Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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 The draft guidance document provides recommendations to sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine on critical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 The draft guidance applies to therapeutic cancer vaccines that are intended to be administered to patients with an existing cancer for the purpose of treatment. The draft guidance does not apply to products intended to be administered to patients to prevent or decrease the incidence of cancer and does not apply to adoptive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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 17, 2009.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                         Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401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                           ( print 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