[Federal Register Volume 74, Number 180 (Friday, September 18, 2009)]
[Notices]
[Pages 47947-47948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22531]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0427]


Draft Guidance for Industry: Clinical Considerations for 
Therapeutic Cancer Vaccines; 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: 
Clinical Considerations for Therapeutic Cancer Vaccines'' dated 
September 2009. The draft guidance document provides recommendations to 
sponsors who wish to submit an Investigational New Drug application 
(IND) for a therapeutic cancer vaccine on critical clinical 
considerations for investigational studies of these products. The draft 
guidance applies to therapeutic cancer vaccines that are intended to be 
administered to patients with an existing cancer for the purpose of 
treatment. The draft guidance does not apply to products intended to be 
administered to patients to prevent or decrease the incidence of cancer 
and does not apply to adoptive immunotherapeutic products such as T 
cell or NK cell products.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 17, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the draft guidance to the Division of 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, 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 draft document entitled 
``Guidance for Industry: Clinical Considerations for Therapeutic Cancer 
Vaccines'' dated September 2009. The draft guidance document provides 
recommendations to sponsors who wish to submit an IND for a therapeutic 
cancer vaccine on critical clinical considerations for early and late 
phase investigational studies intended to support a biologics license 
application. Development of a therapeutic cancer vaccine can present 
different considerations for clinical trial design than development of 
a traditional cytotoxic drug or biological product, due to differences 
in the proposed

[[Page 47948]]

mechanisms of action. The draft guidance applies to therapeutic cancer 
vaccines intended to be administered to patients with an existing 
cancer for the purpose of treatment. It does not apply to products 
intended to be administered to patients to prevent or decrease the 
incidence of cancer. Also, it does not apply to adoptive 
immunotherapeutic products such as T cell or NK cell products.
    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 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

    The draft 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 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; and the collections of information in 21 
CFR part 50 on informed consent have been approved under OMB control 
number 0910-0130.

III. 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 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 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: September 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22531 Filed 9-17-09; 8:45 am]
BILLING CODE 4160-01-S