[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
