[Federal Register Volume 66, Number 224 (Tuesday, November 20, 2001)]
[Notices]
[Pages 58153-58154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0464]


Vaccine Adverse Event Reporting System; Revised Form VAERS-2; 
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 proposed revised form entitled ``Vaccine Adverse 
Event Reporting System'' (Form VAERS-2) dated July 2001. This proposed 
revised form is intended to facilitate electronic reporting. The form 
has been revised by deleting data fields that FDA considers redundant 
or unnecessary, and by

[[Page 58154]]

adding or revising data fields to ensure reporting clarity.

DATES: Submit written or electronic comments on the proposed revised 
Form VAERS-2 to ensure their adequate consideration in preparation of 
the final form by January 22, 2002.

ADDRESSES: Submit written requests for single copies of the proposed 
revised form 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 form may also be 
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800, or by fax by calling the FAX Information 
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the proposed revised Form 
VAERS-2.
    Submit written comments on the proposed revised form to the Dockets 
Management Branch (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: Michael Anderson, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a proposed revised form 
entitled ``Vaccine Adverse Event Reporting System'' (Form VAERS-2) 
dated July 2001. The Vaccine Adverse Event Reporting System is a 
cooperative program for vaccine safety of FDA and the Centers for 
Disease Control and Prevention. VAERS is a postmarketing safety 
surveillance program collecting information about adverse events (side 
effects) that occur after the administration of U.S. licensed vaccines. 
Reports are welcome from all concerned individuals: Patients, parents, 
health care providers, pharmacists, and vaccine manufacturers. The 
proposed revised form is intended to facilitate electronic reporting. 
The form has been revised by deleting data fields that FDA considers 
redundant or unnecessary, and by adding or revising data fields to 
ensure reporting clarity.

II. Comments

    The proposed revised form is being distributed for comment purposes 
only and is not intended for implementation at this time. Interested 
persons may submit to the Dockets Management Branch (address above) 
written or electronic comments regarding the form. Submit written or 
electronic comments on the proposed revised form to ensure their 
adequate consideration in preparation of the final form by January 22, 
2002. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the proposed revised form 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. Electronic Access

    Persons with access to the Internet may obtain the proposed revised 
form at either http://www.fda.gov/cber/vaers/report.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: November 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-28884 Filed 11-19-01; 8:45 am]
BILLING CODE 4160-01-S