[Federal Register Volume 59, Number 208 (Friday, October 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26729]


[Federal Register: October 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92D-0296]


Guidance Manual for Computer Assisted New Drug Applications; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the revised guidance manual entitled ``Computer 
Assisted New Drug Application (CANDA) Guidance Manual.'' This manual 
was developed by FDA's Center for Drug Evaluation and Research (CDER), 
in conjunction with the pharmaceutical industry. The manual provides 
guidance for the submission of computer assisted new drug applications 
(CANDA's), investigational new drug applications (IND's), and 
abbreviated new drug applications (ANDA's).

DATES: Written comments by February 15, 1995.

ADDRESSES:  Submit written requests for single copies of the guidance 
manual to the CDER Executive Secretariat Staff (HFD-8), Center for Drug 
Evaluation and Research, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to 
assist that office in processing your request. Submit written comments 
on the guidance manual to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, rm. 1-24, 12420 Parklawn Dr., Rockville, MD 
20857. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document. A copy of the 
guidance manual and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday. Instructions for obtaining the guidance manual 
electronically can be found in the ``Supplementary Information'' 
section of this document.
FOR FURTHER INFORMATION CONTACT: David M. Moss, Center for Drug 
Evaluation and Research (HFD-70), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-2836.

SUPPLEMENTARY INFORMATION: Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) requires drug sponsors to submit new drug 
applications (NDA's) to FDA for review and approval before marketing in 
the United States. FDA's review processes culminate in a risk-benefit 
assessment and regulatory decision. To arrive at a substantive risk-
benefit assessment and confident regulatory decision, the agency must 
evaluate all information and data provided via the application 
supporting safety, efficacy, and/or other claims.
    The agency has been assessing the use of automation technology to 
support and assist in premarketing review processes and has found that 
technology holds the potential for enhancing review process quality and 
efficiencies. Consequently, the agency supports the use of electronic 
submissions by the pharmaceutical industry.
    In the Federal Register of October 9, 1992 (57 FR 46565), FDA 
published a notice announcing that the draft guidance manual for 
CANDA's was available in hard copy and electronically. The guidance 
manual provides general guidance to assist the pharmaceutical industry 
in preparing and submitting CANDA's that are effective and capable of 
being evaluated. In the Federal Register of April 8, 1993 (59 FR 
18218), the agency published a notice announcing the procedures for 
revising the draft guidance manual, and that the revised guidance 
manual would be available electronically.
    Please note that an accompanying paper submission of the 
application remains a requirement at this time. The electronic version 
should correspond exactly to the paper version; where it does not, the 
differences are to be specified. Currently, assessment of electronic 
submissions versus paper submissions is underway.
    The ``CANDA Guidance Manual'' discusses procedures of general 
applicability that are acceptable to the agency, but are not legal 
requirements. The ``CANDA Guidance Manual'' does not bind the agency, 
nor does it create or confer any rights, privileges, benefits, or 
obligations for or on any person.
    The agency will distribute copies free of charge since the 
electronic submission program is evolving and the manual provides 
recommended interim guidance and procedures, and does not mandate 
electronic submission specifications.
    An electronic version of the guidance manual is available via 
Internet. Requestors should connect to the CDER FTP server using the 
FTP protocol. The manual and updates are available in the sub-directory 
``CANDA'' in both WordPerfect Version 5.2 and an ASCII version. 
Individual chapters are also available. The file READ.ME in the CANDA 
sub-directory lists the file names of the WordPerfect and ASCII 
versions of the entire document and each chapter.

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   Sample for the CANDA Guidance       Sample for Updates To the CANDA  
               Manual                          Guidance Manual          
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FTP CDV2.CDER.FDA.GOV..............  FTP CDV2.CDER.FDA.GOV              
LOGIN ANONYMOUS....................  LOGIN ANONYMOUS                    
.....................                       
BINARY.............................  CD CANDA                           
CD CANDA...........................  GET CANDA.UPDATE                   
GET CANDA.WPC......................                                     
EXIT...............................  EXIT                               
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    Interested persons may, on or before February 15, 1995, submit 
written comments on the guidance manual to the Dockets Management 
Branch (address above). FDA will consider these comments in determining 
whether further revisions to the draft guidance manual are warranted. 
Two copies of any comments should be submitted, except that individuals 
may submit one copy.

    Dated: October 24, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-26729 Filed 10-27-94; 8:45 am]
BILLING CODE 4160-01-F