National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 22159-22160 [E8-9010]
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Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
TABLE 1.—SUMMARY OF POSTMARKETING STUDY COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2007)—Continued
NDAs/ANDAs
(% of Total)
• Terminated
BLAs1
(% of Total)
1 (0.1%)
157 (12%)
81 (20%)
133
26
101 (76%)
21 (81%)
1 (<1%)
0
31 (23%)
5 (19%)
115 (37%)2
• Submitted
3 (1%)
41 (51%)
Concluded studies
(October 1, 2006—September 30, 2007)
• Commitment met
• Commitment not met
• Study no longer needed or feasible
Applications with open postmarketing commitments with annual reports due, but not submitted within
60 days of the anniversary date of U.S. approval
1 On
October 1, 2003, FDA completed a consolidation of certain products formerly regulated by CBER into CDER. The previous association of
BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year statistics for CDER BLA postmarketing study commitments will continue to be counted under BLA totals in this table.
2 Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of U.S. approval as overdue, including reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using this definition, annual reports were subsequently submitted in FY06 for 115/115 (100 percent)
of NDAs/ANDAs and 20/41 (49 percent) of BLAs.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9007 Filed 4–23–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[CFDA Number 93.224; HRSA–09–095,
HRSA–09–096, HRSA–09–097, and HRSA–
09–098]
Amendment to the Fiscal Year 2009
Service Area Competition—New and
Competing Continuation Funding
Health Resources and Services
Administration, HHS.
ACTION: Change in application deadline
and amendment of the available service
areas.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: HRSA is announcing the
reissuance of Fiscal Year 2009 Service
Area Competition—New and Competing
Continuation Funding (HRSA
Announcement Numbers HRSA–09–
095, HRSA–09–096, HRSA–09–097, and
HRSA–09–098). The HRSA Electronic
Handbook (EHB) application deadline
for project periods beginning in
November and December 2008 has been
changed and the list of available service
areas has been updated.
The new EHB application deadline for
HRSA–09–095 is May 9, 2008. (The
grants.gov application deadline of April
7, 2008 remains the same.) All other
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requirements of HRSA–09–095 remain
the same. Please see the chart on pages
6 and 7 of the guidance for a complete
listing of all application deadlines.
In addition, corrections to two service
areas listed in the Service Area
Competition guidance have been made.
In Appendix F of the guidance,
Bismarck, ND, is incorrectly listed as an
available service area in fiscal year (FY)
2009. The correct service area that is
currently available in FY 2009 is
Beulah, ND. Also, Clay, WV, is
incorrectly listed as an available service
area in FY 2009. The correct service area
that is currently available in FY 2009 is
Blacksville, WV. Bismarck, ND and
Clay, WV, are not available service areas
for the FY 2009 Service Area
Competition. For a complete listing of
all available service areas for the FY
2009 Service Area Competition funding
opportunity, please see Appendix F of
the guidance.
The effective date of this
amended Agency guidance is April 24,
2008.
Background: HRSA administers the
Health Center Program, which supports
more than 4,000 health care delivery
sites, including community health
centers, migrant health centers, health
care for the homeless centers, and
public housing primary care centers.
Health centers serve clients that are
primarily low-income and minorities,
and deliver comprehensive, culturally
competent, quality primary health care
services to patients regardless of their
ability to pay. Charges for health care
services are set according to income.
DATES:
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For
questions regarding this notice, please
contact Nicole Amado in the Office of
Policy and Program Development,
Bureau of Primary Health Care, HRSA,
at 301–594–4300 or
Nicole.Amado@hrsa.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Dated: April 17, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–9009 Filed 4–23–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
that the following committee will
convene its fifty-ninth meeting.
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: June 2, 2008, 9 a.m.–4:30
p.m. June 3, 2008, 8:45 a.m.–5:15 p.m. June
4, 2008, 8:15 a.m.–10:30 a.m.
Place: Siena Hotel, 1505 East Franklin
Street, Chapel Hill, NC 27514. Phone: 919–
929–4000.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations to the Secretary with
respect to the delivery, research,
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Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
development and administration of health
and human services in rural areas.
Agenda: Monday morning, at 9 a.m., the
meeting will be called to order by the
Chairperson of the Committee, the Honorable
David Beasley. The first presentation will be
an overview of rural North Carolina. The
Committee will hear presentations on the
three chosen Subcommittee topics. The first
panel will focus on Workforce and
Community Development. Erin Fraher, MPH,
with the Rural Health Research and Policy
Analysis Center, is a confirmed speaker. The
second panel of speakers will lead a
discussion on At-Risk Children. The final
panel for the day is on the Medical Home
Model. After the panel discussions, the
Committee Chair will give an overview of the
site visits. The Monday meeting will close at
4:30 p.m.
Tuesday morning, at 8:45 a.m., the
Committee will break into Subcommittees
and depart to the site visits. The Workforce
and Community Development Subcommittee
will depart to Raleigh, North Carolina, to
visit the Turning Point Allied Health
Regional Skills Partnership. The At-Risk
Children Subcommittee will depart to Siler
City, North Carolina and take a
‘‘ChildWatch’’ Tour where they will learn
about the different services provided for
children and the status of children and
families. After the tour, the Subcommittee
will arrive at the Chatham Family Resource
Center. The Medical Home Subcommittee
will depart for Community Care of Eastern
Carolina in Greenville, North Carolina.
Transportation to the site visits will not be
provided to the public. At 4:15 p.m. the
Subcommittees will arrive back at the Siena
Hotel for Subcommittee meetings. The
Tuesday meeting will close at 5:15 p.m.
The final session will be convened
Wednesday morning, at 8:15 a.m. The
Committee will break into Subcommittee
format and meet for forty-five minutes. The
Committee as a whole will reconvene at 9
a.m. There will be a review of the site visits
and action items will be developed for the
Committee members and staff. The
Committee will draft the letter to the
Secretary and discuss the September
meeting. The meeting will be adjourned at
10:30 a.m.
For Further Information Contact: Anyone
requiring information regarding the
Committee should contact Jennifer Chang,
MPH, Executive Secretary, National Advisory
Committee on Rural Health and Human
Services, Health Resources and Services
Administration, Parklawn Building, Room
9A–55, 5600 Fishers Lane, Rockville, MD
20857, Telephone (301) 443–0835, Fax (301)
443–2803.
Persons interested in attending any portion
of the meeting should contact Michele PrayGibson, Office of Rural Health Policy
(ORHP), Telephone (301) 443–0835. The
Committee meeting agenda will be posted on
ORHP’s Web site https://
www.ruralhealth.hrsa.gov.
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Dated: April 16, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–9010 Filed 4–23–08; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2008–0308]
Houston/Galveston Navigation Safety
Advisory Committee; Meetings
Coast Guard, DHS.
Notice of meetings.
AGENCY:
ACTION:
SUMMARY: The Houston/Galveston
Navigation Safety Advisory Committee
(HOGANSAC) and its working groups
will meet in Houston, Texas to discuss
waterway improvements, aids to
navigation, area projects impacting
safety on the Houston Ship Channel,
and various other navigation safety
matters in the Galveston Bay area. These
meetings will be open to the public.
DATES: The Committee will meet on
Thursday, May 22, 2008 at 9 a.m. The
meeting of the Committee’s working
groups will be held on Thursday May 8,
2008 at 9 a.m. These meetings may close
early if all business is finished. Written
material and requests to make oral
presentations should reach the Coast
Guard at least five (5) working days
before the meeting. Requests to have a
copy of your material distributed to
each member of the committee or
working group should reach the Coast
Guard at least ten (10) working days
before the meeting.
ADDRESSES: The full Committee meeting
and working groups meetings will be
held at the Houston Pilots Association,
8150 South Loop East, Houston, Texas
77011–1747, (713) 645–9620. Send
written material and requests to make
oral presentations to Captain William
Diehl, Designated Federal Officer (DFO)
of HOGANSAC, 9640 Clinton Drive,
Houston, Texas 77029. This notice may
be viewed in our online docket, USCG–
2008–0308 at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Commander Hal R. Pitts, Assistant to
the DFO of HOGANSAC, telephone
(713) 671–5164, e-mail
hal.r.pitts@uscg.mil or Lieutenant Sean
Hughes, telephone (713) 678–9001, email sean.p.hughes@uscg.mil.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given pursuant to the
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Federal Advisory Committee Act, 5
U.S.C. App. (Pub. L. 92–463).
Agendas of the Meetings
Houston/Galveston Navigation Safety
Advisory Committee (HOGANSAC). The
tentative agenda is as follows:
(1) Opening remarks by the
Committee Sponsor (RADM Whitehead)
or the Committee Sponsor’s
representative, DFO (CAPT Diehl) and
Chairperson (Ms. Tava Foret).
(2) Approval of the 26 February 2008
minutes.
(3) Old Business:
(a) Navigation Operations (NAVOPS)/
Maritime Incident
Review subcommittee report;
(b) Deep Draft Entry Facilitation
(DDEF) subcommittee report;
(c) Dredging subcommittee report;
(d) Technology subcommittee report;
(e) Area Maritime Security Committee
(AMSC) Liaison’s report;
(f) Harbor of Safe Refuge
subcommittee report;
(g) HOGANSAC Outreach report;
(h) Maritime Awareness
subcommittee report.
(4) New Business:
Working Groups Meeting. The
tentative agenda for the working groups
meeting is as follows:
(1) Presentation by each working
group of its accomplishments and plans
for the future;
(2) Review and discuss the work
completed by each working group;
(3) Put forth any action items for
consideration at the full committee
meeting.
Working groups have been formed to
examine the following issues: Dredging
and related issues, electronic navigation
systems, aids to navigation (AtoN)
knockdowns, impact of passing vessels
on moored ships, boater education
issues, facilitating deep draft
movements, mooring infrastructure, and
harbor of safe refuge. Not all working
groups will provide a report at this
session. Further, working group reports
may not necessarily include discussions
on all issues within the particular
working group’s area of responsibility.
Procedural: All meetings are open to
the public. Please note that the meetings
may close early if all business is
finished. At the Chair’s discretion,
members of the public may make oral
presentations during the meetings. If
you would like to make an oral
presentation at a meeting, please notify
the Assistant DFO at least five (5)
working days before the meeting.
Written material for distribution at a
meeting should reach the Coast Guard at
least ten (10) working days before the
meeting. If you would like a copy of
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]]>Agencies
[Federal Register Volume 73, Number 80 (Thursday, April 24, 2008)]
[Notices]
[Pages 22159-22160]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9010]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services;
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given that the
following committee will convene its fifty-ninth meeting.
Name: National Advisory Committee on Rural Health and Human
Services.
Dates and Times: June 2, 2008, 9 a.m.-4:30 p.m. June 3, 2008,
8:45 a.m.-5:15 p.m. June 4, 2008, 8:15 a.m.-10:30 a.m.
Place: Siena Hotel, 1505 East Franklin Street, Chapel Hill, NC
27514. Phone: 919-929-4000.
Status: The meeting will be open to the public.
Purpose: The National Advisory Committee on Rural Health and
Human Services provides advice and recommendations to the Secretary
with respect to the delivery, research,
[[Page 22160]]
development and administration of health and human services in rural
areas.
Agenda: Monday morning, at 9 a.m., the meeting will be called to
order by the Chairperson of the Committee, the Honorable David
Beasley. The first presentation will be an overview of rural North
Carolina. The Committee will hear presentations on the three chosen
Subcommittee topics. The first panel will focus on Workforce and
Community Development. Erin Fraher, MPH, with the Rural Health
Research and Policy Analysis Center, is a confirmed speaker. The
second panel of speakers will lead a discussion on At-Risk Children.
The final panel for the day is on the Medical Home Model. After the
panel discussions, the Committee Chair will give an overview of the
site visits. The Monday meeting will close at 4:30 p.m.
Tuesday morning, at 8:45 a.m., the Committee will break into
Subcommittees and depart to the site visits. The Workforce and
Community Development Subcommittee will depart to Raleigh, North
Carolina, to visit the Turning Point Allied Health Regional Skills
Partnership. The At-Risk Children Subcommittee will depart to Siler
City, North Carolina and take a ``ChildWatch'' Tour where they will
learn about the different services provided for children and the
status of children and families. After the tour, the Subcommittee
will arrive at the Chatham Family Resource Center. The Medical Home
Subcommittee will depart for Community Care of Eastern Carolina in
Greenville, North Carolina. Transportation to the site visits will
not be provided to the public. At 4:15 p.m. the Subcommittees will
arrive back at the Siena Hotel for Subcommittee meetings. The
Tuesday meeting will close at 5:15 p.m.
The final session will be convened Wednesday morning, at 8:15
a.m. The Committee will break into Subcommittee format and meet for
forty-five minutes. The Committee as a whole will reconvene at 9
a.m. There will be a review of the site visits and action items will
be developed for the Committee members and staff. The Committee will
draft the letter to the Secretary and discuss the September meeting.
The meeting will be adjourned at 10:30 a.m.
For Further Information Contact: Anyone requiring information
regarding the Committee should contact Jennifer Chang, MPH,
Executive Secretary, National Advisory Committee on Rural Health and
Human Services, Health Resources and Services Administration,
Parklawn Building, Room 9A-55, 5600 Fishers Lane, Rockville, MD
20857, Telephone (301) 443-0835, Fax (301) 443-2803.
Persons interested in attending any portion of the meeting
should contact Michele Pray-Gibson, Office of Rural Health Policy
(ORHP), Telephone (301) 443-0835. The Committee meeting agenda will
be posted on ORHP's Web site https://www.ruralhealth.hrsa.gov.
Dated: April 16, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-9010 Filed 4-23-08; 8:45 am]
BILLING CODE 4165-15-P
