Notice2021-12503
Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments
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Published
June 15, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 113 (Tuesday, June 15, 2021)</title>
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[Federal Register Volume 86, Number 113 (Tuesday, June 15, 2021)]
[Notices]
[Pages 31720-31722]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12503]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 31721]]
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#20434841524c45530e414e44524553604644410e4848530e474f56"><span class="__cf_email__" data-cfemail="c5a6ada4b7a9a0b6eba4aba1b7a0b685a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
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).
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\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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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\
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\2\ <a href="https://www.fda.gov/industry/fda-resources-data-standards">https://www.fda.gov/industry/fda-resources-data-standards</a>.
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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.
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\3\ <a href="http://www.cdisc.org">http://www.cdisc.org</a>.
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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
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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
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