[Federal Register Volume 72, Number 187 (Thursday, September 27, 2007)]
[Notices]
[Page 54917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0155]


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.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Toxicity 
Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in 
Preventive Vaccine Clinical Trials,'' dated September 2007. The 
guidance document 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 guidance includes toxicity grading 
scale tables to use as a guideline for selecting the assessment 
criteria. The guidance announced in this notice finalizes the draft 
guidance of the same title dated April 2005.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist the office 
in processing your requests. The guidance may also be obtained by mail 
by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the 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 either 
http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.

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 document entitled 
``Guidance for Industry: Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials,'' 
dated September 2007. The guidance provides sponsors of vaccine trials 
with toxicity grading scale tables as a guideline when selecting the 
criteria to assess the severity of clinical and laboratory 
abnormalities in healthy adult and adolescent volunteers enrolled in 
clinical trials of a preventive vaccine. FDA recommends the 
incorporation of such appropriate, uniform criteria into the 
investigational plan, case report forms, and study reports and 
correspondence with FDA, sponsors, monitors, investigators, and 
institutional review boards. The parameters in the tables are not 
necessarily applicable to 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.
    In the Federal Register of May 2, 2005 (70 FR 22664), FDA announced 
the availability of the draft guidance of the same title dated April 
2005. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. A summary of 
changes includes: (1) Clarification of the clinical toxicity parameters 
and (2) revision of laboratory parameter limit values based on 
additional published data. The guidance announced in this notice 
finalizes the draft guidance dated April 2005.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA'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 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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 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 guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19155 Filed 9-26-07; 8:45 am]
BILLING CODE 4160-01-S