Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI), 32338-32339 [E8-12641]
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PWALKER on PROD1PC71 with NOTICES
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Federal Register / Vol. 73, No. 110 / Friday, June 6, 2008 / Notices
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting an emergency review
because the collection of this
information is needed before the
expiration of the normal time limits
under OMB’s regulations at 5 CFR Part
1320(a)(2)(ii). This is necessary to
ensure compliance with an initiative of
the Administration. We cannot
reasonably comply with the normal
clearance procedures because of an
unanticipated event, as stated in 5 CFR
1320.13(a)(2)(ii). The agency cannot
reasonably comply with the normal
clearance procedures because the
application and user account
registration form must have OMB
clearance by September 2008 to meet
the time necessary to begin CAS
security administrator training and user
account registration for new
CROWNWeb alpha testers and
CROWNWeb production users.
1. Type of Information Collection
Request: New collection; Title of
Information Collection: CROWNWeb
Authentication Service (CAS) Account
Form; Form Number: CMS–10210
(OMB#: 0938–NEW); Use: The
CROWNWeb Authentication Service
(CAS) application must be completed by
any person needing access to the
CROWNWeb system which include
includes CMS employees, ESRD
Network Organization staff and dialysis
facilities staff. The CROWNWeb system
is the system used as the collection
point of data necessary for entitlement
of ESRD patients to Medicare benefits
and Federal Government monitoring
and assessing of quality and type of care
provided to renal patients. The data
collected in CAS will provide the
necessary security measures for creating
and maintaining active CROWNWeb
user accounts and collection of audit
trail information required by the CMS
Information Security Officers (ISSO).
Frequency: Reporting—One-time;
Affected Public: Business or other forprofit, Not-for-profit; Number of
Respondents: 15,600; Total Annual
Responses: 15,600; Total Annual Hours:
7,800.
CMS is requesting OMB review and
approval of this collection by August 29,
2008, with a 180-day approval period.
Written comments and
recommendations will be considered
from the public if received by the
individuals designated below by August
5, 2008.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
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regulations/pra or E-mail your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by August 5, 2008:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850
and,
OMB Human Resources and Housing
Branch, Attention: CMS Desk Officer,
New Executive Office Building, Room
10235, Washington, DC 20503, Fax
Number: (202) 395–6974.
Dated: June 2, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–12681 Filed 6–5–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0288]
Compliance Policy Guide Sec. 560.700
Processing of Imported Frozen
Products of Multiple Sizes (e.g.,
Shrimp, Prawns, Etc.) (CPG 7119.10);
Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of Compliance Policy Guide
Sec. 560.700 Processing of Imported
Frozen Products of Multiple Sizes (e.g.,
Shrimp, Prawns, Etc.) (CPG 7119.10)
(CPG Sec. 560.700). CPG Sec. 560.700 is
included in FDA’s Compliance Policy
Guides Manual, which was listed in the
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Annual Comprehensive List of
Guidance Documents that published on
March 28, 2006.
DATES: The withdrawal is effective June
6, 2008.
FOR FURTHER INFORMATION CONTACT:
Robert D. Samuels, Center for Food
Safety and Applied Nutrition (HFS–
325), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–2300.
SUPPLEMENTARY INFORMATION: In a notice
containing a cumulative list of
guidances available from the agency that
published in the Federal Register on
March 28, 2006 (71 FR 15422 at 15453),
FDA included the Compliance Policy
Guides Manual, which includes CPG
Sec. 560.700. FDA is withdrawing CPG
Sec. 560.700 because it is obsolete.
Dated: May 15, 2008.
Margaret O’ K. Glavin,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. E8–12766 Filed 6–5–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial
(PLCO) (NCI)
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 (PLCO). Type of
Information Collection Request:
REVISION (OMB #: 0925–0407, current
expiry date 10/31/2008). 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 254,900 deaths annually in
the U.S. The design is a two-armed
randomized trial of men and women
aged 55 to 74 at entry. OMB first
approved this study in 1993 and has
approved it every 3 years since then
through 2008. During the first approval
period a pilot study was conducted to
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32339
Federal Register / Vol. 73, No. 110 / Friday, June 6, 2008 / Notices
evaluate recruitment methods and data
collection procedures. Recruitment was
completed in 2001 and data collection
continues through 2008. When
participants enrolled in the trial they
agreed to be followed for at least 13
years from the time of enrollment. The
current number of respondents in the
study is 136, 341; this is down from the
total initially due to deaths. The
primary endpoint of the trial is cancerspecific 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: Annually.
Affected Public: Individuals. Type of
Respondents: Adult men and women.
The estimated total annual burden
hours requested is 11,401. The
annualized cost to respondents is
estimated at $219,919 per year, for a
total of $659,756 over the proposed
three year renewal. There are no Capital
Costs to report. There are no Operating
or Maintenance Costs to report.
TABLE A.12–1.—ESTIMATES OF ANNUAL BURDEN HOURS
Type of respondents
Survey instrument
Male and Female Participants ..........................
Male Participants ..............................................
...........................
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.
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
FOR FURTHER INFORMATION CONTACT:
PWALKER on PROD1PC71 with NOTICES
Average time per
response (minutes/hour)
Total annual burden hours
133,341
1,333
1,067
1.00
1.00
1.00
5/60
5/60
10/60
11,111.75
111.08
177.83
............................
............................
............................
11,400.66
ASU ..................
HSQ ..................
Prostate ............
Total ...........................................................
Frequency of response
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Number of respondents
received within 60 days of the date of
this publication.
Dated: May 29, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office,
National Institutes of Health.
[FR Doc. E8–12641 Filed 6–5–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors for
Clinical Sciences and Epidemiology
National Cancer Institute.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personal qualifications
and performance, and the competence
of individual investigators, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
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Name of Committee: Board of Scientific
Counselors for Clinical Sciences and
Epidemiology National Cancer Institute.
Date: July 14–15, 2008.
Time: July 14, 2008, 6 p.m. to 10 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Double Tree Hotel, 8120 Wisconsin
Avenue, Bethesda, MD 20814.
Time: July 15, 2008, 9 a.m. to 3:30 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 10,
Bethesda, MD 20892.
Contact Person: Brian E. Wojcik, PhD,
Senior Review Administrator, Institute
Review Office, Office of the Director,
National Cancer Institute, 6116 Executive
Boulevard, Room 2201, Bethesda, MD 20892,
(301) 496–7628, wojcikb@mail.nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
deainfo.nci.nih.gov/advisory/bsc.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
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Agencies
[Federal Register Volume 73, Number 110 (Friday, June 6, 2008)]
[Notices]
[Pages 32338-32339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12641]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial (PLCO) (NCI)
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 (PLCO). Type of Information Collection Request:
REVISION (OMB : 0925-0407, current expiry date 10/31/2008).
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 254,900 deaths annually in the U.S. The design is a two-armed
randomized trial of men and women aged 55 to 74 at entry. OMB first
approved this study in 1993 and has approved it every 3 years since
then through 2008. During the first approval period a pilot study was
conducted to
[[Page 32339]]
evaluate recruitment methods and data collection procedures.
Recruitment was completed in 2001 and data collection continues through
2008. When participants enrolled in the trial they agreed to be
followed for at least 13 years from the time of enrollment. The current
number of respondents in the study is 136, 341; this is down from the
total initially due to deaths. 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: Annually. Affected Public:
Individuals. Type of Respondents: Adult men and women. The estimated
total annual burden hours requested is 11,401. The annualized cost to
respondents is estimated at $219,919 per year, for a total of $659,756
over the proposed three year renewal. There are no Capital Costs to
report. There are no Operating or Maintenance Costs to report.
Table A.12-1.--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time per
Type of respondents Survey instrument Number of Frequency of response Total annual
respondents response (minutes/hour) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Male and Female Participants............... ASU................................ 133,341 1.00 5/60 11,111.75
HSQ................................ 1,333 1.00 5/60 111.08
Male Participants.......................... Prostate........................... 1,067 1.00 10/60 177.83
------------------------------------------------------------------------------------------------------------
Total.................................. ................................... ................ ................ ................ 11,400.66
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: May 29, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-12641 Filed 6-5-08; 8:45 am]
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