Statement of Organization, Functions and Delegations of Authority, 71010-71011 [E8-27776]
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Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
the Evaluation of Proprietary Names.’’
In performance goals agreed to under
the September 27, 2007, reauthorization
of the Prescription Drug User Fee Act
(PDUFA IV), FDA agreed to implement
various measures to reduce medication
errors related to look-alike and soundalike proprietary names, unclear label
abbreviations, acronyms, dose
designations, and error-prone label and
packaging designs. Among these
measures, FDA agreed to publish
guidance on the contents of a complete
submission package for a proposed
proprietary name for a drug/biological
product. FDA also agreed to
performance goals for review of
proprietary names submitted during the
investigational new drug application
(IND) phase or with a new drug
application (NDA) or biologics license
application (BLA); the goals stipulate
that a complete submission is required
to begin the review clock. (See section
IX.A at https://www.fda.gov/oc/pdufa4/
pdufa4goals.html).
This draft guidance, when finalized,
is intended to promote prevention of
medication errors by assisting industry
in the submission of complete product
information that will help FDA to
evaluate the safety of proposed
proprietary drug and biological product
names, taking into account other factors
that, in association with the name, can
contribute to medication errors. In
addition, FDA intends to use this
information in the assessment of
promotional aspects of proposed
proprietary names.
This draft guidance applies to
prescription drug products, including
biologics, that are the subject of an IND,
NDA, or abbreviated new drug
application (ANDA); nonprescription
drug products that are the subject of an
NDA or ANDA; and biological products
that are the subject of a BLA.
The draft guidance does not address
other performance goals under PDUFA
IV, including developing FDA internal
policies and procedures to ensure that
proprietary name review goals are met;
developing guidance on best practices
for naming, labeling, and packaging
drugs and biologics to reduce
medication errors; guidance on
proprietary name evaluation best
practices; and developing and
implementing a pilot program for
evaluating proposed proprietary names.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the contents of a complete
submission for the evaluation of
proprietary names. It does not create or
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confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 and
FDA Form 1571 have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR part 314 have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
part 601 and FDA Form 356h have been
approved under OMB control number
0910–0338.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm, https://www.fda.gov/cber/
guidelines.htm, or https://
www.regulations.gov.
Dated: November 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27896 Filed 11–21–08; 8:45 am]
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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
56605–56606 as amended November 6,
1995; and as amended at 61 FR 65063,
December 10, 1996; and last amended at
72 FR 33099, June 11, 2008.)
This notice reflects organizational
changes in the Health Resources and
Services Administration, Office of Rural
Health Policy (RH). Specifically, this
notice updates the functional statement
of the Office of the Associate
Administrator (RH), and creates the
following components: Hospital-State
Division (RH1), Community-Based
Division (RH2), and the Border Health
Division (RH3).
Chapter RH, Office of Rural Health
Policy
Section RH, 00 Mission
Delete in its entirety and replace with
the following:
The Office of Rural Health Policy
serves as a focal point within the
Department and as a principal source of
advice to the Administrator and
Secretary for coordinating efforts to
strengthen and improve the delivery of
health services to populations in the
Nation’s rural areas and border areas,
providing leadership and interacting
with stakeholders in the delivery of
health care to underserved and at risk
populations.
Section RH–10, Organization
Delete in its entirety and replace with
the following:
The Office of Rural Health Policy (RH)
is headed by the Associate
Administrator who reports directly to
the Administrator, Health Resources
and Services Administration. The Office
of Rural Health Policy includes the
following components:
(1) Office of the Associate
Administrator (RH);
(2) Hospital State Division (RH1);
(3) Community Based Division (RH2);
and
(4) Border Health Division (RH3).
Section RH–20, Functions
Delete the functional statement for the
Office of the Associate Administrator
(RH) and replace in its entirety.
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Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
Office of the Associate Administrator
(RH)
The Office of the Administrator is
headed by the Associate Administrator
who, in conjunction with other
management officials within HRSA, is
responsible for the overall leadership
and management of the Office of Rural
Health Policy. The Office of Rural
Health Policy serves as a focal point
within the Department and as a
principal source of advice to the
Administrator and Secretary for
coordinating efforts to strengthen and
improve the delivery of health services
to populations in the Nation’s rural
areas and border areas, providing
leadership and interacting with
stakeholders in the delivery of health
care to underserved and at risk
populations. Specifically, the Office of
Rural Health Policy is organized around
the following primary issue areas:
Delivery of Health Services: (1)
Collects and analyzes information
regarding the special problems of rural
health care providers and populations;
(2) works with States, State hospital
associations, private associations,
foundations, and other organizations to
focus attention on, and promote
solutions to, problems related to the
delivery of health services in rural
communities; (3) provides staff support
to the National Advisory Committee on
Rural Health and Human Services; (4)
stimulates and coordinates interaction
on rural health activities and programs
in the Agency, Department and with
other Federal agencies; (5) supports
rural health center research and keeps
informed of research and demonstration
projects funded by States and
foundations in the field of rural health
care delivery; (6) establishes and
maintains a resource center for the
collection and dissemination of the
latest information and research findings
related to the delivery of health services
in rural areas; (7) coordinates
congressional and private sector
inquiries related to rural health; (8)
advises the Agency, Administrator and
Department on the effects of current
policies and proposed statutory,
regulatory, administrative, and
budgetary changes in the programs
established under titles XVIII and XIX of
the Social Security Act on the financial
viability of small rural hospitals, the
ability of rural areas to attract and retain
physicians and other health
professionals; (9) oversees compliance
by CMS with the requirement that rural
hospital impact analyses are developed
whenever proposed regulations might
have a significant impact on a
substantial number of small rural
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hospitals; (10) supports specialized
rural programs on minority health,
mental health, preventive health
education, oral health, and occupational
health and safety; (11) directs the
management of a nationwide rural
health grants program; (12) directs the
management of a program of State grants
which support collaboration within
State offices of rural health; (13) funds
radiation exposure screening and
education programs that screen eligible
individuals adversely affected by the
mining, transport and processing of
uranium and the testing of nuclear
weapons for cancer and other diseases.
Intergovernmental Affairs: (1)
Provides the Administrator with a single
point of contact on all activities related
to important State and local
government, stakeholder association,
and interest group activities; (2)
coordinates Agency cross-Bureau
cooperative agreements and activities
with organizations such as the National
Governors Association, National
Conference of State Legislatures,
Association of State and Territorial
Health Officials, National Association of
Counties, and National Association of
County and City Health Officials; (3)
interacts with various commissions
such as the Delta Regional Authority,
Appalachian Regional Commission,
Denali Commission and the United
States and Mexico Border Health
Commission; and (4) serves as the
primary liaison to Department
intergovernmental staff.
Hospital State Division (RH1)
The Hospital State Division serves as
the focal point within the Office of
Rural Health Policy to support rural
hospital and State grant programs
focused on rural populations.
Specifically, the Hospital State Division
is organized around the following
primary issue areas: (1) Plans and
manages a program of State grants
which support collaboration within
State offices of rural health; (2) works
with States, State hospital associations,
private associations, foundations, and
other organizations to focus attention
on, and promote solutions to, problems
related to the delivery of health services
in rural communities; and (3) provides
coordinated technical assistance to
grantees and rural communities.
Community Based Division (RH2)
The Community Based Division
serves as the focal point within the
Office of Rural Health Policy to support
rural community grant programs.
Specifically, the Community Based
Division is organized around the
following primary issue areas: (1) Plans
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71011
and manages several nationwide rural
health grants programs; (2) supports
programs on rural health, public health,
and health status improvement; (3)
funds public and private non-profit
entities for the operation of clinics that
provide diagnosis, treatment and
rehabilitation of active and retired coal
miners and others with respiratory
ailments (black lung) and other
occupational related respiratory disease
impairments; (4) funds radiation
exposure screening and education
programs that screen eligible
individuals adversely affected by the
mining, transport and processing of
uranium and the testing of nuclear
weapons for cancer and other diseases;
and (5) provides technical assistance to
grantees and rural communities.
Border Health Division (RH3)
The Border Health Division provides
leadership and direction to coordinate
the Agency’s assets in border regions.
Specifically, the Border Health Division:
(1) Assures that the Agency’s
engagement with regions of the border
is strategic, performance based, builds
partnerships and alliances, and
maximizes utilization of Agency assets;
(2) assures agency-wide coordination by
establishing border health program
policies and procedures including
tracking mechanisms; (3) conducts
management and evaluation studies to
improve the health delivery system on
the border; (4) serves as the secretariat
and chair for the agency’s Border Health
Workgroup; (5) plans, directs, and
coordinates the Agency’s border health
activities; and (6) plans, coordinates and
facilitates the agency agreements
activities with border health issues.
Section RH–30, Delegations of
Authority
All delegations and re-delegations of
authority made to HRSA officials and
employees of affected organizational
components will continue in them or
their successors pending further redelegations, provided they are
consistent with this reorganization.
This reorganization is effective upon
the date of signature.
Dated: October 28, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–27776 Filed 11–21–08; 8:45 am]
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]]>Agencies
[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71010-71011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27776]
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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 56605-56606 as amended November 6, 1995; and as amended
at 61 FR 65063, December 10, 1996; and last amended at 72 FR 33099,
June 11, 2008.)
This notice reflects organizational changes in the Health Resources
and Services Administration, Office of Rural Health Policy (RH).
Specifically, this notice updates the functional statement of the
Office of the Associate Administrator (RH), and creates the following
components: Hospital-State Division (RH1), Community-Based Division
(RH2), and the Border Health Division (RH3).
Chapter RH, Office of Rural Health Policy
Section RH, 00 Mission
Delete in its entirety and replace with the following:
The Office of Rural Health Policy serves as a focal point within
the Department and as a principal source of advice to the Administrator
and Secretary for coordinating efforts to strengthen and improve the
delivery of health services to populations in the Nation's rural areas
and border areas, providing leadership and interacting with
stakeholders in the delivery of health care to underserved and at risk
populations.
Section RH-10, Organization
Delete in its entirety and replace with the following:
The Office of Rural Health Policy (RH) is headed by the Associate
Administrator who reports directly to the Administrator, Health
Resources and Services Administration. The Office of Rural Health
Policy includes the following components:
(1) Office of the Associate Administrator (RH);
(2) Hospital State Division (RH1);
(3) Community Based Division (RH2); and
(4) Border Health Division (RH3).
Section RH-20, Functions
Delete the functional statement for the Office of the Associate
Administrator (RH) and replace in its entirety.
[[Page 71011]]
Office of the Associate Administrator (RH)
The Office of the Administrator is headed by the Associate
Administrator who, in conjunction with other management officials
within HRSA, is responsible for the overall leadership and management
of the Office of Rural Health Policy. The Office of Rural Health Policy
serves as a focal point within the Department and as a principal source
of advice to the Administrator and Secretary for coordinating efforts
to strengthen and improve the delivery of health services to
populations in the Nation's rural areas and border areas, providing
leadership and interacting with stakeholders in the delivery of health
care to underserved and at risk populations. Specifically, the Office
of Rural Health Policy is organized around the following primary issue
areas:
Delivery of Health Services: (1) Collects and analyzes information
regarding the special problems of rural health care providers and
populations; (2) works with States, State hospital associations,
private associations, foundations, and other organizations to focus
attention on, and promote solutions to, problems related to the
delivery of health services in rural communities; (3) provides staff
support to the National Advisory Committee on Rural Health and Human
Services; (4) stimulates and coordinates interaction on rural health
activities and programs in the Agency, Department and with other
Federal agencies; (5) supports rural health center research and keeps
informed of research and demonstration projects funded by States and
foundations in the field of rural health care delivery; (6) establishes
and maintains a resource center for the collection and dissemination of
the latest information and research findings related to the delivery of
health services in rural areas; (7) coordinates congressional and
private sector inquiries related to rural health; (8) advises the
Agency, Administrator and Department on the effects of current policies
and proposed statutory, regulatory, administrative, and budgetary
changes in the programs established under titles XVIII and XIX of the
Social Security Act on the financial viability of small rural
hospitals, the ability of rural areas to attract and retain physicians
and other health professionals; (9) oversees compliance by CMS with the
requirement that rural hospital impact analyses are developed whenever
proposed regulations might have a significant impact on a substantial
number of small rural hospitals; (10) supports specialized rural
programs on minority health, mental health, preventive health
education, oral health, and occupational health and safety; (11)
directs the management of a nationwide rural health grants program;
(12) directs the management of a program of State grants which support
collaboration within State offices of rural health; (13) funds
radiation exposure screening and education programs that screen
eligible individuals adversely affected by the mining, transport and
processing of uranium and the testing of nuclear weapons for cancer and
other diseases.
Intergovernmental Affairs: (1) Provides the Administrator with a
single point of contact on all activities related to important State
and local government, stakeholder association, and interest group
activities; (2) coordinates Agency cross-Bureau cooperative agreements
and activities with organizations such as the National Governors
Association, National Conference of State Legislatures, Association of
State and Territorial Health Officials, National Association of
Counties, and National Association of County and City Health Officials;
(3) interacts with various commissions such as the Delta Regional
Authority, Appalachian Regional Commission, Denali Commission and the
United States and Mexico Border Health Commission; and (4) serves as
the primary liaison to Department intergovernmental staff.
Hospital State Division (RH1)
The Hospital State Division serves as the focal point within the
Office of Rural Health Policy to support rural hospital and State grant
programs focused on rural populations. Specifically, the Hospital State
Division is organized around the following primary issue areas: (1)
Plans and manages a program of State grants which support collaboration
within State offices of rural health; (2) works with States, State
hospital associations, private associations, foundations, and other
organizations to focus attention on, and promote solutions to, problems
related to the delivery of health services in rural communities; and
(3) provides coordinated technical assistance to grantees and rural
communities.
Community Based Division (RH2)
The Community Based Division serves as the focal point within the
Office of Rural Health Policy to support rural community grant
programs. Specifically, the Community Based Division is organized
around the following primary issue areas: (1) Plans and manages several
nationwide rural health grants programs; (2) supports programs on rural
health, public health, and health status improvement; (3) funds public
and private non-profit entities for the operation of clinics that
provide diagnosis, treatment and rehabilitation of active and retired
coal miners and others with respiratory ailments (black lung) and other
occupational related respiratory disease impairments; (4) funds
radiation exposure screening and education programs that screen
eligible individuals adversely affected by the mining, transport and
processing of uranium and the testing of nuclear weapons for cancer and
other diseases; and (5) provides technical assistance to grantees and
rural communities.
Border Health Division (RH3)
The Border Health Division provides leadership and direction to
coordinate the Agency's assets in border regions. Specifically, the
Border Health Division: (1) Assures that the Agency's engagement with
regions of the border is strategic, performance based, builds
partnerships and alliances, and maximizes utilization of Agency assets;
(2) assures agency-wide coordination by establishing border health
program policies and procedures including tracking mechanisms; (3)
conducts management and evaluation studies to improve the health
delivery system on the border; (4) serves as the secretariat and chair
for the agency's Border Health Workgroup; (5) plans, directs, and
coordinates the Agency's border health activities; and (6) plans,
coordinates and facilitates the agency agreements activities with
border health issues.
Section RH-30, Delegations of Authority
All delegations and re-delegations of authority made to HRSA
officials and employees of affected organizational components will
continue in them or their successors pending further re-delegations,
provided they are consistent with this reorganization.
This reorganization is effective upon the date of signature.
Dated: October 28, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-27776 Filed 11-21-08; 8:45 am]
BILLING CODE 4165-15-P
