05-3106. Draft Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications” dated February 2005. The draft guidance document is intended to assist manufacturers and/or sponsors in the development and testing of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The draft guidance, when finalized, will update and replace the guidance document entitled “Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications” dated December 1996.

DATES:

Submit written or electronic comments on the draft guidance by May 19, 2005, to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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 The draft guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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:

Joseph L. Okrasinski, Jr., 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 draft document entitled “Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications” dated February 2005. The draft guidance is intended to assist manufacturers and/or sponsors in the development and testing of DNA vaccines to prevent infectious diseases. The document describes the manufacturing information that should be submitted to CBER for a new DNA vaccine product for clinical study under an investigational new drug application (IND). Plasmid DNA products intended for non-infectious therapeutic indications are not addressed in the draft guidance. The draft guidance, when finalized, will update and replace the guidance document entitled “Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications” dated December 1996.

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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

The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit written or electronic comments to ensure adequate consideration in preparation of the final 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 draft 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. The Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection(s) of information mentioned in the guidance regarding the submission of manufacturer's information in an IND was approved under OMB control number 0910-0014.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: February 8, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.