Proposed Data Collection Submitted for Public Comment and Recommendations, 79341-79342 [2015-31961]
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Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Since then, the following vaccines have
been added to the National Vaccine
Injury Compensation Program, requiring
use of vaccine information materials for
them as well: Hepatitis B, Haemophilus
influenzae type b (Hib), varicella
(chickenpox), pneumococcal conjugate,
rotavirus, hepatitis A, meningococcal,
human papillomavirus (HPV), and
seasonal influenza vaccines.
Instructions for use of the vaccine
information materials are found on the
CDC Web site at: https://www.cdc.gov/
vaccines/hcp/vis/.
Revised Vaccine Information Materials
The pneumococcal conjugate vaccine
(PCV13) information materials
referenced in this notice were
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and
healthcare provider organizations.
Following consultation and review of
comments submitted, the vaccine
information materials covering
pneumococcal conjugate vaccine
(PCV13) have been finalized and are
available to download from https://www.
cdc.gov/vaccines/hcp/vis/ or
https://www.regulations.gov (see Docket
Number CDC–2015–0014). The Vaccine
Information Statement (VIS) is
‘‘Pneumococcal Conjugate Vaccine
(PCV13): What You Need to Know,’’
publication date November 5, 2015.
With publication of this notice, as of
March 1, 2016, all health care providers
will be required to provide copies of
these updated pneumococcal conjugate
vaccine (PCV13) information materials
prior to immunization in conformance
with CDC’s November 5, 2015
Instructions for the Use of Vaccine
Information Statements.
Dated: December 16, 2015.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2015–31989 Filed 12–18–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0841; Docket No. CDC–2015–
0115]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Management
Information System for Comprehensive
Cancer Control Programs data
collection. CDC uses the electronic MIS
to collect information about cancer
prevention and control activities
conducted by states, territories, and
tribal organizations.
DATES: Written comments must be
received on or before February 19, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0115 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
SUMMARY:
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
FOR FURTHER INFORMATION CONTACT:
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79341
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
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; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Management Information System for
Comprehensive Cancer Control
Programs (OMB No. 0920–0841, exp. 3/
31/2016)—Revision—National Center
for Chronic Disease Prevention and
E:\FR\FM\21DEN1.SGM
21DEN1
79342
Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
From 2007–2012, the Centers for
Disease Control and Prevention (CDC)
provided funding to all 50 states, the
District of Columbia, seven tribes/tribal
organizations, and seven territories/U.S.
Pacific Island Jurisdictions through the
National Cancer Prevention and Control
Program (CDC Funding Opportunity
Announcement [FOA] DP07–703). New
five-year cooperative agreements were
established in June 2012 under FOA
DP12–1205 (‘‘Cancer Prevention and
Control Program for State, Territorial
and Tribal Organizations’’). From 2012–
2015, a subset of 13 awardees received
additional funding for demonstration
programs to advance cancer control
using policy, systems, and
environmental change strategies.
Since 2010, cancer prevention and
control (CPC) awardees have used an
electronic management information
system (MIS) to submit semi-annual
progress reports to CDC (‘‘Management
Information System for Comprehensive
Cancer Control Programs,’’ OMB No.
0920–0841, exp. 3/31/2016). The
progress reports satisfy federal reporting
requirements and allow CDC to provide
targeted technical assistance to
awardees while monitoring their
activities and progress. The MIS also
provides CDC with the capacity to
respond in a timely manner to requests
for information from the Department of
Health and Human Services (HHS),
Congress, and other sources.
annualized, one-time allocation of two
hours response per response for initial
population of the MIS with information
that is specific to the new FOA. Due to
annualization, this activity is
represented in the table as 22 awardees
instead of 65 awardees. CDC is
considering a change in the frequency of
progress reporting, effective with the
new FOA. Routine progress reporting is
likely to occur once per year instead of
twice per year.
OMB approval will be requested for
three years. The total estimated
annualized burden for this reporting
period will decrease due to a reduction
in the estimated burden per response for
semi-annual reporting; a reduction in
the estimated burden per response for
populating the MIS with information
specific to the new FOA; and
discontinuation of semi-annual
reporting for demonstration program
activities.
Awardees are required to submit the
requested information to CDC as a
condition of funding. CDC will use the
information submitted by awardees to
identify training and technical
assistance needs, monitor compliance
with cooperative agreement
requirements, evaluate progress made in
achieving program-specific goals, and
obtain information needed to respond to
Congressional and other inquiries
regarding program activities and
effectiveness. All information will be
collected electronically. There are no
costs to respondents other than their
time.
CDC plans to request a revision of the
current MIS-based reporting system.
Minor modifications will be made to
standardize and streamline data entry;
for example, the open-ended text boxes
previously used to develop objectives
will be replaced with a drop-down
menu of evidence-based indicators. The
modifications will also make MIS
entries and output more user-friendly
for CDC staff who use the MIS to
monitor and evaluate specific program
outcomes. The search function will also
be modified to search for these
indicators.
All 65 DP12–1205 cancer prevention
and control awardees will continue to
submit semi-annual reports to CDC
through the end of the cooperative
agreement period. These reports include
information about personnel, resources,
finances, planning, action plans, and
progress. Information will be submitted
by the program director for the state,
territory, or tribal cancer control
program. Awardees will be responsible
for verifying their current information
and entering new objectives and
progress. To minimize respondent
burden, information that has not
changed does not need to be re-entered
into the MIS. The estimated burden for
ongoing system maintenance and semiannual reporting is being reduced from
three hours per response to two hours
per response.
CDC anticipates that DP12–1205 will
be succeeded in 2017 by a new FOA
based on similar objectives and a
comparable monitoring and evaluation
plan. The burden table includes an
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
Type of respondents
Form name
Program Director for State-, Tribal-,
or Territorial-based Cancer Prevention and Control Program.
Data Elements for All CPC Programs: Semi-annual Reporting.
65
2
2
260
Data Elements for All CPC Programs: Initial MIS Population for
New FOA.
22
1
2
44
..........................................................
........................
........................
........................
304
mstockstill on DSK4VPTVN1PROD with NOTICES
Total ...........................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–31961 Filed 12–18–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79341-79342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31961]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-0841; Docket No. CDC-2015-0115]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on the Management
Information System for Comprehensive Cancer Control Programs data
collection. CDC uses the electronic MIS to collect information about
cancer prevention and control activities conducted by states,
territories, and tribal organizations.
DATES: Written comments must be received on or before February 19,
2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0115 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information, to search data sources, to complete and review the
collection of information; and to transmit or otherwise disclose the
information.
Proposed Project
Management Information System for Comprehensive Cancer Control
Programs (OMB No. 0920-0841, exp. 3/31/2016)--Revision--National Center
for Chronic Disease Prevention and
[[Page 79342]]
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
From 2007-2012, the Centers for Disease Control and Prevention
(CDC) provided funding to all 50 states, the District of Columbia,
seven tribes/tribal organizations, and seven territories/U.S. Pacific
Island Jurisdictions through the National Cancer Prevention and Control
Program (CDC Funding Opportunity Announcement [FOA] DP07-703). New
five-year cooperative agreements were established in June 2012 under
FOA DP12-1205 (``Cancer Prevention and Control Program for State,
Territorial and Tribal Organizations''). From 2012-2015, a subset of 13
awardees received additional funding for demonstration programs to
advance cancer control using policy, systems, and environmental change
strategies.
Since 2010, cancer prevention and control (CPC) awardees have used
an electronic management information system (MIS) to submit semi-annual
progress reports to CDC (``Management Information System for
Comprehensive Cancer Control Programs,'' OMB No. 0920-0841, exp. 3/31/
2016). The progress reports satisfy federal reporting requirements and
allow CDC to provide targeted technical assistance to awardees while
monitoring their activities and progress. The MIS also provides CDC
with the capacity to respond in a timely manner to requests for
information from the Department of Health and Human Services (HHS),
Congress, and other sources.
CDC plans to request a revision of the current MIS-based reporting
system. Minor modifications will be made to standardize and streamline
data entry; for example, the open-ended text boxes previously used to
develop objectives will be replaced with a drop-down menu of evidence-
based indicators. The modifications will also make MIS entries and
output more user-friendly for CDC staff who use the MIS to monitor and
evaluate specific program outcomes. The search function will also be
modified to search for these indicators.
All 65 DP12-1205 cancer prevention and control awardees will
continue to submit semi-annual reports to CDC through the end of the
cooperative agreement period. These reports include information about
personnel, resources, finances, planning, action plans, and progress.
Information will be submitted by the program director for the state,
territory, or tribal cancer control program. Awardees will be
responsible for verifying their current information and entering new
objectives and progress. To minimize respondent burden, information
that has not changed does not need to be re-entered into the MIS. The
estimated burden for ongoing system maintenance and semi-annual
reporting is being reduced from three hours per response to two hours
per response.
CDC anticipates that DP12-1205 will be succeeded in 2017 by a new
FOA based on similar objectives and a comparable monitoring and
evaluation plan. The burden table includes an annualized, one-time
allocation of two hours response per response for initial population of
the MIS with information that is specific to the new FOA. Due to
annualization, this activity is represented in the table as 22 awardees
instead of 65 awardees. CDC is considering a change in the frequency of
progress reporting, effective with the new FOA. Routine progress
reporting is likely to occur once per year instead of twice per year.
OMB approval will be requested for three years. The total estimated
annualized burden for this reporting period will decrease due to a
reduction in the estimated burden per response for semi-annual
reporting; a reduction in the estimated burden per response for
populating the MIS with information specific to the new FOA; and
discontinuation of semi-annual reporting for demonstration program
activities.
Awardees are required to submit the requested information to CDC as
a condition of funding. CDC will use the information submitted by
awardees to identify training and technical assistance needs, monitor
compliance with cooperative agreement requirements, evaluate progress
made in achieving program-specific goals, and obtain information needed
to respond to Congressional and other inquiries regarding program
activities and effectiveness. All information will be collected
electronically. There are no costs to respondents other than their
time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Program Director for State-, Tribal-, or Data Elements for All CPC Programs: 65 2 2 260
Territorial-based Cancer Prevention and Semi-annual Reporting.
Control Program.
Data Elements for All CPC Programs: 22 1 2 44
Initial MIS Population for New FOA.
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. .............. 304
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-31961 Filed 12-18-15; 8:45 am]
BILLING CODE 4163-18-P
