[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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availability of a draft guidance document entitled ``Guidance for 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 This draft guidance document, when 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 This draft guidance document is part of CBER's effort to 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Electronic 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 The draft guidance 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