80 FR 75465 - Proposed Collection; 60-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 80, Issue 231 (December 2, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 231 (December 2, 2015)
| Page Range | 75465-75466 | |
| FR Document | 2015-30527 |
[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)] [Notices] [Pages 75465-75466] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30527] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer (NIEHS) SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), 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. 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 [[Page 75466]] the function of the agency, 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 Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, 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. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer, Revision OMB #0925-0522 Expiration Date: 2/29/2016, National Institute of Environmental Health Sciences (NIEHS), the 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. ---------------------------------------------------------------------------------------------------------------- Estimated Number of Average burden Activity annual number reponses per per response Total burden of respondents respondent (in hours) hours per year ---------------------------------------------------------------------------------------------------------------- Annual Update................................... 32,215 1 10/60 5,369 Follow-Up III (triennial)....................... 16,108 1 40/60 10,739 ---------------------------------------------------------------------------------------------------------------- OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 16,108. Dated: November 23, 2015. Laurie K. Johnson, Acting Deputy Associate Director for Management, NIEHS. [FR Doc. 2015-30527 Filed 12-1-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Notices 75465
may be submitted to an Exchange, Name of Committee: National Deafness and the discussions could disclose
Medicaid or CHIP agency. The Other Communication Disorders Advisory confidential trade secrets or commercial
electronic application process will vary Council. property such as patentable material,
Date: January 22, 2016. and personal information concerning
depending on each applicant’s
Closed: 8:30 a.m. to 9:50 a.m.
circumstances, their experience with Agenda: To review and evaluate grant
individuals associated with the grant
health insurance applications and applications. applications, the disclosure of which
online capabilities. The goal is to solicit Place: National Institutes of Health, would constitute a clearly unwarranted
sufficient information so that in most Building 31, Conference Room 6, 31 Center invasion of personal privacy.
cases no further inquiry will be needed. Drive, Bethesda, MD 20892. Name of Committee: Center for Scientific
Form Number: CMS–10440 (OMB Open: 9:50 a.m. to 2:00 p.m. Review Special Emphasis Panel; Hematology
control number: 0938–1191); Frequency: Agenda: Staff reports on divisional, Small Business.
programmatic, and special activities. Date: December 10, 2015.
Annually; Affected Public: Individuals
Place: National Institutes of Health, Time: 4:30 p.m. to 5:30 p.m.
and Households; Number of Building 31, Conference Room 6, 31 Center Agenda: To review and evaluate grant
Respondents: 7,200,000; Total Annual Drive, Bethesda, MD 20892. applications.
Responses: 7,200,000; Total Annual Contact Person: Craig A. Jordan, Ph.D., Place: National Institutes of Health, 6701
Hours: 2,410,767. (For policy questions Director, Division of Extramural Activities, Rockledge Drive, Bethesda, MD 20892
regarding this collection contact Beth NIDCD, NIH, Room 8345, MSC 9670, 6001 (Telephone Conference Call).
Liu at 301–492–4135.) Executive Blvd., Bethesda, MD 20892–9670, Contact Person: Bukhtiar H. Shah, DVM,
301–496–8693, jordanc@nidcd.nih.gov. Ph.D., Scientific Review Officer, Center for
Dated: November 27, 2015. Scientific Review, National Institutes of
Any interested person may file written
William N. Parham, III, comments with the committee by forwarding Health, 6701 Rockledge Drive, Room 4120,
Director, Paperwork Reduction Staff, Office the statement to the Contact Person listed on MSC 7802, Bethesda, MD 20892, 301–806–
of Strategic Operations and Regulatory this notice. The statement should include the 7314, shahb@csr.nih.gov.
Affairs. name, address, telephone number and when This notice is being published less than 15
[FR Doc. 2015–30534 Filed 12–1–15; 8:45 am] applicable, the business or professional days prior to the meeting due to the timing
affiliation of the interested person. limitations imposed by the review and
BILLING CODE 4120–01–P funding cycle.
In the interest of security, NIH has
instituted stringent procedures for entrance (Catalogue of Federal Domestic Assistance
onto the NIH campus. All visitor vehicles, Program Nos. 93.306, Comparative Medicine;
DEPARTMENT OF HEALTH AND including taxicabs, hotel, and airport shuttles 93.333, Clinical Research, 93.306, 93.333,
HUMAN SERVICES will be inspected before being allowed on 93.337, 93.393–93.396, 93.837–93.844,
campus. Visitors will be asked to show one 93.846–93.878, 93.892, 93.893, National
National Institutes of Health form of identification (for example, a Institutes of Health, HHS)
government-issued photo ID, driver’s license,
Dated: November 25, 2015.
National Institute on Deafness and or passport) and to state the purpose of their
visit. Sylvia Neal,
Other Communication Disorders;
Notice of Meeting Information is also available on the Program Analyst, Office of Federal Advisory
Institute’s/Center’s home page: http:// Committee Policy.
www.nidcd.nih.gov/about/Pages/Advisory- [FR Doc. 2015–30516 Filed 12–1–15; 8:45 am]
Pursuant to section 10(d) of the Groups-and-Review-Committees.aspx, where
Federal Advisory Committee Act, as an agenda and any additional information for
BILLING CODE 4140–01–P
amended (5 U.S.C. App.), notice is the meeting will be posted when available.
hereby given of a meeting of the (Catalogue of Federal Domestic Assistance
National Deafness and Other DEPARTMENT OF HEALTH AND
Program Nos. 93.173, Biological Research HUMAN SERVICES
Communication Disorders Advisory Related to Deafness and Communicative
Council. Disorders, National Institutes of Health, HHS) National Institutes of Health
The meeting will be open to the Dated: November 25, 2015.
public as indicated below, with Sylvia Neal, Proposed Collection; 60-Day Comment
attendance limited to space available. Program Analyst, Office of Federal Advisory Request; The Sister Study: A
Individuals who plan to attend and Committee Policy. Prospective Study of the Genetic and
need special assistance, such as sign [FR Doc. 2015–30518 Filed 12–1–15; 8:45 am] Environmental Risk Factors for Breast
language interpretation or other BILLING CODE 4140–01–P
Cancer (NIEHS)
reasonable accommodations, should SUMMARY: In compliance with the
notify the Contact Person listed below requirement of Section 3506(c)(2)(A) of
in advance of the meeting. DEPARTMENT OF HEALTH AND the Paperwork Reduction Act of 1995,
The meeting will be closed to the HUMAN SERVICES for opportunity for public comment on
public in accordance with the proposed data collection projects, the
provisions set forth in sections National Institutes of Health National Institute of Environmental
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Center for Scientific Review; Notice of Health Sciences (NIEHS), the National
as amended. The grant applications Closed Meeting Institutes of Health (NIH) will publish
and/or contract proposals and the periodic summaries of proposed
discussions could disclose confidential Pursuant to section 10(d) of the projects to be submitted to the Office of
trade secrets or commercial property Federal Advisory Committee Act, as
jstallworth on DSK7TPTVN1PROD with NOTICES
Management and Budget (OMB) for
such as patentable material, and amended (5 U.S.C. App.), notice is review and approval.
personal information concerning hereby given of the following meeting. Written comments and/or suggestions
individuals associated with the grant The meeting will be closed to the from the public and affected agencies
applications and/or contract proposals, public in accordance with the are invited on one or more of the
the disclosure of which would provisions set forth in sections following points: (1) Whether the
constitute a clearly unwarranted 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., proposed collection of information is
invasion of personal privacy. as amended. The grant applications and necessary for the proper performance of
VerDate Sep<11>2014 13:24 Dec 01, 2015 Jkt 238001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1](https://thefederalregister.org/doc/80_FR_75696/page/1.svg)
![75466 Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Notices
the function of the agency, including Formal requests for additional plans and subgroups, more precise estimates of the
whether the information will have instruments must be requested in contribution of environmental and other
practical utility; (2) The accuracy of the writing. non-genetic factors to disease risk may
agency’s estimate of the burden of the Comments Due Date: Comments be possible. Sisters of women with
proposed collection of information, regarding this information collection are breast cancer are one group at increased
including the validity of the best assured of having their full effect if risk for breast cancer; we would expect
methodology and assumptions used; (3) received within 60 days of the date of at least 2 times as many breast cancers
Ways to enhance the quality, utility, and this publication. to accrue in a cohort of sisters as would
clarity of the information to be Proposed Collection: The Sister accrue in a cohort identified through
collected; and (4) Ways to minimize the Study: A Prospective Study of the random sampling or other means. In
burden of the collection of information Genetic and Environmental Risk Factors
addition, a cohort of sisters should be
on those who are to respond, including for Breast Cancer, Revision OMB #0925–
enriched with regard to the prevalence
the use of appropriate automated, 0522 Expiration Date: 2/29/2016,
of relevant genes and/or exposures,
electronic, mechanical, or other National Institute of Environmental
Health Sciences (NIEHS), the National further enhancing the ability to detect
technological collection techniques or gene-environment interactions. Sisters
other forms of information technology. Institutes of Health (NIH).
Need and Use of Information of women with breast cancer will also
To Submit Comments and for Further Collection: This is to continue the long- be at increased risk for ovarian cancer
Information: To obtain a copy of the term follow-up of the Sister Study—a and possibly for other hormonally-
data collection plans and instruments, study of genetic and environmental risk mediated diseases. From August 2003
submit comments in writing, or request factors for the development of breast through July 2009, we enrolled a cohort
more information on the proposed cancer in a high-risk cohort of sisters of of 50,884 women who had not had
project, contact: Dr. Dale P. Sandler, women who have had breast cancer. breast cancer. We estimated that after
Chief, Epidemiology Branch, NIEHS, The etiology of breast cancer is the cohort was fully enrolled,
Rall Building A3–05, P.O. Box 12233, complex, with both genetic and approximately 300 new cases of breast
Research Triangle Park, NC 27709, or environmental factors likely playing a cancer will be diagnosed during each
call non-toll free number (919) 541– role. Environmental risk factors, year of follow-up. Thus far 2,904
4668 or email your request, including however, have been difficult to identify. participants have reported being
your address to: sandler@niehs.nih.gov. By focusing on genetically susceptible diagnosed with breast cancer.
Average
Estimated Number of burden per Total burden
Activity annual number reponses per response hours per year
of respondents respondent (in hours)
Annual Update ................................................................................................. 32,215 1 10/60 5,369
Follow-Up III (triennial) ..................................................................................... 16,108 1 40/60 10,739
OMB approval is requested for 3 confidential trade secrets or commercial Dated: November 25, 2015.
years. There are no costs to respondents property such as patentable material, David Clary,
other than their time. The total and personal information concerning Program Analyst, Office of Federal Advisory
estimated annualized burden hours are individuals associated with the grant Committee Policy.
16,108. applications, the disclosure of which [FR Doc. 2015–30519 Filed 12–1–15; 8:45 am]
Dated: November 23, 2015. would constitute a clearly unwarranted BILLING CODE 4140–01–P
Laurie K. Johnson, invasion of personal privacy.
Acting Deputy Associate Director for Name of Committee: Center for Scientific
Management, NIEHS. DEPARTMENT OF HEALTH AND
Review Special Emphasis Panel; Member
[FR Doc. 2015–30527 Filed 12–1–15; 8:45 am]
HUMAN SERVICES
Conflict: Topics on Pregnancy and
BILLING CODE 4140–01–P Neonatology. National Institutes of Health
Date: December 21, 2015.
Time: 1:00 p.m. to 5:00 p.m. Center for Scientific Review; Notice of
DEPARTMENT OF HEALTH AND Agenda: To review and evaluate grant Closed Meeting
HUMAN SERVICES applications.
Place: National Institutes of Health, 6701 Pursuant to section 10(d) of the
National Institutes of Health Rockledge Drive, Bethesda, MD 20892, Federal Advisory Committee Act, as
(Virtual Meeting). amended (5 U.S.C. App.), notice is
Center for Scientific Review; Notice of Contact Person: Elaine Sierra-Rivera, Ph.D., hereby given of the following meeting.
Closed Meeting Scientific Review Officer, Center for The meeting will be closed to the
Pursuant to section 10(d) of the Scientific Review, National Institutes of public in accordance with the
Federal Advisory Committee Act, as Health, 6701 Rockledge Drive, Room 2200, provisions set forth in sections
MSC 7890, Bethesda, MD 20892, 301 435– 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
jstallworth on DSK7TPTVN1PROD with NOTICES
amended (5 U.S.C. App.), notice is
hereby given of the following meeting. 2514, riverase@csr.nih.gov. as amended. The grant applications and
The meeting will be closed to the (Catalogue of Federal Domestic Assistance the discussions could disclose
public in accordance with the Program Nos. 93.306, Comparative Medicine; confidential trade secrets or commercial
provisions set forth in sections 93.333, Clinical Research, 93.306, 93.333, property such as patentable material,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 93.337, 93.393–93.396, 93.837–93.844, and personal information concerning
as amended. The grant applications and 93.846–93.878, 93.892, 93.893, National individuals associated with the grant
the discussions could disclose Institutes of Health, HHS) applications, the disclosure of which
VerDate Sep<11>2014 13:24 Dec 01, 2015 Jkt 238001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1](https://thefederalregister.org/doc/80_FR_75696/page/2.svg)
Document Created: 2015-12-14 13:48:32
Document Modified: 2015-12-14 13:48:32
| 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 | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| FR Citation | 80 FR 75465 |
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