Proposed Data Collection Submitted for Public Comment and Recommendations, 68543-68545 [2015-28153]
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68543
Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices
Testing Challenges, Exercises and/or
Validation Studies every year consisting
of five to 500 simulated samples
provided by the LRN Program Office. It
is necessary to conduct such challenges
in order to verify the testing capability
of the LRN Laboratories. The rarity of
biological or chemical agents perceived
to be of bioterrorism concern prevents
some LRN Laboratories from
maintaining proficiency as a result of
day-to-day testing. Simulated samples
are therefore distributed to ensure
proficiency across the LRN. The results
obtained from testing these simulated
samples must also be entered into
Results Messenger for evaluation by the
LRN Program Office.
During a surge event resulting from a
bioterrorism or chemical terrorism
attack, LRN Laboratories are also
required to submit all testing results
using LRN Results Messenger. The LRN
Program Office requires these results in
order to track the progression of a
bioterrorism event and respond in the
most efficient and effective way possible
and for data sharing with other Federal
partners involved in the response. The
number of samples tested during a
response to a possible event could range
from 10,000 to more than 500,000
samples depending on the length and
breadth of the event. Since there is
potentially a large range in the number
of samples for a surge event, CDC
estimates the annualized burden for this
event will be 2,250,000 hours or 625
responses per respondent.
There is no cost to the respondents
other than their time. The total
estimated annualized burden is
2,382,300 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
number of
responses per
respondent
Number of
respondents
Average
burden per
response
(hours)
Total burden
hours
Respondents
Forms
Public Health Laboratories ................
Public Health Laboratories ................
150
150
1
25
2
24
300
90,000
150
5
56
42,000
Public Health Laboratories ................
Biennial Requalification ....................
General Surveillance Testing Results.
Proficiency Testing/Validation Testing Results.
Surge Event Testing Results ...........
150
625
24
2,250,000
Total ...........................................
...........................................................
........................
........................
........................
2,382,300
Public Health Laboratories ................
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. 2015–28154 Filed 11–4–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[60Day–16–16BX; Docket No. CDC–2015–
0092]
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
jstallworth on DSK7TPTVN1PROD with NOTICES
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15:06 Nov 04, 2015
Jkt 238001
Written comments must be
received on or before January 4, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0092 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.
DATES:
Centers for Disease Control and
Prevention
SUMMARY:
comment on a proposed information
collection entitled ‘‘Monitoring and
Reporting for the Core State Violence
and Injury Prevention Program
Cooperative Agreement.’’ CDC will use
the information collected to monitor
cooperative agreement awardees and to
identify challenges to program
implementation and achievement of
outcomes.
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.
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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
FOR FURTHER INFORMATION CONTACT:
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68544
Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices
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
Monitoring and Reporting for the Core
State Violence and Injury Prevention
Program Cooperative Agreement—
New—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
tools: Annual Progress Report,
Evaluation and Performance
Management Plan, and Injury Indicator
Spreadsheets. In Year 1, each awardee
will have additional burden related to
initial collection of the reporting tools.
Initial population of the tools is a onetime activity, after completing the initial
population of the tools, pertinent
information only needs to be updated
annually for each report.
CDC will use the information
collected to monitor each awardee’s
progress and to identify facilitators and
challenges to program implementation
and achievement of outcomes.
Monitoring allows CDC to determine
whether an awardee is meeting
performance and goals and to make
adjustments in the type and level of
technical assistance provided to them,
as needed, to support attainment of their
performance measures. With the tools,
the use of a standard set of data
elements, definitions and specifications
at all levels will help to improve the
quality and comparability of
performance information that is
received by CDC for multiple awardees
and multiple award types by ensuring
that the same information is collected
on all strategies and performance
measures with slightly different areas of
emphasis, depending on the awardee
type (BASE, Enhanced with 1
Component, or Enhanced 2
Components).
OMB approval is requested for three
years. Participation in the information
collection is required as a condition of
funding. There are no costs to
respondents other than their time.
Background and Brief Description
Unintentional and violence-related
injuries and their consequences are the
leading causes of death for the first four
decades of life, regardless of gender,
race, or socioeconomic status. More
than 192,000 individuals in the United
States die each year as a result of
unintentional injuries and violence, and
more than 31 million others suffer nonfatal injuries requiring emergency
department visits each year. Given these
factors, the Public Health Service Act
(PHS Act) provides an important
opportunity for states to advance public
health across the lifespan and to reduce
health disparities. Support and
guidance for these programs have been
provided through cooperative agreement
funding and technical assistance
administered by CDC’s National Center
for Injury Prevention and Control
(NCIPC). The goal of this ICR is to
collect information needed to monitor
cooperative agreement programs funded
under the Core State Violence and
Injury Prevention Program (Core SVIPP)
(CDC–RFA–CE16–1602).
Information to be collected will
provide crucial data for program
performance monitoring and provide
CDC with the capacity to respond in a
timely manner to requests for
information about the program from the
Department of Health and Human
Services (HHS), the White House,
Congress, and other sources. Awardees
will report progress and activity
information to CDC on an annual
schedule using an Excel-based fillable
electronic templates. Each awardee will
submit three information collection
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Total burden
(in hours)
Type of respondents
Form name
Core SVIPP BASE Awardees ...........
Initial Population—Annual Progress
Report.
Annual Progress Report ...................
Evaluation and Performance Management Plan.
Injury Indicator Spreadsheet ............
Initial Population—Annual Progress
Report.
Annual Progress Report ...................
Evaluation and Performance Management Plan.
Injury Indicator Spreadsheet ............
Initial Population—Annual Progress
Report.
Annual Progress Report ...................
Evaluation and Performance Management Plan.
Injury Indicator Spreadsheet ............
20
1
22
440
20
20
1
1
11
2
220
40
20
5
1
1
14
73
280
365
5
5
1
1
58
3
290
15
5
5
1
1
14
146
70
730
5
5
1
1
116
4
580
20
5
1
14
70
...........................................................
........................
........................
........................
3,120
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Core SVIPP 1—Enhanced Component Awardees.
Core SVIPP 2—Enhanced Component Awardees.
Total ...........................................
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68545
Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices
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. 2015–28153 Filed 11–4–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–New–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for a
new collection. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
SUMMARY:
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before December 7, 2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier HHS–OS–
0990–New–30D for reference.
Information Collection Request Title:
Information Collection Request Title:
Evaluation of the Office on Women’s
Health Coalition for a Healthier
Community Initiative.
Abstract: This collection is to provide
data for the national evaluation of the
U.S. Department of Health and Human
Services (HHS), Office on Women’s
Health (OWH) Coalition for a Healthier
Community (CHC) Initiative. The
initiative supports 10 communities with
grants to support coalitions in
implementing gender-based public
health systems approaches, evidencebased health interventions, and
outreach and education activities to
reduce barriers to and enhance
facilitators of improvements in women
and girls’ health. Each of the grantees
has implemented an IRB-approved local
evaluation; however, OWH is seeking to
collect core data across grantees to
examine the extent to which the
Government’s investment has resulted
in achieving OWH-related Healthy
People 2020 priorities and yields
lessons learned upon which to plan
future initiatives related to its mission.
Likely Respondents: The proposed
collection includes plans for interviews
with key staff (project directors, project
coordinators, local evaluators), coalition
members (including chairs and cochairs), and community leaders
connected to the coalitions. These
respondents will also complete online
surveys about their perceptions of the
changes in their community as a result
of coalition activities. Program
participants and other community
members exposed to the coalitions’
activities through social media will also
complete online surveys. Project
directors and local evaluators also
annually provide information to OWH
on their coalition’s functioning, the
status of the cost-effectiveness analysis
for their coalition’s interventions, and
the coalition’s plans for sustainability.
The following table summarizes the
‘‘Total Estimated Annualized Burden—
Hours’’ by form and type of respondent.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Average
burden per
response
(in hrs)
Number of
responses per
respondent
Total burden
hours
1—Key Persons Discussion Guide for Telephone Interviews .........................
2—Key Persons, Coalition Members, and Community Leaders Online Survey ................................................................................................................
3—Coalition Participants and Other Community Members Online Survey .....
4—Grantee Annual Report on Coalition Functioning, Cost-Effectiveness,
and Sustainability Planning ..........................................................................
90
2
1
180
200
510
1
1
20/60
20/60
67
170
10
2
2
40
Total ..........................................................................................................
........................
........................
........................
457
Terry Clark,
Asst Information Collection Clearance
Officer.
[FR Doc. 2015–28156 Filed 11–4–15; 8:45 am]
[Docket No. FDA–2015–D–3638]
Minutes of Institutional Review Board
Meetings: Guidance for Institutions
and Institutional Review Boards; Draft
Guidance; Availability
BILLING CODE 4150–33–P
jstallworth on DSK7TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, and the Food and Drug
Administration, HHS.
ACTION: Notice.
AGENCY:
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The Office for Human
Research Protections (OHRP), Office of
the Assistant Secretary for Health, and
the Food and Drug Administration
(FDA) are announcing the availability of
a draft guidance entitled ‘‘Minutes of
Institutional Review Board (IRB)
Meetings: Guidance for Institutions and
IRBs.’’ The draft guidance is intended
for institutions and IRBs that are
responsible for the review and oversight
of human subject research conducted or
supported by the U.S. Department of
Health and Human Services (HHS) or
regulated by FDA. The purpose of the
SUMMARY:
E:\FR\FM\05NON1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68543-68545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-16BX; Docket No. CDC-2015-0092]
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 a proposed
information collection entitled ``Monitoring and Reporting for the Core
State Violence and Injury Prevention Program Cooperative Agreement.''
CDC will use the information collected to monitor cooperative agreement
awardees and to identify challenges to program implementation and
achievement of outcomes.
DATES: Written comments must be received on or before January 4, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0092 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
[[Page 68544]]
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
Monitoring and Reporting for the Core State Violence and Injury
Prevention Program Cooperative Agreement--New--National Center for
Injury Prevention and Control (NCIPC), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Unintentional and violence-related injuries and their consequences
are the leading causes of death for the first four decades of life,
regardless of gender, race, or socioeconomic status. More than 192,000
individuals in the United States die each year as a result of
unintentional injuries and violence, and more than 31 million others
suffer non-fatal injuries requiring emergency department visits each
year. Given these factors, the Public Health Service Act (PHS Act)
provides an important opportunity for states to advance public health
across the lifespan and to reduce health disparities. Support and
guidance for these programs have been provided through cooperative
agreement funding and technical assistance administered by CDC's
National Center for Injury Prevention and Control (NCIPC). The goal of
this ICR is to collect information needed to monitor cooperative
agreement programs funded under the Core State Violence and Injury
Prevention Program (Core SVIPP) (CDC-RFA-CE16-1602).
Information to be collected will provide crucial data for program
performance monitoring and provide CDC with the capacity to respond in
a timely manner to requests for information about the program from the
Department of Health and Human Services (HHS), the White House,
Congress, and other sources. Awardees will report progress and activity
information to CDC on an annual schedule using an Excel-based fillable
electronic templates. Each awardee will submit three information
collection tools: Annual Progress Report, Evaluation and Performance
Management Plan, and Injury Indicator Spreadsheets. In Year 1, each
awardee will have additional burden related to initial collection of
the reporting tools. Initial population of the tools is a one-time
activity, after completing the initial population of the tools,
pertinent information only needs to be updated annually for each
report.
CDC will use the information collected to monitor each awardee's
progress and to identify facilitators and challenges to program
implementation and achievement of outcomes. Monitoring allows CDC to
determine whether an awardee is meeting performance and goals and to
make adjustments in the type and level of technical assistance provided
to them, as needed, to support attainment of their performance
measures. With the tools, the use of a standard set of data elements,
definitions and specifications at all levels will help to improve the
quality and comparability of performance information that is received
by CDC for multiple awardees and multiple award types by ensuring that
the same information is collected on all strategies and performance
measures with slightly different areas of emphasis, depending on the
awardee type (BASE, Enhanced with 1 Component, or Enhanced 2
Components).
OMB approval is requested for three years. Participation in the
information collection is required as a condition of funding. There are
no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Core SVIPP BASE Awardees...... Initial 20 1 22 440
Population--Ann
ual Progress
Report.
Annual Progress 20 1 11 220
Report.
Evaluation and 20 1 2 40
Performance
Management Plan.
Injury Indicator 20 1 14 280
Spreadsheet.
Core SVIPP 1--Enhanced Initial 5 1 73 365
Component Awardees. Population--Ann
ual Progress
Report.
Annual Progress 5 1 58 290
Report.
Evaluation and 5 1 3 15
Performance
Management Plan.
Injury Indicator 5 1 14 70
Spreadsheet.
Core SVIPP 2--Enhanced Initial 5 1 146 730
Component Awardees. Population--Ann
ual Progress
Report.
Annual Progress 5 1 116 580
Report.
Evaluation and 5 1 4 20
Performance
Management Plan.
Injury Indicator 5 1 14 70
Spreadsheet.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 3,120
----------------------------------------------------------------------------------------------------------------
[[Page 68545]]
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. 2015-28153 Filed 11-4-15; 8:45 am]
BILLING CODE 4163-18-P
