[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Notices]
[Pages 8378-8379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3106]
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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Draft Guidance for Industry: Considerations for Plasmid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 The draft guidance document is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 The draft guidance, when finalized, will update and replace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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be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electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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://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://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.
[FR Doc. 05-3106 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S