Submission for OMB Review; Comment Request, 19099-19100 [2011-8164]
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19099
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices
Board of Governors of the Federal Reserve
System, April 1, 2011.
Robert deV. Frierson,
Deputy Secretary of the Board.
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
[FR Doc. 2011–8137 Filed 4–5–11; 8:45 am]
BILLING CODE 6210–01–P
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than April 21,
2011.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Ralph C. Stayer, Naples, Florida,
individually, and Ralph C. Stayer
together with Shelly A. Stayer, Naples,
Florida, the RFS 2010 Irrevocable Trust
F/B/O Ralph C. Stayer, the Shelly A.
Stayer 2010 Childrens Trust, Michael G.
Kuechler and Mary A. Kuechler, Fond
du Lac, Wisconsin, Michael G. Kuechler
and Ralph C. Stayer as trustees of the
RFS 2010 Irrevocable Trust F/B/O Ralph
C. Stayer, and Michael G. Kuechler and
Mary A. Kuechler as trustees of the
Shelly A. Stayer 2010 Childrens Trust,
as a group acting in concert, to acquire
10 percent or more of the voting shares
of Hometown Bancorp, Ltd., Fond du
Lac, Wisconsin, and thereby indirectly
acquire control of Hometown Bank,
Fond du Lac, Wisconsin.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child and Family Services Plan
(CFSP), Annual Progress and Servicers
Review (ASPR), and Annual Budget
Expenses Request and Estimated
Expenditures (CFS–101).
OMB No.: 0980–0047.
Description: Under title IV–B,
subparts 1 and 2, of the Social Security
Act (the Act), States, Territories, and
Tribes are required to submit a Child
and Family Services Plan (CFSP). The
CFSP lays the groundwork for a system
of coordinated, integrated, and
culturally relevant family services for
the subsequent five years (45 CFR
1357.15(a)(1)). The CFSP outlines
initiatives and activities the State, Tribe
or territory will carry out in
administering programs and services to
promote the safety, permanency, and
well-being of children and families. By
June 30 of each year, States, Territories,
and Tribes are also required to submit
an Annual Progress and Services Report
(APSR) and a financial report called the
CFS–101. The APSR is a Yearly report
that discusses progress made by a State,
Territory or Tribe in accomplishing the
goals and objectives cited in its CFSP
(45 CFR 1357.16(a)). The APSR contains
new and updated information about
service needs and organizational
capacities throughout the five-year plan
period. The CFS–101 has three parts.
Part I is an annual budget request for the
upcoming fiscal year. Part II includes a
summary of planned expenditures by
program area for the upcoming fiscal
year, the estimated number of
individuals or families to be served, and
the geographical service area. Part III
includes actual expenditures by
program area, numbers of families and
individuals served by program area, and
the geographic areas served for the last
complete fiscal year.
The Child and Family Services
Improvement Act of 2006 amended Title
IV–B, subparts 1 and 2, adding a
number of requirements that affect
reporting through the APSR and the
CFS–101. Of particular note, the law
added a provision requiring States
(including Puerto Rico and the District
of Columbia) to report data on
caseworker visits (section 424(e) of the
Act). States must provide annual data
on (1) the percentage of children in
foster care under the responsibility of
the State who were visited on a monthly
basis by the caseworker handling the
case of the child; and (2) the percentage
of the visits that occurred in the
residence of the child. In addition, by
June 30, 2008, States must set target
percentages and establish strategies to
meet the goal that; by October 1, 2011;
at least 90 percent of the children in
foster care are visited by their
caseworkers on a monthly basis and that
the majority of these visits occur in the
residence of the child (section
424(e)(2)(A) of the Act).
Respondents: States, Territories, and
Tribes must complete the CFSP, APSR,
and CFS–101. Tribes and territories are
exempted from the monthly caseworker
visits reporting requirement of the
APSR. There are approximately 180
Tribal entities that are eligible for IV–B
funding. There are 52 States (including
Puerto Rico and the District of
Columbia) that must complete the CFSP,
APSR, and CFS–101. There are a total of
232 possible respondents.
ANNUAL BURDEN ESTIMATES
Number of
respondents
mstockstill on DSKH9S0YB1PROD with NOTICES
Instrument
ASPR .............................................................................................................
CFSP .............................................................................................................
CFS–101, Parts I, II, and III ..........................................................................
Caseworker Visits ..........................................................................................
Estimated Total Annual Burden
Hours: 51,845.88.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
VerDate Mar<15>2010
17:57 Apr 05, 2011
Jkt 223001
Number of
responses per
respondent
232
232
232
52
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
1
1
1
1
Average
burden hours
per response
76.58
120.25
4.38
99.33
Total burden
hours
17,766.56
27,898
1,016.16
5,165.16
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
E:\FR\FM\06APN1.SGM
06APN1
19100
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–8164 Filed 4–5–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0450]
Maria Carmen Palazzo: Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act)
permanently debarring Maria Carmen
Palazzo, M.D. from providing services in
any capacity to a person that has an
approved or pending drug product
application. We base this order on a
finding that Dr. Palazzo was convicted
of felonies under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of any drug
product or otherwise relating to the
regulation of any drug product under
the FD&C Act. Dr. Palazzo was given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Dr. Palazzo
failed to respond. Dr. Palazzo’s failure to
respond constitutes a waiver of her right
to a hearing concerning this action.
DATES: This order is effective April 6,
2011.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
ADDRESSES:
VerDate Mar<15>2010
17:57 Apr 05, 2011
Jkt 223001
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs (HFC–230), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) and (B) of the
FD&C Act (21 U.S.C. 335a(a)(2)(A) and
(B)) require debarment of an individual
if FDA finds that the individual has
been convicted of a felony under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product or otherwise relating
to the regulation of any drug product
under the FD&C Act.
On August 19, 2010, the United States
District Court for the Eastern District of
Louisiana accepted Dr. Palazzo’s plea of
guilty, and entered judgment against her
for 15 counts of failure to prepare and
maintain records with intent to defraud
or mislead in violation of 21 U.S.C.
331(e), 333(a)(2), and 18 U.S.C. 2.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the development or
approval, including the process for
development or approval, of any drug
product and otherwise relating to the
regulation of any drug product under
the FD&C Act. The factual basis for
those convictions is as follows: Dr.
Palazzo was a licensed medical doctor
with offices located in New Orleans,
Louisiana. SmithKline Beecham,
Corporation, d.b.a. GlaxoSmithKline
(SKB) was a pharmaceutical company
engaged in developing, testing, and
marketing pharmaceutical products
including Paroxetine, also known as
‘‘Paxil.’’ Under the FD&C Act and its
implementing regulations, SKB had to
apply to FDA for approval to market
Paxil. SKB was required to demonstrate,
through clinical investigations in which
Paxil was given to human subjects, the
safety and effectiveness of the drug in
order to receive approval from FDA.
SKB hired Dr. Palazzo to be a clinical
investigator for the Paxil study. As a
participating investigator, Dr. Palazzo
signed, on multiple occasions, an FDA
Form 1572 committing to conduct the
study in accordance with the study
protocol, to personally conduct or
supervise the investigation, and to
comply with FDA regulations. Dr.
Palazzo agreed to conduct the study in
strict compliance with the criteria set
forth in the study protocol, to personally
review all Case Report Forms, and, in
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
return, SKB agreed to pay for each
subject who completed the study.
FDA regulations require that a clinical
investigator on a drug study prepare and
maintain adequate and accurate case
histories that record all observations
and other data pertinent to the
investigation on each study subject and
provide that information to the drug
sponsor. From on or about October 23,
2000, through May 24, 2001, Dr.
Palazzo, with intent to defraud and
mislead, failed to prepare and maintain
records required under 21 U.S.C. 355(i)
and 21 CFR 312.62(b), all in violation of
21 U.S.C. 331(e), 333(a)(2), and 18
U.S.C. 2.
As a result of her convictions, on
January 11, 2011, FDA sent Dr. Palazzo
a notice by certified mail proposing to
permanently debar her from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(A) and (B) of the FD&C Act,
that Dr. Palazzo was convicted of
felonies under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product and
otherwise relating to the regulation of
any drug product under the FD&C Act.
The proposal also offered Dr. Palazzo an
opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Dr.
Palazzo failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived her opportunity
for a hearing and waived any
contentions concerning her debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(A)
and(B) of the FD&C Act, under authority
delegated to the Acting Director (Staff
Manual Guide 1410.35), finds that Maria
Carmen Palazzo has been convicted of
felonies under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product and
otherwise relating to the regulation of
any drug product under the FD&C Act.
As a result of the foregoing finding,
Dr. Palazzo is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the FD&C
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Pages 19099-19100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8164]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Child and Family Services Plan (CFSP), Annual Progress and
Servicers Review (ASPR), and Annual Budget Expenses Request and
Estimated Expenditures (CFS-101).
OMB No.: 0980-0047.
Description: Under title IV-B, subparts 1 and 2, of the Social
Security Act (the Act), States, Territories, and Tribes are required to
submit a Child and Family Services Plan (CFSP). The CFSP lays the
groundwork for a system of coordinated, integrated, and culturally
relevant family services for the subsequent five years (45 CFR
1357.15(a)(1)). The CFSP outlines initiatives and activities the State,
Tribe or territory will carry out in administering programs and
services to promote the safety, permanency, and well-being of children
and families. By June 30 of each year, States, Territories, and Tribes
are also required to submit an Annual Progress and Services Report
(APSR) and a financial report called the CFS-101. The APSR is a Yearly
report that discusses progress made by a State, Territory or Tribe in
accomplishing the goals and objectives cited in its CFSP (45 CFR
1357.16(a)). The APSR contains new and updated information about
service needs and organizational capacities throughout the five-year
plan period. The CFS-101 has three parts. Part I is an annual budget
request for the upcoming fiscal year. Part II includes a summary of
planned expenditures by program area for the upcoming fiscal year, the
estimated number of individuals or families to be served, and the
geographical service area. Part III includes actual expenditures by
program area, numbers of families and individuals served by program
area, and the geographic areas served for the last complete fiscal
year.
The Child and Family Services Improvement Act of 2006 amended Title
IV-B, subparts 1 and 2, adding a number of requirements that affect
reporting through the APSR and the CFS-101. Of particular note, the law
added a provision requiring States (including Puerto Rico and the
District of Columbia) to report data on caseworker visits (section
424(e) of the Act). States must provide annual data on (1) the
percentage of children in foster care under the responsibility of the
State who were visited on a monthly basis by the caseworker handling
the case of the child; and (2) the percentage of the visits that
occurred in the residence of the child. In addition, by June 30, 2008,
States must set target percentages and establish strategies to meet the
goal that; by October 1, 2011; at least 90 percent of the children in
foster care are visited by their caseworkers on a monthly basis and
that the majority of these visits occur in the residence of the child
(section 424(e)(2)(A) of the Act).
Respondents: States, Territories, and Tribes must complete the
CFSP, APSR, and CFS-101. Tribes and territories are exempted from the
monthly caseworker visits reporting requirement of the APSR. There are
approximately 180 Tribal entities that are eligible for IV-B funding.
There are 52 States (including Puerto Rico and the District of
Columbia) that must complete the CFSP, APSR, and CFS-101. There are a
total of 232 possible respondents.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
ASPR............................................ 232 1 76.58 17,766.56
CFSP............................................ 232 1 120.25 27,898
CFS-101, Parts I, II, and III................... 232 1 4.38 1,016.16
Caseworker Visits............................... 52 1 99.33 5,165.16
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 51,845.88.
Additional Information: Copies of the proposed collection may be
obtained 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. All requests should be identified by the title of the
information collection. E-mail address: infocollection@acf.hhs.gov.
[[Page 19100]]
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-8164 Filed 4-5-11; 8:45 am]
BILLING CODE 4184-01-P
