Agency Information Collection Activities; Proposed Collection; Comment Request, 35000-35002 [2011-14797]
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Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Notices
characteristics of in vitro diagnostic
devices for the detection of MRSA,
including those for the detection or
detection and differentiation of MRSA
versus SA in either human specimens or
bacterial growth detected by continuous
monitoring blood culture systems.
These devices are used to aid in the
prevention and control of MRSA/SA
infections in health care settings. This
document is limited to studies intended
to establish the performance
characteristics of devices that detect
MRSA by growth in culture media or
those devices that test for the protein,
penicillin-binding protein 2a (PBP2a or
PBP2′), expressed by the mecA gene.
This includes culture-based devices that
use selective or chromogenic media. It
does not address the detection of
serological response from the host to the
MRSA antigens or establish the
performance of non-MRSA components
of multianalyte or multiplex nucleic
acid based devices.
jlentini on DSK4TPTVN1PROD with NOTICES
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on establishing the performance
characteristics of in vitro diagnostic
devices for the detection of MRSA for
culture-based devices. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of MethicillinResistant Staphylococcus Aureus
(MRSA) for Culture-Based Devices,’’ you
may either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1729 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
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information found in FDA regulations
and guidance documents. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 21 CFR part 801 and 21
CFR 809.10 have been approved under
OMB control number 0910–0485; and
the collections of information in 42 CFR
493.15 have been approved under OMB
control number 0910–0598.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–14789 Filed 6–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Refugee Resettlement
Award of an Urgent Single-Source
Grant to Heartland Alliance, Chicago,
IL
Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice.
AGENCY:
CFDA Number: 93.676.
Statutory Authority: Awards announced
in this notice are authorized by Section 412
(c)(1)(A) of the Immigration and Nationality
Act (INA) (8 U.S.C. 1522(c)(1)(A), as
amended, and the Refugee Assistance
Extension Act of 1986, Public Law 99–605,
Nov 6, 1986, 100 Stat. 3449.
Project Period: June 1, 2011–May 31,
2012.
SUMMARY: The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) announces
the award of a single-source grant for
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training and technical assistance on
incoming Lesbian, Gay, Bi-Sexual and
Transgender (LGBT) refugee cases to
Heartland Alliance, Chicago, IL, for a
total of $250,000. The additional
funding provided by the award will
support services to refugees through
May 31, 2012.
The current resettlement network has
limited understanding of the issues and
subgroups. Heartland Alliance will
develop training and technical
assistance resources, including capacity
building and service delivery,
specifically targeted at assisting newly
arriving LGBT refugees.
Heartland Alliance will have the
opportunity to receive a continuation
award at the same amount in FY 2012,
which will provide the grantee with a
two-year project period.
FOR FURTHER INFORMATION CONTACT:
Kenneth Tota, Deputy Director, Office of
Refugee Resettlement, Administration
for Children and Families, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Telephone (202) 401–4858.
Dated: June 10, 2011.
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. 2011–14841 Filed 6–14–11; 8:45 am]
BILLING CODE 4120–27–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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)
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Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Notices
a new section entitled ‘‘Violence and
Trauma’’
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.
Proposed Project: Transformation
Accountability Reporting System—
(OMB No. 0930–0285)—Revision
This revised instrument will allow
SAMHSA to collect information on two
new strategic initiatives—Trauma and
Violence and Military Families. The
new items will be added to the
Transformation Accountability (TRAC)
Reporting System is a real-time,
performance management system that
captures information on mental health
services delivered in the United States.
A wide range of client and program
information is captured through TRAC
for approximately 400 grantees.
With the addition of new questions
regarding military families, experiences
with trauma, and experiences with
violence GFA, there is a proposed new
data collection instrument up for
comment. Approval of this information
collection will allow SAMHSA to
continue to meet Government
Performance and Results Act of 1993
(GPRA) reporting requirements that
quantify the effects and
accomplishments of its discretionary
grant programs which are consistent
with OMB guidance.
CMHS has increased the number of
questions in the instrument to satisfy
reporting needs. The following
paragraphs present a description of the
changes made to the information
collection. These questions will be
contained in new sections in the
Services tool.
Violence and Trauma—CMHS
proposes to add the following 6 items in
1. Have you ever experienced violence or
trauma in any setting (including community
or school violence; domestic violence;
physical, psychological, or sexual
maltreatment/assault within or outside of the
family; natural disaster; terrorism; neglect; or
traumatic grief)? No, (skip to next section)
2. Did any of these experiences feel so
frightening, horrible, or upsetting that in the
past and/or the present that you:
2a. Have had nightmares about it or
thought about it when you did not want to?
2b. Tried hard not to think about it or went
out of your way to avoid situations that
remind you of it?
2c. Were constantly on guard, watchful, or
easily startled?
2d. Felt numb and detached from others,
activities, or your surroundings?
3. In the past 30 days, how often have you
been hit, kicked, slapped, or otherwise
physically hurt?
• Experiences with Violence and
Trauma—One of SAMHSA’s 10
Strategic Initiatives is trauma and
violence. In order to capture this
information, CMHS is adding six new
questions to be asked of respondents.
This information will help in
SAMHSA’s overall goal of reducing the
behavioral health impacts of violence
and trauma by encouraging substance
abuse treatment programs to focus on
trauma-informed services.
Military Family and Deployment—
CMHS proposes to add the following 6
new items in a new section entitled
‘‘Military Family and Deployment’’
1. Have you ever served in the Armed
Forces, in the Reserves, or the National
Guard [select all that apply]? No, (Skip to #2)
1b. Are you currently on active duty in the
Armed Forces, in the Reserves, or the
National Guard [select all that apply]?
1c. Have you ever been deployed to a
combat zone?
2. Is anyone in your family or someone
close to you on active duty in the Armed
Forces, in the Reserves, or the National
Guard, or separated or retired from Armed
Forces, Reserves, or the National Guard? No,
(Skip to next section)
3. What is the relationship of that person
(Service Member) to you?
3b. Has the Service Member experienced
any of the following (check all that apply):
Æ Deployed in support of Combat Operations
(e.g. Iraq or Afghanistan)
Æ Was physically Injured during combat
Operations
Æ Developed combat stress symptoms/
difficulties adjusting following
deployment, including PTSD, Depression,
or suicidal thoughts
Æ Died or was killed
• Veteran Family Status and Areas of
Deployment—SAMHSA is also
interested in collecting data on active
duty and veteran military members.
Collection of these data will allow
CMHS to identify the number of
veterans served, deployment status and
location, and family veteran status in
conjunction with the types of services
they may receive. Identifying a client’s
veteran status and deployment area
allows CMHS and the grantees to
monitor these clients and explore
whether special services or programs are
needed to treat them for substance abuse
and other related issues. Identification
of veteran status and other military
family issues will also allow
coordination between SAMHSA and
other Federal agencies in order to
provide a full range of services to
veterans. CMHS will also be able to
monitor their outcomes and activities
per the NOMS. The total annual burden
estimate is shown below:
ESTIMATES OF ANNUALIZED HOUR BURDEN—CMHS CLIENT OUTCOME MEASURES FOR DISCRETIONARY PROGRAMS
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Type of response
Number of
respondents
Client-level baseline
interview ...................
Client-level 6-month reassessment interview
Client-level discharge interview 2 .................
Client-level baseline
chart abstraction .......
Client-level reassessment chart abstraction 3 ..........................
Client-level Subtotal 4 .................
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18:12 Jun 14, 2011
Responses
per
respondent
Total
responses
Hours per
response
Total hour
burden
Hourly wage
cost
Total hour cost
15,681
1
15,681
0.48
7,527
$15 1
$112,905
10,646
1
10,646
0.367
3,907
15
58,605
4,508
1
4,508
0.367
1,655
15
24,825
2,352
1
2,352
0.1
235
15
3,525
9,017
1
9,017
0.1
902
15
13,530
15,681
........................
15,681
........................
14,226
15
213,390
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35002
Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Notices
ESTIMATES OF ANNUALIZED HOUR BURDEN—CMHS CLIENT OUTCOME MEASURES FOR DISCRETIONARY PROGRAMS—
Continued
Type of response
Responses
per
respondent
Number of respondents
Total
responses
Hours per
response
Total hour
burden
Hourly wage
cost
Total hour cost
Infrastructure development, prevention, and
mental health promotion quarterly
record abstraction .....
942
4
3,768
4
15,072
35 5
527,520
Total ......................
16,623
........................
........................
........................
29,298
........................
740,910
1 Based
on minimum wage.
2 Based on an estimate that it will be possible to conduct discharge interviews on 40 percent of those who leave the program.
3 Chart abstraction will be conducted on 100 percent of those discharged.
4 This is the maximum additional burden if all consumers complete the baseline and periodic reassessment interviews.
5 To be completed by grantee Project Directors, hence the higher hourly wage.
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 8–1099, 1 Choke Cherry Road,
Rockville, MD 20857 or e-mail her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
Dated: June 8, 2011.
Elaine Parry,
Director, Office of Management, Technology
and Operations.
[FR Doc. 2011–14797 Filed 6–14–11; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
jlentini on DSK4TPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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)
VerDate Mar<15>2010
16:42 Jun 14, 2011
Jkt 223001
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.
Proposed Project: National Outcome
Measures (NOMs) for Substance Abuse
Prevention—(OMB No. 0930–0230)—
Revision
This revised instrument will allow
SAMHSA to collect information on a
new strategic initiative—Military
Families. The new items will be added
to the Center for Substance Abuse
Prevention’s (CSAP) National Outcome
Measures for Substance Abuse
Prevention (NOMs). Data are collected
from SAMHSA/CSAP grants and
contracts where community and
participant outcomes are assessed. The
analysis of these data helps determine
whether progress is being made in
achieving SAMHSA/CSAP’s mission.
The primary purpose of this system is
to promote the use among SAMHSA/
CSAP grantees and contractors of
common National Outcome Measures
recommended by SAMHSA/CSAP with
significant input from panels of experts
and state representatives.
With the addition of new questions
regarding military families, there is a
proposed new data collection
instrument up for comment. Approval
of this information collection will allow
SAMHSA to continue to meet
Government Performance and Results
Act of 1993 (GPRA) reporting
requirements that quantify the effects
and accomplishments of its
discretionary grant programs which are
consistent with OMB guidance, and
address goals and objectives outlined in
the Office of National Drug Control
Policy’s Performance Measures of
Effectiveness.
CSAP has increased the number of
questions in the instrument to satisfy
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
reporting needs. The following
paragraphs present a description of the
changes made to the information
collection. These questions will be
contained in new sections in the
Services tool.
Military Family and Deployment—
CSAP proposes to add the following 6
new items in the adult tool and 3 new
items in the youth tool in a new section
entitled ‘‘Military Family and
Deployment.’’
Adult
1. Have you ever served in the Armed Forces,
in the Reserves, or the National Guard
[select all that apply]? No, (Skip to #2)
1b. Are you currently on active duty in the
Armed Forces, in the Reserves, or the
National Guard [select all that apply]?
1c. Have you ever been deployed to a
combat zone?
2. Is anyone in your family or someone close
to you on active duty in the Armed
Forces, in the Reserves, or the National
Guard, or separated or retired from the
Armed Forces, Reserves, or the National
Guard? No, (Skip to next section)
3. What is the relationship of that person
(Service Member) to you?
3b. Has the Service Member experienced
any of the following (check all that
apply):
Æ Deployed in support of Combat
Operations (e.g. Iraq or Afghanistan)
Æ Was physically Injured during Combat
Operations
Æ Developed combat stress symptoms/
difficulties adjusting following
deployment, including PTSD,
Depression, or suicidal thoughts
Æ Died or was killed
Youth
1. Is anyone in your family or someone close
to you on active duty in the Armed Forces,
in the Reserves, or the National Guard, or
separated or retired from Armed Forces,
Reserves, or the National Guard? No, (Skip
to next section)
2. What is the relationship of that person
(Service Member) to you?
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 35000-35002]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are 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)
[[Page 35001]]
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.
Proposed Project: Transformation Accountability Reporting System--(OMB
No. 0930-0285)--Revision
This revised instrument will allow SAMHSA to collect information on
two new strategic initiatives--Trauma and Violence and Military
Families. The new items will be added to the Transformation
Accountability (TRAC) Reporting System is a real-time, performance
management system that captures information on mental health services
delivered in the United States. A wide range of client and program
information is captured through TRAC for approximately 400 grantees.
With the addition of new questions regarding military families,
experiences with trauma, and experiences with violence GFA, there is a
proposed new data collection instrument up for comment. Approval of
this information collection will allow SAMHSA to continue to meet
Government Performance and Results Act of 1993 (GPRA) reporting
requirements that quantify the effects and accomplishments of its
discretionary grant programs which are consistent with OMB guidance.
CMHS has increased the number of questions in the instrument to
satisfy reporting needs. The following paragraphs present a description
of the changes made to the information collection. These questions will
be contained in new sections in the Services tool.
Violence and Trauma--CMHS proposes to add the following 6 items in
a new section entitled ``Violence and Trauma''
1. Have you ever experienced violence or trauma in any setting
(including community or school violence; domestic violence;
physical, psychological, or sexual maltreatment/assault within or
outside of the family; natural disaster; terrorism; neglect; or
traumatic grief)? No, (skip to next section)
2. Did any of these experiences feel so frightening, horrible,
or upsetting that in the past and/or the present that you:
2a. Have had nightmares about it or thought about it when you
did not want to?
2b. Tried hard not to think about it or went out of your way to
avoid situations that remind you of it?
2c. Were constantly on guard, watchful, or easily startled?
2d. Felt numb and detached from others, activities, or your
surroundings?
3. In the past 30 days, how often have you been hit, kicked,
slapped, or otherwise physically hurt?
Experiences with Violence and Trauma--One of SAMHSA's 10
Strategic Initiatives is trauma and violence. In order to capture this
information, CMHS is adding six new questions to be asked of
respondents. This information will help in SAMHSA's overall goal of
reducing the behavioral health impacts of violence and trauma by
encouraging substance abuse treatment programs to focus on trauma-
informed services.
Military Family and Deployment--CMHS proposes to add the following
6 new items in a new section entitled ``Military Family and
Deployment''
1. Have you ever served in the Armed Forces, in the Reserves, or
the National Guard [select all that apply]? No, (Skip to 2)
1b. Are you currently on active duty in the Armed Forces, in the
Reserves, or the National Guard [select all that apply]?
1c. Have you ever been deployed to a combat zone?
2. Is anyone in your family or someone close to you on active
duty in the Armed Forces, in the Reserves, or the National Guard, or
separated or retired from Armed Forces, Reserves, or the National
Guard? No, (Skip to next section)
3. What is the relationship of that person (Service Member) to
you?
3b. Has the Service Member experienced any of the following
(check all that apply):
[cir] Deployed in support of Combat Operations (e.g. Iraq or
Afghanistan)
[cir] Was physically Injured during combat Operations
[cir] Developed combat stress symptoms/difficulties adjusting
following deployment, including PTSD, Depression, or suicidal
thoughts
[cir] Died or was killed
Veteran Family Status and Areas of Deployment--SAMHSA is
also interested in collecting data on active duty and veteran military
members. Collection of these data will allow CMHS to identify the
number of veterans served, deployment status and location, and family
veteran status in conjunction with the types of services they may
receive. Identifying a client's veteran status and deployment area
allows CMHS and the grantees to monitor these clients and explore
whether special services or programs are needed to treat them for
substance abuse and other related issues. Identification of veteran
status and other military family issues will also allow coordination
between SAMHSA and other Federal agencies in order to provide a full
range of services to veterans. CMHS will also be able to monitor their
outcomes and activities per the NOMS. The total annual burden estimate
is shown below:
Estimates of Annualized Hour Burden--CMHS Client Outcome Measures for Discretionary Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total hour Hourly wage Total hour
Type of response respondents respondent responses response burden cost cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Client-level baseline interview......... 15,681 1 15,681 0.48 7,527 $15 \1\ $112,905
Client-level 6-month reassessment 10,646 1 10,646 0.367 3,907 15 58,605
interview..............................
Client-level discharge interview \2\ 4,508 1 4,508 0.367 1,655 15 24,825
Client-level baseline chart abstraction. 2,352 1 2,352 0.1 235 15 3,525
Client-level reassessment chart 9,017 1 9,017 0.1 902 15 13,530
abstraction \3\........................
---------------------------------------------------------------------------------------------------------------
Client-level Subtotal \4\........... 15,681 .............. 15,681 .............. 14,226 15 213,390
[[Page 35002]]
Infrastructure development, prevention, 942 4 3,768 4 15,072 35 \5\ 527,520
and mental health promotion quarterly
record abstraction.....................
---------------------------------------------------------------------------------------------------------------
Total............................... 16,623 .............. .............. .............. 29,298 .............. 740,910
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Based on minimum wage.
\2\ Based on an estimate that it will be possible to conduct discharge interviews on 40 percent of those who leave the program.
\3\ Chart abstraction will be conducted on 100 percent of those discharged.
\4\ This is the maximum additional burden if all consumers complete the baseline and periodic reassessment interviews.
\5\ To be completed by grantee Project Directors, hence the higher hourly wage.
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 8-1099, 1 Choke Cherry Road, Rockville, MD 20857 or e-mail her a
copy at summer.king@samhsa.hhs.gov. Written comments should be received
within 60 days of this notice.
Dated: June 8, 2011.
Elaine Parry,
Director, Office of Management, Technology and Operations.
[FR Doc. 2011-14797 Filed 6-14-11; 8:45 am]
BILLING CODE 4162-20-P
