[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]
[Page 11024-11025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-92]
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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Draft Guidance for Industry on Vaccinia Virus--Developing Drugs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availability of a draft guidance for industry entitled ``Vaccinia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 In this draft guidance, FDA provides recommendations on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 This draft
guidance is intended to help research sponsors plan and design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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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to the draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ms/dockets/default.htm.
Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5241 Filed 3-8-04; 8:45 am]
BILLING CODE 4160-01-S