[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Pages 29739-29740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14310]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0317]
Draft ``Guidance for Industry: Electronic Submissions of Case
Report Forms (CRF's), Case Report Tabulations (CRT's) and Data to the
Center for Biologics Evaluation and Research;'' 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availability of a draft guidance document entitled ``Guidance for
Industry: Electronic Submissions of Case Report Forms (CRF's), Case
Report Tabulations (CRT's) and Data to the Center for Biologics
Evaluation and Research.'' This draft guidance document, when
finalized, is intended to provide guidance to industry regarding the
submission of electronic CRF's and CRT's as part of license
applications to the Center for Biologics Evaluation and Research
(CBER). This draft guidance document is part of CBER's effort to
provide an efficient process for electronic submissions of regulatory
information relating to the development and marketing of biological
products. Submissions in electronic format are voluntary.
DATES: Written comments may be submitted at any time, however comments
should be submitted by July 31, 1998, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Electronic
Submissions of Case Report Forms (CRF's), Case Report Tabulations
(CRT's) and Data to the Center for Biologics Evaluation and Research''
to the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike,
[[Page 29740]]
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance
document may also be obtained by mail by calling the CBER Voice
Information System at 1-800-835-4709 or 301-827-1800, or by fax by
calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
Submit written comments on the draft guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance document
entitled ``Guidance for Industry: Electronic Submissions of Case Report
Forms (CRF's), Case Report Tabulations (CRT's) and Data to the Center
for Biologics Evaluation and Research.'' The draft guidance document is
intended to describe those electronic formats that CBER is currently
able to support for review and archive of CRF's and CRT's. This draft
guidance document supersedes two previous draft guidance documents
entitled ``Guidance for Industry: Electronic Submissions of Case Report
Forms and Case Report Tabulations'' (November 1996), and ``Guidance for
Industry: Submitting Application Archival Copies in Electronic Format''
(November 1996).
This draft guidance document represents the agency's current
thinking on electronic submissions of case report forms, case report
tabulations and data to CBER. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirement of the applicable statute, regulations, or both. As with
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to
all situations. The document is intended to provide information and
does not set forth requirements. This draft guidance document applies
only to submissions made to CBER and not to the Center for Drug
Evaluation and Research.
II. Request for Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Dockets Management Branch (address
above) written comments regarding this draft guidance document. Written
comments may be submitted at any time, however, comments should be
submitted by July 31, 1998, to ensure adequate consideration in
preparation of the final document. Two copies of any comments are to be
submitted, except individuals may submit one copy. Comments should be
identified with the docket number found in brackets in the heading of
this document. A copy of the draft guidance document and received
comments are available for public examination in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
document using the World Wide Web (WWW). For WWW access, connect to
CBER at ``http://www.fda.gov/cber/guidelines.htm''.
Dated: May 22, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14310 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F
