30-day notice

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: [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 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]

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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:

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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

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