Notice To Award a Grant, 28700 [E7-9824]

Download as PDF 28700 Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices Civilian Health and Medical Program Records–VA,’’ last published at 68 FR 53784 (September 12, 2003). SSNs of CHAMPVA beneficiaries will be released to CMS pursuant to the routine use number 21 as set forth in the system notice. RECORDS MAINTAINED BY CMS The matching program will be conducted with data maintained by CMS in the EDB, System No. 09–70– 0502, published at 67 FR 3203 (January 23, 2002). Matched data will be released to HAC pursuant to the routine use number 2 as set forth in the system notice. INCLUSIVE DATES OF THE MATCH: The CMP shall become effective no sooner than 40 days after the report of the Matching Program is sent to OMB and Congress, or 30 days after publication in the Federal Register, whichever is later. The matching program will continue for 18 months from the effective date and may be extended for an additional 12 months thereafter, if certain conditions are met. The proposal is within the scope of technical assistance activities that the Abstinence Education Division of the Family and Youth Services Bureau (FYSB) provides to grantees with regard to integrating medical and scientific information into abstinence education programming. The Congress, in appropriating funds for the program, has directed the Administration for Children and Families (ACF) to devote up to five percent of appropriated funds for technical assistance and capacitybuilding for abstinence education grantees. In addition, the proposed activities of this awardee are outside the scope of the ACF’s previous or proposed abstinence education competitive program announcements and would not qualify for any other existing grant opportunities. For Further Information Contact: Stanley Koutstaal, Ph.D., Acting Director, Division of Abstinence Education, 1250 Maryland Ave., SW., Washington, DC 20024, (202) 401–9205, Nina.Degeorge@ACF.hhs.gov. BILLING CODE 4120–03–P Dated: May 16, 2007. Harry Wilson, Associate Commissioner, Family and Youth Services Bureau. [FR Doc. E7–9824 Filed 5–21–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4184–01–P Administration for Children and Families DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice To Award a Grant Food and Drug Administration Program Office: Administration on Children, Youth and Families (ACYF)/ Family and Youth Services Bureau (FYSB). Recipient Name: Medical Institute for Sexual Health. Announcement Type: Notice to Award a Grant. CFDA Number: 93.235. Amount of Award: $207,400. Project Period: 5/1/2007–4/30/2008. Summary: This is a notice to award a grant to the Medical Institute for Sexual Health, Austin, TX, in the amount of $207,400 to support the development of online medical accuracy training for abstinence education providers. Background: The Medical Institute for Sexual Health proposes to develop an online instructor-led workshop to train abstinence education providers in methods to access medically accurate sexual health information via the internet. Participants will learn to identify credible internet resources for sexual health information, efficiently and effectively search the internet, and answer most questions on sexual health topics. [Docket No. 2005E–0248] jlentini on PROD1PC65 with NOTICES [FR Doc. E7–9789 Filed 5–21–07; 8:45 am] VerDate Aug<31>2005 19:44 May 21, 2007 Jkt 211001 Determination of Regulatory Review Period for Purposes of Patent Extension; FOSRENOL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for FOSRENOL 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 which 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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–007), 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, 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 drug 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 FOSRENOL (lanthanum carbonate hydrate). FOSRENOL is indicated to reduce serum phosphate in patients with end stage renal disease. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for FOSRENOL (U.S. Patent No. 5,968,976) from Shire International Licensing, B.V., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 8, 2005, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of FOSRENOL represented the first permitted commercial marketing or use of the product. Shortly thereafter, E:\FR\FM\22MYN1.SGM 22MYN1

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[Federal Register Volume 72, Number 98 (Tuesday, May 22, 2007)]
[Notices]
[Page 28700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


 Notice To Award a Grant

    Program Office: Administration on Children, Youth and Families 
(ACYF)/ Family and Youth Services Bureau (FYSB).
    Recipient Name: Medical Institute for Sexual Health.
    Announcement Type: Notice to Award a Grant.
    CFDA Number: 93.235.
    Amount of Award: $207,400.
    Project Period: 5/1/2007-4/30/2008.
    Summary: This is a notice to award a grant to the Medical Institute 
for Sexual Health, Austin, TX, in the amount of $207,400 to support the 
development of online medical accuracy training for abstinence 
education providers.
    Background: The Medical Institute for Sexual Health proposes to 
develop an online instructor-led workshop to train abstinence education 
providers in methods to access medically accurate sexual health 
information via the internet. Participants will learn to identify 
credible internet resources for sexual health information, efficiently 
and effectively search the internet, and answer most questions on 
sexual health topics.
    The proposal is within the scope of technical assistance activities 
that the Abstinence Education Division of the Family and Youth Services 
Bureau (FYSB) provides to grantees with regard to integrating medical 
and scientific information into abstinence education programming. The 
Congress, in appropriating funds for the program, has directed the 
Administration for Children and Families (ACF) to devote up to five 
percent of appropriated funds for technical assistance and capacity-
building for abstinence education grantees. In addition, the proposed 
activities of this awardee are outside the scope of the ACF's previous 
or proposed abstinence education competitive program announcements and 
would not qualify for any other existing grant opportunities.
    For Further Information Contact: Stanley Koutstaal, Ph.D., Acting 
Director, Division of Abstinence Education, 1250 Maryland Ave., SW., 
Washington, DC 20024, (202) 401-9205, Nina.Degeorge@ACF.hhs.gov.

    Dated: May 16, 2007.
Harry Wilson,
Associate Commissioner, Family and Youth Services Bureau.
[FR Doc. E7-9824 Filed 5-21-07; 8:45 am]
BILLING CODE 4184-01-P