Agency Forms Undergoing Paperwork Reduction Act Review, 2864-2866 [2016-00866]
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2864
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
• BACKGROUND:
• INFORMATION NEEDS:
DATES: Electronic or written comments
should be received on or before March
8, 2016.
ADDRESSES: You may submit comments
identified by CDC–2015–0075 and
Docket Number NIOSH–288 by any of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, OH 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
(CDC–2015–0075; NIOSH–288). All
relevant comments received will be
posted without change to
www.regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
www.regulations.gov. All information
received in response to this notice will
also be available for public examination
and copying at the NIOSH Docket
Office, 1150 Tusculum Avenue, Room
155, Cincinnati, OH 45226.
FOR FURTHER INFORMATION CONTACT:
Gayle DeBord, NIOSH, Division of
Applied Research and Technologies,
Robert A. Taft Laboratories, 1090
Tusculum Avenue, MS–R2, Cincinnati,
Ohio 45226, Phone: (513) 841–4256 [not
a toll-free number], Email:
hazardousdrugs@cdc.gov.
Background: The purpose of the RFI
is to seek information relative to the
development of a performance
evaluation protocol for CSTDs using air
cleaning or filtration technologies. The
draft protocol released for public
comment on September 8, 2015 [80 FR
53802] is applicable to barrier-type
CSTDs only. This RFI expands the scope
of the previous RFI to seek information
to support development of a companion
protocol that would apply to CSTDs
using air cleaning or filtration
technologies, thus covering the
remainder of the currently known CSTD
marketplace.
Information Needs: Additional data
and information are needed to assist
NIOSH to develop or adapt a test
protocol for evaluating the efficiency of
air cleaning or filtration technologies
CSTDs. In particular, NIOSH requests
submission of existing test protocols
developed for efficacy testing of air
cleaning or filtration technologies
CSTDs.
The National Institute for
Occupational Safety and Health seeks
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17:50 Jan 15, 2016
Jkt 238001
public comments in response to the
following questions. Please feel free to
comment on any or all of the questions
below:
1. Are there any other types of CSTDs
available that would not fit into the two
categories described, i.e., (1) barrier
systems, and (2) air-cleaning or filtration
technologies?
2. Is there an existing test protocol for
evaluation of the protective efficacy of
air-cleaning or filtration technologies
CSTDs? Can this test protocol, and/or
the details of the underlying procedures
and test data be shared with NIOSH?
Please apply the following questions
to a protocol you have developed, one
you are aware of, or one you believe to
be feasible to develop:
3. Are there any special restrictions,
limiting assumptions or requirements
for expertise required to conduct the
protocol?
4. What are the performance criteria
used with the protocol tests to
determine acceptability and judge
conformity?
4. Does the protocol apply to
compounding operations,
administration activities or both?
5. Does this protocol use a surrogate
or does it require testing against the
actual hazardous drugs?
6. If a surrogate is used,
a. Does the surrogate represent all
hazardous drugs or a subset?
b. Which criteria are used in selection
of the surrogate?
c. Describe how the selection criteria
address the degree to which the
surrogate or surrogates are
representative of the class of hazardous
drugs to which they apply.
d. Does the surrogate introduce any
potential worker exposure hazards?
7. List the hazardous drugs for which
this protocol has been used.
a. How were these hazardous drugs
selected?
b. Were there any hazardous drugs for
which the test protocol was not or
would not be successful or compatible?
c. During protocol application, in
what state were the hazardous drugs,
e.g., full strength as delivered, full
strength reconstituted, patient dose with
diluent, or drug cocktail?
8. What procedure(s) can be used to
verify that the protocol is applicable for
new hazardous drugs as they are
identified and brought to market?
9. Can the test protocol be used
effectively for different formulations of
the same active pharmaceutical
ingredient?
10. If applicable, are you willing to
share details of your test protocol with
NIOSH? Would you be willing for the
protocol details to be shared publicly or
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would you require the test protocol
details to be protected as proprietary
information?
11. If applicable, are you willing to
share test results from the application of
your air cleaning or filtration
technologies CSTD test protocol with
NIOSH?
12. Are you interested in being a
collaborative partner with NIOSH on the
development of an air cleaning or
filtration technologies CSTD test
protocol?
Responses to this notice are not offers
and cannot be accepted by the
Government to form a binding contract
or to issue a grant. Information obtained
as a result of this RFI may be used by
the government for program planning on
a non-attribution basis. Please do not
include any information that might be
considered proprietary, confidential, or
personally identifying (such as home
address or social security number).
Dated: January 12, 2016.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2016–00827 Filed 1–15–16; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–15BBU]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
E:\FR\FM\19JAN1.SGM
19JAN1
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
The Girl Power Project Efficacy
Trial—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
The 60-day Federal Register Notice,
published on August 12, 2015, was
titled ‘‘Efficacy Study of a Mobile
Application to Provide Comprehensive
and Medically Accurate Sexual Health
Information for Adolescent Girls.’’
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Background and Brief Description
Despite drastic reductions in teen
births across all racial and ethnic
groups, Black and Latino girls continue
to have disproportionately high rates of
teen births. Increasing girls’ access to
medically accurate and comprehensive
sexual health information is the first
step in sustaining momentum in teen
pregnancy reduction among all racial
and ethnic groups, and in promoting
healthy sexual behaviors, especially
among minority girls.
CDC plans to collect the information
needed to test the efficacy of a
comprehensive and medically accurate
mobile application, titled Crush, in
increasing adolescent girls’
contraception use and clinic visitation
for sexual and reproductive health
services. The information disseminated
via Crush is similar to the sexual health
information youth can access via other
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17:50 Jan 15, 2016
Jkt 238001
Web sites, sexual health promotion
educational materials or in clinics.
The study will randomize a sample of
1,200 girls, ages 14–18 years, into two
groups: the intervention group and the
control group. The intervention group
will have access to Crush and will
receive weekly sexual health
information via text to their phones for
six months. The control group will have
access to a fitness mobile application
(‘‘app’’) and will receive general health
information via text to their phones for
six months. Participants are expected to
access either app frequently throughout
a six month period. As part of the
analysis, sexual behavior and key
psychosocial factors will be assessed at
three points in time: at baseline, and at
three- and six-month follow-ups.
Efficacy testing will respond to the
following research questions:
1. Does exposure to Crush increase
consistent contraception use among
participants?
2. Does exposure to Crush increase
clinic utilization rate among
participants?
3. Is media content more attractive to
participants than text-based content?
For research questions 1 and 2, we
hypothesize that participants in the
intervention group will report increased
intent to use effective contraception and
utilize clinic services at three and six
months post-intervention.
The study will also include a usability
testing component to identify the
content and features of Crush that are
most attractive to participants, the
frequency in which Crush was used,
and the navigation patterns within
Crush. Participants will create an
account in the Enrollment Database.
This database will host participants’
enrollment information, basic
demographic information, and will also
track their navigation pattern to monitor
Crush visitation frequency and visit
duration. Navigation data will be used
to assess intervention exposure and
dosage to specific content areas of
Crush. To test real-world utilization of
Crush, control group participants will
gain access to Crush six months after
enrolling into the study, but will not
receive weekly text messages. The study
will track visitation frequency and
duration of each visit. Usability testing
will respond to Research Question #3.
We hypothesize that participants in the
intervention group will spend more
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2865
time using media features than textbased content.
All information will be collected
electronically. This study will collect
data through two mechanisms: (1) Selfadministered online surveys, and (2) the
Crush enrollment database. Participants
will complete a total of three selfadministered online surveys at baseline,
and at three and six month follow-ups.
Survey questions will assess behavior,
attitudes, social norms about sexual
behavior, contraception use and clinic
utilization, and satisfaction with Crush.
The mobile response surveys will be
sent to participants via text message
which they can complete on a
smartphone. The estimated burden per
response is 5–15 minutes. Survey
responses will be matched by each
participant’s unique identifying
number. Each participant will receive
up to two survey reminders starting one
week after the initial survey link is sent,
for two consecutive weeks. There are
minor differences in survey content for
the control and intervention groups.
Each participant will create a profile
in the database upon enrollment. This
database will collect initial
demographic and contact information,
informed consent signatures, and
information about the participant’s
navigation pattern through Crush. Any
information entered directly into Crush
interactive features will not be stored in
the system. The database only collects
web analytics data about page visits and
duration of each visit by User ID and
Internet Protocol (IP) address. Web
analytics will only be collected from
participants navigating Crush and only
when they are logged in as users. Web
analytics are generated for any Web site
and are a standard evaluation
mechanism for assessing the traffic
patterns on Web pages. This technology
permits development of an objective
and quantifiable measure that tracks and
records participants’ exposure to Crush.
This study component does not entail
any response burden to participants.
Findings will be used to inform the
development and delivery of effective
health communications.
OMB approval is requested for one
year. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annualized burden hours are 752.
E:\FR\FM\19JAN1.SGM
19JAN1
2866
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Girls 14–18 years old ......................................
Intervention Group ..........................................
Enrollment Questions .....................................
Baseline Survey .............................................
3-Month Survey ..............................................
6-Month Survey ..............................................
Baseline Survey .............................................
3-Month Survey ..............................................
6-Month Survey ..............................................
Control Group .................................................
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. 2016–00866 Filed 1–15–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2016–0002; NIOSH–
214]
Request for Information on NIOSH
Center for Direct Reading and Sensor
Technologies: Sensors for Emergency
Response Activities
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Request for information (RFI)
and comment.
AGENCY:
The National Institute for
Occupational Safety and Health
(NIOSH), part of the Centers for Disease
Control and Prevention (CDC), requests
information to enhance the value of the
NIOSH Center for Direct Reading and
Sensor Technologies and is seeking
input regarding specific issues on the
availability, capability, suitability,
barriers, limitations, and opportunities
for current or future direct reading
devices and sensor technologies that can
be utilized for emergency response. This
RFI is intended to inform the planning
of a document to evaluate current and
future sensor technologies used in
emergency response.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
Table of Contents
• DATES:
• ADDRESSES:
• INSTRUCTIONS:
• FOR FURTHER INFORMATION:
VerDate Sep<11>2014
17:50 Jan 15, 2016
Jkt 238001
• BACKGROUND:
• INFORMATION NEEDS:
DATES: Electronic or written comments
should be received on or before March
21, 2016.
ADDRESSES: You may submit comments
identified by CDC–2016–0002 and
Docket Number NIOSH–214 by any of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, OH 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
(CDC–2016–0002; NIOSH–214). All
relevant comments received will be
posted without change to
www.regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
www.regulations.gov. All information
received in response to this notice will
also be available for public examination
and copying at the NIOSH Docket
Office, 1150 Tusculum Avenue, Room
155, Cincinnati, OH 45226.
FOR FURTHER INFORMATION CONTACT:
D. Gayle DeBord, NIOSH, Division of
Applied Research and Technologies,
Robert A. Taft Laboratories, 1090
Tusculum Avenue, MS–R2, Cincinnati,
Ohio 45226, Phone: (513) 841–4256 [not
a toll-free number], Email: GDeBord@
cdc.gov.
Background: The NIOSH Center for
Direct Reading and Sensor Technologies
(https://www.cdc.gov/niosh/topics/drst/
default.html) was created in May 2014
to coordinate the development of
recommendations on the use of these
21st century technologies in
occupational safety and health. The
mission of the Center is to develop a
national research agenda, provide
guidance on the selection of sensors and
direct-reading monitors and guidance
for validation, quality control and
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1,200
600
480
384
600
480
384
Number of
responses per
respondent
1
1
1
1
1
1
1
Average
burden per
response
(in hrs.)
5/60
15/60
10/60
15/60
15/60
10/60
15/60
training. Within the overall scope of its
activities, the Center plans to develop a
document to evaluate current and future
sensor technologies used in emergency
response.
Information Needs: Specifically,
emergency responders are increasingly
relying on direct-reading instruments
and other sensor technologies to rapidly
evaluate potentially life-threatening
hazards and exposures.
Recommendations to support the proper
selection, use, validation, calibration
and interpretation of these technologies
are lacking. The use of new generations
of sensors has increased exponentially
in the past few years. While other
Federal agencies and organizations have
developed some recommendations on
this topic, newer sensor technologies
have not been thoroughly evaluated and
guidance has not focused on
interpretation of data or appropriate for
the intended purpose. Other factors that
need to be considered are that multiple
strategies of environmental sampling
will be necessary in any response effort;
and that an understanding of the
advantages and limitations of newer
direct-reading and sensor technologies
is needed to select the appropriate
strategies. Additionally, training for
these new sensor technologies and
environmental sampling strategies may
be lacking.
The National Institute for
Occupational Safety and Health seeks
public comments in response to the
following questions. Please feel free to
comment on any or all of the questions
below:
A. Utilization of Sensors in Emergency
Response
A1. What sensors have the most
immediate impact on emergency
response?
A2. What applications/situations such
as determination of the need for
evacuation, use of personal protective
equipment, or end-of-service-life of
protective equipment are particularly in
need of sensors?
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2864-2866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00866]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-15BBU]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and
[[Page 2865]]
clarity of the information to be collected; (d) Minimize the burden of
the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
The Girl Power Project Efficacy Trial--New--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
The 60-day Federal Register Notice, published on August 12, 2015,
was titled ``Efficacy Study of a Mobile Application to Provide
Comprehensive and Medically Accurate Sexual Health Information for
Adolescent Girls.''
Background and Brief Description
Despite drastic reductions in teen births across all racial and
ethnic groups, Black and Latino girls continue to have
disproportionately high rates of teen births. Increasing girls' access
to medically accurate and comprehensive sexual health information is
the first step in sustaining momentum in teen pregnancy reduction among
all racial and ethnic groups, and in promoting healthy sexual
behaviors, especially among minority girls.
CDC plans to collect the information needed to test the efficacy of
a comprehensive and medically accurate mobile application, titled
Crush, in increasing adolescent girls' contraception use and clinic
visitation for sexual and reproductive health services. The information
disseminated via Crush is similar to the sexual health information
youth can access via other Web sites, sexual health promotion
educational materials or in clinics.
The study will randomize a sample of 1,200 girls, ages 14-18 years,
into two groups: the intervention group and the control group. The
intervention group will have access to Crush and will receive weekly
sexual health information via text to their phones for six months. The
control group will have access to a fitness mobile application
(``app'') and will receive general health information via text to their
phones for six months. Participants are expected to access either app
frequently throughout a six month period. As part of the analysis,
sexual behavior and key psychosocial factors will be assessed at three
points in time: at baseline, and at three- and six-month follow-ups.
Efficacy testing will respond to the following research questions:
1. Does exposure to Crush increase consistent contraception use
among participants?
2. Does exposure to Crush increase clinic utilization rate among
participants?
3. Is media content more attractive to participants than text-based
content?
For research questions 1 and 2, we hypothesize that participants in
the intervention group will report increased intent to use effective
contraception and utilize clinic services at three and six months post-
intervention.
The study will also include a usability testing component to
identify the content and features of Crush that are most attractive to
participants, the frequency in which Crush was used, and the navigation
patterns within Crush. Participants will create an account in the
Enrollment Database. This database will host participants' enrollment
information, basic demographic information, and will also track their
navigation pattern to monitor Crush visitation frequency and visit
duration. Navigation data will be used to assess intervention exposure
and dosage to specific content areas of Crush. To test real-world
utilization of Crush, control group participants will gain access to
Crush six months after enrolling into the study, but will not receive
weekly text messages. The study will track visitation frequency and
duration of each visit. Usability testing will respond to Research
Question #3. We hypothesize that participants in the intervention group
will spend more time using media features than text-based content.
All information will be collected electronically. This study will
collect data through two mechanisms: (1) Self-administered online
surveys, and (2) the Crush enrollment database. Participants will
complete a total of three self-administered online surveys at baseline,
and at three and six month follow-ups. Survey questions will assess
behavior, attitudes, social norms about sexual behavior, contraception
use and clinic utilization, and satisfaction with Crush.
The mobile response surveys will be sent to participants via text
message which they can complete on a smartphone. The estimated burden
per response is 5-15 minutes. Survey responses will be matched by each
participant's unique identifying number. Each participant will receive
up to two survey reminders starting one week after the initial survey
link is sent, for two consecutive weeks. There are minor differences in
survey content for the control and intervention groups.
Each participant will create a profile in the database upon
enrollment. This database will collect initial demographic and contact
information, informed consent signatures, and information about the
participant's navigation pattern through Crush. Any information entered
directly into Crush interactive features will not be stored in the
system. The database only collects web analytics data about page visits
and duration of each visit by User ID and Internet Protocol (IP)
address. Web analytics will only be collected from participants
navigating Crush and only when they are logged in as users. Web
analytics are generated for any Web site and are a standard evaluation
mechanism for assessing the traffic patterns on Web pages. This
technology permits development of an objective and quantifiable measure
that tracks and records participants' exposure to Crush. This study
component does not entail any response burden to participants.
Findings will be used to inform the development and delivery of
effective health communications.
OMB approval is requested for one year. Participation is voluntary
and there are no costs to respondents other than their time. The total
estimated annualized burden hours are 752.
[[Page 2866]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hrs.)
----------------------------------------------------------------------------------------------------------------
Girls 14-18 years old................. Enrollment Questions.... 1,200 1 5/60
Intervention Group.................... Baseline Survey......... 600 1 15/60
3-Month Survey.......... 480 1 10/60
6-Month Survey.......... 384 1 15/60
Control Group......................... Baseline Survey......... 600 1 15/60
3-Month Survey.......... 480 1 10/60
6-Month Survey.......... 384 1 15/60
----------------------------------------------------------------------------------------------------------------
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. 2016-00866 Filed 1-15-16; 8:45 am]
BILLING CODE 4163-18-P
