[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]


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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.

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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, 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 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\
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    \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.
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    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.
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    \2\ See the CDISC website at http://www.cdisc.org.
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    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\
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    \3\ The updated guide can be found at http://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.
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    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.
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    \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.

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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]
 BILLING CODE 4164-01-P


