Administration for Native Americans, 34135 [E6-9209]

Download as PDF 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 http:// 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 Frm 00084 Fmt 4703 Sfmt 4703 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.

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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