Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, 3376 [05-1176]
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3376
Federal Register / Vol. 70, No. 14 / Monday, January 24, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Prostate, Lung, Colorectal and
Ovarian Cancer Screening Trial.
Type of Information Collection
Request: EXTENSION, OMB control
number 0925–0407, expiration date July
31, 2005.
Need and Use of Information
Collection: This trial is designed to
determine if screening for prostate, lung,
colorectal and ovarian cancer can
reduce mortality from these cancers
which currently cause an estimated
263,000 deaths annually in the U.S. The
design is a two-armed randomized trial
of men and women aged 55 to 74 at
entry. The total sample size t is 154,938.
The primary endpoint of the trial is
cancer-specific mortality for each of the
four cancer sites (prostate, lung,
colorectum, and ovary). In addition,
cancer incidence, stage shift, and case
survival are to be monitored to help
understand and explain results. Biologic
prognostic characteristics of the cancers
will be measured and correlated with
mortality to determine the mortality
predictive value of these intermediate
endpoints. Basic demographic data, risk
factor data for the four cancer sites and
screening history data, as collected from
all subjects at baseline, will be used to
assure comparability between the
screening and control groups and make
appropriate adjustments in analysis.
Further, demographic and risk factor
information may be used to analyze the
differential effectiveness of screening in
high versus low risk individuals.
Frequency of Response: On occasion.
Affected Public: Individuals or
households.
Type of Respondents: Adult men and
women.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
145,852;
Estimated Number of Responses Per
Respondent: 1.14;
Average Burden Hours Per Response:
0.14; and
Estimated Total Annual Burden
Hours Requested: 23,278.
The annualized cost to respondents is
estimated at: $232,780. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Type of respondents
Estimated
annual number
of respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Adults ...............................................................................................................
145,852
1.14
0.14
23,278
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.
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 Dr. Christine D.
Berg, Chief, Early Detection Research
Group, National Cancer Institute, NIH,
EPN Building, Room 3070, 6130
Executive Boulevard, Bethesda, MD
20892, or call non-toll-free number 301–
496–8544 or e-mail your request,
VerDate jul<14>2003
18:04 Jan 21, 2005
Jkt 205001
including your address to:
Bergc@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: January 10, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 05–1176 Filed 1–21–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a list of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Workplace Helpline Call Record Form
(OMB NO. 0930–0232)—Revision
Workplace Helpline is a toll-free,
telephone consulting service which
provides information, guidance and
assistance to employers, communitybased prevention organizations and
labor offices on how to deal with
alcohol and drug abuse problems in the
workplace. The Helpline was required
by Presidential Executive Order 12564
and has been operating since 1987. It is
located in the Substance Abuse and
Mental Health Services
Administration’s Center for Substance
Abuse Prevention (CSAP), where it is
managed out of the Division of
Workplace Programs.
Callers access the Helpline service
through one of its Workplace Prevention
Specialists (WPS) who may spend from
several to up to 30 minutes with a
caller, providing guidance on how to
develop a comprehensive workplace
prevention program (written policy,
employee assistance program services,
employee education, supervisor
training, and drug testing) or
components thereof.
When a call is received, the WPS uses
a Call Record Form to record
information about the call, including the
name of the company or organization,
E:\FR\FM\24JAN1.SGM
24JAN1
]]>Agencies
[Federal Register Volume 70, Number 14 (Monday, January 24, 2005)]
[Notices]
[Page 3376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1176]
[[Page 3376]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection
Title: Prostate, Lung, Colorectal and Ovarian Cancer Screening
Trial.
Type of Information Collection Request: EXTENSION, OMB control
number 0925-0407, expiration date July 31, 2005.
Need and Use of Information Collection: This trial is designed to
determine if screening for prostate, lung, colorectal and ovarian
cancer can reduce mortality from these cancers which currently cause an
estimated 263,000 deaths annually in the U.S. The design is a two-armed
randomized trial of men and women aged 55 to 74 at entry. The total
sample size t is 154,938. The primary endpoint of the trial is cancer-
specific mortality for each of the four cancer sites (prostate, lung,
colorectum, and ovary). In addition, cancer incidence, stage shift, and
case survival are to be monitored to help understand and explain
results. Biologic prognostic characteristics of the cancers will be
measured and correlated with mortality to determine the mortality
predictive value of these intermediate endpoints. Basic demographic
data, risk factor data for the four cancer sites and screening history
data, as collected from all subjects at baseline, will be used to
assure comparability between the screening and control groups and make
appropriate adjustments in analysis. Further, demographic and risk
factor information may be used to analyze the differential
effectiveness of screening in high versus low risk individuals.
Frequency of Response: On occasion.
Affected Public: Individuals or households.
Type of Respondents: Adult men and women.
The annual reporting burden is as follows:
Estimated Number of Respondents: 145,852;
Estimated Number of Responses Per Respondent: 1.14;
Average Burden Hours Per Response: 0.14; and
Estimated Total Annual Burden Hours Requested: 23,278.
The annualized cost to respondents is estimated at: $232,780. There
are no Capital Costs to report. There are no Operating or Maintenance
Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated total
Estimated number of Average burden annual burden
Type of respondents annual number responses per hours per hours
of respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Adults...................................... 145,852 1.14 0.14 23,278
----------------------------------------------------------------------------------------------------------------
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.
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 Dr. Christine D. Berg, Chief, Early Detection
Research Group, National Cancer Institute, NIH, EPN Building, Room
3070, 6130 Executive Boulevard, Bethesda, MD 20892, or call non-toll-
free number 301-496-8544 or e-mail your request, including your address
to: Bergc@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: January 10, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-1176 Filed 1-21-05; 8:45 am]
BILLING CODE 4140-01-P
