n)(1)(E)) requires that abbreviated applications for the approval
of a new animal drug (ANADAs) contain information to show that the
generic new animal drug is bioequivalent to the approved new animal
drug. FDA also is authorized to grant conditional approval to certain
new animal drugs. An application for conditional approval must contain
full reports of investigations that have been conducted to show that
the new animal drug is safe and that there is a reasonable expectation
of effectiveness. (See section 571(a)(2)(B) of the FD&C Act (21 U.S.C.
360ccc(a)(2)(B)).) \1\ In addition to the reports of animal studies
conducted to support the safety and effectiveness of a new animal drug,
copies of the underlying study data are submitted to FDA's Center for
Veterinary Medicine (CVM).
---------------------------------------------------------------------------
\1\ Conditional approval allows a sponsor to begin marketing a
new animal drug after demonstrating the safety of the product and
that there is a reasonable expectation of effectiveness, while the
sponsor continues to collect the evidence of effectiveness needed
for the product to receive full approval under section 512 of the
FD&C Act (21 U.S.C. 360b) (i.e., substantial evidence of
effectiveness). Conditional approval is valid for 1 year and can be
renewed by FDA annually for up to a total of 5 years, if the sponsor
shows sufficient progress towards demonstrating substantial evidence
of effectiveness.
---------------------------------------------------------------------------
As part of our continued effort to modernize our information
technology systems and improve efficiency, we have transitioned to an
electronic data format for submission of study data for regulatory
review. Currently, CVM does not require or suggest study data exchange
standards for such submissions. Study data standards are sets of rules
on how particular types of data should be structured, defined,
formatted, or exchanged between computer systems. The lack of
uniformity of submitted electronic data files and the inconsistent use
of terminology across submissions impedes efficiency and complicates
our efforts to display, evaluate, and validate the data using advanced
review and analysis tools. The use of study data exchange standards
would improve the clarity and consistency of our expectations regarding
submission of electronic data files. Additionally, the conformance to
standardized study data format is now being encouraged and implemented
in other parts of the FDA.\2\
---------------------------------------------------------------------------
\2\ https://www.fda.gov/industry/fda-resources-data-standards.
---------------------------------------------------------------------------
Study data exchange standards provide a consistent general
framework for organizing study data, including templates for datasets,
standard or controlled terminology for variables, and standard
calculations for common variables. The Clinical Data Interchange
Standards Consortium (CDISC) is an open, multidisciplinary, nonprofit
organization that has established worldwide industry standards to
support the electronic acquisition, exchange, submission, and archiving
of clinical trial data and metadata for medical and biopharmaceutical
product development.\3\ CDISC facilitates the development of study data
exchange standards as part of a collaboration involving multiple member
organizations, including FDA. Two study data exchange standards
developed by CDISC that CVM is exploring for potential use are the
Standard for Exchange of Nonclinical Data (SEND), a data model
developed to support the exchange of nonclinical tabulated datasets for
toxicology studies conducted in animals, and the Study Data Tabulation
Model (SDTM), a model for exchange of human clinical study data. FDA
accepts both SEND and SDTM study data exchange standards for use in
regulatory submissions.
---------------------------------------------------------------------------
\3\ https://www.cdisc.org.
---------------------------------------------------------------------------
We are inviting comments on the use of study data exchange
standards from persons involved in study conduct, data collection, data
management, and submission of animal study data
[[Page 31722]]
intended to support the approval of NADAs, ANADAs, or applications for
conditional approval (for example, animal drug sponsor, test facility,
developer, vendor, user of electronic data capture (EDC) and data
visualization software, or study data quality control (QC) and quality
assurance (QA) specialist).
II. Other Issues for Consideration
CVM seeks to continuously enhance review efficiency and
interactions with the animal health industry. As part of our continued
effort to engage with the animal health industry, we are interested in
understanding more about the experiences and familiarity of those
involved in animal drug development with the use of data exchange
standards. We specifically request public comment regarding the
questions below. When submitting comments, it would help us if
commenters would identify their animal health industry sector (for
example, animal drug sponsor, test facility, developer, vendor, user of
EDC and data visualization software, or study data QC and QA
specialist). We will consider the comments as we evaluate the potential
use of study data exchange standards for animal studies submitted as
part of the new animal drug approval process.
1. Which study data exchange standards are you currently using, if
any, for the submission of study data to CVM; and which tools do you
use to review, analyze, or validate the study data?
2. If study data exchange standards are included as part of your
study data management process, when are they incorporated (for example,
in protocol development, EDC database and case report form development,
post-study processing)?
3. What are the potential benefits or anticipated challenges to the
animal health industry of harmonizing CVM's data exchange standards
expectations with other FDA Centers' expectations?
4. What can CVM do to help industry to be more prepared for, or to
reduce the burden of implementing, the use of study data exchange
standards?
5. What other comments do you have regarding the use of study data
exchange standards for submission of study data to CVM?
Dated: June 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12503 Filed 6-14-21; 8:45 am]
BILLING CODE 4164-01-P
