[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Notices]
[Pages 11644-11645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6742]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0022]


Computer Assisted Product License Application (CAPLA) Guidance 
Manual (March 1996); 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 a guidance manual entitled ``Computer Assisted Product 
License Application (CAPLA) Guidance Manual (March 1996).'' This 
guidance manual was developed by FDA's Center for Biologics Evaluation 
and Research (CBER). The manual provides guidance for the submission of 
computer assisted license applications. The guidance manual is intended 
to increase the efficiency and quality of the review process for 
applicants and FDA. The manual also supersedes a previous Points to 
Consider guidance made available in November 1990.

DATES: Written comments by June 19, 1996.

ADDRESSES: Submit written requests for single copies of the guidance 
manual entitled ``Computer Assisted Product License Application (CAPLA) 
Guidance Manual (March 1996)'' to the Division of Congressional and 
Public Affairs (HFM-11), Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448. Send two self-addressed adhesive labels to assist that office in 
processing your requests. The guidance manual may also be obtained by 
mail or FAX by calling the Center for Biologics Evaluation and Research 
Voice Information System at 1-800-835-4709.
    Additionally, persons with access to the INTERNET may obtain the 
guidance manual in several ways. Users of ``Web Browser'' software, 
such as Mosaic, Netscape, or Microsoft Internet Explorer may obtain 
this document via the World Wide Web by using the following Uniform 
Resource Locators:
http://www.fda.gov/cber/cberftp.html
ftp://ftp.fda.gov/CBER/
 The document may also be obtained via File Transfer Protocol (FTP). 
Requesters should connect to FDA's FTP Server, FTP.FDA.GOV 
(192.73.61.21). CBER's documents are maintained in a subdirectory 
called ``CBER'' on the server. Logins with the user name of anonymous 
are permitted, and the user's e-mail address should be sent as the 
password. The ``READ.ME'' file in that subdirectory describes the 
available documents which may be available as an ASCII text file 
(*.TXT), or a WordPerfect 5.1 or 6.x document (*.w51,wp6), or both. 
Finally, the document can be obtained by ``bounce-back e-mail''. A 
message should be sent to: ``[email protected]''.
    Submit written comments on the guidance manual to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm 1-23, Rockville, MD 20857. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
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.
FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics 
Evaluation and Research (HFM-630), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: One of FDA's continuing objectives is to 
improve the speed and quality of its biologics licensing review and 
approval program. In order to reach a decision to approve a license 
application the agency must evaluate all information and data provided 
by applicants that support the safety, purity, potency, and efficacy of 
the proposed product. To make the review process more efficient for 
industry and FDA, CBER is utilizing electronic information systems 
technology. FDA believes the increased use of CAPLA's and 
computerization will enhance the timeliness, effectiveness, and 
efficiency of the biologics review process and reduce burdensome, 
nonessential hard-copy handling and storage.
    In the Federal Register of November 20, 1990 (55 FR 48291), FDA 
announced the availability of a document entitled ``Points to Consider 
(PTC): Computer Assisted Submissions for License Applications.'' Since 
the publication of that document, CBER has gained considerable 
experience and expertise in the area of electronic information 
transfer. FDA is announcing in this Federal Register notice a document 
entitled ``Computer Assisted Product License Application (CAPLA) 
Guidance Manual (March 1996).'' This new manual supersedes the 1990 PTC 
document, and should be used as guidance by applicants for 
electronically submitting license applications or new drug applications 
(NDA's) to CBER.
    A CAPLA is any electronic submission, ranging from a single 
diskette containing data files to a complete system including custom 
software and sponsor-owned hardware. Over time, CBER expects CAPLA's 
will evolve from stand-alone systems to submissions containing just 
electronic information files, with no applicant provided hardware or 
software. Applicants should confer with the CBER CAPLA coordinator 
early in the development of a CAPLA to assess whether it is necessary 
to include ``commercial off the shelf'' (COTS) software products or 
custom developed tools to support the CAPLA submission. The manual 
contains a listings of preferred COTS software and CBER contacts.
    The guidance manual provides general information to applicants on 
the design, development, and submission of CAPLA's. The guidance manual 
is intended to address the special circumstances to be considered when 
an applicant electronically submits information in support of a license 
application; however, the guidance manual does not explain the 
scientific, clinical, or regulatory aspects of preparing a license 
application.
    The manual is divided into four main sections: (1) Introduction; 
(2) CAPLA design and development; (3) CAPLA delivery and operations; 
and (4) CBER's computing environment. The manual also provides 
information regarding the following topics: Joint planning between the 
applicant and CBER, cross-platform tools, clinical review, CAPLA 
guidance for biostatistical review, data presentation formats, 
communication with CBER, CBER contacts, and license application forms.
    The CAPLA guidance manual provides information regarding milestones 
that the applicant should consider when planning for CAPLA submissions. 
The following milestones are outlined in the guidance manual: (1) 12 to 
18 months before submission: confer on network system requirements; (2) 
6 months before submission: confer on CAPLA structure and content; (3) 
1 to 3 months before submission: provide demonstration or prototype 
CAPLA; (4) 30 days before submission: submit

[[Page 11645]]
confirmation; and (5) day of submission: provide certifications.
    Please note that an accompanying paper submission of the 
application remains a requirement at this time (21 CFR 601.2 and 
601.3). The information in the electronic submission should not differ 
from the information provided in the paper submission.
    As with other guidance documents, FDA does not intend this guidance 
manual to be all-inclusive. The manual is intended to provide 
information, not to set forth requirements. Applicants may follow the 
guidance or may choose to use alternative methods even though they are 
not provided in the manual. If an applicant chooses to use alternative 
methods, that applicant is encouraged to discuss the matter further 
with CBER.
    This guidance document is not binding on either FDA or persons 
submitting biological license applications or NDA's to CBER, and does 
not create or confer any rights, privileges, or benefits for or on any 
person.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the guidance manual by June 19, 
1996. Received comments will be considered in determining whether 
further revisions to the guidance manual are warranted. If the CAPLA 
guidance manual is revised or updated, a notice will be published in 
the Federal Register announcing its availability.

    Dated: March 13, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-6742 Filed 3-20-96; 8:45 am]
BILLING CODE 4160-01-F