[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]


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

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.

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

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