[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Page 59259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0414]


Guidance for Industry on Food and Drug Administration Review of 
Vaccine Labeling Requirements for Warnings, Use Instructions, and 
Precautionary Information; 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: FDA Review 
of Vaccine Labeling Requirements for Warnings, Use Instructions, and 
Precautionary Information,'' dated September 2004. The guidance 
document provides to vaccine manufacturers, medical practitioners, and 
consumers an overview of the vaccine labeling review process, a 
description of FDA's review of childhood vaccine labeling, and a 
discussion of the type of data FDA examines when determining the 
adequacy of vaccine labeling.

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, 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 the CBER Voice Information System 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 http://www.fda.gov/dockets/ecomments.

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

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: FDA Review of Vaccine Labeling Requirements 
for Warnings, Use Instructions, and Precautionary Information,'' dated 
September 2004. The guidance document provides to vaccine 
manufacturers, medical practitioners, and consumers an overview of the 
vaccine labeling review process, a description of FDA's review of 
childhood vaccine labeling under section 314 of the National Childhood 
Vaccine Injury Act (NCVIA), and a discussion of the type of data FDA 
examines when determining the adequacy of vaccine labeling. The 
processes described represent current FDA practices and do not 
represent any new interpretation of existing labeling statutes, 
regulations, or guidances.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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

    In accordance with 21 CFR 10.115(g)(4)(i), FDA is immediately 
implementing this guidance. Interested persons may, at any time, submit 
written or electronic comments to the Division of Dockets Management 
(see ADDRESSES) regarding this 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, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22213 Filed 10-1-04; 8:45 am]
BILLING CODE 4160-01-S