[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Pages 27583-27584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12650]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0528]
``Guidance for Industry: Efficacy Studies to Support Marketing of
Fibrin Sealant Products Manufactured for Commercial Use''; 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 document entitled ``Guidance for Industry:
Efficacy Studies to Support Marketing of Fibrin Sealant Products
Manufactured for Commercial Use.'' FDA intends to consider, for
licensure of commercially-produced fibrin sealants, data from pivotal
studies in which the primary endpoint is hemostasis effectiveness. This
document is intended to provide guidance to manufacturers of fibrin
sealant products for the design of clinical trials intended to support
licensure.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance for Industry: Efficacy Studies to Support
Marketing of Fibrin Sealant Products Manufactured for Commercial Use''
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, Rockville, MD 20852-1448.
Send one self-addressed adhesive label to assist that office in
processing your requests. The 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 guidance document.
Submit written comments on the guidance document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
[[Page 27584]]
I. Background
FDA is announcing the availability of a guidance document entitled
``Guidance for Industry: Efficacy Studies to Support Marketing of
Fibrin Sealant Products Manufactured for Commercial Use.'' This
document provides guidance regarding clinical data used to support
licensure of safe and effective commercially-produced fibrin sealants
in the United States.
The guidance document announced in this notice replaces the draft
guidance entitled ``Guidance for Industry: Efficacy Studies to Support
Marketing of Fibrin Sealant Products Manufactured for Commercial Use''
that was announced in the Federal Register of January 26, 1998 (63 FR
3750).
The guidance document represents the FDA's current thinking on
efficacy studies to support marketing of fibrin sealant products
manufactured for commercial use. 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 guidance
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.
II. Comments
Interested persons, may at any time, submit written comments to the
Dockets Management Branch (address above) regarding this guidance
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 the brackets in the heading of this document. A
copy of the 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 guidance
document using the World Wide Web (WWW). For WWW access, connect to
CBER at ``http://www.fda.gov/cber/guidelines.htm''.
Dated: May 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12650 Filed 5-19-99; 8:45 am]
BILLING CODE 4160-01-F