
[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68768-68769]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry: Clinical Considerations for Therapeutic 
Cancer Vaccines; 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: Clinical 
Considerations for Therapeutic Cancer Vaccines'' dated October 2011. 
The guidance document provides sponsors who wish to submit an 
Investigational New Drug application (IND) for a therapeutic cancer 
vaccine with recommendations on critical clinical considerations for 
investigational studies of these products. The guidance also provides 
recommendations for the design of clinical trials for cancer vaccines 
conducted under an IND to support a subsequent biologics license 
application (BLA) for marketing approval. The guidance applies to 
therapeutic cancer vaccines that are intended for the treatment of 
patients with an existing diagnosis of cancer. The guidance does not 
apply to vaccines for preventative and therapeutic infectious disease 
indications, to products intended to induce or augment a non-specific 
immune response, or to products intended to prevent or decrease the 
incidence of cancer in individuals without a prior history of that 
cancer. Furthermore, the guidance does not apply to adoptive 
immunotherapeutic products which may mediate their therapeutic effect 
by targeting the tumor directly, such as T cell or NK cell products. 
The guidance announced in this notice finalizes the draft guidance of 
the same title dated September 2009.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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 document entitled 
``Guidance for Industry: Clinical Considerations for Therapeutic Cancer 
Vaccines,'' dated October 2011. The guidance document provides sponsors 
who wish to submit an IND for a therapeutic cancer vaccine with 
recommendations on critical clinical considerations for investigational 
studies of these products. Further, the guidance provides 
recommendations for the design of clinical trials for cancer vaccines 
conducted under an IND (Title 21 Code of Federal Regulations (21 CFR) 
part 312) to support a subsequent BLA for marketing approval. The 
guidance is applicable to therapeutic cancer vaccines that are intended 
for the treatment of patients with an existing diagnosis of cancer. The 
guidance does not apply to vaccines for preventative and therapeutic 
infectious disease indications, to products intended to induce or 
augment a non-specific immune response, or to products intended to 
prevent, or decrease the incidence of cancer in individuals without a 
prior history of that cancer. Furthermore, the guidance does not apply 
to adoptive immunotherapeutic products which may mediate their 
therapeutic effect by targeting the tumor directly, such as T cell or 
NK cell products.
    FDA has held or participated in several meetings to discuss 
development of cancer vaccines. For example, on February 8-9, 2007, 
CBER co-sponsored a workshop with the National Cancer Institute 
entitled ``Bringing Therapeutic Cancer Vaccines and Immunotherapies 
through Development to Licensure.'' In consideration of the input FDA 
received from stakeholders, the guidance provides recommendations for 
the design of clinical trials for cancer vaccines conducted under an 
IND to support a subsequent BLA for marketing approval.
    In the Federal Register of September 18, 2009 (74 FR 47947), FDA 
announced the availability of the draft guidance of the same title 
dated September 2009. FDA received numerous comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. Changes incorporated in the final guidance included adding 
new sections in response to comments, clarification of assay 
standardization, and additional references were included. In addition, 
organizational and editorial changes were made to improve clarity. The 
guidance announced in this notice finalizes the draft guidance dated 
September 2009.
    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 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; and the collection of information in 21 
CFR part 50 on informed consent laws

[[Page 68769]]

have been approved under OMB control number 0910-0130.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28726 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P


