[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Clinical Trial Endpoints for the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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Clinical Trial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 This draft guidance provides recommendations to applicants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 This draft guidance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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 16, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.
---------------------------------------------------------------------------
\1\ ``See the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.''
---------------------------------------------------------------------------
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]
BILLING CODE 4160-01-P