[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68768-68769]
From the Federal Register Online via the Government Publishing 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The guidance announced in this notice finalizes the draft guidance of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]
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