Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 10256-10257 [E9-5024]
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10256
Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices
Section 10.33 (21 CFR 10.33) issued
under section 701(a) of the Federal,
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 371(a)), sets forth the format
and procedures by which an interested
person may request reconsideration of
part or all of a decision of the
Commissioner on a petition submitted
under 21 CFR 10.25 (initiation of
administrative proceedings). A petition
for reconsideration must contain a full
statement in a well-organized format of
the factual and legal grounds upon
which the petition relies. The grounds
must demonstrate that relevant
information and views contained in the
administrative record were not
previously or not adequately considered
by the Commissioner. The respondent
must submit a petition no later than 30
days after the decision involved.
However, the Commissioner may, for
good cause, permit a petition to be filed
after 30 days. An interested person who
wishes to rely on information or views
not included in the administrative
record shall submit them with a new
petition to modify the decision. FDA
uses the information provided in the
request to determine whether to grant
the petition for reconsideration.
Respondents to this collection of
information are individuals of
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions who are requesting from the
Commissioner of FDA a reconsideration
of a matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the act, sets forth
the format and procedures by which an
interested person may request, in
accordance with § 10.20 (submission of
documents to Division of Dockets
Management), the Commissioner to stay
the effective date of any administrative
action.
Such a petition must do the following:
(1) Identify the decision involved; (2)
state the action requested, including the
length of time for which a stay is
requested; and (3) include a statement of
the factual and legal grounds on which
the interested person relies in seeking
the stay. FDA uses the information
provided in the request to determine
whether to grant the petition for stay of
action.
Respondents to this information
collection are interested persons who
choose to file a petition for an
administrative stay of action.
Section 10.85 (21 CFR 10.85), issued
under section 701(a) of the act, sets forth
the format and procedures by which an
interested person may request, in
accordance with § 10.20 (submission of
documents to Division of Dockets
Management), an advisory opinion from
the Commissioner on a matter of general
applicability. An advisory opinion
represents the formal position of FDA
on a matter of general applicability.
When making a request, the petitioner
must provide a concise statement of the
issues and questions on which an
opinion is requested, and a full
statement of the facts and legal points
relevant to the request. Respondents to
this collection of information are
interested persons seeking an advisory
opinion from the Commissioner on the
agency’s formal position for matters of
general applicability.
In the Federal Register of December
30, 2008 (73 FR 79885), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
10.30
162
3
486
12
5,832
10.33
4
2
8
10
80
10.35
7
2
14
10
140
10.85
2
1
2
16
32
Total
1There
6,084
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
agency records and experience over the
past 3 years. In 2007, FDA received
approximately 162 citizen petitions
(§ 10.30), 4 administrative
reconsiderations of action (§ 10.33), 7
administrative stays of action (§ 10.35),
and 2 advisory opinions (§ 10.85).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4972 Filed 3–9–09; 8:45 am]
HHS.
BILLING CODE 4160–01–S
VerDate Nov<24>2008
15:20 Mar 09, 2009
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
ACTION:
Food and Drug Administration,
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: Endocrinologic
and Metabolic Drugs Advisory
Committee.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 April 1 and 2, 2009, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA
Advisory Committee Information Line,
E:\FR\FM\10MRN1.SGM
10MRN1
Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512536. 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 April 1 and 2, 2009, two
different new drug applications (NDAs),
proposed for the treatment of
hyperglycemia in adults with type 2
diabetes mellitus will be discussed. On
April 1, 2009, the committee will
discuss NDA 22–350, saxagliptin
tablets, Bristol-Myers Squibb, and on
April 2, 2009, the committee will
discuss NDA 22–341, liraglutide
injection, Novo Nordisk, Inc.
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
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 March 23, 2009.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on both days. Those
desiring to make 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 March
16, 2009. 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
VerDate Nov<24>2008
15:20 Mar 09, 2009
Jkt 217001
notify interested persons regarding their
request to speak by March 19, 2009.
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 Paul Tran 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/oc/advisory/
default.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: March 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–5024 Filed 3–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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 March 31, 2009, from 8:30 a.m.
to 4:30 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
10257
MD 20857, 301–827–6793, FAX: 301–
827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. 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: The committee will discuss
supplemental biologics license
application (sBLA) 125085/169,
AVASTIN (bevacizumab), Genentech,
Inc., proposed indication as single agent
for the treatment of previously treated
glioblastoma multiforme.
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
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 March 20, 2009.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 2 p.m. Those desiring to make
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 March 16, 2009. 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 March 17, 2009.
E:\FR\FM\10MRN1.SGM
10MRN1
]]>Agencies
[Federal Register Volume 74, Number 45 (Tuesday, March 10, 2009)]
[Notices]
[Pages 10256-10257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5024]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Endocrinologic and Metabolic 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: Endocrinologic and Metabolic 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 April 1 and 2, 2009,
from 8 a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
Contact Person: Paul Tran, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express
delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-
7001, FAX: 301-827-6776, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory
Committee Information Line,
[[Page 10257]]
1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512536. 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 April 1 and 2, 2009, two different new drug applications
(NDAs), proposed for the treatment of hyperglycemia in adults with type
2 diabetes mellitus will be discussed. On April 1, 2009, the committee
will discuss NDA 22-350, saxagliptin tablets, Bristol-Myers Squibb, and
on April 2, 2009, the committee will discuss NDA 22-341, liraglutide
injection, Novo Nordisk, Inc.
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 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/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and 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
March 23, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on both days. Those desiring to
make 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 March 16, 2009. 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 March 19, 2009.
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 Paul Tran 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/oc/advisory/
default.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: March 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-5024 Filed 3-9-09; 8:45 am]
BILLING CODE 4160-01-S
