Submission for OMB Review; Comment Request; Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI), 68065-68066 [E9-30390]
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Federal Register / Vol. 74, No. 244 / Tuesday, December 22, 2009 / Notices
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[FR Doc. E9–30362 Filed 12–21–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Investigator
Registration and Financial Disclosure
for Investigational Trials in Cancer
Treatment (NCI)
SUMMARY: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Cancer Institute (NIH) has submitted to
the Office of Management and Budget
(OMB) a request for review and
approval of the information collected
below. This proposed information
collection was previously published in
the Federal Register on June 10, 2009
(74 FR 27552), and allowed 60-days for
public comment. One public comment
was received regarding pharmaceutical
testing. The submitter responded to the
e-mail. The purpose of this notice is to
allow an additional 30 days for public
comment. The National Institutes of
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
68065
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a valid OMB
control number.
Proposed Collection: Title:
Investigator Registration and Financial
Disclosure for Investigational Trials in
Cancer Treatment (NCI). Type of
Information Collection Request: Existing
Collection in Use without an OMB
Number. Need and Use of Information
Collection: Food and Drug
Administration (FDA) regulations
require requires sponsors to obtain
information from the investigator before
permitting the investigator to begin
participation in investigational studies.
The National Cancer Institute, (NCI) as
a sponsor of investigational drug trials,
has the responsibility to assure the FDA
that investigators in its clinical trials
program are qualified by training and
experience as appropriate experts to
investigate the drug. In order to fulfill
these requirements, a standard
Statement of Investigator (FDA Form
1572 modified), Supplemental
Investigator Data Form, Financial
Disclosure Form and Curriculum vitae
(CV) are required. The NCI will accept
the investigator’s CV in any format. All
investigators maintain a CV as part of
their academic and professional
practice. The data obtained from these
forms allows the NCI to evaluate the
qualifications of the investigator,
identify appropriate personnel to
receive shipment of investigational
agent, ensure supplies are not diverted
for inappropriate protocol or patient use
and identify financial conflicts of
interest. Comparisons are done with the
intention of ensuring protocol, patient
safety and drug compliance for patient
and drug compliance for patient safety
and protections. Frequency of Response:
Annually. Affected Public: Public
sector, businesses or other for-profit that
will include Federal agencies or
employees, non-profit institutions and a
very small number of private practice
physicians. Type of Respondents:
Investigators. The annual reporting
burden is limited to those physicians
who choose to participate in NCI
sponsored investigational trials to
identify new medicinal agents to treat
and relieve those patients suffering from
cancer. The annualized respondents’
burden for record keeping is estimated
to require 8,564 hours (see table below).
E:\FR\FM\22DEN1.SGM
22DEN1
68066
Federal Register / Vol. 74, No. 244 / Tuesday, December 22, 2009 / Notices
TABLE—ESTIMATES OF ANNUAL BURDEN
Number of
respondents
Frequency of
response
Type of respondents
Form
Investigators and Designee ...............
Statement of Investigator ...................
17,128
1
Supplemental Investigator .................
17,128
1
Financial Disclosure ...........................
17,128
1
............................................................
17,128
........................
srobinson on DSKHWCL6B1PROD with NOTICES
Totals ..........................................
There are no capital costs, operating
costs, or maintenance costs.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) 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) 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) Ways to enhance
the quality, utility and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov. or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Charles
L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and
Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or
call non-toll-free number 301–496–5725
or E-mail your request, including your
address, to: Hallch@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days following the
date of this publication.
VerDate Nov<24>2008
18:01 Dec 21, 2009
Jkt 220001
Dated: December 15, 2009.
Kristine Miller,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–30390 Filed 12–21–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–0600]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Model Performance Evaluation
Program for Mycobacterium
tuberculosis and Non-tuberculous
Mycobacterium Drug Susceptibility
Testing (OMB Control No. 0920–0600,
expiration date 03/31/2010)—
Revision—National Center for
Preparedness, Detection, and Control of
Infectious Diseases (NCPDCID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
As part of the continuing effort to
support both domestic and global public
health objectives for treatment of
tuberculosis (TB), prevention of multidrug resistance, and surveillance
programs, CDC is requesting approval
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Average time
per
response
Total hour
burden
0.25 (15 minutes).
0.167 (10
minutes).
0.083 (5 minutes).
4,282
.....................
8,564
2,855
1,427
from the Office of Management and
Budget to revise a currently approved
data collection, the Model Performance
Evaluation Program for Mycobacterium
tuberculosis and Non-tuberculous
Mycobacterium Drug Susceptibility
Testing. This request includes changes
to the Results Form and re-introduction
of the Laboratory Practices
Questionnaire.
While the overall number of cases of
TB in the U.S. has decreased, rates still
remain high among foreign-born
persons, prisoners, homeless
populations, and individuals infected
with HIV in major metropolitan areas.
The rate of TB cases detected in foreignborn persons has been reported to be
more than nine times higher than the
rate among the U.S. born population.
CDC’s goal to eliminate TB will be
virtually impossible without
considerable effort in assisting heavy
disease burden countries in the
reduction of tuberculosis. The Model
Performance Evaluation Program for
Mycobacterium tuberculosis and Nontuberculous Mycobacterium Drug
Susceptibility Testing program supports
this role by monitoring and evaluating
the level of performance and practices
among national and international
laboratories performing M. tuberculosis
susceptibility testing. Participation in
this program is one way laboratories can
ensure high-quality laboratory testing,
resulting in accurate and reliable testing
results.
By providing an evaluation program
to assess the ability of the laboratories
to test for drug resistant M. tuberculosis
and selected strains of Non-tuberculous
Mycobacteria (NTM), laboratories also
have a self-assessment tool to aid in
optimizing their skills in susceptibility
testing. The information obtained from
laboratories on susceptibility testing
practices and procedures is used to
establish variables related to good
performance, assessing training needs,
and aid with the development of
practice standards.
Participants in this program include
clinical and public health laboratories.
E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[Federal Register Volume 74, Number 244 (Tuesday, December 22, 2009)]
[Notices]
[Pages 68065-68066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30390]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Investigator
Registration and Financial Disclosure for Investigational Trials in
Cancer Treatment (NCI)
SUMMARY: In compliance with the requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute,
the National Cancer Institute (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collected below. This proposed information collection was
previously published in the Federal Register on June 10, 2009 (74 FR
27552), and allowed 60-days for public comment. One public comment was
received regarding pharmaceutical testing. The submitter responded to
the e-mail. The purpose of this notice is to allow an additional 30
days for public comment. The National Institutes of Health may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a valid OMB
control number.
Proposed Collection: Title: Investigator Registration and Financial
Disclosure for Investigational Trials in Cancer Treatment (NCI). Type
of Information Collection Request: Existing Collection in Use without
an OMB Number. Need and Use of Information Collection: Food and Drug
Administration (FDA) regulations require requires sponsors to obtain
information from the investigator before permitting the investigator to
begin participation in investigational studies. The National Cancer
Institute, (NCI) as a sponsor of investigational drug trials, has the
responsibility to assure the FDA that investigators in its clinical
trials program are qualified by training and experience as appropriate
experts to investigate the drug. In order to fulfill these
requirements, a standard Statement of Investigator (FDA Form 1572
modified), Supplemental Investigator Data Form, Financial Disclosure
Form and Curriculum vitae (CV) are required. The NCI will accept the
investigator's CV in any format. All investigators maintain a CV as
part of their academic and professional practice. The data obtained
from these forms allows the NCI to evaluate the qualifications of the
investigator, identify appropriate personnel to receive shipment of
investigational agent, ensure supplies are not diverted for
inappropriate protocol or patient use and identify financial conflicts
of interest. Comparisons are done with the intention of ensuring
protocol, patient safety and drug compliance for patient and drug
compliance for patient safety and protections. Frequency of Response:
Annually. Affected Public: Public sector, businesses or other for-
profit that will include Federal agencies or employees, non-profit
institutions and a very small number of private practice physicians.
Type of Respondents: Investigators. The annual reporting burden is
limited to those physicians who choose to participate in NCI sponsored
investigational trials to identify new medicinal agents to treat and
relieve those patients suffering from cancer. The annualized
respondents' burden for record keeping is estimated to require 8,564
hours (see table below).
[[Page 68066]]
Table--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time per Total hour
Type of respondents Form respondents response response burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee... Statement of 17,128 1 0.25 (15 4,282
Investigator. minutes).
Supplemental 17,128 1 0.167 (10 2,855
Investigator. minutes).
Financial 17,128 1 0.083 (5 1,427
Disclosure. minutes).
----------------------------------------------------------------------------------
Totals................... ............... 17,128 .............. ................ 8,564
----------------------------------------------------------------------------------------------------------------
There are no capital costs, operating costs, or maintenance costs.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) 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) 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) Ways to enhance the quality, utility and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the Attention: NIH Desk Officer, Office of Management and
Budget, at OIRA_submission@omb.eop.gov. or by fax to 202-395-6974. To
request more information on the proposed project or to obtain a copy of
the data collection plans and instruments, contact Charles L. Hall,
Jr., Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation
Program, Division of the Cancer Treatment and Diagnosis, and Centers,
National Cancer Institute, Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or call non-toll-free number 301-
496-5725 or E-mail your request, including your address, to:
Hallch@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
following the date of this publication.
Dated: December 15, 2009.
Kristine Miller,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-30390 Filed 12-21-09; 8:45 am]
BILLING CODE 4140-01-P
