81 FR 9865 - 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)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 38 (February 26, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 38 (February 26, 2016)
| Page Range | 9865-9865 | |
| FR Document | 2016-04179 |
[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)] [Notices] [Page 9865] From the Federal Register Online [www.thefederalregister.org] [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, [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: 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: [email protected]. 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
![Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices 9865
DEPARTMENT OF HEALTH AND time, should be directed to the: Office complex, with both genetic and
HUMAN SERVICES of Management and Budget, Office of environmental factors likely playing a
Regulatory Affairs, OIRA_submission@ role. Environmental risk factors,
National Institutes of Health omb.eop.gov or by fax to 202–395–6974, however, have been difficult to identify.
Attention: NIH Desk Officer. By focusing on genetically susceptible
Submission for OMB Review; 30-Day DATES: Comment Due Date: Comments subgroups, more precise estimates of the
Comment Request The Sister Study: A regarding this information collection are contribution of environmental and other
Prospective Study of the Genetic and best assured of having their full effect if non-genetic factors to disease risk may
Environmental Risk Factors for Breast received within 30-days of the date of be possible. Sisters of women with
Cancer (NIEHS) this publication. breast cancer are one group at increased
SUMMARY: Under the provisions of FOR FURTHER INFORMATION CONTACT: To risk for breast cancer; we would expect
Section 3507(a)(1)(D) of the Paperwork obtain a copy of the data collection at least 2 times as many breast cancers
Reduction Act of 1995, the National plans and instruments or request more to accrue in a cohort of sisters as would
Institutes of Health (NIH) has submitted information on the proposed project accrue in a cohort identified through
to the Office of Management and Budget contact: Dr. Dale P. Sandler, Chief, random sampling or other means. In
(OMB) a request for review and Epidemiology Branch, NIEHS, Rall addition, a cohort of sisters should be
approval of the information collection Building A3–05, P.O. Box 12233, enriched with regard to the prevalence
listed below. This proposed information Research Triangle Park, NC 27709, or of relevant genes and/or exposures,
collection was previously published in call non-toll free number (919)–541– further enhancing the ability to detect
the Federal Register on 02 December 4668 or Email your request, including gene-environment interactions. Sisters
2015, Vol. 80, page 75465 and allowed your address to: sandler@niehs.nih.gov. of women with breast cancer will also
60-days for public comment. No public Formal requests for additional plans and be at increased risk for ovarian cancer
comments were received The purpose of instruments must be requested in and possibly for other hormonally-
this notice is to allow an additional 30 writing. mediated diseases. From August 2003
days for public comment. The National Proposed Collection: Revision: The
through July 2009, we enrolled a cohort
Institute of Environmental Health Sister Study: A Prospective Study of the
of 50,884 women who had not had
Sciences (NIEHS), National Institutes of Genetic and Environmental Risk Factors
breast cancer. We estimated that after
Health, may not conduct or sponsor, for Breast Cancer, 0925–0522, National
the cohort was fully enrolled,
and the respondent is not required to Institute of Environmental Health
approximately 300 new cases of breast
respond to, an information collection Sciences (NIEHS), National Institutes of
cancer will be diagnosed during each
that has been extended, revised, or Health (NIH).
Need and Use of Information year of follow-up. Thus far 2,904
implemented on or after October 1,
Collection: This is to continue the long- participants have reported being
1995, unless it displays a currently valid
OMB control number. term follow-up of the Sister Study—a diagnosed with breast cancer.
Direct Comments to OMB: Written study of genetic and environmental risk OMB approval is requested for 3
comments and/or suggestions regarding factors for the development of breast years. There are no costs to respondents
the item(s) contained in this notice, cancer in a high-risk cohort of sisters of other than their time. The total
especially regarding the estimated women who have had breast cancer. estimated annualized burden hours are
public burden and associated response The etiology of breast cancer is 16,350.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Annual Number of Total
burden per
Activity number of reponses per burden hours
response
respondents respondent per year
(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. DEPARTMENT OF HEALTH AND Kennedy Shriver National Institute of
Jane Lambert, HUMAN SERVICES Child Health and Human Development
Project Clearance Liaison, NIEHS. (NICHD), the National Institutes of
[FR Doc. 2016–04179 Filed 2–25–16; 8:45 am]
National Institutes of Health Health, has submitted to the Office of
BILLING CODE 4140–01–P
Management and Budget (OMB) a
Submission for OMB Review; 30-Day request for review and approval of the
Comment Request: A Clearance for the
information collection listed below.
mstockstill on DSK4VPTVN1PROD with NOTICES
Eunice Kennedy Shriver National
This proposed information collection
Institute of Child Health and Human
Development Data and Specimen Hub was previously published in the Federal
(DASH) Register on October 30, 2015 on pages
66913–4 and allowed 60-days for public
SUMMARY: Under the provisions of comment. No public comments were
Section 3507(a)(1)(D) of the Paperwork received. The purpose of this notice is
Reduction Act of 1995, the Eunice to allow an additional 30 days for public
VerDate Sep<11>2014 20:41 Feb 25, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1](https://thefederalregister.org/doc/81_FR_9903/page/1.svg)
Document Created: 2018-02-02 14:36:52
Document Modified: 2018-02-02 14:36:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | 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. | |
| 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 | |
| FR Citation | 81 FR 9865 |
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