[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