[Federal Register Volume 69, Number 46 (Tuesday, March 9, 2004)]
[Notices]
[Pages 11024-11025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0553]


Draft Guidance for Industry on Vaccinia Virus--Developing Drugs 
to Mitigate the Complications Associated With Vaccinia Virus Used for 
Smallpox Vaccination; 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availability of a draft guidance for industry entitled ``Vaccinia 
Virus--Developing Drugs to Mitigate the Complications from Smallpox 
Vaccination.'' In this draft guidance, FDA provides recommendations on 
the development of drugs to be used to treat complications that may 
occur from smallpox vaccination with vaccinia virus. This draft 
guidance is intended to help research sponsors plan and design 
appropriate nonclinical and clinical studies during the development of 
these drugs.

[[Page 11025]]


DATES: Submit written or electronic comments on the draft guidance by 
May 10, 2004. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lewis Schrager, Center for Drug 
Evaluation and Research (HFD-970), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7265, or Debra Birnkrant, 
CDER (HFD-530) 301-827-2330.
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-6210; or
    Steve Gutman, Center for Devices and Radiological Health (HFZ-440), 
Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 
301-594-3084.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Vaccinia Virus--Developing Drugs to Mitigate the 
Complications from Smallpox Vaccination.'' This draft guidance provides 
recommendations on the development of drugs to be used to treat 
complications that may occur from smallpox vaccination with vaccinia 
virus. The study of vaccinia complications poses challenges in drug 
development, such as sparse human data. Therefore, this draft guidance 
focuses on the design and characterization of animal models and of 
clinical trials and on the use of combinations of animal and human 
data. In addition, this draft guidance addresses data collection 
encompassing both preterrorism event controlled vaccination and 
postterrorism event emergent vaccination. It also addresses the 
collection of long-term and special population safety data.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practice regulation (21 CFR 10.115). The guidance 
represents the agency's current thinking on developing drugs to 
mitigate the complications associated with vaccinia virus used for 
smallpox vaccination. 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 or regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed 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 Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain this document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5241 Filed 3-8-04; 8:45 am]
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