[Federal Register Volume 74, Number 236 (Thursday, December 10, 2009)]
[Notices]
[Pages 65540-65541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0561]


Electronic Margin of Safety and NonClinical Toxicology Study Data 
Submission; Notice of Pilot Project

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration's (FDA's) Center for 
Veterinary Medicine (CVM) is seeking sponsors interested in 
participating in a pilot project to test the electronic submission of 
margin of safety and nonclinical toxicology study data using the 
Standard for Exchange of Nonclinical Data (SEND), a new electronic data 
standard format which is used to support review activity. FDA 
anticipates that a successful pilot will enable CVM to accept margin of 
safety and nonclinical toxicology study data related to investigational 
new animal drug (INAD) files and new animal drug applications (NADA's) 
electronically in SEND format.

DATES:  Submit electronic or written requests to participate in the 
pilot project by March 10, 2010. General comments on the pilot project 
are welcome at any time.

ADDRESSES: Submit electronic requests to participate in the pilot and 
comments regarding the project to http://www.regulations.gov. Submit 
written requests and comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit a single copy of electronic comments or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments should be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Janis Messenheimer, Food and Drug 
Administration, Center for Veterinary Medicine, Office of New Animal 
Drug Evaluation (HFV-135), 7500 Standish Pl., Rockville, MD 20855, 240-
276-8348, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing an opportunity to participate in a 3-year CVM 
pilot project. This pilot involves FDA's ongoing testing of SEND, a 
data model initially developed for non-clinical data from animal 
toxicology studies submitted in support of applications for approval of 
human drugs. This pilot is designed to test the ability of SEND to 
support the review of margin of safety and nonclinical toxicology study 
data submitted to INAD files and as part of NADA's at CVM. CVM 
considers this pilot to be the beginning of a phased implementation of 
SEND that will enable CVM to receive and evaluate data from toxicology 
studies as part of the human food safety evaluation and margin of 
safety studies.

[[Page 65541]]

    SEND was developed by the Clinical Data Interchange Standards 
Consortium's (CDISC's) SEND Team. CDISC is an open, multidisciplinary, 
nonprofit organization that has established worldwide industry 
standards to support the electronic acquisition and submission of 
clinical trial data and metadata for medical and biopharmaceutical 
product development (http://www.cdisc.org\1\). CDISC is currently 
facilitating and testing the extension of the same SEND standard for 
nonclinical toxicology data. Where possible, the standards developed 
for clinical datasets and metadata, as described in the overall Study 
Data Tabulation Model (SDTM), are being used to develop a standardized 
dataset format for nonclinical studies.
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    \1\ FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site address after 
this document publishes in the Federal Register.
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    Recently, the Center for Drug Evaluation and Research (CDER) 
completed a pilot project (phase 1) using the SEND format in sample 
toxicology datasets, that is, outside of a regulatory setting (68 FR 
3885, January 27, 2003). The phase 1 CDER pilot also evaluated data 
validation and analysis tools specifically designed to validate 
datasets according to the current SEND standard and to enable a 
reviewer to display and evaluate data efficiently from animal toxicity 
studies submitted in the SEND format. The phase 1 pilot resulted in 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. Following 
the phase 1 pilot, CDER announced a second pilot (phase 2) to test SEND 
formatted datasets in a regulatory setting (72 FR 56363, October 3, 
2007). To support the new CDER pilot, the SENDIG has been updated to 
ensure the harmonized implementation of the CDISC SDTM and SEND models. 
The updated guide can be found at http://www.cdisc.org.
    CVM currently receives margin of safety and nonclinical toxicology 
study data in paper, portable document format (PDF), and other 
electronic formats. The lack of uniformity in the formats used by 
sponsors to submit data, in addition to the inconsistent use of 
terminology across submissions, complicates the agency's efforts to 
validate, display, and evaluate the data using modern, computer-based 
review and analysis tools. As part of FDA's effort to modernize its 
information technology systems and improve efficiency, CVM is planning 
to transition to a true electronic data format for submission of study 
data for regulatory review.

II. Pilot Project Description

    This pilot is intended to help CVM evaluate the adequacy of the 
current SEND format (SAS transport files, XPT version 5) in 
accommodating margin of safety and nonclinical toxicology study data 
submitted to the Center. As part of this evaluation and in anticipation 
of FDA receiving datasets for regulatory review, the CDISC SEND Team, 
in collaboration with FDA and available pilot participants, will first 
update the SENDIG as needed to include veterinary-specific data 
elements and terms.
    As experience from the ongoing pilot is gained with various types 
of margin of safety and nonclinical toxicology study data, CVM expects 
to recommend new technical specifications for margin of safety and 
toxicology studies as part of a continuing process of transitioning 
from paper-based submissions to the submission of study data by 
electronic means.

III. Participation

    CVM is seeking a limited number of sponsors (approximately five to 
eight, but no more than eight) to participate in this pilot. Because a 
limited group of voluntary participants is needed, CVM will use its 
discretion in choosing volunteers, based on their experience with 
datasets previously submitted to CVM. The duration of the pilot is 
expected to be approximately 3 years, but it may be extended as needed. 
A familiarity with SEND (e.g., from involvement in the CDER pilot) 
would benefit participants but is not necessary for participation in 
the project. A participant should be willing to provide the same study 
data in both paper format and SEND electronic format using SAS 
transport files (XPT version 5). The pilot provides the best 
opportunity to compare and evaluate the same data available in paper 
and SEND formats in order to test the accuracy and reliability of the 
SEND format.
    For the purposes of this pilot, study reports from margin of safety 
and nonclinical toxicology study data will be requested for submission. 
We anticipate that a successful pilot, including the implementation of 
any needed changes to the SENDIG and/or the data validation, viewing, 
and analysis tools, will allow CVM to accept specific types of margin 
of safety and nonclinical toxicology study data electronically based on 
the SEND format.
    Requests to participate in the pilot project should be submitted to 
the Division of Dockets Management (see ADDRESSES). Requests are to be 
identified with the docket number found in brackets in the heading of 
this document.
    Under current FDA regulations, applicants must provide evidence to 
establish safety and effectiveness as part of their NADA (21 CFR 
514.1(b)(8)). Participation in this pilot program will not exempt 
participants from compliance with applicable requirements for the 
submission of evidence to establish safety and effectiveness.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this pilot 
project. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: December 4, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29419 Filed 12-9-09; 8:45 am]
BILLING CODE 4160-01-S