Submission for OMB Review; 30-Day Comment Request; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI), 66548-66549 [2015-27586]

Download as PDF 66548 Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) inspected or x-rayed as they enter the NIH campus. For more information about the security measures at NIH, please visit https://www.nih.gov/about/ visitorsecurity.htm. Dated: October 23, 2015. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. Dated: October 22, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015–27583 Filed 10–28–15; 8:45 am] [FR Doc. 2015–27627 Filed 10–28–15; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Center for Scientific Review; Notice of Closed Meetings asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 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: Center for Scientific Review Special Emphasis Panel; Neural injury and Neurodegeneration. Date: November 12, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Laurent Taupenot, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4188, MSC 7850, Bethesda, MD 20892, 301–435– 1203, laurent.taupenot@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Application Re-Review: Neurobiology of the Cochlear. Date: November 18, 2015. Time: 2:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5181 MSC 7846, Bethesda, MD 20892–7846, 301– 435–1236, zhaow@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 Submission for OMB Review; 30-Day Comment Request; A Multi-Center International Hospital-Based CaseControl Study of Lymphoma in Asia (AsiaLymph) (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 28, 2015, page number 52325 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Nathaniel Rothman, Senior Investigator, Division of Cancer Epidemiology and Genetics, 9609 Medical Center Drive MSC 9776 Room SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 6E134, Rockville, MD 20850 or call nontoll-free number (240) 276–7169 or Email your request, including your address to: rothmann@mail.nih.gov. Proposed Collection: A Multi-Center International Hospital-Based CaseControl Study of Lymphoma in Asia (AsiaLymph) (NCI), 0925–0654, Expiration Date 10/31/2015— REVISION, National Institutes of Health (NIH). Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in the United States and in many other parts of the world. The contribution of environmental, occupational, and genetic factors to the cause of lymphoma and leukemia has generated a series of novel findings from epidemiological studies conducted in the United States that have attempted to explain this increase. However, none of the chemical associations have been conclusively established and the identification of the key, functional alleles in gene regions associated with risk of lymphoma requires further elucidation. Further, the ability to follow-up, confirm, and extend these observations in the United States is limited by the low prevalence and limited range of several important chemical and viral exposures and the high to complete linkage disequilibrium among key candidate genetic loci in Western populations. To optimize the ability to build on and clarify these findings, it is necessary to investigate populations that differ from those in the West in both exposure patterns and underlying genetic structure. A multidisciplinary case-control study of lymphoma in Asia, where lymphoma rates have also risen, provides an opportunity to replicate and extend recent and novel observations made in studies in the West in a population that is distinctly different with regard to patterns of key risk factors, including range of exposures, prevalence of exposures, correlations between exposures, and variation in gene regions of particular interest. It will also improve the ability to understand the causes of certain types of rare lymphoma tumors in the United States that occur at much higher rates in Asia. As such, AsiaLymph will confirm and extend previous findings and yield novel insights into the causes of lymphoma and leukemia in both Asia and in the United States. The major postulated risk factors for evaluation in this study are chemical exposures (i.e., organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other factors potentially related to lymphoma, such as viral infections, E:\FR\FM\29OCN1.SGM 29OCN1 66549 Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices ultraviolet radiation exposure, medical conditions, and other lifestyle factors will also be studied. Patients from 11 participating hospitals will be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and cases with lymphoma or leukemia will be asked to make available a portion of their pathology sample. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 3,262. Estimated Annualized Burden Hours TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS Number of respondents Types of respondents Instrument Potential Study Subjects ................... Eligible Potential Study Subjects ...... Consented Patient Cases ................. Screening Questions ........................ Consent Form .................................. Core Questionnaire & Occupational Job Module. Core Questionnaire & Occupational Job Module. Pathology sample request and tracking form. Tracking forms ................................. Consented Patient Controls .............. Study Pathologists ............................ Interviewers ....................................... Dated: October 16, 2015. Karla Bailey, Project Clearance Liaison, National Cancer Institute, NIH. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Opportunity for Public Comment on the Dietary Supplement Label Database The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at https:// dsld.nlm.nih.gov. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: To ensure full consideration, all comments must be received by 11:59 p.m. EST, November 27, 2015. DATES: Interested individuals and organizations should submit their responses to ODS@nih.gov. ADDRESSES: VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 5/60 5/60 105/60 176 150 1,692 300 1 105/60 525 10 97 5/60 81 15 85 30/60 638 The DSLD is a free resource that captures all information present on dietary supplement labels as provided by the seller, including contents, ingredient amounts, and any health-related product statements, claims, and cautions. It also provides a downloadable photo of each label. Users can search for and organize this information in various ways. Research scientists, for example, could use the DSLD to determine total nutrient intakes from food and supplements in populations they study. Health care providers can learn the content of products their patients are taking. Consumers might use the DSLD to search for and compare products of interest. The DSLD currently contains 50,000 labels, and it is expected to grow rapidly over the next three years to include most of the estimated 75,000+ dietary supplement products sold to American consumers. The DSLD is updated regularly to include any formulation changes and label information in a product. It also includes the labels of products that have been discontinued and are no longer sold. More information about the DSLD and its current capabilities is available at SUPPLEMENTARY INFORMATION: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Annual burden hours 1 1 1 Richard Bailen MBA, MHA., Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892–7517, Phone: 301–435–2920, Fax: 301–480–1845, Email: ODS@nih.gov. BILLING CODE 4140–01–P Time per response (hours) 2,110 1,801 967 FOR FURTHER INFORMATION CONTACT: [FR Doc. 2015–27586 Filed 10–28–15; 8:45 am] Frequency of response https://www.dsld.nlm.nih.gov and at Dwyer et al., 2014.1 ODS would like would like to receive ideas and suggestions for how the DSLD might evolve. What features might be added, improved, or enhanced—for example, in capabilities related to search, sorting, organization, and downloading of information—that would make it a more valuable tool for users? Dated: October 23, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015–27625 Filed 10–28–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting 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 meeting. The meeting will be closed to the public in accordance with the 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 1 Dwyer JT, Saldanha LG, Bailen RA, et al. A free new dietary supplement label database for registered dietitian nutritionists. J Acad Nutr Diet. 2014;114(10):1512–7. E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66548-66549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27586]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; A Multi-Center 
International Hospital-Based Case-Control Study of Lymphoma in Asia 
(AsiaLymph) (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), the 
National Institutes of Health, has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on August 
28, 2015, page number 52325 and allowed 60-days for public comment. One 
public comment was received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Cancer Institute 
(NCI), National Institutes of Health, may not conduct or sponsor, and 
the respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact: Nathaniel Rothman, Senior Investigator, 
Division of Cancer Epidemiology and Genetics, 9609 Medical Center Drive 
MSC 9776 Room 6E134, Rockville, MD 20850 or call non-toll-free number 
(240) 276-7169 or Email your request, including your address to: 
rothmann@mail.nih.gov.
    Proposed Collection: A Multi-Center International Hospital-Based 
Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI), 0925-0654, 
Expiration Date 10/31/2015--REVISION, National Institutes of Health 
(NIH).
    Need and Use of Information Collection: Incidence rates of certain 
lymphomas have increased in the United States and in many other parts 
of the world. The contribution of environmental, occupational, and 
genetic factors to the cause of lymphoma and leukemia has generated a 
series of novel findings from epidemiological studies conducted in the 
United States that have attempted to explain this increase. However, 
none of the chemical associations have been conclusively established 
and the identification of the key, functional alleles in gene regions 
associated with risk of lymphoma requires further elucidation. Further, 
the ability to follow-up, confirm, and extend these observations in the 
United States is limited by the low prevalence and limited range of 
several important chemical and viral exposures and the high to complete 
linkage disequilibrium among key candidate genetic loci in Western 
populations. To optimize the ability to build on and clarify these 
findings, it is necessary to investigate populations that differ from 
those in the West in both exposure patterns and underlying genetic 
structure. A multidisciplinary case-control study of lymphoma in Asia, 
where lymphoma rates have also risen, provides an opportunity to 
replicate and extend recent and novel observations made in studies in 
the West in a population that is distinctly different with regard to 
patterns of key risk factors, including range of exposures, prevalence 
of exposures, correlations between exposures, and variation in gene 
regions of particular interest. It will also improve the ability to 
understand the causes of certain types of rare lymphoma tumors in the 
United States that occur at much higher rates in Asia. As such, 
AsiaLymph will confirm and extend previous findings and yield novel 
insights into the causes of lymphoma and leukemia in both Asia and in 
the United States. The major postulated risk factors for evaluation in 
this study are chemical exposures (i.e., organochlorines, 
trichloroethylene, and benzene) and genetic susceptibility. Other 
factors potentially related to lymphoma, such as viral infections,

[[Page 66549]]

ultraviolet radiation exposure, medical conditions, and other lifestyle 
factors will also be studied. Patients from 11 participating hospitals 
will be screened and enrolled. There will be a one-time computer-
administered interview, and patients will also be asked to provide a 
one-time blood and buccal cell mouth wash sample and cases with 
lymphoma or leukemia will be asked to make available a portion of their 
pathology sample.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 3,262.
Estimated Annualized Burden Hours

                                 Table A.12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Time per
     Types of respondents          Instrument        Number of     Frequency of      response      Annual burden
                                                    respondents      response         (hours)          hours
----------------------------------------------------------------------------------------------------------------
Potential Study Subjects......  Screening                  2,110               1            5/60             176
                                 Questions.
Eligible Potential Study        Consent Form....           1,801               1            5/60             150
 Subjects.
Consented Patient Cases.......  Core                         967               1          105/60           1,692
                                 Questionnaire &
                                 Occupational
                                 Job Module.
Consented Patient Controls....  Core                         300               1          105/60             525
                                 Questionnaire &
                                 Occupational
                                 Job Module.
Study Pathologists............  Pathology sample              10              97            5/60              81
                                 request and
                                 tracking form.
Interviewers..................  Tracking forms..              15              85           30/60             638
----------------------------------------------------------------------------------------------------------------


    Dated: October 16, 2015.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2015-27586 Filed 10-28-15; 8:45 am]
 BILLING CODE 4140-01-P
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