Administration for Native Americans, 34135 [E6-9209]
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Federal Register / Vol. 71, No. 113 / Tuesday, June 13, 2006 / Notices
appreciate the public’s assessment of
whether: (1) The policy issues identified
in the draft report are appropriately
focused; (2) any policy issues have been
overlooked; and, (3) the issues are
organized in appropriate categories and
addressed in such a way as to give
policy makers sufficient understanding
of why the issue is important. In
addition, the committee would value
feedback on the sections of the draft
report that discuss the importance of
public engagement and the mechanisms
that could be employed to achieve such
engagement.
SACGHS will be able to consider
comments received by July 31, 2006, as
it prepares its final report. The report
and public comments will be discussed
at a future SACGHS meeting.
Comments will be available for public
inspection at the NIH Office of
Biotechnology Activities Monday
through Friday between the hours of
8:30 a.m. and 5 p.m.
volunteers to assist youth and members
of the community in coping with this
event; and building support systems,
which will aid in preventing future
tragedies.
Dated: June 2, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6–9136 Filed 6–12–06; 8:45 am]
[Docket No. 2006E–0025]
FOR FURTHER INFORMATION CONTACT:
Sheila Cooper, Director of Program
Operations, toll-free at 877–922–9262.
SUPPLEMENTARY INFORMATION: This
award will be made pursuant to Section
803 of the Native American Programs
Act of 1974.
Dated: June 7, 2006.
Kimberly Romine,
Deputy Commissioner, Administration for
Native Americans.
[FR Doc. E6–9209 Filed 6–12–06; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Determination of Regulatory Review
Period for Purposes of Patent
Extension; INCRELEX
BILLING CODE 4140–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Administration for Children and
Families
Administration for Native Americans
jlentini on PROD1PC65 with NOTICES
AGENCY: Administration for Native
Americans, Administration for Children
and Families, HHS.
ACTION: Award announcement.
SUMMARY: The Administration for
Native Americans (ANA) herein
announces a Program Expansion
Supplement to the Red Lake Band of
Chippewa Indians, Red Lake,
Minnesota. This supplement for
$136,400 will extend funding for 11
youth volunteers through the second
year of the project. In FY 2005, ANA
provided an urgent grant award to the
Tribe to assist in mitigating the effects
of the tragic events of the school
shooting in March 2005 that resulted in
the death of students, faculty and staff.
The shooting marked the highest death
toll in U.S. school shootings since the
Columbine High School massacre in
April 1999.
Due to the devastation created by the
high school shooting, ANA is providing
urgent financial assistance for minor
renovations to the local community
centers to support positive community
development; funding to hire 11
VerDate Aug<31>2005
16:40 Jun 12, 2006
Jkt 208001
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
INCRELEX and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
that claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
PO 00000
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34135
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the product. Although only a portion of
a regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (for example,
half the testing phase must be
subtracted, as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product INCRELEX
(mecasermin [rDNA origin] injection).
INCRELEX is indicated for the long-term
treatment of growth failure in children
with severe primary IGF–1 deficiency
(Primary IGFD) or with growth hormone
gene deletion who have developed
neutralizing antibodies to growth
hormone. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for INCRELEX (U.S. Patent
No. 5,681,814) from Genentech, Inc.,
and the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
February 24, 2006, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of INCRELEX represented the
first permitted commercial marketing or
use of the product. Shortly thereafter,
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
INCRELEX is 4,828 days. Of this time,
4,644 days occurred during the testing
phase of the regulatory review period,
while 184 days occurred during the
approval phase. These periods of time
were derived from the following dates:
E:\FR\FM\13JNN1.SGM
13JNN1
]]>Agencies
[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Page 34135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Administration for Native Americans
AGENCY: Administration for Native Americans, Administration for
Children and Families, HHS.
ACTION: Award announcement.
-----------------------------------------------------------------------
SUMMARY: The Administration for Native Americans (ANA) herein announces
a Program Expansion Supplement to the Red Lake Band of Chippewa
Indians, Red Lake, Minnesota. This supplement for $136,400 will extend
funding for 11 youth volunteers through the second year of the project.
In FY 2005, ANA provided an urgent grant award to the Tribe to assist
in mitigating the effects of the tragic events of the school shooting
in March 2005 that resulted in the death of students, faculty and
staff. The shooting marked the highest death toll in U.S. school
shootings since the Columbine High School massacre in April 1999.
Due to the devastation created by the high school shooting, ANA is
providing urgent financial assistance for minor renovations to the
local community centers to support positive community development;
funding to hire 11 volunteers to assist youth and members of the
community in coping with this event; and building support systems,
which will aid in preventing future tragedies.
FOR FURTHER INFORMATION CONTACT: Sheila Cooper, Director of Program
Operations, toll-free at 877-922-9262.
SUPPLEMENTARY INFORMATION: This award will be made pursuant to Section
803 of the Native American Programs Act of 1974.
Dated: June 7, 2006.
Kimberly Romine,
Deputy Commissioner, Administration for Native Americans.
[FR Doc. E6-9209 Filed 6-12-06; 8:45 am]
BILLING CODE 4184-01-P
