Proposed Collection; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI), 58520-58521 [2011-24219]

Download as PDF 58520 Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Notices https://collaboration.fda.gov/rcac/ to hear and see the proceedings. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–24168 Filed 9–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. wreier-aviles on DSK7SPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on November 2, 2011, from 8 a.m. to 3:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993–0002. Information regarding special VerDate Mar<15>2010 15:20 Sep 20, 2011 Jkt 223001 accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Bldg. 1. Contact Person: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, e-mail: ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/ pharmacodynamic studies to support a pediatric indication for anticoagulants. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 person on or before October 19, 2011. Oral presentations from the public will be scheduled between approximately 12:50 p.m. and 1:50 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 11, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 12, 2011. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 15, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–24162 Filed 9–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI) In compliance with the requirement of Section 3506(c)(2)(A) of SUMMARY: E:\FR\FM\21SEN1.SGM 21SEN1 Federal Register / Vol. 76, No. 183 / Wednesday, September 21, 2011 / Notices the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, 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: Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI). Type of Information Collection Request: Reinstatement with change of a previously approved collection (OMB No. 0925–0405, expiration 02/28/2011). Need and Use of Information Collection: By conducting a fourth cohort follow-up survey in an ongoing cohort study of U.S. Radiologic Technologists (USRT), updated information will be collected on cancer and other medical outcomes, personal medical radiation procedures, and other risk factors from all participants, plus detailed employment data from subgroups of participants who performed or assisted with fluoroscopically-guided or radioisotope procedures. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 23,454 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and 58521 thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. The fourth survey will be administered by mail to approximately 93,000 living and located cohort members who completed at least one of the three previous surveys to collect information on new cancers and other disease outcomes, detailed work patterns and practices from technologists who worked with radioisotopes and interventional radiography procedures, and new or updated risk factors that may influence health risks. New occupational and medical radiation exposure information will be used to improve radiation dose estimates. The annual reporting burden is reported in Table 1. There are no capital costs, operating costs and/or maintenance costs to report. TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS Number of respondents Frequency of response Average time per response (hours) Annual hour burden Instrument Cohort members (overall target group). Cohort members (subgroup 1 of overall target group). Cohort members (subgroup 2 of overall target group). Medical office clerks .......................... Fourth Survey CORE Module (Attachment 1A). Fourth Survey NM Module (Attachment 1B). Fourth Survey FG Module (Attachment 1C). Medical Validation (Attachment 3) ... 21,700 1 30/60 (0.5) 10,850 7,000 1 20/60 (0.33) 2,333 6,300 1 10/60 (0.17) 1,050 2,053 1 15/60 (0.25) 513 Total ........................................... wreier-aviles on DSK7SPTVN1PROD with NOTICES Type of respondent .......................................................... 37,053 ........................ ........................ 14,746 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 functioning of the National Cancer Institute, 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 additional information on the proposed collection of information contact: Michele M. Doody, Radiation Epidemiology Branch, National Cancer Institute, Executive Plaza South, Room 7051, Bethesda, MD 20892–7238, or call FOR FURTHER INFORMATION CONTACT: VerDate Mar<15>2010 15:20 Sep 20, 2011 Jkt 223001 non-toll-free at 301–594–7203. You may also e-mail your request to doodym@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 this publication. Dated: September 15, 2011. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2011–24219 Filed 9–20–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel, Superfund Hazardous Substance Research and Training Program. Date: October 11–12, 2011. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Raleigh-Durham Airport Hotel, 4810 Page Creek Lane, Durham, NC 27703. Contact Person: Janice B. Allen, PhD, Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Science, P. O. Box 12233, MD EC–30/Room 3170 B, Research Triangle Park, NC 27709, (919) 541–7556. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel, Human Health Effects Of E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58520-58521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24219]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Cancer Risk in U.S. 
Radiologic Technologists: Fourth Survey (NCI)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of

[[Page 58521]]

the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Cancer Institute, 
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: Cancer Risk in U.S. Radiologic 
Technologists: Fourth Survey (NCI). Type of Information Collection 
Request: Reinstatement with change of a previously approved collection 
(OMB No. 0925-0405, expiration 02/28/2011). Need and Use of Information 
Collection: By conducting a fourth cohort follow-up survey in an 
ongoing cohort study of U.S. Radiologic Technologists (USRT), updated 
information will be collected on cancer and other medical outcomes, 
personal medical radiation procedures, and other risk factors from all 
participants, plus detailed employment data from subgroups of 
participants who performed or assisted with fluoroscopically-guided or 
radioisotope procedures. Researchers at the National Cancer Institute 
and The University of Minnesota have followed a nationwide cohort of 
146,000 radiologic technologists since 1982, of whom 110,000 completed 
at least one of three prior questionnaire surveys and 23,454 are 
deceased. This cohort is unique because estimates of cumulative 
radiation dose to specific organs (e.g. breast) are available and the 
cohort is largely female, offering a rare opportunity to study effects 
of low-dose radiation exposure on breast and thyroid cancers, the two 
most sensitive organ sites for radiation carcinogenesis in women. The 
fourth survey will be administered by mail to approximately 93,000 
living and located cohort members who completed at least one of the 
three previous surveys to collect information on new cancers and other 
disease outcomes, detailed work patterns and practices from 
technologists who worked with radioisotopes and interventional 
radiography procedures, and new or updated risk factors that may 
influence health risks. New occupational and medical radiation exposure 
information will be used to improve radiation dose estimates. The 
annual reporting burden is reported in Table 1. There are no capital 
costs, operating costs and/or maintenance costs to report.

                                                        Table 1--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Average time
               Type of respondent                               Instrument                   Number of     Frequency of    per response     Annual hour
                                                                                            respondents      response         (hours)         burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cohort members (overall target group)..........  Fourth Survey CORE Module (Attachment            21,700               1     30/60 (0.5)          10,850
                                                  1A).
Cohort members (subgroup 1 of overall target     Fourth Survey NM Module (Attachment 1B)           7,000               1    20/60 (0.33)           2,333
 group).
Cohort members (subgroup 2 of overall target     Fourth Survey FG Module (Attachment 1C)           6,300               1    10/60 (0.17)           1,050
 group).
Medical office clerks..........................  Medical Validation (Attachment 3)......           2,053               1    15/60 (0.25)             513
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................          37,053  ..............  ..............          14,746
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 functioning of the National 
Cancer Institute, 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 additional information on 
the proposed collection of information contact: Michele M. Doody, 
Radiation Epidemiology Branch, National Cancer Institute, Executive 
Plaza South, Room 7051, Bethesda, MD 20892-7238, or call non-toll-free 
at 301-594-7203. You may also e-mail your request to 
doodym@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 this publication.

    Dated: September 15, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-24219 Filed 9-20-11; 8:45 am]
BILLING CODE 4140-01-P
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