[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]


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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 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).
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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\ https://www.fda.gov/industry/fda-resources-data-standards.
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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\ http://www.cdisc.org.
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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

[[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]
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