80_FR_66757 80 FR 66548 - Submission for OMB Review; 30-Day Comment Request; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer."> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer." /> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer." />

80 FR 66548 - Submission for OMB Review; 30-Day Comment Request; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 209 (October 29, 2015)

Page Range66548-66549
FR Document2015-27586

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, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer.

Federal Register, Volume 80 Issue 209 (Thursday, October 29, 2015)
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66548-66549]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected] 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: 
[email protected].
    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



                                                    66548                       Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices

                                                    inspected or x-rayed as they enter the NIH              93.337, 93.393–93.396, 93.837–93.844,                 6E134, Rockville, MD 20850 or call non-
                                                    campus. For more information about the                  93.846–93.878, 93.892, 93.893, National               toll-free number (240) 276–7169 or
                                                    security measures at NIH, please visit                  Institutes of Health, HHS)                            Email your request, including your
                                                    http://www.nih.gov/about/                                 Dated: October 23, 2015.                            address to: rothmann@mail.nih.gov.
                                                    visitorsecurity.htm.
                                                                                                            Anna Snouffer,                                           Proposed Collection: A Multi-Center
                                                      Dated: October 22, 2015.                              Deputy Director, Office of Federal Advisory           International Hospital-Based Case-
                                                    Lawrence A. Tabak,                                      Committee Policy.                                     Control Study of Lymphoma in Asia
                                                    Deputy Director, National Institutes of Health.         [FR Doc. 2015–27583 Filed 10–28–15; 8:45 am]          (AsiaLymph) (NCI), 0925–0654,
                                                                                                            BILLING CODE 4140–01–P
                                                                                                                                                                  Expiration Date 10/31/2015—
                                                    [FR Doc. 2015–27627 Filed 10–28–15; 8:45 am]
                                                                                                                                                                  REVISION, National Institutes of Health
                                                    BILLING CODE 4140–01–P
                                                                                                                                                                  (NIH).
                                                                                                            DEPARTMENT OF HEALTH AND                                 Need and Use of Information
                                                                                                            HUMAN SERVICES                                        Collection: Incidence rates of certain
                                                    DEPARTMENT OF HEALTH AND
                                                                                                                                                                  lymphomas have increased in the
                                                    HUMAN SERVICES
                                                                                                            National Institutes of Health                         United States and in many other parts
                                                    National Institutes of Health                                                                                 of the world. The contribution of
                                                                                                            Submission for OMB Review; 30-Day                     environmental, occupational, and
                                                    Center for Scientific Review; Notice of                 Comment Request; A Multi-Center                       genetic factors to the cause of
                                                    Closed Meetings                                         International Hospital-Based Case-                    lymphoma and leukemia has generated
                                                                                                            Control Study of Lymphoma in Asia                     a series of novel findings from
                                                      Pursuant to section 10(d) of the                      (AsiaLymph) (NCI)                                     epidemiological studies conducted in
                                                    Federal Advisory Committee Act, as                                                                            the United States that have attempted to
                                                    amended (5 U.S.C. App.), notice is                      SUMMARY:   Under the provisions of
                                                                                                            Section 3507(a)(1)(D) of the Paperwork                explain this increase. However, none of
                                                    hereby given of the following meetings.                                                                       the chemical associations have been
                                                      The meetings will be closed to the                    Reduction Act of 1995, the National
                                                                                                            Cancer Institute (NCI), the National                  conclusively established and the
                                                    public in accordance with the                                                                                 identification of the key, functional
                                                    provisions set forth in sections                        Institutes of Health, has submitted to the
                                                                                                            Office of Management and Budget                       alleles in gene regions associated with
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                                                    risk of lymphoma requires further
                                                    as amended. The grant applications and                  (OMB) a request for review and
                                                                                                                                                                  elucidation. Further, the ability to
                                                    the discussions could disclose                          approval of the information collection
                                                                                                                                                                  follow-up, confirm, and extend these
                                                    confidential trade secrets or commercial                listed below. This proposed information
                                                                                                                                                                  observations in the United States is
                                                    property such as patentable material,                   collection was previously published in
                                                                                                                                                                  limited by the low prevalence and
                                                    and personal information concerning                     the Federal Register on August 28,
                                                                                                                                                                  limited range of several important
                                                    individuals associated with the grant                   2015, page number 52325 and allowed
                                                                                                                                                                  chemical and viral exposures and the
                                                    applications, the disclosure of which                   60-days for public comment. One public
                                                                                                                                                                  high to complete linkage disequilibrium
                                                    would constitute a clearly unwarranted                  comment was received. The purpose of
                                                                                                                                                                  among key candidate genetic loci in
                                                    invasion of personal privacy.                           this notice is to allow an additional 30
                                                                                                                                                                  Western populations. To optimize the
                                                                                                            days for public comment. The National
                                                      Name of Committee: Center for Scientific                                                                    ability to build on and clarify these
                                                    Review Special Emphasis Panel; Neural                   Cancer Institute (NCI), National                      findings, it is necessary to investigate
                                                    injury and Neurodegeneration.                           Institutes of Health, may not conduct or              populations that differ from those in the
                                                      Date: November 12, 2015.                              sponsor, and the respondent is not                    West in both exposure patterns and
                                                      Time: 1:00 p.m. to 5:00 p.m.                          required to respond to, an information                underlying genetic structure. A
                                                      Agenda: To review and evaluate grant                  collection that has been extended,                    multidisciplinary case-control study of
                                                    applications.                                           revised, or implemented on or after
                                                      Place: National Institutes of Health, 6701                                                                  lymphoma in Asia, where lymphoma
                                                                                                            October 1, 1995, unless it displays a                 rates have also risen, provides an
                                                    Rockledge Drive, Bethesda, MD 20892,                    currently valid OMB control number.
                                                    (Virtual Meeting).                                                                                            opportunity to replicate and extend
                                                                                                               Direct Comments to OMB: Written                    recent and novel observations made in
                                                      Contact Person: Laurent Taupenot, Ph.D.,
                                                    Scientific Review Officer, Center for                   comments and/or suggestions regarding                 studies in the West in a population that
                                                    Scientific Review, National Institutes of               the item(s) contained in this notice,                 is distinctly different with regard to
                                                    Health, 6701 Rockledge Drive, Room 4188,                especially regarding the estimated                    patterns of key risk factors, including
                                                    MSC 7850, Bethesda, MD 20892, 301–435–                  public burden and associated response                 range of exposures, prevalence of
                                                    1203, laurent.taupenot@nih.gov.                         time, should be directed to the: Office               exposures, correlations between
                                                      Name of Committee: Center for Scientific              of Management and Budget, Office of                   exposures, and variation in gene regions
                                                    Review Special Emphasis Panel; Application              Regulatory Affairs, OIRA_submission@
                                                    Re-Review: Neurobiology of the Cochlear.
                                                                                                                                                                  of particular interest. It will also
                                                                                                            omb.eop.gov or by fax to 202–395–6974,                improve the ability to understand the
                                                      Date: November 18, 2015.                              Attention: NIH Desk Officer.
                                                      Time: 2:00 p.m. to 3:30 p.m.                                                                                causes of certain types of rare
                                                      Agenda: To review and evaluate grant                  DATES: Comment Due Date: Comments                     lymphoma tumors in the United States
                                                    applications.                                           regarding this information collection are             that occur at much higher rates in Asia.
                                                      Place: National Institutes of Health, 6701            best assured of having their full effect if           As such, AsiaLymph will confirm and
                                                    Rockledge Drive, Bethesda, MD 20892,                    received within 30 days of the date of                extend previous findings and yield
                                                    (Telephone Conference Call).                            this publication.                                     novel insights into the causes of
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                      Contact Person: Wei-Qin Zhao, Ph.D.,                  FOR FURTHER INFORMATION CONTACT: To                   lymphoma and leukemia in both Asia
                                                    Scientific Review Officer, Center for
                                                    Scientific Review, National Institutes of
                                                                                                            obtain a copy of the data collection                  and in the United States. The major
                                                    Health, 6701 Rockledge Drive, Room 5181                 plans and instruments, or request more                postulated risk factors for evaluation in
                                                    MSC 7846, Bethesda, MD 20892–7846, 301–                 information on the proposed project,                  this study are chemical exposures (i.e.,
                                                    435–1236, zhaow@csr.nih.gov.                            contact: Nathaniel Rothman, Senior                    organochlorines, trichloroethylene, and
                                                    (Catalogue of Federal Domestic Assistance               Investigator, Division of Cancer                      benzene) and genetic susceptibility.
                                                    Program Nos. 93.306, Comparative Medicine;              Epidemiology and Genetics, 9609                       Other factors potentially related to
                                                    93.333, Clinical Research, 93.306, 93.333,              Medical Center Drive MSC 9776 Room                    lymphoma, such as viral infections,


                                               VerDate Sep<11>2014   23:37 Oct 28, 2015   Jkt 238001   PO 00000   Frm 00061   Fmt 4703   Sfmt 4703   E:\FR\FM\29OCN1.SGM   29OCN1


                                                                                      Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices                                                             66549

                                                    ultraviolet radiation exposure, medical                            patients will also be asked to provide a                    OMB approval is requested for 3
                                                    conditions, and other lifestyle factors                            one-time blood and buccal cell mouth                      years. There are no costs to respondents
                                                    will also be studied. Patients from 11                             wash sample and cases with lymphoma                       other than their time. The total
                                                    participating hospitals will be screened                           or leukemia will be asked to make                         estimated annualized burden hours are
                                                    and enrolled. There will be a one-time                             available a portion of their pathology                    3,262.
                                                    computer-administered interview, and                               sample.                                                   Estimated Annualized Burden Hours
                                                                                                           TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
                                                                                                                                                                                                       Time               Annual
                                                                                                                                                               Number of       Frequency of
                                                              Types of respondents                                          Instrument                                                             per response           burden
                                                                                                                                                              respondents        response             (hours)              hours

                                                    Potential Study Subjects ...................           Screening Questions ........................                2,110                 1               5/60                 176
                                                    Eligible Potential Study Subjects ......               Consent Form ..................................             1,801                 1               5/60                 150
                                                    Consented Patient Cases .................              Core Questionnaire & Occupational                             967                 1             105/60               1,692
                                                                                                             Job Module.
                                                    Consented Patient Controls ..............              Core Questionnaire & Occupational                             300                 1             105/60                  525
                                                                                                             Job Module.
                                                    Study Pathologists ............................        Pathology sample request and                                   10                97                5/60                  81
                                                                                                             tracking form.
                                                    Interviewers .......................................   Tracking forms .................................               15                85              30/60                  638


                                                      Dated: October 16, 2015.                                         FOR FURTHER INFORMATION CONTACT:                          http://www.dsld.nlm.nih.gov and at
                                                    Karla Bailey,                                                      Richard Bailen MBA, MHA., Office of                       Dwyer et al., 2014.1
                                                    Project Clearance Liaison, National Cancer                         Dietary Supplements, National                               ODS would like would like to receive
                                                    Institute, NIH.                                                    Institutes of Health, 6100 Executive                      ideas and suggestions for how the DSLD
                                                    [FR Doc. 2015–27586 Filed 10–28–15; 8:45 am]                       Boulevard, Room 3B01, Bethesda, MD                        might evolve. What features might be
                                                    BILLING CODE 4140–01–P                                             20892–7517, Phone: 301–435–2920,                          added, improved, or enhanced—for
                                                                                                                       Fax: 301–480–1845, Email:                                 example, in capabilities related to
                                                                                                                       ODS@nih.gov.                                              search, sorting, organization, and
                                                    DEPARTMENT OF HEALTH AND                                                                                                     downloading of information—that
                                                    HUMAN SERVICES                                                     SUPPLEMENTARY INFORMATION:      The DSLD                  would make it a more valuable tool for
                                                                                                                       is a free resource that captures all                      users?
                                                    National Institutes of Health                                      information present on dietary                              Dated: October 23, 2015.
                                                                                                                       supplement labels as provided by the                      Lawrence A. Tabak,
                                                    Notice of Opportunity for Public
                                                                                                                       seller, including contents, ingredient                    Deputy Director, National Institutes of Health.
                                                    Comment on the Dietary Supplement
                                                                                                                       amounts, and any health-related
                                                    Label Database                                                                                                               [FR Doc. 2015–27625 Filed 10–28–15; 8:45 am]
                                                                                                                       product statements, claims, and
                                                                                                                                                                                 BILLING CODE 4140–01–P
                                                    SUMMARY:   The Office of Dietary                                   cautions. It also provides a
                                                    Supplements (ODS) at the National                                  downloadable photo of each label. Users
                                                    Institutes of Health, in partnership with                          can search for and organize this                          DEPARTMENT OF HEALTH AND
                                                    the National Library of Medicine (NLM),                            information in various ways. Research                     HUMAN SERVICES
                                                    has developed a Dietary Supplement                                 scientists, for example, could use the
                                                    Label Database (DSLD) that is compiling                            DSLD to determine total nutrient intakes                  National Institutes of Health
                                                    all information from the labels of dietary                         from food and supplements in
                                                                                                                       populations they study. Health care                       National Institute of Allergy and
                                                    supplements marketed in the United
                                                                                                                                                                                 Infectious Diseases; Notice of Closed
                                                    States. ODS welcomes comments about                                providers can learn the content of
                                                                                                                                                                                 Meeting
                                                    features to add and functionality                                  products their patients are taking.
                                                    improvements to make so the DSLD may                               Consumers might use the DSLD to                             Pursuant to section 10(d) of the
                                                    become a more useful tool to users.                                search for and compare products of                        Federal Advisory Committee Act, as
                                                       A federal stakeholder panel for the                             interest.                                                 amended (5 U.S.C. App.), notice is
                                                    DSLD will consider all comments                                       The DSLD currently contains 50,000                     hereby given of the following meeting.
                                                    received. The ODS requests input from                              labels, and it is expected to grow rapidly                  The meeting will be closed to the
                                                    academic researchers, government                                   over the next three years to include                      public in accordance with the
                                                    agencies, the dietary supplement                                                                                             provisions set forth in sections
                                                                                                                       most of the estimated 75,000+ dietary
                                                    industry, and other interested parties,                                                                                      552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                                       supplement products sold to American
                                                    including consumers. The DSLD can be                                                                                         as amended. The grant applications and
                                                                                                                       consumers. The DSLD is updated                            the discussions could disclose
                                                    accessed online at http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                       regularly to include any formulation                      confidential trade secrets or commercial
                                                    dsld.nlm.nih.gov.                                                  changes and label information in a                        property such as patentable material,
                                                    DATES: To ensure full consideration, all                           product. It also includes the labels of                   and personal information concerning
                                                    comments must be received by 11:59                                 products that have been discontinued                      individuals associated with the grant
                                                    p.m. EST, November 27, 2015.                                       and are no longer sold. More
                                                                                                                       information about the DSLD and its                          1 Dwyer JT, Saldanha LG, Bailen RA, et al. A free
                                                    ADDRESSES:  Interested individuals and                             current capabilities is available at                      new dietary supplement label database for
                                                    organizations should submit their                                                                                            registered dietitian nutritionists. J Acad Nutr Diet.
                                                    responses to ODS@nih.gov.                                                                                                    2014;114(10):1512–7.



                                               VerDate Sep<11>2014       23:37 Oct 28, 2015      Jkt 238001     PO 00000     Frm 00062     Fmt 4703     Sfmt 4703   E:\FR\FM\29OCN1.SGM   29OCN1



Document Created: 2015-12-14 15:21:00
Document Modified: 2015-12-14 15:21:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ContactTo 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
FR Citation80 FR 66548 

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