Statement of Organization, Functions and Delegations of Authority, 1882 [2014-00221]
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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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
16:40 Jan 09, 2014
Jkt 232001
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).
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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)
E:\FR\FM\10JAN1.SGM
10JAN1
Agencies
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Page 1882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00221]
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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).
Section RU-30, Delegations of Authority
All delegations of authority and re-delegations 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