Submission for OMB Review; Comment Request The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer, 66851-66852 [2012-27237]
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66851
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices
2. Limmathurotsakul D., S.
Wongratanacheewin, N. Teerawattanasook, et
al, ‘‘Increasing Incidence of Human
Melioidosis in Northeast Thailand,’’
American Journal of Tropical Medicine and
Hygiene, vol. 82(6), pp. 1113–1117, 2010.
3. Wiersinga W.J., B.J. Currie, and S.J.
Peacock, ‘‘Melioidosis,’’ The New England
Journal of Medicine, vol. 367(11), pp. 1035–
1044, 2012.
4. Limmathurotsakul D., W. Chaowagul, W.
Chierakul, et al., ‘‘Risk Factors for Recurrent
Melioidosis in Northeast Thailand,’’ Clinical
Infectious Diseases, vol. 43(8), pp. 979–986,
2006.
5. U.S. Department of Health and Human
Services, ‘‘2012 Public Health Emergency
Medical Countermeasures Enterprise
(PHEMCE) Strategy,’’ (Washington, DC: U.S.
Department of Health and Human Services,
2012), available at: https://www.phe.gov/
Preparedness/mcm/phemce/Documents/
2012-PHEMCE-Strategy.pdf, accessed
October 16, 2012.
6. Srinivasan A., ‘‘Glanders in a Military
Research Microbiologist,’’ The New England
Journal of Medicine, vol. 345(4), pp. 256–258,
2001.
7. Gregory, B.C., and D.M. Waag,
‘‘Glanders,’’ in Textbook of Military
Medicine: Medical Aspects of Chemical and
Biological Warfare (Washington, DC: Office
of the Surgeon General, 2007), available at:
https://ke.army.mil/bordeninstitute/
published_volumes/biological_warfare/BWch06.pdf, accessed October 16, 2012.
Dated: November 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27146 Filed 11–6–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request The Sister Study: A
Prospective Study of the Genetic and
Environmental Risk Factors for Breast
Cancer
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
SUMMARY:
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 geneenvironment 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 1,634
participants have reported being
diagnosed with breast cancer. Frequency
of Response: For the remainder of the
study, women will be contacted once
each year (when not scheduled for
‘‘triennial’’) to update contact
information and health status (10
minutes per response); and asked to
complete short (75 minutes per
response) follow-up interviews or
questionnaires (‘‘triennial’’) every three
years. Follow-up and validation of
reported incident breast cancer and
other health outcomes is conducted
under Clinical Exemption CE 2009–09–
004. Affected Public: Study participants,
next-of-kin/proxies. Type of
Respondents: Participants enrolled in
high-risk cohort study of risk factors for
breast cancer; next-of-kin/proxies. The
annual reporting burden is as follows:
Estimated Number of Respondents:
50,884 study participants or next-of-kin/
proxies. Estimated Number of
Responses per Respondent: See
annualized table below:
Reduction Act of 1995, the National
Institute of Environmental Health
Sciences (NIEHS), 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 15 August 2012
on page 48993 and allowed 60-days for
public comment. 1 public comment was
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
5 CFR 1320.5 (General requirements)
Reporting and Recordkeeping
Requirements: Final Rule requires that
the agency inform the potential persons
who are to respond to the collection of
information that such persons are not
required to respond to the collection of
information unless it displays a
currently valid OMB control number.
This information is required to be stated
in the 30-day Federal Register Notice.
Proposed Collection: Title: The Sister
Study: A Prospective Study of the
Genetic and Environmental Risk Factors
for Breast Cancer. Type of Information
Collection Request: Revision. Need and
Use of Information Collection: This is to
continue the Phase II follow-up of the
Sister Study — a study of genetic and
environmental risk factors for the
development of breast cancer in a highrisk 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
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
number of
respondents
Activity
Estimated responses per
respondent
Average burden hours
per response
Estimated total
burden hours
requested
pmangrum on DSK3VPTVN1PROD with NOTICES
Annual Updates ...............................................................................................
Follow-Up II (triennial) ......................................................................................
33,923
16,961
1
1
10/60
1.25
5,654
21,202
Total ..........................................................................................................
........................
........................
........................
26,856
Average Burden Hours Per Response:
42 minutes; and Estimated Total
Annual Burden Hours Requested:
26,856. The estimated total annualized
cost to respondents $537,120 (assuming
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$20 hourly wage × 26,856). There are no
capital, operating, or maintenance costs.
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
E:\FR\FM\07NON1.SGM
07NON1
66852
Federal Register / Vol. 77, No. 216 / Wednesday, November 7, 2012 / Notices
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.
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: Desk
Officer for NIH. To request more
information on the project or to obtain
a copy of the data collection plans and
instruments, 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.
Comments 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.
Dated: October 25, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012–27237 Filed 11–6–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Hazardous Waste
Worker Training
National Institute of
Environmental Health Sciences,
AGENCY:
classroom and hands-on training
courses, which have accounted for
nearly 36 million contact hours of actual
training. Generally, the grant will
initially be for one year, and subsequent
continuation awards are also for one
year at a time. Grantees must submit a
separate application to have the support
continued for each subsequent year.
Grantees are to provide information in
accordance with S65.4 (a), (b), (c) and
65.6(a) on the nature, duration, and
purpose of the training, selection
criteria for trainees’ qualifications and
competency of the project director and
staff, cooperative agreements in the case
of joint applications, the adequacy of
training plans and resources, including
budget and curriculum, and response to
meeting training criteria in OSHA’s
Hazardous Waste Operations and
Emergency Response Regulations (29
CFR 1910.120). As a cooperative
agreement, there are additional
requirements for the progress report
section of the application. Grantees are
to provide their information in hard
copy as well as enter information into
the WETP Grantee Data Management
System. The information collected is
used by the Director through officers,
employees, experts, and consultants to
evaluate applications based on technical
merit to determine whether to make
awards. Frequency of Response:
Biannual. Affected Public: Non-profit
organizations. Public reporting burden
for this collection of information is
estimated to average 14 hours per year,
including the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing the collection of information.
The annual reporting hour burden is as
follows: number of respondents: 20;
number of responses per respondent: 2;
and annual hour burden per response:
560. The average time per response is 14
hours per year. The estimated hour
burden for each respondent includes
nine hours to create documents and five
hours for support staff to compile the
documents. The annualized cost to
respondents is estimated at: $18,200.00.
Division of Extramural Research and
Training, NIH, HHS.
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Environmental Health
Sciences (NIEHS), 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 May 14, 2012,
pages 28395–28396 and allowed 60days 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 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.
Proposed Collection: Title: Hazardous
Waste Worker Training—42 CFR part
65. Type of Information Collection
Request: Revision of OMB No. 0925–
0348 and expiration date November 30,
2012. Need and Use of Information
Collection: This request for OMB review
and approval of the information
collection is required by regulation 42
CFR part 65(a)(6). The National Institute
of Environmental Health Sciences
(NIEHS) was given major responsibility
for initiating a worker safety and health
training program under Section 126 of
the Superfund Amendments and
Reauthorization Act of 1986 (SARA) for
hazardous waste workers and
emergency responders. A network of
non-profit organizations that are
committed to protecting workers and
their communities by delivering highquality, peer-reviewed safety and health
curricula to target populations of
hazardous waste workers and
emergency responders has been
developed. In twenty-four years (FY
1987–2011), the NIEHS Worker Training
program has successfully supported 20
primary grantees that have trained more
than 2.7 million workers across the
country and presented over 160,913
pmangrum on DSK3VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Frequency of
response
Average time
per response
(in hours)
Total hour
burden
(in hours)
Grantees ..........................................................................................................
20
2
14
560
Total ..........................................................................................................
20
2
14
560
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]]>Agencies
[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66851-66852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request The Sister Study: A
Prospective Study of the Genetic and Environmental Risk Factors for
Breast Cancer
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Environmental Health
Sciences (NIEHS), 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 15 August 2012 on page 48993 and allowed 60-days for public comment.
1 public comment was received. The purpose of this notice is to allow
an additional 30 days for public comment.
5 CFR 1320.5 (General requirements) Reporting and Recordkeeping
Requirements: Final Rule requires that the agency inform the potential
persons who are to respond to the collection of information that such
persons are not required to respond to the collection of information
unless it displays a currently valid OMB control number. This
information is required to be stated in the 30-day Federal Register
Notice.
Proposed Collection: Title: The Sister Study: A Prospective Study
of the Genetic and Environmental Risk Factors for Breast Cancer. Type
of Information Collection Request: Revision. Need and Use of
Information Collection: This is to continue the Phase II 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
1,634 participants have reported being diagnosed with breast cancer.
Frequency of Response: For the remainder of the study, women will be
contacted once each year (when not scheduled for ``triennial'') to
update contact information and health status (10 minutes per response);
and asked to complete short (75 minutes per response) follow-up
interviews or questionnaires (``triennial'') every three years. Follow-
up and validation of reported incident breast cancer and other health
outcomes is conducted under Clinical Exemption CE 2009-09-004. Affected
Public: Study participants, next-of-kin/proxies. Type of Respondents:
Participants enrolled in high-risk cohort study of risk factors for
breast cancer; next-of-kin/proxies. The annual reporting burden is as
follows: Estimated Number of Respondents: 50,884 study participants or
next-of-kin/proxies. Estimated Number of Responses per Respondent: See
annualized table below:
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated Estimated Average burden total burden
Activity number of responses per hours per hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Annual Updates.................................. 33,923 1 10/60 5,654
Follow-Up II (triennial)........................ 16,961 1 1.25 21,202
---------------------------------------------------------------
Total....................................... .............. .............. .............. 26,856
----------------------------------------------------------------------------------------------------------------
Average Burden Hours Per Response: 42 minutes; and Estimated Total
Annual Burden Hours Requested: 26,856. The estimated total annualized
cost to respondents $537,120 (assuming $20 hourly wage x 26,856). There
are no capital, operating, or maintenance costs.
Request For Comments: 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 the function of the agency,
including whether the
[[Page 66852]]
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.
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: Desk Officer for NIH. To request more information on the
project or to obtain a copy of the data collection plans and
instruments, 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.
Comments 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.
Dated: October 25, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012-27237 Filed 11-6-12; 8:45 am]
BILLING CODE 4140-01-P
