Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 34085-34086 [2011-14343]
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Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[Docket No. FDA–2011–N–0002]
Food and Drug Administration
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
[FR Doc. 2011–14410 Filed 6–9–11; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0418]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Institutional Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Institutional Review Boards’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In the
Federal Register of December 15, 2010
(75 FR 78252), the Agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0130. The
approval expires on April 30, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14409 Filed 6–9–11; 8:45 am]
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Food and Drug Administration,
HHS.
Jkt 223001
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 July 19, 2011, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910.
The hotel’s telephone number is 301–
589–5200.
Contact Person: Paul Tran, 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:
EMDAC@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 19, 2011, the
committee will discuss new drug
application (NDA) 202293 dapagliflozin,
manufactured by Bristol-Myers Squibb
and AstraZeneca. Dapagliflozin is the
first drug in the class of sodium-glucose
co-transporter 2 (SGLT2) inhibitors,
developed as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
FDA intends to make background
material available to the public no later
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34085
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/
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 5, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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 24,
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 27, 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 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/
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).
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34086
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
Dated: June 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–14343 Filed 6–9–11; 8:45 am]
[FR Doc. 2011–14441 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Dated: June 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Substance Abuse and Mental Health
Services Administration
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIH Support for
Conferences and Scientific Meetings.
Date: July 25–28, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, 3201, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Brandt R. Burgess, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, 301–451–2584,
bburgess@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Peer Review Meeting.
Date: July 28, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Dharmendar Rathore, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Rm 3134,
Bethesda, MD 20892–7616, 301–435–2766,
rathored@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, NIDDK Telephone
SEP.
Date: July 6, 2011.
Time: 10 to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Xiaodu Guo, MD, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 761, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Nephrotic
Syndrome Ancillary Studies.
Date: July 13, 2011.
Time: 2 to 2:45 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Lakshmanan Sankaran,
PhD, Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 755, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7799, ls38z@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
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Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: June 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–14440 Filed 6–9–11; 8:45 am]
BILLING CODE 4140–01–P
Mandatory Guidelines for Federal
Workplace Drug Testing Programs;
Request for Information Regarding
Specific Issues Related to the Use of
the Oral Fluid Specimen for Drug
Testing
Substance Abuse and Mental
Health Services Administration
(SAMHSA), HHS.
ACTION: Request for Information.
AGENCY:
This document is a request for
information regarding specific aspects of
the regulatory policies and standards
that may be applied to the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (oral fluid specimen).
DATES: Comment Close Date: To be
assured consideration, comments must
be received at one of the addresses
provided below on or before August 9,
2011.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
• Electronically. You may submit
electronic comments to https://
www.regulations.gov. Follow ‘‘Submit a
comment’’ instructions.
• By regular mail. You may mail
written comments to the following
address only: Substance Abuse and
Mental Health Services Administration,
Attention: Division of Workplace
Programs, 1 Choke Cherry Road, Room
2–1049, Rockville, MD 20857. Please
allow sufficient time for mailed
comments to be received before the
close of the comment period.
• By express or overnight mail. You
may send written comments to the
following address only: Substance
Abuse and Mental Health Services
Administration, Attention: Division of
Workplace Programs, 1 Choke Cherry
SUMMARY:
E:\FR\FM\10JNN1.SGM
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Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34085-34086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14343]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 July 19, 2011, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910. The hotel's telephone number
is 301-589-5200.
Contact Person: Paul Tran, 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: EMDAC@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 19, 2011, the committee will discuss new drug
application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers
Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of
sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an
adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus.
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/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
5, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 24, 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 27, 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 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/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).
[[Page 34086]]
Dated: June 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-14343 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P