[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Notices]               
[Page 8378-8379]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe05-82]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0047]

 
Draft Guidance for Industry: Considerations for Plasmid 
Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; 
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 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 The draft guidance document is 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 The draft guidance, when finalized, will update and replace 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may also be 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electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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.

[[Page 8379]]

    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: February 8, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3106 Filed 2-17-05; 8:45 am]

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