[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Notices]
[Pages 68269-68270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0400]


Points to Consider on Plasmid DNA Vaccines for Preventive 
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 points to consider (PTC) document entitled ``Points 
to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease 
Indications.'' The PTC document is intended to provide manufacturers 
with preliminary guidance regarding the manufacture and preclinical 
evaluation of plasmid deoxyribonucleic acid (DNA) vaccines intended for 
clinical studies in preventive infectious disease indications and to 
assist manufacturers in the preparation of investigational new drug 
(IND) applications for use of these vaccines. This document is also 
intended to assist manufacturers with their product development plans 
for preventive vaccines for infectious diseases.

DATES: Written comments may be submitted at any time; however, to 
ensure comments are considered in any future revisions they should be 
submitted by February 25, 1997.

ADDRESSES: Submit written requests for single copies of ``Points to 
Consider on Plasmid DNA Vaccines for Preventive Infectious Disease 
Indications'' 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 that office in processing your requests. The document may also 
be obtained by mail by calling the CBER Voice Information System at 1-
800-835-4709 or 301-827-1800, or by fax by calling the FAX Information 
System at 1-888-CBER-FAX or 301-827-3844. Persons with access to the 
INTERNET may obtain the document using the World Wide Web (WWW) or 
bounce-back e-mail. For WWW access, connect to CBER at ``http://
www.fda.gov/cber/cberftp.html''. To receive the document by bounce-back 
e-mail, send a message to ``[email protected]''. Submit written 
comments on the PTC document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Two copies of any comments are to be submitted, 
except individuals may submit one copy. Requests and comments should be 
identified with the docket number found in brackets in the heading of 
this notice. A copy of the PTC document and received comments are 
available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a PTC 
document entitled ``Points to Consider on Plasmid DNA Vaccines for 
Preventive Infectious Disease Indications.'' Plasmid DNA vaccines are 
defined as purified preparations of plasmid DNA designed to contain a 
gene or genes for the intended vaccine antigen as well as genes 
incorporated into the construct to allow for production in a suitable 
host system. The use of purified preparations of plasmid DNA 
constitutes a new approach to vaccine development.
    The following topics are addressed in the PTC document to assist 
manufacturers with their product development plans: (1) CBER's approach 
to regulation of plasmid DNA preventive vaccines; (2) product 
considerations for an IND submission; (3) considerations for plasmid 
DNA vaccine modifications; (4) preclinical immunogenicity and safety 
evaluation; (5) use of adjuvants and devices to deliver the vaccine; 
(6) pre-IND meetings; and (7) IND submissions.
    This PTC document is intended to provide manufacturers with 
information regarding concerns that are associated with the new 
technology of plasmid DNA preventive vaccines and to provide early 
guidance to the regulated industry. The goal is to create a regulatory 
environment that will encourage innovation and at the same time ensure 
that products are both safe and effective.
    As with other PTC documents, FDA does not intend this PTC document 
to be all-inclusive and cautions that not all information may be 
applicable to all situations. The PTC document is intended to provide 
information and does not set forth requirements. FDA anticipates that 
manufacturers and other interested parties may develop alternative 
methods and procedures, and discuss them with FDA. FDA recognizes that 
advances will continue in the area of plasmid DNA vaccines and intends 
to update and revise the document in order to improve its usefulness.
    Although the PTC document does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public, it 
does represent CBER's current thinking regarding issues related to 
plasmid DNA vaccines.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding the PTC 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the PTC document and received comments are available for public 
examination in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.
    Received comments will be considered in determining whether

[[Page 68270]]

further revision of the PTC document is warranted.

    Dated: December 16, 1996.
William K. Hubbard.
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32930 Filed 12-26-96; 8:45 am]
BILLING CODE 4160-01-F