Organization, Function, and Delegations of Authority; Part G; Proposed Functional Statement, 1882-1883 [2014-00264]
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Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
Agency in full compliance with section
510 of the FD&C Act before January 9,
2014. As previously stated, drug
products covered by this document that
are currently marketed but not listed
with the Agency on the date of this
document must, as of the effective date
of this document, have approved
applications before their shipment in
interstate commerce. Moreover, any
person or firm that has submitted or
submits an application but has yet to
receive approval for such products is
still responsible for full compliance
with this document.
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V. Discontinued Products
Some firms may have previously
discontinued manufacturing or
distributing products covered by this
document without removing them from
the listing of their products under
section 510(j) of the FD&C Act. Other
firms may discontinue manufacturing or
distributing listed products in response
to this document. Firms are required to
electronically update the listing of their
products under section 510(j) of the
FD&C Act to reflect discontinuation of
unapproved products covered by this
document (21 CFR 207.21(b)). Questions
on electronic drug listing updates
should be sent to: eDRLS@fda.hhs.gov.
In addition to the required update, firms
can also notify the Agency of product
discontinuation by sending a letter,
signed by the firm’s chief executive
officer and fully identifying the
discontinued product(s), including the
product NDC number(s), and stating that
the manufacturing and/or distribution of
the product(s) has (have) been
discontinued. The letter should be sent
electronically to Astrid Lopez-Goldberg
(see ADDRESSES). FDA plans to rely on
its existing records, including its drug
listing records, the results of any
subsequent inspections, or other
available information when it targets
violations for enforcement action.
VI. Reformulated Products
FDA cautions firms against
reformulating their products into
unapproved new drugs without codeine
sulfate, codeine phosphate, or
dihydrocodeine bitartrate, and
marketing them under the same name or
substantially the same name (including
a new name that contains the old name)
in anticipation of an enforcement action
based on this document. As stated in the
Marketed Unapproved Drugs CPG, FDA
intends to give higher priority to
enforcement actions involving
unapproved drugs that are reformulated
to evade an anticipated FDA
enforcement action. In addition,
reformulated products marketed under a
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name previously identified with a
different active ingredient have the
potential to confuse healthcare
practitioners and harm patients.
Dated: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–00257 Filed 1–9–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 78 FR 42089–42090
dated July 15, 2013).
This notice reflects organizational
changes in the Health Resources and
Services Administration. This notice
corrects the administrative codes for the
Bureau of Clinician Recruitment and
Service (RU); the Division of Regional
Operations (RU2) and the Office of
Business Operations (RU3).
Chapter RU—Bureau of Clinician
Recruitment and Service
Section RU–10, Organization
Delete and replace in its entirety.
The Office of the Associate
Administrator (RU) is headed by the
Associate Administrator, Bureau of
Clinician Recruitment and Service
(BCRS), who reports directly to the
Administrator, Health Resources and
Services Administration. BCRS includes
the following components:
(1) Office of the Associate
Administrator (RU);
(2) Office of Legal and Compliance
(RU1);
(3) Division of Regional Operations
(RU2);
(4) Office of Business Operations
(RU3);
(5) Division of National Health
Service Corps (RU5);
(6) Division of Nursing and Public
Health (RU6);
(7) Division of External Affairs (RU7);
(8) Division of Policy and Shortage
Designation (RU8); and
(9) Division of Program Operations
(RU9).
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Section RU–30, Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
date of signature.
Dated: December 26, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014–00221 Filed 1–9–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Organization, Function, and
Delegations of Authority; Part G;
Proposed Functional Statement
Indian Health Service, HHS.
Notice of change in name of an
organizational component.
AGENCY:
ACTION:
The Indian Health Service is
announcing the name change of the
Aberdeen Area Indian Health Service to
the Great Plains Area Indian Health
Service at the request of Tribes served
by the Aberdeen Area Indian Health
Service.
SUMMARY:
Ms.
Mona Galpin, Office of Management
Services, Management Policy and
Internal Control Staff, 801 Thompson
Avenue, TMP Suite 625A, Rockville,
MD 20852, Telephone 301–443–2650.
FOR FURTHER INFORMATION CONTACT:
Section GF–10, Indian Health Service
Area Offices—Organization
An Area Office is a second echelon
organization under the direction of an
Area Director, who reports to the IHS
Director.
Indian Health Service Area Offices of
the Indian Health Service in
alphabetical order:
• Alaska Area Office (GFB)
• Albuquerque Area Office (GFC)
• Bemidji Area Office (GFE)
• Billings Area Office (GFF)
• California Area Office (GFG)
• Great Plains Area Office (GFA)
• Nashville Area Office (GFH)
• Navajo Area Office (GFJ)
• Oklahoma Area Office (GFK)
• Phoenix Area Office (GFL)
• Portland Area Office (GFM)
• Tucson Area Office (GFN)
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Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
Dated: December 6, 2013.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014–00264 Filed 1–9–14; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFAs:
PAR12–138 and PAR13–026—NHLBI
Systems Biology.
Date: February 4–5, 2014.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Ai-Ping Zou, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9497, zouai@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Clinical Neuroplasticity and
Neurotransmitters Study Section.
Date: February 6–7, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave. NW., Washington, DC 20037.
Contact Person: Suzan Nadi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Cognition and Perception Study
Section.
Date: February 6–7, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: The Westin St. Francis, 335 Powell
Street, San Francisco, CA 94102.
Contact Person: Dana Jeffrey Plude, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, (301) 435–
2309, pluded@csr.nih.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Psychosocial Development, Risk and
Prevention Study Section.
Date: February 6–7, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue NW., Washington, DC
20036.
Contact Person: Anna L Riley, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
MSC 7759, Bethesda, MD 20892, 301–435–
2889, rileyann@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group Clinical
and Integrative Diabetes and Obesity Study
Section.
Date: February 6, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Nancy Sheard, SCD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6046–E,
MSC 7892, Bethesda, MD 20892, 301–408–
9901, sheardn@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS).
Dated: January 6, 2014.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–00162 Filed 1–9–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Vessel Entrance or
Clearance Statement
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day Notice and request for
comments; Extension of an existing
collection of information: 1651–0019.
AGENCY:
U.S. Customs and Border
Protection (CBP) of the Department of
SUMMARY:
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Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Vessel Entrance or
Clearance Statement (CBP Form 1300).
This is a proposed extension of an
information collection that was
previously approved. CBP is proposing
that this information collection be
extended with no change to the burden
hours. This document is published to
obtain comments from the public and
affected agencies. This proposed
information collection was previously
published in the Federal Register (76
FR 39114) on October 29, 2013,
allowing for a 60-day comment period.
This notice allows for an additional 30
days for public comments. This process
is conducted in accordance with 5 CFR
1320.10.
DATES: Written comments should be
received on or before February 10, 2014
to be assured of consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to oira_submission@
omb.eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13;
44 U.S.C. 3507). The comments should
address: (a) Whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s
estimates of the burden of the collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden including the use
of automated collection techniques or
the use of other forms of information
technology; and (e) the annual costs
burden to respondents or record keepers
from the collection of information (a
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Agencies
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1882-1883]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Organization, Function, and Delegations of Authority; Part G;
Proposed Functional Statement
AGENCY: Indian Health Service, HHS.
ACTION: Notice of change in name of an organizational component.
-----------------------------------------------------------------------
SUMMARY: The Indian Health Service is announcing the name change of the
Aberdeen Area Indian Health Service to the Great Plains Area Indian
Health Service at the request of Tribes served by the Aberdeen Area
Indian Health Service.
FOR FURTHER INFORMATION CONTACT: Ms. Mona Galpin, Office of Management
Services, Management Policy and Internal Control Staff, 801 Thompson
Avenue, TMP Suite 625A, Rockville, MD 20852, Telephone 301-443-2650.
Section GF-10, Indian Health Service Area Offices--Organization
An Area Office is a second echelon organization under the direction
of an Area Director, who reports to the IHS Director.
Indian Health Service Area Offices of the Indian Health Service in
alphabetical order:
Alaska Area Office (GFB)
Albuquerque Area Office (GFC)
Bemidji Area Office (GFE)
Billings Area Office (GFF)
California Area Office (GFG)
Great Plains Area Office (GFA)
Nashville Area Office (GFH)
Navajo Area Office (GFJ)
Oklahoma Area Office (GFK)
Phoenix Area Office (GFL)
Portland Area Office (GFM)
Tucson Area Office (GFN)
[[Page 1883]]
Dated: December 6, 2013.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014-00264 Filed 1-9-14; 8:45 am]
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