[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Page 29742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0315]
Draft ``Guidance for Industry: Instructions for Submitting
Electronic Lot Release Protocols 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availability of a draft guidance document entitled ``Guidance for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: Instructions for Submitting Electronic Lot Release Protocols
to the Center for Biologics Evaluation and Research.'' The draft
guidance document, when finalized, is intended to provide instructions
to manufacturers regarding the submission of the electronic protocols
to the Center for Biologics Evaluation and Research (CBER). This draft
guidance document is part of CBER's continuing effort to develop an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 guidance document.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Instructions for
Submitting Electronic Lot Release Protocols 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, Food and Drug Administration, 1401 Rockville Pike, 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 The draft guidance document may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. 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comments on the draft guidance document to the Dockets Management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. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, 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: Instructions for Submitting
Electronic Lot Release Protocols to the Center for Biologics Evaluation
and Research.'' Under 21 CFR 610.2(a), samples of any lot of licensed
product, together with the protocols showing results of applicable
tests, may at any time be required to be submitted to CBER for review
and confirmatory testing. This draft guidance document, when finalized,
is intended to assist those manufacturers who choose to submit the
required protocols electronically.
This draft guidance document represents the agency's current
thinking with regard to the submission of electronic lot release
protocols. 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 draft guidance document to be all-
inclusive and cautions that not all information may be applicable to
all situations. The draft guidance document is intended to provide
information and does not set forth requirements.
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 guidance document. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments and requests for copies 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 by 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. 98-14312 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F