Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer, 48993-48994 [2012-20067]
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Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
Manufacturing Facility Visits, please
submit a request either electronically to
https://www.regulations.gov or in writing
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lindsay Tobias, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 877–287–1373,
email: lindsay.tobias@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Public Law 111–31; 123
Stat. 1776) was signed into law,
amending the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) and giving
FDA authority to regulate tobacco
product manufacturing, distribution,
and marketing. The new provisions
include, among other things, the
authority to issue regulations related to
tobacco product manufacturing practice
in order to protect the public health and
to assure that tobacco products are in
compliance with the FD&C Act.
Specifically, section 906(e) of the FD&C
Act (21 U.S.C. 387f(e)) provides that ‘‘in
applying manufacturing restrictions to
tobacco, the Secretary shall * * *
prescribe regulations (which may differ
based on the type of tobacco product
involved) requiring that the methods
used in, and the facilities and controls
used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a tobacco product),
packing, and storage of a tobacco
product conform to current good
manufacturing practice, or hazard
analysis and critical control point
methodology.’’
CTP is instituting Tobacco Product
Manufacturing Facility Visits to provide
FDA staff with the opportunity to:
• Observe tobacco product
manufacturing operations—from the
receipt of raw materials to the
distribution of finished products, and
• Learn about the manufacturing
practices and processes unique to your
facility and regulated tobacco products.
This program will also inform FDA
staff as they implement the tobacco
provisions of the FD&C Act.
II. Description of the Tobacco Product
Manufacturing Facility Visits
In this program, groups of FDA staff
plan to observe the following facilities
and their operations:
• Manufacturing facilities, including
facilities that process, package, label,
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and distribute different types of
regulated tobacco products (cigarettes,
cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco products),
• Laboratory facilities that perform
tobacco testing (whether third-party or
in-house),
• Manufacturing facilities for
components, parts, and accessories
(including, but not limited to, cigarette
paper, tipping paper, filters), and
• Manufacturing facilities for
materials used for further processing in
finished tobacco products (including,
but not limited to, flavors, casings).
Please note that Tobacco Product
Manufacturing Facility Visits are not
intended to include or replace official
FDA inspections of facilities to
determine compliance with the FD&C
Act; rather, these facility visits are
meant to educate FDA staff and improve
their understanding of the tobacco
industry and its manufacturing
operations.
III. Site Selection
CTP plans to select one or more of
each of the following:
• Cigarette manufacturers,
• Cigarette tobacco and roll-your-own
tobacco manufacturers,
• Smokeless tobacco manufacturers,
• Tobacco laboratories,
• Importers of finished tobacco
products,
• Distributors and wholesalers of
regulated tobacco products,
• Manufacturers of components,
parts, accessories, and
• Manufacturers of materials used for
further processing in finished tobacco
products.
Final site selections will be based on
the availability of CTP funds and
resources for the relevant fiscal year, as
well as the following factors, as
applicable: (1) Compliance status of the
requesting facility and affiliated firm; (2)
whether the requesting facility is in
arrears for user fees; and (3) whether the
requesting facility will be engaged in
active manufacturing or processing
during the proposed time of the visit.
All travel expenses associated with
Tobacco Product Manufacturer Facility
Visits will be the responsibility of CTP.
IV. Requests for Participation
The request for participation should
include the following identification
information:
• The name and contact information
(including address, phone number, and
email) of your point of contact for the
request,
• The physical address(es) of the
site(s) for which you are submitting a
request,
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48993
• The type of processes (e.g.,
manufacturing, laboratory practices,
packaging, labeling, and distribution
activities) performed at your facility,
• The type of tobacco products tested,
processed, or manufactured at your
facility, and
• A proposed program agenda.
Requests are to be identified with the
docket number found in brackets in the
heading of this document. Requests
received by the Agency are available for
public examination in the Division of
Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19992 Filed 8–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health/National
Institute of Environmental Health
Sciences
Proposed Collection; Comment
Request; The Sister Study: A
Prospective Study of the Genetic and
Environmental Risk Factors for Breast
Cancer
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.
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.
SUMMARY:
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48994
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
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 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:
Activity
Estimated
number of
responses
Estimated responses per
respondent
Average burden hours per
response
Estimated total
burden hours
requested
Annual Updates ...............................................................................................
Triennial Update ..............................................................................................
Total ..........................................................................................................
33,923
16,961
........................
1
1
........................
10/60
1.25
........................
85,654
21,202
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 × 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
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
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, PO 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.
srobinson on DSK4SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
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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.
Dated: August 7, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012–20067 Filed 8–14–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Population
Assessment of Tobacco and Health
(PATH) Study
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on May 18, 2012,
pages 29667–29668 and allowed 60days for public comment. Two 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
SUMMARY:
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extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Population
Assessment of Tobacco and Health
(PATH) Study. Type of Information
Collection Request: NEW. Need and Use
of Information Collection:
This is a large national longitudinal
cohort study on tobacco use behavior
and health in the United States
conducted under the direction of the
National Institutes of Health (NIH)
National Institute on Drug Abuse
(NIDA) and in partnership with the
Food and Drug Administration (FDA).
The field test is scheduled to begin in
the fall of 2012 and the baseline
collection is scheduled to begin in the
fall of 2013. Using annual interviews
and the collection of biospecimens from
adults, the PATH study is designed to
establish a population-based framework
for monitoring and evaluating the
behavioral and health impacts of
regulatory provisions by FDA as it meets
its mandate under the Family Smoking
Prevention and Tobacco Control Act
(FSPTCA) to regulate tobacco-product
advertising, labeling, marketing,
constituents, ingredients, and additives.
These regulatory changes are expected
to influence tobacco-product risk
perceptions, exposures, and use patterns
in the short term, and to reduce tobaccorelated morbidity and mortality in the
long term. By measuring and accurately
reporting tobacco product use behaviors
and health effects associated with these
regulatory changes, this study will
provide an empirical evidence base to
inform the development,
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]]>Agencies
[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48993-48994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20067]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health/National Institute of Environmental
Health Sciences
Proposed Collection; Comment Request; The Sister Study: A
Prospective Study of the Genetic and Environmental Risk Factors for
Breast Cancer
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.
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.
[[Page 48994]]
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
Estimated Estimated Average burden total burden
Activity number of responses per hours per hours
responses respondent response requested
----------------------------------------------------------------------------------------------------------------
Annual Updates.................................. 33,923 1 10/60 85,654
Triennial Update................................ 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 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.
FOR FURTHER INFORMATION CONTACT: 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, PO 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 60 days
of the date of this publication.
Dated: August 7, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012-20067 Filed 8-14-12; 8:45 am]
BILLING CODE 4140-01-P
