[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Notices]
[Pages 45163-45164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21452]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95S-0193]


Pharmacology/Toxicology Electronic Submissions Pilot Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
Pharmacology/Toxicology (P/T) Electronic Submissions Pilot Project 
developed by the Center for Drug Evaluation and Research (CDER). This 
project is intended to increase the efficiency of both the 
investigational new drug application (IND) and the new drug application 
(NDA) review processes by providing for the electronic submission of 
preclinical P/T study reports. CDER is requesting that interested 
sponsors submit, on a voluntary basis, electronic copies of P/T study 
reports containing complete text and graphic material for review in 
word processor format, in addition to paper submissions.

FOR FURTHER INFORMATION CONTACT: 
    Regarding general information about the pilot project: Joseph F. 
Contrera, Center for Drug Evaluation and Research (HFD-400), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
4750.
    Regarding technical information about participation in the pilot 
program: Patricia A. Sylvia, Center for Drug Evaluation and Research 
(HFD-72), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-443-3695.

SUPPLEMENTARY INFORMATION: CDER is exploring ways in which electronic 
submissions can be used to increase the efficiency of the drug review 
process. A key part of this process is the review of preclinical animal 
studies, most of which are conducted during the IND phase of the 
application. CDER has established a pilot project requesting that 
sponsors voluntarily submit electronic copies of P/T study reports, in 
addition to paper submissions. These reports would contain complete 
text and graphic material for review in word processor format. 
Electronic submissions of P/T study reports would allow for efficient 
storage and the capacity to retrieve, copy, and print pertinent 
sections of submissions for review.
    This pilot project is expected to be most useful during the IND 
review process because the large proportion of preclinical P/T studies 
is submitted during this period. The agency believes that increasing 
the efficiency of the IND review process will have a positive effect on 
the NDA review process. If this pilot project is successful, CDER may 
consider acceptance of only electronic submissions. In the Federal 
Register of August 31, 1994 (59 FR 45160), FDA published a proposed 
rule entitled ``Electronic Signatures; Electronic Records.'' This pilot 
project is consistent with the goals of the proposed rule.
    A description of the pilot project, as well as the general format 
and media specifications for electronic submissions, follows:

The Center for Drug Evaluation and Research (CDER) Pharmacology/
Toxicology (P/T) Electronic Submissions

I. Background

    CDER is exploring ways in which electronic submissions can be 
used to increase the efficiency of the drug review process. A key 
part of this process is the review of preclinical animal studies, 
most of which are conducted during the IND phase of the application. 
The Information Technology (IT) Subcommittee of the CDER 
Pharmacology/Toxicology Coordinating Committee (the P/T IT 
Subcommittee) is responsible for furthering the concept of 
electronic submissions for P/T reviews. In November 1994, after 
discussions between FDA and the Pharmaceutical Research and 
Manufacturers of America, three firms agreed to submit electronic 
preclinical P/T reports to CDER. In addition, CDER optically scanned 
P/T reports that were submitted in paper form, prepared reviews of 
these submissions electronically, and evaluated the utility of 
receiving the P/T submissions electronically. As a result of this 
experience, space has been allocated on the CDER Local Area Network 
(LAN) for P/T submissions and reviews, and the P/T IT Subcommittee 
agreed to solicit additional preclinical P/T electronic submissions 
from sponsors.
    Each CDER reviewer is responsible for many IND's and NDA's that 
are in various stages of development and assigned different 
priorities. As a result, study reports may be stored in reviewers' 
offices for considerable periods of time until they can be reviewed. 
In addition, reviews often contain the results of multiple studies 
from amendments to an IND submitted at different times. This 
requires the storage, retrieval, collation, and merging of 
information from several studies into a single review. Electronic 
submissions of P/T reports would allow for efficient storage and the 
capacity to retrieve, copy, and print pertinent sections of 
submissions for review.

II. Objectives of Electronic Submission Pilot Project

A. Facilitate the Rapid and Convenient Retrieval of Information 
Contained in Submissions and Minimize Storage Space

    A major time-consuming task for reviewers is searching through 
the large volume of paper submissions to find relevant documents 
when they are needed. Electronic documents and appropriate document 

[[Page 45164]]
retrieval software make possible indexing of documents by content and 
the rapid retrieval of documents containing the desired information. 
The reviewer can electronically survey the document and copy or 
print those sections of the document that contain the required 
information. Electronic submissions will reduce the short-term and 
long-term storage space requirements and facilitate long-term 
retrieval of information.

B. Facilitate the Writing of Reviews

    Currently, tabular or graphic material derived from a sponsor's 
paper submissions are either optically scanned and merged into a 
review or photocopied and physically pasted into a printed paper 
copy of a review. In the latter case, the table will not appear in 
electronic archival copies of the reviews. Electronic submissions 
will facilitate the ability of reviewers to copy portions of text, 
``cut and paste'' tables or graphs, and incorporate them into a 
review. They will also allow the transfer of digital photographic 
images of histopathology or other images into a review in the near 
future.

C. Obtain Experience with Reviewing Electronic P/T Submissions and 
Make Recommendations for Expansion of the Pilot Program to Routine 
Use, Including Possible Elimination of Paper Submissions

    The P/T IT Subcommittee intends to gain experience with the 
review of electronic P/T submissions, evaluate that experience, and 
develop recommendations on how electronic submissions can be used 
most efficiently in the P/T program. If electronic submissions can 
be successfully incorporated, CDER may consider acceptance of only 
electronic submissions. (See 59 FR 45160, August 31, 1994.) During 
the initial phase of the pilot program, CDER has a goal of receiving 
at least 10 toxicology study reports electronically. CDER now has 
sufficient LAN capacity and staff experience to review these 
submissions. CDER plans to complete the initial phase of the pilot 
project and issue a final report with recommendations by the end of 
1995.

III. General Specifications for the Electronic Submission of 
Pharmacology and Toxicology Reports

A. Eligible Submissions

    All preclinical P/T study reports are eligible for electronic 
submission. A paper copy must also be submitted.

B. Desirable Electronic Capabilities

    --Complete text, tables, and graphics.
    --Word search capability within a document and, if possible, 
between documents.
    --Copy, print, cut, and paste capability.
    --Index and abstract or document summary containing major 
subject and topic key words to facilitate document search and 
retrieval.

C. Hardware Specifications

    --Optical disks (CDROM).
    --Read only DOS diskettes.
    --DOS 6.0 compatible hard disks.
    --Tape, 4/8 millimeter.
    --Hardware should be discussed with the Division of Information 
Systems Design (DISD) before submission.

D. Software Specifications

    --WordPerfect 5.1 (DOS) or 6.0a (for Windows) or Microsoft Word 
6.0.
    --ASCII text with associated graphic format files (e.g., TIFF or 
equivalent for tables and graphics).
    --Text/tabular format for tables is preferred.

E. Reviewer Access

    Electronic submissions will be loaded into the CDER LAN by DISD. 
Electronic submissions will be accessible on personal computer 
workstations by authorized reviewers via the CDER LAN.

    Dated: August 23, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-21452 Filed 8-29-95; 8:45 am]
BILLING CODE 4160-01-F