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