[Federal Register: June 1, 1998 (Volume 63, Number 104)] [Notices] [Page 29739-29740] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01jn98-106] ----------------------------------------------------------------------- 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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Electronic Submissions of Case Report Forms (CRF's), Case Report Tabulations (CRT's) and Data to the Center for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 This draft guidance document, when finalized, is intended to provide guidance to industry regarding the submission of electronic CRF's and CRT's as part of license applications to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 This draft guidance document is part of CBER's effort to provide an efficient process for electronic submissions of regulatory information relating to the development and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 ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ``Guidance for Industry: Electronic Submissions of Case Report Forms (CRF's), Case Report Tabulations (CRT's) and Data to the Center for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 The draft guidance document may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax by calling the FAX Information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