[Federal Register Volume 65, Number 125 (Wednesday, June 28, 2000)]
[Notices]
[Page 39912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16294]



[[Page 39912]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1318]


Draft Guidance for Industry on Chronic Cutaneous Ulcer and Burn 
Wounds--Developing Products for Treatment; 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availability of a draft guidance for industry entitled ``Chronic 
Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment.'' 
This draft document is intended to provide guidance on the development 
of drug and biological products intended to treat venous stasis ulcers, 
diabetic foot ulcers, pressure ulcers, and burn wounds. The draft 
guidance contains recommendations about labeling claims, outcome 
measures, trial design, and special considerations for preclinical 
development.

DATES: Submit written comments on the draft guidance by August 28, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. For information on how to obtain 
copies, see the Supplementary Information section of this document.

FOR FURTHER INFORMATION CONTACT:
Maryjane Walling, Center for Drug Evaluation and Research (HFD-105), 
Food and Drug Administration, 9201 Corporate Blvd., Rockville, MD 
20850, 301-827-2268;
Bette A. Goldman, Center for Biologics Evaluation and Research (HFM-
500), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-5098; or
Charles N. Durfor, Center for Devices and Radiological Health (HFZ-
410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-594-3090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Chronic Cutaneous Ulcer and Burn Wounds--Developing Products 
for Treatment.'' This draft document is intended to provide guidance on 
the development of drug and biological products intended to treat 
venous stasis ulcers, diabetic foot ulcers, pressure ulcers, and burn 
wounds. The draft guidance contains recommendations about labeling 
claims, outcome measures, trial design, and special considerations for 
preclinical development.
    Extensive discussions were held during two advisory committee 
meetings in July and November 1997 about the treatment of ulcers and 
burns. In response to requests from industry, the agency has developed 
this draft guidance. The comments received from industry, professional 
societies, and consumer groups represented at those meetings have been 
taken into consideration in drafting this guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The draft guidance 
represents the agency's current thinking on clinical development of 
products for the treatment of chronic cutaneous ulcer and burn wounds. 
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 requirements of the applicable 
statutes, regulations, or both.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance 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. How to Obtain Copies

    You may submit written requests for single copies of the draft 
guidance by sending one self-addressed adhesive label to assist the 
office in processing your request to:
The Office of Training and Communications,
Division of Communications Management,
Drug Information Branch (HFD-210),
Center for Drug Evaluation and Research,
Food and Drug Administration,
5600 Fishers Lane,
Rockville, MD 20857;
    Or
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,
CBER Voice Information System: 1-800-835-4709 or 301-827-1800
Fax: 1-888-CBER-FAX or 301-827-3844;
    Or
The Division of Small Manufacturers Assistance (HFZ-220),
Center for Devices and Radiological Health,
Food and Drug Administration,
1350 Piccard Dr.,
Rockville, MD 20850,
Phone: 800-638-2041,
E-mail: [email protected],
Fax: 1-301-443-8818,
Facts-On-Demand: 800-899-0381.
    An electronic version of the draft guidance also is available via 
the Internet at CDER's Internet site at http://www.fda.gov/cder/guidance/index.htm or at CBER's Internet site at http://www.fda.gov/cber/guidelines.htm.

    Dated: June 16, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-16294 Filed 6-27-00; 8:45 am]
BILLING CODE 4160-01-F