Replacement Grant Award, 58973 [E8-23774]
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jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices
for 3,000 trials of drugs and biologics
and 445 trials of medical devices each
year. Each initial registration is
estimated to take 7 hours and each of
the subsequent 8 updates to the record
are estimated to take 2 hours, resulting
in an annual burden of 79,235 hours. It
is estimated that there will be voluntary
submissions of registration information
for 6,000 trials of drugs and biologics,
545 trials of devices, and 5,280 trials of
other types of medical interventions.
Using the same hour estimates as for
mandatory registration, the burden
associated with voluntary registrations
is estimated at 271,975 hours, bringing
the total registration burden to 351,210
hours. In the first year of operation, it
is estimated that there will be an
additional burden of 84,150 hours
associated with the updating of
information for 7,000 trials of drugs and
biologics and 650 trials of medical
devices that were previously registered
in the databank and ongoing as of
December 26, 2007 (90 days after
enactment). It is estimated that such
trials will require one update of 3 hours
to bring them into compliance with the
new law (FDAAA) and 4 subsequent
updates of 2 hrs each. Results reporting
is required only for those applicable
clinical trials of drugs, biologics, and
devices that are subject to the
mandatory registration requirements of
FDAAA and for which the product(s)
under study have been approved or
cleared by the FDA. It is estimated that
results reporting will be required for
1,645 trials of drugs and biologics and
375 trials of medical devices each year.
Initial submission of results information
is estimated to require 10 hours, and
each result submission is expected to
require two updates that take 5 hours
each. The total burden for results
reporting is therefore estimated at
40,400 hours per year. There are no
capital costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
VerDate Aug<31>2005
18:10 Oct 07, 2008
Jkt 217001
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: David Sharlip,
National Library of Medicine, Building
38A, Room B2N12, 8600 Rockville Pike,
Bethesda, MD 20894, or call non-toll
free number 301–402–9680 or E-mail
your request to sharlipd@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: September 30, 2008.
Betsy L. Humphreys,
Deputy Director, National Library of
Medicine, National Institutes of Health.
[FR Doc. E8–23790 Filed 10–7–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Refugee Resettlement
Replacement Grant Award
CFDA#: 93.576.
Office of Refugee Resettlement,
ACF, DHHS.
ACTION: Notice to award a replacement
grant to Catholic Charities of Tennessee,
Inc.
AGENCY:
SUMMARY: In Fiscal Year 2005, in an
effort to assist local school systems that
were being strained by the arrivals of
large numbers of refugee children, The
Office of Refugee Resettlement (ORR)
awarded, through competition, a
Refugee School Impact grant to the
Tennessee Department of Human
Services, Nashville, TN, for a project
period of August 15, 2005 through
August 14, 2010. The Tennessee
Department of Human Services served
as the fiscal sponsor and legal entity for
the project. As of June 30, 2008, the
Tennessee Department of Human
Services relinquished the grant. Catholic
Charities of Tennessee, Inc., Nashville,
TN, is now awarded a non-competitive
replacement grant to continue to
provide services under the Refugee
School Impact project. Services
provided under the grant to Catholic
Charities of Tennessee, Inc., are within
the scope and operation of the original
award. Under the award, Catholic
PO 00000
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58973
Charities of Tennessee, Inc., is eligible
apply for a non-competitive
continuation award for the period of
August 15, 2009 through August 14,
2010.
FOR FURTHER INFORMATION CONTACT:
Pamela Green-Smith, Director, Division
of Refugee Assistance, Office of Refugee
Resettlement, 370 L’Enfant Promenade,
SW., Washington, DC 20447. Telephone:
202–401–4531. E-mail:
Pamela.Greensmith@acf.hhs.gov
SUPPLEMENTARY INFORMATION:
Legislative Authority: This program is
authorized by Section 412 (c)(1)(A)(iii),
as amended of the Immigration and
Nationality Act (8 U.S.C. 1522
(c)(1)(A)(iii)) and covers the following
Services: (1) English as a Second
Language instruction (2) After-school
tutorials focused on helping students
understand and complete programs that
encourage high school completion and
full participation in school activities (3)
After-school summer programs that
support remedial work or promote
school readiness (4) Parental
involvement programs (5) Interpreter
services for parent/teacher meetings and
conferences and (6) Bi-lingual/bicultural counselors and aides.
Amount of Award: $224,834.76.
Project Period: August 15, 2008—
August 14, 2010.
Dated: October 1, 2008.
Pamela Green-Smith,
Director, Division of Refugee Assistance,
Office of Refugee Resettlement.
[FR Doc. E8–23774 Filed 10–7–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2008–1006]
National Offshore Safety Advisory
Committee; Meeting
Coast Guard, DHS.
Notice of meeting.
AGENCY:
ACTION:
SUMMARY: The National Offshore Safety
Advisory Committee (NOSAC) will
meet, in New Orleans, LA, to discuss
various issues relating to offshore safety
and security. The meeting will be open
to the public.
DATES: NOSAC will meet on Thursday,
November 13, 2008, from 9 a.m. to 3
p.m. The meeting may close early if all
business is finished. Written material
and requests to make oral presentations
should reach the Coast Guard on or
before October 30, 2008. Requests to
E:\FR\FM\08OCN1.SGM
08OCN1
]]>Agencies
[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Notices]
[Page 58973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23774]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Office of Refugee Resettlement
Replacement Grant Award
CFDA#: 93.576.
AGENCY: Office of Refugee Resettlement, ACF, DHHS.
ACTION: Notice to award a replacement grant to Catholic Charities of
Tennessee, Inc.
-----------------------------------------------------------------------
SUMMARY: In Fiscal Year 2005, in an effort to assist local school
systems that were being strained by the arrivals of large numbers of
refugee children, The Office of Refugee Resettlement (ORR) awarded,
through competition, a Refugee School Impact grant to the Tennessee
Department of Human Services, Nashville, TN, for a project period of
August 15, 2005 through August 14, 2010. The Tennessee Department of
Human Services served as the fiscal sponsor and legal entity for the
project. As of June 30, 2008, the Tennessee Department of Human
Services relinquished the grant. Catholic Charities of Tennessee, Inc.,
Nashville, TN, is now awarded a non-competitive replacement grant to
continue to provide services under the Refugee School Impact project.
Services provided under the grant to Catholic Charities of Tennessee,
Inc., are within the scope and operation of the original award. Under
the award, Catholic Charities of Tennessee, Inc., is eligible apply for
a non-competitive continuation award for the period of August 15, 2009
through August 14, 2010.
FOR FURTHER INFORMATION CONTACT: Pamela Green-Smith, Director, Division
of Refugee Assistance, Office of Refugee Resettlement, 370 L'Enfant
Promenade, SW., Washington, DC 20447. Telephone: 202-401-4531. E-mail:
Pamela.Greensmith@acf.hhs.gov
SUPPLEMENTARY INFORMATION:
Legislative Authority: This program is authorized by Section 412
(c)(1)(A)(iii), as amended of the Immigration and Nationality Act (8
U.S.C. 1522 (c)(1)(A)(iii)) and covers the following Services: (1)
English as a Second Language instruction (2) After-school tutorials
focused on helping students understand and complete programs that
encourage high school completion and full participation in school
activities (3) After-school summer programs that support remedial work
or promote school readiness (4) Parental involvement programs (5)
Interpreter services for parent/teacher meetings and conferences and
(6) Bi-lingual/bi-cultural counselors and aides.
Amount of Award: $224,834.76.
Project Period: August 15, 2008--August 14, 2010.
Dated: October 1, 2008.
Pamela Green-Smith,
Director, Division of Refugee Assistance, Office of Refugee
Resettlement.
[FR Doc. E8-23774 Filed 10-7-08; 8:45 am]
BILLING CODE 4184-01-P
