[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Notices]
[Pages 35450-35451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0432]


Draft Guidance for Industry on Clinical Trial Endpoints for the 
Approval of Non-Small Cell Lung Cancer Drugs and Biologics; 
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availability of a draft guidance for industry entitled ``Clinical Trial 
Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and 
Biologics.'' This draft guidance provides recommendations to applicants 
on endpoints for lung cancer clinical trials submitted to FDA to 
support effectiveness claims in new drug applications, biologics 
license applications, or supplemental applications. This draft guidance 
should speed the development and improve the quality of protocols 
submitted to the Agency to support anticancer effectiveness claims.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 16, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, 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. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written

[[Page 35451]]

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: 
Rajeshwari Sridhara, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3512, 
Silver Spring, MD 20903-0002, 301-796-2070;
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell 
Lung Cancer Drugs and Biologics.'' FDA is developing guidance on 
oncology endpoints through a process that includes public workshops of 
oncology experts and discussions before FDA's Oncologic Drugs Advisory 
Committee (ODAC). This draft guidance considers the discussions 
regarding lung cancer endpoints from the April 15, 2003, workshop and 
the December 16, 2003, ODAC meeting. Applicants are encouraged to use 
this guidance to design clinical trials for the treatment of lung 
cancer and to discuss protocols with the Agency. This draft guidance is 
a companion to the guidance for industry entitled ``Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics;'' \1\ it is 
the first in a series of oncology indication-specific guidances, and 
focuses on endpoints for lung cancer to support drug approval or 
labeling claims. The endpoints discussed in this draft guidance are for 
drugs to treat patients with lung cancer. This guidance does not 
address endpoints for drugs to prevent or decrease the incidence of 
lung cancer.
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    \1\ ``See the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.''
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    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on clinical 
trial endpoints for the approval of non-small cell lung cancer drugs 
and biologics. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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 parts 312, 314, and 601 
have been approved under OMB control numbers 0910-0014, 0910-0001, and 
0910-0338, respectively.

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 document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: June 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15089 Filed 6-16-11; 8:45 am]
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