Statement of Organizations, Functions, and Delegations of Authority, 37131-37132 [2011-15801]
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Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
comments may be seen 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.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–15814 Filed 6–23–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Joint Meeting of the Gastrointestinal
Drugs Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committees: Gastrointestinal
Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 20, 2011, from 8 a.m. to
1 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: Kristine T. Khuc,
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:
GIDAC@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
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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: The meeting will be open to
the public from 8 a.m. to 9 a.m., unless
public participation does not last that
long; from 9 a.m. to 1 p.m., the meeting
will be closed to permit discussion and
review of trade secret and/or
confidential commercial information.
FDA generally makes background
material available to the public no later
than 2 business days before the meeting
or follows other procedures to make
such material available to the public.
There is no background material that is
publicly available for this meeting.
Procedure: On July 20, 2011, from
8 a.m. to 9 a.m., the meeting is open to
the public. 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
8 a.m. to 9 a.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 27,
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 28, 2011.
Closed Committee Deliberations: On
July 20, 2011, from 9 a.m. to 1 p.m., the
meeting will be closed to permit
discussion and review of trade secret
and/or confidential commercial
information (5 U.S.C. 552b(c)(4)).
During this session, the committees will
discuss the drug development program
of an investigational gastroenterology
drug.
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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 Kristine T.
Khuc 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.
Dated: June 21, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–15823 Filed 6–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0013]
Statement of Organizations, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that it has reorganized the Center for
Drug Evaluation and Research (CDER),
Office of Compliance. This
reorganization includes the
organizations and substructure
components as listed in this document.
This document is announcing
availability of the Staff Manual Guide
that explains the details of this
reorganization.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Karen Koenick, Center for Drug
Evaluation and Research (HFD–063),
Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852,
301–796–4422.
I. Summary
The Statement of Organization,
Functions, and Delegations of Authority
for CDER (35 FR 3685, February 25,
1970, 60 FR 56605, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
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37132
Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
August 30, 2007, and 76 FR 19376,
April 7, 2011) is amended to reflect the
restructuring of CDER, FDA. This
reorganization is explained in Staff
Manual Guides 1262.1, 1262.3, 1262, 31,
1262.32, 1262.4, 1262.41, 1262.42,
1262.43, 1262.44, 1262.5, 1262.51,
1262.52, 1262.53, 1262.6, 1262.61, and
1262.62. This reorganization includes
establishing four Offices and their
substructures under the Office of
Compliance: Office of Drug Security,
Integrity and Recalls (ODSIR), Office of
Unapproved Drugs and Labeling
Compliance (OUDLC), Office of
Manufacturing and Product Quality
(OMPQ), and Office of Scientific
Investigations (OSI). ODSIR will consist
of the Division of Import Operations and
Recalls and the Division of Supply
Chain Integrity. OUDLC will consist of
the Division of Prescription Drugs and
the Division of Non-Prescription Drugs
and Health Fraud. OMPQ will consist of
the Division of International Drug
Quality, the Division of Domestic Drug
Quality, the Division of Policy,
Collaboration and Data Operations, and
the Division of GMP Assessment. OSI
will consist of the Division of
Bioequivalence and Good Laboratory
Practice Compliance, the Division of
Good Clinical Practice Compliance, and
the Division of Safety Compliance. Also
included is the abolishment of the
Division of Compliance Risk
Management.
II. Delegations of Authority
Pending further delegation, directives
or orders by the Commissioner of Food
and Drugs or Center Director, CDER, all
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegations, provided they are
consistent with this reorganization.
III. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
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 meeting.
The meeting 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.
Name of Committee: National Institute of
Child Health and Human Development,
Special Emphasis Panel, ZHD1 DSR–L 50 1.
Date: July 20, 2011.
Time: 4:30 to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Dennis E. Leszczynski,
Ph.D., Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Rockville, MD 20852,
301–435–6884, leszczyd@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 20, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
srobinson on DSK4SPTVN1PROD with NOTICES
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s Web site at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
[FR Doc. 2011–15872 Filed 6–23–11; 8:45 am]
Dated: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
National Institutes of Health
[FR Doc. 2011–15801 Filed 6–23–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
Name of Committee: National Heart, Lung,
and Blood Institute, Special Emphasis Panel;
Revision for Resuscitation Outcomes Center
Randomized Clinical Trial.
Date: July 15, 2011.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: William J. Johnson, PhD,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute, Special Emphasis Panel.
Studies to Identify Genetic Determinants of
COPD.
Date: July 20, 2011.
Time: 2 to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Stephanie J. Webb, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7196,
Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: June 20, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–15875 Filed 6–23–11; 8:45 am]
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National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
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.
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]]>Agencies
[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37131-37132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0013]
Statement of Organizations, Functions, and Delegations of
Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has reorganized the Center for Drug Evaluation and Research (CDER),
Office of Compliance. This reorganization includes the organizations
and substructure components as listed in this document. This document
is announcing availability of the Staff Manual Guide that explains the
details of this reorganization.
FOR FURTHER INFORMATION CONTACT: Karen Koenick, Center for Drug
Evaluation and Research (HFD-063), Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852, 301-796-4422.
I. Summary
The Statement of Organization, Functions, and Delegations of
Authority for CDER (35 FR 3685, February 25, 1970, 60 FR 56605,
November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112,
[[Page 37132]]
August 30, 2007, and 76 FR 19376, April 7, 2011) is amended to reflect
the restructuring of CDER, FDA. This reorganization is explained in
Staff Manual Guides 1262.1, 1262.3, 1262, 31, 1262.32, 1262.4, 1262.41,
1262.42, 1262.43, 1262.44, 1262.5, 1262.51, 1262.52, 1262.53, 1262.6,
1262.61, and 1262.62. This reorganization includes establishing four
Offices and their substructures under the Office of Compliance: Office
of Drug Security, Integrity and Recalls (ODSIR), Office of Unapproved
Drugs and Labeling Compliance (OUDLC), Office of Manufacturing and
Product Quality (OMPQ), and Office of Scientific Investigations (OSI).
ODSIR will consist of the Division of Import Operations and Recalls and
the Division of Supply Chain Integrity. OUDLC will consist of the
Division of Prescription Drugs and the Division of Non-Prescription
Drugs and Health Fraud. OMPQ will consist of the Division of
International Drug Quality, the Division of Domestic Drug Quality, the
Division of Policy, Collaboration and Data Operations, and the Division
of GMP Assessment. OSI will consist of the Division of Bioequivalence
and Good Laboratory Practice Compliance, the Division of Good Clinical
Practice Compliance, and the Division of Safety Compliance. Also
included is the abolishment of the Division of Compliance Risk
Management.
II. Delegations of Authority
Pending further delegation, directives or orders by the
Commissioner of Food and Drugs or Center Director, CDER, all
delegations and redelegations of authority made to officials and
employees of affected organizational components will continue in them
or their successors pending further redelegations, provided they are
consistent with this reorganization.
III. Electronic Access
Persons interested in seeing the complete Staff Manual Guide can
find it on FDA's Web site at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.
Dated: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15801 Filed 6-23-11; 8:45 am]
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