[Federal Register Volume 79, Number 97 (Tuesday, May 20, 2014)]
[Notices]
[Pages 28926-28927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0092]


Electronic Study Data Submission; Data Standards; Availability of 
Validation Rules for Standard for Exchange of Nonclinical Data 
Formatted Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER), is announcing the availability of the 
Validation Rules for Standard for Exchange of Nonclinical Data (SEND) 
Formatted Studies document. CDER is making this document available to 
improve the standardization and quality of nonclinical data that are 
submitted to CDER as well as to improve the predictability of data 
quality and usefulness.

FOR FURTHER INFORMATION CONTACT: Office of Strategic Programs, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 1183, Silver Spring, MD 20993, email: 
[email protected].

SUPPLEMENTARY INFORMATION: On February 6, 2014, FDA issued a Federal 
Register notice (79 FR 7201) announcing the availability of a revised 
draft guidance for industry entitled ``Providing Regulatory Submissions 
in Electronic Format--Standardized Study Data''. The revised draft 
guidance incorporates by reference a technical specifications document 
entitled ``Study Data Technical Conformance Guide.'' On February 6, 
2014, FDA issued a Federal Register notice (79 FR 7204) announcing the 
availability of the Guide and an update to the Data Standards Catalog. 
The Guide is available at http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf.

[[Page 28927]]

Section 8.2.3 of the Guide, ``Support on Data Validation Rules,'' 
states that ``[t]he Standards Web page provides links to the validation 
rules needed to ensure data compliance with CDISC standards, such as 
SDTM, SEND, ADaM, and define.xml.'' In this notice, we are announcing 
the availability of the SEND validation rules.
    The Validation Rules for SEND Formatted Studies is an Excel file 
that provides human readable description of a rule set for validation 
(Nonclinical Validator Specifications (XLS)). Submitters of nonclinical 
study data can use this information to identify how FDA validates the 
data. It is available from the FDA Study Data Standards Resources Web 
page: http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm. The file contains a combination of conformance rules 
(i.e., how well the data conform to the standard) and business rules 
(i.e., quality checks; how well the data may support meaningful 
analysis). The file may be updated periodically as new or updated 
validation rules are developed. The Change History tab will provide a 
descriptive change history of the document.
    The validation rules in the Nonclinical Validator Specifications 
document were created following the suggested human readable validation 
rule syntax published by a Computational Science Symposium workgroup. 
This document is available at: http://www.phusewiki.org/wiki/index.php?title=Guidelines_for_Validation_Rule_Developers.

    Dated: May 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11522 Filed 5-19-14; 8:45 am]
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