Statement of Organization, Functions and Delegations of Authority, 28701-28702 [E7-9786]
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jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices
the Patent and Trademark Office
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
FOSRENOL is 2,449 days. Of this time,
1,538 days occurred during the testing
phase of the regulatory review period,
while 911 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: February 13,
1998. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on February 13, 1998.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: April 30, 2002. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
FOSRENOL (NDA 21–468) was initially
submitted on April 30, 2002.
3. The date the application was
approved: October 26, 2004. FDA has
verified the applicant’s claim that NDA
21–468 was approved on October 26,
2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 951 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by July 23, 2007.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 19, 2007. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
VerDate Aug<31>2005
18:21 May 21, 2007
Jkt 211001
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–9787 Filed 5–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: June 13, 2007, 9
a.m.–5 p.m. June 14, 2007, 8:30 a.m.–3
p.m.
Place: Four Points by Sheraton
Washington DC Downtown Hotel, 1201
K Street, NW.,Washington, DC
20005,(202)–289–7600.
Status: The meeting is open to the
public with attendance limited to space
availability.
Purpose: The Committee provides
advice and recommendations to the
Secretary of Health and Human Services
on the following: Department of Health
and Human Services’ programs that
focus on reducing infant mortality and
improving the health status of pregnant
women and infants, and factors affecting
the continuum of care with respect to
maternal and child health care. It
includes outcomes following childbirth;
strategies to coordinate the variety of
Federal, State, local and private
programs and efforts that are designed
to deal with the health and social
problems impacting on infant mortality;
and the implementation of the Healthy
Start Program and Healthy People 2010
infant mortality objectives.
Agenda: Topics that will be discussed
include the following: Cesarean section
and its effect on pre-term and infant
mortality, SIDS and related causes of
infant death and Preconceptional care.
Proposed agenda items are subject to
change as priorities indicate.
Time will be provided for public
comments limited to five minutes each;
comments are to be submitted no later
than June 1, 2007.
For Further Information Contact:
Anyone requiring information regarding
the Committee should contact Peter C.
van Dyck, M.D., M.P.H., Executive
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28701
Secretary, ACIM,Health Resources and
Services Administration (HRSA), Room
18–05, ParklawnBuilding, 5600 Fishers
Lane, Rockville, MD 20857, Telephone:
(301) 443–2170.
Individuals who are submitting public
comments or who have questions
regarding the meeting and location
should contact David S. de la Cruz, PhD,
M.P.H., HRSA, Maternal and Child
Health Bureau, telephone: (301) 443–
6332, e-mail:
David.delaCruz@hrsa.hhs.gov.
Dated: May 15, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–9784 Filed 5–21–07; 8:45 am]
BILLING CODE 4165–15–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
56605–56606 as amended November 6,
1995; and as last amended at 72 FR
19540–19544, April 18, 2007.)
This notice reflects organizational
changes in the Health Resources and
Services Administration, Bureau of
Primary Health Care (RC). Specifically,
this notice updates the mission
statement of the Bureau of Primary
Health Care (RC) and the functional
statement of the Office of the Associate
Administrator (RC), and deleted the
Office of Administrative Management
(RCM).
Chapter RC, Bureau of Primary Health
Care
Section RC, 00 Mission
Delete in its entirety and replace with
the following:
The mission of the Bureau of Primary
Health Care is to improve the health of
the Nation’s underserved communities
and vulnerable populations by assuring
access to comprehensive, culturally
competent, quality primary health care
services.
Section RC–10, Organization
Delete in its entirety and replace with
the following:
The Bureau of Primary Health Care
(BPHC) is headed by an Associate
Administrator, who reports directly to
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Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices
the Administrator, Health Resources
and Services Administration. The
Bureau of Primary Health Care includes
the following components:
(1) Office of the Associate
Administrator (RC);
(2) Office of Minority and Special
Populations (RCG);
(3) Office of Policy and Program
Development (RCH);
(4) Office of Quality and Data (RCK);
(5) Eastern Division (RCN);
(6) Central Mid-Atlantic Division
(RCP);
(7) Western Division (RCQ);
(8) Division of National Hansen’s
Disease Programs (RC7); and
(9) Division Immigration Health
Service (RC9).
Section RC–20, Functions
(1) Delete the functional statement for
the Office of the Associate
Administrator (RC) and replace in its
entirety; and (2) Delete the functional
statement for the Office of
Administrative Management (RCM).
Office of the Associate Administrator
(RC)
jlentini on PROD1PC65 with NOTICES
Provides overall leadership, direction,
coordination, and planning in support
of Bureau of Primary Health Care
programs that are designed to improve
the health of the Nation’s underserved
communities and vulnerable
populations by assuring access to
comprehensive, culturally competent,
quality primary health care services.
Specifically, (1) Establishes program
goals, objectives and priorities, and
provides oversight as to their execution;
(2) plans, directs, coordinates and
evaluates Bureau-wide management
activities; (3) maintains effective
relationships within HRSA and with
other Department of Health and Human
Services (HHS) organizations, other
Federal agencies, State and local
governments, and other public and
private organizations concerned with
primary health care, eliminating health
disparities, and improving the health
status of the Nation’s underserved and
vulnerable populations; and (4) plans,
directs, and coordinates Bureau-wide
administrative management activities,
i.e., budget, finance, personnel,
procurements, delegations of authority,
emergency planning, training, executive
secretariat, and has responsibilities
related to the awarding of BPHC grant
and contract funds.
Section RC–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
VerDate Aug<31>2005
18:21 May 21, 2007
Jkt 211001
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
the date of signature.
Dated: May 15, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–9786 Filed 5–21–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Compositions and Methods for
Increasing Recombinant Protein Yields
Through the Modification of Cellular
Properties
Description of Technology: This
technology relates to compositions and
methods for improving the growth
characteristics of cells engineered to
produce biologically active products
such as antibodies or glycosylated
proteins. Featured is a method that uses
gene candidates (e.g., cdkl3, siat7e, or
lama4), or their expressed or inhibited
products in cell lines, such as Human
Embryonic Kidney (including HEK–
293), HeLa, or Chinese Hamster Ovary
(CHO). The gene expression modulates
growth characteristics, such as adhesion
properties, of the cell lines thereby
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increasing recombinant protein yields
and reducing product production costs.
Applications: This technology may be
used to improve production of
therapeutic and/or diagnostic
compounds, including therapeutic
proteins or monoclonal antibodies from
mammalian cells. Optimization of
mammalian cells for use as expression
systems in the production of
biologically active products is very
difficult. For certain applications,
anchorage-independent cell lines may
be preferred, whereas for other
applications, a cell line that adheres to
a surface, e.g. is anchorage-dependent,
may be preferable. This technology
provides a method for identifying a gene
whose expression modulates such
cellular adhesion characteristics. This
method thus leads to an increase in the
expression or yield of polypeptides,
including therapeutic biologicals, such
as antibodies, cytokines, growth factors,
enzymes, immunomodulators,
thrombolytics, glycosylated proteins,
secreted proteins, and DNA sequences
encoding such polypeptides and a
reduction in the associated costs of such
biological products.
Advantages: This technology offers
the ability to improve yields and reduce
the cost associated with the production
of recombinant protein products
through the selection of cell lines
having: Altered growth characteristics;
altered adhesion characteristics; altered
rate of proliferation; improvement in
cell density growth; improvement in
recombinant protein expression level.
Market: Biopharmaceuticals,
including recombinant therapeutic
proteins and monoclonal antibodybased products used for in vivo medical
purposes and nucleic acid based
medicinal products now represent
approximately one in every four new
pharmaceuticals on the market. The
market size has been estimated at $33
billion in 2004 and is projected to reach
$70 billion by the end of the decade.
The list of approved biopharmaceuticals
includes recombinant hormones and
growth factors, mAB-based products
and therapeutic enzymes as well as
recombinant vaccines and nucleic acid
based products.
Mammalian cells are widely used
expression systems for the production of
biopharmaceuticals. Human embryo
kidney (including HEK–293) and
Chinese hamster ovary (CHO) are host
cell of choice. The genes identified in
this technology (e.g., cdkl3, sia7e, or
lama4) can be used to modify these
important cell based systems.
This technology is ready for use in
drug/vaccine discovery, production and
development. The technology provides
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]]>Agencies
[Federal Register Volume 72, Number 98 (Tuesday, May 22, 2007)]
[Notices]
[Pages 28701-28702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9786]
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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 last
amended at 72 FR 19540-19544, April 18, 2007.)
This notice reflects organizational changes in the Health Resources
and Services Administration, Bureau of Primary Health Care (RC).
Specifically, this notice updates the mission statement of the Bureau
of Primary Health Care (RC) and the functional statement of the Office
of the Associate Administrator (RC), and deleted the Office of
Administrative Management (RCM).
Chapter RC, Bureau of Primary Health Care
Section RC, 00 Mission
Delete in its entirety and replace with the following:
The mission of the Bureau of Primary Health Care is to improve the
health of the Nation's underserved communities and vulnerable
populations by assuring access to comprehensive, culturally competent,
quality primary health care services.
Section RC-10, Organization
Delete in its entirety and replace with the following:
The Bureau of Primary Health Care (BPHC) is headed by an Associate
Administrator, who reports directly to
[[Page 28702]]
the Administrator, Health Resources and Services Administration. The
Bureau of Primary Health Care includes the following components:
(1) Office of the Associate Administrator (RC);
(2) Office of Minority and Special Populations (RCG);
(3) Office of Policy and Program Development (RCH);
(4) Office of Quality and Data (RCK);
(5) Eastern Division (RCN);
(6) Central Mid-Atlantic Division (RCP);
(7) Western Division (RCQ);
(8) Division of National Hansen's Disease Programs (RC7); and
(9) Division Immigration Health Service (RC9).
Section RC-20, Functions
(1) Delete the functional statement for the Office of the Associate
Administrator (RC) and replace in its entirety; and (2) Delete the
functional statement for the Office of Administrative Management (RCM).
Office of the Associate Administrator (RC)
Provides overall leadership, direction, coordination, and planning
in support of Bureau of Primary Health Care programs that are designed
to improve the health of the Nation's underserved communities and
vulnerable populations by assuring access to comprehensive, culturally
competent, quality primary health care services. Specifically, (1)
Establishes program goals, objectives and priorities, and provides
oversight as to their execution; (2) plans, directs, coordinates and
evaluates Bureau-wide management activities; (3) maintains effective
relationships within HRSA and with other Department of Health and Human
Services (HHS) organizations, other Federal agencies, State and local
governments, and other public and private organizations concerned with
primary health care, eliminating health disparities, and improving the
health status of the Nation's underserved and vulnerable populations;
and (4) plans, directs, and coordinates Bureau-wide administrative
management activities, i.e., budget, finance, personnel, procurements,
delegations of authority, emergency planning, training, executive
secretariat, and has responsibilities related to the awarding of BPHC
grant and contract funds.
Section RC-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 the date of signature.
Dated: May 15, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-9786 Filed 5-21-07; 8:45 am]
BILLING CODE 4165-15-P
