Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI), 32338-32339 [E8-12641]

Download as PDF PWALKER on PROD1PC71 with NOTICES 32338 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/ VerDate Aug<31>2005 16:09 Jun 05, 2008 Jkt 214001 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] BILLING CODE 4120–01–P 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 E:\FR\FM\06JNN1.SGM 06JNN1 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 VerDate Aug<31>2005 16:09 Jun 05, 2008 Jkt 214001 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 E:\FR\FM\06JNN1.SGM 06JNN1

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]
BILLING CODE 4140-01-P
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