Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability, 17095 [05-6647]
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Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
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Dated: March 24, 2005.
John P. Burke, III,
CMS Paperwork Reduction Act Reports
Clearance Officer, Office of Strategic
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Regulations Development Group.
[FR Doc. 05–6534 Filed 4–1–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0112]
Draft Guidance for Industry on Clinical
Trial Endpoints for the Approval of
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availability of a draft guidance for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 Cancer
Drugs and Biologics.’’
This is the first of a series of
guidances that will provide
recommendations to sponsors on
endpoints for cancer clinical trials
submitted to FDA to support
effectiveness claims in new drug
applications (NDAs), biologics license
applications (BLAs), or supplemental
applications. Sponsors are encouraged
to use this draft guidance to design
cancer clinical trials and to discuss
protocols with the agency. This draft
guidance provides background
information and discusses general
regulatory principles. Each subsequent
guidance will focus on endpoints for
specific cancer types (e.g., lung cancer,
colon cancer) to support drug approval
or labeling claims. These guidances are
expected to speed the development and
improve the quality of protocols
submitted to the agency to support
anticancer effectiveness claims.
DATES: Submit written or electronic
comments on the draft guidance by June
3, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
VerDate jul<14>2003
15:19 Apr 01, 2005
Jkt 205001
Administration, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
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.
The draft guidance may also be obtained
by mail by calling the Center for
Biologics Evaluation and Research
Voice Information System at 1–800–
835–4709 or 301–827–1800. 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 https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Grant Williams, Center for Drug
Evaluation and Research (HFD–
150), Food and Drug
Administration, 1451 Rockville
Pike, Rockville, MD 20852, 301–
594–5758;
Patricia Keegan, Center for Drug
Evaluation and Research (HFD–
107), Food and Drug
Administration, 1451 Rockville
Pike, Rockville, MD 20852, 301–
827–5097; or
Steven Hirschfeld, Center for
Biologics Evaluation and Research
(HFM–755), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–6536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Clinical Trial Endpoints for the
Approval of 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. This draft guidance is the
first in a planned series of cancer
endpoint guidances. It provides
background information and general
principles. The endpoints discussed in
this draft guidance are for drugs to treat
patients with an existing cancer. This
draft guidance does not address
endpoints for drugs to prevent or
decrease the incidence of cancer.
This draft guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
17095
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 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
one 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. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6647 Filed 4–1–05; 8:45 am]
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HUMAN SERVICES
National Institutes of Health
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2004 (Volume 69, No. 209, pages 63159–
63160) and allowed 60 days for public
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[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Page 17095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6647]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0112]
Draft Guidance for Industry on Clinical Trial Endpoints for the
Approval of 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 Cancer Drugs and Biologics.''
This is the first of a series of guidances that will provide
recommendations to sponsors on endpoints for cancer clinical trials
submitted to FDA to support effectiveness claims in new drug
applications (NDAs), biologics license applications (BLAs), or
supplemental applications. Sponsors are encouraged to use this draft
guidance to design cancer clinical trials and to discuss protocols with
the agency. This draft guidance provides background information and
discusses general regulatory principles. Each subsequent guidance will
focus on endpoints for specific cancer types (e.g., lung cancer, colon
cancer) to support drug approval or labeling claims. These guidances
are expected to speed the development and improve the quality of
protocols submitted to the agency to support anticancer effectiveness
claims.
DATES: Submit written or electronic comments on the draft guidance by
June 3, 2005. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), 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. The draft guidance may
also be obtained by mail by calling the Center for Biologics Evaluation
and Research Voice Information System at 1-800-835-4709 or 301-827-
1800. 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 https://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Grant Williams, Center for Drug Evaluation and Research (HFD-150),
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852,
301-594-5758;
Patricia Keegan, Center for Drug Evaluation and Research (HFD-107),
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852,
301-827-5097; or
Steven Hirschfeld, Center for Biologics Evaluation and Research
(HFM-755), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-6536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Trial Endpoints for the Approval of 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. This
draft guidance is the first in a planned series of cancer endpoint
guidances. It provides background information and general principles.
The endpoints discussed in this draft guidance are for drugs to treat
patients with an existing cancer. This draft guidance does not address
endpoints for drugs to prevent or decrease the incidence of cancer.
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 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit one 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. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/ohrms/dockets/default.htm.
Dated: March 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6647 Filed 4-1-05; 8:45 am]
BILLING CODE 4160-01-S