Preference for Healthy Start Grantees, 27839 [E8-10684]

Download as PDF jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 94 / Wednesday, May 14, 2008 / Notices phase of the regulatory review period, while 183 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: January 24, 2000. The applicant claims October 2, 1999, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 24, 2000, which was the date the IND was removed from clinical hold. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: April 7, 2006. The applicant claims December 6, 2005, as the date the new drug application (NDA) for ZOLINZA (NDA 21–991) was initially submitted. However, FDA records indicate that NDA 21–991 was submitted in several modules under the fast track drug development program. It is FDA’s position that the approval phase begins when the marketing application is complete for review. The final module of the NDA making it complete for review was submitted on April 7, 2006. 3. The date the application was approved: October 6, 2006. FDA has verified the applicant’s claim that NDA 21–991 was approved on October 6, 2006. 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 1,433 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 14, 2008. 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 10, 2008. 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 VerDate Aug<31>2005 16:39 May 13, 2008 Jkt 214001 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 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 through FDMS only. Dated: April 28, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–10689 Filed 5–13–08; 8:45 am] 27839 grantees with expiring or recently expired project periods.’’ FOR FURTHER INFORMATION CONTACT: Maribeth Badura, Director, Division of Healthy Start and Perinatal Services, Maternal and Child Health Bureau, HRSA, Room 18–12, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443–0543; e-mail MBadura@hrsa.gov. Dated: May 2, 2008. Dennis Williams, Acting Administrator. [FR Doc. E8–10684 Filed 5–13–08; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4160–01–S Fogarty International Center; Notice of Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Preference for Healthy Start Grantees Health Resources and Services Administration (HRSA), HHS. ACTION: General notice. AGENCY: This notice supplements the 2007 HRSA announcement (HRSA 08–023/08–031) of the availability of fiscal year (FY) 2008 funding for new and competing continuation applications for Healthy Start. Healthy Start strengthens communities to effectively address the causes of infant mortality, low birth weight and other poor perinatal outcomes for women and infants. Recently, new guidance became available with regards to funding FY 2008 Healthy Start programs. SUMMARY: The Conference Report (H.R. Rep. No. 110–107) accompanying the Consolidated Appropriations Act 2008 (Pub. L. 110–161), Division G— Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008, indicates concurrence with the Senate report language regarding the recompetition of Healthy Start programs. Following the Senate Committee’s recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2008 competition to current Healthy Start grantees. Senate Report 110–107 urges ‘‘HRSA to give preference to current and former BACKGROUND: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Fogarty International Center Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Fogarty International Center Advisory Board. Date: May 19–20, 2008. Closed: May 19, 2008, 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, Lawton Chiles International House, Bethesda, MD 20892. Closed: May 20, 2008, 8:30 a.m. to 10:30 a.m. Agenda: To review and evaluate grant applications and/or proposals. E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 73, Number 94 (Wednesday, May 14, 2008)]
[Notices]
[Page 27839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Preference for Healthy Start Grantees

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: General notice.

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BACKGROUND: This notice supplements the 2007 HRSA announcement (HRSA 
08-023/08-031) of the availability of fiscal year (FY) 2008 funding for 
new and competing continuation applications for Healthy Start. Healthy 
Start strengthens communities to effectively address the causes of 
infant mortality, low birth weight and other poor perinatal outcomes 
for women and infants. Recently, new guidance became available with 
regards to funding FY 2008 Healthy Start programs.
SUMMARY: The Conference Report (H.R. Rep. No. 110-107) accompanying the 
Consolidated Appropriations Act 2008 (Pub. L. 110-161), Division G--
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 2008, indicates concurrence with 
the Senate report language regarding the recompetition of Healthy Start 
programs. Following the Senate Committee's recommendation, the Health 
Resources and Services Administration (HRSA) will give funding 
preference during the FY 2008 competition to current Healthy Start 
grantees.
    Senate Report 110-107 urges ``HRSA to give preference to current 
and former grantees with expiring or recently expired project 
periods.''

FOR FURTHER INFORMATION CONTACT:  Maribeth Badura, Director, Division 
of Healthy Start and Perinatal Services, Maternal and Child Health 
Bureau, HRSA, Room 18-12, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857; telephone (301) 443-0543; e-mail 
MBadura@hrsa.gov.

    Dated: May 2, 2008.
Dennis Williams,
Acting Administrator.
[FR Doc. E8-10684 Filed 5-13-08; 8:45 am]
BILLING CODE 4165-15-P