01-28884. Vaccine Adverse Event Reporting System; Revised Form VAERS-2; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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.