Submission for OMB Review; 30-Day Comment Request The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer (NIEHS), 9865 [2016-04179]

Download as PDF 9865 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer (NIEHS) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 02 December 2015, Vol. 80, page 75465 and allowed 60-days for public comment. No public comments were received The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Environmental Health Sciences (NIEHS), 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 SUMMARY: complex, with both genetic and environmental factors likely playing a role. Environmental risk factors, however, have been difficult to identify. By focusing on genetically susceptible subgroups, more precise estimates of the contribution of environmental and other non-genetic factors to disease risk may be possible. Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect at least 2 times as many breast cancers to accrue in a cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect gene-environment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonallymediated diseases. From August 2003 through July 2009, we enrolled a cohort of 50,884 women who had not had breast cancer. We estimated that after the cohort was fully enrolled, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Thus far 2,904 participants have reported being diagnosed with breast cancer. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 16,350. 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: Dr. Dale P. Sandler, Chief, Epidemiology Branch, NIEHS, Rall Building A3–05, P.O. Box 12233, Research Triangle Park, NC 27709, or call non-toll free number (919)–541– 4668 or Email your request, including your address to: sandler@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Revision: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer, 0925–0522, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: This is to continue the longterm follow-up of the Sister Study—a study of genetic and environmental risk factors for the development of breast cancer in a high-risk cohort of sisters of women who have had breast cancer. The etiology of breast cancer is ESTIMATED ANNUALIZED BURDEN HOURS Annual number of respondents Activity Number of reponses per respondent Average burden per response (hours) Total burden hours per year Annual Update ................................................................................................. Follow-Up III (triennial) ..................................................................................... Follow-Up III Telephone Prompting Script ....................................................... 32,215 16,108 4,832 * 1 1 1 10/60 40/60 3/60 5,369 10,739 242 Total per year ........................................................................................... 48,323 ........................ ........................ 16,350 * These Respondents are included in the 16,108 for Follow-Up III, thus not added into Total Respondents per year. Dated: February 19, 2016. Jane Lambert, Project Clearance Liaison, NIEHS. [FR Doc. 2016–04179 Filed 2–25–16; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: A Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Data and Specimen Hub (DASH) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Eunice SUMMARY: VerDate Sep<11>2014 20:41 Feb 25, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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 October 30, 2015 on pages 66913–4 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public E:\FR\FM\26FEN1.SGM 26FEN1

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[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Page 9865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04179]

[[Page 9865]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request The Sister
Study: A Prospective Study of the Genetic and Environmental Risk
Factors for Breast Cancer (NIEHS)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) 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 02 December 2015, Vol. 80, page 75465 and allowed 60-days
for public comment. No public comments were received The purpose of
this notice is to allow an additional 30 days for public comment. The
National Institute of Environmental Health Sciences (NIEHS), 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: Dr. Dale P. Sandler, Chief, Epidemiology
Branch, NIEHS, Rall Building A3-05, P.O. Box 12233, Research Triangle
Park, NC 27709, or call non-toll free number (919)-541-4668 or Email
your request, including your address to: sandler@niehs.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Proposed Collection: Revision: The Sister Study: A Prospective
Study of the Genetic and Environmental Risk Factors for Breast Cancer,
0925-0522, National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
Need and Use of Information Collection: This is to continue the
long-term follow-up of the Sister Study--a study of genetic and
environmental risk factors for the development of breast cancer in a
high-risk cohort of sisters of women who have had breast cancer. The
etiology of breast cancer is complex, with both genetic and
environmental factors likely playing a role. Environmental risk
factors, however, have been difficult to identify. By focusing on
genetically susceptible subgroups, more precise estimates of the
contribution of environmental and other non-genetic factors to disease
risk may be possible. Sisters of women with breast cancer are one group
at increased risk for breast cancer; we would expect at least 2 times
as many breast cancers to accrue in a cohort of sisters as would accrue
in a cohort identified through random sampling or other means. In
addition, a cohort of sisters should be enriched with regard to the
prevalence of relevant genes and/or exposures, further enhancing the
ability to detect gene-environment interactions. Sisters of women with
breast cancer will also be at increased risk for ovarian cancer and
possibly for other hormonally-mediated diseases. From August 2003
through July 2009, we enrolled a cohort of 50,884 women who had not had
breast cancer. We estimated that after the cohort was fully enrolled,
approximately 300 new cases of breast cancer will be diagnosed during
each year of follow-up. Thus far 2,904 participants have reported being
diagnosed with breast cancer.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 16,350.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Annual number Number of burden per Total burden
Activity of reponses per response hours per year
respondents respondent (hours)
----------------------------------------------------------------------------------------------------------------
Annual Update................................... 32,215 1 10/60 5,369
Follow-Up III (triennial)....................... 16,108 1 40/60 10,739
Follow-Up III Telephone Prompting Script........ 4,832 * 1 3/60 242
---------------------------------------------------------------
Total per year.............................. 48,323 .............. .............. 16,350
----------------------------------------------------------------------------------------------------------------
* These Respondents are included in the 16,108 for Follow-Up III, thus not added into Total Respondents per
year.

Dated: February 19, 2016.
Jane Lambert,
Project Clearance Liaison, NIEHS.
[FR Doc. 2016-04179 Filed 2-25-16; 8:45 am]
BILLING CODE 4140-01-P

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