Oncologic Drugs Advisory Committee; Notice of Meeting, 35451-35452 [2011-15019]
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Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Notices
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:
emcdonald on DSK2BSOYB1PROD with NOTICES
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a draft guidance for industry entitled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 This draft guidance considers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 This draft guidance is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discussed in this draft guidance are for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.
This draft guidance is being issued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The draft guidance, when finalized, will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
1 ‘‘See the FDA Drugs guidance Web page at
https://www.fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/default.htm.’’
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17:39 Jun 16, 2011
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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 https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
35451
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 14, 2011, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, e-mail:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On July 14, 2011, during the
morning session, the committee will
discuss biologics license application
(BLA) 125388, with the proposed trade
name ADCETRIS (brentuximab vedotin)
for injection, submitted by Seattle
Genetics, Inc. The proposed indication
(use) for this product is for the treatment
of relapsed or refractory (resistant to
previous standard treatments) Hodgkin’s
lymphoma.
During the afternoon session, the
committee will discuss BLA 125399,
with the proposed trade name
ADCETRIS (brentuximab vedotin) for
injection, submitted by Seattle Genetics,
Inc. The proposed indication (use) for
this product is for the treatment of
relapsed or refractory systemic
anaplastic large cell lymphoma.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
E:\FR\FM\17JNN1.SGM
17JNN1
35452
Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Notices
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 6, 2011. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m. and 3:30 p.m. to 4 p.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before June 29, 2011. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 30, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 9, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–15019 Filed 6–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Healthy Communities Study:
How Communities Shape Children’s
Health (HCS)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Healthy
Communities Study: How Communities
Shape Children’s Health (HCS). Type of
Information Collection Request: New.
Need and Use of Information Collection:
The HCS will address the need for a
cross-cutting national study of
community programs and policies and
their relationship to childhood obesity.
The HCS is an observational study of
communities conducted over five years
that aims to (1) Determine the
associations between community
programs/policies and Body Mass Index
(BMI), diet, and physical activity in
SUMMARY:
Estimated
number of
respondents *
emcdonald on DSK2BSOYB1PROD with NOTICES
Type of respondents
Estimated
number of
responses per
respondent
169,650
20,358
10,179
2,410
20,358
4,820
3,615
964
964
1
1.46
1
1
1.46
1
2.74
1
1
Parents (screening) .........................................................................................
Parents/Caregivers ..........................................................................................
Second Parents ...............................................................................................
Parents who refuse to participate ....................................................................
Children ............................................................................................................
Key Informants (screening) .............................................................................
Key Informants .................................................................................................
Food Service Personnel ..................................................................................
Physical Education Instructors ........................................................................
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PO 00000
children; and (2) identify the
community, family, and child factors
that modify or mediate the associations
between community programs/policies
and BMI, diet, and physical activity in
children. A total of 279 communities
and over 23,000 children and their
parents will be part of the HCS over the
five-year study. A HCS community is
defined as a high school catchment area
and the age range of children is 3–15
years upon entry into the study. The
study examines quantitative and
qualitative information obtained from
community-based initiatives;
community characteristics (e.g., school
environment); measurements of
children’s physical activity levels and
dietary practices; and children’s and
parents’ BMIs. Results from the Healthy
Communities Study may influence the
future development and funding of
policies and programs to reduce
childhood obesity. Furthermore, HCS
results will be published in scientific
journals and will be used for the
development of future research
initiatives targeting childhood obesity.
Frequency of Response: Varies by
participant type from once to 2.74 times.
Affected Public: Families or households;
businesses, other for-profit, and nonprofit. Type of Respondents: Parents,
children, community key informants
(who have knowledge about community
programs/policies related to healthy
nutrition, physical activity, and healthy
weight of children), food service
personnel, physical education
instructors, state health department
employees, and physicians or medical
secretaries. The annual reporting burden
is as follows: Estimated number of
respondents: 247,619; Estimated
Number of Responses per Respondent:
1.1; Average (Annual) Burden Hours per
Response: 0.12; and Estimated Total
Burden Hours Requested: 32,958. The
annualized cost to respondents is
estimated at $213,764.58. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\17JNN1.SGM
17JNN1
Average
burden hours
per response
0.17
1.14
0.12
0.17
0.78
0.08
0.85
0.42
0.25
Estimated total
annual burden
hours
requested *
9,614
11,295
407
137
7,728
129
2,806
135
80
]]>Agencies
[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Notices]
[Pages 35451-35452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15019]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Oncologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 14, 2011, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: ODAC@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On July 14, 2011, during the morning session, the committee
will discuss biologics license application (BLA) 125388, with the
proposed trade name ADCETRIS (brentuximab vedotin) for injection,
submitted by Seattle Genetics, Inc. The proposed indication (use) for
this product is for the treatment of relapsed or refractory (resistant
to previous standard treatments) Hodgkin's lymphoma.
During the afternoon session, the committee will discuss BLA
125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for
injection, submitted by Seattle Genetics, Inc. The proposed indication
(use) for this product is for the treatment of relapsed or refractory
systemic anaplastic large cell lymphoma.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background
[[Page 35452]]
material on its Web site prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA's
Web site after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
6, 2011. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
29, 2011. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 30, 2011.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Caleb Briggs at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 9, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-15019 Filed 6-16-11; 8:45 am]
BILLING CODE 4160-01-P
