[Federal Register Volume 72, Number 208 (Monday, October 29, 2007)]
[Notices]
[Page 61172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0047]


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 document entitled ``Guidance for Industry: 
Considerations for Plasmid DNA Vaccines for Infectious Disease 
Indications'' dated November 2007. The guidance document is intended to 
assist manufacturers and sponsors in the development of 
deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. 
The guidance supersedes the guidance document entitled ``Points to 
Consider on Plasmid DNA Vaccines for Preventive Infectious Disease 
Indications'' dated December 1996. In addition, the guidance announced 
in this notice finalizes the draft guidance of the same title dated 
February 2005.

DATES: Submit written or electronic comments on agency guidances at any 
time. 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, suite 200N, 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 CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

ADDRESSES: 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: Joseph L. Okrasinski, Jr., Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Considerations for Plasmid DNA Vaccines for 
Infectious Disease Indications,'' dated November 2007. The guidance is 
intended to assist manufacturers and sponsors in the development of DNA 
vaccines to prevent infectious diseases. The document describes the 
manufacturing information that should be submitted to CBER for a new 
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 guidance. This 
guidance supersedes the guidance document entitled ``Points to Consider 
on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' 
dated December 1996. In addition, the guidance announced in this notice 
finalizes the draft guidance dated February 2005.
    In the Federal Register of February 18, 2005 (70 FR 8378), FDA 
announced the availability of the draft guidance of the same title 
dated February 2005. FDA received several comments on the draft 
guidance, and those comments were considered as the guidance was 
finalized. In addition, editorial changes were made to improve clarity.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA'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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 of information mentioned in the guidance regarding the 
submission of manufacturer's information in an IND was approved under 
OMB control number 0910-0014.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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.

IV. 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: October 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21266 Filed 10-26-07; 8:45 am]
BILLING CODE 4160-01-S