```

[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12312-12313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4785]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0130]

Electronic Submission of Nonclinical Study Data; Notice of Pilot 
Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) Center for Biologics 
Evaluation and Research (CBER) is announcing an invitation to 
participate in a pilot evaluation program to test the electronic 
submission of nonclinical study data using the Standard for Exchange of 
Nonclinical Data (SEND), a new electronic data standard format, which 
can be used to support review activity. Participation in the pilot 
program is open to all sponsors. The pilot program is intended to 
provide industry and CBER regulatory review staff the opportunity to 
evaluate SEND and determine if it facilitates the submission process of 
nonclinical study data related to investigational new drug applications 
(INDs).

DATES: Submit either electronic or written requests for participation 
in this pilot program by May 29, 2012.

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.

FOR FURTHER INFORMATION CONTACT: Amy Malla, Center for Biologics 
Evaluation and Research (HFM-25), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6085, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products and is committed to 
advancing the public health through innovative activities that help 
ensure the safety, effectiveness and timely delivery of these products 
to patients. Further, CBER seeks to continuously enhance and update 
review efficiency and quality, and the quality of its regulatory 
efforts and interactions, by providing CBER staff and industry with 
improved processes. In support of this goal, CBER has participated in 
the development of the Clinical Data Interchange Standards Consortium 
(CDISC) SEND, a data model initially developed for nonclinical data 
from animal 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 nonclinical study data submitted to CBER. The 
ultimate goal of the pilot is to replace the existing paper and 
portable document format (PDF)-based listings of nonclinical study 
data.
    SEND was developed by the CDISC SEND Team. 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 (http://www.cdisc.org). 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 
format for nonclinical studies.
    Recently, CBER has adopted a standard for clinical study data based 
on the CDISC SDTM standard. FDA believes the use of standardized SEND 
datasets, together with new and better analysis tools, will enhance 
CBER's review and evaluation of nonclinical data.
    The Center for Drug Evaluation and Research (CDER) completed a 
pilot project (phase 1) using the SEND format in sample nonclinical 
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

[[Page 12313]]

from animal studies submitted in the SEND format. The 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). The phase 2 pilot was aimed at evaluating animal toxicity data 
submitted in SEND format in a regulatory setting by comparing SEND-
formatted data provided electronically as SAS transport file (XPT 
version 5) datasets with data provided in PDF.
    CBER currently receives nonclinical study data in paper, 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 CBER'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, CBER is planning to 
transition to an electronic data format for submission of study data 
for regulatory review.

II. Pilot Project Description

    This pilot is intended to help CBER evaluate the adequacy of the 
current SEND format (SAS transport files, XPT version 5) in 
accommodating nonclinical 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 update the SENDIG as needed to 
include biologic-specific data elements and terms.

III. Requests for Participation

    Requests to participate in the SEND pilot are to be identified with 
the docket number found in brackets in the heading of this document. 
You should include the following information in your request: Contact 
name, contact phone number, email address, name of the establishment, 
address, and license number. Once requests for participation are 
received, FDA will contact interested establishments to discuss the 
pilot program. CBER is seeking a limited number of sponsors 
(approximately three to five, but no more than six) to participate in 
this pilot. The duration of the pilot is expected to be approximately 
12 months but may be extended as needed. A familiarity with SEND would 
benefit participants but is not required for participation in the 
project. Participants should be willing to provide the same nonclinical 
study data in both paper format and SEND electronic format using SAS 
transport files (XPT version 5). Participation in this pilot will be 
outside the regulatory pathway and as such will not be used to make 
regulatory decisions.
    We anticipate that a successful pilot program, including the 
implementation of any needed changes to the SENDIG and/or data 
validation, viewing and analysis tools, will allow CBER to accept 
specific types of nonclinical study data electronically based on the 
SEND format.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4785 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P
```