Grant to United States Conference of Catholic Bishops, 55403-55404 [05-18847]
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55403
Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices
families. Families that apply (or
reapply) for subsidies and are
determined to be eligible under current
rules will be randomly assigned to the
experimental co-payment schedule or
the existing schedule. (Families with copayments from the experimental
schedule will either pay the same
amount, or less, than families whose copayments are calculated using the
existing schedule.) Families will retain
the same co-payment schedule for two
years, provided they continue to be
eligible for subsidies. Outcomes will be
measured through analysis of
administrative data and periodic
interviews with parents.
Massachusetts. In Massachusetts, the
study is an experimental test of the
effectiveness of a developmental
curriculum implemented in family child
care homes. Family child care providers
who serve subsidized and other low-
income children and are linked to
family child care networks will be
randomly assigned to a treatment or
control group. Providers in the
treatment group will use the
developmental curriculum and be
trained through regular visits to the
home by specially trained mentors.
These providers will receive materials
to use with children from 0 to 5 years
of age. Providers in the control group
will receive the more general technical
assistance and support visits that they
currently receive. Impacts on provider
behavior and the home environment
will be measured through direct
observations in the homes. Child
assessments will be conducted through
provider reports for the younger
children and through standardized tests
for children 30 months and older.
Respondents: Illinois. Parents who
apply (or reapply) for subsidies and are
eligible and agree to be in the study will
be interviewed by telephone up to three
times in the 24 months after they enter
the study.
Washington State. Parents who apply
(or reapply) for subsidies and are
eligible and agree to be in the study will
be interviewed by telephone up to three
times over the 24 months of the study.
Approximately 30 state employees
working at the Department of Health
and Human Services in the Division of
Child Care and Early Learning or the
Division of Community Service will be
interviewed as part of the
implementation study.
Massachusetts. Children will be
assessed 7 months after implementing
the curriculum, after 11 months, and
after 23 months. Providers will be asked
to respond to a brief survey 7 and 23
months after the study begins.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Illinois parent survey ....................................................................................
Washington parent survey ...........................................................................
Washington process study interview ...........................................................
Massachusetts child assessments ..............................................................
Massachusetts provider questionnaire ........................................................
Estimated Total Annual Burden
Hours: 6,679.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information colleciton described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
grjohnson@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
VerDate Aug<31>2005
14:40 Sep 20, 2005
Jkt 205001
Number of
responses per
respondent
5,000
2,000
30
700
350
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: September 15, 2005.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 05–18771 Filed 9–20–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Refugee Resettlement
Grant to United States Conference of
Catholic Bishops
Office of Refugee Resettlement,
Administration for Children and
Families (ACF), Department of Health
and Human Services (DHHS).
AGENCY:
ACTION:
Award announcement.
CFDA#: The Catalog of Federal Domestic
Assistance (CFDA) number for this program
is 93.576. The title is the Refugee Family
Enrichment Program.
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
1.5
1.5
.5
1.5
1
Average
burden hours
per response
.58
.58
.5
.5
.16
Total
burden hours
4,350
1,740
8
525
56
Amount of Award: $194,000.
Notice is hereby given that a
noncompetitive single source program
expansion supplement to an ongoing
competitive award is being made to the
United States Conference of Catholic
Bishops (USCCB) in response to an
unsolicited application. The application
is not within the scope of any existing
or expected to be issued program
announcement for the Fiscal Year 2006.
USCCB’s application is expected to
address issues critical to the
development and implementation of
marriage education programs for
refugees by opening three new program
sites.
In September of 2003, ORR awarded
USCCB a grant of $1,000,000,000 to
develop a Refugee Family Enrichment
program which included technical
assistance to subgrantees. Over the past
two years, USCCB has established an
effective program in sites that have
successfully prepared thousands of
refugee families for the challenges they
will face during resettlement. Because
other Refugee Marriage Enrichment
grantees are primarily regional in scope,
we believe USCCB is uniquely suited to
effectively implement this supplemental
award. USCCB has affiliates across the
country and has no physical or
SUMMARY:
E:\FR\FM\21SEN1.SGM
21SEN1
55404
Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices
programmatic limitations regarding
which ethnic groups they can serve. We
believe that by allowing them to
increase the number of sites, that it
would be a cost-effective way of helping
more refugees develop the skills that
help their marriages succeed and give
their children a better chance of success
in the U.S. Without it, these sites might
struggle to provide refugee clients with
the programs they need in order to
achieve self-sufficiency.
The proposed project period is 9/30/
2005–9/29/2006.
Assistance to support grantees in
developing better approaches to the
delivery of services provided to refugees
is authorized by section 412(c)(1)(A) of
the Immigration and Nationality Act (8
U.S.C. 1522(c)(1)).
FOR FURTHER INFORMATION CONTACT:
Administration for Children and
Families, Office of Refugee
Resettlement, 370 L’Enfant Promenade,
SW., Washington, DC 20447, Loren
Bussert—(202) 401–4732,
lbussert@acf.hhs.gov.
Dated: September 15, 2005.
Nguyen Van Hanh,
Director, Office of Refugee Resettlement.
[FR Doc. 05–18847 Filed 9–20–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0143]
High Chemical Co. et al.; Withdrawal of
Approval of 13 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of 13 new drug applications
(NDAs) from multiple holders of these
applications. The basis for the
withdrawals is that the holders of the
applications have repeatedly failed to
file required annual reports for the
applications.
Effective September 21, 2005.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
DATES:
The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
14:40 Sep 20, 2005
Jkt 205001
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81). In the Federal
Register of January 28, 2005 (70 FR
4134), FDA published a notice offering
an opportunity for a hearing (NOOH) on
a proposal to withdraw approval of 13
NDAs because the firms had failed to
submit the required annual reports for
these applications. On April 28, 2005,
the agency withdrew that notice (70 FR
22054) and reissued the corrected
NOOH (70 FR 22052). FDA received two
responses to the NOOH:
1. The Kendall Co. (Kendall), 15
Hampshire St., Mansfield, MA 02048,
notified the agency that they no longer
market the following products: NDA 10–
337, Fling Antiperspirant Foot Powder;
NDA 10–823, BIKE Foot and Body
Powder; and NDA 10–824, BIKE AntiFungal Aerosol Spray. Kendall informed
FDA that their historical files show they
sold their rights to these three products
(including the licenses) many years ago;
however, they did not notify the agency
of the sale. Because Kendall sold the
products many years ago, they have no
record of the new application holder.
Neither The Kendall Co. nor the new
license holder requested a hearing.
2. Bayer HealthCare LLC, Biological
Products Division, 800 Dwight Way,
Berkeley, CA 94701–1966, notified the
agency that NDA 10–541, BY-NA-MID
(Butylphenamide or B and Zinc Oxide
or Stearate) Tincture, Ointment, Lotion,
and Powder, is not a product produced
at their Berkeley site, and that they
would forward the NOOH to Bayer
HealthCare LLC, Pharmaceutical
Division, 400 Morgan Lane, West
Haven, CT 06516–4175. Bayer
HealthCare LLC in West Haven, CT,
informed the agency that NDA 10–541,
BY-NA-MID, is not their product and
that they have no regulatory files for this
product. Bayer HealthCare LLC did not
request a hearing.
No other firms responded to the
NOOH. Failure to file a written notice
of participation and request for hearing
as required by § 314.200 (21 CFR
314.200) constitutes an election by the
applicant not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and a waiver of any
contentions concerning the legal status
of the drug products. Therefore, the
Director, Center for Drug Evaluation and
Research, is withdrawing approval of
the 13 applications listed in the table of
this document.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Application
No.
Drug
Applicant
NDA 0–
763
Sterile Solution
Procaine Injection 2% (Procaine Hydrochloride (HCl))
High Chemical
Co., 1760 N.
Howard St.,
Philadelphia, PA
19122
NDA 2–
959
Nicotinic Acid
(Niacin) Tablets
The Blue Line
Chemical Co.,
302 South
Broadway, St.
Louis, MO
63102
NDA 4–
236
Sherman (thiamine HCl) Elixir
Do.
NDA 4–
368
Ascorbic Acid
Tablets
Do.
NDA 5–
159
D.S.D.
(diethylstilbestrol
dipropionate)
Do.
NDA 9–
452
Multifuge (piperazine citrate)
Syrup
Do.
NDA
10–
055
Fire Gard ThreeAlarm Burn Relief
(Methylcellulose)
Gard Products,
Inc., 2560 Tara
Lane, Brunswick, GA 31520
NDA
10–
337
Fling Antiperspirant Foot
Powder
Bauer & Black,
A Division of
The Kendall Co.,
One Federal St.,
Boston, MA
02110
NDA
10–
541
BY-NA-MID
(Butylphenamide
or B and Zinc
Oxide or Stearate) Tincture,
Ointment, Lotion, and Powder
Miles Inc., Cutter
Biological, P.O.
Box 1986,
Berkeley, CA
94701
NDA
10–
823
BIKE Foot and
Body Powder
Bauer & Black,
A Division of
The Kendall Co.
NDA
10–
824
BIKE AntiFungal Aerosol
Spray
Do.
NDA
11–
233
TKO with Entrin
Roll-On Liquid
Modern-Labs,
Inc., Maple Rd.,
Gambrills, MD
21504
NDA
19–
432
Spectamine
(Iofetamine Hydrochloride I–
123) Injection
IMP Inc., 8050
El Rio, Houston,
TX 77054
The Director, Center for Drug
Evaluation and Research, under section
505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)), and
under authority delegated by the
Commissioner of Food and Drugs, finds
that the holders of the applications
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Notices]
[Pages 55403-55404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Refugee Resettlement
Grant to United States Conference of Catholic Bishops
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families (ACF), Department of Health and Human Services (DHHS).
ACTION: Award announcement.
-----------------------------------------------------------------------
CFDA#: The Catalog of Federal Domestic Assistance (CFDA) number for
this program is 93.576. The title is the Refugee Family Enrichment
Program.
Amount of Award: $194,000.
SUMMARY: Notice is hereby given that a noncompetitive single source
program expansion supplement to an ongoing competitive award is being
made to the United States Conference of Catholic Bishops (USCCB) in
response to an unsolicited application. The application is not within
the scope of any existing or expected to be issued program announcement
for the Fiscal Year 2006. USCCB's application is expected to address
issues critical to the development and implementation of marriage
education programs for refugees by opening three new program sites.
In September of 2003, ORR awarded USCCB a grant of $1,000,000,000
to develop a Refugee Family Enrichment program which included technical
assistance to subgrantees. Over the past two years, USCCB has
established an effective program in sites that have successfully
prepared thousands of refugee families for the challenges they will
face during resettlement. Because other Refugee Marriage Enrichment
grantees are primarily regional in scope, we believe USCCB is uniquely
suited to effectively implement this supplemental award. USCCB has
affiliates across the country and has no physical or
[[Page 55404]]
programmatic limitations regarding which ethnic groups they can serve.
We believe that by allowing them to increase the number of sites, that
it would be a cost-effective way of helping more refugees develop the
skills that help their marriages succeed and give their children a
better chance of success in the U.S. Without it, these sites might
struggle to provide refugee clients with the programs they need in
order to achieve self-sufficiency.
The proposed project period is 9/30/2005-9/29/2006.
Assistance to support grantees in developing better approaches to
the delivery of services provided to refugees is authorized by section
412(c)(1)(A) of the Immigration and Nationality Act (8 U.S.C.
1522(c)(1)).
FOR FURTHER INFORMATION CONTACT: Administration for Children and
Families, Office of Refugee Resettlement, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Loren Bussert--(202) 401-4732,
lbussert@acf.hhs.gov.
Dated: September 15, 2005.
Nguyen Van Hanh,
Director, Office of Refugee Resettlement.
[FR Doc. 05-18847 Filed 9-20-05; 8:45 am]
BILLING CODE 4184-01-P
