[Federal Register Volume 70, Number 83 (Monday, May 2, 2005)]
[Notices]
[Pages 22664-22665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0155]


Draft ``Guidance for Industry: Toxicity Grading Scale for Healthy 
Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials;'' Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 22665]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials,'' dated April 2005. The 
draft guidance provides sponsors of vaccine trials with recommendations 
on assessing the severity of clinical and laboratory abnormalities in 
healthy adult and adolescent volunteers enrolled in clinical trials. In 
particular, the draft guidance includes toxicity grading scale tables 
to use as a guideline for selecting the assessment criteria.

DATES: Submit written or electronic comments on the draft guidance by 
August 1, 2005 to ensure their adequate consideration in preparation of 
the final guidance. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 the 
office in processing your requests. The draft guidance may also be 
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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.

FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'' 
dated April 2005. The draft guidance provides sponsors of vaccine 
trials with toxicity grading scale tables as a guideline for selecting 
the criteria to assess the severity of clinical and laboratory 
abnormalities in healthy adult and adolescent volunteers enrolled in 
clinical trials. The parameters in the tables are not necessarily 
warranted for every clinical trial of healthy volunteers. The 
parameters monitored should be appropriate for the specific study 
vaccine. In addition, the use of toxicity grading scales to categorize 
adverse events observed during clinical trials does not replace 
regulatory requirements to monitor, investigate, and report adverse 
events.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
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 
statutes and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final guidance. Submit a single copy of electronic 
comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in the brackets in the heading of this 
document. A copy of 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 the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8634 Filed 4-29-05; 8:45 am]
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