80 FR 22211 - Proposed Collection; 60-Day Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 76 (April 21, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 76 (April 21, 2015)
| Page Range | 22211-22212 | |
| FR Document | 2015-09090 |
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)] [Notices] [Pages 22211-22212] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09090] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day 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), 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. 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 Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kelly Yu, Ph.D., Division of Cancer Prevention, 9609 Medical Center Drive, Room 5E230, Rockville, MD 20850 or call non-toll-free number 240-276-7041 or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. Comment 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. Proposed Collection: Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), 0925-0407, Extension, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for a revision of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO). This trial was designed to determine if cancer screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which caused an estimated 253,320 deaths in the U.S. in 2014. 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. Recruitment was completed in 2001, baseline cancer screening was completed in 2006, and data collection continues on the current cohort of 77,281 participants who are actively being followed. The additional follow-up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of cancer screening in high versus low risk individuals. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 26,320. [[Page 22212]] Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average time Form name Type of Number of responses per per response Annual burden respondents respondents respondent (minutes/hour) hours ---------------------------------------------------------------------------------------------------------------- Annual Study Update(ASU) Form. Participants who 77,281 1 5/60 6,440 complete the ASU. ASU Telephone Script.......... Non Responders 3,091 1 5/60 258 to the ASU. Authorization to Release Participants who 2,700 1 3/60 135 Medical Records. report new cancers. Health Status Questionnaire Female 960 1 5/60 87 (Female) (HSQ). participants who complete the HSQ. Health Status Questionnaire Male 1,040 1 5/60 80 (Male) (HSQ). participants who complete the HSQ. Medication Use Questionnaire Participants who 77,281 1 15/60 19,320 (MUQ). complete the MUQ. ---------------------------------------------------------------------------------------------------------------- Dated: April 7, 2015. Karla Bailey, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2015-09090 Filed 4-20-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22211
Dated: April 14, 2015. Park, NC 27709, (919) 541–1446 eckertt1@ technological collection techniques or
Genevieve deAlmeida, niehs.nih.gov. other forms of information technology.
Project Clearance Liaison, National Institute (Catalogue of Federal Domestic Assistance To Submit Comments and for Further
on Drug Abuse. Program Nos. 93.115, Biometry and Risk
Information: To obtain a copy of the
Estimation—Health Risks from
[FR Doc. 2015–09089 Filed 4–20–15; 8:45 am]
Environmental Exposures; 93.142, NIEHS data collection plans and instruments,
BILLING CODE 4140–01–P Hazardous Waste Worker Health and Safety submit comments in writing, or request
Training; 93.143, NIEHS Superfund more information on the proposed
Hazardous Substances—Basic Research and project, contact: Kelly Yu, Ph.D.,
DEPARTMENT OF HEALTH AND Education; 93.894, Resources and Manpower Division of Cancer Prevention, 9609
HUMAN SERVICES Development in the Environmental Health Medical Center Drive, Room 5E230,
Sciences; 93.113, Biological Response to Rockville, MD 20850 or call non-toll-
National Institutes of Health Environmental Health Hazards; 93.114,
free number 240–276–7041 or Email
Applied Toxicological Research and Testing,
National Institute of Environmental National Institutes of Health, HHS) your request, including your address to:
Health Sciences Notice of Closed yuke@mail.nih.gov. Formal requests for
Dated: April 15, 2015. additional plans and instruments must
Meetings Carolyn Baum, be requested in writing.
Pursuant to section 10(d) of the Program Analyst, Office of Federal Advisory Comment Due Date: Comments
Federal Advisory Committee Act, as Committee Policy.
regarding this information collection are
amended (5 U.S.C. App.), notice is [FR Doc. 2015–09061 Filed 4–20–15; 8:45 am]
best assured of having their full effect if
hereby given of the following meetings. BILLING CODE 4140–01–P received within 60 days of the date of
The meetings will be closed to the this publication.
public in accordance with the
provisions set forth in sections DEPARTMENT OF HEALTH AND Proposed Collection: Prostate, Lung,
552b(c)(4) and 552b(c)(6), title 5 U.S.C., HUMAN SERVICES Colorectal, and Ovarian Cancer
as amended. The grant applications and Screening Trial (PLCO), 0925–0407,
the discussions could disclose National Institutes of Health Extension, National Cancer Institute
confidential trade secrets or commercial (NCI), National Institutes of Health
property such as patentable material, Proposed Collection; 60-Day Comment (NIH).
and personal information concerning Request; Prostate, Lung, Colorectal Need and Use of Information
individuals associated with the grant and Ovarian Cancer Screening Trial Collection: This is a request for a
applications, the disclosure of which (PLCO) (NCI) revision of the Prostate, Lung, Colorectal
would constitute a clearly unwarranted SUMMARY: In compliance with the and Ovarian Cancer Screening Trial
invasion of personal privacy. requirement of Section 3506(c)(2)(A) of (PLCO). This trial was designed to
Name of Committee: National Institute of the Paperwork Reduction Act of 1995, determine if cancer screening for
Environmental Health Sciences Special for opportunity for public comment on prostate, lung, colorectal, and ovarian
Emphasis Panel, Child Health and the proposed data collection projects, the cancer can reduce mortality from these
Environment Review Committee. National Cancer Institute (NCI), cancers which caused an estimated
Date: May 12–14, 2015. National Institutes of Health (NIH), will 253,320 deaths in the U.S. in 2014. The
Time: 8:00 a.m. to 4:00 p.m. design is a two-armed randomized trial
publish periodic summaries of proposed
Agenda: To review and evaluate grant of men and women aged 55 to 74 at
applications. projects to be submitted to the Office of
Management and Budget (OMB) for entry. OMB first approved this study in
Place: Crystal City Marriott at Reagan
National Airport, 1999 Jefferson David review and approval. 1993 and has approved it every 3 years
Highway, Arlington, VA 22202. Written comments and/or suggestions since then. Recruitment was completed
Contact Person: Linda K Bass, Ph.D., from the public and affected agencies in 2001, baseline cancer screening was
Scientific Review Officer, Scientific Review are invited on one or more of the completed in 2006, and data collection
Branch, Division of Extramural Research and following points: (1) Whether the continues on the current cohort of
Training, Nat’l Institute Environmental proposed collection of information is 77,281 participants who are actively
Health Sciences, P.O. Box 12233, MD EC–30, being followed. The additional follow-
Research Triangle Park, NC 27709, (919) 541–
necessary for the proper performance of
the function of the agency, including up will provide data that will clarify
1307.
whether the information will have further the long term effects of the
Name of Committee: National Institute of screening on cancer incidence and
Environmental Health Sciences Special practical utility; (2) The accuracy of the
Emphasis Panel, Cell Differentiation Assays. agency’s estimate of the burden of the mortality for the four targeted cancers.
Date: May 15, 2015. proposed collection of information, Further, demographic and risk factor
Time: 8:00 a.m. to 5:00 p.m. including the validity of the information may be used to analyze the
Agenda: To review and evaluate grant methodology and assumptions used; (3) differential effectiveness of cancer
applications. Ways to enhance the quality, utility, and screening in high versus low risk
Place: Sheraton Chapel Hill, One Europa clarity of the information to be individuals.
Drive, Chapel Hill, NC 27517.
Contact Person: Sally Eckert-Tilotta, Ph.D.,
collected; and (4) Ways to minimize the OMB approval is requested for 3
Scientific Review Officer, Nat. Institute of burden of the collection of information years. There are no costs to respondents
Environmental Health Sciences, Office of on those who are to respond, including other than their time. The total
Program Operations, Scientific Review the use of appropriate automated, estimated annualized burden hours are
electronic, mechanical, or other 26,320.
tkelley on DSK3SPTVN1PROD with NOTICES
Branch, P.O. Box 12233, Research Triangle
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![22212 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Type of Number of Annual burden
Form name responses per per response
respondents respondents hours
respondent (minutes/hour)
Annual Study Update(ASU) Form .... Participants who complete the ASU 77,281 1 5/60 6,440
ASU Telephone Script ...................... Non Responders to the ASU ........... 3,091 1 5/60 258
Authorization to Release Medical Participants who report new cancers 2,700 1 3/60 135
Records.
Health Status Questionnaire (Fe- Female participants who complete 960 1 5/60 87
male) (HSQ). the HSQ.
Health Status Questionnaire (Male) Male participants who complete the 1,040 1 5/60 80
(HSQ). HSQ.
Medication Use Questionnaire Participants who complete the MUQ 77,281 1 15/60 19,320
(MUQ).
Dated: April 7, 2015. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant
Karla Bailey, Agenda: To review and evaluate grant applications.
applications. Place: National Library of Medicine, 6705
NCI Project Clearance Liaison, National
Place: National Institute on Aging, Rockledge Drive, Suite 301, Bethesda, MD
Institutes of Health.
Gateway Building, Suite 2C212, 7201 20817, (Telephone Conference Call).
[FR Doc. 2015–09090 Filed 4–20–15; 8:45 am] Wisconsin Avenue, Bethesda, MD 20892, Contact Person: Zoe E. Huang, MD,
BILLING CODE 4140–01–P (Telephone Conference Call). Scientific Review Officer, Extramural
Contact Person: Jeannette L. Johnson, Programs, National Library of Medicine, NIH,
Ph.D., National Institutes on Aging, National 6705 Rockledge Drive, Suite 301, Bethesda,
DEPARTMENT OF HEALTH AND Institutes of Health, 7201 Wisconsin Avenue, MD 20892–7968, 301–594–4937, huangz@
HUMAN SERVICES Suite 2C212, Bethesda, MD 20892, 301–402– mail.nih.gov.
7705, JOHNSONJ9@NIA.NIH.GOV. (Catalogue of Federal Domestic Assistance
National Institutes of Health (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library
Program Nos. 93.866, Aging Research, Assistance, National Institutes of Health,
National Institute on Aging; Notice of National Institutes of Health, HHS) HHS)
Closed Meetings Dated: April 15, 2015. Dated: April 15, 2015.
Pursuant to section 10(d) of the Melanie J. Gray, Michelle Trout,
Federal Advisory Committee Act, as Program Analyst, Office of Federal Advisory Program Analyst, Office of the Federal
amended (5 U.S.C. App.), notice is Committee Policy. Advisory Committee Policy.
hereby given of the following meetings. [FR Doc. 2015–09056 Filed 4–20–15; 8:45 am]
[FR Doc. 2015–09062 Filed 4–20–15; 8:45 am]
The meetings will be closed to the BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
as amended. The grant applications and HUMAN SERVICES HUMAN SERVICES
the discussions could disclose
National Institutes of Health National Institutes of Health
confidential trade secrets or commercial
property such as patentable material, Eunice Kennedy Shriver National
and personal information concerning National Library of Medicine; Notice of
Closed Meeting Institute of Child Health and Human
individuals associated with the grant Development; Notice of Closed
applications, the disclosure of which Meeting
Pursuant to Section 10(d) of the
would constitute a clearly unwarranted
Federal Advisory Committee Act, as Pursuant to section 10(d) of the
invasion of personal privacy.
amended (5 U.S.C. App), notice is Federal Advisory Committee Act, as
Name of Committee: National Institute on hereby given of the following meeting.
Aging Special Emphasis Panel; Age-Related
amended (5 U.S.C. App.), notice is
The meeting will be closed to the hereby given of the following meeting.
Hearing Loss.
Date: May 20, 2015.
public in accordance with the The meeting will be closed to the
Time: 3:00 p.m. to 6:00 p.m. provisions set forth in sections public in accordance with the
Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., provisions set forth in section 552b(c)(4)
applications. as amended. The grant applications and and 552b(c)(6), Title 5 U.S.C., as
Place: National Institute on Aging, the discussions could disclose amended. The grant applications and
Gateway Building, Suite 2C212, 7201 confidential trade secrets or commercial the discussions could disclose
Wisconsin Avenue, Bethesda, MD 20892, property such as patentable materials, confidential trade secrets or commercial
(Telephone Conference Call). and personal information concerning property such as patentable material,
Contact Person: Elaine Lewis, Ph.D., individuals associated with the grant and personal information concerning
Scientific Review Branch, National Institute
on Aging, Gateway Building, Suite 2C212,
applications, the disclosure of which individuals associated with the grant
tkelley on DSK3SPTVN1PROD with NOTICES
MSC–9205, 7201 Wisconsin Avenue, would constitute a clearly unwarranted applications, the disclosure of which
Bethesda, MD 20892, 301–402–7707, invasion of personal privacy. would constitute a clearly unwarranted
elainelewis@nia.nih.gov. Name of Committee: National Library of invasion of personal privacy.
Name of Committee: National Institute on Medicine Special Emphasis Panel; Scholarly Name of Committee: National Institute of
Aging Special Emphasis Panel; Alzheimer Works G13. Child Health and Human Development
Pathogenesis. Date: June 26, 2015. Special Emphasis Panel; Functions and
Date: June 18, 2015. Time: 9:00 a.m. to 6:00 p.m. Development of the Mirror Neuron System.
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Document Created: 2015-12-16 08:33:26
Document Modified: 2015-12-16 08:33:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| FR Citation | 80 FR 22211 |
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