Proposed Data Collections Submitted for Public Comment and Recommendations, 20921-20923 [2013-08051]
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Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
exposure potential. That information
represents an individual’s exposure
history. With these data, we can assess
the presence or absence of a specific
exposure and estimate how long and
how frequently people have had contact
with the chemical(s) of interest. The
responses also provide data about
exposure to other sources of the
chemical(s).
Participation in an EI is completely
voluntary and requires participants’
written consent. To assist in interpreting
the sampling results, a survey
questionnaire appropriate to the specific
contaminant is administered to
participants. Information is generally
gathered in a face-to-face interview with
potentially exposed participants, but
could occasionally be administered by
phone or mail. All information is
usually collected and recorded
electronically and, on occasion, hard
copy forms will be used.
ATSDR uses approximately 12–20
questions about environmental
exposures per investigation. This
number can vary depending on the
number of chemicals being investigated
the route of exposure (e.g., breathing,
eating, touching), and number of other
sources of the chemical(s) (e.g., products
used, jobs).
Typically, the number of participants
in an individual EI ranges from 10 to
100. Questionnaires are generally
needed in less than half of the EIs
(approximately than 12 per year).
The DCHI SSB EI team and the
ATSDR staff and partners in the DCHI
cooperative agreement program will use
the EI Generic Clearance for OMB
submittals for each EI. EIs are usually
nonresearch investigations, but
occasionally may be classified as
research. The DCHI cooperative
agreement operates across ten ATSDR
regions across the nation. In 2012,
ATSDR was functionally reorganized
and DCHI was divided into three
functional units that administer its ten
regions and its cooperative agreement
program: Eastern Branch, Central
Branch and Western Branch. The DCHI
SSB supports all three DCHI branches.
It is uncertain at this time how many EIs
across the states, regions, and branches
will require an expedited approval at
the same time.
EI participants will likely include
community members that are concerned
about being exposed to environmental
contamination. Investigations tend to
focus on the most highly exposed at the
site, such as those living in proximity to
the site. On occasion, small businesses
may be included as EI participants.
The estimated annual burden hours
are 600, which is an increase from the
previously approved burden hours of
375 hours. The increase is due to the
addition of EIs conducted by
cooperative agreement states requiring a
survey each year. There are no costs to
the respondents other than their time.
EIs are performed under the authority
of the Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA), commonly
known as the ‘‘Superfund’’ Act, as
amended by the Superfund
Amendments and Reauthorization Act
(SARA) of 1986.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Exposure Investigation Participants ................
Chemical Exposure Questions .......................
1,200
1
30/60
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08067 Filed 4–5–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–13PR]
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Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
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20:02 Apr 05, 2013
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instruments, call 404–639–7570 or send
comments to Ron Otten, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Evaluating the Implementation and
Outcome of Policy and Environmental
Cancer Control Activities—New—
National Center for Chronic Disease
Prevention and Health Promotion
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Through the National Comprehensive
Cancer Control Program (NCCCP), CDC
provides cooperative agreement funding
to 65 health departments in states, the
District of Columbia, tribal
organizations, and territories. NCCCP
funding is used to design, implement,
and evaluate comprehensive cancer
control plans (CDC–RFA–DP12–1205).
Support for these programs is a
cornerstone of CDC efforts to reduce the
burden of cancer throughout the nation.
NCCCP awardees have consistently
included policy, system and
environmental (PSE) change strategies
in their program plans and initiatives.
In 2010, CDC provided additional
funding (CDC–RFA–DP10–1017) to 13
NCCCP awardees to increase their focus
on PSE change strategies. The 13 funded
pilot programs include: Cherokee
Nation, Colorado, Florida, Indiana,
Kentucky, Louisiana, Massachusetts,
Michigan, Minnesota, New York,
Oregon, Utah, and Wisconsin. The goal
of the pilot is to examine what a modest
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08APN1
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Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
investment can yield, building on the
successes that NCCCP awardees have
already experienced. Pilot program
funding aims to increase each awardee’s
capacity to implement PSE change
initiatives, to effectively implement
policies that address local priorities,
and to increase collaboration with both
traditional and nontraditional partners.
CDC plans to collect the information
needed to describe the implementation
and outcomes of the pilot program, and
to compare the experiences of pilot
program awardees with the experiences
NCCCP awardees that did not receive
pilot program funding. Information
collection will include a web-based
survey of all NCCCP program directors,
a longitudinal case study of selected
pilot program awardees, a survey of
pilot program coalition members, and
focus groups with individuals who have
provided technical assistance (TA) to
pilot program awardees.
The self-administered NCCCP
program director survey will be
completed at two points in time
approximately 18–24 months apart. The
survey will include questions that
address capacity for PSE change,
technical assistance and training, and
descriptive information about two PSE
change initiatives being undertaken.
The estimated burden per response is 30
minutes.
The longitudinal, multiple-site case
study will be conducted with six
awardees that received pilot program
funding. In selecting case study sites,
CDC will consider features that are
expected to influence PSE change
processes and outcomes, such as: the
of PSE change from the perspective of
the trainers who have had direct
interaction with the awardees. Focus
groups will be conducted with
approximately 10 non-federal
respondents per group. The estimated
burden per response is 90 minutes.
Finally, CDC plans to conduct a
survey of coalition members in the third
year of the evaluation. The content of
the survey may include questions from
the program director survey as well as
other issues identified during the
evaluation process. CDC estimates 20
responses in each of 13 sites for a total
of 260 responses. The estimated burden
per response is 20 minutes.
Specific evaluation questions to be
addressed in this pilot program
evaluation include: (1) How the pilot
program enhanced comprehensive
cancer control; (2) whether the pilot
program facilitated a shift towards
primary prevention; (3) the program’s
effects on cancer control infrastructure;
(4) pilot program implementation
strategies; (5) key outcomes; (6) the role
of the state task force; and (7) lessons
learned.
The case studies will allow CDC to
understand how differences in
programmatic characteristics and
context influence overall
implementation processes and
outcomes. Information to be collected
may also inform the development of
technical assistance and the future
allocation of program resources.
OMB approval is requested for three
years. Participation is voluntary and
there are no costs to the respondents
other than their time.
structure of the awardee’s public health
system, the state/local policy climate,
the awardee’s capacity for PSE change,
the focus areas that awardees have
chosen to address in their work plans,
and the demographics and population
characteristics of the awardee’s
jurisdiction. One individual at each site
will be asked to assist in coordinating a
site visit.
During initial site visits to the six
selected pilot programs, interviews will
be conducted with key informants
including NCCCP staff, partners who are
members of the awardee’s policy task
force, and community members who
play an important role in implementing
PSE change initiatives. Approximately
three NCCCP staff members and 12
partners/community members per site
will be asked to participate. The
estimated burden per response is 90
minutes for NCCCP staff and 60 minutes
for partners/community members.
Interview data will be supplemented
with documentary evidence and
program monitoring data already
collected by local program staff and by
CDC. Approximately two years after the
site visit, a second round of interviews
will be conducted by telephone. The
respondents for the telephone
interviews may be the same individuals
who were interviewed during the initial
site visits, or other key informants.
CDC also plans to conduct an annual
focus group involving CDC staff and
national partners who have provided
technical assistance and training to the
pilot programs. The purpose of the focus
groups is to gather information about
the capacity, challenges, and facilitators
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
CCC Program Directors ....................
TA Providers .....................................
Program Directors Web Survey
Questionnaire.
Key Informant Selection ...................
Key Informant Recruitment/Scheduling.
Key Informant Interview ...................
Key Informant Recruitment/Scheduling.
Key Informant Interview ...................
Coalition Survey ...............................
Focus Group Guide ..........................
Total ...........................................
...........................................................
CCC Staff ..........................................
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CCC Partners ....................................
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Number of
responses per
respondent
Average
burden per
response
(in hr)
Total
response
burden
(in hr)
43
1
30/60
22
2
12
1
1
8
5/60
16
1
12
48
1
1
1.5
5/60
18
4
48
87
10
1
1
1
1
20/60
1.5
48
29
15
........................
........................
........................
153
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20923
Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
Dated: April 1, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08051 Filed 4–5–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[Docket No. FDA–2012–N–0977]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
OMB control number 0910–0312. Also
include the FDA docket number found
in brackets in the heading of this
document.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 8,
2013.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
ADDRESSES:
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco To Protect Children
and Adolescents—21 CFR Part 1140
(OMB Control Number 0910–0312)—
Revision
This is a request for an extension of
OMB approval of the information
collection requirements contained in
FDA’s regulations for cigarettes and
smokeless tobacco containing nicotine.
The regulations that are codified at 21
CFR part 1140 (previously codified at 21
CFR part 897) are authorized by section
102 of the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31). Section
102 of the Tobacco Control Act required
FDA to publish a final rule regarding
cigarettes and smokeless tobacco
identical in its provisions to the
regulation issued by FDA in 1996 (61 FR
44396, August 28, 1996), with certain
specified exceptions—which included
striking subpart C (with § 897.24) and
§ 897.32(c) from the reissued rule
(section 102(a)(2)(B). The reissued final
rule was published in the Federal
Register on March 19, 2010 (75 FR
13225).
This collection includes reporting
information requirements for § 1140.30,
which directs persons to notify FDA if
they intend to use a form of advertising
that is not addressed in the regulations.
Disclosure requirements for § 1140.32
state that the advertising must use black
text on a white background, but that this
particular requirement does not apply to
adult newspapers, magazines,
periodicals, or other publications.
Recordkeeping requirements under
§ 1140.32 indicate that competent and
reliable survey evidence is required to
determine whether a particular
publication is an ‘‘adult’’ publication.
The requirements are as follows:
• Reporting—§ 1140.30 directs
persons to notify FDA if they intend to
use a form of advertising that is not
described in § 1140.30(a)(1).
• Disclosure—§ 1140.32 requires
firms to use black text on white
backgrounds in labeling and advertising.
• Recordkeeping—§ 1140.32 indicates
that firms advertising in ‘‘adult’’
magazines or publications may need
survey evidence demonstrating that the
publication meets the criteria for an
‘‘adult’’ publication.
For the disclosure and recordkeeping
requirements under § 1140.32, FDA has
decided to use its discretionary
enforcement and has placed
placeholders of 1 burden hour for
disclosure and 1 burden hour for
reporting because FDA does not intend
to enforce the requirements for this
section for the next 3 years.
In the Federal Register of September
28, 2012 (77 FR 59622), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1140.30 (Scope of permissible forms of labeling and advertising) ...........................................................................
300
1
300
1
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1140.32 (Format and content requirements for labeling
and advertising) ................................................................
1
1
1
1
1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20921-20923]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-13PR]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Evaluating the Implementation and Outcome of Policy and
Environmental Cancer Control Activities--New--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Through the National Comprehensive Cancer Control Program (NCCCP),
CDC provides cooperative agreement funding to 65 health departments in
states, the District of Columbia, tribal organizations, and
territories. NCCCP funding is used to design, implement, and evaluate
comprehensive cancer control plans (CDC-RFA-DP12-1205). Support for
these programs is a cornerstone of CDC efforts to reduce the burden of
cancer throughout the nation. NCCCP awardees have consistently included
policy, system and environmental (PSE) change strategies in their
program plans and initiatives.
In 2010, CDC provided additional funding (CDC-RFA-DP10-1017) to 13
NCCCP awardees to increase their focus on PSE change strategies. The 13
funded pilot programs include: Cherokee Nation, Colorado, Florida,
Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, New
York, Oregon, Utah, and Wisconsin. The goal of the pilot is to examine
what a modest
[[Page 20922]]
investment can yield, building on the successes that NCCCP awardees
have already experienced. Pilot program funding aims to increase each
awardee's capacity to implement PSE change initiatives, to effectively
implement policies that address local priorities, and to increase
collaboration with both traditional and nontraditional partners.
CDC plans to collect the information needed to describe the
implementation and outcomes of the pilot program, and to compare the
experiences of pilot program awardees with the experiences NCCCP
awardees that did not receive pilot program funding. Information
collection will include a web-based survey of all NCCCP program
directors, a longitudinal case study of selected pilot program
awardees, a survey of pilot program coalition members, and focus groups
with individuals who have provided technical assistance (TA) to pilot
program awardees.
The self-administered NCCCP program director survey will be
completed at two points in time approximately 18-24 months apart. The
survey will include questions that address capacity for PSE change,
technical assistance and training, and descriptive information about
two PSE change initiatives being undertaken. The estimated burden per
response is 30 minutes.
The longitudinal, multiple-site case study will be conducted with
six awardees that received pilot program funding. In selecting case
study sites, CDC will consider features that are expected to influence
PSE change processes and outcomes, such as: the structure of the
awardee's public health system, the state/local policy climate, the
awardee's capacity for PSE change, the focus areas that awardees have
chosen to address in their work plans, and the demographics and
population characteristics of the awardee's jurisdiction. One
individual at each site will be asked to assist in coordinating a site
visit.
During initial site visits to the six selected pilot programs,
interviews will be conducted with key informants including NCCCP staff,
partners who are members of the awardee's policy task force, and
community members who play an important role in implementing PSE change
initiatives. Approximately three NCCCP staff members and 12 partners/
community members per site will be asked to participate. The estimated
burden per response is 90 minutes for NCCCP staff and 60 minutes for
partners/community members. Interview data will be supplemented with
documentary evidence and program monitoring data already collected by
local program staff and by CDC. Approximately two years after the site
visit, a second round of interviews will be conducted by telephone. The
respondents for the telephone interviews may be the same individuals
who were interviewed during the initial site visits, or other key
informants.
CDC also plans to conduct an annual focus group involving CDC staff
and national partners who have provided technical assistance and
training to the pilot programs. The purpose of the focus groups is to
gather information about the capacity, challenges, and facilitators of
PSE change from the perspective of the trainers who have had direct
interaction with the awardees. Focus groups will be conducted with
approximately 10 non-federal respondents per group. The estimated
burden per response is 90 minutes.
Finally, CDC plans to conduct a survey of coalition members in the
third year of the evaluation. The content of the survey may include
questions from the program director survey as well as other issues
identified during the evaluation process. CDC estimates 20 responses in
each of 13 sites for a total of 260 responses. The estimated burden per
response is 20 minutes.
Specific evaluation questions to be addressed in this pilot program
evaluation include: (1) How the pilot program enhanced comprehensive
cancer control; (2) whether the pilot program facilitated a shift
towards primary prevention; (3) the program's effects on cancer control
infrastructure; (4) pilot program implementation strategies; (5) key
outcomes; (6) the role of the state task force; and (7) lessons
learned.
The case studies will allow CDC to understand how differences in
programmatic characteristics and context influence overall
implementation processes and outcomes. Information to be collected may
also inform the development of technical assistance and the future
allocation of program resources.
OMB approval is requested for three years. Participation is
voluntary and there are no costs to the respondents other than their
time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average Total
Number of Number of burden per response
Type of respondent Form name respondents responses per response (in burden (in
respondent hr) hr)
----------------------------------------------------------------------------------------------------------------
CCC Program Directors......... Program 43 1 30/60 22
Directors Web
Survey
Questionnaire.
CCC Staff..................... Key Informant 2 1 8 16
Selection.
Key Informant 12 1 5/60 1
Recruitment/
Scheduling.
Key Informant 12 1 1.5 18
Interview.
CCC Partners.................. Key Informant 48 1 5/60 4
Recruitment/
Scheduling.
Key Informant 48 1 1 48
Interview.
Coalition Survey 87 1 20/60 29
TA Providers.................. Focus Group 10 1 1.5 15
Guide.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 153
----------------------------------------------------------------------------------------------------------------
[[Page 20923]]
Dated: April 1, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-08051 Filed 4-5-13; 8:45 am]
BILLING CODE 4163-18-P
